chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 29th April 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 30th April 2018, 1 days after receiving SHINGRIX, the patient experienced swelling arm, erythema of extremities, flu-like aching, rash and pain in arm. On an unknown date, the outcome of the swelling arm, erythema of extremities, flu-like aching, rash and pain in arm were recovered/resolved. It was unknown if the reporter considered the swelling arm, erythema of extremities, flu-like aching, rash and pain in arm to be related to SHINGRIX. Additional information was received as follows: The healthcare professional reported that the patient experienced a severe rash, redness, swelling, and soreness on the upper arm. The rash was only on one side. The patient also experienced flu-like body aches. All symptoms were lasted for a week and have resolved. The healthcare professional did not have information of the vaccine lot number and expiry date administered. The patient thought that she received the vaccine on 29th April 2018, but was not sure if it was the exact date. For dose and route of administration, she stated it was the normal dose and route.
Started at 2:00pm with itching and redness on left arm at the injection site. By 6:30pm rash/hives spread to legs, arms, feet, stomach and back. Severe itching. Took 25mg of Benadryl at 6:30pm. Rash appeared to subside. By 10:30pm rash and severe itching returned on legs, feet, back, stomach and arm. Felt tingling and numbness in tongue. Took additional 25mg of benadryl and called 911. Paramedics arrived and assessed vitals. Rash began to subside. Sunday 3/21 had residual internal itching all over body.
No adverse event Covid 19 vaccine expired 10/27/2022 Given 11-16-2022
vertigo; dizzy; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 08:15 (Lot number: EN6199) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MICROGESTIN. The following information was reported: VERTIGO (non-serious) with onset 10Mar2021, outcome "recovering", described as "vertigo"; DIZZINESS (non-serious) with onset 10Mar2021, outcome "not recovered", described as "dizzy". The events "vertigo" and "dizzy" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of vertigo, dizziness.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Two days following dose 1 I experienced vertigo that after a few days became less severe and have been dizzy ever since After the second dose I had immediate numbness in left hand. Numbness returns frequently in left hand. 6 wks. following 2nd dose tingling in right arm and feet and ankles. the adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2022, the patient experienced vaccine exposure during pregnancy. The date of the patient's last menstrual period and expected delivery date were not reported. On an unspecified date, the pregnancy resulted in an unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine exposure during pregnancy was not reported. This report was non-serious. This case, from the same reporter is linked to 20220136407, 20220114730 and 20220137233.
CHANGE IN VOICE; PAIN AT INJECTION SITE; This spontaneous report received from a patient via a company representative 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, and batch number were not reported) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the patient experienced pain at injection site. On an unspecified date, the patient experienced change in voice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at injection site, and the outcome of change in voice was not reported. This report was non-serious.
Unauthorized age to receive the Moderna booster; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Unauthorized age to receive the Moderna booster) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer vaccine (Pfizer vaccine for her primary series). Past adverse reactions to the above products included No adverse event with Pfizer vaccine.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Unauthorized age to receive the Moderna booster). On 12-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Unauthorized age to receive the Moderna booster) 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.
Vaccine was frozen rather than refrigerated. Dose was given to patient. Offered a revaccination. No symptoms reported.
Approximately 28 hours after receiving vaccine, patient flushed bright red on face, torso, extremities. Hives formed on upper back. No difficulty breathing. Taken to ER; symptoms had subsided by the time she was seen. She was given Benadryl and discharged.
Injection Site Itching; Injection Site Irritation; Sore arm/Difficulty laying on her side due to the sore arm; Chills; Sleepiness; Red 3 inch circle at injection site; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (on face, about 10 years ago).   On 9th September 2019, the patient received the 1st dose of Shingrix. On 9th September 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 10th September 2019, the patient experienced chills and sleepiness. On 12th September 2019, the patient experienced injection site erythema, injection site itching and injection site irritation. On an unknown date, the outcome of the pain in arm, chills, sleepiness and injection site erythema were recovered/resolved and the outcome of the injection site itching and injection site irritation were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, chills, sleepiness, injection site erythema, injection site itching and injection site irritation to be related to Shingrix.  Additional case details were provided as follows: The patient received Shingrix on left arm. On the day of getting the vaccine, the patient had sore arm that lasted for about 3 days.  Due to the sore arm, she had difficulty laying on her side.  On the next day, the patient experienced chills and sleepiness that lasted for about one day.  On day 3 after vaccination, the patient noticed red 3 inch circle at injection site associated with itching and irritation. After 7 days, the redness had faded but the itching and irritation were still present periodically. The patient did not consent to follow-up. This case has been linked to US2019AMR168832, reported by the same reporter. No further details were provided.
