chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had terrible diarrhea.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Jun2021 10:30 (Lot number: EW0169) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing); "covid", start date: Dec2020 (unspecified if ongoing), notes: I had covid in Dec2020, if covid prior vaccination: Yes; "diarrhea " (unspecified if ongoing), notes: "diarrhea I experienced when I had covid in Dec2020". Concomitant medication(s) included: TYLENOL. Past drug history included: Flexeril, reaction(s): "Known allergies: Flexeril"; Nizoral, reaction(s): "Known allergies: Nizoral"; Claritin, reaction(s): "Known allergies: Claritin"; Chlorine, reaction(s): "Known allergies: Chlorine". The following information was reported: DIARRHOEA (non-serious) with onset 21Jun2021 12:00, outcome "recovered", described as "Had terrible diarrhea.". Therapeutic measures were not taken as a result of diarrhoea.  Additional information: The patient had no other vaccine in four weeks. Other medications in two weeks: Tylenol one week earlier. Prior vaccinations: none. Diarrhea started approx. 1 1/2 hours after her first shot. It was bad and lasted all day. It was like the diarrhea patient had experienced when she had covid in Dec2020. It stopped after about 12 hours. Patient drank a lot of fluids and ate toast and felt better in a day or two. The patient also received 2nd dose of BNT162B2 administered in arm left, administration date 19Jul2021 10:30 (Batch/Lot number: Pfizer EW0162) at the age of 66 years as dose 2, single for covid-19 immunisation. The patient had not tested post vaccination. Patient did not have diarrhea with second shot. Patient reported it because she did not see it listed as a side effect on the information sheet she received.   No follow-up attempts are possible. No further information is expected.
Headache on 4.11, 4.12-took ibuprofen prescribed for ankle injury and it went away Left leg pain on 4.11, 4.12 but went away. Dry cough since 4.11.21
The refrigerator where the vaccines ares tored had a temperature excursion that exceeded the viability of teh vaccines IPOL and MMR. No adverse effects were reported. The patient will be revaccinated at a later date.
Onset of Flu like symptoms on the evening of the day received the shot 10/05/2010). Steadily worsened the next day. By Day 3 (10/07/2010) into chills, significant fever, soreness of joints, productive cough, general malaise.
sore arm; Stingy pain in calf; This is a spontaneous report from a Pfizer-sponsored program support. A contactable female consumer (Patient). A female patient of unspecified age received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot no. unknown, Expiration date: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Patient medical history and concomitant medication were not reported. it was reported that after second dose patient experienced sore arm, a Stingy pain in calf. The outcome of the events was unknown.  Information about lot/ batch number has been requested.
Information has been received from a registered nurse concerning an elementary school aged child who was vaccinated with a dose of varicella virus vaccine live. On approximately 23-FEB-2006, the patient developed breakthrough chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/12/2006. Information has been received froma registered nurse concerning an elementary school-aged child who on 18-MAY-2006, the patient developed breakthrough chickenpox. Unsupecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additionsl information has been requested.
DVT in left leg below knee and minor shortness of breath. Lovenox 150 1x/day for 3 months.
Nausea; Vomiting; Headache; This is a spontaneous report from a contactable consumer (patient).  A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Dec2020 at single dose in right upper arm for COVID-19 immunisation. Medical history was none.  There were no concomitant medications. On 29Dec2020 the patient experienced nausea, vomiting and headache: patient worked at the hospital; 30-45 minutes after she received the vaccine, she got really nauseated. She was also vomiting and had a headache. She has stopped vomiting on 29Dec2020 (30 min before the report). Events were all non-serious. Patient recovered from vomiting on 29Dec2020; outcome of nausea and headache was not recovered. Information on the lot/batch number has been requested.
