chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician referring to 10 weeks old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 07-JUN-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB (exact dose, dose number, route of administration were not reported; lot# reported as N00236 with the expiration date of 24-OCT-2019) for prophylaxis. On 09-AUG-2017, the patient received another dose of improperly stored PEDVAXHIB (exact dose, dose number, route of administration were not reported; lot# reported as N00235 with the expiration date of 26-OCT-2019) for prophylaxis. The administered doses of PEDVAXHIB underwent multiple temperature excursion between 34 and 54 Fahrenheit degrees, which lasted for 16 hours, since 19-MAY-2017. Digital data logger was not involved to capture the temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter.
Diffuse Rash, itching all over, neck, arms, abdomen, thighs, low back  predominantly.  Tried to find other cause, but could not. Started within 5 days of vaccine. Now fading wish use of hydrocortisone cream/lotion.
low back discomfort "over both kidneys" that is described as soreness. began approximately 1 hour after the vaccine was administered. denies radiation of pain, dysuria, n/v, fever. pain intermittent for about a wee, increased to constant soreness and increased intensity on 12/31/2020. referred to urgent care
This case was reported by a nurse and described the occurrence of allergy in a adult female patient who received Flu Seasonal QIV Dresden. Concurrent medical conditions included systemic lupus erythematosus, obesity, fall, drug allergy (was allergic to BENLYSTA, Codeine, Compazine, TIGAN) and food allergy (no known food allergy). On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced allergy. On an unknown date, the outcome of the allergy was unknown. It was unknown if the reporter considered the allergy to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were reported as follows: The patient's concurrent condition included cholecystectomy. This case has been linked with case US2017093096, pharma case.
:MODERNA COVID-19 VACCINE EUA" ACCORDING TO PATIENT ON 03.28.21 HIS RIGHT ARM STARTED HURTING AND HE DID SEE HIS PRIMARY CARE WHO PRESCRIBE MEDS BUT DID NOT HELP AND PAIN KEPT GETTING WORSE AND HIS RIGHT SIDE FELT PARALYSED OR FELT NO FEELING ON RIGHT SIDE. HE DID SEEK MEDICAL CARE AT HOSPITAL.. HAD SEVER MUSCLE SORNESS AND FELT NO FEELING ON RIGHT SIDE. PT RECEIVED PREDNISONE AND BACLOFEN FROM HOSPITAL.. HE WAS NOT HOSPITALIZED AND STATED THAT HE IS SLOWLY IMPROVING.
Right arm going numb, but pain in right wrist. Lips feel like they are numb, numbing sensation in lips. Also, I have periodic feeling of shrinking. Kinda like vertigo but more of a shrinking sensation
Patient received FluMist. As she was driving home, she felt like she was going to pass out two times. Each lasted a few seconds, but patient had to pull over until the episode passed. (OMIC)
Patient reported chills, fever of 101 degrees, whelp at site of injection. Red, hot, swollen arm 4-5 inches down from site of injection.
Patient came back to pharmacy today 11/27 to let us know that she did have significant arm swelling and heat as well as immobility of her left arm for 3 days. She did go to her doctor who told her to let us know that she was allergic to the vaccine.
SEVERAL HEART ATTACKS; FREEZING ALL THE TIME; This spontaneous report received from a patient via a company representative concerned an adult male in late thirties to forties. The patient's height was given as average and weight was not reported. The patient was average to slight build. The patient was a healthy person previously with no significant medical conditions or issues.  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, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Three days after receiving the vaccine, the patient had several heart attacks. The patient had stents placed and was given medicine to thin the blood and since then was freezing all of the time. The patient seemed angry. The patient definitely attributed his experience to the vaccine.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the several heart attacks and freezing all the time was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210660367- covid-19 vaccine ad26.cov2.s-Several Heart attacks. 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).
Leg red and swollen at site on 03/09. Leg swollen less than size of quarter, redness gone 03/10. No fever.
Headache & NauseaVomiting Narrative:  HA & nauses  Other Relevant History:
Pain aggravated / Increase in pain; Weakness; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain aggravated / Increase in pain), ASTHENIA (Weakness) and PYREXIA (Fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In September 2021, the patient experienced PAIN (Pain aggravated / Increase in pain), ASTHENIA (Weakness) and PYREXIA (Fever). At the time of the report, PAIN (Pain aggravated / Increase in pain), ASTHENIA (Weakness) and PYREXIA (Fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications were not reported.  No treatment information was provided by the reporter.   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.
