chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Ocular hyperaemia, Oral herpes, Pain, Paraesthesia oral
Clinical narrative: 4/2/21 Within 10 minutes Tingling at usual hsv1 site on upper lip right side,  flu like symptoms body aches .  4/16/23 started getting cold sore. 4/17/21 woke with swollen right side of  face, cold sore climbing up face larger and worse then ever before, red eye,  face pain. Went to urgent care 4/17/21 anti virals and prednisone prescribed. Felt better next day.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: 4/2/21 Within 10 minutes Tingling at usual hsv1 site on upper lip right side,  flu like symptoms body aches .  4/16/23 started getting cold sore. 4/17/21 woke with swollen right side of  face, cold sore climbing up face larger and worse then ever before, red eye,  face pain. Went to urgent care 4/17/21 anti virals and prednisone prescribed. Felt better next day.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy test, Pruritus, Rash
Clinical narrative: Rash resembling chicken pox which started about 2-3 weeks after vaccine and is ongoing.  Severe itching on trunk, torso, arms, legs, buttocks.  Several trips to MD and dermatologist. Rash is still present.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AE; pediatric doses were accidentally administered to adult patients; This spontaneous report was received from physician, referring to an adult patient of unknown gender.  The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 05-JUN-2023, the patient was vaccinated with a dose of pediatric doses of hepatitis a vaccine, inactivated (VAQTA) (incorrect dose administered) intramuscular injection, administered intramuscularly for prophylaxis (lot #W029899 which has been confirmed as a valid lot, expiry date was not provided but upon internal validation was verified as: 16-MAY-2024; dose, vaccination scheme, anatomical location and strength were not provided). No additional adverse event (AE) (no adverse event).  This is one of five cases received from the same reporter. ; Sender's Comments:  US-009507513-2312USA010325:02526665 US-009507513-2312USA010468:02526668 US-009507513-2312USA010683:02526670 US-009507513-2312USA010691:02526672
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed no symptoms or side effects reported. No additional AE/no PQC.; Physician called to report a T/E on PROQUAD and reported it was administered to one patient on 12/21/2023; This spontaneous report has been received from a physician, regarding a patient of unspecified age and gender. The patient's pertinent medical history, previous drug reactions or allergies were not reported.  On 21-DEC-2023, the patient was vaccinated with improperly storage doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, at a dose of 0.5 milliliters once as prophylaxis (lot number: X019301, which was determined to be valid, with an expiration date on 14-JAN-2025), in combination with sterile diluent (lot number: 1950610, which was determined to be valid, with an expiration date on 11-OCT-2025). (Product storage error).  The administered dose underwent a temperature excursion of 0.6 degrees Celsius (C) for 25 hours. No previous temperature excursions and confirmed no symptoms or side effects reported.  No additional information was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The nurse is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VARIVAX x017489  6/25/2025 Temperature 17.2F Time frame 50 Mi; The nurse is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VARIVAX x017489  6/25/2025 Temperature 17.2F Time frame 50 Mi; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant therapies were not reported.  On 27-DEC-2023, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 1 dose, lot# X017489; expiry date: 25-JUN-2025 as prophylaxis (route of administration was not provided) that was improperly stored, with a temperature excursion of 17.2 Fahrenheit for 50 minutes (product storage error). There were no previous temperature excursions. No additional adverse events reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The nurse is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) PROQUAD  x020566   2/3/2025 Temperature 17.2F Time frame 50 M; The nurse is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) PROQUAD  x020566   2/3/2025 Temperature 17.2F Time frame 50 M; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patients' concurrent conditions, medical history or concomitant therapies were not reported.  On 29-DEC-2023, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, recombinant Human albumin (rHA) status, 1 dose, lot# X020566; expiry date: 03-FEB-2025 as prophylaxis that was improperly stored, with a temperature excursion of 17.2 Fahrenheit for 50 minutes (product storage error). There were no previous temperature excursions. No additional adverse events reported.
