chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bad, strong chemical taste in mouth from approximately 10 minutes after vaccination for about 6 days after. Slight confusion from about 15 minutes after vaccination, lasting about 15 minutes. Second morning after vaccination woke up seeing a greenish tint to my vision. That cleared in about 5 minutes after drinking a cup of water. Besides these more unusual reactions, my vaccinated arm was sore for several days and I had a runny nose for about 30 -60 minutes on the 4th day afterward and some queasiness and upset stomach also for a day on the 4th day with some fatigue.
Headache within 30 minutes of rec. vaccine.  Swelling in arm and hard knot with rash and heat in the area of injection noticed the next day.
This spontaneous report was received from a registered nurse regarding unspecified patients unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # L050907 with expiration date 14-JUL-2017 or lot # M011664 with expiration date 08-SEP-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 11.5 degrees Fahrenheit for 3 hours and 54 minutes. Data logger was involved. The temperature was back in range. The previous excursions were the following: 15 degrees Fahrenheit during one hour and 20 minutes, 7 degrees Fahrenheit during two hours and 24.1 unspecified degrees during five hours and 41 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
back ache (bones); headache; body ache; nausea; lymph node inflammation both armpits (ongoing); This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back ache (bones)), VACCINATION SITE LYMPHADENOPATHY (lymph node inflammation both armpits (ongoing)), HEADACHE (headache), MYALGIA (body ache) and NAUSEA (nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 041L20A) for COVID-19 vaccination.     Concomitant products included OXCARBAZEPINE (TRILEPTAL), GABAPENTIN (NEURONTIN), SERTRALINE HYDROCHLORIDE (ZOLOFT), ATORVASTATIN, METFORMIN and VITAMINS NOS for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced BACK PAIN (back ache (bones)), HEADACHE (headache), MYALGIA (body ache) and NAUSEA (nausea). In 2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (lymph node inflammation both armpits (ongoing)). The patient was treated with Immunotherapy for Myalgia. On 18-Feb-2021, BACK PAIN (back ache (bones)), HEADACHE (headache), MYALGIA (body ache) and NAUSEA (nausea) had resolved. At the time of the report, VACCINATION SITE LYMPHADENOPATHY (lymph node inflammation both armpits (ongoing)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Mammogram: lymph node inflammation (abnormal) lymph node inflammation. In October 2021, Mammogram: nodules were still inflamed (abnormal) nodules were still inflamed.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 19-Jan-2021, the patient received the first dose of vaccine and states no adverse event after first dose. On 16-Feb-2021, she receive the second dose of vaccine and experienced headache, body ache, back ache (bones), nausea. All side effects started the next day after the second dose and lasted during all day. By midday of the third day everything was back to normal. She did not notice any lymph node inflammation at the time, these appeared in the mammogram in August/September. She did perform another mammogram in October, and the nodules were still inflamed.  It was stated that, she might have taken something for the pain, but does not recall.  No concomitant medications were reported.  No treatment information was reported.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Experiencing side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. 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 VACCINATION COMPLICATION (Experiencing side effects). At the time of the report, VACCINATION COMPLICATION (Experiencing side effects) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Severe itchy skin, itchy bumps, itch is so bad it wakes me up in the middle of the night, the scratching has cause bruising and lesions on my skin. I was told from the PCP that I had "severe dry skin." Changed soaps, detergents and lotions as directed with no relief. Dermatologists recommended a steroid cream and Allegra x 1 in the morning and Xyzal x 1 at night, with no relief. Symptoms started days after receiving the 2nd dose.
Employee received flu vaccine at work "flu clinic" she is having pain with shoulder ROM at 90 degrees forward flexion, internal rotation and adduction/flexion. Pain can go up to 4-5/10. She still have pain 7 wks later.
