chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 30-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 29 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as treatment.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported event Bacterial enteritis.Case will be reviewed on receipt of FU information.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Petit mal epilepsy
Clinical narrative: Petite mal seizures starting sometime shortly after 1st COVID; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on [29Aug2023], this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 74-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EM9809), in left arm for covid-19 immunization in morning. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PETIT MAL EPILEPSY (medically significant), outcome "recovered", described as "Petite mal seizures starting sometime shortly after 1st COVID". Therapeutic measures were taken as a result of petit mal epilepsy. His doctor finally got them under control with Xcopri. Since then each time he has gotten a booster he has had 1 or 2 seizures within a week. He never had seizures before the shots. The event was fine now but on meds XCOPRI. The reason reporter believe it was the vaccine is because each time he has gotten a booster, he would have at least 1 episode even though he has been takin XCOPRI 200s daily.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300288375 same patient/drug/AE, different dose number;US-PFIZER INC-202300288377 same patient/drug/AE, different dose number;US-PFIZER INC-202300288376 same patient/drug/AE, different dose number;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Wednesday about midnight I began coughing/Did not think of COVID/Thursday, I tested positive; Wednesday about midnight I began coughing/Did not think of COVID/Thursday, I tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 24Aug2023, outcome "unknown" and all described as "Wednesday about midnight I began coughing/Did not think of COVID/Thursday, I tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Aug2023) Positive, notes: Thursday I tested positive. Clinical course: It was stated that just over COVID. Had all vaccines (Pfizer) & have still wear masks out but not at doctors. It was stated that, "I was at doctors and removed my mask - always did there. Soon, I realized she was sick. I asked & she said yes. She was not wearing mask. Not sure why I did not put mine back on. This was a Monday at 1 pm & Wednesday about midnight I began coughing. Did not think of COVID. Thursday, I tested positive. Could I get it that fast? Doctor tested negative on Tuesday. I do not go out often. Checked with other contacts. No COVID".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness
Clinical narrative: sick; chills; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer.), for Covid-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; CHILLS (non-serious), outcome "unknown". Additional information: When she got the Pfizer Covid-19 vaccine booster. She got really sick and got the chills.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Graves' disease
Clinical narrative: Graves Disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GRAVES' DISEASE (medically significant), outcome "unknown", described as "Graves Disease".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 2.0
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: received PENTACEL, DAPTACEL and ACT-HIB so the DTAP and Hib portion is doubled with no reported adverse event; Initial information received on 25-Aug-2023 regarding an unsolicited valid  non-serious case received from an other health professional.  This case involves a 2 years old female patient who received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)], daptacel and act-hib so the dtap and hib, portion is doubled 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 Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Daptacel), Hib Vaccine Conj (Tet Tox) (Act Hib) and Hepatitis A Vaccine (Hepatitis A) for Prophylactic vaccination.  On 22-Aug-2023, the patient received a dose of Suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine (lot: UJ737AAA, Expiry date: 18-Sep-2023) via intramuscular route in unknown administration site for prophylactic vaccination (immunization) (extra dose administered) (latency- same day).  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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: F
Vaccine: DTAP
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: patient received PENTACEL, DAPTACEL and ACT-HIB so the DTAP and Hib portion is doubled with no reported adverse event; Initial information received on 25-Aug-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 2 years old female patient where patient received pentacel, diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] and act-hib so the dtap and hib portion is doubled 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 diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (pentacel), HIB VACCINE conj (tet tox) (ACT HIB) and hepatitis A vaccine (hepatitis A) for Immunisation.  On 22-Aug-2023, the patient received 0.5 ml (TOTAL) dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection (lot C6013AA and expiration date- 05-Jul-2024) via intramuscular route in Left leg (strength: not provided) for Immunization (extra dose administered) (latency- same day).  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.   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: 5.0
