chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: TDAP, TDAP, MNQ
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient did not show any signs of adverse event for the first minute, but when exiting the vaccine room they felt light headed and fell over, landing on their shoulder. The patient's father and I tended to him and he responded after a few seconds with some confusion. Emergency services were called immediately and the Nurse Practitioner from the Clinic came to help as well. EMT's showed up very soon and took the patient to the hospital.
Age: 16.0
Sex: M
Vaccine: TDAP, TDAP, MNQ
Symptoms: Confusional state, Dizziness, Fall, Limb injury, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient did not show any signs of adverse event for the first minute, but when exiting the vaccine room they felt light headed and fell over, landing on their shoulder. The patient's father and I tended to him and he responded after a few seconds with some confusion. Emergency services were called immediately and the Nurse Practitioner from the Clinic came to help as well. EMT's showed up very soon and took the patient to the hospital.
Age: 16.0
Sex: M
Vaccine: TDAP, TDAP, MNQ
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient did not show any signs of adverse event for the first minute, but when exiting the vaccine room they felt light headed and fell over, landing on their shoulder. The patient's father and I tended to him and he responded after a few seconds with some confusion. Emergency services were called immediately and the Nurse Practitioner from the Clinic came to help as well. EMT's showed up very soon and took the patient to the hospital.
Age: 16.0
Sex: M
Vaccine: TDAP, TDAP, MNQ
Symptoms: Asthenia, Dizziness, Flushing, Hyperhidrosis, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient did not show any signs of adverse event for the first minute, but when exiting the vaccine room they felt light headed and fell over, landing on their shoulder. The patient's father and I tended to him and he responded after a few seconds with some confusion. Emergency services were called immediately and the Nurse Practitioner from the Clinic came to help as well. EMT's showed up very soon and took the patient to the hospital.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in arms, fingers legs and feet
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: symptoms lasting 4 days of stomach upset, sore arm, headache, shivering, mild fever, For stomach treatment, took Gas-x and IBGuard. for sore arm, mild fever, headache took Advil
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Medium
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Headache-Medium, Systemic: Unable to Sleep-Severe, Systemic: Weakness-Severe, Additional Details: Started about 9 hours after and lasted about 12-14 hours and the arm is still sore.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Lethargy, Pain, Pain in extremity, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Headache-Medium, Systemic: Unable to Sleep-Severe, Systemic: Weakness-Severe, Additional Details: Started about 9 hours after and lasted about 12-14 hours and the arm is still sore.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Cold sweat, Dizziness, Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Around 1310, I had just exited the clinic and found that patient was sitting in the waiting room chair with mother by her side. Patient looked pale and clammy and was slow to respond. I immediately went to get my gloves, blood pressure cuff, stethoscope, and pulse ox. I then assisted the patient to lay on the floor also assisted by her mother. Feet elevated with chair. Immediately, patient's face color came back to pink and patient was able to speak to me when I asked questions. Blood pressure t
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Chest pain, Immediate post-injection reaction, Infection, Intensive care
Clinical narrative: I was previously healthy and had no serious health problems besides common seasonal allergies. I started having problems immediately after receiving the COVID vaccine, which included rash, chest pain, swollen lymph nodes in breast area and arm pits.  6 months later I was hospitalized for sepsis and sinus infection, I was in ICU for 4 days and was told by several physicians that I could have died due to the severity of the infection. Then recently I was hospitalized again for Bell's Palsy.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash, Sepsis, Sinusitis
Clinical narrative: I was previously healthy and had no serious health problems besides common seasonal allergies. I started having problems immediately after receiving the COVID vaccine, which included rash, chest pain, swollen lymph nodes in breast area and arm pits.  6 months later I was hospitalized for sepsis and sinus infection, I was in ICU for 4 days and was told by several physicians that I could have died due to the severity of the infection. Then recently I was hospitalized again for Bell's Palsy.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Sleep disorder
Clinical narrative: continuing pain in left arm muscle between shoulder and elbow; less pain when standing; pain keeps patient awake at night when lying down
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Laboratory test normal
Clinical narrative: Joint pains that still persist over 2 years later
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Arthralgia, Deep vein thrombosis, Muscle spasms, Muscular weakness
Clinical narrative: DVT Right femoral vein on left leg. Blood clot behind left knee in popliteal vein that wont go away.  Was on blood thinners. Then put on  blood thinners again after appearance of clot behind the knee. Possible new blood clot having another ultrasound this week. Been 2 years off and on blood thinners. Never had this until the covid vaccine. Left arm will hurt, left elbow pain and shoulder. Left arm feels weaker.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Thrombosis, Ultrasound Doppler abnormal
Clinical narrative: DVT Right femoral vein on left leg. Blood clot behind left knee in popliteal vein that wont go away.  Was on blood thinners. Then put on  blood thinners again after appearance of clot behind the knee. Possible new blood clot having another ultrasound this week. Been 2 years off and on blood thinners. Never had this until the covid vaccine. Left arm will hurt, left elbow pain and shoulder. Left arm feels weaker.
