chrisvoncsefalvay/vaers-outcomes huggingface dataset:
woke up next morning with a knot and extremely red area at injection site. Arm began swelling, was painful and was hot to the touch. After 2 weeks of this and the area affected, I went to the doctor
Tenivac was administered after it expired on 23Oct2020, with no AE; Initial information received on 10-Nov-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 50 years old male patient who was administered DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (TENIVAC) after it expired (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On 10-Nov-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot number, administration route was unknown and expiry date: 23-Oct-2020) for prophylactic vaccination.  This was potential medication error case due to expired vaccine used (same day).  The patient did not present any 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 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.  There will be no information available on the batch number for this case
A female, now 64 years of age, reported that she received an injection of Tetanus Toxoid Adsorbed, more than 20 years ago. Subsequently, she became "very ill" and was "in bed for a week". She also developed swelling at the injection site. The reporter indicated that her arm swelled "3 times the size". She recovered.
Mom  came to clinic stating child needed Pfizer dose 3 booster. She was not registered for this so child was registered . Mom had received other vaccine and did not have a written card with dates on it. The dates were in her phone. Vaccine was prepared and administered. Dates  of other vaccines were written down to enter into system- a few days later when entering vaccine into system  it was noted that the child had received two Moderna Infant Vaccines and should have received Modern Infant Bivalent vaccine instead of Pfizer bivalent infant vaccine.
Had 6 wk vaccines in office and later Dad called as has a fever of 101.4 (rectal) - fussy/calmness episodes. Sent to the ER.
C/O tingling feeling on left side of neck that resolved after applying ice pack for 10 minutes.
after recv vax pt exp around 12:30 weakness & lightheadedness, discomfort in back, felt tired, couldn't go back to sleep. heart felt beating fast(75-80) temp 98.4. fatigued
28 hours after 2nd Pfizer vaccine administered:   First symptom was inability to suck from a straw.  Lips could not be closed together on left side of mouth.  Second symptom noticed was left eye not blinking or closing all the way compared to right eye.   Third symptom was drooping smile on left side of face.   We did not connect the timing of vaccine to this event until the following morning.  It was Saturday morning and the symptoms still existing.  We observed and monitored through the weekend and called the Doctor's office on Monday.  The Doctor asked us to go to Emergency Room right away for possible stroke.
6 year old male patient was given expired Ipol, with no adverse event; Initial information received on 19-Apr-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 year old male patient who was vaccinated with an expired dose of IPV (VERO) [IPOL] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation.  On 07-Apr-2021, the patient received a 0.5 ml fourth dose of suspect IPV (VERO) (lot R1B25 and expiry date: 13-Mar-2021) (Strength  standard) via an intramuscular route in the left thigh for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  At the time of report no adverse event was reported.  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.
Approximately 5 minutes after receiving vaccine, pt reports feeling lightheaded. Pt did experience syncopal event, and fell, hitting left side of forehead and left knee. LOC lasted a few seconds.
Hives to upper body, neck and face within 10-15 minutes of getting the vaccination at 4:00 pm. Sent to the ER. Given IV solu-medrol, Pepcid and Benadryl. Was rechecked after about 45 minutes and rash had not improved, so was given Decadron. Waited another 45 minutes and rash was finally fading.  Was discharged around 7 pm. Went home and took 50 mg Benadryl. The next morning the rash had resolved.
Within 12 hours of vaccine receipt, painful left axilla lymphadenopathy. Developed; followed by low grade fever, myalgias, fatigue and severe headache. Duration of systemic symptoms about 48 hours.  Painful, swollen left axilla lymphadenopathy continues day 3 after injection. I was unable to go about normal daily activities for 48 hours, which is unusual for me as I am generally very healthy. I literally felt as though I'd been hit by a mack truck.
Rash developed 1 week after vaccination to  bilateral arms,  no redness at site, no, sob, no elevated temperature. As of today 03/24/2020 rash to bilateral legs and stomach and itching to site . No other complaints. Treatment at home consisted of alovera and other home remedies.  Advised for patient to contact a provider in town for treatment /evaluation of rash and itching. Again no other complaints was mentioned.
Taking them a long time to get over it / knocked for a loop / not expecting / pain, to last for so long; This case was reported by a consumer via call center representative and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   The reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's friend. Age at vaccination was not reported, the patient was in her late 70's. The patient had the Shingrix shot and told her that it was taking them a long time to get over it.  They were knocked for a loop and not expecting the side effects, such as pain, to last for so long. The reporter provided limited information. This is 1 of 4 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021017003: US-GLAXOSMITHKLINE-US2021017036:Same reporter US-GLAXOSMITHKLINE-US2021017037:Same reporter. Case for friend 1 of 2. US-GLAXOSMITHKLINE-US2021017003: US-GLAXOSMITHKLINE-US2021017036:Same reporter. Case for friend 2 of 2.