No additional AE reported; Improperly stored administered VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies, current conditions, and concomitant medications were not reported.      On 09-FEB-2021, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T021825 with an expiration date on 25-JUN-2022) at a dose of 0.5 milliliters (strength and route of administration were not reported) for prophylaxis (product storage error).     The administered dose of the vaccine was stored at a temperature of 6 degrees Fahrenheit (F) to 14 F (6.1°F) during a time frame of 87 hours, as recorded by a digital data logger. There was not previous temperature excursión.   No additional adverse events were reported.
she had fever; chills; nausea; felt sick for 24 hours, had to stay in bed; felt sick for 24 hours, had to stay in bed; This non-serious case was reported by a consumer via call center representative and described the occurrence of sickness in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: felt sick for 24 hours, had to stay in bed), fever (Verbatim: she had fever), chills (Verbatim: chills), nausea (Verbatim: nausea) and bedridden (Verbatim: felt sick for 24 hours, had to stay in bed).The outcome of the sickness was resolved (duration 24 hrs) and the outcome of the fever, chills, nausea and bedridden were resolved.   It was unknown if the reporter considered the sickness, fever, chills, nausea and bedridden to be related to Shingrix.  It was unknown if the company considered the sickness, fever, chills, nausea and bedridden to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-OCT-2023 The reporter stated that she received Shingrix in early April 2023.  She stated that she was sick for 24 hours after and had to stay in bed.  She also mentioned that she had fever, chills and nausea that only lasted a few days.  She would be getting dose 2 before the 6 month window ended. The reporter did not consent to follow-up.
Vertigo upon awakening next morning. Subsided in about 1/2 hour (w/ mild nausea).
23JUL96 pt exp free air in small bowel w/multiple perforations which required surgery;14SEP96 pt died;COD unk;reporter felt pt exp of perforated bowel & hyaline membrane disease r/t prematurity;
Had covid and took Plaxovid right away; Had covid and took Plaxovid right away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: El9264), in right arm, on 26Feb2021 as dose 2, single (Lot number: En6203), in right arm and on 06Oct2021 as dose 3 (booster), single (Lot number: 301558A) at the age of 66 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Mar2022, outcome "unknown" and all described as "Had covid and took Plaxovid right away". Therapeutic measures were taken as a result of covid-19. Clinical course: No known allergies. 8 (maybe fewer) days after taking Plaxovid my covid symptoms got worse: Had covid and took Plaxovid right away: had fever for two days and then steadily got better. Then a few days after finishing Plaxovid I had a fever for 2.5 days and developed new symptoms. Felt worse the second time. Fever cough and shortness of breath. I still have the cough sometimes abs shortness of breath daily, though improving. If patient recovered: Recovered with lasting effects.  Follow-up attempts are completed. No further information is expected.
RECEIVE THE BOOSTER FOR MODERNA EARLIE IT HASN'T BEEN APPROVE YET RECEIVE A FULL DOSE OF THE MODERNA VACCINE. CDC RECOMENDS HALF.
Engerix B below recommended temperature, administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect product storage in a patient who received HBV (Engerix B) (batch number N4GA4, expiry date unknown) for prophylaxis.   On 3rd May 2022, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.   Additional Information: GSK Receipt Date: 11-May-2022 Reporter's comments: Engerix-B vaccines went below recommended temperature range on 21st March 2022. The lowest temperature was 30.2F. The readings were then ranging from 32.9F to 41.8F. The duration was 7 hr. 45 min.  A dose was subsequently administered. The reporter did not have expiration date, or patient information aside from initials. Till the time of reporting, a repeat dose had not been administered. The reporter consented to follow up. Additional Supportive Information: The patient received incorrectly stored vaccine, which led to product storage error; Sender's Comments:  US-GLAXOSMITHKLINE-US2022077006:Same reporter US-GLAXOSMITHKLINE-US2022077007:Same reporter US-GLAXOSMITHKLINE-US2022077008:Same reporter US-GLAXOSMITHKLINE-US2022077005:Same reporter
-Redness, itching, swelling at injection site. -Arm remained red and swollen and migrated (hives) toward elbow. -Symptoms resolved on 11/5/15.
