chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 3/10/02, received Hepatitis B vaccine at Nursing home. 6 hours later seen @ clinic with shortness of breath, swelling of neck which responded to Epinephrine o3cc SQ. Dexamithsone 4 mg IM. follow-up 3/11/02-still with swelling and SOB. Repeat epinephrine 0.3 cc SQ, Prednisone 10 mg BID and taper. 3/18/02-Doing much better.
After receiving shots, child said she felt fine, was talking & smiling. Suddenly turned very pale & fainted. Only lasted < one minute. Examined by Dr - B/P 119/68 Glucose 98. Father said this has happened before after shots.
This spontaneous report was received from a nurse regarding a 67-year-old female patient. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 21-FEB-2018, the patient received a dose of PNEUMOVAX 23 lot# N025384 with expiry date of 19-APR-2019, intramuscularly for medicare annual wellness visit (prophylaxis). The patient returned to the physician's office visit on 28-FEB-2018, complaining of left upper arm pain. The nurse reported that it was unspecified how long after the injection when the pain originated. On 28-FEB-2018, the patient was admitted to the medical center with diagnosis of injection site infection. Patient received treatment of unspecified dose and duration of vancomycin. The patient was fully recovered and was discharged from the medical center on 05-MAR-2018. Causality of the event was not reported. No product quality complaint was present. The event was considered to be serious due to hospitalization.
LEG PAIN,CHILLS,WEAKNESS IN LEGS,SHAKING,HEADACHE,DIZZINESS AND FATIGUE 24 HOURS FOLLOWING INJECTION
I got the first vaccine (Covid Vaccine) already administered and then I actually contracted corona virus about a week and a half later/tested positive for Covid-19; This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 22Feb2021 as 1st dose single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Any unaddressed medical questions were not referred or forwarded to Medical Information. Patient stated that on the 22Feb2021, he got the first vaccine (Covid Vaccine) already administered and then I actually contracted corona virus about a week and a half later on 03Mar2021. He was scheduled to get the second vaccine on 17Mar2021 (Covid Vaccine). He was scheduled for 2nd dose more than 21 days. His question was, does he had to delay his second vaccine or he was allowed to get it as he tested positive. He was little confused and he was not able to get an answer on getting the second vaccine. The outcome of the event was unknown.   Follow-up (14Mar2021): This is a follow-up spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer (patient) reported that included patient gender, clarified vaccine start date, event onset date as updated in the initial narrative.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
patient states had an allergic reaction - developed urticaria, petechia, and rash similar to dematitis
Patient incorrectly received a full dose Monovalent Moderna instead of the indicated Bivalent Moderna Booster.  The vaccinator was confused as to which vaccine to administer since patient had not previously received a booster.
Patient received second series of Shingrix and complains of pain and not being able to lift arm up.
This is a spontaneous report from a contactable Certified Medical Assistant calling on behalf of a patient. A 65-year-old female patient received PREVNAR 13 (Lot R45377; Expiration Date 01Dec2017), intramuscular on 28Nov2016 at 0.5 ml, single for immunization as pneumonia prevention. Medical history included ongoing diabetes mellitus, and ongoing hypertension. The patient was on several unspecified concomitant medications. The patient lost all her hair within a month of the injection. There was no treatment for the hair loss. The patient fall on Jan2017 and in 2017 had tibial fracture and dislocated shoulder. Fall, tibial fracture and dislocated shoulder were serious for hospitalization. The patient was hospitalized from 06Mar2017 to 10Mar2017 for tibial fracture surgery and had intervention for the dislocated shoulder. No testing was done for the hair loss. The patient underwent lab tests and procedures which included x-ray for the fall, but results were unknown. The outcome of all the events was unknown.
This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group. A 36-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 36 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), 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: COUGH (non-serious), FATIGUE (non-serious) all with onset 25May2022, outcome "unknown" and all described as "Traveled to Wedding and then exposed 21May & 22May then ST cough and fatigue HA 25May2022 and then + Ag test 26May2022"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26May2022, outcome "unknown" and all described as "Traveled to Wedding and then exposed 21May & 22May then ST cough and fatigue HA 25May2022 and then + Ag test 26May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26May2022) Positive, notes: Nasal Swab. It was unknown if patient had Covid-19 previous to vaccination. Investigation conclusion for lot FF2589: The complaint for 'Lack of Effect' of the PFIZER BIONTECH COVID-19 VACCINE lot FF2589 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FF2589, fill lot FF2558, and the bulk formulated drug product lot FE5318. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. No follow-up attempts are possible. No further information is expected. Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Shivering all night, muscle pain, headache, general malaise. Painful at injection site.
On the night of the vaccine: Fever of 101.5. and headache(6/10).  Morning after vaccine: Fever 100.5, headache (6/10), pallor, diaphoretic, nausea. Stood up and then passed out for approximately 2 minutes, hitting his head on the wall. Regained consciousness on his own.
