chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Moderna COVID-19 vaccine administered to patients post temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patients post temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patients post temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patients post temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patients post temperature excursion).    No concomitant medications were reported.  It was reported that there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose.   No treatment medications were reported.  This case contains information for the 27th of 104 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791, US-MODERNATX, INC.-MOD-2022-680489 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master case Same reporter US-MODERNATX, INC.-MOD-2022-680489:Master case Same reporter
Arm swelling & redness. Sore throat - pt describes it as "golf balls in throat".
Shingles outbreak even after 2 doses of shingrix/Suspected vaccination failure; Shingle outbreak; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Shingles outbreak even after 2 doses of shingrix/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingle outbreak). The outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 27-JUN-2023 The physician reported that her and her partner medical provider had between 5 to 7 patients experience a shingles outbreak after the patient completed the full 2-dose series of Shingrix, doses unknown, 2 doses each patient at unknown intervals.  One patient had their series of Shingrix completed 4 to 5 years prior to the shingles outbreak and had Zostavax in the past prior to starting the Shingrix series. The outcome of the shingles outbreaks was reported as unknown. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow up. This case is 1 out of 5 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR089463:Same reporter US-GSK-US2023AMR089467:Same reporter US-GSK-US2023AMR089457:Same reporter US-GSK-US2023AMR089465:Same reporter
Large raised, red, hard rash around injection site. Prednisone and Ranitidine prescribed.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 039A21A) for COVID-19 vaccination.     No past medical history was provided by reporter.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 16-Mar-2021 and the estimated date of delivery was 21-Dec-2021. On 07-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 07-Apr-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. Not Provided          Concomitant medications included medicine for birth control. Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: LMP date provided
Sharp pain in chest near the heart accompanied with arhythmic heartbeats. Side effects started  within a week after getting the shot, then the pain gradually subsided, however I still feel like my heart is beating abnormally sometimes.
First dose of shingirx 7/18/19 / Second dose 10/24/2020 / quarantine; Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18th July 2019).   On 24th October 2020, the patient received the 2nd dose of Shingrix. On 24th October 2020, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the fever was not recovered/not resolved and the outcome of the product supply issue was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and developed a fever, which had resolved.  The vaccines were staggered per patient because of availability of the product and the quarantine caused by Covid19. The reporter consented to follow up.
Within 24 hours, 3 baseball sized lumps showed up at his 3 sites of injection.  They were hard, swollen, painful and hot to the touch.  He also had a temperature and was crying nonstop.  We brought him in to the doctors weekend office a day later and were told it was an odd reaction, but the lumps should gradually reabsorb back into his system within a month.  We were told to give him tylenol for comfort and try warm baths.  These lumps did get smaller as time went by, but did not fully dissipate until 2 months after the fact.  We were told to continue fully vax'ing on schedule, regardless of this reaction...yet we are VERY weary and have yet to.
Right upper arm abscess. Vaccine was administerd about 2 weeks prior to admission to hospital on 10/12/2008. Patient experienced fever, chills, runny nose, cough, decreased appetite, nausea, vomiting. 10/14/08-records received for DOS 10/12-10/13/08-DC DX: Right arm abscess. Presented to ED with right upper arm abscess after receiving flu shot in same area 2 weeks ago. One week ago noticed redness and swelling at site progressed to erythematous abscess.  C/O flu-like symptoms for past week, low grade fever, chills, runny nose, clear sputum, flushing, decreased appetite. Abscess I & D.
Sweating increased; Right arm sore; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating increased) and PAIN IN EXTREMITY (Right arm sore) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic plaque psoriasis).   In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In August 2021, the patient experienced PAIN IN EXTREMITY (Right arm sore). On an unknown date, the patient experienced HYPERHIDROSIS (Sweating increased). In August 2021, PAIN IN EXTREMITY (Right arm sore) had resolved. At the time of the report, HYPERHIDROSIS (Sweating increased) had not resolved.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna   No concomitant medication was reported.  The patient had noticed since starting on Skyrizi had been feeling more tired than usual and sweat more when he was outside.  In Aug-2021, got first Covid shot. His right arm was sore for a couple days but that was about it.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was reported.  The reporter's causality for the events of right arm sore, body aches and nausea was not provided. The reporter's causality for the events of sweating increased and really tired with Skyrizi (risankizumab) was a reasonable possibility.      Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Live follow-up appended: Event was added, suspect drug information and narrative description was updated.
