chrisvoncsefalvay/vaers-outcomes huggingface dataset:
52-year-old woman with no significant past medical history who presented with bruising on her upper and lower extremities - non traumatic. Was found to have platelet count of 3000. Was admitted and transfused 1 unit of platelets. She was reporting chest pain but Chest CT angio negative for pulm embolism. Leg US neg for DVT. Post transfusion counts increased to 55K but slowly drifted down to 24K. She was given pulse dexamethasone. Count 30 K on discharge.
Burning pain with administration of vaccine. Persistent discomfort in left arm with redness. Examined on 12/13/02 by MD and had a 6cm erythematous, warm area. Seen on 12/17/02 and there was no erythema evident. Full ROM.
Multisystem Inflammatory Syndrome; This is a literature report for the following literature source(s).  An adult patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation, infection. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MULTISYSTEM INFLAMMATORY SYNDROME (medically significant), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Multisystem Inflammatory syndrome. 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
pt recv vax; prolonged crying 12-18 hrs, high pitched cry; no tx, resolved spontaneously;
None Covid -19 vaccine expired 10/25/2022 given 01/06/2023
pt recvd vax 2DEC94 & pt screamed inconsolably, high pitched for 6hrs & area surrounding the vax site was red, swollen & warm to touch for several days;no fever;given APAP;no MD visit;
The patient came in on 5/28/19 and received the first vaccine, then on 7/2/19 she received the second vaccine which is too soon
No Adverse event; received 0.25 ml of bivalent dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) in a 31-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose).    No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MODERNATX, INC.-MOD-2022-662961, MODERNATX, INC.-MOD-2022-662973, MODERNATX, INC.-MOD-2022-662974 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-662961:Same reporter MODERNATX, INC.-MOD-2022-662973:Same reporter MODERNATX, INC.-MOD-2022-662974:Same reporter
Daughter tested positive for COVID-19/Experiencing symptoms of low grade fever, chest congestion, cough, nasal congestion.; Daughter tested positive for COVID-19/Experiencing symptoms of low grade fever, chest congestion, cough, nasal congestion.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 13 year-old female patient received bnt162b2 (BNT162B2), administration date 10Jun2021 (Batch/Lot number: unknown) as dose 2, single and administration date 20May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Treated for asthma; "Allergies" (unspecified if ongoing), notes: Treated for asthma and allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Daughter tested positive for COVID-19/Experiencing symptoms of low grade fever, chest congestion, cough, nasal congestion.". The patient has not received the booster.   The lot number for bnt162b2 was not provided and will be requested during follow up.
first singles shot a year ago, didn't get second because covid; This case was reported by a consumer via interactive digital media and described the occurrence of covid-19 in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced covid-19. On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-APR-2022 Reporter's comments: This case was reported by patient via interactive digital media. The patient received 1st dose a year ago of reporting date and did not receive second because of COVID-19. The patient asked whether he/she should get second shot within six months. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Within minutes of receiving the vaccine I had pain and soreness at the injection site. The pain continued for approximately 30hrs.  I had a headache, dizziness, and heightened emotional state  for approximately 30hrs.  I developed a twitch underneath my eyebrow but above the eyelid on the right side of my face, which was constant for 24hrs. following the vaccine, but is still twitching at various moments throughout the days.
dysphagia, dyspnea, edema Narrative: Pt c/o neck swelling/angioedema, dysphagia, dyspnea, and edema on 3/8/21 three hours after COVID-19 (Pfizer) vaccine administration. Pt was admitted to hospital and discharged on 3/11/21. Pt with recurring sx's hours after discharge and readmitted to hospital on 3/11/21. Pt was transferred to ICU on the same day and discharged on 3/14/21. Pt with another episode of recurring sxs on 3/15/21 and referred by provider on 3/16/21 to go to ED. Pt was seen in ED and discharged with low-dose steroid taper. Told that vaccine needed to get out of system and that after vaccine had run its course that sxs would improve.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 01Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received treatment for event included Paxlovid, treatment started on 03Jan2023 and stopped on 08Jan2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
having trouble with her close vision; dry eyes; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9267, and Expiration date: May2021), via an unspecified route of administration on 21Feb2021 (at the age of 74-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included cataract surgery (surgery a year and a half ago) and rubella (when she was a child, she has caught rubella three times when you are only supposed to get the infection once, which was before rubella shots and was back in 1950s). The historical vaccines included Hepatitis B vaccine (she had an immunity of 14 while the cut of was 10, she was barely above immunity which they checked again and she had to start another series of the 4 vaccinations and she had 98, then they never tested it again) and 2 shots of unspecified flu A and flu B vaccine (She said the recommended dosage of vaccines did not work on her, she always tried get this vaccine at the end of September, she knew one date she got it again was February, and then she came down with it again and then they just started giving her two Flu shots a year, one at the end of September, and one at the beginning of January). The concomitant medications for patient were not reported. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9265, and Expiration date: May2021), via an unspecified route of administration on 28Jan2021 (at the age of 74-year-old) as dose 1, single for COVID-19 immunization. It was reported that, on an unspecified date in 2021, the patient was "having trouble with her close vision" which she clarified was due to having cataract surgery a year and a half ago. On an unspecified date in 2021, she had "dry eyes" and had not gotten drops yet that she was not allergic to, as well as she had problems with the glasses she got after cataract surgery, they were not right on her close vision, so she was having trouble with it. No further details provided about her dry eye drops. The patient considered herself not getting immunity with the Pfizer COVID-19 vaccine since she had history of not being immune to infections and vaccines before. The patient reported that, her doctor recommended her to get the COVID-19 vaccine and she was wondering if there was a way, she could run a titer to see if she was immune or not to COVID-19. She wanted to know if there a test currently available. The investigation assessment was not provided. The outcome of events was reported as unknown.  Follow-up attempts completed. No further information expected.