Presented to ED w/ c/o weakness; c/o fever and sore throat; COVID+; pt admitted for COVID infection & sepsis; tx w/abx, steroids, remdesivir; dc home
received a late second dose / first dose was administered on 06April2018 and the second dose on 08Mar2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 6th April 2018).   On 8th March 2021, the patient received the 2nd dose of Shingrix. On 8th March 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details was reported as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. No vaccine data was available. The reporter declined follow up.
itchy rash which hasn't gone away, fatigue, heart palpitations, low grade fever, soreness all over, nausea
Received booster 5 months after second vaccine/received booster dose of Moderna COVID-19 vaccine 1 month early.; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received booster 5 months after second vaccine/received booster dose of Moderna COVID-19 vaccine 1 month early.) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received booster 5 months after second vaccine/received booster dose of Moderna COVID-19 vaccine 1 month early.). On 18-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received booster 5 months after second vaccine/received booster dose of Moderna COVID-19 vaccine 1 month early.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment information were given. Patient received booster dose of Moderna COVID-19 vaccine 1 month early.
Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' concurrent condition and medical history were not reported. The concomitant therapy included sterile diluent (manufacturer unknown). Since 22-MAY-2017 to 23-AUG-2017, the patients administered improperly stored doses of GARDASIL 9 (dose, frequency and route unknown, lot #M023169, lot#M028323, expiration date: 26-SEP-2018, lot# M037770,) for prophylaxis. The temperature excursion was at 9 Celsius Degree to 25 Celsius Degree for 4.5 hours. There was no previous temperature excursion. Data logger involved. No adverse effects were reported in any patients. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA006063: US-009507513-1709USA006065: US-009507513-1709USA006062: US-009507513-1709USA006064.
Swelling, redness of the forearm where vaccine was administered. Patient seen in my office on 7/3/13 as swelling was increasing--started the pt on Motrin, warm compresses and antibiotics as a precaution.
Easy on right lower extemity; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737), via an unspecified route of administration in the right arm on 02Apr2021 at 10:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, hypertension, breast cancer (breast cancer survivor), anxiety and depression. The patient was not allergic to any medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included glipizide (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), atenolol (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and simvastatin (ZOCOR). Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within four weeks prior to the COVID-19 vaccination. On 04Apr2021 at 03:30, the patient experienced easy on right lower extremity (Lower extremity dysfunction). The event did not result in a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event lower extremity dysfunction was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Flu like symptoms; This spontaneous case was received on 27-Nov-2020 from other non-health professional (consumer) via Communications (reference number: SEQW20-05445) and concerned an adult male patient. At the time of this report, the patient was 83-year-old.  The patient's medical history and concomitant medications were not reported.  On an unspecified date (reported as many years ago), the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration, indication and anatomical location: not reported). The batch number was not reported.   On an unspecified date, an unknown amount of time after receiving influenza virus vaccine polyvalent, the patient developed flu like symptoms that lasted for one day.  On an unspecified date, one day after the onset, the patient recovered from the event.  The reporter did not provide a causality assessment.  The reporter assessed this case as non-serious.  This case is linked with the case 202007420 (the same patient).  Company comment:The patient developed influenza like illness on an unspecified date and unknown amount of time after receiving the suspect product, influenza virus vaccine polyvalent. Chronology is unclear. The patient's medical history and concomitant medications were not reported. Due to lack of information regarding temporal relationship, causal relationship is assessed as unassessable.; Sender's Comments: The patient developed influenza like illness on an unspecified date and unknown amount of time after receiving the suspect product, influenza virus vaccine polyvalent. Chronology is unclear. The patient's medical history and concomitant medications were not reported. Due to lack of information regarding temporal relationship, causal relationship is assessed as unassessable.
Patient presented with swollen and red left arm from injection site down to elbow. Was hot to the touch and painful. Started immediately after vaccination, unknown resolution date. Had Televisit with MD who advised ice, Advil and Benadryl. Symptoms were starting to improve when she came into the pharmacy the following afternoon.
had full body itching/the itching was still there/The itching comes, then hives, rash and it goes away few minutes later/It has gotten better but she is still itching; experienced an allergic reaction/had a delayed allergic reaction after the first dose; hives/She itches, she gets hives; was breaking out in rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (had full body itching/the itching was still there/The itching comes, then hives, rash and it goes away few minutes later/It has gotten better but she is still itching), ALLERGY TO VACCINE (experienced an allergic reaction/had a delayed allergic reaction after the first dose), URTICARIA (hives/She itches, she gets hives) and RASH (was breaking out in rash) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     Concurrent medical conditions included Smoker.    On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, the patient experienced PRURITUS (had full body itching/the itching was still there/The itching comes, then hives, rash and it goes away few minutes later/It has gotten better but she is still itching), ALLERGY TO VACCINE (experienced an allergic reaction/had a delayed allergic reaction after the first dose), URTICARIA (hives/She itches, she gets hives) and RASH (was breaking out in rash). The patient was treated with PREDNISONE at an unspecified dose and frequency; ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) at an unspecified dose and frequency and CAMPHOR, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL [CAMPHOR;DIPHENHYDRAMINE HYDROCHLORIDE;ZINC OXIDE]) at an unspecified dose and frequency. In 2021, URTICARIA (hives/She itches, she gets hives) and RASH (was breaking out in rash) had resolved. At the time of the report, PRURITUS (had full body itching/the itching was still there/The itching comes, then hives, rash and it goes away few minutes later/It has gotten better but she is still itching) had not resolved and ALLERGY TO VACCINE (experienced an allergic reaction/had a delayed allergic reaction after the first dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Reporter went to the ER on the 27th and they confirmed it was an allergic reaction   She takes Tagamet for heart burn as needed Patient is a little overweight.