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Developed atrial fibrillation; This serious, initial spontaneous safety report was received by Novavax on 29-DEC-2023 from a physician.  A female individual of an unspecified race and age was vaccinated with intramuscular Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter suspect COVID-19 vaccine unspecified dose on 18-NOV-2023.  No medical history was reported.  No concomitant medications were reported.  On an unspecified day in DEC-2023, about 4 weeks after vaccination, the individual developed atrial fibrillation (PT: Atrial fibrillation) (Serious: Medically Significant). The individual did not go to the hospital and treated herself.  At the time of reporting, the event outcome of Atrial fibrillation was unknown.  Lot number was not provided in the report.; Sender's Comments: This female of an unspecified age experienced: Atrial fibrillation after vaccination with Novavax Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter. The event Atrial fibrillation was assessed as serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) and the reported event is considered Possible.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram abdomen, Computerised tomogram thorax, Lung adenocarcinoma, Scan with contrast
Clinical narrative: Lung adenocarcinoma
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Erythema, Immediate post-injection reaction, Injection site pain
Clinical narrative: Patient states left arm sting during the shot, and within 12 hours redness spread through left arm on shot site. patient then reported develop cellulitis and was treated with antibiotics and prednisone
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Administration site pain, Injected limb mobility decreased, Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: Had RSV vaccine administered into left upper arm muscle. More painful than other vaccines I had received in the past. Some muscle pain at first and now muscle pain has been worsening with each day as well as more pain when moving my arm. My range of movement in my left arm is restricted because of pain while reaching up and also while reaching out to the side.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Pyrexia, SARS-CoV-2 test
Clinical narrative: Cough, fever
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site pain
Clinical narrative: fatigue; body aches; Soreness at injection site; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Pfizer / biontech, start date: 25Oct2023, stop date: 25Oct2023, notes: Dose Number: 1, Batch/Lot No: HG2649, Location of injection: Arm Right. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 25Oct2023, outcome "recovered" (28Oct2023), described as "Soreness at injection site"; FATIGUE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "body aches". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.  Batch/lot number is not provided, and it cannot be obtained.
Age: 62.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Arthralgia, Injection site pain, Product administered at inappropriate site
Clinical narrative: Patient reports that she believes injection was given to high - in reviewing placement over the phone, patient states that vaccination was within the space of three fingers from acromion process. Patient reports immunization injecton hurt and immediately noticed arm pain - that has progressed - making it difficult and painful to use left arm.
Age: 62.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient reports that she believes injection was given to high - in reviewing placement over the phone, patient states that vaccination was within the space of three fingers from acromion process. Patient reports immunization injecton hurt and immediately noticed arm pain - that has progressed - making it difficult and painful to use left arm.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: no report of symptoms from patient involved/No additional AE; improperly stored and administered PROQUAD/excursion occurred on 30-NOV-2023 and the PROQUAD involved was administered on 02-DEC-2023; This spontaneous report has been received from a physician and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not provided.  On 30-NOV-2023, a temperature excursion occurred, and on 02-DEC-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) injection 0.5 milliliter as prophylaxis, lot number X018729 has been verified to be valid, expiration date 06-JAN-2025 (route of administration and anatomical location of vaccination were not provided) (product storage error). The physician confirmed no report of medical concerns or symptoms from patient involved.
Sex: U
Vaccine: PNC15, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No side effects reported/No additional AE reported; HCP called to report T/E. HCP stated ROTATEQ and VAXNEUVANCE were administered on 26-DEC-2023.; This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not provided.  It was reported that a temperature excursion of 48.2 Fahrenheit (F) occurred during 1 hour and 32 minutes; and on 26-DEC-2023, the patient was vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally, as prophylaxis, lot number X010217 has been verified to be valid, expiration date 05-NOV-2024 (strength and dose were not provided); and with the second dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) 0.5 milliliter injection, lot number X022028 has been verified to be valid, expiration date 22-OCT-2025 (dose, route of administration and anatomical location of vaccination were not provided). Both vaccines were administered as prophylaxis (product storage error). There was no previous temperature excursion and no Data logger involved. No side effects were reported.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Appendicectomy, Appendicitis, Asthenia, Complicated appendicitis
Clinical narrative: Received Shingrix vaccine on Saturday, 10/28. Typical muscle soreness for a couple of days. Decreased energy level noted on a road bicycling ride the following day (much less energy than normal). In the early morning of 11/1, woke up with significant abdominal discomfort. By mid-morning, diagnosed with acute appendicitis and had surgery to remove it. Was told appendix and part of the cecum was necrotic.   Within 2 weeks after the vaccine, experiencing increased skin dryness and sensitivity on face/scalp. Rx obtained for thick moisturizing cream. Dryness persists and skin on face became inflamed and swollen - requiring another PCM visit and allergy meds, to include a medrol dose pack to address the swelling. Improved
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis, Dry skin, Gastrointestinal necrosis, Myalgia, Sensitive skin
Clinical narrative: Received Shingrix vaccine on Saturday, 10/28. Typical muscle soreness for a couple of days. Decreased energy level noted on a road bicycling ride the following day (much less energy than normal). In the early morning of 11/1, woke up with significant abdominal discomfort. By mid-morning, diagnosed with acute appendicitis and had surgery to remove it. Was told appendix and part of the cecum was necrotic.   Within 2 weeks after the vaccine, experiencing increased skin dryness and sensitivity on face/scalp. Rx obtained for thick moisturizing cream. Dryness persists and skin on face became inflamed and swollen - requiring another PCM visit and allergy meds, to include a medrol dose pack to address the swelling. Improved
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin swelling
Clinical narrative: Received Shingrix vaccine on Saturday, 10/28. Typical muscle soreness for a couple of days. Decreased energy level noted on a road bicycling ride the following day (much less energy than normal). In the early morning of 11/1, woke up with significant abdominal discomfort. By mid-morning, diagnosed with acute appendicitis and had surgery to remove it. Was told appendix and part of the cecum was necrotic.   Within 2 weeks after the vaccine, experiencing increased skin dryness and sensitivity on face/scalp. Rx obtained for thick moisturizing cream. Dryness persists and skin on face became inflamed and swollen - requiring another PCM visit and allergy meds, to include a medrol dose pack to address the swelling. Improved
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Headache, Hyperhidrosis, Injection site swelling, Injection site warmth
Clinical narrative: Day 1-2 a lot of swelling and heat on injection site. Day 3-current, a lot of sweating and flushing. Pt states he feels he has urinated himself. He is very thirsty and has headaches as well.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: Day 1-2 a lot of swelling and heat on injection site. Day 3-current, a lot of sweating and flushing. Pt states he feels he has urinated himself. He is very thirsty and has headaches as well.