Sex: F
Vaccine: MEN, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient inadvertently received a dose of Menquadfi, she was intended to receive MMR/Varicella with no reported adverse event; Initial information was received on 28-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 5 years old female patient who reported that inadvertently received a dose of Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi], she was intended to receive MMR/VARICELLA 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 Hepatitis A vaccine and diphtheria vaccine toxoid, pertussis vaccine acellular, polio vaccine inact, tetanus vaccine toxoid (TDAP IPV) for Prophylactic vaccination.  On 21-Aug-2023, the patient received a dose 1 of 0.5 ml of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine (Solution for injection) (lot U7643AB, Expiry date : 27-Jun-2025, strength was unknown) via intramuscular route in the right arm for Immunization and  inadvertently received a dose of Menquadfi, she was intended to receive MMR/VARICELLA with no reported adverse event (wrong product administered) (latency : same day).  It was reported that "Caller reporting the patient has not received prior doses of meningococcal vaccinations on their records, but she didn't think it was approved for a 5-year-old to receive. This situation is reported as a medication error due to administering vaccination in error."  No lab data reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event patient inadvertently received a dose of Menquadfi, she was intended to receive MMR/VARICELLA with no reported adverse event.  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: 3.0
Sex: M
Vaccine: IPV
Symptoms: Extra dose administered, Medication error
Clinical narrative: 3 year old was given a dose of PENTACEL and IPOL (extra dose of IPOL) with no reported adverse event; Initial information received on 28-Aug-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 3 years old male patient who experienced 3 year old was given a dose of pentacel IPV (vero) [IPOL] (extra dose of ipol) 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 diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine INACT 3V (MRC 5), tetanus vaccine toxoid (pentacel) and pneumococcal vaccine conj 13v (crm197) (Prevnar 13) for prophylactic vaccination and hepatitis A vaccine for Prophylactic vaccination.  On 25-Aug-2023, the patient received 0.5 ml dose 3 of suspect IPV (VERO) Suspension for injection (lot W1A101M and expiration date- 10-Feb-2025) via subcutaneous route in the right thigh (strength: not provided) for Immunization (extra dose administered) (latency- same day).  Action taken- Not applicable.  At time of reporting, the outcome was Unknown for the event.   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: 12.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: administered daptacel instead of adacel with no reported adverse event; Initial information received on 28-Aug-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked to case 2023SA264528(CLUSTER).  This case involves a 12 years old female patient who was administered diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] instead of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] 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 measles vaccine, mumps vaccine, rubella vaccine (MMR), polio vaccine (Polio Vaccine); varicella zoster vaccine (Varicella Vaccine) and hepatitis B vaccine (HEP B VAX) for Prophylactic vaccination (immunization).  On 24-Aug-2023, the patient received a dose 0.5 ml of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine Suspension for injection lot C5969AD expiry date:17-Feb-2024 via intramuscular route in the left arm for immunization instead of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection with no reported adverse event (wrong product administered) on the same day following the administration of vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event administered daptacel instead of adacel with no reported adverse event.  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: 17.0
Sex: F
Vaccine: DTAP
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 17 years old adolescent was inadvertently administered Daptacel instead of Adacel (with no reported adverse event); 17 years old adolescent was inadvertently administered Daptacel instead of Adacel (with no reported adverse event); Initial information received on 28-Aug-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked to case 2023SA264531(CLUSTER).  This case involves a 17-year-old adolescent was inadvertently administered Diphtheria-15/Tetanus/5 AC pertussis vaccine [Daptacel] instead of Diphtheria-2/Tetanus/5 AC pertussis vaccine [Adacel] 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 Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR), Varicella Zoster Vaccine (Varicella Vaccine); Hepatitis B Vaccine and Polio Vaccine (POLIO), all for Prophylactic vaccination.  On 24-Aug-2023, the 17-year-old adolescent patient inadvertently received a dose of 0.5 ml of suspect Diphtheria-15/Tetanus/5 AC pertussis vaccine [Daptacel] suspension for injection of standard strength (lot: C5969AD, Expiry date: 17-Feb-2024) via intramuscular route in the left arm for Immunization instead of Diphtheria-2/Tetanus/5 AC pertussis vaccine [Adacel] with no reported adverse event (product administered to patient of inappropriate age) (wrong product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.  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.