Information has been received through the Merck pregnancy registry and from a 26 year old female with a sulfonamide allergy who on 30-OCT-2006 was vaccinated with the first dose of Gardasil (Lot#653735/0688F). Concomitant therapy included prenatal vitamins. On 16-NOV-2006 the patient had an ultrasound which confirmed she was pregnant. No adverse event was noted. Additional information received from a pediatrician indicated that on 04-JUN-2007 the patient gave birth by c-section due to pre-eclampsia to a 4lb 4oz female. The patient was 35.6 weeks from LMP. On 16-JAN-2007, laboratory diagnostic studies included tetra-screening at 16 weeks and was reported to be normal. The infant was reported to be normal. Upon internal review, pre-eclampsia was considered to an other important medical event. Additional information is not expected.
Caller stated that an expired dose of Adacel was given; Initial information received on 21-Jun-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional (office staff) by phone.  This case involves adult patient of unknown demographics who was vaccinated with an expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   It was a case of actual medication error due to expired vaccine used.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.   Information on the batch number was requested.  Documents held by the sender: none.
tenderness and swelling in armpit, soreness at injection site Narrative:  Employee states: he is experiencing pulsating arm soreness at the injection site; the morning after the injection he has swelling in his underarm it is tender and sore it has gone done some but it is still sore today (1/14/21)
This is a spontaneous report from a contactable nurse reported for herself. A 79-year-old female patient received PREVNAR 13, (lot L99271) for immunization on 13Nov2015 at single dose. No medical history was reported. Concomitant medications were none. On 14Nov2015 the patient experienced big discomfort in her arm for a week and it also went down the body and muscle aches and pain. The outcome of the events was reported as recovered on 21Nov2015.
Large bruise, muscular pain, irritability, difficulty sleeping. Onset of symptoms was delayed several days, including the bruising and arm pain -- there was only a small jab mark two days after vaccination.
Chills; Fever; Redness,itching and swelling of the injection site; Redness,itching and swelling of the injection site; Redness,itching and swelling of the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Redness,itching and swelling of the injection site), VACCINATION SITE PRURITUS (Redness,itching and swelling of the injection site) and VACCINATION SITE SWELLING (Redness,itching and swelling of the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0Z7AZIA and 041L20A) for COVID-19 immunisation.     No relevant past medical history was provided.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness,itching and swelling of the injection site), VACCINATION SITE PRURITUS (Redness,itching and swelling of the injection site) and VACCINATION SITE SWELLING (Redness,itching and swelling of the injection site). On 10-Mar-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Redness,itching and swelling of the injection site), VACCINATION SITE PRURITUS (Redness,itching and swelling of the injection site) and VACCINATION SITE SWELLING (Redness,itching and swelling of the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 99.7 degree fahrenheit (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not have any problems with first dose.  Additional concomitant drugs included diabetic medication, blood pressure  medication and thyroid medication (all unspecified).
Pt received the flu shot and pneumococcal vaccine in the left deltoid and had a cellulitis within 24 hours.  Alcohol was used to prep the skin.  Bandaids were applied.  Pt's PMH pertinent for long time smoker, copd
dizzy, weak and having headache,  elevated blood pressures - hypertensive urgency/emergency - required urgent care and then ER evaluation.
2hrs post vax pt became limp, pale & very listless, t102; Remained very lethargic x 24hrs & listless x 24 more hrs; Did not have vomiting, but had episode of pallor & limpness;
15mo developed rash 1 wk p/MMR; knots on back of head & behind rt ear. rash x 2 days fever 101 x 3 day & N & V, sometimes whiny; Looks like measles rash.
just really tired; nausea and vomiting; nausea and vomiting; incredibly sleepy; unable to move arm and soreness in left upper body; unable to move arm and soreness in left upper body; sore arm; This is a spontaneous report from a contactable Consumer (patient).  A 67-year-old female patient (not pregnant) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL9296), via an unspecified route of administration  in Arm Left on 07Feb2021 at 11:30 (at 67 years) as single dose for covid-19 immunisation. Medical history included asthma; she also had allergies to penicillin, to valsartan (DIOVAN), to tetanus and to passion fruit. Concomitant medications included hydrochlorothiazide, spironolactone, amlodipine besilate, dexlansoprazole (DEXILANT) and estrogens conjugated (PREMARIN), all taken for an unspecified indication, start and stop date were not reported. The patient experienced sore arm on 07Feb2021 at 16:00 (day 1); on 08Feb2021 (day 2)patient was unable to move arm and soreness in left upper body;  on 09Feb2021 (day 3) soreness was gone but she was incredibly sleepy and on 10Feb2021 (day 4) she had sleepy, nausea and vomiting; on 11Feb2021 (day 5) nausea, on 12Feb2021 and 13Feb2021 (days 6 and 7) fairly normal, just really tired and sleepy. Events were non serious. No treatment given. The final outcome of all the events was reported as recovering.Follow-up attempts are completed. No further information is expected.