1 day post vax pt experienced worsening of her arthritis & profound fatigue & malaise; Rec'd 2nd dose of vax w/out recurrence of her sx;
Had flu like symptoms? fever,?. aches?tiredness  Last year had heart issues like fast heart beat & heart pains
Shingles outbreak on right side if face from chin, up around mouth and onto side of nose. Red, painful, itchy fluid filled blisters.
Friday evening started with a headache and eyes feeling bulging. I went to sleep at 9pm until noon waking occasionally. Saturday I felt great.  Sunday started great, but late afternoon i had dihedra, which I had on the first shoot. I laid down afterward and feel asleep on and off for a few hours. After waking, I went back to doing house hold jobs and started having shortness of breath, and some mild coughing for an hour or so., then it passed. A few hours later the berthing  issues came back with harder coughs like whooping cough. My oxygen level stayed at 99. I finally feel asleep and Monday morning I am fine.
He then came back with Covid; He then came back with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 78-year-old male 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 included: "hypertension/high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "He then came back with Covid". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient stated he was planning to visit his grandkids and better to come up first week of Sept. He doesn't want to leave until he was vaccinated. He called and was told he can get the shot 15Aug2023. And so, he ended up getting the booster. He then came back with Covid, he did have Paxlovid and needed to go around with N95 mask. He added he got his first shot of Covid, got tested and was clean. He wanted to know what was given to him that's why he called Pfizer to check when was the new vaccine released. He was told he cannot get a flu shot or get a test. He said had they told him it was an old vaccine version, he would have waited and rescheduled his trip. He also mentioned he did not get into the Facility till May 2014. He said he has hypertension/high blood pressure but Facility turned him down and said it was not bad enough. And so he quit Facility and moved his medical.  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.
feel like vomiting; dizzy; Booster; Off label use; Interchange of vaccine products; arm hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 41 year-old female patient received bnt162b2 (COMIRNATY), administration date 27Nov2021 (Batch/Lot number: unknown) at the age of 41 years as dose 2 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine from johnson & johnson (DOSE 1, received her first dose of COVID-19 vaccine from Johnson & Johnson on 17Mar2021), administration date: 17Mar2021, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Nov2021, outcome "unknown", described as "Booster"; OFF LABEL USE (non-serious) with onset 27Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 27Nov2021, outcome "unknown", described as "Interchange of vaccine products"; PAIN IN EXTREMITY (non-serious) with onset 27Nov2021, outcome "recovered" (29Nov2021), described as "arm hurt"; VOMITING (non-serious) with onset 06Dec2021, outcome "recovered" (Dec2021), described as "feel like vomiting"; DIZZINESS (non-serious) with onset 06Dec2021, outcome "not recovered", described as "dizzy".  Additional information: female patient received her first dose of COVID-19 vaccine from Johnson & Johnson on 17Mar2021, she mentioned that she got scared of what she heard about the Johnson & Johnson vaccine. She got the booster dose of Pfizer COVID-19 vaccination on Saturday 27Nov2021 and reported: "Tomorrow it'll be 2 weeks from getting her Pfizer booster, she had a reaction; arm hurt only for a day and a half, and then it subsided, she got the shot and the next day, and by Monday she was fine. Last Monday (06Dec2021) started to feel like vomiting and felt dizzy. She spent 2 or 3 days with the feeling of vomiting and not being able to eat well due to vomiting, then the vomiting stopped but the dizziness continues still, although the feeling has decreased a little bit. It has affected in daily activities, she have hardly worked, because still feel a little dizzy to work.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Injection site soreness, chills, muscle aches onset at 28 hrs after injection; have not yet subsided. Nausea, chest tightness onset at 34 hours post  injection; subsided after 2 hours.
