chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient) from the Pfizer-sponsored program. A 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL3248, expiration date: Apr2021) via an unspecified route of administration in left arm on 24Jan2021 13:30 at single dose for COVID-19 immunization. Medical history included lupus from 26Feb2019 and ongoing, biopsy done/diagnosed 26Feb2019, known to be cutaneous, unknown if systemic lupus erythematosus (SLE)-not officially diagnosed as SLE yet but keep monitoring to see, patient sister has possibly compromised immune system with lupus; ongoing allergies, included ongoing allergies/reactions to insect stings, wasp stings-that was first reaction 8-9 years ago-carried EpiPen since then, dye in a contrast medium for CT scan in Sep2020; had serious surgery, 2 subsequent surgeries, couldn't remember anything within last couple of years, 1st surgery: fall or beginning of 2019; scheduled to have surgery to repair abdominal surgery as a result of all the other stuff, had to cancel it and reschedule for spring due to rash, rash diagnosed as lupus; compromised immune status; respiratory illness; genetic / chromosomal abnormalities; endocrine abnormalities (including diabetes) and obesity; overweight. No allergies/reactions to vaccines historically. Concomitant medications included ongoing hydroxychloroquine (Zydus Pharmaceuticals, Lot number: E003901, Expiry date: 31May2022, NDC: Unknown, UPC: 4181077301, repeatedly verified dispensed in standard amber/orange pharmacy bottle; but had manufacturer label on bottle-no NDC) for lupus. The patient previously used epinephrine (EPIPEN, reported as Epi-pen) first/only time 2020: maybe summer/fall/Sep2020 for anaphylactic reaction to yellow jacket sting. On 24Jan2021 around 2:30pm she had onset of extreme fatigue (just like kind of an overwhelming fatigue). She had not even discussed having the vaccine with her PCP and did not consider extreme fatigue to be serious or something she needed to contact the doctor about. She ended up getting home, eating something, going upstairs and going to sleep (went "straight to bed"). She slept really well. Outcome improved, she was better, ok. She wondered if this was an extreme reaction to the vaccine or was this normal because this was the first shot, she read that the second dose creates even more pronounced side effects. She was asking if that was a normal reaction and can she expect that after the second dose? No vaccines administered on same date of the Pfizer suspect. The adverse event did not result in Emergency Room or Physician Office, and patient was not hospitalized. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The outcome of the event was recovering.
Pt's lower extremities became red and warm to touch giving injections to right and left thighs subsided within 1/2 hour.
This is a spontaneous report from a non-contactable consumer. A 70 years old female consumer received PREVNAR13 on unknown date in DEC2014, at single dose, in left arm. Medical history was not provided, however, the consumer stated she was in very good health. Concomitant medications were none. The first two days, since 09DEC2014 the arm was very sore. The consumer stated it felt like somebody had punched it and it hurt to lift the arm. The next day it was improved an don day of reporting it was fine. She also stated that on the second day (the day before the report) her left jaw was very sore. She could not eat and chew on it. The patient recovered from arm pain. Event outcome of jaw pain was reported as resolving.
headache; vomiting; This spontaneous report was received from a nurse and refers to a 14 year old female patient. The patient's concurrent conditions included migraine and anxiety. No other information was given regarding the patient's concomitant medications or medical history.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, frequency, route of adminstration, lot number and expiration date were not reported).    On an unknown date, after administration of the firs dose, the patient experienced headache and vomiting.      The outcome of headache and vomiting and the causal relationship between vaccination and the events were not reported.
10 minutes after vaccination I began experiencing itchiness all over body, tightening of airways. Took benadryl. Itching stopped. Airway still tight. Making it difficult to swallow. Went to urgent care for oral steroid.
I tested positive for Covid 19 on October 20, 2022, I experienced sore throat, mild congestion, mild headache, no temperature, mild cough. I was using TYLENOL for my symptoms.
Pt was under 5 year old when vaccine was administered. He developed fever the day after vaccination, followed by cough and difficulty breathing. He was given his albuterol inhaler overnight last night and into the morning, and was seen in the office this morning, 1/16/22. The pulse ox was 96% and had some crackles at lung bases.
Since the day 12, I feel bad with headaches, neck, accelerated palpitations, I feel nervous, my hands go numb, my left foot hurts up to the calf, I do not feel much improvement despite the medication, I do not have peace of mind
First bout of diarrhea occurred at 9:30pm on 9/14/04.  Second bout of explosive diarrhea and first and only occurrence of vomitting occurred at 7:30am on 9/15/04.
