chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The initial case was missing the following minimal criteria: no identifiable patient. Upon receipt of follow up information on 06Oct2015, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. This pharmacist reported similar events for seven patients. This is the seventh of the seven reports. A patient of unspecified age, ethnicity and gender received a single dose of PREVNAR 13 via an unspecified route of administration on an unspecified date (between Nov2014-Sep2015). The patient medical history and concomitant medications were not reported. The patient experienced rashes, chills, pain and concern for cellulitis on an unspecified date. The outcome of the events was unknown.
Pfizer covid vaccine was stored outside of manufacturer's recommendation. Specifically, the vaccine was frozen longer than recommended.
Intermittent cardiac palpitations. Last for a short time. Felt pulse in trachea, rapid heart rate. Episodes lasted on and off for 6 weeks. Saw cardiologist who says this is being observed in patients.
I am a male, 5' 10" height; 172 lbs weight. Received injection with no issues. Approx 1:45PM. Felt fine until about 8:30PM when my nose starting draining and my hips and shoulders started to ache. By 9:30PM, I was shaking hard and had severe full body aches. I had to put my winter coat on with a blanket. Indoor temp was 74F. I had decided that I was getting the flu and better just get to bed. Thought I should have gotten the shot a month earlier. I had to wear a sweatshirt and pants in bed to overcome chills and shaking. Did not really sleep unitl about 2AM. Woke up at 7:45AM. Sat up on the bed and assessed my condition fully expecting that I would be laying down again. I felt as if nothing had ever happened. No chills, no shaking, no fever, no aches.
Patient came in at scheduled time to receive their second vaccination.  In error - the initial DOSE 1 was put in the computer as having been the Pfizer COVID-19 vaccine.  This would place the patient coming in between 17-42 days for dose #2.  The patient was permitted to schedule.  When the patient came in their presented their COVID Admin. Record care and it was listed on the card that the patient received Moderna vs what the Pharmacy computer listed as Pfizer.  It was confirmed that the patient indeed received the Moderna.  We went ahead and administered inadvertently missing that they were on day 22/23 instead of the CDC recommended minimum of 25 days.  SO PT RECEIVED THE VACCINE EARLIER THAN INDICATED!
Patient was given Moderna Monovalent after date to stop administering  brand of vaccine. As well as patient may not have been eligible for the 2nd booster was not immunocompromised.
Pt recvd 4th doses of Hep B vax on 3MAY92 devel fever of 104 to 105.7 & a rash described as macular, papular; 4MAY92 hospitalized due to persistance of sx; had a dec WBC & platelet count; Rocky Mountain spotted fever or meningococcemia;
Redness, induration and warmth at the injection site measuring 5-6 cm in Diameter.
Developed right shoulder tendinitis/bursitis to right arm after first 2 vaccinations; Developed right shoulder tendinitis/bursitis to right arm after first 2 vaccinations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Lot number: en6198) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID. The following information was reported: BURSITIS (disability), TENDONITIS (disability) all with onset 2021, outcome "not recovered" and all described as "Developed right shoulder tendinitis/bursitis to right arm after first 2 vaccinations". The event "developed right shoulder tendinitis/bursitis to right arm after first 2 vaccinations" required physician office visit. Therapeutic measures were taken as a result of tendonitis, bursitis (Cortisone shots, prednisone).
Cranky, colicky, constipated for 2 weeks, 2 days before shot until death. Had 5 dirty diapers day he died; 2 with diarrhea. Noticed a bone in frontal lobe protruding. Hive/Rash on neck, back, chest. Sweating.
Information has been received from a physician concerning a 13 year old female who was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced swelling in her face, stomach was extended with fluids and her lower extremities were swollen. Unspecified medical attention was sought. The patient was put on "hydrosteroids". She is scheduled for a follow-up visit the week of November 13th. No product quality complaint was involved. Additional information has been requested.
Facial swelling of both eyes, nose, lips. Mother gave dose of Benadryl. Denies any respiratory distress or any other symptoms.  Declines taking child to doctor at this time.
Joint pain/polyarthralgias and paresthesias affecting feet and hands. Itching and redness at site. Experienced body aches, malaise and swollen glands. No fever or chills.
Abrupt onset headache, nausea, vomiting and dizzine a few hours after injection.
2nd shingrix dose given within 3 weeks of 1st shingrix.I checked with patient 2 days after immunization, she reports fatigue and chills for 24 hrs, these side effects should be related to fluzone hd and shingrix. Ive submitted this because I immunized too early for 2nd shingrix.
sore arm at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (sore arm at the injection site) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (sore arm at the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported   This case was linked to MOD-2021-388396, MOD-2021-388405, MOD-2021-388405 (Patient Link).
