chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TOOK DOSES 1, 2, AND 3 AND THEN HOPPED ON A PLANE WITHOUT TAKING 4; This spontaneous case report was received from a nurse (PVX2019-445) on 18-Feb-2019. The report describes a male consumer who "took doses 1, 2, and 3 and then hopped on a plane without taking 4". The consumer was receiving oral Vivotif for typhoid prophylaxis.   It was reported that the consumer took the three doses of Vivotif on 18-Jan-2019, 20-Jan-2019, and 22-Jan-2019 respectively before travelling for three weeks. Then, he took his last dose today on 18-Feb-2019, after returning home.  The action taken with Vivotif with respect to the event "took doses 1, 2, and 3 and then hopped on a plane without taking 4" was not applicable.  The clinical outcome of the event "took doses 1, 2, and 3 and then hopped on a plane without taking 4" was unknown.  Company's Comment: The causality of the event "took doses 1, 2, and 3 and then hopped on a plane without taking 4" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took doses 1, 2, and 3 and then hopped on a plane without taking 4" was considered as not applicable.
Patient reported on form that they had a previous allergic reaction to a meningitis vaccine in the past (10+ years ago). Immunizer informed patient to stay at pharmacy for the next 30 minutes following the vaccination to be able to monitor for allergic reaction. At around minutes 20-30, we checked in on patient who said she was experiencing shortness of breath. She began administering her inhaler that she had on hand (Ventolin/albuterol), it was not having any noticeable effect. Patient reported worsening shortness of breath and reported that she felt a swelling sensation and felt that her ears were swelling. She was visibly struggling with breathing. At this time we helped her back into the immunization area for privacy. Myself (pharmacist) and the other pharmacist on duty were talking her through breathing and trying to calm her down while helping her contact a family member in the area. We administered 1 dose of epinephrine 0.3 mg after about 10-15 minutes of her experiencing a visible serious allergic reaction. Right before administering the Epinephrine we instructed a technician on staff to call EMS. Within about 5 minutes of administering epi the patient began to be able to breathe better. We kept trying to keep her calm and within 10 minutes from administering EPI the EMS had arrived and they took her outside to allow her more fresh air to determine if she needed to go to the hospital.
prolonged reaction of angioedema; prolonged reaction of hives; Initial information was received on 26-Oct-2020 regarding an unsolicited valid serious case from the physician via medical representative via an email .  This case involves an unknown demographic patient who had a prolonged reaction of hives (urticaria) and angioedema, while patient received INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination, family history and concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient developed prolonged reaction of angioedema (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  On an unknown date, the patient developed prolonged reaction of hives (urticaria) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome of both the events was unknown.  It was reported that, reactions were secondary to the vaccine based on the timing.   Information on the batch number was requested.; Sender's Comments: This poorly documented case concerns a patient who had urticaria and angioedema after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. Also, the patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
got the vaccine but still got / shingles/ suspected vaccination failure; got / shingles.; This case was reported by a consumer via media and described the occurrence of suspected 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 details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received vaccine but still got the horrible shingles. The patient stated that he/she paid but still got shingles. The follow-up would not possible as no contact details were available. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
Patient is a new admission to our facility and the sending facility did not endorse to us that this patient patient received a single dose of J&J vaccine on 5/12/2021. He received 100 mcg of Moderna vaccine on 8/19/2022 instead of getting a booster dose of 50 mcg of Moderna. No adverse reaction noted since the event. Per CDC, no need to repeat the booster dose  if full dose was given.
Patient developed pain in arm which escalated. Required ER visit. Arm became enable to move. Patient referred to orthopedist and diagnosed with transient synovitis by Dr.
a patient received an expired dose of ActHIB vaccine, NO AE; Initial information received on 30-Sep-2020 regarding an unsolicited valid non-serious case from a nurse.   This case is linked to case 2020SA271339 and 2020SA271357 (same reporter).  This case involves a patient (unknown demographics) who received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (batch number, expiry date, via an unknown route at an unknown administration site) (expired product administered) on 21-Apr-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to expired vaccine used (latency: same day)  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.  There will be no information available on the batch number for this case.
Patient reports redness, streaking edema, numbness to arm, within minutes after vaccination given.  7/9/2015 pt returned to clinic for unrelated reason and reported that all signs and symptoms resolved.
