chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist, and refers to a 65 year old patient of unknown gender. No information was provided regarding the patient's medical history or concurrent conditions. On 13-DEC-2017, the patient was vaccinated with an expired dose of ZOSTAVAX 19400 PFU, lot number M038350, expiration date 06-DEC-2017, for prophylaxis (route of administration was not reported). The dose of ZOSTAVAX was reconstituted with sterile diluent (MERCK) which was not expired (lot number M044949, expiration date 18-JUN-2019). No adverse effects were reported. This is one of two cases received from the same reporter. Sender's Comments: US-009507513-1712USA012708.
body aches,sore throat, fatigue Narrative: Pt presents with symptoms of mild sore throat for 4 days with fatigue. He had received his first dose of Moderna COVID-19 vaccine 1 week ago and was wondering if his symptoms were related to this. He did develop initial body aches for a couple of days but the sore throat and fatigue came later. He denies any fevers, chills, sweats, diarrhea, loss of taste or smell, rash, cognitive deficits. He also has a history of allergic rhinitis and has not been taking his antihistamines and was wondering if the fatigue and sore throat could be related to this also. Since booking his appointments, his symptoms have improved today.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 27-AUG-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
No immediate side effects but upon waking up on Monday, March 29, 2021 I had a bad rash on my torso, lower legs and top of both feet.  The rash was very itchy.  I went to Urgent Care on Tuesday, March 30, 2021 and the doctor wasn't sure what had caused rash as I've had no new medications, foods, soaps, shampoos, etc.  I asked if it could be delayed reaction to my first Covid vaccine and he didn't think I'd have a reaction 3 weeks after the vaccine.
The vaccine was used 2 days post beyond use date. The manufacturer Moderna was contacted, their analysis states that the lot number AS7148B maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration therefore no further actions needed.
This spontaneous report as received from a medical assistant refers to an unspecified patients of unknown demographics. On an unknown dates the patients were vaccinated with improperly stored GARDASIL 9 (strength, dosage and route unspecified) with lot # L037554 and expiration date 25-DEC-2017; with lot# M011117 and expiration date 07-DEC-2017. The vaccine with the lot# M011117 was exposed to temperature of 34.9F and the vaccine with the lot# L037554; both for 26.2F for the time frame of 1 hour. Call was because of a date logger. There was no previous temperature excursion. Temperature was back in range. No adverse effects were reported. No product quality complaint involved. No further information was provided. This is two of several reports received of several reports received from the same reporter. Additional information has been requested.
Skin reaction; Rash all over the body; Headaches; Low energy; Itching; This spontaneous case was reported by a physician and describes the occurrence of ASTHENIA (Low energy), PRURITUS (Itching), SKIN REACTION (Skin reaction), RASH (Rash all over the body) and HEADACHE (Headaches) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN for an unknown indication.   In October 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced SKIN REACTION (Skin reaction). In November 2021, the patient experienced ASTHENIA (Low energy), PRURITUS (Itching), RASH (Rash all over the body) and HEADACHE (Headaches). The patient was treated with CYPROHEPTADINE for Itching, at an unspecified dose and frequency. At the time of the report, ASTHENIA (Low energy), PRURITUS (Itching), SKIN REACTION (Skin reaction), RASH (Rash all over the body) and HEADACHE (Headaches) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient did not required hospitalization.   This case was linked to MOD-2021-414620 (Patient Link).
received a booster dose of the Moderna Vaccine that was pretty bad shaken for around 15 seconds; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT PREPARATION ISSUE (received a booster dose of the Moderna Vaccine that was pretty bad shaken for around 15 seconds) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) 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 PRODUCT PREPARATION ISSUE (received a booster dose of the Moderna Vaccine that was pretty bad shaken for around 15 seconds). At the time of the report, PRODUCT PREPARATION ISSUE (received a booster dose of the Moderna Vaccine that was pretty bad shaken for around 15 seconds) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.   This case was linked to MOD-2021-396547, MOD-2021-396583 (Patient Link).
Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, COVID-19: positive Positive. On 06-Feb-2021, COVID-19: negative Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were provided. No treatment medication details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: he patient reported that no symptoms occurred and tested negative for COVId-19 on 06-FEB-2021. The patient reported that she believes it was a false positive.
This spontaneous report was received from a medical assistant via a sales representative concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) (manufacturer unknown) (lot number, expiry date, dose and route unspecified) (unknown details and unknown arm). Other suspect therapy included a dose of KINRIX (unknown details and unknown arm). Both the vaccines were given in the same arm (arm unspecified). No concomitant medications were reported. On an unknown date, after the vaccination, the patient experienced bruise injection site. The reporter stated that the patient experienced a local reaction (Injection site bruising) to KINRIX. A dose of VARIVAX (Merck) (manufacturer unknown) was also received in the same arm, so it could be a reaction to reaction to both. The reporter described the local reaction was looking like a bruise. The mother of the patient provided pictures to the office of the physician. At the time of reporting, the outcome of the event was unspecified. The reporter considered the event to be related to VARIVAX (Merck) (manufacturer unknown) and KINRIX (reported as it could be a reaction to both). Additional information has been requested.
