chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mild symptoms and tested positive for COVID.  Runny nose, slight fever and cough; Mild symptoms and tested positive for COVID.  Runny nose, slight fever and cough; Interchange of vaccine products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 55-year-old male patient received BNT162b2 (BNT162B2), on 08Nov2021 as dose 2 (booster), single (Lot number: 330268D), in left arm and on 01Aug2022 as dose 3 (booster), single (Lot number: Lp7139) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), on 18Mar2021 as dose 1 , single (Lot number: 1805025) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: STATIN [ATORVASTATIN CALCIUM]. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Nov2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Oct2022, outcome "recovering" and all described as "Mild symptoms and tested positive for COVID.  Runny nose, slight fever and cough". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Oct2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical information: The patient had no covid prior vaccination. Patient was covid tested post vaccination.   No follow-up attempts are possible. No further information is expected.
Received the vaccine in the morning, and came home and didn't feel too much of anything until 6-7 hours  later.  She went to stand up and felt like she was under water, head pressure.  Her lower extremities felt very head like lead, very weak.  Sat down, took some Tylenol and called her doctor, who told her that it was from the vaccine and to take Benadryl, which she did.  She laid down and woke up about 2 hours later and her muscles in her lower extremities felt very tight, fatigued, weak.  That night she felt chills, feet were cold.  The next day she woke up and felt very light headed and dizzy and her arm was really red, tripled the area of the vaccine, size of an orange.  Was red, hot.  Put some ice on it, took Tylenol, and still had head pressure, dizzy like she was under water.  That night felt chills for about 6 days, no fever.  Still felt dizzy, muscles weak and heavy and fatigued.  She was on Prednisone and weaned off of then.   On Saturday she did not still feel good and was told to take Tylenol.   She still feels very weak in the legs, fatigue and her arm is still tender, not swollen anymore, but is still tender.  Monday she notified her doctor and they told her that it was from the vaccine, rest, drink fluids.  She is due to get the 2nd shot on Thursday and wondering if she should get it.  Nobody knew what to tell her to do for treatment of the reactions.  Lower leg muscles still feel very weak.
2 weeks after my second shot, I had a CVA causing complete loss of sensation in my left arm.  I am in good health and do not have multiple risk factors for CVA.  While the scans showed evidence of a CVA, no underlying cause has yet to be determined.
05/20/98 pt recv vax found out later 7 wk pregnant. LMP 20MAY98; 07/23/98 lab results revealed positive varicella antibodies.
Headache, Diarrhea,  Diarrhea is Post prandial; Pain at injection left  shoulder  Narrative:
By Monday night (L) deltoid had 3/4 square lump and arm was painful. Rash all across upper arm, reddened & painful to touch. No rxn (R) deltoid.
Warm red, circular rash appeared day after vaccine administered. Still warm and red a few days later.
I have a really bad cough right now; This is a spontaneous report from a contactable consumer or other non hcp.    A patient of unspecified age and gender received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 2 via an unspecified route of administration on Jul2021 as dose 2, single for covid-19 immunisation .The patient medical and concomitant medications was not reported. It was Reported that, the patient experienced had a really bad cough right now on 24Jul2021 with outcome of not recovered.
Patient given Pfizer vaccine and fainted after receiving it.  This was a witnessed event.  Patient did not fall or have any injuries.  Patient re-gained consciousness  and sat on the floor until she felt better.  Water was provided to patient.
Afyer first dose, extreme nausea and dizziness for about an hour. Almost called  911. Slowly subsided over the course of day one. After that, ten days of extreme fatigue. Ringing in my ears that resurfaced after second dose.
8 days after vaccine arm became red, itchy, hot and sore. I had a head ache and body aches. Called doctor the second day of reaction and was prescribed Zyrtec , Benadryl and steroid cream. Within 24 hours significantly better. Redness , soreness and itch mostly gone. No headache or body aches as well
This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored ROTATEQ lot L004466, expiry date 02-AUG-2016 and K020181, expiry date 24-JUN-2016, (dose, frequency and route of administration were not reported). No adverse effect reported. No product quality complaint (PQC) was involved. This is one of four reports received from the same reporter. Additional information has been requested.
Fever and headache x 24 hr. L leg red and swollen-doubled in size over night, tender to touch.
This spontaneous report was received from a pharmacist refers to 2 unspecified patients (gender and age not reported). It was reported that on an unknown date the patients were vaccinated with a dose of ZOSTAVAX (lot number and expiration date not reported) (dose, frequency, route not reported). No other co suspect or concomitant medications were reported. The pharmacist reported that the patients reported similar injection site reactions (red, swollen, warm and painful to the touch area at the injection site) following vaccination with ZOSTAVAX. At the time of the report the patient's conditions were unknown. This case is linked to the case # 1303USA009625. Additional information has been requested.