17 patients were administered expired doses of the Moderna COVID-19 vaccine bivalent as booster doses; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (17 patients were administered expired doses of the Moderna COVID-19 vaccine bivalent as booster doses) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (17 patients were administered expired doses of the Moderna COVID-19 vaccine bivalent as booster doses) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (17 patients were administered expired doses of the Moderna COVID-19 vaccine bivalent as booster doses) 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 EXPIRED PRODUCT ADMINISTERED (17 patients were administered expired doses of the Moderna COVID-19 vaccine bivalent as booster doses).    Concomitant and treatment medications were not reported.  17 patients were administered expired doses of the Moderna COVID-19 vaccine bivalent as booster doses.  This case included information for patient 11 out of 17.   This case was linked to MODERNATX, INC.-MOD-2023-698998 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2023: Non significant information received. Sender's Comments:  MODERNATX, INC.-MOD-2023-698998:master case
Patient experienced a flushing sensation and dizziness about 1/2 hour post vaccine. She felt hot and was pink. A couple of hours after vaccination, she felt nauseous. The nausea had subsided but the warmth remained at the time of reporting. Patient is about 31 weeks pregnant. (patient has received TDAP before..about 5 years ago...but does not recall any type of reaction.)
pt recv vax & devel a 6cm x 3.8cm area of redness, swelling & tenderness @ inj site;
pt recvd vax; 3 days inconsolable crying, was high pitched; fever; mom reported never very high but controlled by apap; crying never improved;
she had soreness in her arm; swelling in the arm; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that 9 days after she received the Pfizer COVID vaccine, she had soreness in her arm. The patient also said if it was common to have swelling in the arm. The outcome of the events was unknown.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained. No further information is expected.
low grade head ache; GI c/o; anaphylaxis; Difficulty breathing; Lightheaded; throat felt like swollen/Throat getting narrower; did not feel well; hr 112; nausea; Didn't feel right; This is a spontaneous report from a contactable Physician who reported for a patient (staff member). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of vaccine and during 15 min observation window did not feel well. It was later reported by the same reporter that within 3-5 minutes after injection the patient didn't feel right. Felt lightheaded, wasn't there. Having difficulty breathing and felt throat was getting narrower. Stated throat felt like swollen and heart rate was 112. Went up to people at vaccine center, was given Benadryl and sent to the Emergency Room (ER). Told she was having anaphylaxis. ER was not convinced of anaphylaxis, but was given epinephrine. Ultimately was given epinephrine although they stated that unclear if anaphylaxis or not. Was given 50mg of Benadryl. Was given Zofran for nausea. 'Today' (28Jan2021) had low grade head ache and GI c/o (gastrointestinal complaints of). Had no previous issues with vaccine or drug reaction. Has comorbidities. The reporter was seeking recommendations for the second COVID-19 Vaccine. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and safety profile of suspect drug. 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 RAs, Ethics Committees, and Investigators, as appropriate.
about 3hr p/vax pt had brief episode of shaking, listlessness & pallor;slowly responded to stimulation over 20-30 minutes & then fell asleep;pt was examined by MD an hr later, was entirely nl;
Client reported symptoms of dizziness and weakness.  Fire Department first responded.   Client presented hypotension.  Clients BP recovered within normal limits.  Client stated she felt good.  No further treatment needed as per Fire Department.  Client was released to home at 10:10am.
Metallic taste; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 36-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID 19 mRNA VACCINE; Lot number: EN6202), via unspecified route of administration in the right arm on 25Feb2021 at 17:00 hours as a single dose for COVID-19 immunisation. Medical history includes major depressive disorder, ADD (attention deficit disorder), hyperprolactinemia, Prolactinoma, vitamin D deficiency, anemia (only during week of period or if ill) from an unknown date. The patient has sensitivities to Hydrocodone, latex, Neomycin, nuts, dairy, gluten. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID 19. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included VYVANSE, hydroxychloroquine (MANUFACTURER UNKNOWN) and bupropion (MANUFACTURER UNKNOWN) which were received within two weeks of vaccination. On 25Feb2021, the patient experienced metallic taste within 1 to 2 minutes of having the vaccine shot, which lasted 12 to 24 hours and headache within 3 to 4 hours after having the vaccine shot, which lasted 24 hours. Patient did not received treatment for the reported events. The clinical outcome of the events metallic taste and headache was recovered.   No follow up attempts are possible. No further information is expected.
Daily headaches, elevated blood pressure 8 weeks most days . Treated with Tylenol or Advil
Delayed-onset mild intramuscular itching at injection site on day 8-9.  Associated nontender geographic red plaque-like area with underlying firmness measuring ~4 inches at injection site on day 9-10.  Resolved by day 11.