Hard swelling at injection site the size of an egg with very dark redness and pain. Further swelling and redness extending down to elbow and half way around arm, itching. At 2 weeks all swelling and soreness still not gone.
pt recv vax & 2hr later devel myoclonic jerking & tremors; exam nl;
Small blisters with scab on top at right medial upper arm. Small blisters without scab on left medial arm. Itchy, painful, and feels warm. denies having fever, recent illness.
Patient called in the pharmacy and explain that she notice hard red patches about 2 inches around the injection site, there is no other symptoms or pain, no any issue in breathing. Ask the primary doctor for patient. Advice any breathing problem or feel emergency then 911 or seek medical assistance, and can also see the primary doctor.
PATIENT RECEIVED TWO VACCINES, ONE IN EACH ARM. PATIENT REPORTED FEELING FINE AFTER VACCINE, BUT FELT DIZZY AND FAINTED MOMENTARILY UPON LEAVING IN FRONT OF THE ELEVATOR. DAD HELD DAUGHTER. PATIENT WAS MOVED TO ROOM AND LAID ON EXAMINE TABLE AND VITALS WERE TAKEN. PULSE WAS SLIGHTLY ELEVATED.PATIENT CLAMMY. PATIENT REPORTED FEELING DIZZY. PATIENT REPORTED SHE HADN'T EATEN MUCH. PATIENT WAS GIVEN WATER AND REMAINED LYING DOWN FOR 10 MIN.
Pt recieved Moderna on 08/25/21, 10/27/21 and booster on 12/09/21. Pt had enlarged left arm (grapefruit size) on 12/11/21 went to emergency room.  ER took patient out of work for 3 days.  Pt then went to pcp on 12/14/22, md took patient out of work for 2 weeks.  Pt went to follow up and md took patient out of work for 2 more weeks until 01/11/22.  Pharmacy notified on  02/23/22, was able to get ahold of pt on 03/01/22.  Pt states that swelling has subsided but arm still occasionally aches.  No loss of strength.
Information has been received from a physician concerning a 13 month old Asian female with protein C deficiency who on 24Jul03 (also reported as 28Sep03) AT 13:30 was vaccinated in the right arm with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Concomitant therapy included enoxaparin sodium (LOVENOX) being given for protein C deficiency. The day after vaccination, on 25Jul03, the pt developed a fever of 103F, which continued for 3 to 4 days. The pt also developed a generalized maculopapular rash, which started on her head and face and progressed down, including the oral mucosa. The pt was seen by the physician on 28Jul03 and still had the rash. The pt was prescribed calamine lotion and diphenhydramine hydrochloride (Benadryl) PO. It was noted that the pt's mother is a physician's assistant and was going to decide if a follow up visit was needed. Follow up information indicated that no diagnostic or laboratory studies were performed. The pt's outcome was reported as unknown. Additional information has been requested.
Patient reported pain in right arm a couple hours after vaccine was administered.  She reported that she is unable to lift her arm without pain/discomfort.  Patient reported side effects to pharmacy late afternoon/early evening on 09/11/2023 and was advised to use acetaminophen for pain and to contact PMD if pain persisted.  Patient saw PMD on 09/12/20023 and was given a methylprednisolone dose pack.
Pt experienced swollen, warm, red, injection site. Onset one day post vax. Felt feverish for 2 days. Site was sore the first day.
staying curled back; This case was reported by a consumer via call center representative and described the occurrence of finger contracture in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2018, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced finger contracture. On an unknown date, the outcome of the finger contracture was unknown.   It was unknown if the reporter considered the finger contracture to be related to Shingrix.  Additional details were provided as follows: The patient received the vaccine and sent in the paperwork with the adverse reaction that the patient was having. The patient went to a hand surgeon.  The patient had to get a shot in my hand so the patient could straighttmymiddle finger.  It was staying curled back.