Felt his sugar was going low; felt tired; had no strength; heart was sometimes beating too fast, sometimes beating slower; Felt dizzy; Uncomfortable; 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.  A 50 year-old male patient received bnt162b2 (BNT162B2), administration date 24Apr2021 (Lot number: 0175, Expiration Date: Aug2021) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetic" (ongoing), notes: Has been diabetic for about 10 years. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus (ongoing). The following information was reported: BLOOD GLUCOSE DECREASED (non-serious) with onset 26Apr2021, outcome "unknown", described as "Felt his sugar was going low"; FATIGUE (non-serious) with onset 26Apr2021, outcome "unknown", described as "felt tired"; ASTHENIA (non-serious) with onset 26Apr2021, outcome "unknown", described as "had no strength"; HEART RATE ABNORMAL (non-serious) with onset 24Apr2021, outcome "recovered" (Apr2021), described as "heart was sometimes beating too fast, sometimes beating slower"; DIZZINESS (non-serious) with onset 24Apr2021, outcome "recovered" (24Apr2021), described as "Felt dizzy"; DISCOMFORT (non-serious) with onset 24Apr2021, outcome "unknown", described as "Uncomfortable". Relevant laboratory tests and procedures are available in the appropriate section.  Clinical Information: It was reported that the patient scheduled for the second dose on 15May2021. Patient doesn't know if he should get the second dose of the Covid Vaccine. The patient was diabetic. He doesn't know if he should take his diabetes pills, he doesn't know what to do. Sometimes his sugar goes up. He was taking metformin and another medicine he doesn't remember. Patient does not take this medication on a regular basis. Patient also asked If he has a headache can he take medication for that or can he take any other medication. Patient denied any other medical conditions, medications, labs, testing, or treatments relevant to events. There was no history of previous immunizations with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional vaccines administered on Same Date of the Pfizer Suspect. No Prior Vaccinations (within 4 weeks) and AE(s) following prior vaccinations were reported. The caller mentioned that the only other vaccine he had gotten was the flu vaccine many years ago.  No follow-up attempts are possible. No further information is expected.
She had enlarged heart; She had enlarged liver; She is very angry that this happened to her.; She felt as if she was dying.; Patient received her 1st dose on 06Apr2021 and 2nd dose on 18May2021; Within 7 days after receiving 2nd dose, she had a stroke.; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Within 7 days after receiving 2nd dose, she had a stroke.) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Within 7 days after receiving 2nd dose, she had a stroke.) (seriousness criteria medically significant and life threatening). On an unknown date, the patient experienced CARDIOMEGALY (She had enlarged heart), HEPATOMEGALY (She had enlarged liver), ANGER (She is very angry that this happened to her.), FEELING ABNORMAL (She felt as if she was dying.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her 1st dose on 06Apr2021 and 2nd dose on 18May2021). At the time of the report, CEREBROVASCULAR ACCIDENT (Within 7 days after receiving 2nd dose, she had a stroke.), CARDIOMEGALY (She had enlarged heart), HEPATOMEGALY (She had enlarged liver), ANGER (She is very angry that this happened to her.) and FEELING ABNORMAL (She felt as if she was dying.) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her 1st dose on 06Apr2021 and 2nd dose on 18May2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication were not provided Treatment medication were not reported  Patient went to ER within those 7 days. Patient mentioned that her husband was also sick after receiving vaccine.  Action taken with mRNA-1273 in response to the events was not applicable.  As an intervention patient had 3 blood transfusions and was on ventilator  Based on the current available information and temporal association between the use of the product and the start date (within 7 days) of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date (within 7 days) of the events, a causal relationship cannot be excluded.
The next day after my vaccination, I had a migraine, I was vomiting and I have severe body ache and this lasted for 4 days and I took my migraine medicine for those 4 days and eventually the symptoms subsided.