Information has been received from a physician concerning a 14 year old female patient with anemia who on 10-AUG-2010, was vaccinated IM with the first dose of GARDASIL (Lot# 666118/1539Y). Subsequently, the patient began to feel weakness, tired and wanted to stay in bed. She found it hard to swallow. The patient was also being treated for anemia. She went in the office on 23-AUG-2010, for medical attention and the patient would not be given the other two doses of GARDASIL. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
The patient presented to the ED via MMR with complaints of a near syncopal episode. The patient had decreased appetite, diarrhea, fatigue, rhinorrhea and a clear, productive cough. Pt found to be covid positive. PT was monitored and given fluid replacement.
Discomfort and pain with range of motion  in upper arm and shoulder with intermittent numbness in lower arm. Was given steroid dose pack and NSAID in December.
myocarditis; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  An adult female patient (unknown if pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer Unknown, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization; Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer Unknown, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown". The event "myocarditis" required physician office visit. It was unknown if therapeutic measures were taken as a result of myocarditis.  Clinical course: It was unknown if patient received any other vaccine in four weeks. Five months after getting the bivalent vaccine, a female patient experienced myocarditis. Pharmacist called Pfizer inquiry line too ask whether or not she could give the patient the monovalent omicron vaccine at patients request. The pharmacist also said the patient told her that the patients doctor advised her against getting the Omnicrion monovalent vaccine. It was unknown if patient tested covid prior and post vaccination.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, the events of Myocarditis is assessed as related to suspect product BNT162b2. 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.
APPROX 24 HRS POST INJECTION, DEVELOPED SWELLING AND ERYTHEMA MASS THAT WAS BELOW INJECTION SITE. SITE WAS HOT TO TOUCH AND NOTICEABLE SWOLLEN AND PAINFUL AXILLARY LYMPHNODES.
Poison ivy; irregular heart beat; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS CONTACT (Poison ivy), HEART RATE IRREGULAR (irregular heart beat) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered ) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 20-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered ). On an unknown date, the patient experienced DERMATITIS CONTACT (Poison ivy) and HEART RATE IRREGULAR (irregular heart beat). At the time of the report, DERMATITIS CONTACT (Poison ivy), HEART RATE IRREGULAR (irregular heart beat) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered ) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: Irregular.         No relevant concomitant medications were reported. No treatment medication reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of poison ivy and irregular heart beat with HUMIRA(ADALIMUMAB) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Started having stabbing pain in my lymph node in the groin area for two days. Then it moved to the lymph node in my throat and I had pain for three days.
pt recvd vax & w/in 12hrs post vax pt exp a generalized rash;sx was untreated & persists;
shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported. The patient reported that he/she received first dose of Shingles shot 2 weeks ago and got Shingles, it was horrible. The patient would get second shot in mid September.
My left ear felt plugged and I did not go until February to get it checked out but it had begun since having COVID in December. I went to see my physician and he said I had an infection. He put me on an antibiotic which did not completely clear it up. I was then put on Claritin and Flonase daily and was sent to an ENT. She felt I should continue on the Claritin and nasal spray. She does feel it could be from COVID but if so it is bilateral. My ear is better but not back to normal.
Patient explains that for the past several days she has weak and lethargic.  She is having a difficult time ambulating.  she has had intermittent episodes of fevers and chills, frequent episodes of diarrhea (nonbloody) associated with nausea.
woke up from 2AM nap around 2PM;screaming-inconsolable crying;calmed down around 1Pm cont to cry alot since 8JAn97;12JAN97 con to cry & held breath;to MD on 13JAN97 dx vaccine rxn;
Flu like symptoms; joint pain; low grade fever; chills; This is a spontaneous report received from a contactable consumer (Patient). This 42-year-old female non pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection; Lot Number and expiry date was not reported), via an unspecified route administration on left arm on 06Mar2021 14:15 as a 1st dose single for COVID-19 immunisation. Medical history included uveitis and Covid-19 (prior vaccination). Concomitant medication included esomeprazole magnesium (NEXIUM) received within two weeks of vaccination. The patient had COVID prior vaccination, and patient was tested for COVID post vaccination. The patient underwent nasal swab test on 22Feb2021 and on 27Feb2021 and the test result were negative. The patient had no known allergies. On 06Mar2021 15:30, the patient experienced Flu like symptoms, joint pain, low grade fever and chills. Patient did not receive any treatment for the events. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Wheezing, shortness of breath, macular itchy rash at site and distal sites, headache, fatigue and joint pain at 7-8 pm.  Benadryl improved eruption, albuterol and airduo and assisting with wheezing but symptoms return after 2-4 hours.
Immediately after getting the vaccine, patient experienced facial numbness. His forehead, nose, chin, cheeks were all slightly numb. He felt tingling all over the facial area. No issues eating, drinking or speaking. Felt slightly warm to touch, but didn't feel like he was feverish. Did not develop a fever.  There was no facial drooping. Issue resolved about 36 hours after receiving vaccination. He did not have this side effect after either of the first 2 doses in the series. The primary series was also Moderna.