Age: 55.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Joint lock, Trigger finger, X-ray
Clinical narrative: In the middle of the night after my vaccine, my left thumb started to lock into place. I saw a doctor on 3/22/2023 who suspected trigger finger and ordered an x-ray, and made a referral to occupational therapy for assessment. I attended 5 OT appointments for the thumb until I could see the hand specialist. Trigger thumb was confirmed. On 5/8/2023 at my appointment with the hand specialist, I received a cortisone injection in the thumb. On 5/23/2023 I had my final OT appointment, with much improvement in my thumb. After the vaccine I did have joint pain in ankles, knees, elbows for about 5-6 days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Redness and swelling to left arm around site of injection starting the evening after vaccine received. Fevers, and pain associated
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: swelling and pain at injection site.
Age: 33.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Chest X-ray, Chills, Colitis, Computerised tomogram abdomen
Clinical narrative: fever, chills, hallucinations, severe shaking, severe diarrhea, abdominal pain and rectal bleeding.   I was hospitalized in April for the side effects. it destroyed my colon and increased my inflammation. my immune system went completely haywire.
Age: 33.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Electrocardiogram, Hallucination, Immune system disorder, Pyrexia
Clinical narrative: fever, chills, hallucinations, severe shaking, severe diarrhea, abdominal pain and rectal bleeding.   I was hospitalized in April for the side effects. it destroyed my colon and increased my inflammation. my immune system went completely haywire.
Age: 33.0
Sex: F
Vaccine: VARZOS
Symptoms: Rectal haemorrhage, Tremor
Clinical narrative: fever, chills, hallucinations, severe shaking, severe diarrhea, abdominal pain and rectal bleeding.   I was hospitalized in April for the side effects. it destroyed my colon and increased my inflammation. my immune system went completely haywire.
Age: 78.0
Sex: F
Vaccine: PNC20, TDAP, VARZOS
Symptoms: Mobility decreased, Neck pain, Peripheral swelling, Pyrexia, Swelling
Clinical narrative: patient developed fever severe swelling in left arm spreading up through neck  very painful in her neck and she states she cant turn her head
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: COVID-19 BIVALENT Pediatric dose not reconstituted 0.2ml administered to Left Deltoid. Patient tolerated procedure well.  No adverse events noted at time medication administration Message left on child's parent's voice mail to call The Clinic.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient reports she is still experiencing soreness in her right arm.
Age: 19.0
Sex: F
Vaccine: HEPAB, MMR, UNK, UNK, UNK, UNK
Symptoms: Autoimmune disorder, Gene mutation identification test positive, Heavy metal test, Immune system disorder, Inflammation
Clinical narrative: Ever since being vaccinated, I have suffered from chronic urticaria , brought on by temperature change  and chronic inflammation throughout entire body. I am currently being seen by a naturopathic doctor to treat my symptoms and it is believed that I am suffering from an autoimmune disorder due to my immune system being overloaded from my vaccinations.
