chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart fluttering; chest pressure; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EK5730; expiration date: not known), via an unspecified route of administration in the left arm at hospital on 31Dec2020 10:00 at at single dose for COVID-19 immunization. Medical history included known allergies with sulfa. The patient is not pregnant. The patient's concomitant medications were not reported. The patient previously took clarithromycin (BIAXIN), metronidazole benzoate (FLAGYL), and sulfamethoxazole, trimethoprim (BACTRIM), and all but experienced allergies (reported as "known allergies: Biaxin, Flagyl, sulfa, Bactrim"). No COVID prior to vaccination and no COVID tested post vaccination. The patient experienced heart fluttering and chest pressure on 04Jan2021. There was no treatment received for the reported events. The outcome of the events was not recovered.; Sender's Comments: A causal relationship between the reported heart fluttering and the use of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded due to temporal relationship.  The case will be reassessed should additional information become available.  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.
Sore injection site left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site left arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025D21A, 032M20A and 014M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site left arm). At the time of the report, VACCINATION SITE PAIN (Sore injection site left arm) outcome was unknown.            Concomitant product use was not provided by the reporter.  The patient did not experience any adverse reaction after the primary doses of Moderna COVID-19 vaccine.  Treatment information was not provided.   This case was linked to MOD-2022-660904 (Patient Link).
EMS contacted due to pt becoming less responsive; pt found to be hypoxic; brought to ED and intubated; pt had been in the hospital from 12/24 - 12/25/21 for opioid overdose, COVID pneumonia, blood cultures growing staph and pseudomonas; pt left hospital; returns to hosp on 12/31/21 hypoxic; started on remdesivir, dexamethasone, steroids, anticoagulant, ABX; AKI; hypotensive requiring vasopressors; pt's condition worsened; family dc'd aggressive invasive care with medications only to alleviate suffering; pt extubated and died in the hospital
When I raised my arms up there was soreness (3-4 times in an hour or 2 hour period) where they gave the vaccine; This is a spontaneous report from a contactable Nurse (self). A 65-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Jan2021 (at 65 years of age), as single dose for COVID-19 immunisation.  Medical history was lung disease, scar tissue in lungs and Sarcoidosis. Concomitant medication was not reported. After reading the documents she realized the second dose should be scheduled 21 days after first dose. Her schedule for the second dose is 28 days after the first dose. The patient experienced "Yesterday evening (22Jan2021) when I raised my arms up there was soreness (3-4 times in an hour or 2-hour period) where they gave the vaccine."  Outcome of event "When I raised my arms up there was soreness (3-4 times in an hour or 2 hour period) where they gave the vaccine" was unknown.    The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
itching; Had sore arm after the injection; Had couple of lump in her back; 8 days later development rash on her breast, her back under her arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), PAIN IN EXTREMITY (Had sore arm after the injection), MASS (Had couple of lump in her back) and RASH (8 days later development rash on her breast, her back under her arm) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M24A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching), PAIN IN EXTREMITY (Had sore arm after the injection), MASS (Had couple of lump in her back) and RASH (8 days later development rash on her breast, her back under her arm). At the time of the report, PRURITUS (itching) and RASH (8 days later development rash on her breast, her back under her arm) had not resolved, PAIN IN EXTREMITY (Had sore arm after the injection) had resolved and MASS (Had couple of lump in her back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided.  treatment medication include Topical cream  Action taken with mRNA-1273 in response to the event was unknown
Redness and firmness, warmth over 5-6 cm Lt deltoid. No systemic symptoms.
red spots all over body, about the size of a quarter doctor said it may be morbilloform
Coughing heard in hallway where child was playing at 16:40 to 16:45. Child's face was red, increased tearing, runny nose, coughing with mild inspiratory stridor, good air entry, expiratory wheezing, P 104. Rapidly mucousy SOB. Given Adrenalin at 16:45. O2 by mask, Benadryl, IM, increased SOB and colapse into deep cyanosis; BP 90/60 from 16:45 to 16:55. Then albuterol by nebulizer. Transferred to ER by EMS-given adrenalin, albuterol  by mask, prednisone and discharged.
On 1/10,  noted GI symptoms, nausea, diarrhea and on 1/12 the arm became red and warm and itchy.  The area of redness expanded on 1/13.
On an unspecified date the pt received a vax. Some time later (exact date not provided) the pt filed a Workers Compensation claim on 1/1/98. The pt developed Sjorgens Syndrome and fibromyalgia. It is unknown what treatment the pt received or if she was hospitalized. Per follow-up received on 8/24/00, no additional information is expected in this report.  Per the reporting lawyer, the pt claims the events were as a result of receiving the vaccine.  The most recent information received on 2/29/00 reports the outcome of pt as unknown.  This case has been classified as serious because the pt claims that she has been unable to work.
On 5/2/01 the pt woke with hives to injection site and both legs. No itching, no restlessness, afebrile, no dyspnea. Not at 9:20 has urticaria to her back, hands, arms, wrists as reported by mother and pediatrician. No treatment given at this time.
