chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient experienced "tightness in neck and throat. Patient provided one 25 mg dose of Benadryl, tightness resolved after admin of Benadryl per patient report. VSS during observation. Patient observed for additional 30 minutes.
Beginning at 24 hours after the Pfizer Covid booster shot, patient began early symptoms of Shingles (pain in right torso region).  Pain persisted for the next 4 days, and at 5 days post-booster, a rash on the torso appeared.  Patient visited her primary care physician at 6 days post-booster (11/4/2021), who confirmed it as a case of Shingles.  Additional information:  Patient received the J&J Covid vaccine on 4/7/2021.  This Pfizer shot administered on 10/29/2021 was a booster shot.
The pt received the influenza virus vax in 11/1998 and subsequently experienced muscle pain all over with weakness, total exhaustion and difficulty sleeping around 12/1998. The pt noted 'can't make it up a flight of stairs.' Additional information has been requested.
arm was tender at site that night /  soreness; This case was reported by a consumer via and described the occurrence of injection site tenderness in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number J454X, expiry date 4th October 2022) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. In November 2020, less than a day after receiving Shingrix, the patient experienced injection site tenderness. On an unknown date, the outcome of the injection site tenderness was recovered/resolved.   It was unknown if the reporter considered the injection site tenderness to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient himself/herself. The patient did not have a history of reaction to any previous vaccines. The patient experienced that her arm was tender at site that night, and next day the soreness was lessened, and by 3rd day it was fine. The patient had not yet discussed symptoms with her physician and was referred to her physician for further evaluation and discussion. The reporter consented to follow up with her as well as with her pharmacist who administered the vaccine. For tolerance of 2nd dose, refer case US2021025175. This case had been linked with US2021025187 and US2021025175, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021025187:same reporter US-GLAXOSMITHKLINE-US2021025175:same reporter
moderate focal jaw pain on the side where she got the vaccine; flushing of the face; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (moderate focal jaw pain on the side where she got the vaccine), FLUSHING (flushing of the face) and DIZZINESS (dizziness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN JAW (moderate focal jaw pain on the side where she got the vaccine), FLUSHING (flushing of the face) and DIZZINESS (dizziness). At the time of the report, PAIN IN JAW (moderate focal jaw pain on the side where she got the vaccine), FLUSHING (flushing of the face) and DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.
Patient began having shortness of breath a few minutes after receiving vaccine. EMS was called to assess patient. While waiting, patient used a dose of his Symbicort inhaler and reported to feeling a little bit better. Patient refused care by the EMS. Patient was repeated told by pharmacist and EMS that it would be better for him to receive care and several times the patient refused. Patient signed a waver and was able to walk out. EMS reported that his lungs sounded clear, pulse was good, but heart rate was irregular. Patient walked out of the pharmacy about 40 minutes after receiving his vaccine.
Pateint received improperly stored HPV vaccine; This spontaneous report was received from a registered nurse referring to an 11 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 26-SEP-2017, the patient was vaccinated with either quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) lot # N000326, expiration date 14-OCT-2019 or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored (incorrect product storage).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-1709USA008666:
Patient monitored x 15 min per guidelines. Returned within 10 mins c/o itching hands. 25 mg diphenhydramine given IM per order. Post adm VS stable. Symptoms resolved within 15 min.
Swelling noted around lips, face and ears, hives all over body, 12/07/2005 hives and swelling subsided. 12/28/05 Review of medical records (ER & progress note) indicates final diagnosis of 'allergic reaction with angioedema'.
Pneumococcal 0.1 ml given intradermal for PPD. Pt developed redness, soreness. Size of area 1 1/2 x 1 inches. No treatment required.
Patient kept for observation after immunization in exam room with mother and approximately 5 minutes after injection mother comes out stating patient feeling faint.  Patient very pale in appearance.  Staff did get her laid down and she did start responding to questions and pulse became more notable versus the weak pulse when first entering room
"patient had no adverse reactions"; Caller states that improperly stored vaccine was "possibly" administered on unknown dates to unknown patients./patient was administered PROQUAD on 25-MAY-2022, which had been incorrectly stored in the refrigerator.; This spontaneous report has been received from a nurse and refers to an unspecified number of patients of unknown age and gender.  The patient's pertinent medical history, previous drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date, there was an improperly storage for measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD), rHA lot number U014143 has been verified to be valid, expiration date: 31-OCT-2022, administered for prophylaxis (strength, dose, anatomical location of vaccination and route of administration were not provided), (product storage error). It was accidentally stored in the refrigerator with a temperature of 38 degree Fahrenheit (F) for a time frame of 168 hours. Moreover, on an unknown date, that improperly storage vaccine was possibly administered to unidentified patients. No previous temperature excursion was reported.  Follow information has been received on from the registered nurse 11-JUL-2022.  A call was received from the Nurse Practitioner reporting information on a 4-year-old male child with a history of asthma (well-controlled). Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX). There was no known drug allergies.   On 25-MAY-2022, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD), which had been incorrectly stored in the refrigerator. It was administered subcutaneously in the left arm. There was no adverse reactions.