Age: 55.0
Sex: M
Vaccine: UNK, UNK, UNK, UNK
Symptoms: Balance disorder, Burning sensation, Electric shock sensation, Facial paralysis, Hypoaesthesia
Clinical narrative: 10 days after the vaccine, I awoke with terrible vertigo. I vomited multiple times and went to the doctor the next day. They simply said that it could possibly be an adverse reaction to the vaccine. I had follow-up vaccines over the next year. During this period, I started to have numbness and weakness in my right hand, as well as subtle balance problems, and radiating pins and needles in different parts of my body. At the time, I didn't connect the symptoms to the vaccine. The symptoms began to get far worse by the summer of 2022, and really became excruciating by the winter of 2022, shortly after my 4th vaccine. I became overwhelmed by burning, pins and needles, and numbness radiating throughout my body, in my neck, head, arms, and legs. My balance was off, and my legs felt incredibly weak.   I also felt strange electrical shocks in my arms and in my legs. For the next six months, from December 2022 through April 2023, I was in a fog of numbness, pins and needles, electrical shocks, and burning sensations. Sometimes there would be numbness in my face and my mouth would droop. I have seen two neurologists, as well as spine specialists, who all have been baffled by my condition.  The spine center, as well as the neurologist I saw there, differentiated between the weakness in my right arm, claiming it was due to an ulnar nerve entrapment, but could not explain the other symptoms. A nerve test was done on my right arm in November 2022, but an entrapment could not be localized. Again, the other symptoms could not be explained and I was prescribed gabapentin. In March 2023, I went to hospital for a second opinion. I saw a neurologist, Dr., who also cannot explain my symptoms, but doubt it they were neurological. He ordered another nerve test on my right arm in April, but once again the ulnar nerve entrapment could not be localized. I was then referred to a nerve specialist, Dr.. She was concerned that the owner nerve entrapment could possibly be further up, an MRI of my brachial plexus. this did not offer any explanation and I was referred to Dr., a spine specialist. The symptoms didn't correlate in his mind either, so full nerve tests were done once again, but the owner nerve entrapment still could not be found. There has been no explanation for my burning, pins and needles, and numbness throughout my body over the past year and a half. Dr. has mentioned that it all seems to correlate with the period when I had my Covid vaccines, so there is some speculation they could be related.
Age: 55.0
Sex: M
Vaccine: UNK, UNK, UNK, UNK
Symptoms: Magnetic resonance imaging normal, Muscular weakness, Nerve conduction studies, Pain, Paraesthesia
Clinical narrative: 10 days after the vaccine, I awoke with terrible vertigo. I vomited multiple times and went to the doctor the next day. They simply said that it could possibly be an adverse reaction to the vaccine. I had follow-up vaccines over the next year. During this period, I started to have numbness and weakness in my right hand, as well as subtle balance problems, and radiating pins and needles in different parts of my body. At the time, I didn't connect the symptoms to the vaccine. The symptoms began to get far worse by the summer of 2022, and really became excruciating by the winter of 2022, shortly after my 4th vaccine. I became overwhelmed by burning, pins and needles, and numbness radiating throughout my body, in my neck, head, arms, and legs. My balance was off, and my legs felt incredibly weak.   I also felt strange electrical shocks in my arms and in my legs. For the next six months, from December 2022 through April 2023, I was in a fog of numbness, pins and needles, electrical shocks, and burning sensations. Sometimes there would be numbness in my face and my mouth would droop. I have seen two neurologists, as well as spine specialists, who all have been baffled by my condition.  The spine center, as well as the neurologist I saw there, differentiated between the weakness in my right arm, claiming it was due to an ulnar nerve entrapment, but could not explain the other symptoms. A nerve test was done on my right arm in November 2022, but an entrapment could not be localized. Again, the other symptoms could not be explained and I was prescribed gabapentin. In March 2023, I went to hospital for a second opinion. I saw a neurologist, Dr., who also cannot explain my symptoms, but doubt it they were neurological. He ordered another nerve test on my right arm in April, but once again the ulnar nerve entrapment could not be localized. I was then referred to a nerve specialist, Dr.. She was concerned that the owner nerve entrapment could possibly be further up, an MRI of my brachial plexus. this did not offer any explanation and I was referred to Dr., a spine specialist. The symptoms didn't correlate in his mind either, so full nerve tests were done once again, but the owner nerve entrapment still could not be found. There has been no explanation for my burning, pins and needles, and numbness throughout my body over the past year and a half. Dr. has mentioned that it all seems to correlate with the period when I had my Covid vaccines, so there is some speculation they could be related.