Rash on both forearmand itching after 4 days, Did not associate it with the Hepatitis B shot, Went to Dr 3 weeks after 1st shot, Dr stated ?allergic reaction, Got 2nd Hepatitis B 06/13/02, left on missions trip to Jamaica 6/14/02 for 8 days and the itchy started 3 days after shot this time. Itching worsen and c/o pain in arms still has itching, Dr advised not to take another Hepatitis vaccine.
Redness to RT upper arm, slightly raised and warm to touch, c/o soreness area of redness is where varicella vaccine was given . Advised warm compresses, to seek med. care if continue to swell.
Patient started to feel nauseated. I feel this was due to her sugar dropping but am reporting it just to be on the safe side.
tingling in legs & muscles aches;handled the plastic bag that was chewed by a rabid skunk;31MAR95 f/u only given 3 doses of vax;titer check on 10JAN95=>1:50 all sx resolved
Fluttering in heart  flu like symptoms feeling this way 25 days later. Severe shortness of breath.
starting 10 minutes after the vaccine was given my mouth was very briefly tingling, warm wave came over me, my heart starts to race and del lightheaded. they told me to lean back and relax and it went away in less than a minute.
Per mom Pts thigh swelled up and a red rash appeared after the vaccines were given.
tingling in right hand progressing up arm, patient felt like heart was racing, felt hot and sweaty. Heart rate was normal and skin felt normal to touch per medical staff. Patient denied shortness of breath, itching, no rash noted. Medical Authority, assessed patient, ordered Benadryl 25mg po. Patient intially denied need to take Benadryl, advised patient will need to be observed in emergency department. Patient did not want to go to the ED and instead took Benadryl 25mg po. Patient was monitored for 1 hour and 10 minutes, 55 minutes after Benadryl given. Patient felt ready to leave at this time.
Bruised; Vaccination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruised) and VACCINATION SITE SWELLING (Vaccination site swelling) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukemia.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced CONTUSION (Bruised) and VACCINATION SITE SWELLING (Vaccination site swelling). On 02-May-2021, CONTUSION (Bruised) and VACCINATION SITE SWELLING (Vaccination site swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment include hydrocortisone cream.   This case was linked to MOD-2021-194420 (Patient Link).
Localized reaction right upper arm + edema + red.  No complaint of tenderness.  Treated with BENADRYL & TYLENOL.
Shingles; Tingling; Itching; Rash appeared on my back and got worse over a few days; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ewo175) via an unspecified route of administration in the left arm on 28Apr2021 at 12:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included loratadine (CLARITIN) and RITUAL multivitamin. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took penicillin and experienced allergy. The patient previously also received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8729) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 15:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 03May2021, a few days after the injection on Monday, the patient noticed itching, tingling, a rash appeared on the back, got worse over a few days and patient also stated it was a possible case of shingles. On 06May2021, the patient visited her dermatologist and he suspected shingles. On an unknown date in May2021, the patient underwent viral test done to confirm shingles and results were unknown. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with antiviral. The clinical outcome of the events shingles, itching, tingling and rash was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Grand Mal Tonic-Clonic seizure 3:30 p.m.
I had a patient come in today for her second dose of the Moderna vaccine and when asking her about any reactions to her first dose, she stated the usual dizziness and tiredness, but also complained of periodic "eyebrow twitching" that started approximately 3 days post-vaccination and lasted about 3 days. During this time she had one occurrence of what she described as a "brain twitch" on the 4th day after vaccination. She joked that she was wondering if what she was experiencing was an aneurysm, but the feeling only happened once and went away so she didn't think about it again. While talking to her she said she has never experienced any eyebrow or "brain" twitches in the past, however she has experienced eyelid twitches before. I asked her if she experienced any major changes this past month at may cause a change in her stress level and she said she has not. We decided to hold off on her second dose today while I looked into this more. I reached out to my Clinical Coordinator and am awaiting a response.
Left deltoid with erythemic area of 4 inches in circumference tender to touch/warm. Fever of 102.4.  c/o:  Malaise, SOB, difficult breathing, difficult ambulating.
I felt like I had the flu/I was really sick.; I started to feel achy; My arm hurt/Felt like someone sucker-punched me in the arm; ince I got the shot, I got more pain in my spine area. I had to increase the frequency of Ibuprofen; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (ince I got the shot, I got more pain in my spine area. I had to increase the frequency of Ibuprofen), ILLNESS (I felt like I had the flu/I was really sick.), PAIN (I started to feel achy) and VACCINATION SITE PAIN (My arm hurt/Felt like someone sucker-punched me in the arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (In left breast.). Concomitant products included LISINOPRIL, ATENOLOL, CLONIDINE, OMEPRAZOLE, ROSUVASTATIN and AMLODIPINE BESYLATE for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced SPINAL PAIN (ince I got the shot, I got more pain in my spine area. I had to increase the frequency of Ibuprofen) and VACCINATION SITE PAIN (My arm hurt/Felt like someone sucker-punched me in the arm). On 02-Feb-2021, the patient experienced ILLNESS (I felt like I had the flu/I was really sick.) and PAIN (I started to feel achy). The patient was treated with IBUPROFEN on 20-Jan-2021 for Pain in arm, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) on 02-Feb-2021 for Flu like symptoms, at a dose of 2 dosage form. On 21-Jan-2021, VACCINATION SITE PAIN (My arm hurt/Felt like someone sucker-punched me in the arm) had resolved. On 05-Feb-2021, SPINAL PAIN (ince I got the shot, I got more pain in my spine area. I had to increase the frequency of Ibuprofen), ILLNESS (I felt like I had the flu/I was really sick.) and PAIN (I started to feel achy) had resolved. Split for coding purposes      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included Vitamin D, E  and Ibuprofen as needed.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Non-significant follow-up information was received.