Patient presented to clinic with complaint of left arm redness from PCV 13 vaccine given on 1/27/22. Patient reports redness began this morning and there is heat on her arm, as well. This RN observed redness covering the whole upper part of left extremity to the elbow. Patient's primary care physician came and evaluated patient. Antibiotics were prescribed and patient was instructed to take a daily antihistamine and Benadryl at night. Patient was also instructed to apply ice to site.
Redness and itchy at injection site 6 days after vaccine. then it is just getting redder and larger of an area that is red/swollen/itchy. about 2 cennimeters below the injection site. Progressively getting worse. No onther symptoms
Client awakened approx. midnight, post vax, complaining of itching legs, nausea and vomiting. Child's body was very red, especially legs. Was taken to ER and was completely red on face, trunk, legs and arms. Treated with steroids for allergic reaction.
On the morning of 03NOV91, pt started w/lethargy, then had loss of muscle control & became unresponsive; MD termed it "hyporesponsive collapse"; pt was placed on a heart monitor;
FAINTING X 2, SHAKY, CHILLS, FEVER, PAIN, FATIGUE, VOMITING.
This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 39-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.       For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/undergone several temperature excursions).    No concomitant products reported.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. The Nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. Date vial moved from freezer to refrigerator was 07 Sep 2022. The vial underwent temperature excursion.  No adverse reactions reported for the patient.  No treatment products reported.
Within 4 hrs of receiving the vaccine, the left arm became tender and worsened in intensity such that by 12 hrs later it hurt to lift the arm.  24 hrs after the vaccination full body aches began (shoulders, neck, back arms, hands, legs, and bottom of feet) and a headache.  The body aches worsened from 24-40 hrs post injection, and became so bad it hurt even rolling over in bed.  Tylenol (1000 mg) taken at even intervals 4x during that timeframe helped to lessen the intensity, but the pain was such that it was too uncomfortable to do anything other than stay in bed.  At 40 hrs post injection glands in neck felt sore and persisted for another 24 hrs. Additionally,  stomach/abdominal discomfort began about 24 hrs post injection and continued to 80 hrs post injection.  Miralax was taken to attempt to ease the abdominal discomfort at about 78 hrs post injection.
VACCINE ADMINISTERED OUTSIDE OF RECOMMENDED STORAGE CONDITIONS; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine administered outside of recommended storage conditions, and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered outside of recommended storage conditions and incorrect product storage was not reported. This report was non-serious.
RECEIVED 2ND DOSE OF PFIZER COVID VACCINE 1/5/21 1600.  DURING 15 MIN OBSERVATION COMPLAINED OF FEELING DIZZY/LIGHTHEADED.  FELT BETTER AFTER EXTENDED OBSERVATION.  STATED SHE FLE FINE TO OBSERVER.  ON 1/6 WENT TO WORK AND FELT SICK WITH HEADACHE, FATIGUE, FEVER, CHILLS.  PATIENT WENT TO ER AND WAS DISCHARGED AFTER 30 MINS
After I had the vaccine, I woke up with a very bad headache. I waited for a few days, but the headache never went away at all. Tylenol and nothing worked. I made an appointment with my doctor to see if I can get a prescription for the pain. I went to walk in clinic they prescribed 50 mg of Imitrex (1/21) daily. No relief after I took the pills.  On 1/24 I went to the ER.  They gave me an infusion and that help with the headache. I left the hospital.  And I am planning to see my doctor, this time with a Neurologist. Appointment is March 17, 2022.