Age: 55.0
Sex: M
Vaccine: UNK, UNK, UNK, UNK
Symptoms: Vertigo, Vomiting
Clinical narrative: 10 days after the vaccine, I awoke with terrible vertigo. I vomited multiple times and went to the doctor the next day. They simply said that it could possibly be an adverse reaction to the vaccine. I had follow-up vaccines over the next year. During this period, I started to have numbness and weakness in my right hand, as well as subtle balance problems, and radiating pins and needles in different parts of my body. At the time, I didn't connect the symptoms to the vaccine. The symptoms began to get far worse by the summer of 2022, and really became excruciating by the winter of 2022, shortly after my 4th vaccine. I became overwhelmed by burning, pins and needles, and numbness radiating throughout my body, in my neck, head, arms, and legs. My balance was off, and my legs felt incredibly weak.   I also felt strange electrical shocks in my arms and in my legs. For the next six months, from December 2022 through April 2023, I was in a fog of numbness, pins and needles, electrical shocks, and burning sensations. Sometimes there would be numbness in my face and my mouth would droop. I have seen two neurologists, as well as spine specialists, who all have been baffled by my condition.  The spine center, as well as the neurologist I saw there, differentiated between the weakness in my right arm, claiming it was due to an ulnar nerve entrapment, but could not explain the other symptoms. A nerve test was done on my right arm in November 2022, but an entrapment could not be localized. Again, the other symptoms could not be explained and I was prescribed gabapentin. In March 2023, I went to hospital for a second opinion. I saw a neurologist, Dr., who also cannot explain my symptoms, but doubt it they were neurological. He ordered another nerve test on my right arm in April, but once again the ulnar nerve entrapment could not be localized. I was then referred to a nerve specialist, Dr.. She was concerned that the owner nerve entrapment could possibly be further up, an MRI of my brachial plexus. this did not offer any explanation and I was referred to Dr., a spine specialist. The symptoms didn't correlate in his mind either, so full nerve tests were done once again, but the owner nerve entrapment still could not be found. There has been no explanation for my burning, pins and needles, and numbness throughout my body over the past year and a half. Dr. has mentioned that it all seems to correlate with the period when I had my Covid vaccines, so there is some speculation they could be related.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Tremor, Vomiting
Clinical narrative: Vomiting, shaking, and chills
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Sinus disorder
Clinical narrative: Sinus; she tested positive on Saturday, 23Dec2023; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (she tested positive on Saturday, 23Dec2023) and SINUS DISORDER (Sinus) in a 75-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 23-Dec-2023, the patient experienced COVID-19 (she tested positive on Saturday, 23Dec2023). On an unknown date, the patient experienced SINUS DISORDER (Sinus). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (she tested positive on Saturday, 23Dec2023) had not resolved and SINUS DISORDER (Sinus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2023, SARS-CoV-2 test: Positive. On 25-Dec-2023, Body temperature: ranging between 99 to 100.4.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       The concomitant medication was not reported by reporter.   On 22 Dec 2023 patient had sore throat, it was scratchy, and didn't feel well. On 25 Dec 2023 she had fever on and off and it was ranging from 99 to 100.4.  She had sinus, stuffy nose, runny nose and coughing also difficult breathing.  She took cough drops as a treatment medication.   This case was linked to US-MODERNATX, INC.-MOD-2024-755580 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-755580:Husband's case
Age: 78.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a physician called to inform that a 78-year-old patient had received a dose of Kinrix; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 78-year-old female patient who received DTPa-IPV (Kinrix) (batch number G9N2M) for prophylaxis.   On 07-AUG-2023, the patient received Kinrix. On 07-AUG-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a physician called to inform that a 78-year-old patient had received a dose of Kinrix). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-JAN-2024. The reporter called to inform that a 78 year old patient had received a dose of Kinrix. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. A 78 year old patient received Kinrix which led to inappropriate age at vaccine administration.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Chills, frontal lobe headache
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Gait inability, Laboratory test, Mobility decreased, Nervous system disorder
Clinical narrative: I felt like I was dying. I couldn't get up at a bed I was totally paralyzed. I still today. It affected my whole central nervous system couldn't walk. I do with this stuff on a daily basis now. I was