Information has been received from a physician and from the medical record which was reviewed concerning a nine week old female infant with no known allergies, upper respiratory infection and nasal congestion.  It was also reported that the infant had physical examination on 03-JUN-2008 and her hip was slightly lax and tight.  The infant had a history of physiological jaundice of infancy (on 02-JUN-2008 total serum bilirubin was 16.7 mg/dL).  On 04-AUG-2008 the infant was vaccinated with a first dose of ROTATEQ lot # 660877/0305X oral.  On 03-OCT-2008 the infant was vaccinated with a second dose of ROTATEQ lot # 660877/0305X oral.  Concomitant therapy included PEDIARIX, ACTHIB and PREVNAR.  On 11-AUG-2008 the infant had an office visit to the doctor's office.  It was reported that the infant had diarrhea for two days (2-3 x day).  On the same day she had fever and the temperature was 101 axillary.  She had decreased appetite but she was drinking small amount.  On 16-SEP-2008 the infant came to the doctor's office for check up.  It was reported in the medical record that the patient had not been able to sleep for about three days.  She had some coughing, some sneezing and had runny nose.  She had lots of drooling and she gags when she was about to be fed.  She had no fever at this visit.  Her laboratory result of complete blood count was showed red blood cell count of 3.85 10x6/uL and serum creatinine was 0.29 mg/dL.  On 24-SEP-2008 the infant for another visit to the doctor's office.  It was reported that the infant experienced chest congestion and nasal congestion for the last one week.  On 24-SEP-2008 the patient had fever and the temperature was 101.  She was prescribed amoxicillin 250mg/5cc twice a day by mouth.  The outcome of the events were unknown.  No other information was available.  Additional information has been requested. Follow reported that the physician could not comment on adverse reaction of ROTATEQ or any other vaccine regarding the patient. The parent did not report any signs or symptoms to the physician or office staff. If the physician received information regarding a suspected adverse reaction. The information would have been submitted. Additional information is not expected.
Patient reports swelling below the elbow.  The swelling occurred after the 3rd Moderna Covid vaccine.
Within 10 minutes she started feeling dizzy.  Throat tightened and short of breath.  Epi was administered via E-Kit at facility per Pharmacist instructions.  within minutes, she began to breathe better and throat felt better.
she has had a cyst on her labia for the past 4 years now.after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine, she said that the cyst started becoming painful and red.; she said that the cyst started becoming painful and red. Eventually, it also popped.; the cyst started becoming painful; the cyst started becoming red; This is a spontaneous report from a contactable consumer (Patient). A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9265 and expiration date was not reported), via intramuscular route, administered in arm left on 03Feb2021 10:00 (at the age of 36 years) as 1st dose, single for preventative. Medical history included ongoing high blood pressure which was diagnosed at least 6 or 7 years ago, ongoing anxiety which was diagnosed about 5 years ago and patient had a cyst on her labia for the past 4 years, she had it checked a couple of weeks ago last 19Jan2021 and was told it was fine nothing to worry about. Concomitant medications included hydroxyzine 25mg tablet, up to three times a day as needed by mouth taken for anxiety, but patient does not take every day and Buspirone 15mg tablet three time a day by mouth taken for anxiety followed by hydralazine hcl 25mg tablet three times a day by mouth taken for high blood pressure and Clonidine 0.3mg tablet three times a day by mouth taken for high blood pressure. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After receiving the 1st dose of the Pfizer vaccine, at night (03Feb2021) the cyst was red and painful and this morning(04Feb2021) the cyst burst. Family doctor of patient prescribed her antibiotic. Patient informed that She would go see her gynaecologist tomorrow as her gynaecologist did not think it was bad enough to go to the ER. Patient was asking if there is a chance this could be a reaction from the vaccine. Patient also checked in with her doctors and they were unsure. Patient is looking for any information and had not heard of anything similar regarding a side effect. Patient will go tomorrow to Physician Office. Patient had scheduled for a second dose. The patient underwent lab tests and procedures which included blood pressure measurement as high. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
bilateral deep veins thrombosis of both legs; had multiple pulmonary emboli; This is a spontaneous report from a contactable physician (patient's spouse). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Deltoid Right on 01Sep2021 10:00 (at the age of 72 years) (Batch/Lot number was not reported) as dose 3 (booster), single for COVID-19 immunization. Medical history included arthritis and is taking a biological agent called Xeljanz but is not taking it this time, hernia repair in mid-Aug2021. The patient's concomitant medications were not reported. Patient previously took Xeljanz for arthritis. The patient previously received the first and second doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in Jan2021. On 01Sep2021, the patient had her third booster shot of Pfizer vaccine and six weeks later, in Oct2021, she had a clotting event. She had an ultrasound that showed bilateral deep veins thrombosis of both legs and had multiple pulmonary emboli as result of that. The patient was hospitalized and she is on anticoagulants. The patient underwent lab tests and procedures which included ultrasound scan: normal in Aug2021 and ultrasound scan: shows bilateral deep veins thrombosis of both legs and had multiple pulmonary emboli as result of that in Oct2021. Therapeutic measures were taken as a result of the events. Outcome of the events was unknown.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on temporal association and profile of the product the contributory role of the suspect product to reported events is possible.