8/8/06 at 7:50 nurse was administering primary small pox series (jabs) to pt. On last jab he moved, causing Bifurcated needle to release fluid that contacted inner canthus of her right eye. Immediately 15 min flush with tap water conducted. Then taken to Hosp. Evaluation by ophthalmology. Released same day.
BLOOD CLOT; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was reported that on an unspecified date, the patient experienced a blood clot. There was no additional information provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210626844-COVID-19 VACCINE AD26.COV2.S-blood clot. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Light headed - within 15 minutes, nausea, fatigue, headache - persistent. Treated with ZOFRAN.
My arm/shoulder (injection site) became visibly bruised, sore, and itchy.  It remained itchy and sore for about 2 weeks.  I've never had a reaction like this before to the flu vaccine.
Enlarged axillary lymph node, tender left collar bone, intractable pain of the axila.
Vaccine administered too high on right deltoid near the shoulder/clavicle resulting in frozen shoulder/bursitis
Injection site redness, swelling & redness; Fever, chills, extreme all over body pain, headache.
Immediately after shots she became limp and lost consciousness. Was sitting on exam table & nurse was at her side and laid her down on table. She did have some jerks and generalized stiffening of arms and body. Her eye rolled back. No tonic-clonic jerking. No lateral eye movements. Very Pale and Diaphoretic. Entire event 1 minute with syncope post vaccination. Wish myoclonic jerks, watched for 30 min. Better when left.
Health concern: Patient received 2 doses of Moderna Covid 19 Vaccine in this office. 1st dose was administered on 02/26/2021 Lot# 010A21A and 2nd dose on 03/26/2021 lot # 031A21A. After patient received his 2nd dose, this provider was writing his vaccine card, when his DOB was entered, it was then noticed that patient was under 18 years of age, by this time, patient had already been monitored for 15 minutes with no reaction to the vaccine. Patient had also indicated he had no side effects from first dose. Patient was given his card and he left accompanied by his mother.
pt recv vax 5SEP97 & had positive pregnancy test 24SEP97;DEC 12MAY98;
Patient came to pharmacy and stated that after getting the vaccine she experienced dizziness, swelling and rash.
This spontaneous report as received from a nurse refers to a 03-month-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 20-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M042170, expiry date: 22-JUN-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
Migraine Headaches; Shortened Menstrual Cycle; PMS; Ear Ringing/Tinnitus; This is a spontaneous report from a non-contactable consumer (patient). A 33-years-old female patient received First dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: ER8734 and Expiration date: unknown) via an unknown route of administration, in left arm on 31Mar2021 at 15:45 as single dose, second dose via an unknown route of administration, in left arm on 22Apr2021 at 17:15 (Batch/Lot Number: EW0162) as single dose for covid-19 immunisation. Medical history included Tear Duct Clog as a Child and had Surgery to unblock both tear ducts as at the age of 4 and Heightened Local reactions to Beestings and those alike. Concomitant medications included alprazolam (ALPRAZOLAM) and methylphenidate (METHYLPHENIDATE). Patient was not tested positive for covid prior vaccination. Patient has not received other vaccine in four weeks. On an unknown date in Apr2021, the patient experienced migraine headaches (never experienced previously) began as gradual, now debilitating. Onset same time each day, shortened menstrual cycle followed by extreme PMS symptoms: Hot flashes, mood swings, extreme fatigue, brain fog. Also ear ringing/tinnitus, consistent ringing in the ears throughout the day, gradually builds throughout the day. Subsides after sleeping. Patient was not tested covid positive post vaccination. No treatment was received for events. The Outcome of events Polymenorrhoea, Premenstrual syndrome and Tinnitus was not recovered wheareas outcome of event migraine was recovering.  No follow-up attempts are possible. No further information is expected.
Shoulder and arm soreness, could not lift arm above waist.  Took some tynenol and put icy hot on my arm and shoulder.
Got the shot and then shingles/suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 7-Oct-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The patient (a friend of reporter's daughter's) got the shot and then got shingles. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Systemic: she can not move her head/ can not drive/ neck is sore-Medium
EVENING OF 1/13/21, DEVELOPED FEVER OF 100.2, THREW UP, AND WAS THIRSTY.
After receiving PCV13 on 11/11/19, patient reports feeling dizzy and tired that night. This self-resolved but on 11/12/19, she started getting Left arm pain with redness, swelling. No fever, chills, nausea, or vomiting.  Might have had similar vaccine reaction in past (not sure) but never this significant.   Slight pain, 3/10.  Rash is not spreading, no where else on body.