chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No known adverse effects, just an administration error. Patient had full series given here at pharmacy in 2021. She was at pharmacy in another location and had a 3rd dose given in October 2023. She said she forgot she already had 2 doses. We caught it when she came back to us for her next dose.
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Mobility decreased, Neuralgia, Pain in extremity
Clinical narrative: Sore arm, can't lift above shoulder. Patient states they are experiencing nerve pain
Age: 0.5
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: inadvertently administered a fluzone high dose quadrivalent to a 6 month old baby with no reported adverse event; Initial information received on 17-Dec-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 6-month-old male patient who was inadvertently administered a influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Dec-2023, the 6-month-old patient inadvertently received unknown dose of suspect influenza quadrival A-B high dose HV vaccine (strength, formulation, lot number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization) with no reported adverse event (product administered to patient of inappropriate age) (same day latency).  Reportedly, He states that he made a potential error but is not sure that the error happened. On Thursday, he mistakenly ordered a fluzone high dose QIV vaccine for a 6-month-old. He cannot tell if the nurse gave Fluzone HD QIV because the lot number that was documented is for the "routine" flu vaccine and not the high-dose. He further states that his clinic does not have much supply of the high-dose vaccine.   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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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: 2.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: patient was given only the DTAP-IPV liquid solution of the PENTACEL without the HIB component with no reported adverse event; Initial information received on 19-Dec-2023 regarding an unsolicited valid non-serious case received via consumer/non-healthcare professional.  This case involves a 2-year-old male patient was given only the dtap-ipv liquid solution of the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] without the hib component with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.   On 18-Dec-2023, the patient received an unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (strength: unknown) (lot: UJ843AB) via unknown route in unknown administration site for immunization and patient was given only the dtap-ipv liquid solution of the pentacel without the hib component with no reported adverse event (single component of a two-component product administered) (latency: same day).  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 Directive and Regulatory Authority Practices. 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: 72.0
Sex: U
Vaccine: FLU4
Symptoms: Pain in extremity, Peripheral swelling, Tremor
Clinical narrative: Hand shaking, finger tip, and shaking, arm swollen, at night it hurt like nail hammer in my arm
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Dry skin, Pruritus, Swelling, Tenderness
Clinical narrative: 6 days post-vaccine site began to itch, swell, tendered, skin dry
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No side effects or issues were reported with the administration of the MMR II to the patient; A HCP called to report a TE for MMR II that resulted in an outcome that was not supported and was also administered to a patient on 12/11/2023; This spontaneous report was received from a nurse referring to a 12-month-old patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 11-DEC-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) lot number X002058, expiration date 19-JAN-2025, 0.5 milliliter (route of administration not reported) for prophylaxis that was diluted with 0.5 milliliters of sterile diluent (product storage error). No adverse event was reported.  The vaccine underwent a temperature excursion of 65.3 degrees Fahrenheit for 10 hours and 29 minutes, with no previous excursions detected.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs or PQC reported; Caller reported expired dose of GARDASIL 9 was administered. No other information provided. No additional AEs or PQC reported.; This spontaneous report was received from the physician's office by a reporter stated as "other" referring to a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not provided.  On 13-DEC-2023, the patient was vaccinated with an expired HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection at a dosage reported as 0.5 milliliter (mL) intramuscularly (IM) at the right (Rt) deltoid (strength, dose number, and vaccination scheme frequency were not reported; lot number 1780878 that was verified to be valid for syringe formulation with an expiration date reported and established as 02-DEC-2023) for prophylaxis (expired product administered).  No additional adverse events (AEs) or product quality complaint (PQC) were reported.
Age: 54.0
Sex: M
Vaccine: FLUC4
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: patient had already received a prior flu vaccine and was seeking an updated covid vaccine
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: pt wanted pfizer and was given moderna. No known issues just wrong vaccine.