Body aches began 10pm on 2/9/2021, following vaccine given at 10:39am. Erythema near injection site noticed 7am 2/11/2021
This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site), LYMPHADENOPATHY (Lymph Node Swollen), LYMPH NODE PAIN (Lymph Node hurt), PAIN (Body Aches) and PYREXIA (Increase in temperature 100.4F) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN, GLIPIZIDE and METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain at injection site), LYMPHADENOPATHY (Lymph Node Swollen), LYMPH NODE PAIN (Lymph Node hurt), PAIN (Body Aches), PYREXIA (Increase in temperature 100.4F), FATIGUE (Fatigue), NASOPHARYNGITIS (Cold) and PAIN IN EXTREMITY (pain in arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Pain at injection site), LYMPHADENOPATHY (Lymph Node Swollen), LYMPH NODE PAIN (Lymph Node hurt), PAIN (Body Aches), PYREXIA (Increase in temperature 100.4F), FATIGUE (Fatigue), NASOPHARYNGITIS (Cold) and PAIN IN EXTREMITY (pain in arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This case was reported by a physician via sales rep and described the occurrence of intussusception in a infant patient who received ROTARIX for prophylaxis. On an unknown date, the patient received ROTARIX (oral). On an unknown date, less than a year after receiving ROTARIX, the patient experienced intussusception (serious criteria GSK medically significant). On an unknown date, the outcome of the intussusception was unknown. It was unknown if the reporter considered the intussusception to be related to ROTARIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter had seen patient that developed intesessuption after having received ROTARIX. No specific details were available. The reporter did not agree to follow up from GlaxoSmithKline. This case has been linked to the cases US2019AMR047518 and US2019GSK048422, reported by same reporter.
Guillain Barr Symptoms, no reflexes on right side, weakness, muscle aches, liver function test abnormal. Medical records state migraine, viral infection, rash, splenomegaly. msv
broke out in shingles rash on lower left arm and hand two days after second dose of vaccine
Breakthrough COVID infection in boosted patient (J&J 3/2021; Moderna 11/17/2021). Patient in aflutter and with SOB (on 4-6L O2 at home). Treated COVID with dexamethasone 6 mg daily.
Approximately 45 minutes after vaccine administration, family noticed hives on patient's cheeks, neck, arms and torso, hives not bothering patient. Patient did not have any vomiting, swelling of lips, tongue or throat. No changes to breathing.  Family gave one dose of Benadryl and monitored throughout the evening, hives had resolved by the next morning.
Hospitalized in pediatric ICU 05/20/2000.  Transferred to hospital 06/11/00 - 07/14/00. Encephalitis -
Pt reported hard knot in arm at injection site 10/15/13 30 days after injection. She went to ER. She was administered an ultrasound, the muscle was full of pus. The physician drained the wound and packed it w/gauze, she was given BACTRIM DS bid x 10 days. Pt reports the hard knot occurred at and since the shot.
After first dose, "normal" side effects of extremely sore arm, headache lasting one day.  After second dose, fever to 101.5 at 1:00am after receiving shot at 3:00pm previous day. Extreme arm and shoulder pain. Waking up again at 3:00am experienced FULL BODY paralysis. Estimate fever at 103+ but was unable to move to verify. Eyes were in pain and blurry vision. unable to reach phone to call 911. These symptoms lasted 1 hour and son called to check on me and rushed over. Fever was at 101 but immediate does of motrin and then later tylenol, broke fever. Arm remained immobile for full day. Now it is mobile but still painful to lift overhead. All other symptoms subsided.
Information has been received from a physician concerning a cluster of six of seven patients who did not develop sufficient titer after vaccinations with RECOMBIVAX HB. On 23-NOV-2010, 5 patients were vaccinated with a dose of RECOMBIVAX HB (lot number: 666029/1456Y), thimerosal free (dose and site of administration not reported) and 2 patients were vaccinated with a dose of RECOMBIVAX HB (lot number: 666806/0732Z), thimerosal free (dose and site of administration not reported). On 22-DEC-2010, all 7 patients were vaccinated with a dose of RECOMBIVAX HB (lot number: 666805/0657Z), thimerosal free (dose and site of administration not reported). On 25-MAY-2011, 6 patients were vaccinated with a dose of RECOMBIVAX HB (lot number: 669597/0294AA), thimerosal free (dose and site of administration not reported). On 25-MAY-2011, 1 patient was vaccinated with a dose of RECOMBIVAX HB (lot number: 666809/1631Z), thimerosal free (dose and site of administration not reported). Titers drawn in June 2011 showed that six of seven total patients did not developed sufficient titers. The titers were repeated in July 2011 at a second laboratory. The patients did not seek medical attention. Follow up information has been received from a physician concerning a patient who on 23-NOV-2010 was vaccinated with the first dose of