This spontaneous report was received from a pharmacist referring to a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 03-NOV-2016, the patient was vaccinated with GARDASIL (route, dose, dose number, frequency, lot # and expiration date were unknown) for prophylaxis. Subsequently, on 14-APR-2017 after the dose of GARDASIL the pharmacist reported that the patient went into the pharmacy  to received a dose of GARDASIL 9 (route, dose, dose number, frequency, lot # and expiration date were unknown) for prophylaxis. No adverse effect were reported. This is one of two cases from  the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA002180:
Headache started approximately 12 hours after receiving vaccine , lasted all night - took 2 Tylenol 325 mg caplets and headache was gone within a couple of hours.  Also arm was quite sore first night but much better 2nd night.
Wheezing for 1 hour 2 days after. Rash on wrist, arm of vaccine itchy.
Fever of 102 Fahrenheit; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 102 Fahrenheit) and CHILLS (Chills) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PYREXIA (Fever of 102 Fahrenheit) and CHILLS (Chills). At the time of the report, PYREXIA (Fever of 102 Fahrenheit) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.  Treatment of events was not reported.
Achy arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Achy arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 013A21A and 010M20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Synthetic rubber sensitivity (Neoprene) and Allergy to antibiotic (Bacitracin). Concomitant products included APIXABAN (ELIQUIS), FLECAINIDE ACETATE, METOPROLOL SUCCINATE, SIMVASTATIN, FAMOTIDINE and FISH OIL for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Achy arm). At the time of the report, PAIN IN EXTREMITY (Achy arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medications included Centrum Silver (1/day). the patient had never tested positive for COVID-19.  The patient reported that with all the 3 doses she just experienced achy arm.  No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-658626 (Linked Report). This case was linked to MOD-2022-658776 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658626:Husband case
Delayed menstrual period by 6 days.; This is a spontaneous report received from a contactable consumer, the patient. A 36-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) via unspecified route of administration in left arm on 20Feb2021 at 14:00 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. The medical history was not reported. The patient was allergic to latex, gabapentin and scopolamine. Concomitant medications included ondansetron (ZOFRAN) and oxycodone (MANUFACTURER UNKNOWN) from an unspecified date for an unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318) via unspecified route of administration on left arm on 01Feb2021 at 10:00 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient was tested for COVID-19. On 18Mar2021, the patient experienced delayed menstrual period by 6 days. The patient heard from other friends that this was also the case for them. The patient had looked online and saw more reports from other women on forums. The patient thinks this should be investigated or warned about as its pretty worrisome for many women when their periods were late, especially when trying to conceive. The patient underwent lab tests and procedures, which included COVID-19 virus test (nasal swab) on 04Mar2021 and was tested negative. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. The patient did not received treatment for the reported event. The clinical outcome of the event menstruation delayed was recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Information has been received from a registered nurse concerning a 63 years old male patient, who in approximately 2010 ("about 2 years ago") was vaccinated with a dose of PNEUMOVAX23 0.5 ml intramuscularly (lot # not reported) and on an unknown date he experienced extreme fatigue and achiness and was in bed about 5 days. No treatment was given. The outcome of extreme fatigue and achiness was reported as recovered (date unspecified). The patient did not seek medical attention. The relatedness for achiness and extreme fatigue was unknown for PNEUMOVAX23. Additional information has been requested.
She just felt bad all day; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.  Additional details were provided as follows: The case was reported by the friend of the patient. The age at vaccination was not reported. Patient received Shingrix vaccine and felt bad all day. The reporter refused to provide any other details other than what was reported in this report. The reporter did not consent to follow up. This case is one of the 5 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021097925:Same reporter US-GLAXOSMITHKLINE-US2021AMR099468:Same reporter US-GLAXOSMITHKLINE-US2021AMR099469:Same reporter US-GLAXOSMITHKLINE-US2021AMR099471:Same reporter US-GLAXOSMITHKLINE-US2021097926:Same reporter
I have developed a patch, approximately 3cm x 3cm, right inner forearm, which has a rash, cellulitis, pruritus.  It started as a few small bubbles, is getting bigger.  This started 5 days after first Pfizer covid shot
Vomiting, Dry-heaving, 102.2 temperature, severe headache
Pt recvd Engerix-B 8OCT91 & exp severe h/a on 12OCT & 13OCT91 nausea & vomiting; pt considered going to ER because pain was so bad;