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: Circumstance or information capable of leading to medication error, Expired product administered, No adverse event, Product administration error
Clinical narrative: Staf member gave vaccine and then entered into EHR which was a proedure error. The vaccine should have been entered first, and then given to avoid error. It was noted that the vaccine was expired after it had been given. Department notifed and advised staff to notify family and advise an additional dose. Custodial GMA notified and agreeavble to give additional dose. No adverse reactions noted.  All clincial staff  administering vaccines will be retrained regarding correct procuedures.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache, Impaired work ability, Loss of personal independence in daily activities, Migraine
Clinical narrative: I received Moderna booster at 9:45 am on 12/8/21. I had the first migraine of my life at ~2am on 12/9/21. It was the worst headache of my life. It felt as though metal daggers were stabbing into my eyes and then I vomited for several hours. I had 2 incidences of mild chest pain in the following 2 weeks. I now have regular ocular migraines with splotchy vision that will progress to full-blown migraines with vomiting if I do not stop what I am doing. I cannot look through the ocular migraines to view screens. These migraines limit my ability to work and parent.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: I received Moderna booster at 9:45 am on 12/8/21. I had the first migraine of my life at ~2am on 12/9/21. It was the worst headache of my life. It felt as though metal daggers were stabbing into my eyes and then I vomited for several hours. I had 2 incidences of mild chest pain in the following 2 weeks. I now have regular ocular migraines with splotchy vision that will progress to full-blown migraines with vomiting if I do not stop what I am doing. I cannot look through the ocular migraines to view screens. These migraines limit my ability to work and parent.
Age: 17.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction, Vomiting
Clinical narrative: The patient, aged 17, came in to get a FLU shot and a COVID shot. She was accompanied by her mother and brother, who also got the same two shots. Immediately after administering them to the patient, she said she felt dizzy. She was informed that she would have to sit in the booth for an additional 30 minutes, while her brother was already waiting on the pharmacy bench for 15 minutes. Within a couple of minutes, she stated that she had to throw up, which she did, and the Pharmacy protocol for responding to adverse events was immediately implemented. Store management was alerted (code white), and the patient remained under observation for 30 minutes. She stated that she felt better after throwing up. She stopped sweating and had no breathing difficulties neither did she collapse. She was offered some water to drink, which she refused; she was more interested in washing her hands. She was directed to the rest rooms at the end of the 30-minute observation and the Market Leader was informed of the incident. Every other requirement following this incident is being implemented as per the Pharmacy Administered Immunizations: Responding to Adverse Events document (Revised 7/2023) located on the database.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Anxiety, Arthralgia, Confusional state, Depression, Diarrhoea
Clinical narrative: A few hours after vaccine; very painful shoulder joint and left hip pain. Overall felt anxious, depressed and confused. The other event I associate with the vaccine is severe, instant diarrhea. I didn't have a upset stomach or feel nauseated. It was without warning, and instant liquid. I had None of these problems before the vaccine. I have had knee replacement and revision , as well as several other very invasive surgeries, all well tolerated with limited medication. I'm just saying I know when something is out of the ordinary and VERY painful. The joint pain has improved but I still have unexplained, without warning, diarrhea.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a second dose of Spikevax monovalent 2023-2024 vaccine.  First dose was given 09/20/2023.  Pharmacist did not notice previous vaccination history until vaccine was already administered.  Patient was not immunocompromised. NO adverse reaction reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient received duplicate dose of the 2023-2024 formulation 3 months apart from each other
Age: 14.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Syncope
Clinical narrative: Patient fainted briefly after getting the second shot (spikeVax). we helped him to the floor on his back and called 911. he woke up after 2 to 3 seconds. He was alert. he had clear vision, normal HR and normal RR.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Sore throat, stuffy nose
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Cough
Clinical narrative: Cough
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV1, DTPPVHBHPB, PNC15, RV1
Symptoms: Incorrect dose administered, Vomiting