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Paralysis
Clinical narrative: I felt like I was dying. I couldn't get up at a bed I was totally paralyzed. I still today. It affected my whole central nervous system couldn't walk. I do with this stuff on a daily basis now. I was
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Wrong product administered
Clinical narrative: reports no symptoms to side effects; Expired Dose Administered; This spontaneous report was received from a licensed practical nurse (LPN) referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medications, historical drugs, pertinent medical history and drug reactions/allergies were not reported.  On 06-DEC-2023, the patient was inadvertently vaccinated with a single dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection (0.5ml/once, lot #W032494 was verified as a valid lot #, expiration date was reported and confirmed as 22-NOV-2023, strength, anatomical site of administration and route of administration were not provided) for prophylaxis by a health professional (expired product administered). The reporter (HCP) reported no symptoms to side effects/no further adverse event (AE) details (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; pediatric doses were accidentally administered to adult patients; This spontaneous report as received from a physician refers to a patient of unknown age and gender. On an unknown date, the patient was accidentally vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) (lot # W029899 exp date 16-MAY-2024) (dose and route not reported).   This is one of several reports received from the same source. ; Sender's Comments:  US-009507513-2312USA010778:02526670 US-009507513-2312USA010325: US-009507513-2312USA010468: US-009507513-2312USA010691:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; pediatric doses were accidentally administered to adult patients; This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 12-DEC-2023, the patient was accidentally vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) (lot # W029899 exp date 16-MAY-2024) (dose and route not reported).  This is one of several reports received from the same source. ; Sender's Comments:  US-009507513-2312USA010778:02526672 US-009507513-2312USA010683: US-009507513-2312USA010325: US-009507513-2312USA010468:
Age: 1.67
Sex: U
Vaccine: PNC15, PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: no patient symptoms have been reported/No additional AE; patient received 1 dose of VAXNEUVANCE after the product was involved in a temperature excursion; This spontaneous report has been received from a registered nurse and refers to a 20-month-old patient of unknown gender. Information regarding the patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On 27-DEC-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection, 1 dose, as prophylaxis (lot number X022026 has been verified to be valid, expiration date 22-OCT-2025 or lot number X022028 has been verified to be valid, expiration date 22-OCT-2025; the reporter was unable to confirm which lot number was administered) (route of administration and anatomical location of vaccination were not provided) after the vaccine being involved in a temperature excursion of 13.08 Celsius (C) degrees during 1 hour and 15 minutes (product storage error). There was no symptoms and no previous temperature excursion reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2312USA010665: US-009507513-2401USA000001: US-009507513-2401USA000041: US-009507513-2401USA000132: US-009507513-2401USA000129: US-009507513-2312USA010648: US-009507513-2312USA010641: US-009507513-2401USA000138: US-009507513-2401USA000104: US-009507513-2401USA000120: US-009507513-2401USA000110: US-009507513-2312USA010597: US-009507513-2312USA010785: US-009507513-2312USA010768: US-009507513-2312USA010711: US-009507513-2312USA010625:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; a patient who was inadvertently administered an improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant and referred to a patient with unknown age and gender. The patient's concurrent condition, concomitant medication, pertinent medical history and drug reactions/ allergies were not provided.  On an unknown date in 2023, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA])(PROQUAD) was improperly stored. Temperature and duration were minus 10.8 degree Celsius (C) / minus 14 degree C up to minus 10 degree C for 0 hours 23 minutes 0 seconds and 9 degree C to 25 degree C for 0 hours 20 minutes 0 seconds. On 20-DEC-2023, the patient was inadvertently vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (0.5 milliliter [mL]/dose, lot # X019302 has been verified to be a valid lot number, expiration date was reported as 14-JAN-2025, route and anatomical location were not provided) for prophylaxis (product storage error). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) supported to use within 3 months. There was no previous temperature excursion. No symptoms and additional adverse event (AE) were reported (No adverse event).