Age: 19.0
Sex: F
Vaccine: HEPAB, MMR, UNK, UNK, UNK, UNK
Symptoms: Methylenetetrahydrofolate reductase gene mutation, Temperature intolerance, Toxicologic test, Urticaria chronic
Clinical narrative: Ever since being vaccinated, I have suffered from chronic urticaria , brought on by temperature change  and chronic inflammation throughout entire body. I am currently being seen by a naturopathic doctor to treat my symptoms and it is believed that I am suffering from an autoimmune disorder due to my immune system being overloaded from my vaccinations.
Age: 21.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site pain, Injection site pruritus, Pyrexia
Clinical narrative: injection site pain and itchy feeling, fever
Age: 19.0
Sex: F
Vaccine: HEPAB, MMR
Symptoms: Autoimmune disorder, Gene mutation identification test positive, Heavy metal test, Immune system disorder, Inflammation
Clinical narrative: Ever since being vaccinated, I have suffered from chronic urticaria , brought on by temperature change  and chronic inflammation throughout entire body. I am currently being seen by a naturopathic doctor to treat my symptoms and it is believed that I am suffering from an autoimmune disorder due to my immune system being overloaded from my vaccinations.
Age: 19.0
Sex: F
Vaccine: HEPAB, MMR
Symptoms: Methylenetetrahydrofolate reductase gene mutation, Temperature intolerance, Toxicologic test, Urticaria chronic
Clinical narrative: Ever since being vaccinated, I have suffered from chronic urticaria , brought on by temperature change  and chronic inflammation throughout entire body. I am currently being seen by a naturopathic doctor to treat my symptoms and it is believed that I am suffering from an autoimmune disorder due to my immune system being overloaded from my vaccinations.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Diarrhea, abdominal cramps,
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin, Eczema
Clinical narrative: Spongiotic Dermatitis on arms, chest, face, neck, inner ears,  inner nostrils, back of neck, scalp, and armpits.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Pain
Clinical narrative: I am internal medicine physician.   This vaccine reaction was unacceptible.   Within 3 hours and had 4/10 pain in my lower deltoid and by that night there was redness that was 10cm and lasted 4 days - slowly subsiding.   But worst symtpoms were onset of fatigue, diffuse aching and a sense of fever but T 99-100 and that lasted 36 hours requiring Tylenol every eight hours to manage the symptoms.    This vaccine side effect is just unacceptable.      I read that the GSK liposome with SA21 is likely cause of the reactiveness of this vaccine and this was moderately severe  reaction to me.  I will not take this vaccine again and you should consider suspending this until modifications in the SA21 are made.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Pruritus, Scab, Scar, Urticaria
Clinical narrative: I have had large hives - urticaria -- since my January 11, 2022 booster.  I thought I would wait to report them until they subsided, and now,  more than a year later,  they are almost gone.   At first I had them all over the the back of my shoulders and neck,  and my upper arms,  with a few on my chest,  and a few on my thighs.  Now I have just a few on my shoulders,  two on my right thigh,  and one on my right upper arm.  They manifest first as large hard lumps,  then become very itchy,  then the tops open and bleed,  then scab over and take a very long time to go away,  often leaving hard scar tissue behind.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Wound, Wound haemorrhage
Clinical narrative: I have had large hives - urticaria -- since my January 11, 2022 booster.  I thought I would wait to report them until they subsided, and now,  more than a year later,  they are almost gone.   At first I had them all over the the back of my shoulders and neck,  and my upper arms,  with a few on my chest,  and a few on my thighs.  Now I have just a few on my shoulders,  two on my right thigh,  and one on my right upper arm.  They manifest first as large hard lumps,  then become very itchy,  then the tops open and bleed,  then scab over and take a very long time to go away,  often leaving hard scar tissue behind.