Clinical narrative: While administering RVl orally, patient vomited large amount of white (formula looking ) liquid.; Patient received about half of the RVl dose. Mother of patient requested to not administer the rest of the RVl.; This spontaneous safety report, with reference number 2664173 (VAERS ID # 2664173-1), was received by a partner on 21-SEP-2023 and forwarded to Agency 25-SEP-2023, from a HCP.  The reporter did not provide an assessment of causal relationship between Vaxelis and the event " While administering RVl orally, patient vomited large amount of white (formula looking) liquid" and the causal relationship between Vaxelis and the reported event " Patient received about half of the RVl dose. Mother of patient requested to not administer the rest of the RVl" was assessed as not applicable due to the nature of these reported event  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received first dose of Rotateq at 6 months (vaccine 8/2/2023). No harm noted.; No adverse event; This spontaneous safety report, with reference number 2667673 (VAERS ID# 2667673-1), was received by the partner on 21-SEP-2023 and forwarded to UBC on 25-SEP-2023, from a health professional in the United States.   Due to the nature of the event, the causality between the events "Product administered to patient of inappropriate age and no adverse event" and Vaxelis was not applicable.  No further information is expected as the safety report was retrieved from VAERS-FDA.   FOLLOW-UP INFORMATION was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID number 2667673-1. The case is maintained as non-serious. The original narrative from the sender is the following:  "Patient received first dose of Rotateq at 6 months (vaccine 8/2/2023). Merck notified for alternative vaccine schedule recommendations. No harm noted."  Due to the nature of the event, the causality between the events "Product administered to patient of inappropriate age and no adverse event", "No adverse event" and Vaxelis was Not Applicable.   No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Needle issue, Syringe issue
Clinical narrative: As nurse was administering vaccine Vaxneuvance, vaccine syringe (prefilled) broke at the luer-lock hub leaving the child with a needle inside of the right thigh, needle was removed without complication leaving the child without harm; As nurse was administering vaccine Vaxneuvance, vaccine syringe (prefilled) broke at the luer-lock hub leaving the child with a needle inside of the right thigh, needle was removed without complication leaving the child without harm; Adverse event; Product administered to patient of 0.08 years (1 month); This spontaneous safety report, with reference number 02477067 (VAERS ID # 2668630-1) was received by the partner on 21-SEP-2023 and forwarded to Company on 22-SEP-2023, from a health professional. Additional information was received on 22-SEP-2023 by the partner and forwarded to Company on 26-SEP-2023.  The case is classified as off-label use due to Product use issue (Product use in unapproved population)   Due to the nature of the event, the causality between the events "As nurse was administering vaccine Vaxneuvance, vaccine syringe (prefilled) broke at the luer-lock hub leaving the child with a needle inside of the right thigh, needle was removed without complication leaving the child without harm ", "Adverse event" and " Product administered to patient of 0.08 years (1 month)" and Vaxelis was not applicable.   No further information is expected.  Non-Significant follow-up information was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2668630-1. Case is maintained as non-serious and off label use.  The reporter assessed the causal relationship between Vaxelis and the events " As nurse was administering vaccine Vaxneuvance, vaccine syringe (prefilled) broke at the luer-lock hub leaving the child with a needle inside of the right thigh, needle was removed without complication leaving the child without harm", "Adverse event" and " Product administered to patient of 0.08 years (1 month)" as not applicable due to the nature of the event.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Needle issue, Off label use, Product use issue, Syringe issue
Clinical narrative: As nurse was administering vaccine Vaxneuvance, vaccine syringe (prefilled) broke at the luer-lock hub leaving the child with a needle inside of the right thigh, needle was removed without complication leaving the child without harm; As nurse was administering vaccine Vaxneuvance, vaccine syringe (prefilled) broke at the luer-lock hub leaving the child with a needle inside of the right thigh, needle was removed without complication leaving the child without harm; Adverse event; Product administered to patient of 0.08 years (1 month); This spontaneous safety report, with reference number 02477067 (VAERS ID # 2668630-1) was received by the partner on 21-SEP-2023 and forwarded to Company on 22-SEP-2023, from a health professional. Additional information was received on 22-SEP-2023 by the partner and forwarded to Company on 26-SEP-2023.  The case is classified as off-label use due to Product use issue (Product use in unapproved population)   Due to the nature of the event, the causality between the events "As nurse was administering vaccine Vaxneuvance, vaccine syringe (prefilled) broke at the luer-lock hub leaving the child with a needle inside of the right thigh, needle was removed without complication leaving the child without harm ", "Adverse event" and " Product administered to patient of 0.08 years (1 month)" and Vaxelis was not applicable.   