Sex: M
Vaccine: VARZOS
Symptoms: Lip swelling, Throat tightness, Urticaria
Clinical narrative: hives all over my body; Condition aggravated; swelling of my lips; minor tightness in my throat; This non-serious case was reported by a consumer and described the occurrence of hives in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of urticaria (On 10th July 2023, received first dose, for tolerance refer).   On 10-OCT-2023, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced hives (Verbatim: hives all over my body), condition aggravated (Verbatim: Condition aggravated), lip swelling (Verbatim: swelling of my lips) and throat tightness (Verbatim: minor tightness in my throat). The patient was treated with loratadine and fexofenadine. Rechallenge with Shingrix was positive. The outcome of the hives was not resolved and the outcome of the condition aggravated, lip swelling and throat tightness were not reported.   The reporter considered the hives, condition aggravated, lip swelling and throat tightness to be probably related to Shingrix.   The company considered the hives, condition aggravated, lip swelling and throat tightness to be probably related to Shingrix.   Linked case(s) involving the same patient:   Additional Information: RA Receipt Date: 31-DEC-2023 On 10th October 2023, patient received second vaccine shot not aware it was causing the hives.  The reaction became more severe.  The patient went back to his dermatologist on November 9th.  She increased his dosage of Loratadine to (4 per day) 2 in the AM and 2 in the PM supplemented with Fexofenadine around noon. She confirmed that it was highly probable that he was having a rare reaction to the vaccine.  He was still taking both medications having good days with little flare ups and bad days where he had swelling of my lips and minor tightness in his throat along with numerous flare ups over his body. The reporter did not consent to follow up.; Sender's Comments:  US-GSK-US2023181722:same reporter
Sex: F
Vaccine: TDAP
Symptoms: Product dispensing error
Clinical narrative: dispensing error was made on a patient regarding DTap and Tdap; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of drug dispensing error in a female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient did not received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced drug dispensing error (Verbatim: dispensing error was made on a patient regarding DTap and Tdap). The outcome of the drug dispensing error was unknown.   Additional Information: GSK receipt date: 02-JAN-2024 The Caller stated an dispensing error was made on a patient regarding DTap and Tdap and had questions about potential error, which led drug dispensing error.  No additional information provided regarding patient.  Follow-up not possible as no contact details provided.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Blood pressure increased, Cardiac flutter, Chest pain
Clinical narrative: It began with a very sore throat Sunday AM, also my tongue was swollen*,  later in the day  joints in my fingers on my right hand became painful and I could not bend them. *  Other side effects that I experienced:    Swelling of your face and throat. * A fast heartbeat.*  Dizziness and weakness.* Also Chest pain *, Feelings of having a fast-beating, fluttering, or pounding heart, * not actually Shortness of breath but congestion in chest and felt out of breath with exertion; also had elevated BP during this time.  I NEVER HAD ANY SIDE EFFECTS WITH THE PFIZER VACCINES AND WHEN I WENT TO PHARMACY ON SEPTEMBER 30, 2023 THE PHARMACIST ADVISED ME THAT PHARMACY HAD DECIDED TO ONLY ADMINISTER THE MODERNA VACCINE AND THIS WAS A NEW FORMULA BASED ON CHANGES IN COVID AND FORMULAS WERE THE SAME AND THERE WOULD NOT BE ANY DIFFERENCE AS THE OTHER VACCINES WERE ADNINISTERED A LONG TIME AGO,  THE LOT # ON MY CARD IS 3031279.  AFTER I BEGAN TO EXPEREINCE SYMPTOMS I CONTACTED PHARMACY BY PHONE AND WAS TOLD THAT PTS HAD BEEN EXPERIENCE SOME SIDE EFFECTS AND THEY SHOULD LIKLEY GO AWAY IN ABOUT 5 DAYS,  THEY DID NOT.  I WAS NEVER ADVISED ON THE POTENTIAL SIDE EFFECTS THAT I HAVE SUFFERED FOR ALMOST 3 MONTHS!!
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dizziness, Dyspnoea exertional, Electrocardiogram abnormal, Electrocardiogram ambulatory, Electrocardiogram normal
Clinical narrative: It began with a very sore throat Sunday AM, also my tongue was swollen*,  later in the day  joints in my fingers on my right hand became painful and I could not bend them. *  Other side effects that I experienced:    Swelling of your face and throat. * A fast heartbeat.*  Dizziness and weakness.* Also Chest pain *, Feelings of having a fast-beating, fluttering, or pounding heart, * not actually Shortness of breath but congestion in chest and felt out of breath with exertion; also had elevated BP during this time.  I NEVER HAD ANY SIDE EFFECTS WITH THE PFIZER VACCINES AND WHEN I WENT TO PHARMACY ON SEPTEMBER 30, 2023 THE PHARMACIST ADVISED ME THAT PHARMACY HAD DECIDED TO ONLY ADMINISTER THE MODERNA VACCINE AND THIS WAS A NEW FORMULA BASED ON CHANGES IN COVID AND FORMULAS WERE THE SAME AND THERE WOULD NOT BE ANY DIFFERENCE AS THE OTHER VACCINES WERE ADNINISTERED A LONG TIME AGO,  THE LOT # ON MY CARD IS 3031279.  AFTER I BEGAN TO EXPEREINCE SYMPTOMS I CONTACTED PHARMACY BY PHONE AND WAS TOLD THAT PTS HAD BEEN EXPERIENCE SOME SIDE EFFECTS AND THEY SHOULD LIKLEY GO AWAY IN ABOUT 5 DAYS,  THEY DID NOT.  I WAS NEVER ADVISED ON THE POTENTIAL SIDE EFFECTS THAT I HAVE SUFFERED FOR ALMOST 3 MONTHS!!