Fatigue, body aches, chills, slight fever, and headache. The chills and fever were gone within 12 hours. Fatigue and body aches were much less after 12 hours period. Fatigue lasted throughout 48 period after shot, but less and less severe.
Nauseous; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) and NAUSEA (Nauseous) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Rheumatoid arthritis. Concurrent medical conditions included Hypertension and Hyperlipidemia. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Hyperlipidemia, LISINOPRIL for Hypertension, TESTOSTERONE and CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]).    On 20-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 21-Feb-2021, the patient experienced NAUSEA (Nauseous). The patient was treated with IBUPROFEN at a dose of UNK dosage form. On 21-Feb-2021, NAUSEA (Nauseous) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pt recvd vax & devel mild clinical varicella on 18MAR96;
This spontaneous report was received from a physician referring to 18 months old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 30-MAY-2017, the patient was vaccinated with improperly stored dose of VAQTA which had the lot # N005274, expiration date 03-APR-2018 (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved.  No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768:
Throwing up at bedtime due to upset stomach. Complaining of a headache. During the night he started coughing, over the next few days the coughing got worse. He also continued to run a between 99.9- 102 fever. Administered children's Motrin on 5/6/2015. He began to contract hives that were raised and itchy. They started from his buttocks down the backs of his legs towards the bottom of his feet, and the backs of his arms from the elbows down. Later the rash was on his hands and shoulders, on 5/6/2015 administered Benadryl for hives- hives lessened. Administered Benadryl again on 5/7/2015 for hives returning.  Coughing has continued. Hoping these reactions go away soon.
This spontaneous report as received from a pharmacy technician refers to 120 unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On unspecified dates since 10-JUL-2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot # M006708, expiry date 02-JUN-2018 (dose, route of administration and anatomical location were not specified). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information is not expected as there was no consent for further contact.
Mandated annual flu shot for all employees received 10/13. 10/14 swelling at site (L) arm, mild fever malaise. 10/15 (L) shoulder swelling & pain & mild (L) clavicular lymph node swelling 10/16 swelling progressed to (L) neck & face unable to move (L) arm or turn head to (L). Reported to employee health 10/17.
Pt. called 30 min after vaccination c/o lip swelling. Advised to take BENADRYL 50 mg. Returned to office 1 hr after vaccination c/o lip swelling, eyes erythema, generalized hives. Denied respiratory sx. exam - lungs clear, BP 138/82, P 100, pF 310, SPO2 98%. Given prednisone 20 mg po. Hives got progressively worse with severe itching, however no resp sx. Pt d/c'd 11:45 am with instructions to continue BENADRYL 50 mg Q 3-4 hrs prn prednisone 20 mg BID x 5d with food, no driving.
Patient received Moderna COVID vaccine on 2/11/21 (lot # 031L20A), 3/11/21 (lot # 001B21A), and 1/26/22 (lot # 084J21A). On 11/7/22, patient admitted to our inpatient facility (med/surg unit) with COVID-19 infection, generalized weakness, systemic inflammatory response syndrome, and pancytopenia. As of today (11/11/22), patient is still admitted in the med/surg unit.