Sex: U
Vaccine: MEN
Symptoms: Rash
Clinical narrative: rash; Initial information received on 28-Aug-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case is linked to case 2023SA265322(CLUSTER).  This case involves a patient of an unknown age and gender who experienced rash after receiving Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine solution for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site for immunization.  On an unknown date, the patient developed a rash (unknown latency).  Information on the batch number was requested.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (rash).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event.
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: received expired ACT-HIB, with no reported adverse event; Initial information was received on 29-Aug-2023 regarding an unsolicited valid  non-serious case received from a Nurse.  This case is linked to case 2023SA264892(CLUSTER).  This case involves an unknown age female patient who received expired HIB (PRP/T) vaccine [ACT-HIB] 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 Prophylactic vaccination.  On 21-Aug-2023, the patient received a 0.5ml, once dose of suspect HIB (PRP/T) vaccine (Powder and solvent for solution for injection) (lot UJ739ABA, expiry date: 10-Aug-2023, Strength: standard) via intramuscular route in unknown administration site for Immunisation and received expired act-hib, with no reported adverse event (expired product administered) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Temperature excursion prior to vaccination. Temperature was outside recommended range.  Outside normal range over a period of 10 days adding up to a total of 100 hours. Lowest temperature was recorded as 23.8. Temperature was not consistently outside of the temperature range.  The monitoring system had just been upgraded and the thermobuffer gel bottle was placed too close to the blower in the fridge causing this excursion. Since this time the placement of the gel has been moved and we have not had any excursions.
Age: 50.0
Sex: M
Vaccine: HEP, VARZOS
Symptoms: Heart rate increased, Pain, Pyrexia
Clinical narrative: Elevated resting heart rate, fever and body ache
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Asthenia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Intense pain at the time of injection, injection site was red, hot, swollen for a few days, pain did not go away and later progressed to loss of range of motion and loss of strength in that arm. Intense pain in right shoulder keeps me up at night.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Injection site warmth, Joint range of motion decreased, Product administered at inappropriate site, Sleep disorder
Clinical narrative: Intense pain at the time of injection, injection site was red, hot, swollen for a few days, pain did not go away and later progressed to loss of range of motion and loss of strength in that arm. Intense pain in right shoulder keeps me up at night.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Administration site infection
Clinical narrative: patient called and stated the administration site is infected. advised patient to see an urgent care because patient does not have a PCP
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Burning sensation, Bursitis, Immediate post-injection reaction, Injection site pain
Clinical narrative: Right after the injection, I felt a burning sensation and immense pain. The pharmacist advised I move my arm around and apply ice to the injection spot as needed. However, the pain in my shoulder continued to progress and I brought it to my primary care physician?s attention about a month after. She recommended home exercises program and concluded I had unspecified pain chronicity in my left shoulder. The home exercises did not help. I then saw a  doctor who diagnosed me with bicipital tendonitis and bursitis of my left shoulder in the month of April 2023. The doctor recommended physical therapy and to take ibuprofen for a week straight. In June, I began to regress in physical therapy where I had first had an X-ray and then later  received an ultrasound guided injection into my left bicep tendon. The injection offer very little relief of pain. I was told to continue physical therapy and get an MRI. My PCP referred my to an orthopedic surgeon who ordered an MRI. The MRI findings showed I had frozen shoulder. My orthopedic surgeon recommended more physical therapy. My doctor also recommended more physical therapy and believe my diagnosis to be bicipital tendonitis and subdeltoid bursitis. She had recommend that I receive an MSI injection into my shoulder joint and continue my physical therapy treatment.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Magnetic resonance imaging abnormal, Pain, Periarthritis, Tendonitis, Ultrasound scan