No further information is expected.  Non-Significant follow-up information was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2668630-1. Case is maintained as non-serious and off label use.  The reporter assessed the causal relationship between Vaxelis and the events " As nurse was administering vaccine Vaxneuvance, vaccine syringe (prefilled) broke at the luer-lock hub leaving the child with a needle inside of the right thigh, needle was removed without complication leaving the child without harm", "Adverse event" and " Product administered to patient of 0.08 years (1 month)" as not applicable due to the nature of the event.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Rash
Clinical narrative: a rash errupted all over patients skin; This spontaneous safety report, with reference number 2675856 (VAERS ID # 2675856-1) was received by the partner on 22-SEP-2023 and forwarded to Agency on 26-SEP-2023, from a health professional.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "a rash errupted all over patients skin".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Syringe issue
Clinical narrative: After administration of VAXNEUVANCE the prefilled syringe broke at the hub when the needle safety was applied; Unspecified adverse event; This spontaneous safety report, with reference number 02477799 (VAERS ID # 2676132-1 / interaction # 02477797) was received by the partner on 22-SEP-2023 and forwarded on the same day, from a health professional. Additional information was received on 25-SEP-2023 by the partner and forwarded on 26-SEP-2023.   Due to the nature of the event, the causality between the events "After administration of VAXNEUVANCE the prefilled syringe broke at the hub when the needle safety was applied and Unspecified adverse event" and Vaxelis was not applicable.   No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Adverse event, Syringe issue
Clinical narrative: After administration of VAXNEUVANCE the prefilled syringe broke at the hub when the needle safety was applied; Unspecified adverse event; This spontaneous safety report, with reference number 02477799 (VAERS ID # 2676132-1 / interaction # 02477797) was received by the partner on 22-SEP-2023 and forwarded on the same day, from a health professional. Additional information was received on 25-SEP-2023 by the partner and forwarded on 26-SEP-2023.   Due to the nature of the event, the causality between the events "After administration of VAXNEUVANCE the prefilled syringe broke at the hub when the needle safety was applied and Unspecified adverse event" and Vaxelis was not applicable.   No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Infant irritability, Pyrexia
Clinical narrative: Extreme Fussiness; Pt developed a high fever. Fever range was 103.4degressF to 99 degrees F (today); This spontaneous non-serious safety report, with reference number 2684993 (VAERS ID # 2684993-1) was received by the partner on 08-NOV-2023 and forwarded to Company on 10-NOV-2023, from a health professional.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Extreme Fussiness" and " Pt developed a high fever. Fever range was 103.4degressF to 99 degrees F (today)".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Irritability, Pyrexia
Clinical narrative: Extreme Fussiness; Pt developed a high fever. Fever range was 103.4degressF to 99 degrees F (today); This spontaneous non-serious safety report, with reference number 2684993 (VAERS ID # 2684993-1) was received by the partner on 08-NOV-2023 and forwarded to Company on 10-NOV-2023, from a health professional.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Extreme Fussiness" and " Pt developed a high fever. Fever range was 103.4degressF to 99 degrees F (today)".  No further information is expected.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Ageusia, Chills, Oropharyngeal pain, Pyrexia, Stomatitis
Clinical narrative: Chills the night after vaccine on 11/22. The morning of 11/23 I had lost my taste. Then developed sore throat and sores at the back of tongue. On 11/27 I went to urgent care and was told that maybe the vaccine had lowered my immune system to allow a potential virus to access me, etc. Returned to urgent care on 11/29 b/c symptoms had worsened. Inability to taste, eat, ear pain, reduction in ability to create saliva and eat food, etc. Was started on antivirals in case I did get Shingles somehow. On 12/5 I saw my primary physician b/c I had last 10lbs by then. That day I noticed my smile was lopsided and I had problems with my right eye not closing normally. I told him on Thursday 12/7 about these symptoms and he had me go to the ER where they diagnosed me with Bell's Palsy. I was the put back on antivirals and steroids. My conditions have improved somewhat, but my smile has still not returned to normal, nor my taste, and I have lost 15lbs since Thanksgiving. The ONLY variable here was the vaccine.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Ageusia, Aptyalism, Bell's palsy, Ear pain, Facial paresis