Onset round pink-red flat rash-started clusters on trunk, then to arms and legs in 48 hours.  fussy.  Treatment: supportive
SARS-COV 2 PCR test positive; SARS-COV 2 PCR test positive; This is a literature report for the following literature source(s): DOI:doi.org/10.21203/rs.3.rs-1588371/v2.  A 69-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Lot number: unknown), as dose 2, single (Lot number: unknown), as dose 3 (booster), single (Lot number: Unknown) and as dose 4 (booster), single (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 "recovered" and all described as "SARS-COV 2 PCR test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Day 0-3; negative, notes: Day 4-9; 28.6, notes: Day 2; 25.8, notes: day 10; 36.4, notes: Day 12. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events: "Drug ineffective", "COVID-19" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.,Linked Report(s) : DE-PFIZER INC-202200740728 Same article, other patient (1)
This is a spontaneous report from a contactable healthcare professional (HCP) received via a Pfizer sales representative. A patient of unspecified age, race/ethnicity and gender received PREVNAR 13 on an unspecified date, at single dose, for immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced pneumonia, otitis and sinus. The outcome of the reported events was unknown. Information on the batch number has been requested. Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded toward the occurrence of pneumonia and otitis.  Further information like confirmative pathological/serotype results and vaccination details including age, location and schedule are needed for full medical assessment.
12 hours after severe painful debilitating headache, random stabbing pains all over body sporadically, fever (101.5), chills, body aches.  Motrin, Tylenol for 24 hours.  After 24 hours of severe symptoms another 12 hours fatigue and low grade headache. 48 hours later just low fatigue.
Child received 2 month vaccines as Pentacel, Prevnar and Rotateq.  Vaccines given at 10:30 AM, Infant had inconsolable crying and mild fever (not recorded) for a period of 5-6 hrs with a small nap in between.  Child was seen in my office later in the evening at 4.30 PM, tylenol was given and ice pack applied on the thighs.  Child gradually settled in 1.5 hrs after Tylenol and Ice, fed BF and remained OK since, temp in ofice was 99.1.  Called mom today and said to be doing fine.  Mom did give a total of 4 doses of Tylenol
pain in my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in my arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in my arm). At the time of the report, PAIN IN EXTREMITY (pain in my arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
1st Moderna vaccine 3/18/21, no symptoms/adverse events. 2nd moderna vaccine 4/14/21, no adverse events until 5/28/21 had lost ability to move left side, was found on floor in home 4 days later on 5/26. Taken to hospital and was diagnosed with stroke. I asked the physician to report this to VAERS and he wouldn't because he didn't believe the vaccine was the cause. CDC states healthcare providers are required by law to report any unplanned hospitalization, disability (no date limit) after covid-19 vaccination, but physician kept refusing to report this to VAERS. My husband was from home independently and is now disabled, unable to move his left side and is going to a facility for long term care.
Received shingles vaccine on Monday June 4, 2012. Two days later the area around my upper left arm where Dr.'s PA gave me the shot was red, swollen & quite sore. Went to Dr. & he prescribed BENADRYL topically & by mouth if needed. (I only used topical BENADRYL). The "rash" lasted 2 weeks and the upper arm is still slightly sore.
Patient passed away of a heart attack on 7-15-2021 Unsure if this was related but he had several EKG that were clear. But I thought I should let you know
Information has been received from a pharmacist via Pfizer refers to an approximately 67 year old male patient. The patient's concurrent condition included wheezing and shortness of breath, gastroesophageal reflux disease, blood pressure disorder, thyroid function abnormal and hypertension. On 23-JAN-2014 (also reported as 16 months ago) the patient was vaccinated with a dose of PNEUMOVAX 23 (1 injection, lot#, expiration date, strength and route unknown). Concomitant therapies included PROAIR, omeprazole, metoprolol, levothyroxine sodium, furosemide and clopidogrel (the reporter was not quite sure why the patient was taking clopidogrel, other than the fact that it was an anticoagulant). The pharmacist reported lack of effect of PNEUMOVAX 23, as since the vaccination, the patient had experienced pneumonia 3 times during 2014 to 2015. Unspecified outpatient treatment was given for the event of pneumonia. The patient had been hospitalized on an unknown date. It was unknown if the patient was hospitalized for the pneumonia or not. Outcome of the event was unknown. The reporter considered the event to be not related to PNEUMOVAX 23. Additional information has been requested.