Sex: U
Vaccine: HEP, IPV, TDAP, VARCEL, VARCEL
Symptoms: Expired product administered
Clinical narrative: the patient did not experience any other adverse event.; Caller reported an AE for VARIVAX. The caller said the patient received an expired dose of VARIVAX on 4/26/2023.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 26-APR-2023, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dose (valid lot number U012222 [expiration date 16-APR-2023]) (dose, frequency, vaccination scheme, route of administration, and anatomical location, lot number and expiration date were not provided) administered for prophylaxis (Expired product administered). The patient did not experience any other adverse event.
Sex: U
Vaccine: HEP, IPV, TDAP, VARCEL, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: the patient did not experience any other adverse event.; Caller reported an AE for VARIVAX. The caller said the patient received an expired dose of VARIVAX on 4/26/2023.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 26-APR-2023, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dose (valid lot number U012222 [expiration date 16-APR-2023]) (dose, frequency, vaccination scheme, route of administration, and anatomical location, lot number and expiration date were not provided) administered for prophylaxis (Expired product administered). The patient did not experience any other adverse event.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AEs; ROTATEQ was administered on 16MAY2023 after the temperature excursion.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 16-MAY-2023, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 time dose, lot #1938950, expiration date: 31-MAR-2024, administered orrally for prophylaxis (strength and dose were not provided) (Product storage error). It was reported that this vaccine underwent the temperature excursion at 1.8C for 0 hours 9 minutes and 0 seconds, 1.3C for 1 hour 12 minutes and 0 seconds, 1.2C for 1 hour 58 minutes and 0 seconds. There was no previous temperature excursion. No other AEs (No adverse event).  This is one of five reports received from the same reporter.; Sender's Comments:  US-009507513-2305USA006001: US-009507513-2305USA005987: US-009507513-2305USA005974: US-009507513-2305USA005810:
Age: 57.0
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: No additional AE; patient missed dose 2 on 2-OCT-2022 and dose 3 on MARCH 2023 (unspecified day).; patient missed dose 2 on 2-OCT-2022; This spontaneous report was received from a pharmacy technician referring to a 57-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported.  On 02-SEP-2022, the patient was vaccinated with the first dose (reported as dose 1) of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection (strength, dose, lot#, expiration date, route and anatomical location were unknown) for prophylaxis.  On 02-OCT-2022, the patient missed dose 2 of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (product dose omission issue), and the patient missed dose 3 on an unspecified date in March 2023 (product dose omission issue). No side effects or symptomatic events was reported. No additional adverse event (AE) (no adverse event). The patient called HCP office to inquire about getting vaccine. The reporter called to request information on alternate dosing schedule for hepatitis b vaccine (recombinant) (RECOMBIVAX HB) and whether to restart series or were extra doses required.
Age: 15.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient had no adverse reactions; administered a dose of PROQUAD on 5/3/23 instead of the MMR and Varicella separately; This spontaneous report was received from a nurse referring to a 15-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported.  On 03-MAY-2023, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter (mL) injection (0.5 mL (also reported as 1 dose), lot#, expiration date, and anatomical location were unknown) subcutaneously (SQ), instead of the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacture unknown) injection and varicella virus vaccine live (oka/merck) (manufacture unknown) injection separately (all for prophylaxis) (wrong product administered). The patient had no adverse reactions (no adverse event). No other information was provided or known by reporter. No PQC was reported.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No adverse effects reported.; Medical assistant calling to report MMRII administered to patient after TE occurred.; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 22-MAY-2023, the patient was vaccinated with an improperly storage measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, therapy type: rHA, valid lot #W021191, expiration date: 29-MAR-2024, administered for prophylaxis (strength, anatomical location and route of administration were not provided). Temperature excursion was reported as 73 Fahrenheit (F) for 51 hours and 30 minutes. No previous temperature excursion was reported. No additional adverse event was reported.  This is one several reports from the same reporter.; Sender's Comments:  US-009507513-2305USA008554: US-009507513-2305USA008288: US-009507513-2305USA008329:
Age: 11.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Wrong product administered
Clinical narrative: patient was supposed to receive the Menactra vaccine, but instead was given Trumenba with reported no adverse event; Initial information received on 23-May-2023 regarding an unsolicited valid non-serious courtesy case received from  Pfizer via other health professional (nurse).  This case involves a 11 years old male patient who was supposed to receive the Meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] vaccine, but instead was given Meningococcal Vaccine B RFHBPA/FHBPB [Trumenba] with reported no adverse event.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On 19-May-2023, the patient was supposed to receive the menactra vaccine, but instead was given trumenba with unknown formulation, strength, batch number & expiry date for prophylactic vaccination with reported no adverse event (wrong product administered) (unknown latency).  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  Action taken: not applicable.  At time of reporting, the outcome was Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Penile swelling
Clinical narrative: My wiener grew to 3 times it's normal size.  Left untreated, as my partners found it very enjoyable.  No other complications.  Wiener stabilized.  It's a feature, not a bug.