Patient received 1st dose of Pfizer COVID-19 vaccine today at 0820 hours. At 0835 patient experienced Hypotension and dizziness, numbness, sweating and diaphoretic. Emergency response team arrived and assumed care of patient. Improved as he laid on liter and denied further obs in the ED. Stayed an additional 20 mins in the vaccine obs area and was stable when he left.
pt states that approx 6-7hr p/vax pt was noted to devel a wheeze;lips swollen & numb & puffy eyes;cleared spontaneously;
Tingling in one side of face; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in one side of face) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling in one side of face). At the time of the report, PARAESTHESIA (Tingling in one side of face) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route), the reporter did not provide any causality assessments. Concomitant product is not provided. treatment is not provided.
Bumps on left arm, increased in size about 9 inches diameter, fever 104, swelling, headache, cellulitis, unable to work.
3 days after receiving the injection, patient woke up with severe bruising on both arms, particularly behind his elbows. VERY LARGE bruised areas when injury or trauma had not occured as if his blood vessels are leaking.
DIARRHEA; STOMACH PAIN; HEADACHE; VOMITING; TIREDNESS; This spontaneous case report was received from a consumer on 15-Jan-2019 and a follow-up was received on 16-Jan-2019. The report describes a male consumer who experienced diarrhea, stomach pain, headache, and vomiting following the intake of Vivotif for typhoid prophylaxis. The consumer also experienced tiredness from not sleeping last night.  The consumer's concomitant medication included simvastatin (40 mg daily) for cholesterol, citalopram (10 mg daily as happy pill, and multivitamin. The consumer's past medication included peg-intron for cancer treatment.  It was reported that the consumer took the fourth dose of Vivotif on 14-Jan-2019 and he woke up with diarrhea, stomach pain, a bad headache, and vomiting. At the time of the call, he had light stomach pain, a light headache, and a little bit of fatigue, but he stated that the fatigue was from not getting much sleep last night. He was getting much better as the day went on. He stated that he was able to eat everything now. He had not taken any treatment for his adverse events.   He stated that he had no medical history of headaches, although he had finished treatment about a year ago for cancer (melanoma), and the cancer treatment (peg-intron) had given him headaches. He had stopped taking the treatment in Mar 2018. The consumer had been taking citalopram for about a year and seven months, and simvastatin for fifteen years or so.   The action taken with Vivotif with respect to the events diarrhea, stomach pain, headache, vomiting, and tiredness was not applicable.  The clinical outcome of the events diarrhea, stomach pain, headache, vomiting, and tiredness was resolved.  The reporter's causality with respect to the events diarrhea, stomach pain, headache, and vomiting was not provided while with respect to the event tiredness was not related.  Company Comment: In this case a male consumer experienced diarrhea, stomach pain, headache, vomiting following the intake of Vivotif. The consumer also experienced tiredness from not sleeping the last night. There seems to be a temporal association between the intake of the vaccine and the events diarrhea, stomach pain, headache and vomiting. Also, diarrhea, stomach pain, headache and vomiting are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. The causality of the event tiredness was assessed as not related with Vivotif as it was associated with the reported events.; Sender's Comments: Company Comment : In this case a male consumer  experienced diarrhea, stomach pain, headache, vomiting following the intake of Vivotif. The consumer also experienced tiredness from not sleeping last night.There seems to be a temporal association between the intake of the vaccine and the events diarrhea, stomach pain, headache and vomiting. Also, diarrhea, stomach pain, headache and vomiting are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. The causality of the event tiredness was assessed as not related with vivotif as it was associated with the reported events.
This is a spontaneous report from a contactable nurse practitioner (NP) based on information received by Pfizer from Novartis Pharmaceuticals Corporation (Novartis Reference# PHEH2012US000906-OS). A 52-year-old female patient of an unspecified ethnicity started to receive PREVNAR 13, via an unspecified route of administration, on 28Oct2014. The patient's medical history was not reported. The patient's concomitant medications were not reported. The nurse reported the following: "patient received PREVNAR on 28Oct2014 and experienced generalized pain, nausea, vomiting, fever. The patient was then hospitalized with sickle cell disease with vaso-occlusive crisis." The patient's clinical outcome was not provided.
Pt broke out in rash, started with red bumps, turning into blisters especially on face and genitals. Advised aveeno bath, baking soda paste, tylenol if feverish and benadyl cream.