have both now been diagnosed with COVID; This is a spontaneous report from a contactable consumer. This consumer reported for a 21-year-old male patient (Reporter's son) received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, solution for injection, Batch/ lot number was not reported), via unspecified route on 08Jul2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021 patient experienced Covid-19, Caller is looking for information about when her and son could get the second dose, patient was feeling better now and their Primary care physician said he could go ahead and proceed and get his scheduled second dose on 29Jul2021, the patient had COVID-19 Test on15Jul2021 and result was positive. The outcome of event was recovered in Jul2021.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100958348 same reporter/drug, different event/ patient
FEVER; HEADACHE; FELT TERRIBLE; BODY ACHE; SWEATING; CHILLS; FATIGUE; This spontaneous report received from a consumer concerned a 26 year old female. The patient's weight was 190 pounds, and height was 59 inches. The patient's concurrent conditions included asthma, non alcohol user, and electronic cigarette user, and other pre-existing medical conditions included no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced felt terrible. On 12-APR-2021, the subject experienced body ache. On 12-APR-2021, the subject experienced sweating. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, felt terrible, body ache, fever, and sweating, and had not recovered from fatigue, and headache. This report was non-serious.
Headache; Feels weak; Doesn't feel good; Numbness in her legs; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (BNT162B2), administration date 17Apr2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Apr2021, outcome "unknown", described as "Headache"; ASTHENIA (non-serious) with onset Apr2021, outcome "unknown", described as "Feels weak"; MALAISE (non-serious) with onset Apr2021, outcome "unknown", described as "Doesn't feel good"; HYPOAESTHESIA (non-serious) with onset Apr2021, outcome "unknown", described as "Numbness in her legs".  Additional information: The patient received first dose yesterday. The patient had a headache. The patient felt weak, doesn't feel good, and numbness in her legs. The patient wanted to know if she can take acetylsalicylic acid (ASPIRIN). She is concerned about blood clots.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pain on the right side of my chest and upper right side of my back; pain on the right side of my chest and upper right side of my back; rash; blisters; Shingles; redness; swelling; Pain; This is a spontaneous report from a contactable Consumer (patient). A 48-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0191), via an unspecified route of administration, administrated in right arm on 13Jul2021 12:00 (age at the time of vaccination 47-years-old), as a single dose for COVID-19 immunization. The patient medical history included Chronic fatigue, and tinnitus. The patient concomitant medications included Metoprolol, Montelukast, Atorvastatin, and Zolpidem. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW01a1), via an unspecified route of administration, administrated in right arm on 22Jun2021 14:00 (age at the time of vaccination 47-years-old), as a single dose for COVID-19 immunization and experienced the first vaccine caused pain at the injection site. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. No known allergies. On 20Jul2021 15:00, the patient experienced pain on the right side of my chest and upper right side of my back, rash, blisters, Shingles; and on an unspecified date 2021 redness, swelling, pain. Patient's doctor diagnosed with Shingles. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient took Tramadol and Pregabalin as a treatment for adverse events. The outcome for all the events was recovering.  Follow-Up (29 Sep2021): Follow-up attempts are completed. No further information is expected.
On May 29, 2021, I experienced the loss of hearing in the right ear, and one day later I developed a constant ringing in my ears which persists to the date of this report.
EXTREME PAIN RADIATING TO THE NECK AND ALL THE WAY DOWN TO THE FINGERS , TINGLING PAIN IN THE FINGERS . PAIN LASTED FOR 4 DAYS . TAKED IBUPROFEN  AND ALEVE BUT DIDN'T HELP. TALKED TO  THE DOCTOR'S OFFICE ON SATURDAY. EACH DAY IS GETTING BETTER BUT IT WAS TOO MUCH PAIN THE FIRST 4 DAYS .
Patient received a positive result on a COVID test on Sep 18 2022; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient received a positive result on a COVID test on Sep 18 2022) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa drugs).   On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2022, the patient experienced COVID-19 (Patient received a positive result on a COVID test on Sep 18 2022). At the time of the report, COVID-19 (Patient received a positive result on a COVID test on Sep 18 2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Sep-2022, SARS-CoV-2 test: (Positive) Positive.   Concomitant products included Thyroid pill. No treatment details were reported. Patient had experienced after vaccination the following symptoms: Scratchy throat and a runny nose and sneezing, so patient took COVID-19 test and it came out positive. Patient had not seek medical care. Patient had not experienced the similar events in the past.   Reporter did not allow further contact
patient states she received Moderna Vaccine for COVID 2/17/21 and 3/5/21 and then tested positive for COVID 4/22/21- admitted to hospital 4/27/21 for treatment of COVID Pneumonia
Case number PHEH2016US023469, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 56 years old patient of unknown gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in left arm on 19 Mar 2016. On 19 Mar 2016, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursions was administered to patient. The nurse stated that, no adverse event was reported following this administration error. The case was assessed as non serious by the nurse.
The patient was given a booster or third dose of Pfizer even though she is under 18 years old.  The patient's father was contacted by supervising pharmacist regarding the incident.