Information has been received from a registerd nurse via a field representative referring to a patient of unknown age and gender. No relevant medical history was reported. On 16-MAR-2015 the patient was vaccinated with the first dose of GARDASIL. The second and the third dose were received on 04-JUN-2013 and 03-JAN-2014 respectively. On 16-MAR-2015 the patient was given a fourth dose of GARDASIL in error. Dose, route and lot number of the four doses of GARDASIL were unknown. No adverse effects were noted. Product was confirmed not to be GARDASIL. Additional information has been requested.
I lost feeling in my left arm for a month. It felt like it was asleep and had tingling.
This case was reported by a healthcare professional and described the occurrence of erythema in a 38-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). On 1 March 2010 at 17:00 the subject received booster dose of INFANRIX (unknown). On 1 March 2010, at the time of vaccination with INFANRIX, the subject experienced drug use for unapproved indication. The 38-year old subject received INFANRIX in error. On 03 March 2010, 2 days after vaccination with INFANRIX, the subject experienced erythema, body pain, and fever. At the time of reporting the erythema was unresolved. On 04 March 2010 body pain fever resolved. The healthcare professional considered the events were probably related to vaccination with INFANRIX.
6 days after injection pain in left arm. Uable to lift arm by 7th day. Constant throbbbing in muscle below shoulder joint. Still hurts after 2 1/2 weeks. Have to take 800mg  ibuprofen for relief. Still waiting for resoloution .
Pt devel urticaria p/vax w/2nd dose of Hep B; pt was subsequently treated w/DPH; No further details were provided;
URINARY TRACT INFECTION; EXTREMELY LOW BLOOD PRESSURE; POSITIVE DIAGNOSTIC TEST FOR COVID; This spontaneous report received from a consumer concerned a 69 year old female. The patient's height, and weight were not reported.  The patient's past medical history included gastrointestinal infection, and concurrent conditions included dialysis. The patient was hospitalized on an unspecified date in MAR-2021, (a week before vaccination) due to gastrointestinal infection and was discharged approximately on 29-MAR-2021 or 30-MAR-2021. On 31-MAR-2021, the patient had dialysis and was administered the vaccine as well in the dialysis center. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered to left arm on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-APR-2021, the patient experienced extremely low blood pressure and was taken to the emergency room. On the same day, the patient was admitted to the hospital and was diagnosed with a urinary tract infection. The patient took the quick COVID-19 test which was negative. The patient took another unspecified diagnostic test for COVID-19 on the same day which was positive. It was reported that, the patient did not have COVID-19 related symptoms (or previous symptoms) and was asymptomatic.  Laboratory data included: Blood pressure (NR: not provided) Extremely low, COVID-19 antigen test (NR: not provided) Negative, and COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the urinary tract infection, extremely low blood pressure and positive diagnostic test for COVID was not reported. This report was serious (Hospitalization Caused / Prolonged). The case is associated with Product Quality Complaint number # 90000175206. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210407177 -covid-19 vaccine ad26.cov2.s-extremely low blood pressure, urinary tract infection. 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).
pt complained of fatigue, red, and soreness 1 day after she received the vaccine. She still has sore arm 2 days after.
Appears to have been anaphylaxis that resolved spontaneously without epinephrine. She notes nausea, vomiting, throat sensation of closure, dyspnea and oral tingling.  Of note, lot number is either ER8736 or 91300, I am unsure but venture to guess ER8736 is correct.
RECIEVED PREVNAR VACCINE #3 ON 10/04/04..  ON 10/05/04, DEVELOPED 103.0 AXILLARY TEMP AND HAS MAINTAINED THAT TEMP TO THIS DATE.  RECEIVING ANTIPYRETICS, ONLY DECREASE TEMP TO 100.0 THEN BACK UP TO 103.  HARD NODULE, REDNESS, SWELLING AND WARMTH AT SITE OF INJECTION.  HAS NOT HAD THIS REACTION IN THE PAST DURING PREVIOUS INJECTIONS OF SAME VACCINE.
sever reaction; headache; fatigue; feverish; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ADVERSE REACTION (sever reaction), HEADACHE (headache), FATIGUE (fatigue) and PYREXIA (feverish) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 25-Feb-2021, the patient experienced ADVERSE REACTION (sever reaction), HEADACHE (headache), FATIGUE (fatigue) and PYREXIA (feverish). On 27-Feb-2021, PAIN IN EXTREMITY (sore arm), ADVERSE REACTION (sever reaction), HEADACHE (headache), FATIGUE (fatigue) and PYREXIA (feverish) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Patient used Tylenol and unspecified pain killer to treat the events.
Pt devel a large area of erythema & induration (approx 3x7 cm) @ inject site approx 48 hrs p/receiving Td;
Developed hives and itching which needed IV steroids to help (has done away), also developed dermatagraphia which has not resolved yet (Jan 4 2022)