Shingles appeared one week after receiving first dose of the Pfizer vaccine.  Took seven days of pills recommended by my dermatologist.  Fourteen days later it seems it is disappearing.  And I got my second dose of vaccine today (05/18/2021).
fever, very runny nose, sore throat, aches, agitated feeling, diarrhea, feeling nauseous, crawling skin
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Rash, UrticariaPruritus,   12/31 itchy rash, 1/1 large rash erythema and itchiness 1/1-1/3 larger everyday,  warm and itchy 1/7 now half size of upper arm itchy and warm on injection site arm   Narrative: 12/31 itchy rash, 1/1 large rash erythema and itchiness 1/1-1/3 larger  everyday, warm and itchy 1/7 now half size of upper arm itchy and warm on  injection site arm. Hx of psoriasis. Atarax for itchiness at night, anti dermatitis SQ  injection 14 days finished on 12/25. cold compress applied.
her arm does not hurt that much; second vaccine may have been adversely impacted by the anti-inflammatory (Naproxen); a little tired for one hour; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 09May2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on 08May2021 as dose 2, single for COVID-19 immunisation; naproxen (Batch/Lot number was not reported), via an unspecified route of administration from 04May2021 to 08May2021 at an unspecified frequency for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: not reported), via an unspecified route of administration on 17Apr2021 as dose 1, single for COVID-19 immunisation and experienced arm felt like it weighs 500 pounds. The patient reported to be on another medication (Naproxen). The patient had asked her pharmacy if there would be any issues with her taking this medication and being on the vaccine and they said "No". The patient reported that she didn't have any symptoms. The patient looked up if being on anti-inflammatory (Naproxen) can impact the vaccine effectiveness and she read yes. The patient had minimal symptoms to the second vaccine and was concerned that the second vaccine may have been adversely impacted by the anti-inflammatory (Naproxen) and wanted to find out what she should do. Furthermore, it was reported that on an unspecified date the patient took a nap for an hour and reported to be a little tired for one hour, no fever, no ache or no chills and even her arm does not hurt that much. In her first vaccine her arm felt like it weighs 500 pounds. The patient said that it had been because she had to wake up very early in the morning to get the vaccine. Outcome of fatigue was recovered on an unspecified date and unknown for all other events. The action taken in response to the event for naproxen was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
a patient was administered an expired dose of ACT-HIB vaccine/ No AE; a two years old patient was administered a second dose of ACT-HIB vaccine/ No AE; Initial information received on 21-May-2021 regarding an unsolicited valid non-serious case received from nurse via phone via Medical Information (Reference number- 00611667).  This case involves a two years old female patient who was administered an expired 0.5 ml second dose of suspect vaccine HIB (PRP/T) VACCINE [ACT-HIB] Frequency: Once, Strength: Standard [lot UJ207AA, expiry date 30-Apr-2021] via intramuscular route in the right thigh on 21-May-2021 for prophylactic vaccination (expired product administered and inappropriate schedule of product administration).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID [PEDIARIX], PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PNEUMOCOCCAL VACCINE CONJ 13V (CRM197)) [PCV13] and INFLUENZA VACCINE [FLU] vaccine for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used and drug dose administration interval too long (latency: same day).  Potential Product Technique Complain: No, Caller stated that she gave and expired ACT-HIB vaccine to patient. Caller would like to know what to do at this point. Confirmed nurse question about an expired dose of ACTHIB that was given. Nurse explained what happened and provider told her to repeat the ACT-HIB dose. Patient was in late with her vaccines. No further information was provided.   At the time of reporting, 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 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.
About 15 minutes after shots (TDAP, VARIVAX & Hep A) were given, pt fainted. Mom & I helped him to the chair. He did hit his head on the wall while going to the chair. Came to as he laid down on the chairs. As pt awoke he c/o not being able to see at first & c/o very sore throat. No SOB present & no other s/s present. After just 2-3 seconds he was able to see again & said his throat was fine. Asked for a drink. Got him a drink but only took one sip. C/o nausea at that point but never vomited. Pt was very pale but pulse & respirations were good. Pt wanted to leave but mom & I walked him to the next room where there was a bed to lay him down. As we got to the bed, he fainted again. Came to as we laid him on the bed. Awoke with no c/o throat soreness this time. He gradually over the next few seconds was feeling fine and wanted to go home. After waiting 15 minutes & pt c/o being hungry, he left walking on his own without no help with mom. Instructed mom to take to MD if any s/s returns.