Age: 9.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abnormal behaviour, Decreased appetite, Discomfort, Dyskinesia, Fatigue
Clinical narrative: Patient awoke writhing and grunting in apparent extreme pain; she thrashed in bed and indicated arm pain. This behavior has never before been seen in the patient. No fever. Was given 5mg acetaminophen in liquid suspension ("Little Remedies" brand) and was moved into parent's bed for comfort and overnight observation. Patient showed improvement with some apparent discomfort through the night; she awoke markedly improved the following morning, though tired and sluggish, and had no appetite until 5PM that evening. Now, 24 hours later, she appears back to normal.
Age: 9.0
Sex: F
Vaccine: COVID19-2
Symptoms: Grunting, Pain, Pain in extremity, Sluggishness
Clinical narrative: Patient awoke writhing and grunting in apparent extreme pain; she thrashed in bed and indicated arm pain. This behavior has never before been seen in the patient. No fever. Was given 5mg acetaminophen in liquid suspension ("Little Remedies" brand) and was moved into parent's bed for comfort and overnight observation. Patient showed improvement with some apparent discomfort through the night; she awoke markedly improved the following morning, though tired and sluggish, and had no appetite until 5PM that evening. Now, 24 hours later, she appears back to normal.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Atrial fibrillation, ongoing since vaccination.
Age: 57.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Asthenia, Contusion, Headache, Injection site pain
Clinical narrative: generally not feeling well, joint pain in every joint, wicked headache,100.2 temp (normally 96.8) injection sight painful, 2 day lates visible bruising and red rash in a 4 " diameter, very low energy
Age: 57.0
Sex: M
Vaccine: UNK
Symptoms: Malaise
Clinical narrative: generally not feeling well, joint pain in every joint, wicked headache,100.2 temp (normally 96.8) injection sight painful, 2 day lates visible bruising and red rash in a 4 " diameter, very low energy
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial).    Concomitant medication was not reported.  Patient age was between 6 months to 5-years.  The vaccination clinic received incorrect guidance from the Department of Health in regard to the vaccination, who instructed to order and administer the vials with pink top to 6month-5year previously unvaccinated patients when the switch from monovalent to bivalent happened. This resulted in 24 patients being under vaccinated.  It was reported that 24 pediatric patients were administered underdose bivalent vaccine doses for either their first or second doses. They received 0.2 ml dose from the pink vial instead of the 0.25 ml dose from the blue cap vial. The patients were being contacted and revaccinated with the correct dose.  Treatment medication was not reported.  This case contains information for the 2nd of 24 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723339 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:master case
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Extra dose administered, No adverse event
Clinical narrative: No adverse event; Patient received vaccine 1 day past its use by date.; Patient received Moderna Covid-19 bivalent booster vaccine on 22-Sep-2022 and second bivalent moderna on 19-May-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine 1 day past its use by date.), EXTRA DOSE ADMINISTERED (Patient received Moderna Covid-19 bivalent booster vaccine on 22-Sep-2022 and second bivalent moderna on 19-May-2023) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 069H22A and AS7140C) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1, lot number 015M20A) on 16-Feb-2021, Moderna COVID-19 Vaccine (Dose 2, lot number 044A21A) on 16-Mar-2021, Moderna COVID-19 Vaccine (Dose 3, lot number 939903 , received in left arm) on 22-Oct-2021, Moderna COVID-19 Vaccine (Dose 4, lot number-335M21A expiration date 14-July-2022 and received in right arm) on 18-Apr-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.   On 22-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-May-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 19-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine 1 day past its use by date.) and EXTRA DOSE ADMINISTERED (Patient received Moderna Covid-19 bivalent booster vaccine on 22-Sep-2022 and second bivalent moderna on 19-May-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine 1 day past its use by date.), EXTRA DOSE ADMINISTERED (Patient received Moderna Covid-19 bivalent booster vaccine on 22-Sep-2022 and second bivalent moderna on 19-May-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received vaccine 1 day past its use by date.) and EXTRA DOSE ADMINISTERED (Patient received Moderna Covid-19 bivalent booster vaccine on 22-Sep-2022 and second bivalent moderna on 19-May-2023).    No concomitant information was reported. It was reported that no adverse reactions were reported. No treatment information was provided.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: patient mentions he can not move left arm and that pain radiates and some time get numbness; he also mention that he did a bad movement and does not know if pain if from the bad movement or vaccine