When he got the first shot it was sore; This is a spontaneous report from a contactable consumer. A 80-year-old male patient received BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number and Expiration date: was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE dose for covid-19 immunisation. The patient medical history and concomitant was not reported. It was reported that, the patient experienced when he got the first shot it was sore on an unspecified date with outcome of unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe upper arm pain, especially noticeable at night. I would wake up in pain. Unable to lift arm laterally. Pain from 10/14/15 to 3-1-16. Suddenly healed.
Patient received the vaccine in the morning and later that day became confused, encephalopathic. Cleared day after.  No further Hep B vaccine given. All other vaccines given without issue.
This spontaneous report was received from the office manager who is also a health care worker and refers to a 13 month old female patient. None known allergies, medical history and concurrent conditions were reported. The office managers informed that on 24-MAR-2015 at 09:30 hrs, the patient was vaccinated with the first dose of MMR II (HSA) (lot# K020188, expiration date 22-OCT-2016) (strength, dosage and route were not reported). Subcutaneous, right arm reported as "high", that was shipped on 04-MAR-2015 and received on 10-MAR-2015. The product was in transit for 6 days, an the temperature was unspecified. The same day at the same time, the patient also received as concomitant vaccination the first dose (Merck) VARIVAX (lot No. K011084, Expiration date was not reported) left arm (high) and one the first dose of VAQTA (lot no. K023870, Expiration date was not reported) left arm (high). None illness at the time of vaccination was reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information is not expected because all information required was received.
Pfizer-BioNTech COVOD-19 Vaccine EUA: At 30 minutes after injection of vaccine, I experienced numbness of my lips and tongue.  This lasted approximately 5 hours.
Client complained that she had fevers and generalized itching after receiving her Hepatitis B Vaccine.
no AE; expirienced an excursion; This spontaneous report was received from a nurse referring to a 4-years-old patient of unknown gender. For all the patients, the concurrent conditions, medical history and concomitant medications were not provided.  On 10-SEP-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 1 dose (strength, dose, route, frequency, were not provided) for prophylaxis; Lot No. U015682 has been verified to be a valid lot number for [varicella virus vaccine live (Oka/Merck)], expiration date reported as 18-MAY-2023, and upon internal validation established as the same.  The nurse reported that the vaccine dose was administered on 10-SEP-2021 and there was a temperature excursion for varicella virus vaccine live (Oka/Merck) (VARIVAX). The product experienced an excursion of 4 Celsius degrees (C) from -10 C to 8 C for 20 minutes on 07-SEP-2021 during the transport; and of 4C from -10 C to 8 C for 20 minutes on 09-SEP-2021, again during transport. Previous temperature excursion included from -10°C to 8°C (4C) for 7 hours and 30 minutes. And no adverse events were reported.  This is one of four reports received from the same source.; Sender's Comments:  US-009507513-2109USA005618: US-009507513-2109USA005628: US-009507513-2109USA005632: US-009507513-2109USA005639:
Adverse events:  Swollen Left Leg @ 6 weeks, Bleeding Rectum @ 5 weeks, Swollen Lower Gut/Scrotum @5 weeks, Blood in Urine @8 months.
Rash with itch to the extremities (upper and lower) as well as itch/ irritation to the vaccination site (right upper arm/ deltoid
severe hives on trunk of body; general malaise; temperature of 102.8 next day; Very sore arm; mild headache; cold/unable to get warm in middle of first night (Sun.); This is a spontaneous report from a contactable consumer (patient). A 71-year-old non-pregnancy female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 26Sep2021 14:30 (Lot Number: EW0176, at age of 71 years old) as single dose for COVID-19 immunisation. Medical history included hypo-thyroid, osteopenia, mild MGUS. Concomitant medications included levothyroxine; raloxifene; calcium; colecalciferol (D3); krill oil. The patient previously took codeine and amoxicillin and experienced drug allergy. The patient experienced very sore arm and a mild headache a few hours after (at 04:30 PM on 26Sep2021) and throughout, cold/unable to get warm in middle of first night (Sun. on 26Sep2021), general malaise and temperature of 102.8 next day (Mon. on 27Sep2021), severe hives on trunk of body (discovered on 2nd day (Tues on 28Sep2021), but did not undress on Monday (on 27Sep2021) so don't know if were there on Mon (on 27Sep2021). Temperature down to 99 on Tues. morn (on 28Sep2021). Normal later in day (on 28Sep2021). Back to 99 Wed. night (on 29Sep2021). Hives remain but less solid. Self-treating temperature with tylenol beginning Mon. (on 27Sep2021) and starting benadryl Wed. night (on 29Sep2021). The outcome of events hives and fever was recovering, the outcome of rest events was unknown.  Follow-up attempts are completed. No further information is expected.