second dose: arm pain; popping veins in ankle; headache; extremely exhausted; chills; nausea; right leg joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (second dose: arm pain), LIMB DISCOMFORT (popping veins in ankle), HEADACHE (headache), FATIGUE (extremely exhausted) and CHILLS (chills) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Sulfur medication). Concomitant products included AMLODIPINE for Blood pressure high, METFORMIN for Diabetes, MULTIVITAMINS [VITAMINS NOS] for Nutritional supplement.    On 16-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced PAIN IN EXTREMITY (second dose: arm pain), LIMB DISCOMFORT (popping veins in ankle), FATIGUE (extremely exhausted), NAUSEA (nausea) and ARTHRALGIA (right leg joint pain). 17-Sep-2021, the patient experienced HEADACHE (headache) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 4 doses in the span of 4 hours. At the time of the report, PAIN IN EXTREMITY (second dose: arm pain), LIMB DISCOMFORT (popping veins in ankle), HEADACHE (headache), FATIGUE (extremely exhausted), CHILLS (chills), NAUSEA (nausea) and ARTHRALGIA (right leg joint pain) outcome was unknown.            Other concomitant medications include Cardiac medication once a day and Vitamin 15mg.   This case was linked to MOD-2021-322206 (Patient Link).
Information has been received from a health professional concerning a patient (25 out of 40) who was vaccinated with Pneumovax 23 (lot number 651406/0620F).  It is unknown if the patient was vaccinated with the influenza virus vaccine (unspecified) on the same day.  Subsequently the patient experienced fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  Subsequently, the patient recovered from fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
Same day post vax, the pt noticed itching and rash on arms, legs, torso, and neck. Went to ER on 9/10/00, briefly examined and was given Benadryl capsules. No further treatment recommended.
Administrated an expired dose of Bexsero; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number abxb58aa, expiry date 20th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 7th October 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-OCT-2022 Reporter's Comment: The reporter was a nurse. The reporter reported that the patient received an expired dose of Bexsero vaccine. No adverse event was reported Patient identifiers was not provided. The reporter did consent to follow up. Additional supportive information: The patient received a Bexsero which was already expired, which led to expired vaccine used.
rash all over body, temp;dx MMR rxn;hlth dept did not give any info on vaccine;
Itchy, erythematous rash on mid-lower back... the rash and itchiness improved over course of 1 day.  No fever or any other symptoms.  No treatment given.
This spontaneous case, initially received from a pharmacist on 23-Oct-2018, concerns a 69-year-old, elderly male patient. It was reported that during administration of the vaccine, since the pharmacist did not fasten the needle tip correctly (explicitly coded as wrong technique in product usage process), part of the vaccine leaked out of the syringe between the needle tip and the place where the needle fastens onto the pre-filled syringe (explicitly coded as product leakage). On 10-Oct-2018, the patient was administered an incomplete dose of FLUAD TIV [dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250783 and expiry date: 30-Apr-2019] (explicitly coded as incomplete dose administered). No adverse reactions reported after administration of the vaccine. The reporter assessed this case as non-serious. Follow up report received from the pharmacist on 19-Nov-2018: The gender (male) of the patient was added. The dose (0.5ml), anatomical location (deltoid), batch number (250783) and expiry date (30-Apr-2019) were updated. The narrative was amended accordingly.
Pt was drowsy, lethargic, limp started eye rolling went to ER had sz;
2cm local induration, t102 x 2 noc; rx symptomatic;
First dose I was fine,second dose I had reactions next day with face swelling lip swelling  tired next day swelling went down then I have big lymph node knots on both sides of neck with chills and fatigue. I  am on third day and still have nodes on neck and tired with chills. My eyes fill little swollen also.
After immunization was given pt went to the waiting where she stated she was "feeling like she is going to throw up".  Pt was given .30 Epi pen in left thigh, 6L 02, notified Dr.  Pt was treated over 3 hrs.
vax given on 11JAN93 @ approx 3PM that noc pt c/o soreness rt arm; this AM arm swollen w/rash around inject site & under arm pit; t101;
I was going to pass out, so I just let myself to go on the floor I was staring up  and I didn''t know; When I get up to go the bathroom, I couldn't even to go by my legs; I felt like I was going to faint; I felt like I was drugged; dizzy sometimes/little dizzy/ lightheaded; I was off balance; I get light headache; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), vaccinated at age of 81 years old, dose 2 via an unspecified route of administration, administered in Arm Left on 05Mar2021 (Batch/Lot Number: EN6205; Expiration Date: Jun2021) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included blood pressure. Concomitant medication included metoprolol taken for blood pressure. The patient was received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, Expiration date: May2021) in left arm on 12Feb2021 for covid-19 immunisation at the age of 81 years old. Patient stated the first day she had it she was ok, the second day she had it, she went to take a nap, when she get up to go the bathroom, she couldn't even to go by her legs. Her husband had to help her up. She felt like she was going to faint, she felt like she was drugged, he finally could get patient to the bathroom and on the way out she knew she was going to pass out, so she just let herself to go on the floor and he said she was staring up at him and she didn't know. He washed her face and patient finally come to and then the second day in evening she almost passed out again after that for about a week or two, patient was off balance and dizzy sometimes. All events happened in Apr2021. No treatment was received for all events. Date of first shot and second shot: Consumer stated that she had Pfizer number 1 and then she had Pfizer number 2. Number 2 was when she had the reaction. Sometimes, she got light headache and little dizzy now and she didn't know if it was coordinated. Patient did not have any blood anywhere in the last 2 weeks. Patient got up in the morning and sometimes she was lightheaded. No prior vaccination (4 weeks). The outcomes of events were unknown.   Follow-up attempts are completed. No further information is expected.