Clinical narrative: Right after the injection, I felt a burning sensation and immense pain. The pharmacist advised I move my arm around and apply ice to the injection spot as needed. However, the pain in my shoulder continued to progress and I brought it to my primary care physician?s attention about a month after. She recommended home exercises program and concluded I had unspecified pain chronicity in my left shoulder. The home exercises did not help. I then saw a  doctor who diagnosed me with bicipital tendonitis and bursitis of my left shoulder in the month of April 2023. The doctor recommended physical therapy and to take ibuprofen for a week straight. In June, I began to regress in physical therapy where I had first had an X-ray and then later  received an ultrasound guided injection into my left bicep tendon. The injection offer very little relief of pain. I was told to continue physical therapy and get an MRI. My PCP referred my to an orthopedic surgeon who ordered an MRI. The MRI findings showed I had frozen shoulder. My orthopedic surgeon recommended more physical therapy. My doctor also recommended more physical therapy and believe my diagnosis to be bicipital tendonitis and subdeltoid bursitis. She had recommend that I receive an MSI injection into my shoulder joint and continue my physical therapy treatment.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: X-ray limb
Clinical narrative: Right after the injection, I felt a burning sensation and immense pain. The pharmacist advised I move my arm around and apply ice to the injection spot as needed. However, the pain in my shoulder continued to progress and I brought it to my primary care physician?s attention about a month after. She recommended home exercises program and concluded I had unspecified pain chronicity in my left shoulder. The home exercises did not help. I then saw a  doctor who diagnosed me with bicipital tendonitis and bursitis of my left shoulder in the month of April 2023. The doctor recommended physical therapy and to take ibuprofen for a week straight. In June, I began to regress in physical therapy where I had first had an X-ray and then later  received an ultrasound guided injection into my left bicep tendon. The injection offer very little relief of pain. I was told to continue physical therapy and get an MRI. My PCP referred my to an orthopedic surgeon who ordered an MRI. The MRI findings showed I had frozen shoulder. My orthopedic surgeon recommended more physical therapy. My doctor also recommended more physical therapy and believe my diagnosis to be bicipital tendonitis and subdeltoid bursitis. She had recommend that I receive an MSI injection into my shoulder joint and continue my physical therapy treatment.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Dyspnoea
Clinical narrative: Patient became very short of breath several minutes after immunization.  911 was called upon patients request, but soon prior to their arrival patient symptoms started to improve.  Paramedics quickly took over, started doing patient work-up, and shortly after escorted patient out of the store.
Age: 15.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Blood glucose normal, Loss of consciousness, Muscle rigidity
Clinical narrative: About 10 minutes after receiving vaccination, patient passed out in to the lap of her sibling and lost consciousness for about 5 seconds. Before fully coming to, she exhibiting an involuntary muscle response where her body was contorted. EMS did not believe it to be a seizure especially because the patient was alert and oriented when speaking to her.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Contusion, Injection site discolouration, Pain
Clinical narrative: The patient received her RSV vaccine on 8/26/23. She returned to the pharmacy on 8/29/23.  She had a severely bruised arm and discoloration at the injection site. Her pain had resolved.
Age: 72.0
Sex: F
Vaccine: FLUA4
Symptoms: Asthenopia, Headache, Peripheral vascular disorder, Photopsia, Vitreous floaters
Clinical narrative: Patient started having headaches/tired eyes/ floaters/ and flashes of light in peripheral  vision 2 days after shot. She also had the same symptoms 1 day after Fluzone HD shot in 2021. Both times diagnosed with  PVD by optometrist. No reaction to shot in 2022.
