chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant concerning to multiple patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medication, were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ Lot# M031802, expiration date: 09-NOV-2017, orally for prophylaxis, which had a temperature excursion 32°F for 45 days. No previous temperature excursion were reported. The reporter stated that the temperature excursion was detected by a data logger. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA009044: US-009507513-1702USA009042: US-009507513-1702USA009043: US-009507513-1702USA006132: US-009507513-1702USA009041.
Patient was administered her second Pfizer COVID19 vaccine. Shortly after she became dizzy and a dark rash appeared on her face. There were no signs of itching, swelling or difficulty in breathing. Pharmacy provided patient with 50 mg of diphenhydramine and called #911.
every joints were aching; body was aching/ feels achy; This is a spontaneous report received from contactable reporters (healthcare professional and consumer) for a Pfizer sponsored program (141003).  A 47 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) at the age of 47 years, as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Rheumatoid Arthritis" (ongoing), notes: since the patient was 34 years old; "hair loss" (unspecified if ongoing), "thinning of nails" (unspecified if ongoing), "recurring bad acne" (ongoing), all with notes: Side effects of ongoing methotrexate oral. Concomitant medication(s) included: METHOTREXATE SODIUM taken for rheumatoid arthritis, start date: Sep2020 (ongoing); BENZOYL PEROXIDE taken for acne (ongoing). The following information was reported: ARTHRALGIA (non-serious), outcome "recovered", described as "every joints were aching"; PAIN (non-serious), outcome "recovered", described as "body was aching/ feels achy". Additional information: Events were reported as resolved after two days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Inadvertently gave TDAP to early, no S/S at time of vaccination.  Notified parent 3/24/2022, he stated, no adverse reaction or complications since receiving TDAP.
PT C/O FACIAL FLUSHING, FATIGUE, PAIN IN JOINTS AND A HEADACHE. VS @ 10:46 AM BP 124/93 HR 78 SpO2 98% PT REACTION RESOLVED  WITH TIME AND HYDRATION WITH GATORADE.
Refrigeration excursions identified/undergone several temperature excursions; No adverse event; Vaccines have undergone several temperature excursions and may have been administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patients), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 27-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 24-Sep-2022 at 4:06 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 24-Sep-2022 at 4:06 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patients), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions).    No concomitant medication was provided. On an unknown dates, patient had received dose 1, dose 2, dose 3 of moderna vaccines. Route was Intramuscular and body site was deltoid for all three doses. Patient had received on deltoid body site for dose 4.  Date vial was moved from freezer to refrigerator on 7-Sep-2022.  The vial had undergone temperature excursions. It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the local authority and made aware of the situation.  Reportedly, the nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022.  It was reported that no adverse reactions were reported to their knowledge for any patients. Treatment medication was not provided by the reporter.
I started with a slight cough, somewhat productive. On the 15th I was thinking was this something or not. On the next day the cough was getting worse and I had head congestion and I had a runny nose. I never had a fever. I felt tired at times and I was able to just take a nap every once in a while. It didn't feel like anything outside of a cold. So I really didn't think it was COVID-19. But I had things coming up and I took an at home test and it came up positive. And at that point I contacted my doctor. On Monday 6/20/2022, I noticed that I had no sense of smell.
The day after the vaccine the patient had facial swelling and rash. Two days after the vaccine she awoke with aphasia.  MRI of the brain was negative for stroke or obvious encephalitis.  Then lumbar puncture was done which showed an eosinophilic pleocytosis
aching; Injection site redness and sweling; Injection site redness and sweling; fever; Chill's; This spontaneous report as received from a physician referring to a 74 year old male patient. The patient's concurrent conditions, medical history and concomitant medications were not provided. The patient had no known allergies.  On 17-JUL-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, strength and frequency were not provided) intramuscularly for "prophylactic precaution".  Lot No. S004548 has been verified to be a valid lot number for pneumococcal vaccine, polyvalent, expiration date reported as 12-AUG-2020, but upon internal validation established as the same date.  On 17-JUL-2019, the patient called to report having "injection site redness and swelling, and fever, chills, and aching (pain)". The medical assistant has requested a Lot Check. The medical assistant wanted a response quickly and reported that they would not administer any more doses of the vaccine from that Lot, until they receive a response. The outcome of pain and injection site swelling, injection site erythema was unknown. The outcome of pyrexia and chills was reported as not resolved. No laboratories were performed, and it was unknown if treatment was given for the events.  The causal relationship between the events and the vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine was not provided.