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Heart rate increased, Mobility decreased, Oropharyngeal pain, Palpitations, Pharyngeal swelling
Clinical narrative: It began with a very sore throat Sunday AM, also my tongue was swollen*,  later in the day  joints in my fingers on my right hand became painful and I could not bend them. *  Other side effects that I experienced:    Swelling of your face and throat. * A fast heartbeat.*  Dizziness and weakness.* Also Chest pain *, Feelings of having a fast-beating, fluttering, or pounding heart, * not actually Shortness of breath but congestion in chest and felt out of breath with exertion; also had elevated BP during this time.  I NEVER HAD ANY SIDE EFFECTS WITH THE PFIZER VACCINES AND WHEN I WENT TO PHARMACY ON SEPTEMBER 30, 2023 THE PHARMACIST ADVISED ME THAT PHARMACY HAD DECIDED TO ONLY ADMINISTER THE MODERNA VACCINE AND THIS WAS A NEW FORMULA BASED ON CHANGES IN COVID AND FORMULAS WERE THE SAME AND THERE WOULD NOT BE ANY DIFFERENCE AS THE OTHER VACCINES WERE ADNINISTERED A LONG TIME AGO,  THE LOT # ON MY CARD IS 3031279.  AFTER I BEGAN TO EXPEREINCE SYMPTOMS I CONTACTED PHARMACY BY PHONE AND WAS TOLD THAT PTS HAD BEEN EXPERIENCE SOME SIDE EFFECTS AND THEY SHOULD LIKLEY GO AWAY IN ABOUT 5 DAYS,  THEY DID NOT.  I WAS NEVER ADVISED ON THE POTENTIAL SIDE EFFECTS THAT I HAVE SUFFERED FOR ALMOST 3 MONTHS!!
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Respiratory tract congestion, Supraventricular extrasystoles, Swelling face, Swollen tongue
Clinical narrative: It began with a very sore throat Sunday AM, also my tongue was swollen*,  later in the day  joints in my fingers on my right hand became painful and I could not bend them. *  Other side effects that I experienced:    Swelling of your face and throat. * A fast heartbeat.*  Dizziness and weakness.* Also Chest pain *, Feelings of having a fast-beating, fluttering, or pounding heart, * not actually Shortness of breath but congestion in chest and felt out of breath with exertion; also had elevated BP during this time.  I NEVER HAD ANY SIDE EFFECTS WITH THE PFIZER VACCINES AND WHEN I WENT TO PHARMACY ON SEPTEMBER 30, 2023 THE PHARMACIST ADVISED ME THAT PHARMACY HAD DECIDED TO ONLY ADMINISTER THE MODERNA VACCINE AND THIS WAS A NEW FORMULA BASED ON CHANGES IN COVID AND FORMULAS WERE THE SAME AND THERE WOULD NOT BE ANY DIFFERENCE AS THE OTHER VACCINES WERE ADNINISTERED A LONG TIME AGO,  THE LOT # ON MY CARD IS 3031279.  AFTER I BEGAN TO EXPEREINCE SYMPTOMS I CONTACTED PHARMACY BY PHONE AND WAS TOLD THAT PTS HAD BEEN EXPERIENCE SOME SIDE EFFECTS AND THEY SHOULD LIKLEY GO AWAY IN ABOUT 5 DAYS,  THEY DID NOT.  I WAS NEVER ADVISED ON THE POTENTIAL SIDE EFFECTS THAT I HAVE SUFFERED FOR ALMOST 3 MONTHS!!
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site rash, Injection site warmth, Rash erythematous, Rash papular
Clinical narrative: rash at injection site - red, raised, warm, and firm to the touch. did not react to Benadryl. went away an appx. 48 hrs
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Urticaria
Clinical narrative: Ongoing Hives
Age: 3.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Redness and Swelling on R Deltoid at injections site approx. 3in in length and width. Tenderness to palpation to area as well Firm to touch.