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Injection site pruritus, Pruritus, Psoriasis, Rash
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: itchy scalp flaky rough skin on elbow legs and stomach after the two vaccines were administered together-Medium, Additional Details: Pt reported after recieving shingles and covid vaccine together a month later in june and july she experience itchly flaky scalp on elbows, legs, and stomach and was diagnosied with psoriasis per dermatologists
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Skin exfoliation
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: itchy scalp flaky rough skin on elbow legs and stomach after the two vaccines were administered together-Medium, Additional Details: Pt reported after recieving shingles and covid vaccine together a month later in june and july she experience itchly flaky scalp on elbows, legs, and stomach and was diagnosied with psoriasis per dermatologists
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fever-Mild, Systemic: Headache-Medium.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fever-Mild, Systemic: Headache-Medium.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Fever-Medium, Systemic: Joint Pain-Severe, Systemic: Weakness-Severe, Additional Details: Patient experienced a reaction after receiving the shot. It was a delayed reaction and the patient reported severe pain and swelling to the injection area. Pain radiated throughout the arm and the arm was very hot. Patient went to see her primary care physician 6 days later due to the adverse effects that she experienced from the vaccination.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Skin warm
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Fever-Medium, Systemic: Joint Pain-Severe, Systemic: Weakness-Severe, Additional Details: Patient experienced a reaction after receiving the shot. It was a delayed reaction and the patient reported severe pain and swelling to the injection area. Pain radiated throughout the arm and the arm was very hot. Patient went to see her primary care physician 6 days later due to the adverse effects that she experienced from the vaccination.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: No adverse event
Clinical narrative: Patient received 2 mon. vaccines on Feb 8, 2022 and Feb. 24 2022. NO Adverse event/No treatment needed
Age: 1.92
Sex: M
Vaccine: HEPA
Symptoms: Cough, Sneezing, Urticaria
Clinical narrative: Coughing sneezing hives
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Asthenia, Drooling, Dysstasia, Gait inability, Grip strength decreased
Clinical narrative: My child cannot walk he cannot hold nothing he cannot stand he cannot crawl he cannot turn over he cannot do nothing for his self now it this short messed up his nerve system he cannot do nothing nothing he has to wear bib you have to feed him he cannot do nothing nothing what this shot did to my baby oh my God
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Inability to crawl, Laboratory test normal, Loss of personal independence in daily activities, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal
Clinical narrative: My child cannot walk he cannot hold nothing he cannot stand he cannot crawl he cannot turn over he cannot do nothing for his self now it this short messed up his nerve system he cannot do nothing nothing he has to wear bib you have to feed him he cannot do nothing nothing what this shot did to my baby oh my God
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Mobility decreased, Nervous system disorder, Sensory loss, Speech disorder
Clinical narrative: My child cannot walk he cannot hold nothing he cannot stand he cannot crawl he cannot turn over he cannot do nothing for his self now it this short messed up his nerve system he cannot do nothing nothing he has to wear bib you have to feed him he cannot do nothing nothing what this shot did to my baby oh my God