Initial unsolicited report received from a non-health care professional on 08-May-2017. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE QIV (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on 14-Oct-2016. Medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed rash and ultimately was hospitalized on 02-Nov-2016 with a Guillain-Barre syndrome (Hospital reported diagnosis). Laboratory investigations and corrective treatment were not reported. The outcome of events were not reported. List of documents held by sender: none. Sender's Comments: This case concerns female patient who received INFLUENZA QUADRIVAL A-B VACCINE and developed rash and Guillain Barre syndrome. Time to onset is not reported for rash while it is not compatible for Guillain Barre syndrome. However, this case is poorly documented and further information regarding etiological work up, concurrent condition at the time of vaccination, concomitant medication, and investigation results to rule out the alternative cause are needed for a complete assessment of the case.
The patient received the Pfizer 5-11 vaccine in error. The patient should have received a dose of Pfizer 12+.  No adverse reaction was oberserved.
Possible temperature excursion; Patient received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Possible temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Possible temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Possible temperature excursion) outcome was unknown and EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.  The nurse reported a possible temperature excursion at facility. According to the nurse, the shipment of vaccines were received on 08-Jul-2021 to a different team and was placed in the refrigerator. The nurse received vaccines on 30-Jul-2021 and remained in the refrigerator but was missing the expiration label of when they were previously placed in the fridge. The nurse was unaware that the vaccines were initially received and placed in the fridge 08-Jul-2021. The max temperature reached was 41.4 F and min 40.6 F. The number of Moderna vials affected were 4 vials. Of those 4 vials, 3 of the vials were used to administer vaccinations to 9 patients over 3 days from 09-Aug-2021 to 11-Aug-2021. At the time of excursion the vials remained refrigerated. The 1 vial that was not used was discarded. The nurse reported not noticing any vaccine state changes. The patient received an expired vaccine past 30 days in the fridge.
local hypersensitivity rxn: raised, pruritic erythematous patch approx 3in diameter @ site of inj;
Anaphylaxis, after the second dose.; Throat swelling, after second dose.; This is a spontaneous report from a contactable pharmacist. A female patient of unspecified age received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0158, expiration date: 31Jul2021) via an unspecified route of administration on 15Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization, experienced tingling in throat, after first vaccine.  The reporter stated the throat swelling was resolved and she was given Benadryl IM and transferred to the emergency department. There, she was given Epinephrine, and she had an increased heart rate. The reporter was not sure if that was a complication, but did not know for sure. The reporter did not have any information specifically. Eventually the patient improved. Anaphylaxis was resolved after treatment in the emergency room, but was unsure exactly. The reporter stated that 14 prime, or first doses were given and 21 boosters, or second doses were given. No additional Vaccines Administered on Same Date of the Pfizer Suspect.  The patient required visit to the Emergency Room for events. About the medical intervention, the reporter stated that a Rapid Response was called at the site of the vaccination, and an intravenous line was started and the patient was given Solumedrol. In the emergency room, the patient was given Benadryl intramuscularly and Epinephrine was given. The heart rate increased after the Epinephrine, and then the employee had a good outcome. The patient was hospitalized. There was no multiorgan involvement, respiratory involved. Outcome of the events was recovered. Reporter seriousness for Throat swelling and anaphylaxis was Life threatening. Event relatedness was reported as related.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events throat swelling and anaphylaxis based on the known safety profile.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
vomiting, diarrhea, fever, fussiness greater than 3 hours. small sips of fluid.
Severe headache; Cheek and jaw pain; Cheek and jaw pain; Fever between 99.3 and 100.6; Severe fatigue; Unable to eat; Severe shaking started about 10 hours after shot, lasted almost 2 hours,; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FG3527) via an unspecified route of administration in the left arm on 03Nov2021 at 13:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included mild high blood pressure. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received influenza vaccine (MANUFACTURER UNKNOWN) for immunisation on 26Oct2021 in the left arm. Concomitant medications included magnesium (MANUFACTURER UNKNOWN), amlodipine besilate (AMLODIPINE BESYLATE) and krill oil (MANUFACTURER UNKNOWN), all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 02Mar2021 (at the age of 71-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 25Mar2021 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. On 03Nov2021 at 23:30 10 hours after the shot, the patient experienced severe shaking and lasted almost 2 hours. On 04Nov2021, day following the shot patient experienced severe headache, cheek and jaw pain, fever between 99.3 and 100.6 (unspecified units), severe fatigue and unable to eat. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe shaking was resolved on 04Nov2021 at 01:30; while that of the events severe headache, fever between 99.3 and 100.6, cheek and jaw pain, severe fatigue and unable to eat were resolving at the time of this report.
Approximately 8-10 following the vaccine, the patient exhibited signs of lightheadedness and dizziness. They were then asked to be seated while they recovered.
This spontaneous report was received from a 81 year old male patient regarding himself. On an unknown date in 2008, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not reported). On an unknown date, the patient experienced shingles recently. The patient indicated he had red bumps and a rash on his stomach and back and he itches. The patient had blood work done every 3 months. Treatment rendered was Triamcinolone cream for hives rash. The outcome of the events were reported as not recovered. The patient sought medical attention. Additional information has been requested.