10am recv'd flu shot L arm. 11:30am c/o severe neck pain and numbness L upper arm. Cried, grimaced > 30 mins from severe pain. Ice pack applied, positioned in reclined posotion. 11:40am: HR 88, RR 20, BP 135/90. T 99.3. 12 noon: HR 80, RR 20, BP 124/90. Mother infomed, picked up at 12:53pm and recommended be seen by PCP that day. MD told mother to administer TYLENOL. Student slept at home adn today 11/6 has no pain (per mother).
We received on 16 JAN 2008 via local agency, from a consumer the following information: Consumer left voice mail stating that she received vaccine in November. She wants to report an adverse event that she had her colleague (see case no. MA2008-0051) experienced. No additional information left with message. Addendum: On 16 JAN 2008 we received the following information: A 31-year-old female patient, born on 02 APR 1976 was vaccinated i.m. with 0.5 ml Fluvirin, batch no. unknown, on 14 NOV 2007. At 9 weeks gestational age caller discovered that she had miscarried on 29 NOV 2007. Company assessment: Seriousness criterion: medically significant. Causality: insufficient data (the amount of data is insufficient to finally assess causality as information about the pregnancy is missing). Expectedness assessment according to agency and local product information: Miscarriage is unexpected drug exposure during pregnancy is expected after vaccination with Fluvirin. On a case level, the case is considered unexpected. No change in benefit-risk-ratio. No measures necessary. Local agency no.: NA08-00160
shingles; Bump on nose; It is painful; broke out in rash/rash under right eye; pretty sick; This is a spontaneous report from a contactable nurse (the patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left upper arm on 19Jan2021 at 11:15 to 11:30 (at the age of 58-years-old) as a single dose for Covid-19 immunization. Medical history included COVID-19 in Mar2020 and was reported as recovering (ongoing). The patient's concomitant medications were reported and none. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Feb2021, the patient experienced a bump on her nose and later got a rash under the right eye and broke out in a rash; on 08Feb2021, the patient was diagnosed with shingles; on an unknown date in Feb2021 she experienced she was pretty sick now; not feeling well and it was painful. The patient went to the emergency room about 3:40am on 08Feb2021. The events were considered serious per disabling since she was not able to return to work until blisters were crusted over. Has missed a couple days of work. Her only concern was that it was not in her eye and she was good. Treatment was given for the shingles which included Acyclovir. The clinical outcome of the events herpes zoster, rash, illness, skin disorder and pain was not recovered. The reporter stated she was supposed to get her second dose but cannot now.  The reported considered the events herpes zoster, rash, illness, skin disorder and pain related to BNT162B2.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product 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.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration of vaccine was 7-May-2021.  No concomitant medication was provided.  No treatment medication was provided.
Very severe spasm/cramps from waist down in both legs, thighs, calves and feet.  Reaction was delayed until 12 hours after booster shot was administered.
Had the booster vaccine 10/13/21 began feeling not well on 10/14/21 contacted wellness nurses on 10/15/21 assessed with 28 apical heartrate and sent 911 to the hospital emergency room.
Mom states that approx 4 hrs p/vax on 27JAN93 pt cried unconsollably for 6 hrs; temp got as high as 101R; tempra drops were given; MD suggested not to have pertussis administered anymore;
This case was reported by a other health professional via call center representative and described the occurrence of hives ina 4-year-old male patient who received FLUARIX QUADRIVALENT (batch number L5E9G, expiry date unknown). In October 2014, the patient received FLUARIX QUADRIVALENT (injection). In October 2014, 1 hr after receiving FLUARIX QUADRIVALENT, the patient experienced hives. The patient was treated with BENADRYL. On an unknown date, the outcome of the hives was recovered/resolved. The reporter considered the hives to be possibly related to FLUARIX QUADRIVALENT. Additional information received: The caller reports that a patient that comes to their clinic received the flu shot in October 2014. The patient experienced hives about one hour after receiving the shot. The patient has since recovered completely from the hives. The caller did not know the expiration date of the vaccine.