The day after receiving his 2nd dose in the Shingrix series, the patient began experiencing dryness, hardening, swelling at the base of the middle finger on the LEFT hand (opposite hand from where vaccine was given.  Over the next 2 days, these symptoms extended to additional fingers on the left hand and palm and also to the fingers of the right hand.  Patient noticed swelling as ring fit more snugly and also experienced some pain when bending fingers.  Pt used some hand lotion (that he had used previously without reaction), but it gave no relief to dryness.  Pt has appointment to see PCP, Dr, on Monday the 19th.  Told patient to inform us regarding outcome or if symptoms change over the weekend.
I developed symptoms on 12/6/22 of very mild coughing. On 12/8 I definitely had harsher symptoms but still mild. Stuffy head, blowing my nose a lot, coughing, sneezing. It only really lasted Thursday and Friday. Thursday night I felt chills and assume I had a fever, but didn't have a way to check my temperature. Friday I was better and by Saturday I felt quite good and was tested negative by 12/12. I spoke with a doctor at my PCP office and they thought I should forego the antivirals as it was mild.
Adverse reaction to Rubella vaccine.  Conjunctivitis, lymphadenopathy, macular rash, arthralgia.  Symptoms started 10 days after vaccine was given.
Adverse event observed via Garmin watch.  Persistent reduction of HRV (heart rate variability) beginning day after vaccination, lasting several weeks.
Petechial rash scattered on trunk & face. Bumps on legs for 2-3 wks now since 1 week after vaccines given.
Lf arm still pain after 3 weeks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single 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 "Lf arm still pain after 3 weeks".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The child rolled over while recieving their MMR vaccine. Less than 0.1ml was not injected, next time we will  have an additional MA help hold the child.
also a little bit on my right arm and big welts all over my back; felt like something was biting me; Itchy at injection site; these giant welts all over where I got the injection; arm was killing me for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was killing me for 2 days), VACCINATION SITE DYSAESTHESIA (felt like something was biting me), VACCINATION SITE URTICARIA (these giant welts all over where I got the injection), URTICARIA (also a little bit on my right arm and big welts all over my back) and VACCINATION SITE PRURITUS (Itchy at injection site) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (NOS) (in remission). Concomitant products included PALBOCICLIB (IBRANCE), LETROZOLE and VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for an unknown indication.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was killing me for 2 days). On 19-Jan-2021, the patient experienced VACCINATION SITE DYSAESTHESIA (felt like something was biting me), VACCINATION SITE URTICARIA (these giant welts all over where I got the injection), URTICARIA (also a little bit on my right arm and big welts all over my back) and VACCINATION SITE PRURITUS (Itchy at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 19-Jan-2021 for Adverse event, at a dose of UNK dosage form (for 2 days). On 12-Jan-2021, PAIN IN EXTREMITY (arm was killing me for 2 days) had resolved. On 22-Jan-2021, VACCINATION SITE URTICARIA (these giant welts all over where I got the injection) and URTICARIA (also a little bit on my right arm and big welts all over my back) had resolved. At the time of the report, VACCINATION SITE DYSAESTHESIA (felt like something was biting me) and VACCINATION SITE PRURITUS (Itchy at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was due for her second dose on 07-Feb-2021. The patient took the first doe when she was on her off week of Ibrance. The patient took Ibrance on 18-Jan-2021 and on 19-Jan-2021, the patient developed giant welts all over where she got the injection and also a little bit on her right arm and big welts all over her back. The doctor asked her to stop Ibrance for the time.
Hospitalized for a Breakthrough COVID infection in patient who received the primary 2 shot series and a booster.
She got her vaccine, initially was a sore arm, terrible fatigue and general malaise.  The long term reaction is that you is having general body aches, very achy and fatigue continuing still after almost 30 days after the 2nd vaccine.  She has pain all over her body, but particularly her back, shoulders which is worse than any pain she had previous to her vaccines, and has been continuous since the vaccine.  She wonders if this is going to go away.  She is miserable.    With the first vaccine she had the usual side effects that diminished within a day or so.