Age: 65.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Aphasia, Feeling hot, Gait disturbance, Migraine, Pain
Clinical narrative: Severe Pain, Migraine, trouble walking,  trouble speaking, Achy/hot, lasted for 2-3 days
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Small intestinal resection, Thrombectomy, Thrombosis
Clinical narrative: blood clot in abdomen; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 20Apr2021 as dose 2, single (Lot number: ew0164) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing). Concomitant medication(s) included: XELJANZ. Vaccination history included: BNT162b2 (Dose 1, Single, Lot number: ew0151, Anatomical location: Left arm), administration date: 01Apr2021, for COVID-19 immunisation. The following information was reported: THROMBOSIS (hospitalization, disability, medically significant, life threatening) with onset 29Jul2022, outcome "recovered with sequelae", described as "blood clot in abdomen". The patient was hospitalized for thrombosis (hospitalization duration: 14 day(s)). The event "blood clot in abdomen" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: all test: negative, notes: all test were negative as to possible genetic / health. Therapeutic measures were taken as a result of thrombosis. Clinical course: No indication as to possible cause. Patient was Recovered with lasting effects. Patient did not have known allergies. Patient did not have covid prior vaccination. Patient had immediate risk of death from the event.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300289303 Same patient/product, different dose/events;
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Investigation, Thrombosis
Clinical narrative: blood clot in abdomen; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 20Apr2021 as dose 2, single (Lot number: ew0164) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing). Concomitant medication(s) included: XELJANZ. Vaccination history included: BNT162b2 (Dose 1, Single, Lot number: ew0151, Anatomical location: Left arm), administration date: 01Apr2021, for COVID-19 immunisation. The following information was reported: THROMBOSIS (hospitalization, disability, medically significant, life threatening) with onset 29Jul2022, outcome "recovered with sequelae", described as "blood clot in abdomen". The patient was hospitalized for thrombosis (hospitalization duration: 14 day(s)). The event "blood clot in abdomen" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: all test: negative, notes: all test were negative as to possible genetic / health. Therapeutic measures were taken as a result of thrombosis. Clinical course: No indication as to possible cause. Patient was Recovered with lasting effects. Patient did not have known allergies. Patient did not have covid prior vaccination. Patient had immediate risk of death from the event.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300289303 Same patient/product, different dose/events;
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: blood clot in abdomen; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 20Apr2021 as dose 2, single (Lot number: ew0164) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing). Concomitant medication(s) included: XELJANZ. Vaccination history included: BNT162b2 (Dose 1, Single, Lot number: ew0151, Anatomical location: Left arm), administration date: 01Apr2021, for COVID-19 immunisation. The following information was reported: THROMBOSIS (hospitalization, disability, medically significant, life threatening) with onset 29Jul2022, outcome "recovered with sequelae", described as "blood clot in abdomen". The patient was hospitalized for thrombosis (hospitalization duration: 14 day(s)). The event "blood clot in abdomen" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: all test: negative, notes: all test were negative as to possible genetic / health. Therapeutic measures were taken as a result of thrombosis. Clinical course: No indication as to possible cause. Patient was Recovered with lasting effects. Patient did not have known allergies. Patient did not have covid prior vaccination. Patient had immediate risk of death from the event.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300289303 Same patient/product, different dose/events;
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Small intestinal resection, Thrombectomy, Thrombosis
Clinical narrative: covid test result=Positive; covid test result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: ew0151), in left arm and on 20Apr2021 as dose 2, single (Lot number: ew0164) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "psoriatic arthritis" (unspecified if ongoing). Concomitant medication(s) included: XELJANZ. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Jan2022, outcome "unknown" and all described as "covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jan2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300289282 same patient, different dose number/event;
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Investigation, Thrombosis
Clinical narrative: covid test result=Positive; covid test result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: ew0151), in left arm and on 20Apr2021 as dose 2, single (Lot number: ew0164) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "psoriatic arthritis" (unspecified if ongoing). Concomitant medication(s) included: XELJANZ. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Jan2022, outcome "unknown" and all described as "covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jan2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300289282 same patient, different dose number/event;