Hepatitis B vaccine (Recombivax HB) was ordered and signed for patient. Verbally communicated with MA the vaccines to be given: Pentacel, Hepatitis B, and Rotavirus vaccines. After MA gave vaccines, another MA was entering them into the system and noted that patient had been incorrectly given Vaqta (Hepatitis A) vaccine instead of Recombivax (Hepatitis B) vaccine as ordered. Supervising physician Dr.  was immediately notified, and mother of patient was notified subsequently. Reviewed adverse symptoms to watch for with plan to follow-up via telephone tomorrow. No immediate adverse events or symptoms were noted with the patient in office. He was breastfeeding at time of re-assessment.
sore arm; 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.  An adult male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300012926 same patient, events after different doses of the vaccine;
Post vaccine rash c/w varicella day4 1/2 - 5.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 21-AUG-2017, the patient was vaccinated with VARIVAX (lot # N002204, expiration date 19-JAN-2019) (route, dosage and frequency were not reported) which was improperly stored. The sterile diluent used to reconstitute the VARIVAX was properly stored. No symptoms reported. The vaccine was stored at -1.6 degree centigrade for 15 hours. The vaccine had previous temperature excursion which was stored at a temperature from -9 degree centigrade to 8 degree centigrade for 30 hours and 15 minutes. Data logger was involved. No further information was provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010758: US-009507513-1708USA010756: US-009507513-1708USA010757: US-009507513-1708USA010762: US-009507513-1708USA010759: US-009507513-1708USA010754: US-009507513-1708USA010761.
After my second shot of Pfizer COVID-19 shot, my hair has been falling out. Was diagnosed with Telogen Effluvium.
Immediately after inoculation , back of throat was burning ,  heart rate went 140 bpm , and the blood pressure to 156/ 86
chills overnight; fever over night; This case was reported by a other health professional via interactive digital media and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a day after receiving Shingrix, the patient experienced chills and fever. On an unknown date, the outcome of the chills and fever were unknown.   It was unknown if the reporter considered the chills and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix shot and had chills and fever overnight. The reporter enquired that if he/she was contagious.
Severe acute debilitating bursitis and tendinopathy, right shoulder, and Concurrent more mild pain and swelling in joints for left foot and left hip (MRI run) - March 20.  ER visits March 21:  Negative culture of joint tap.  Once all tests were done, RA factor and then more specific test for rheumatoid disease confirmed early rheumatoid disease with no visible arthritis on x-rays.  Responded but did not resolve with NSAIDS Responding to methotrexate 12.5 mg once weekly.
Bilateral cataracts; Flu like symptoms; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (Not Aplicable). The reporter is the patient. Other Case identifier(s): 22K-163-4297958-00 (Agency).  A 78-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Feb2021 (Batch/Lot number: unknown) at the age of 78 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HUMIRA taken for psoriasis (ongoing). Vaccination history included: Bnt162b2 (Dose 2, single, Route of Administration: Intramuscular), administration date: Feb2021, when the patient was 78 years old, for Covid-19 immunization; Bnt162b2 (Dose 1, single, Route of Administration: Intramuscular), administration date: Jan2021, when the patient was 78 years old, for Covid-19 immunization. The following information was reported: CATARACT (medically significant), outcome "unknown", described as "Bilateral cataracts"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "Flu like symptoms".  Clinical course: On unknown dates, the patient experienced cataracts in both eyes and second vaccination and booster for covid-19 made felt like having flu. On an unknown date, second vaccination and Booster for covid-19 made felt like having flu resolved. Pfizer biontech covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's assessment of the causal relationship of the events with the suspect product was provided at the time of this report. Since possible determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events cataract, influenza like illness and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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) : US-PFIZER_INC-202200363827 same patient/drug, different vaccine dose
Injection site was tender to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site was tender to touch) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jul-2021, the patient experienced VACCINATION SITE PAIN (Injection site was tender to touch). On 02-Jul-2021, VACCINATION SITE PAIN (Injection site was tender to touch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       List of concomitant medication were not given. The patient informed that injection site was tender to touch at night until the next morning. Treatment information was not provided.   This case was linked to MOD-2021-271724 (Patient Link).