1st dose: 24Mar2021; 2nd dose: 24Mar2021; Mysterious bumps ("bite like") bumps forming; Extremely itchy; form in a row (arms, torso, crusted, leaving dark scars; This is a spontaneous report from a contactable consumer (patient). A 54-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/lot number: EW0153), dose 2 via an unspecified route of administration, administered in Arm Left on 24Mar2021 15:00 (at the age of 54-years-old) as DOSE 2, SINGLE for covid-19 immunization at pharmacy or drug store. The patient medical history was not reported. Concomitant medication(s) included venlafaxine 37.5 mg, taken for an unspecified indication, start and stop date were not reported. Historical vaccine included received first dose of bnt162b2 (BNT162B2, solution for injection, batch/lot number: ER8732), via an unspecified route of administration, administered in arm left on 24Mar2021 at 15:00 as dose 1, single for covid-19 immunization and after 4 days experienced bumps, extremely itchy, crusted and left dark scars. The patient previously took, septra and experienced allergy. The patient did not receive any other vaccines within 4 weeks. The patient was not pregnant at time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that patient received both the doses on 24Mar2021. On an unspecified date, patient developed mysterious bumps (bite like) bumps forming, extremely itchy, form in a row (arms, torso, crusted, leaving dark scars for which patient had to visit doctor or other healthcare professional office/clinic visit. The patient did not received any treatment for the events. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Fainting; syncope Emergency room visit: low blood pressure, high heart rate, administered a bag of fluids to hydrate High fever, chills and lightheadedness
Splitting Headache 101 Fever Body weakness  Pain at injection site, but no rash, no swelling
pt recv vax 28FEB97 & 8MAR98 pt devel 12-15 chickenpox;
Dizziness, Headache, NauseaVomiting, 99 temp. fatigue Narrative: Symptoms lasted until 1/31/2021@1700, Felt better until 2/1/2021 about 9, starting feeling nausea/dizzy/headache. Went home, still felt bad, checked blood pressure 184/80, took evening blood pressure medication and went to bed. Continues to feel dizziness and blood pressure issues. Went to primary care, changed blood pressure medications. Primary care unsure if 2nd vaccine has anything to do with Blood pressure issues. Still feeling dizzy and headache, day 5,
Pericarditis occurs within days of first Moderna booster in November 2021. Pericarditis recurrence within hours of second Moderna booster on July 15 2022.
Patient was given FLu vaccine, less than 5 to 10 min. later she was lightheaded and dizzy. She fell to floor passed out less than 1 minute. I checked her pulse and we called 911. Patient felt better after some time and refused transport to hospital.
mom noted that pt cry was higher pitched & pt was more fussy the day p/vax; 2 days p/vax pt was very uncomfortable, arching, had unusual extremity movements & questionable arm jerking;
mom states pt was irritable throughout the noc; would cry, but not continously; about 830AM started w/a hoarse cough that would make the pt turn cyanotic; mom took pt to MD & was admitted to the hospital;
Narrative: Headache, arthralgia, fatigue, chills, local lymph node tenderness/swelling on side of site, site pain/tenderness/swelling
My brothers wife had the Pfizer vaccine and had a rash after the second shot; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (reporter's brothers wife) that:  A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on unspecified date as single dose for COVID-19 immunisation. The patient stated that his sister-in-law had the pfizer vaccine and had a rash after the second shot on an unspecified date. He was not sure which vaccine she got. There were 50/50 chance she had the Pfizer vaccine. Patient stated do I had to report it without confirming it was a Pfizer Product. The patient did not state when he became aware of the adverse events and the MI agent did not inquire. The outcome of event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101076604 same drug/event, different patient
ringing of the ear; Rashes; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing of the ear) and RASH (Rashes) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0210A21A and 013L201A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included PANTOPRAZOLE and PSYLLIUM HYDROPHILIC MUCILLOID (METAMUCIL [PSYLLIUM HYDROPHILIC MUCILLOID]) for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced TINNITUS (ringing of the ear) and RASH (Rashes). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, TINNITUS (ringing of the ear) and RASH (Rashes) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
The pt said his right arm was swollen down to his elbow and real sore. He said his arm got "flabby" like jello and he couldn't lift his arm above his waist. He said it hurt the day the vaccine was given and the next day and then it got better.