RECOMBIVAX HB (Lot # lot number 666806/0732Z, exp: 10-NOV-2012), on 22-DEC-2010 was vaccinated with the second dose of RECOMBIVAX HB (Lot # lot number: 6666805/0657Z, exp: 09-NOV-2012) and on 25-MAY-2011 was vaccinated with the third dose of RECOMBIVAX HB (Lot # lot number: 669597/0294AA, exp: 07-SEP-2013). Follow up information was received from the physician who reported that his office does not treat any pediatric patients, the office only treats adults. The physician reported that the office purchased the pediatric vials (0.5 vial dose) "which are cheaper" and dispensed two vials to each patient to provide an adult dose. Related WAES#s included: 1107USA03575, 1108USA01426, 1108USA01427, 1108USA01428, 1108USA01429. This is one of several reports from the same source. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process checks for the lot numbers 666806/0732Z, 666805/0657Z and 669597/0294AA were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Extreme soreness in both arms started around 1:00 am on 6/8/2021.  Took Tylenol throughout entire day but soreness turned pain by  noon on 6/8/2021.  Continued Tylenol but woke up throughout night if turned on either arm, especially left arm.  Woke up at 8:30 am on 6/9/2021 with right arm red, hot to touch and swollen.  Started icing off and on and took Tylenol.  Around 3:30 pm, noticed left arm was now red and swollen too.   Went to urgent care (inside same clinic facility) and saw a nurse practitioner.  She took measurements of the swollen red circle areas on both arms. She then prescribed taking Advil for pain.  Also Instructed patient to continue to ice both arms and to take a Zyrtec and Pepcid each morning and benedryl and Pepcid each night.  Gave me this website name so I could report .
Narrative: RN Signed: 11/08/21 12:16 11/08/2021 ADDENDUM STATUS: COMPLETED Patient said coming in that he reacts to needles. He thought that he might get woozy. He did get clammy and said that he had ringing in his ears. He said that ould not her. Patient said that it is needle. Gave him a benedryl. He apologized several times. Kept patient waiting till he said he was feeling better.
Chief Complaint: generalized weakness.  Pt is COVID positive . Pt was COVID vaccinated without the booster.  on Remdesvir
About 5:30 pm patient c/o headache. C/O mom found patient in tub asleep about 6 pm. Patient got out of tub was in moms room bent over to pick up cup. Patient could not grab a hold of cup. C/O dizziness, talking to mom incoherently. Took to ER local. Patient was real drowsy want to sleep. ER did - EKG, blood test, B/S, Blood gases CT scan drug testing U/A. ER couldn't find out the problem. Transfer by helicopter to hospital. Heart monitored overnight. Patient was fine the next morning.
This spontaneous report was received from a medical assistant (also an office manager) and refers to a patient of unknown age and gender. There was no information about the patient's concomitant therapies, medical history and drug reactions or allergies provided. On 10-APR-2017, the patient was vaccinated with improperly stored dose of VARIVAX 0.5 ml, once, subcutaneously, lot# M038857, expiration date: 14-SEP-2018 (site of administration was not reported). Sterile diluent, lot#: M033585, expiration date: 21-APR-2019, subcutaneously, was used to reconstitute the dose of improperly stored VARIVAX received by the patient. No temperature excursion was identified for the sterile diluent. No adverse effects were reported. Administered dose of vaccine was stored in temperature between 15 degrees Fahrenheit to 46 degrees Fahrenheit (the range was 35.5 degrees Fahrenheit) for 3 hours. Digital data logger was used to capture the temperature excursion. There were no previous temperature excursions. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015679: US-009507513-1705USA015680: US-009507513-1705USA015681: US-009507513-1705USA015682: US-009507513-1705USA015683:
This spontaneous report was received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates (reported as from 06-DEC-2016 to 04-JAN-2017), the patients underwent the administration of improperly stored doses of LIQUID PEDVAXHIB lot # M025194, expiration date 22-MAR-2019 (dose and route of administration were not provided) for prophylaxis. There were no adverse events reported. Administered doses of LIQUID PEDVAXHIB were exposed to a temperature excursion of 35°F for 60 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007869: US-009507513-1701USA007870: US-009507513-1701USA007871: US-009507513-1701USA003063:
Myalgia Felt like she burned her tongue and had an odd taste in her mouth for about 3 hours; fatigue Narrative:  1/13 about an hour after she got the shot she felt like she burned her tongue and had an odd taste in her mouth. Resolved after 3 hours. 1/14 developed body aches and fatigue. She took a 2-hour nap and the symptoms resolved. Also took tylenol.
Two red streaks below injection site. Then next morning slight redness and swelling. Warm to touch. Labs normal. Started on BACTRIM and KEFLEX by NP. Could be skin infection.