Louder tinnitus than before and swooshing on my left ear. It got worse after the second dose and it has been so since. My tinnitus is significantly louder than before and hard to sleep, whereas before, for 3 years, it was manageable.
I had a complete memory blackout, starting at around 10pm, with no memory at all of going to bed or normal my bedtime routine, but on waking in the morning, discovered that I had not done things I always do - like taking out my contact lenses or turning off the TV.
Mild headache, mild muscle aches, light headedness.  Regular aspirin taken about 11 hrs after onset were effective for the aches.   Mild light headedness continued for about 12 more hrs.
Information regarding PREVNAR 13 was received from a physician assistant regarding a patient who experienced cellulitis, erythema, tenderness on palpation, warmth and swelling. The patient received a dose on an unspecified date. On an unknown date, after the immunization, the patient experienced erythema, swelling, warmth and tenderness on palpation at the injection site. The child was treated in an unspecified manner for cellulitis. They suspect a problem with the product. Outcome of the events was unknown. No additional information was available at the time of this report.
Noted to have red area on right deltoid, increased warmth, slightly firm, tender to touch, no open areas, no drainage.  States that she has fatigue, had a low-grade fever yesterday, has a bit of nausea today and some body aches.  Denies that she has have any cough, no shortness of breath, no chest pain
This spontaneous report was received from a pharmacist and refers to a patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medication was provided. On 13-FEB-2018, the patient was vaccinated with a dose of M-M-R II lot # N008365 with expiration date on 13-MAR-2019 intramuscularly (instead of subcutaneously) for prophylaxis. No adverse effects were reported.
5 minutes after injection, left cheek was numb, then right side, lips and throat felt like they were swelling.  Went to the ER one hour after.  BP was 209/100.  Tachy HR.  Denies SOB. rash.  Benadryl 25 mg given  in ER.  Had improvement in symptoms within 15 minutes.
COVID positive. Symptoms include:  fever, runny nose, sore throat, and cough.
he doesn't go to sleep well; having pain at the injection site/like a burning sensation inside like where the shot was; This is a spontaneous report from a Pfizer sponsored program COVAX US support from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 24Mar2021 14:10 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history was not reported. Patient didn't drink, didn't smoke, didn't do anything. Maybe the end of the year, he got a physical and nothing, everything came back normal. The patient's concomitant medications were not reported. Patient experienced pain at the injection site and stated it was like he had like a burning sensation inside like where the shot was on and he still had it. It began about 2 days after the shot (27Mar2021). Sometimes he didn't go to sleep well because he woke up every hour or so. He didn't sleep well because of the pain. He was supposed to get the second one this coming Saturday (24Apr2021). Outcome of having pain at the injection site/like a burning sensation inside like where the shot was not resolved. Outcome of didn't go to sleep well was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
"Covid arm"/ Arm so sensitive the sheet hurt-nothing could touch her arm; shingles; "Covid arm"/ Arm so sensitive the sheet hurt-nothing could touch her arm; This is a spontaneous report from a contactable consumer via a sales representative. A patient of unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number was not reported) on an unspecified date via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization.  Historical Vaccine included first dose of BNT162B2 for COVID-19 immunization, on an unspecified date; the patient experienced severe vertigo for 3 days with nausea. Medical history was not reported. Concomitant medications were not reported. On an unspecified date, she experienced "Covid arm" and shingles one day post second dose; arm so sensitive the sheet hurt-nothing could touch her arm. The clinical outcome of the events Covid arm, shingles, arm so sensitive the sheet hurt-nothing could touch her arm was unknown.  Information about batch/lot number has been requested.
Left shoulder pain, weakness, numbness since injection of Hep B vaccination on 6/8/12.