Age: 81.0
Sex: F
Vaccine: FLUA4
Symptoms: Asthenia, Blood pressure increased, Chills, Cough, Pyrexia
Clinical narrative: 09.09.2023 (24 hrs post injection) Chills and fever (100.7); 09.10.2023 chills and fever (101) ; 09.11.2023 fever (99.2).  Energy level very low, continued for weeks.  OTC Vick's Niquel - HBP; Vicks Sinex Severe Ultra Fine Mist.  Severe cough; sinus congestion.  My BP level elevated: monitoring daily.
Age: 81.0
Sex: F
Vaccine: FLUA4
Symptoms: Sinus congestion
Clinical narrative: 09.09.2023 (24 hrs post injection) Chills and fever (100.7); 09.10.2023 chills and fever (101) ; 09.11.2023 fever (99.2).  Energy level very low, continued for weeks.  OTC Vick's Niquel - HBP; Vicks Sinex Severe Ultra Fine Mist.  Severe cough; sinus congestion.  My BP level elevated: monitoring daily.
Age: 74.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: COVID-19
Clinical narrative: hospitalized with COVID
Age: 74.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with COVID
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discomfort, Injection site erythema, Injection site oedema, Injection site pruritus, Injection site swelling
Clinical narrative: Had flu vaccine here 1/2/2024 in left arm Since then, has developed warmth, swelling and discomfort in that area. Also, itchy at times. no fever no achiness no other symptoms.  has full range of motion. left upper outer arm with a local reaction to the flu vaccine - erythema, edema over muscle. FROM; able to palpate without discomfort
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Local reaction
Clinical narrative: Had flu vaccine here 1/2/2024 in left arm Since then, has developed warmth, swelling and discomfort in that area. Also, itchy at times. no fever no achiness no other symptoms.  has full range of motion. left upper outer arm with a local reaction to the flu vaccine - erythema, edema over muscle. FROM; able to palpate without discomfort
Age: 67.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Back pain, Musculoskeletal chest pain, Rash
Clinical narrative: 7-10 days after I had back pain and pain up under the ribcage. I thought it was my kidney. I called pharmacy about the steroid I was on due to the poison ivy I had. They didn't give me any good advice. The pain persisted and I took Tylenol and Advil. A few days and I had a rash on my back that wrapped around to the front up under my ribcage. I did my research and I am sure it is shingles. It's been 2-4 weeks.
Age: 67.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Herpes zoster
Clinical narrative: 7-10 days after I had back pain and pain up under the ribcage. I thought it was my kidney. I called pharmacy about the steroid I was on due to the poison ivy I had. They didn't give me any good advice. The pain persisted and I took Tylenol and Advil. A few days and I had a rash on my back that wrapped around to the front up under my ribcage. I did my research and I am sure it is shingles. It's been 2-4 weeks.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Pharyngeal swelling, Sensation of foreign body
Clinical narrative: My throat, where I swallow, felt swollen. I felt a lump when I swallowed, and it affected my speech. My left upper arm had a large, itchy, reddish welt.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Speech disorder, Urticaria
Clinical narrative: My throat, where I swallow, felt swollen. I felt a lump when I swallowed, and it affected my speech. My left upper arm had a large, itchy, reddish welt.
Age: 1.75
Sex: F
Vaccine: DTPPVHBHPB, HEPA, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: At this time I do not know of any adverse reaction.  I have tried calling the mother, but her phone is disconnected.  I have sent a letter for her to call me at the Health Department.  On 12-21-2023 mom brought the patient in for a  appointment and stated she is not up to date on vaccines.  I asked her if she would like for me to give her the vaccines.  She stated yes.  I asked for help pulling the vaccines from another nurse RN.  Nurse assisted in pulling the vaccines, between the 2 of use we pulled MMRV instead of MMR.  Therefore, the patient received 2 Varicella vaccines.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: patient was homebound and the RN who provided care administered peditric formula vs the 12 and older  formula
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Electromyogram normal, Insurance issue, Muscular weakness, Nerve conduction studies normal
Clinical narrative: The morning after the vaccination, Patient woke up with pain and weakness in the left shoulder and arm. This has persisted with varying degrees of intensity since then. He has been treated with a steroid dosepack x2, naproxen, and gabapentin 300 mg HS. He started PT which has been interrupted due to denial of his workmen's compensation.  EMG/NCS are unremarkable.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: The morning after the vaccination, Patient woke up with pain and weakness in the left shoulder and arm. This has persisted with varying degrees of intensity since then. He has been treated with a steroid dosepack x2, naproxen, and gabapentin 300 mg HS. He started PT which has been interrupted due to denial of his workmen's compensation.  EMG/NCS are unremarkable.