blood in her urine with clots; urine was dark like the color of syrup and it was a brown thick stream; sharp severe headache; chills; fatigue; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of HAEMORRHAGE URINARY TRACT (blood in her urine with clots) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced HEADACHE (sharp severe headache), CHILLS (chills) and FATIGUE (fatigue). On 08-Apr-2021, the patient experienced HAEMORRHAGE URINARY TRACT (blood in her urine with clots) (seriousness criterion medically significant) and CHROMATURIA (urine was dark like the color of syrup and it was a brown thick stream). On 09-Apr-2021, HAEMORRHAGE URINARY TRACT (blood in her urine with clots) and CHROMATURIA (urine was dark like the color of syrup and it was a brown thick stream) had resolved. At the time of the report, HEADACHE (sharp severe headache), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown. Not Provided   No relevant concomitant medications were provided.   The patient received acetaminophen for symptoms. She is currently seeking help from her health care provider regarding this situation and is undergoing some tests in the meantime such as a renal ultrasound.  Action taken with mRNA-1273 in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the event (headache, chills, and fatigue), a causal relationship cannot be excluded. Very limited information regarding the events (Haemorrhage urinary tract, chromaturia) has been provided at this time. The subject's medical history and concomitant medications are required for analysis. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event (headache, chills, and fatigue), a causal relationship cannot be excluded. Very limited information regarding the events (Haemorrhage urinary tract, chromaturia) has been provided at this time. The subject's medical history and concomitant medications are required for analysis. Further information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of ulcerative colitis in a 68-year-old female patient who received SHINGRIX for prophylaxis.  In July 2018, the patient received the 1st dose of SHINGRIX. In September 2018, less than a year after receiving SHINGRIX, the patient experienced ulcerative colitis (serious criteria GSK medically significant). On an unknown date, the outcome of the ulcerative colitis was unknown. It was unknown if the reporter considered the ulcerative colitis to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. After receiving SHINGRIX the patient was diagnosed with ulcerative colitis. The patient was consented to follow up. The patient's full address was not obtained during call.
Abrupt sensation of nausea and sweating followed by intense chills, fatigue, body aches, low grade fever, and night sweats that lasted for approximately 18 hours.
None. ROTARIX 3rd dose given oral GlaxoSmithKline lot 374XB.
Began to eat and felt sudden stomach ache. Then began to sweat profusely, and feel nauseated and dizzy. My hands and feet began to feel tingly. My feet were only mildly tingly and able to move but my hands and fingers were very tingly/numb and my fingers became rigid and I was unable to move my fingers.  The symptoms began to dissipate in the same order that they began with my hands and fingers being the last to resolve.
This spontaneous report was received from a physician and refers to a 19 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided. On 11-MAR-2016, the patient was vaccinated with an improperly dose of RECOMBIVAX HB (lot# L042846, expiration date 15-SEP-2017) 1 ml, intramuscularly in unspecified deltoid. No adverse events were reported. Administered dose of vaccine experienced the temperature excursion of 49 degrees Fahrenheit. This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by the post office.
I received strep throat; stuffy sinus; coughing for 4 days and I took PAXLOVID and felt better.
The patient receive dose 2 of the Moderna vaccine on March 31 at approximately 9:30am.  Began having symptoms of low grade fever, severe malaise, nausea with vomiting, and body aches about 5:30 that evening.  The patient presents to the Emergency room on 04/01/2021 at about 3:30pm with skin redness, back pain, nausea,vomiting, low blood pressure and tachycardia.
Had a sore arm; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 22Mar2021 13:00 (Lot number: BPT534) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibrous tissue in her bone marrow" (unspecified if ongoing); "red count gets low" (unspecified if ongoing); "she has to get blood transfusions" (unspecified if ongoing), notes: about once a month. Concomitant medication(s) included: RETACRIT [EPOETIN ALFA EPBX] taken for anaemia. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 22Mar2021, outcome "recovered" (23Apr2021), described as "Had a sore arm". Additional information: Patient thought lot was BPT534, she was unsure.Patient got the first dose of the vaccine at 1:00pm on 22Mar2021 and by that night her arm was a little sore and it was gone by the next day.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021486025 same patient, different dose/AE