Clinical narrative: Chills the night after vaccine on 11/22. The morning of 11/23 I had lost my taste. Then developed sore throat and sores at the back of tongue. On 11/27 I went to urgent care and was told that maybe the vaccine had lowered my immune system to allow a potential virus to access me, etc. Returned to urgent care on 11/29 b/c symptoms had worsened. Inability to taste, eat, ear pain, reduction in ability to create saliva and eat food, etc. Was started on antivirals in case I did get Shingles somehow. On 12/5 I saw my primary physician b/c I had last 10lbs by then. That day I noticed my smile was lopsided and I had problems with my right eye not closing normally. I told him on Thursday 12/7 about these symptoms and he had me go to the ER where they diagnosed me with Bell's Palsy. I was the put back on antivirals and steroids. My conditions have improved somewhat, but my smile has still not returned to normal, nor my taste, and I have lost 15lbs since Thanksgiving. The ONLY variable here was the vaccine.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Feeding disorder, Glossodynia, Oropharyngeal pain, SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: Chills the night after vaccine on 11/22. The morning of 11/23 I had lost my taste. Then developed sore throat and sores at the back of tongue. On 11/27 I went to urgent care and was told that maybe the vaccine had lowered my immune system to allow a potential virus to access me, etc. Returned to urgent care on 11/29 b/c symptoms had worsened. Inability to taste, eat, ear pain, reduction in ability to create saliva and eat food, etc. Was started on antivirals in case I did get Shingles somehow. On 12/5 I saw my primary physician b/c I had last 10lbs by then. That day I noticed my smile was lopsided and I had problems with my right eye not closing normally. I told him on Thursday 12/7 about these symptoms and he had me go to the ER where they diagnosed me with Bell's Palsy. I was the put back on antivirals and steroids. My conditions have improved somewhat, but my smile has still not returned to normal, nor my taste, and I have lost 15lbs since Thanksgiving. The ONLY variable here was the vaccine.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Weight decreased
Clinical narrative: Chills the night after vaccine on 11/22. The morning of 11/23 I had lost my taste. Then developed sore throat and sores at the back of tongue. On 11/27 I went to urgent care and was told that maybe the vaccine had lowered my immune system to allow a potential virus to access me, etc. Returned to urgent care on 11/29 b/c symptoms had worsened. Inability to taste, eat, ear pain, reduction in ability to create saliva and eat food, etc. Was started on antivirals in case I did get Shingles somehow. On 12/5 I saw my primary physician b/c I had last 10lbs by then. That day I noticed my smile was lopsided and I had problems with my right eye not closing normally. I told him on Thursday 12/7 about these symptoms and he had me go to the ER where they diagnosed me with Bell's Palsy. I was the put back on antivirals and steroids. My conditions have improved somewhat, but my smile has still not returned to normal, nor my taste, and I have lost 15lbs since Thanksgiving. The ONLY variable here was the vaccine.
Age: 44.0
Sex: F
Vaccine: FLU4, FLUC4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Pain, Pain in extremity
Clinical narrative: Immediate pain in shoulder, radiated down right arm, ongoing symptoms since injection
Age: 44.0
Sex: F
Vaccine: FLU4, FLUC4
Symptoms: Ultrasound scan
Clinical narrative: Immediate pain in shoulder, radiated down right arm, ongoing symptoms since injection
Age: 44.0
Sex: F
Vaccine: FLU4, FLUC4
Symptoms: Arthralgia, Immediate post-injection reaction, Magnetic resonance imaging, Pain, Pain in extremity
Clinical narrative: Immediate pain in shoulder, radiated down right arm, ongoing symptoms since injection
Age: 44.0
Sex: F
Vaccine: FLU4, FLUC4
Symptoms: Ultrasound scan, X-ray limb
Clinical narrative: Immediate pain in shoulder, radiated down right arm, ongoing symptoms since injection
Age: 33.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: Arexvy was administered to a patient during her 34 week of pregnancy; Arexvy was administered to a 33 years old patient, before the 60 years old approved age; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 33-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 42852) for prophylaxis.   On 15-DEC-2023, the patient received Arexvy. On 15-DEC-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Arexvy was administered to a 33 years old patient, before the 60 years old approved age). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy was administered to a patient during her 34 week of pregnancy). The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 18-DEC-2023 The pharmacist reported Arexvy was administered to a patient during her 34 week of pregnancy, before the 60 years old approved age. which led to inappropriate age at vaccine administration and vaccine exposure during pregnancy. The Vaccine Administration Facility was the same as primary reporter. The reporter consented to follow up via email agreed. The case US2023176742 was found as duplicate of this case. All the information from the case US2023176742 was merged into this case. The case US2023176742 was deleted and this case stand as case of record for this patient.