This spontaneous report as received from a pharmacist refers to a 57 years old female patient with no pertinent medical history and no drug reactions or allergies. The reporter stated that she held a ZOSTAVAX clinic, on 02-MAY-2014, patient was administered with ZOSTAVAX lot number K000456, expiration date-15-DEC-2014, dose single dose, route SQ. On an unknown date in May 2014, the patient developed redness, swelling and induration at injection site. The pharmacist stated she became aware of the adverse events the patient was experiencing on the weekend (03-MAY-2014 and 04-MAY-2014). The vaccine clinic took place at a high school. Vaccine recipient was teacher. The pharmacist spoke to the school nurse on Monday 05-MAY-2014. The school nurse shared with the pharmacist that the adverse experiences, the teacher was experiencing, was resolving. There was no hospitalization. No specific treatments mentioned. The pharmacist shared the initials, gender and age of each ZOSTAVAX vaccine recipient. All vaccine recipients were women. The pharmacist learned from school nurse that one of the patient experiences of redness spread to over 5 inches from injection site, the pharmacist unable to identify which patient. Patient sought medical attention (called pharmacy). The patient did not receive treatment for the adverse event. There was no lab diagnosis or studies performed. The outcome of redness, swelling and induration at injection site was recovering. No product quality complaint was involved. This is one of 9 reports from the same source. Additional information has been requested.
Reports feeling hot, nauseated, dizzy, chills and sweating.  Also reported tingling in left elbow.
Patch of hair lost on side of head. Noticed as a pea-size spot of hair loss. As of today, it is 4 to 5 times the size of original hair loss.
Took shot in early July.  Then had pain in knees and shoulders and right side of collar bone.  Pain sent away in August except one spot on top of shoulder.  Pain increased in shoulder and I reported it upon redeployment.  They sent me to the orthopedist.  Treatment has been ongoing with a physical therapist and recieved cortisone shots from the orthopedist.  Pain has yet to go completely away.  Physical therapy is continuing.
Itching on arms, face. resolved with benadryl x 2 Narrative:  c/o itching on arms bilaterally which increased to face. improved with benadryl
15 hours after vaccination had chills, fever 0f 100 F. 16 hours post vac. had nausea and vomiting (dry heaving) for 6 hours.
Sore arm; Couldn't get warm; More tired/Feeling fatigued; Had chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FEELING COLD (Couldn't get warm), FATIGUE (More tired/Feeling fatigued) and CHILLS (Had chills) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), FEELING COLD (Couldn't get warm), FATIGUE (More tired/Feeling fatigued) and CHILLS (Had chills). At the time of the report, PAIN IN EXTREMITY (Sore arm), FEELING COLD (Couldn't get warm), FATIGUE (More tired/Feeling fatigued) and CHILLS (Had chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided Treatment information was not provided   This case was linked to MOD21-078105, MOD21-078105 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Additional information was received and new event sore arm was added.; Sender's Comments:  MOD21-078105:MOD-2021-080342 MOD21-078105:MOD-2021-080336
Chest pains and shortness of breath, the first shot was given and the same symptoms but over the course of a couple weeks these went away and returned to normal.  Now this has been 3 weeks and still having shortness of breath and pain in my chest
pt recvd vax; nausea, d, tingling & numbness in extremities; 12 hrs later fever of 101; d & dehydration;
This is a spontaneous report from a contactable consumer via Pfizer sales representative, who reported same event for the four patients. This is the first of four reports. A male patient (age range reported as 50-70) receive a single dose of PREVNAR 13, on an unspecified date as vaccination. The patient medical history and concomitant medications were not reported. On an unknown date, few days after vaccination, the patient complained of soreness between the elbow and shoulder. There was redness as well. The outcome of the events was unknown.  Sender's Comments: Linked Report(s): US-PFIZER INC-2016487683 same reporter/drug/event, different patient;US-PFIZER INC-2016487681 same reporter/drug/event, different patient; US-PFIZER INC-2016487682 same reporter/drug/event, different patient.
shortly after, lightheaded & few hrs. later headache, neckaches, joint aches especially in wrists & finger joints, fatigue & fever: All these lasted about24 hrs. with fever of 101.5. Tylenol taken 1 pill-   4 X during course of symptoms. These resolved within 36 hours from onset. However, ADVERSE REACTION: beginning exactly 1 week later, on 8/22/2021 about 4 pm, onset of  "SEVERE TINNITUS" bilaterally. This SEVERE TINNITUS continues more than  27 hours later at severe level.  Very loud and interfering with hearing.
After the first shot, I had swelling and pain in my arm. A week after the first shot, I had a rash on my arm where the shot was administered.  Since the rash is a less common effect, I wanted to submit a report.