chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 04-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA003923: US-009507513-2102USA005233: US-009507513-2102USA005234: US-009507513-2102USA005235: US-009507513-2102USA005236: US-009507513-2102USA005237: US-009507513-2102USA005238: US-009507513-2102USA005239: US-009507513-2102USA005240: US-009507513-2102USA005241: US-009507513-2102USA005242: US-009507513-2102USA005243: US-009507513-2102USA005244: US-009507513-2102USA005245: US-009507513-2102USA005246: US-009507513-2102USA005247: US-009507513-2102USA005248: US-009507513-2102USA005249: US-009507513-2102USA005250: US-009507513-2102USA005251: US-009507513-2102USA005252: US-009507513-2102USA005253: US-009507513-2102USA005254: US-009507513-2102USA005255: US-009507513-2102USA005256: US-009507513-2102USA005257: US-009507513-2102USA005258: US-009507513-2102USA005227: US-009507513-2102USA005228: US-009507513-2102USA005229: US-009507513-2102USA005230: US-009507513-2102USA005231: US-009507513-2102USA005232:
red from elbow to shoulder; black/blue at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red from elbow to shoulder) and VACCINATION SITE DISCOLOURATION (black/blue at injection site) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced ERYTHEMA (red from elbow to shoulder) and VACCINATION SITE DISCOLOURATION (black/blue at injection site). At the time of the report, ERYTHEMA (red from elbow to shoulder) and VACCINATION SITE DISCOLOURATION (black/blue at injection site) outcome was unknown. Not Provided          Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.   This case was linked to MOD-2021-028149 (Patient Link).
very fast heart rate; vice-like tightness across lower back; Weak /greater weakness; not walking straight forward; growing tightness of my lower back from side to side with significant pain; arm pain; severe headache; This is a spontaneous report from a contactable consumer (patient). An elderly non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN9581) via an unspecified route of administration in Arm Right on 17Feb2021 08:30 as dose 1, single for COVID-19 immunisation at hospital. Medical history included known allergies. Concomitant medication taken in two weeks included montelukast sodium (SINGULAIR), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), acetylsalicylic acid (ASPRIN), and VITAMINS all taken for an unspecified indication, start and stop date were not reported. Patient did not received other vaccine within four weeks of COVID vaccine. Patient did have COVID prior to vaccination. The patient experienced very fast heart rate, vice-like tightness across lower back, weak /greater weakness, not walking straight forward, arm pain, severe headache, growing tightness of my lower back from side to side with significant pain on 17Feb2021 08:45. Event reported as, within a half hour, very fast heart rate, vice-like tightness across lower back, weak and not walking straight forward. By evening, arm pain, severe headache, greater weakness, and growing tightness of my lower back from side to side with significant pain. All effects continued to increase for three and a half days until patient was taken to the emergency room. weeks later patient was a bit weak and have occasional minor pain. Treatment was received with many tests and then IV pain medication. Patient did not tested for COVID post vaccination. The patient underwent lab tests and procedures which included heart rate: very fast, laboratory test: unknown results on an unspecified date. Outcome of all the events were recovering.  No follow-up attempts are possible. No further information is expected.
Blemishes on face and neck; This case was reported by a consumer via call center representative and described the occurrence of skin disorder in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On 23rd February 2023, the patient received the 1st dose of Shingrix and Tdap Vaccine (intramuscular). In February 2023, 2 days after receiving Shingrix and Tdap Vaccine, the patient experienced skin disorder. On an unknown date, the outcome of the skin disorder was not recovered/not resolved.   It was unknown if the reporter considered the skin disorder to be related to Shingrix and Tdap Vaccine.     Additional Information: GSK Receipt Date: 27-FEB-2023  Reporter's comment: The wife of the patient reported that herself and her husband both received dose 1 of shingrix.  The reporter stated that patient received shingrix in right arm and Tdap in left arm  at the same time.  Medical disclaimer and phone number were provided.  The reporter consented to follow up. Additional Supportive Information: This case had been linked with US2023031968, reported by the same reporter.; Sender's Comments:  US-GSK-US2023031968:same reporter
Patient reported chest tightness post vaccination and then reported feeling dizzy and light-headed and "shaky" all inside. Angioedema was noted by vaccinator and patient was escorted to the Emergency Department. In the ED, the patient reported chest feeling tight, difficulty swallowing, shortness of breath, and feeling itchy. ED physician noted she was feeling anxious and noted no angioedema and that oxygen saturation was 100% on room air. 50 mg of IV diphenhydramine and 1 mg IV lorazepam were administered. Patient was discharged from the emergency department with a prescription for Medrol dosepak.
lingering nerve issues; This case was reported by a consumer via interactive digital media and described the occurrence of nervous system disorder in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of nervous system disorder (had 1st original shot of non GSKK on an unknown date and experienced lingering nerve issue).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced nervous system disorder. On an unknown date, the outcome of the nervous system disorder was not recovered/not resolved.   It was unknown if the reporter considered the nervous system disorder to be related to Shingles vaccine.   Additional details were provided as follows: Age at vaccination was not reported. Age group was captured as adult as per vaccine indication. The patient received the 2 shots of shingles vaccine and still had lingering nerve issues that crop up years later.