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Fever ranging from 100.3-101 F for 48 hours, followed by full body rash spreading from the trunk up to the neck and areas of the face.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic spontaneous urticaria
Clinical narrative: Chronic Spontaneous Urticaria lasting over 2 years
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cardiac arrest, Hyperhidrosis, Hypoaesthesia, Myocardial infarction
Clinical narrative: Heart attack - 5/22/2021; occurred at PRIVACY Hospital in PRIVACY after a bike ride and increasing symptoms of shoulder pain, profuse sweating, arm numbness
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Atrial fibrillation, Cardiac function test normal, Fibrin D dimer normal, Influenza virus test negative, Pyrexia
Clinical narrative: None stated.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: SARS-CoV-2 test negative, Troponin normal
Clinical narrative: None stated.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Blood creatine phosphokinase increased, Chromaturia, Feeling abnormal, Headache, Laboratory test abnormal
Clinical narrative: After receiving the flu vaccine. Pt. began to feel bad. He started with headache and then progressed to weakness in his extremities. Subsequently, he was hospitalized and diagnosed with Rhabdomyolysis. He had bilateral weakness of his extremities. He was hospitalized Thanksgiving Day for 5+ days at Medical Center.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Muscular weakness, Rhabdomyolysis
Clinical narrative: After receiving the flu vaccine. Pt. began to feel bad. He started with headache and then progressed to weakness in his extremities. Subsequently, he was hospitalized and diagnosed with Rhabdomyolysis. He had bilateral weakness of his extremities. He was hospitalized Thanksgiving Day for 5+ days at Medical Center.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus, beginning two months after injection. As of this date (05/31/23) same or slightly worse, both ears.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Autoimmune disorder, Blood test, Brain fog, Burning sensation
Clinical narrative: Red, hot swollen hands, knees and feet in all weather Finger joint stiffness/synovitis White and blue blanching numb/painful fingers in cold weather Feeling like I'm on fire on the inside Debilitating fatigue Extreme brain fog All over pain/deep muscle aches Feeling feverish
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cyanosis, Erythema, Erythromelalgia, Fatigue, Feeling hot
Clinical narrative: Red, hot swollen hands, knees and feet in all weather Finger joint stiffness/synovitis White and blue blanching numb/painful fingers in cold weather Feeling like I'm on fire on the inside Debilitating fatigue Extreme brain fog All over pain/deep muscle aches Feeling feverish
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Joint stiffness, Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: Red, hot swollen hands, knees and feet in all weather Finger joint stiffness/synovitis White and blue blanching numb/painful fingers in cold weather Feeling like I'm on fire on the inside Debilitating fatigue Extreme brain fog All over pain/deep muscle aches Feeling feverish
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pallor, Peripheral swelling, Raynaud's phenomenon, Synovitis
Clinical narrative: Red, hot swollen hands, knees and feet in all weather Finger joint stiffness/synovitis White and blue blanching numb/painful fingers in cold weather Feeling like I'm on fire on the inside Debilitating fatigue Extreme brain fog All over pain/deep muscle aches Feeling feverish
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Temperature intolerance, Ultrasound scan, X-ray
Clinical narrative: Red, hot swollen hands, knees and feet in all weather Finger joint stiffness/synovitis White and blue blanching numb/painful fingers in cold weather Feeling like I'm on fire on the inside Debilitating fatigue Extreme brain fog All over pain/deep muscle aches Feeling feverish
Age: 0.42