BLOOD CLOT IN BOTH LUNGS; BLOOD CLOT IN THE LEFT CALF; COVID-19 PNEUMONIA; This spontaneous report received from a patient concerned a 71 year old male. 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, intramuscular, batch number: 1805022, expiry: unknown) dose was not reported, 1 total, administered on 06-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, patient developed a high fever with body temperature approximately 104 degree fahrenheit. He decided to go to urgent care and he was tested positive for covid-19 and was given monoclonal antibody treatment and was sent home. Since he had a pulse oximeter at home, when he checked oxygen saturation, it was dipping to 80 and he did not felt well. He decided to go to the hospital and was hospitalized on 20-MAR-2021, where he was diagnosed with covid-19 pneumonia. His computed tomography scan with contrast and doppler ultrasound showed blood clot on each lung (left & right) and one on the left calf (lower end of the left leg). He was hospitalized for 8 days and was discharged on 27-MAR-2021 with oxygen and prescribed with xarelto (rivaroxaban, 20 mg tablet). On 04-APR-2021, he reported that he finally removed the oxygen and felt better. His pulmonologist had also informed that he was cleared of any blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 pneumonia, blood clot in both lungs, and blood clot in the left calf on 04-APR-2021. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000192893. The suspected product quality complaint has been confirmed to be voided (tested positive for covid-19 2 days post vaccination does not meet the definition of a product quality complaint for loss of effect) based on the PQC evaluation/investigation performed.; Sender's Comments: V0:20210918314-Covid-19 vaccine ad26.cov2.s -covid-19 pneumonia, blood clot in both lungs, blood clot in the left calf. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient broke out in bullous eruption diffusely on the entire body with the diagnosis of bullous pemphigoid.
Information has been received from a physician concerning a 61 year old female patient who "5 years ago", in October 2005, was vaccinated with the first dose of PNEUMOVAX 23 without reaction. On 20-OCT-2010, the patient was vaccinated with a second dose of PNEUMOVAX 23 (lot # reported as 667913/1021Z). The patient called the next day to say that she had a severe reaction. The patient was seen and the caller the patient as looking "like she had pancake under the flesh of her arm all around injection site". The patient was treated and was recovering at the time of the report. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
12 hours after flu shot, felt light-headed and had abdominal pain.  Chills soon followed and kept me awake for ~3 hours.  The abdominal pain peaked about 14-16 hours after the shot and remains now, about 24 hours after the shot; am also feeling warm and appear flushed 24 hours later.
ALL THESE ISSUES THAT I HAVE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced all these issues that i have. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of all these issues that i have was not reported. This report was non-serious. This case, from the same reporter is linked to 20221147999.
Patient received Pentacel and PCV13 for 15 month well visit on 06/17/2021 around 6pm. The morning of 6/18 , she had fever noticed at 7 AM, followed by seizures for ~ 8-10 minutes. It involved all her body, no asymmetry. 911 was called, had midazolam administered intranasal and through IV.  No more episodes since arriving at the ER. Diagnosed with febrile seizure and sent home.
Had covid systems on Feb. 2nd 2021,  Got tested Feb 3rd, Received call Feb 4th positive.  Recovered on Feb. 15th. First vaccine shot Mar.31 at 12:30pm.  Apr 1st at 4:20am, woke up and felt like sitting in a tub of ice. Severe chills lasted 1 hour,  Had terrible aches and chills, that lasted for about 30 hours.  Stayed in bed the whole time, only got up to pee & get water hurt so bad to move.  Ran a temp  about 100. till Fri morn.  Fri. morn about 3:00am, woke up and had flashes going off in the eyes, like looking at a strobe light, with eyes closed and open.  That stopped after about 20 min.  Finally got out of bed Fri.  9:00am.  Still felt out of it for a day.  This was worse that the whole 13 days of covid.  During covid no temperture
19MAR93 pt had high fever mom says pt was jumping-not sure if it was a sz; & doesn't know how high the fever was but pt cooled him down & jumping stopped;
red blotchy area at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (red blotchy area at the injection site) 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 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE RASH (red blotchy area at the injection site). At the time of the report, INJECTION SITE RASH (red blotchy area at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient received the dose of the vaccine on 20Feb2021 and she developed 3 inches red blotchy area at the injection site