It was reported that a male patient received a Typhim VI and a Hepatitis A vaccination on 05/03/01. Reportedly that same day, the patient developed general malaise and a rash on his arms. A physician did not evaluate the patient. From mailed correspondence received on 06/18/01, it was reported that the patient recovered from this experience. Additional patient, vaccine, responsible physician and vaccine administrator information was provided. This case is closed.
Client stood up after in the injections. He walked down the hallway, lost consciousness falling the the floor. Pale, jerking movements of bil arms, elbows bent and drawn up to his head. Client turned to recovery position regain consciousness in 2 minutes with no further problems.
Right arm swelling and redness; it was tender for 2 days and stopped hurting today.
About 15 minutes after vaccine was given, patient started feeling numbness and pain in right upper arm where vaccine was given. Patient has a PMH of stroke on the right side and diabetes. Patient also reported itchiness in right leg and dizziness. Vitals were taken and neuro exam performed. Patient given water and snack but started feeling stiffness in neck. Referred to ED for evaluation of symptoms.
After flu shot, patient has had sharp pain in arm. She is unable to lift arm all the way. Patient has tried to give nerve time to heal but is still having pain in left arm.
hearing loss/deafness; Fluid in middle ear; Ear infection; This spontaneous case was reported by an other health care professional and describes the occurrence of DEAFNESS (hearing loss/deafness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEUPRORELIN ACETATE (ELIGARD) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced DEAFNESS (hearing loss/deafness) (seriousness criterion medically significant), MIDDLE EAR EFFUSION (Fluid in middle ear) and EAR INFECTION (Ear infection). The patient was treated with PREDNISONE at a dose of 40 mg once a day. At the time of the report, DEAFNESS (hearing loss/deafness), MIDDLE EAR EFFUSION (Fluid in middle ear) and EAR INFECTION (Ear infection) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Patient had 60% hearing loss/deafness due to fluid buildup and infection in ears that developed shortly after his first Moderna vaccine after 14-Apr-2021.  Patient developed same symptoms shortly after second vaccine on 15-May-1021.  Both times the patient was treated with a 5-day course of Prednisone 40 mg PO QD, and events resolved.  Action taken with mRNA-1273 in response to the event was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
anaphylactic reaction; A spontaneous report was received from a health care professional concerning a 45-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic reaction.   The patient's medical history was not provided. Concomitant medications reported included levothyroxine sodium for unknown indication.  On 14 Jan 2021  prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 026L20A)  in the right  arm for prophylaxis of COVID-19 infection.   On 14 Jan 2021, prior to receiving mRNA-1273, the patient felt anaphylactic reaction and was medically significant. Patient received treatment in Hospital ER and got discharged after 10 hours of observation.  Treatment for the events included  intravenous steroid, Pepcid ,Oxygen and Benadryl.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event anaphylactic reaction was unknown. ; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Information has been received from a nurse practitioner concerning a 14 year old female, who, on an unspecified date, was vaccinated with a dose of Gardasil. Subsequently, the patient developed urticaria. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Received injections @ 5pm increased pain and red swollen, cramping at sites by 12am next day.
1/6 ER w/ swollen arm, red (1/2 size of golf ball). Applied ice. 1/7 rash around area. Gave Benedryl. 1/10 improving.
This is a spontaneous report obtained from a contactable consumer through a Pfizer sales representative. A female patient of an unspecified age, race and ethnicity received PREVNAR 13 on an unknown date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the arm swelled, the whole arm swelled up. The patient recovered from the adverse event on an unspecified date. The information on the lot number has been requested.
swelling in bilateral lower extremeties 2 days after vaccine. No redness, mild pain
Heart rate dropped into the 30's; A spontaneous report was received from a consumer concerning her mother, a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced decreased in heart rate to 30's.    The patient's medical history was not provided. No concomitant medications were provided.  The patient received their first of two planned doses of mRNA-1273 (Lot/batch number: unknown) on an unspecified date. On an unspecified date, prior to onset of the events decreased in heart rate to 30's and reaction, the patient received their second of two planned doses of mRNA-1273 (Lot/batch number: unknown) for prophylaxis of COVID-19 infection.  On an unspecified date, the patient's heart rate decreased to 30's (medically significant). The patient having to get a pacemaker.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore action taken with the drug in response to the events was not applicable.  The event, decreased in heart rate to 30's was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Critical details such as treatment date, the onset date of event, patient's medical history and concomitant medication, hospitalization details including diagnostic results are lacking. Further information has been requested.