Pt. faint after 3rd shot (HPV). Improved after lying down and feet elevated, cool cloth. Advised to lie down or sit for 15 minutes. While I stepped out of the room to get water and crackers. Mom reported pt was nauseated and stood to lean over trash can when pt. fainted. Mom reported pt. hit forehead on trash bin. Improved after 30 min.
back in 2013, patient was vaccinated with a first dose of GARDASIL but he never completed the series then on 11-JUL-2019, patient got his 1st dose of GARDASIL 9; back in 2013, patient was vaccinated with a first dose of GARDASIL but he never completed the series then on 11-JUL-2019, patient got his 1st dose of GARDASIL 9; No adverse reaction reported; This spontaneous report was received from a currently 27 year old male patient concerning himself. Patient's concurrent conditions, medical history and concomitant therapies were not reported.     Sometime back in 2013, the patient was vaccinated with a first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis but he never completed the series. Then on 11-JUL-2019, patient got his 1st dose of the newer HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) for prophylaxis in an unknown "clinic" and he said he was told by the clinic that he should come back to the clinic in approximately 6 monlhs to receive his 2nd dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) series, which he had not done yet.   Patient said he was getting mixed information from the clinic who told him to get vaccinated wifh his 2nd dose 6 months from the 1st dose (administered on 11-JUL-2019) and then he would still need to get his 3rd dose, however, his unknown physician told him he would only need one more dose of the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) to complete the series. No adverse reaction reported. No PQC involved. No additional AE information was given.
neurological problems; shingles; tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of NEUROLOGICAL SYMPTOM (neurological problems), HERPES ZOSTER (shingles) and TINNITUS (tinnitus) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced NEUROLOGICAL SYMPTOM (neurological problems), HERPES ZOSTER (shingles) and TINNITUS (tinnitus). At the time of the report, NEUROLOGICAL SYMPTOM (neurological problems), HERPES ZOSTER (shingles) and TINNITUS (tinnitus) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient reports she was on social media and had seen so many people post about having neurological issues like Tinnitus and Shingles after receiving the vaccine.  No specific information on the brand of vaccine.  No information was provided that the patient experienced these symptoms herself.    Concomitant medications were not reported.   Treatment information if any was not provided.   This case was linked.   Reporter did not allow further contact; Sender's Comments:
Had nausea, fever, chills, headache and body aches following vaccine. Symptoms resolved. On 2/23, 3 days post vaccine, she developed abdominal cramping and diarrhea.
Patient states still having pain in left arm following vaccination beginning day after vaccination. Pain/numbness radiates up to neck and down to wrist. Recommended patient seek advice of her primary doctor and use over the counter tylenol and heat to manage pain
On 8/23/21 Patient said he had skin reaction (itching) after first shot of Pfizer COVID vaccine on 6/26/21. After the second vaccine on 8/6/21, he continued to have skin reaction.  In addition he passed out at night time.  He also hears noise in his ears.  He will see his family doctor shortly.
Mildly pruritic maculopapular rash at sites of immunoglobulin injection & rabies vaccines injection. Asked mom to give 2-5 ml of children's BENADRYL every 8-10 hrs as needed.
No adverse event; expired dose of ROTATEQ was administered; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported.  On 03-MAY-2021, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot # 1660991, expiration date 27-APR-2021 (dose and route of administration were not reported) for prophylaxis. No additional adverse event or product quality concern was reported.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 10:56 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 10:50 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  The age of patient was provided as 24.02 on 27-Feb-2021 and 24.10 on 27-Mar-2021.  On 27-Feb-2021, Excursion time was 09 AM to 5 PM temperature range was from 33 to 35, total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  On 27-Feb-2021, vials were stored in cooler 1, at following time and temperature excursion was in the range of 33 to 36 degree Celsius from 08 AM to 4 PM.   On 27-Mar-2021, Excursion time was 9 AM and 10 AM, temperature was 35, total doses given for the day was 195, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021,vial was moved to clinic on 27-Mar-2021. 20 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Started with sudden headache which gradually worsened.  Dizziness/light headed followed by progressive foggy thought process, severe arm soreness,  and general aches all worsening through the night.
On September 29 patient felt feverish and clammy. She felt worse Saturday as the day continued. Sunday morning she went to Urgent Care. Three cysts were erupting and very painful. Cultures later confirmed septic condition. She went to her doctor Monday and was diagnosed with 3 pilonidal cysts that were MRSA. She never had anything of this nature before. It was extremely painful and they were surgically removed and drainage tubes inserted. She is still fighting off the infection.
Generally sore legs, unwillingness to walk, resistance to being picked up in the week after the shots. On 3/10/23, while mother was bathing her, a markedly red area with a central, raised, more pale, welt like lesion (described as looking like a bug bite) was noted over the more inferior injection site on the left leg. This resolved on its own the same day. Later two of the injection sites were noted to have small nontender <0.5cm subcutaneous nodules beneath the injection site on the right thigh and the uppermost injectionsite on the left thigh.