On 03/22/2021 I started feeling a heavy sensation on my right side of my body it lasted about 3-4 hours. I went to the ER about 20-30 min after it started. They did an MRI & blood work and everything came back cleared. I got discharged. Then last week on 4/15/2021 they sent me with a stroke specialist and he diagnosed me and said I had a mini stroke. He prescribed me baby aspirin of 20mg.
1:30pm mother called states, broke out in hives eyes/mouth area, hoarse voice? difficulty breathing, advised to go to ER.
never followed up with the second injection; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date 4 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never followed up with the second injection). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 27-JUL-2023 The reporter stated that if a patient never followed up with the second injection, were they required to repeat the initial injection? Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medications were not provided by the reporter. Reporter reported that the patient experienced stroke following vaccination.  Treatment information was not provided.  Company comment: This spontaneous case concerns a female patient of unknown age and no medical history reported, who experienced the unexpected serious AESI of  Cerebrovascular accident, on an unspecified date after receiving a dose of mRNA-1273 vaccine (dose number not specified). The patient had experienced stroke and outcome was unknown. No further details on clinical presentation, diagnostic and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age and no medical history reported, who experienced the unexpected serious AESI of  Cerebrovascular accident, on an unspecified date after receiving a dose of mRNA-1273 vaccine (dose number not specified). The patient had experienced stroke and outcome was unknown. No further details on clinical presentation, diagnostic and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
A non-serious, spontaneous report of administered FLUMIST to an adult greater in age than 49, was received from a physician, involving a a 69-year-old patient subsequent to FLUMIST. The event was reported 19 days after the administration and the physician indicated that the patient was doing fine and no reactivity was reported. There was no adverse associated with this medication error; therefore treatment and reporter/sponsor causality assessment are not applicable and the event is considered resolved.
Pain and swelling in left knee to the point that it has progressed where walking is difficult. Doctor prescribed steroids that brought down swelling and pain until you reached the end of the dose pack. It would return within 1-2 days after last steroid dose.
35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment medications were provided. It was reported that vial at that clinic was punctured 30 times and All doses given were Booster doses. Patient date of birth was reported as --1962.
On 10-31-08 this clt was seen in walk-in clinic because of hive reaction possibly from HPV vaccine given on 10-28-08. Clt reports on Friday am, she woke up with swollen, red eye. Later that day, foot started itching and noticed on set of hives on foot. C/o being itchy all day. Later that day, developed blister like hives on back. Was instructed to use OTC Benedryl and was given an RX for Prednisone plus ABX for bronchitis.
Started with redness and swelling and extreme pain hot to touch. Later bnecame an open raw area with the skin turning black extreme pain, burning and needle like pain. Very sensitive to touch, Went to  clinic weekly until Sept 2022. Picture included in medical records
1st event: 5 hours to 36 hours after first dose (Symptoms: Arm Pain, Joint Pain, Muscle Aches, Fever (101.4 - highest))   2nd event: Started 2/5/2021 and continuing until today 2/10/2021; (Symptoms: Joint Pain, Fever (101.6 - highest on 02/06/2021), Muscle Aches, Extreme Fatigue)
Patient received the vaccine and was instructed to wait for the 15 minutes.  A few minutes into the wait she need to get something off the sales floor.  She became light headed and fainted as she was checking out her items.  EMT's arrived just a few minutes later and transported her to the ER
Patient developed chills, fever (101.4), pain/aches in legs.  Patient took tylenol and aspirin and went to sleep.  Within 6 hours, symptoms had resolved.
pain in right arm of injection sight radiating to upper shoulder, tingling pinpoint feeling in upper shoulder,  pinpoint pain in thighs above calf area, under knee caps hurt, left hip joint pain, prominent red rash covering trunk area, fever, headache, nausea, tiredness, eyes swollen, chills, have labor breathing when walking, weakness and have broken out in sweat twice. legs hurt and slow to move.