Starting on 6/6/21, the patient began to have low-grade fevers (usually ranging 100F to 100.4F), myalgias, and weakness. This occurred daily for 2 weeks. It is slowly improving without interventions. His symptoms were improved with ibuprofen.
Rash on both side of belly and it looks like heat rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on both side of belly and it looks like heat rash) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Rash on both side of belly and it looks like heat rash). The patient was treated with CALAMINE at an unspecified dose and frequency. At the time of the report, RASH (Rash on both side of belly and it looks like heat rash) outcome was unknown. Not provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
tightness in arm; slight headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (tightness in arm), HEADACHE (slight headache) and FATIGUE (fatigue) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Insomnia and Brachial plexus injury. Concomitant products included CYCLOSPORINE for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 24-Mar-2021, the patient experienced MUSCLE TIGHTNESS (tightness in arm), HEADACHE (slight headache) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 25-Mar-2021, HEADACHE (slight headache) had resolved. On 26-Mar-2021, MUSCLE TIGHTNESS (tightness in arm) and FATIGUE (fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with the drug was not applicable.
Complained of cold sensation outer surface of left leg which towards knee yet joint was not affected. On 3/31/05, leg felt wet although not wet. She has had taken shower before and dried herself and put lotion on her legs. Felt same off and on throughout the day lasting 3-4 seconds. Noticed while walking, sitting, or standing. Same true during evening but not at night (heavy sleeper). She still has similar symptoms but less frequent and of less duration.
Left thigh with 2x3 inch area of erythema. Patient given KEFLEX 4ml PO TID for 10 days.
Rash and hives on torso; Rash and hives on torso; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the right arm on 15Apr2021 at 10:45 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 21:00, the patient experienced rash and hives on torso. The events did not result in a visit to the doctors 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. The clinical outcome of the events rash and hives on torso were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
pt exp swelling;pain lt leg/ankle;c/o pain in foot w/ambulation;consultant's exam:marked 2+pitting edema lt foot up to distal 3rd of tibia;tenderness medial malleolus& posterior tibial tendon/tendinitis;edema this area;vascular insufficienc
This spontaneous report as received from a physician via company representative refers to a 72 year old female patient. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On an unknown date in 2012, the patient was vaccinated with ZOSTAVAX, via injection route, (strength, dosing details, anatomical location, lot# and expiration date were unknown). Recently (approximately in 2016), the patient experienced shingles and the patient was in physician's office on 24-OCT-2016 (also reported as 'today'). Treatment was given for the adverse event. The outcome of shingles was reported as not recovered. Causality assessment was not provided. The physician was interested in VZV (Varicella Zoster Virus) Analysis by PCR (Polymerase Chain Reaction) and wants to send viral isolates. VZV kit was faxed to the reporting physician. No product quality complaint was involved. Additional information has been requested.
feeling funky; pain at the injection site; body aches; enlarged lymph node under the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling funky), VACCINATION SITE PAIN (pain at the injection site), MYALGIA (body aches) and LYMPHADENOPATHY (enlarged lymph node under the injection arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Depression. Concurrent medical conditions included Sulfonamide allergy.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced FEELING ABNORMAL (feeling funky), VACCINATION SITE PAIN (pain at the injection site), MYALGIA (body aches) and LYMPHADENOPATHY (enlarged lymph node under the injection arm). At the time of the report, FEELING ABNORMAL (feeling funky), VACCINATION SITE PAIN (pain at the injection site), MYALGIA (body aches) and LYMPHADENOPATHY (enlarged lymph node under the injection arm) outcome was unknown.            No concomitant drug details were reported. No treatment details were reported. It was reported that the symptoms went away initially and returned later.
SORE ARM AT INJECTION SITE; This spontaneous report received from a patient concerned an adult 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, route of admin not reported, batch number: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm at injection site was not reported. This report was non-serious. This case, from the same reporter is linked to 20210818227, 20210818021, 20210817805, 20210818401 and 20210820974.
She received the COVID vaccine on 9/24/21 at 8am she had "chills, fever, weakness, fatigue, body aches, joint pain, and left arm swelling. States left arm swelling did not resolve until 9/27/21. She states she had these reactions with the first 2 vaccines but with the booster the reaction was the worst.
my third booster shot Problems with third booster shot; 100 degree fever; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (my third booster shot Problems with third booster shot) and PYREXIA (100 degree fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (my third booster shot Problems with third booster shot) and PYREXIA (100 degree fever). At the time of the report, ADVERSE REACTION (my third booster shot Problems with third booster shot) and PYREXIA (100 degree fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 100 (High) having a 100 degree temperature one day after my third booster shot.         No concomitant medications were provided. No treatment medications were reported.