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: vaccine administered on 04-JAN-2002, 10-APR-2002, 07-JAN-2003; This spontaneous report has been received from a lawyer and physician, via a memo and medical records from a case in litigation for quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (2302USA008667), concerning a 9-month-old female patient. Her historical conditions included pharyngitis, gastroenteritis, viral syndrome, ear infections, allergic rhinitis, upper respiratory infection, abdominal pain and eczema. Family history of mixed hyperlipidemia. family history included: add/adhs (brother), fibromyalgia (maternal aunt), irritable bowel syndrome (mother and maternal grandmother), allergies (mother). Historical vaccines included: diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTaP), and pneumococcal conjugate vaccine, polio unspecified vaccine.  On 04-JAN-2002 the patient was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) (reported as Hep B, unspecified) (dose, route of vaccination, vaccination site, lot # and expiration date were not reported) for prophylaxis. On the same day, the pt was also vaccinated with diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTaP), haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) and pneumococcal conjugate vaccine.  On 10-APR-2002 and 07-JAN-2003, the patient was vaccinated with following doses of hepatitis b vaccine (recombinant) (manufacturer unknown) (reported as Hep B, unspecified) (dose, route of administration, vaccination site, lot # and expiration date were not provided) for prophylaxis (inappropriate schedule of product administration). On 07-JAN-2023, the patient was also vaccinated with diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTaP) and polio unspecified vaccine. Other vaccines included: quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL), hepatitis A vaccine, inactivated (VAQTA), measles vaccine, mumps vaccine, rubella vaccine (MMR), meningococcal vaccine b rfhbp/nada/nhba omv (BEXSERO), meningococcal vaccine a/c/y/w conj (DIP TOX) (MENACTRA), pneumococcal conjugate vaccine, polio unspecified vaccine, diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Tdap) and varicella virus vaccine live (Oka/Merck) (VARIVAX).  This is one of the three reports received from the same reporter, concerning the same patient.; Sender's Comments:  US-009507513-2305USA007526: US-009507513-2302USA008667:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; Caller reported VARIVAX administered after temperature excursion.; This spontaneous report has been received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 19-MAY-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter (ml), intramuscular (IM) (valid lot number W034708 [expiration date 01-NOV-2024]) (dose number, frequency, vaccination scheme, and anatomical location were not provided), administered for prophylaxis, after a temperature excursion of 6.4 degrees Fahrenheit with a time frame of 42 minutes (product storage error). No previous temperature excursion.  No additional adverse events (AEs).
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: the patient did not experience any other adverse event; The caller said the patient received an expired dose of VARIVAX on 4/26/2023; This spontaneous report was received from nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-APR-2023, the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, lot #u012222, expiration date: 16-APR-2023, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered). Confirmed with caller the patient did not experience any other adverse event.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No Adverse Event; Caller reports that improperly stored vaccines were administered. No other adverse events reported. No product quality complaints. No further information.          ?    Names of vaccines involved (including lot/exp) GARDASIL 9 (lot: U031056 exp: 06; This spontaneous report was received by customer refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 02-MAR-2023, the patient was vaccinated with improper storage hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot #U031056, expiration date: 16-JUN-2024, (, exact dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error).  Administered dose of vaccine experienced the temperature excursion of - 40.0 degrees Fahrenheit for 70 hours and 5 minutes. No previous temperature excursion had occurred. There were no additional adverse events reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2305USA008276
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No other adverse events reported.; Caller reports that improperly stored vaccines were administered.; This spontaneous report was received from an administrator and refers to a unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-MAR-2023, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 time dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). Caller reports that improperly stored vaccines were administered (Product storage error). The vaccine underwent temperature excursion -40 Fahrenheit (F) for 70 hours 5 minutes. No other adverse events reported.  Lot number #3397T1 is not valid for hepatitis a vaccine, inactivated.