Age: 33.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: Arexvy was administered to a patient during her 34 week of pregnancy; Arexvy was administered to a 33 years old patient, before the 60 years old approved age; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 33-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 42852) for prophylaxis.   On 15-DEC-2023, the patient received Arexvy. On 15-DEC-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Arexvy was administered to a 33 years old patient, before the 60 years old approved age). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy was administered to a patient during her 34 week of pregnancy). The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 18-DEC-2023 The pharmacist reported Arexvy was administered to a patient during her 34 week of pregnancy, before the 60 years old approved age. which led to inappropriate age at vaccine administration and vaccine exposure during pregnancy. The Vaccine Administration Facility was the same as primary reporter. The reporter consented to follow up via email agreed. The case US2023176742 was found as duplicate of this case. All the information from the case US2023176742 was merged into this case. The case US2023176742 was deleted and this case stand as case of record for this patient.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptomatic adverse events reported; Patient was inadvertently administered an expired dose of MMR II; This spontaneous report was received from a nurse and refers to a patient of unknown age or gender.  Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.  On 12-DEC-2023 (reported as today), the patient was inadvertently administered an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5ml/ series, expiration date: 22-NOV-2023, (Expired product administered) as prophylaxis (strength, lot #, and route of administration were not provided). The dose was supported by the post expiry memo. No symptomatic adverse events reported (No adverse event). No additional information provided
Age: 1.25
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No reported signs/symptoms of adverse effects; HCP called regarding GARDASIL 9. Caller reported that vaccine was given to a 15 month old.; This spontaneous report was received from a medical assistant and refers to a 15-month-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 18-DEC-2023, the patient was vaccinated with HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Product use issue). No reported signs or symptoms of adverse effects (No adverse event).
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report TE. Product underwent multiple current excursions and was administered to one patient.; This spontaneous report was received from a medical assistant and refers to a 63-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not provided.  On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 0.5 milliliter (ml) (valid lot number X018278, expiration date 24-NOV-2024), administered for prophylaxis (dose, dose number, frequency, and route of administration were not provided), after a temperature excursion, temperature: 31.6 degrees Fahrenheit (F) for 1 hours 0 minutes and 0 seconds; and  32.2 degrees F for 0 hours 45 minutes and 0 seconds. No previous temperature excursion occurred.  No adverse additional adverse events reported.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal disorder, Seronegative arthritis, Tendon rupture
Clinical narrative: They have loss the use of thumb in their right hand; seronegative spondyl arthropathy; spontaneous tendon rupture; This spontaneous case was reported by a physician and describes the occurrence of SERONEGATIVE ARTHRITIS (seronegative spondyl arthropathy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (has mild hypertension) and Penicillin allergy.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced SERONEGATIVE ARTHRITIS (seronegative spondyl arthropathy) (seriousness criterion medically significant) and TENDON RUPTURE (spontaneous tendon rupture). On an unknown date, the patient experienced MUSCULOSKELETAL DISORDER (They have loss the use of thumb in their right hand). At the time of the report, SERONEGATIVE ARTHRITIS (seronegative spondyl arthropathy) and MUSCULOSKELETAL DISORDER (They have loss the use of thumb in their right hand) outcome was unknown and TENDON RUPTURE (spontaneous tendon rupture) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. Within a month patient developed a spot of arthropathy including tendons and joints within weeks of the second injection. Patient saw a rheumatologist. Patient stated it was developing and evolving and including this tendons. Patient was not responding to the usual treatment of inflammatory arthritis. It was reported that patient was in very good health prior to it, running and lifting. Now they were fairly debilitated. The treatment medication was not reported by reporter.  Company comment: This spontaneous case concerns a male patient of unknown age, with no relevant medical history, who experienced the unexpected serious (medically significant) AESI of Seronegative arthritis and non serious events of tendon rupture and musculoskeletal disorder. The events occurred approx. weeks to month after the second dose of mRNA-1273. As reported, within a month patient developed a spot of arthropathy including tendons and joints within weeks of the second injection. Patient has visited rheumatologist with condition developing and evolving and have had a spontaneous tendon rupture. Reportedly, patient is not responding to the usual treatment of inflammatory arthritis and has lost the use of thumb in their right hand and now are fairly debilitated. The technical diagnosis is seronegative spondyl arthropathy, as reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Myalgia, Peripheral swelling, Thrombosis