Nasal congestion; Mild headache; Fatigue; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), NASAL CONGESTION (Nasal congestion), HEADACHE (Mild headache) and FATIGUE (Fatigue) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced RHINORRHOEA (Runny nose). On 18-Jan-2021, the patient experienced NASAL CONGESTION (Nasal congestion), HEADACHE (Mild headache) and FATIGUE (Fatigue). At the time of the report, RHINORRHOEA (Runny nose), NASAL CONGESTION (Nasal congestion), HEADACHE (Mild headache) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
fully vaccinated with Pfizer COVID vaccine recently tested positive for COVID.; fully vaccinated with Pfizer COVID vaccine recently tested positive for COVID.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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.The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "recovering", COVID-19 (medically significant), outcome "recovering" and all described as "fully vaccinated with Pfizer COVID vaccine recently tested positive for COVID.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid test type post vaccination=Unknown. It was unknown if therapeutic measures were taken as a result of covid-19.  Clinical course : Was made aware that individual who was fully vaccinated with Pfizer COVID vaccine recently tested positive for COVID. As the reporter I am unsure of number of boosters or brands of possible boosters. Reporting as an Pfizer employee to meet reporting responsibility. No COVID prior vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a other health professional and refers to unspecified number of patient of unknown age. On unknown dates, those patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M036059 for prophylaxis. No adverse events were reported. Additional information has been requested.
could not sleep; arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (could not sleep) and PAIN IN EXTREMITY (arm hurts) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Blood sugar abnormal and High cholesterol.    On 17-Feb-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced INSOMNIA (could not sleep) and PAIN IN EXTREMITY (arm hurts). At the time of the report, INSOMNIA (could not sleep) and PAIN IN EXTREMITY (arm hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was concomitantly taking high blood pressure pills, blood sugar pills, and high cholesterol pills. No treatment related information has been reported.   Reporter did not allow further contact
This patient was not eligible for a 3rd dose of this vaccine AT THE TIME that it was given. No true adverse reaction.
Patient's wife called and stated that pharmacist gave shot too low (below deltoid muscle) and now he has inflammation in the form of a knot.
This spontaneous case, initially received on 08-Jan-2018, reported by a pharmacist, concerning a 59-year-old  adult male patient. The patient's current condition included glaucoma (since an unspecified date). The patient did not receive any concomitant medication. On 06-Jan-2018, the patient was administered with FLUAD (dose: 05 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 179203, expiry date: 30-Jun-2018) under 65 years of age (explicitly coded as inappropriate age at vaccine administration). It was reported that, the patient did not experienced any adverse event after the vaccination. The reporter assessed this case as non-serious.
Developed a medium size knot where shot was given that was hard and sore to the touch.  Then also developed the same thing up on my collar bone area (may be a lymph node) that is more sensitive to the touch than my arm.  Makes me arm feel somewhat numb and harder to grip at times.
PAIN AT SITE OF INJECTION FOR PNEUMOVAX. PATIENT WENT TO PCP WHO DIAGNOSED INFECTION AT SITE OF INJECTION FOR PNEUMOVAX AND PRESCRIBED ANTIBIOTICS
Pt given DT 8JAN91, on 14JAN91 pt became very lethargic & weak; Unable to sit up;
chills; headaches; body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headaches) and MYALGIA (body aches) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 05-Mar-2021, the patient experienced CHILLS (chills), HEADACHE (headaches) and MYALGIA (body aches). At the time of the report, CHILLS (chills), HEADACHE (headaches) and MYALGIA (body aches) outcome was unknown.            No concomitant medication was provided.  No treatment details were provided.
Information provided by the son.  The patient experienced shaking of the hands, sitting in a chair and stomping his feet, slow to walk, both shoulders were hurting, and put both arms up around his neck. The son stated they called the family physician and he recommended to take tylenol.  The patient took the tylenol and is doing much better as reported by the son.
caller already had the Pfizer Covid vaccine primary series and had Covid; caller already had the Pfizer Covid vaccine primary series and had Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "caller already had the Pfizer Covid vaccine primary series and had Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: had Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Caller took paxlovid a month and half ago and asked is there any reason he can't get the pfizer booster shot after taking Paxlovid a month and half ago. - Gathered caller's Name- unable to verify spelling of name - Warm transferred to another line- ( Created and submitted Manual AE form Precautionary because caller already had the Pfizer Covid vaccine primary series and had Covid, causing caller to take Paxlovid. Also unable to ask if caller already took the booster dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient presented to urgent care with shortness of breath.  Patient had positive D-dimer and referred to the ER for CT.  At ER visit, he reports progressive worsening shortness of breath over the past 3 to 4 weeks.  Dyspnea on exertion 5/20/2021. Patient was admitted to the hospital with diagnoses of bilateral PE with small saddle embolus and left DVT (left popliteal vein occlusion).  Treatment included heparin drip in the hospital with a conversion to Eliquis.
Patient called the pharmacy two hours after receiving the vaccine saying she couldn?t breathe and called the EMT to her house.
Patient was given vaccines around 10:30 am, around 3 pm patient started with facial swelling, Patient's eyes were swollen shut. No trouble breathing, no itching and no other complaints.