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test result=Positive; covid test result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: ew0151), in left arm and on 20Apr2021 as dose 2, single (Lot number: ew0164) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "psoriatic arthritis" (unspecified if ongoing). Concomitant medication(s) included: XELJANZ. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Jan2022, outcome "unknown" and all described as "covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jan2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300289282 same patient, different dose number/event;
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 28May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "Connective tissues disorder" (unspecified if ongoing); "mast cell disorder" (unspecified if ongoing); "history of spontaneous cerebrospinal fluid leak" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Pots" (unspecified if ongoing); "tachycardia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Fibrin glue, reaction(s): "known allergies: Fibrin glue". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 28May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "Connective tissues disorder" (unspecified if ongoing); "mast cell disorder" (unspecified if ongoing); "history of spontaneous cerebrospinal fluid leak" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Pots" (unspecified if ongoing); "tachycardia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Fibrin glue, reaction(s): "known allergies: Fibrin glue". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 4.0
Sex: F
Vaccine: PPV
Symptoms: Gait inability, Pain in extremity, Peripheral swelling
Clinical narrative: leg was swollen, lot of pain, and could not walk; leg was swollen, lot of pain, and could not walk; leg was swollen, lot of pain, and could not walk; This spontaneous report was received from a consumer referring to a 4 years old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.  On 02-AUG-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength, dose, route of administration, lot number and expiration date were not reported).   On the same day, the patient's leg was swollen, lot of pain, and she could not walk. The patient's health care professional (HCP) who administered the vaccine was notified, and the HCP advised to give the patient diphenhydramine hydrochloride (BENADRYL) and ibuprofen (MOTRIN) for the symptoms. It was reported that the patient's allergist had told them it was OK to receive pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). At the reporting time, the outcome of the events was unknown.  The causal relationship between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and all the events was not reported.
Sex: M
Vaccine: HPV9
Symptoms: Device leakage
Clinical narrative: No adverse event; the vaccine fluid leaked out at the hub with needle attached. Nothing came through the needle; This spontaneous report was received from a medical assistant referring to a 15-year-old male patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were reported as none. The patient's concurrent condition was not reported.  On 31-JUL-2023, while administering HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) intramuscularly for prophylaxis (lot # w026977, expiration date: 04-JAN-2025; strength and dose were not reported), the vaccine fluid leaked out at the hub with needle attached, and nothing came through the needle (device leakage). After the patient was taken care of, the same syringe and needle was used, which was filled with water, and the same thing happened. The patient was given the vaccine again with a new syringe and new needle per health care professional (HCP) instructions.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: pregnant patient who got the Fluzone with no reported adverse event; Initial information received on 25-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 30 years old female patient who was pregnant and got the influenza quadrival a-b vaccine [Fluzone Quadrivalent] with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported pregnant patient who got the Fluzone with no reported adverse event occurred at 30 weeks of pregnancy and the patient was exposed to influenza quadrival A-B vaccine at 30 weeks of pregnancy, during third pregnancy trimester for influenza quadrival A-B vaccine.  The date of last menstrual period was reported as 27-Jan-2023. The estimated due date is 03-Nov-2023. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On 25-Aug-2023, the pregnant patient received a Dose 1 of suspect influenza quadrival A-B vaccine Suspension for injection (lot 4T8040NA) (with an unknown dosage, strength, expiry date) via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation) with no reported adverse event (exposure during pregnancy) (latency- same day).  Relevant prenatal testing after exposure was not reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  Additionally, at time of reporting, the pregnancy is still ongoing.
Sex: U
Vaccine: MEN
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Patient received Menquadfi subcutaneousversus IM with no reported adverse event; Initial information received on 28-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who had received meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] subcutaneous versus IM with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (lot number, strength, dosage, expiry date- not reported) via subcutaneous route in unknown administration site for prophylactic vaccination (Immunisation). Information on the batch number was requested.  On an unknown date the patient received meningococcal A-C-Y-W135 (T CONJ) vaccine subcutaneous versus IM (intramuscular) with no reported adverse event (incorrect route of product administration) (latency- same day). Caller was asking do they need to be revaccinated?   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered.
Age: 43.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered