chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 10:45 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 10:45 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 74.11.   Concomitant products were not provided.  On 17-Feb-2021 Excursion time was reported at 09.00 am with  temperature as 22 degrees Fahrenheit, total doses given for the day was 62, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 11-Feb-2021 , vial was moved to clinic on 17-Feb-2021. 5 vials were sent to clinic. Vaccine BUD date was 13-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.) Immediately got chest pain; Itchy tongue; Severe dizziness and lightheadedness; Turned whiter than white; Lip started to swell and got really itchy; Lip started to swell and got really itchy; Feels tired; Almost died;  This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 53-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: FC3181), via an unspecified route of administration, administered in Arm Left on 16Aug2021 11:00 as dose 1, single for covid-19 immunisation (age at vaccination: 53 years). Medical history included ongoing rheumatoid arthritis diagnosed with about 6 years ago, overweight from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took bactrim and experienced allergy, cipro [ciprofloxacin] and experienced drug allergy. The patient experienced almost died, feels tired on an unspecified date in Aug2021, immediately got chest pain, itchy tongue, severe dizziness and lightheadedness with, turned whiter than white, lip started to swell and got really itchy on 16Aug2021. The reporter stated that, she received her first dose Pfizer Covid Vaccine on Monday, 16Aug2021. She immediately got chest pain, itchy tongue, severe dizziness and light headedness. The caller s daughter stated, the patient got whiter than white after receiving the first dose Pfizer Covid Vaccine. The caller stated she had the chest pains. Her lip started to swell and got really itchy. She received the first dose Pfizer Covid Vaccine at the Pharmacy and they Pharmacy did not do anything, it was awful. The caller stated she almost died and the pharmacy did nothing. The caller stated she was allergic to Cipro and Bactrim and was overweight. The caller shared this information with the Pharmacy and they said it would be fine. It was reported that, chest pain was still ongoing back and forth. The caller still felt tired and bouts of dizziness. The caller stated the chest pain had improved but still getting bouts and was super tired. Itchy tongue went away maybe about 2.5 hours after, was still having severe dizziness and lightheadedness off and on throughout the day, turned whiter than white, lip swelling and got really itchy went away like a few hours after the first dose. The caller stated, she knew she had to go to the hospital and was covered in hives and had trouble breathing (Caller clarified this occurred after taking Cipro). The caller could not drive and the Pharmacist was a moron and did not do anything, she could have died right there in the pharmacy. The outcome of almost died was unknown, immediately got chest pain was recovering. The outcome of severe dizziness and lightheadedness and feels tired was not recovered, other events: recovered on16Aug2021.  Follow-up attempts are completed. No further information is expected.
COVID-19 vaccine was mixed with 0.8 ml instead of 1.8 ml after administration patient didn't have any reactions.
Near fatal anaphylactic reaction; This serious case was reported by a consumer via market research programs and described the occurrence of anaphylactic reaction in a elderly female patient who received Flu unspecified (Flu vaccine unspecified) for prophylaxis.   On an unknown date, the patient received Flu vaccine unspecified. On an unknown date, an unknown time after receiving Flu vaccine unspecified, the patient experienced anaphylactic reaction (Verbatim: Near fatal anaphylactic reaction) (serious criteria GSK medically significant and life threatening). The outcome of the anaphylactic reaction was not reported.   The reporter considered the anaphylactic reaction to be possibly related to Flu vaccine unspecified.   The company considered the anaphylactic reaction to be possibly related to Flu vaccine unspecified.   Additional Information: GSK Receipt Date: 17-MAY-2023 This case was reported by the consumer via research programs. The patient had near fatal anaphylactic reaction to a Flu shot. The reporter thought that the event might have been related to the vaccine. The reporter consented to follow-up.
Fever and chills, large red and swollen area on arm, approx 7 inches long x 6 inches wide. Painful and swollen, growing.
Extreme fatigue, muscle aches, nausea, sore muscles, chest pain, difficulty breathing, difficulty concentrating. Ongoing.
Information has been received from a physician concerning a 16 year old female patient who in approximately 2007 "approximately 3 years ago" received and completed the RECOMBIVAX HB series (Lot numbers unknown) and a recent titer was antibody negative. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. No further information is available.
pt recv vax 23SEP97 & about 3 days p/vax pt exp h/a, nausea, body aches & lesions on the face;
Information has been received from a consumer and a school nurse concerning 41 child patients who in approximately 1995 were each vaccinated with a dose of varicella virus vaccine live. In approximately 2003, the patients developed mild cases of chickenpox. Most of the children were in the first grade and had been vaccinated at their private pediatrician's offices in the area. The reporter noted that her elementary school was the only one out of six in the area that has experienced a chickenpox outbreak. The reporter notified the elementary school parents of the outbreak. Follow-up information from the nurse indicated that 13 of the reported 41 patients were not previously vaccinated with a dose of varicella virus vaccine live and all of the cases of chickenpox have recovered. One of the previously vaccinated patients was a 7 year old patient (Grade 03 1Sa) who on 10 Sep 1997 was vaccinated with a dose of varicella virus vaccine live. On 26-Feb-2003, the patient developed chickenpox. The previously vaccinated patients included two siblings in elementary school who were vaccinated by the same pediatrician and subsequently developed mild outbreaks of chickenpox. The other patients that developed chickenpox post vaccination with varicella virus vaccine live were also identified (WAES #0305USA00974, 0306USA00276, 0306USA00277, 0309USA01822 through 0309USA01825 and 0309USA01827 through 0209USA01846). Additional information is not expected.
Saturday (10/3/15) evening patient developed redness, warm, painful area around injection site that was size of a quarter.  On Sunday (10/4/15), this area increased to the size of a baseball per patient.  Today (10/8/15) the area is down to about the size of a silver dollar.  Patient also had some burning/tingling at injection site when injection was given.
Improper preparation of thawed vial; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Improper preparation of thawed vial) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Improper preparation of thawed vial). On 21-Apr-2021, PRODUCT STORAGE ERROR (Improper preparation of thawed vial) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
got his first vaccine/antibody test done and came back non reactive; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 23Dec2020 at a single dose as COVID-19 vaccine. Medical history included lupus and RA. Concomitant medications were not reported. The patient got his first vaccine last 23Dec2020. After his first done, he had his antibody test done and came back non reactive on Jan2021. He got his second dose last 13Jan2021 and would still be undergoing an antibody test to see if he has traces of the antibodies. The patient was asking if it would show zero efficacy. Does he need a third dose or revaccination? The outcome of the event was unknown.  Information about lot and batch number has been requested.
Pt came for covid vaccine clinic. She received the moderna vaccine (her 2nd dose) at 10:04 AM. At 10:08 AM pt c/o difficulty breathing, dizziness, CP. Pt had noted increased work of breathing and resp distress. Was placing her hands on her chest while saying it felt hard to breath. Pt began vomiting, and was diaphoretic. Sent staff member to get provider, and had LPN call EMS. EpiPen 0.3MG administered in right thigh at 10:10 AM (Lot#0GM229, exp 12/31/2021).  PAC came in to evaluate pt Per his instruction pt was moved to an exam room at this time. Vitals checked at 10:15-BP 117/69, HR 80, O2 99%, resp 24. At 10:18 pt reported sx are improving and it feels easier to breath. Vitals rechecked at 10:20 AM-BP 108/74, HR 72, O2 99%, resp 20. Pt's breathing was more regular, and had normal resp effort at this time. Rechecked vitals at 10:22-BP 114/76, HR 78, O2 99%. EMS arrived at this time. Report was given to them by PAC, and EMS took over care of patient. Patient was transported to the ER for ongoing care.
Patient came to drive through flu and covid clinic with family (daughter and son in law). Family did not know that she already had her flu vaccine for the year. She was signed up to get both flu and covid vaccine. During Drive-thrus we do not have time to check Immunization Registry prior to each vaccination. Patient was given flu and covid vaccine. Upon entering vaccine into Immunization Registry it was noted that patient already received a flu vaccine for the 2021-2022 flu season. Spoke with son in law. He states that patient is feeling fine and has no concerns. He was already aware that she received 2 doses and stated when he brought her to the drive-thru he did not realize she already received it through her doctor.
This initial non-serious spontaneous case, was received on 04-Oct-2017, from other health professional, concerning a 40-year-old adult patient of unspecified gender. The patient's medical history and concomitant medications were not reported. On 04-Oct-2017, the patient was administered with FLUVIRIN THIOMERSAL (dose: 0.5 ml, batch number: 1618621, expiry date: Apr-2017, route of administration: intramuscularly, anatomical location: deltoid). It was reported that the patient was administered with the vaccine that had expired in the month of April of that year (explicitly coded as expired vaccine used). No adverse effects were reported. Revaccination with the current season was advised. The reporter assessed the events as non-serious. Follow-up received on 12-Oct-2017: Reporter stated that, the age of the patient was 40 years, vaccine was administered intramuscularly in the deltoid and confirmed that, the patient did not experience adverse event. Non-significant case correction received 04-Oct-2017: Added no adverse events noted verbatim in description as reported of the event no adverse effect and narrative was corrected.
Feeling fast heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Feeling fast heartbeat) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced HEART RATE INCREASED (Feeling fast heartbeat). At the time of the report, HEART RATE INCREASED (Feeling fast heartbeat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Decerebrate posturing, loss of consciousness for ten seconds, wheezing, atypical seizure, eyes rolled back,  EMS called, supplimental oxygen administered Went to ED, given ativan, zofran, 1L LR bolus and neuro assessment by PA-C Severe nausea for 5 days, slept off and on for five days, dizzyness for five days, brain fog for 5 days
1. OK day of innoculation 2. Next day 1/25/21, 7:30 am, Blood Pressure (BP) was 141/76.  Temp 98.1, pulse 88. (note my normal temp is 95.5-96.5)    8:30 am BP dropped to 66/46, cold sweat, dizziness. Woozy, passed out, but woke when I hit the deck.      9:26 am, BP up to 85/50, 80 bps, 96.2 degrees.      10:08 am, BP 98/55, 82 pps,  temp 96.1.      1:23 pm, BP 88/54, temp 96.1.     6:30 pm, BP 103/60, 82 bps.      8:19 pm, BP 156/72, 80 bps. Temp up to 100.4 degrees.       11:28 pm, BP 125/65, 68 bps, temp 98.4 degrees 1/26/2021:  5:15 am, BP 123/70, 71 bps, temp 99.7 degrees                 8:14 am, BP 110/60, 64 bps, temp 97.4                   8:02 pm, BP 124/70, 72 bps, temp 97.6 1/27/21:  1:06 am, BP 132/75, 62 bps, temp 97.6.                     7:35 am,  BP 123/75, 63 bps, temp 95.3 (back to normal range)  1/27/21
Administration error. Patient received a dose of Pfizer vaccine some time in January. This was not revealed prior to vaccination.
On day 7 after first dose of Moderna COVID vaccine, patient developed a red spot on her arm, below where shot was given. Area was from mid-upper arm down to elbow. States was about 6in x 2.5in. Describes as red, raised edges, and extremely itchy. This persisted for about 7 days. She did try applying lotion to the area without improvement. She began taking Zyrtec on day 5 and states was clear about 3 days later.
The day after my second shot I started spotting like a period and have been spotting since.    I haven?t had a period in 10 years and now am spotting since the vaccine.
Parents took pt to ER 7NOV due to unconsolable crying; mom thought pt was constipated; On admission to ER t97.2; pt admitted to hosp w/dx of dehydration, FTT, r/o encephalitis & meningitis; all lab results WNL (CSF) WBC's slightly inc-11;
PATIENT RECEIVED COVID VACCINE 12/26/20, SHE CALLED THE HD TODAY REPORTING SHE WOKE UP WITH A SORE THROAT THIS MORNING. DENIES ANY OTHER SIDE EFFECTS.  SHE STATES SHE IS GOING TO GO TO A WALK IN CLINIC TO GET TESTED "JUST TO BE SURE".
This spontaneous report was received from a consumer, the patient's mother who referred to a 2-month-old patient of unknown gender. The patient had sensitivity to dairy, soy, possibly wheat and eggs. No information regarding the patient's pertinent medical history and concomitant medications was provided. On 06-OCT-2017, the patient was vaccinated with the first dose of ROTATEQ orally (lot# and expiration date were not reported). On the same day, a few hours after vaccination, the patient experienced nonspecific gastrointestinal (GI) discomfort and stomach pain. The patient did not seek medical attention or hospitalization. The outcome of nonspecific GI discomfort and stomach pain was reported as recovered. No causality assessment was provided by the reporter.
20 vesicles scattered on chest, arms, testicles, afeb, itching;
Fever, chills, extreme arm pain day 2. Arm pain lasted through day 4. Hair loss starting 1 week after shot resulting in bald spots
Low estrogen; cannot sleep; cannot focus; depressed; has anxiety; cannot concentrate; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number and Expiry Date was not reported) via an unspecified route of administration on 30Apr2021 as DOSE 2, SINGLE for COVID-19 immunization and dose 1, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number and Expiry Date was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On unspecified date in 2021, the patient experienced low estrogen, cannot sleep, cannot focus, depressed, has anxiety and cannot concentrate. It was reported that she was tested and test proved that she had low estrogen. She wanted to make sure to notify because this could impact people who want to have babies her two nieces are waiting because they are young. Patient stated that she was thankful that she no longer wants to have children. She went on to state that she was aware of 10 people who experienced the similar reactions. 5 of which are asians and she is chinese and did not mention the nationality of the other 5. On an unspecified date, the patient underwent lab tests and procedures which included blood oestrogen: low. The outcome for the events was unknown.No follow-up attempts are needed; information about lot/batch number cannot be obtained; Sender's Comments: Linked Report(s) : -PFIZER_INC-202101533633 ;-PFIZER_INC-202101533634 ;-PFIZER_INC-202101533635 ;-PFIZER_INC-202101533636 ;-PFIZER_INC-202101533637 ;-PFIZER_INC-202101533638 ;-PFIZER_INC-202101533639 ;-PFIZER_INC-202101533640 ;-PFIZER_INC-202101533641
STROKE; This spontaneous report received from a patient via social media a company representative concerned a female of unspecified age of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: lung surgery. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  The patient reported that "I had a stroke 2 days after my 1st shot. I had to wait so long because I had lung surgery. I was so happy to start and already made the 2nd appointment and ended up being taken by the ambulance to the hospital. After 2 days went to a rehab because I couldn't stand. I'm fine now. Good thing I wasn't paralyzed".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stroke. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220245951-covid-19 vaccine ad26.cov2.s-Stroke. 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). Therefore, this event(s) is considered unassessable.
tingling  in left arm, hot/cold sensation intermittently in left arm, left arm heaviness.
Fever, confusion, dizzines resolved with Tylenol in approxiamately 24hrs.
12 hours after vaccine administration, patient complained of joint pain, body aches, fever, nausea, headache, sweating. 18 hours later symptoms decreasing.
A report has been received from a Health Professional concerning multiple patients of unknown gender, who had been receiving FLUMIST (intranasal). FLUMIST started on an unknown date. The patients experienced sick. The outcome of the event of sick is unknown. The report was considered to be non-serious by the company physician.
My two thumbs turned orange almost immediately after vaccine.  Had a break out of psoriasis and arthritis, and I had never been diagnosed with psoriasis and arthritis, diagnosed. Saw my PCP telehealth at end of May. Saw rheumatologist around Mid June.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 60 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Apr2021 as dose 1, single (Lot number: EW0158), in left arm, on 03May2021 as dose 2, single (Lot number: EW0173), in right arm, on 15Nov2021 as dose 3 (booster), single (Lot number: FH8027), in left arm and on 01Apr2022 as dose 4 (booster), single (Lot number: FJ9943), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "dural sinus venus thrombosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: The patient had no known allergies.