This spontaneous case was reported by a consumer and describes the occurrence of CYST (Existing Cyst on leg became infected) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced CYST (Existing Cyst on leg became infected). The patient was treated with CEFALEXIN (CEPHALEX [CEFALEXIN]) for Symptomatic treatment, at a dose of 500 mg. At the time of the report, CYST (Existing Cyst on leg became infected) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This is a spontaneous report from a contactable Nurse. A 61-year-old male patient received PREVNAR 13 (lot R49358, exp.date 30Apr2018) for Pneumococcal immunization on 02May2017 02:59 at 0,5ml single dose via an unspecified route of administration in the left deltoid muscle. Relevant medical history included ongoing Crohn's disease.  On 04May2017 the patient was admitted with pneumococcal sepsis. The patient was discharge on levofloxacin for 12 days. The outcome of the event was unknown. Sender's Comments: Reported event of Pneumococcal sepsis occurred 2 days following vaccination with PREVENAR 13. Considering the timeframe between the event and vaccination date far shorter than 14 days, the minimum time interval after vaccine administration for a person to develop antibody response to PREVENAR 13 containing serotyped pneumococcal infection, the occurrence of the event is not due to the lack of efficacy with PREVENAR 13 but instead most likely indicates that the very short time lag cannot elicit adequate antibody response to provide full protection against pneumococcal infection. Further information like confirmative serotype results are needed for full medical assessment.
cried non-stop since 2PM yesterday; fever 101 R in AM; not sleeping; appetite fine; APAP given; rt leg sl warm, not tender or red; t100.9 R when seen in office;
The patient stated her right arm begin to hurt about 48 hours after receiving her vaccines while she was driving. She stated the underside of her arm and armpits were swollen. She stated she could feel a knot in her arm about the size of a small egg. She stated there was no redness or itchiness at the injection site, but the underside of the arm was very tender. She did not go to the doctor. I called and checked on her 48 hours later and she stated her arm felt much better and the swelling had gone down. She had taken diphenhydramine after her arm began to swell. The patient stated she was receiving these vaccines because she is preparing for surgery to remove her spleen.
Booster; severe PTSD; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: Mar2020 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 Immunization; Bnt162b2 (2nd Dose), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; POST-TRAUMATIC STRESS DISORDER (non-serious), outcome "unknown", described as "severe PTSD".  Additional Information: She was worried about the injection site because the person who administered the booster shot to her son accidentally rubbed it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101655501 Same reporter different patient
Inappropriate schedule of drug administration  Information has been received from a pharmacist concerning his 4 month old daughter who was vaccinated PO with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) when she was four months old. It was unknown if medical attention was sought. It was noted that the patient would get the second dose when she was six month old at the request of the physician. Therefore the patient would only get the total of two doses. Additional information has been requested.
Severe Congestion; Coughing; Fatigue; Runny Nose; Sneezing; Not sick but has Colds/Slight Colds; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny Nose), SNEEZING (Sneezing), NASAL CONGESTION (Severe Congestion), COUGH (Coughing) and NASOPHARYNGITIS (Not sick but has Colds/Slight Colds) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0035252A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Previously administered products included for Product used for unknown indication: Pfizer (second dose) in April 2021 and Pfizer (first dose) in April 2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 21-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced NASOPHARYNGITIS (Not sick but has Colds/Slight Colds). On 21-Jan-2022, the patient experienced RHINORRHOEA (Runny Nose) and SNEEZING (Sneezing). On 25-Jan-2022, the patient experienced NASAL CONGESTION (Severe Congestion), COUGH (Coughing) and FATIGUE (Fatigue). The patient was treated with PHENYLEPHRINE HYDROCHLORIDE (SUDAFED PE) at a dose of 2tabs 4x a day every 6hrs and IBUPROFEN at a dose of 400 milligram twice a day. On 28-Jan-2022, NASAL CONGESTION (Severe Congestion), COUGH (Coughing), NASOPHARYNGITIS (Not sick but has Colds/Slight Colds) and FATIGUE (Fatigue) had resolved. At the time of the report, RHINORRHOEA (Runny Nose) had not resolved and SNEEZING (Sneezing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2022, Blood pressure measurement: normal (normal) Normal. On 23-Jan-2022, Vital signs measurement: normal (normal) Normal.         No concomitant medication, no vitamins and no allergies were reported. Reported to physician on the 23rd Monday for normal check-up.
Diagnosed with Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with Covid-19) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced COVID-19 (Diagnosed with Covid-19). At the time of the report, COVID-19 (Diagnosed with Covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Within 5 minutes of receiving injection, she became  pale, clammy and complained of dizziness and nausea.  Her B/P was 60/40.  She was transported by wheelchair to exam room and layed down with feet elevated.  Dr examined her and she was observed for 20 moinutes.  at discharge her B/P was 110/70, color pink skin warm & dry, and she was alert and oriented.