Clinical narrative: blood clotted in my arms and hands; numbness in the hands and frequent swelling due to the vaccine, is like the blood in arms and hands gets coagulated; pain in the arm and shoulder and hand muscles; numbness in the hands; This is a spontaneous report received from a Consumer or other non HCP.  A 37-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history included: "drug allergy" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "numbness in his hands and frequent swelling as a result of the vaccination", "muscle pain in the arms, shoulders and hands", "numbness in his hands and frequent swelling as a result of the vaccination", "it was like blood clotted in his arms and hands"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "numbness in his hands and frequent swelling as a result of the vaccination", "Muscle pain in the arms, shoulders and hands", "numbness in his hands and frequent swelling as a result of the vaccination", "it was like blood clotted in his arms and hands". The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "blood clotted in my arms and hands"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "numbness in the hands and frequent swelling due to the vaccine, is like the blood in arms and hands gets coagulated"; MYALGIA (non-serious), outcome "unknown", described as "pain in the arm and shoulder and hand muscles"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness in the hands". Therapeutic measures were not taken as a result of thrombosis, peripheral swelling, myalgia, hypoaesthesia. Clinical course: The patient had pain in the arm and shoulder and hand muscles, numbness in the hands and frequent swelling due to the vaccine, is like the blood in his arms and hands gets coagulated since he took 4 doses, 2 in each arm.  Follow-up (19Dec2023): This is a spontaneous follow-up report received from same Consumer. Updated information included: Age of patient, Historical vaccines and reactions added, Newevent Clot blood added and events (Arthralgia and pain in extremity) deleted.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300450904 Same patient/vaccine, different dose/events;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Nurse.  A 47-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: soy, mustard, peas" (unspecified if ongoing); "Known allergies: lactose intolerant" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 09Dec2023 to 13Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by varied factors; however, a contributory role of the suspect product to the reported Vaccination failure /COVID-19 cannot be ruled out.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Maternal exposure before pregnancy
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine exposure before pregnancy; This is a spontaneous report received from an Other HCP.  A 27-year-old female patient (pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 26 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Peanut" (unspecified if ongoing). The patient was 24 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 10Apr2024. The patient's concomitant medications were not reported. The following information was reported: MATERNAL EXPOSURE BEFORE PREGNANCY (non-serious) with onset Nov2022, outcome "unknown", described as "Vaccine exposure before pregnancy"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 18Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by varied factors; however, a contributory role of the suspect product to the reported Drug ineffective /COVID-19 cannot be ruled out.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 39-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Oct2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 09Dec2023 to 13Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Pharmacist.  A 32-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 at 12:30 as dose 1, single (Lot number: HH7595) at the age of 32 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Dec2023, outcome "recovered" (Dec2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Dec2023) Positive, notes: Binax; (10Dec2023) Negative; (11Dec2023) Negative; (15Dec2023) Negative. Therapeutic measures (Paxlovid treatment start date: 08Dec2023, stop date: 13Dec2023) were taken as a result of vaccination failure, covid-19. Clinical course: 08Dec2023 - sore throat and first positive RAT; symptoms largely gone besides fatigue.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by varied factors; however, a contributory role of the suspect product to the reported Vaccination failure /COVID-19 cannot be ruled out.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 50-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered" (Dec2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) Negative, notes: Rebound Covid after testing negative a couple of days previous. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 12Dec2023 to 17Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.