This is a spontaneous report from a contactable consumer. A 24-year-old (age at vaccination was 24-year-old) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 04Feb2021 02:00 PM at single dose in left arm for COVID-19 immunization at Workplace clinic. Medical history was not reported. No Known allergies. The patient was not pregnant at time of vaccination. No covid prior vaccination. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), ibuprofen, melatonin. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Jan2021, 02:00 PM in left arm for COVID-19 immunization. On 04Feb2021 08:00 PM patient experienced soreness in arm where injection occurred, general body aches, migraine headache, slight nausea and fatigue. No treatment for adverse events. No covid tested post vaccination. No other vaccine in four weeks. The outcome of events was recovering.   Information about batch number has been requested.
Site: Bruising at Injection Site-Mild, Site: Redness at Injection Site-Mild, Additional Details: Patient developed a red rash on her arm and it had some bruising as well she went to the doctor and he gave her cephalexin to take incase of skin infection
Patient states her R arm, where vaccine given (SQ) was red, hot, firm and tender.  States over weekend she noticed aching and burning pain traveling across posterior shoulder blade up to lateral R neck.  Patient states she applied salve to area Friday night, which improved discomfort slightly, but returned Saturday afternoon-again she applied salve which improved again overnight Saturday night, redness, burning pain, etc returned Sunday am.  Did not apply salve last night.  Today site is reddened, hot to touch, tender, and states still has burning pain that travels from injection site across R posterior shoulder blade and up to lateral R neck.
After vaccination patient reported dizziness while waiting in the waiting area.  Patient laid on bench and had some water.  After 10 - 15 minutes she felt better and left the pharmacy with her parents.
chills; Nausea; bad sore throat; a little soreness on her arm; Headaches; Fever(103.4°F); This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (bad sore throat), PAIN IN EXTREMITY (a little soreness on her arm), HEADACHE (Headaches), PYREXIA (Fever(103.4°F)) and CHILLS (chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062l70a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (bad sore throat), PAIN IN EXTREMITY (a little soreness on her arm), HEADACHE (Headaches) and PYREXIA (Fever(103.4°F)). On an unknown date, the patient experienced CHILLS (chills) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at a dose of every 4hs. At the time of the report, OROPHARYNGEAL PAIN (bad sore throat), PAIN IN EXTREMITY (a little soreness on her arm), HEADACHE (Headaches), PYREXIA (Fever(103.4°F)), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 103.4 (Inconclusive) 103.4.         She also had "a bad time" with the 1st dose as she had a relapse of her rheumatoid arthritis   This case was linked to MOD-2021-036146, MOD21-044393 (Patient Link).
similar to chicken pox; This case was reported by a other health professional via call center representative and described the occurrence of vesicular rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.  The anonymous individual who identifies themselves as a healthcare provider reported that got the Shingrix vaccine 10 days ago and experienced  rash similar to chicken pox. The follow up consent was not granted.
This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 30th January 2018, the patient received the 1st dose of SHINGRIX. On 24th April 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, 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. Additional details were provided as follows: The age at vaccination was not reported. After receiving doses of SHINGRIX, the patient continued to have shingles outbreaks. The patient was asking whether there was anything that the patient should or should not do to reduce or lessen outbreaks. This case was considered as suspected vaccination failure as the vaccination schedule and the time to onset for Shingles was not provided at the time of reporting.
Chills for 3 hours. started at 9 hours post vaccine. resolved on own.
Pt states about an hour after she was given the vaccine, the back of her tongue started to get tingly and numb, also got nauseated.  States the symptoms went away over an hour.
High Fever (103 F), Headache, Chills, Body Pain. Fever went away after 1 day but other symptoms lasting over 5 days
Booster was given 3 weeks early (had not been 5 months since last vaccine).
patient experienced feeling of lump in the throat. She also stated that her throat felt dry and was hard to swallow.
Information has been received from a third party claims administrator on behalf of a pharmacy concerning a female patient. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot # H021717, expiration date 07-Mar-2014). On 29-Aug-2013, the patient experienced an adverse reaction (not further specified) to the ZOSTAVAX vaccine. Treatment and outcome of the adverse reactions were unknown. Additional information has been requested.
Fine through the day except sore arm. Arm sore at night, slightly restless night and through next day.  Severe flu like symptoms next day, nausea, fever, pain in calf muscles and around hip peaking in afternoon. In bed 4 hrs through afternoon; resisting to stand up and walk about! 10 hr sleep night of day-02. Body returned to normal when awake.
On the injection site left posterolateral part of upper arm, erythema, swelling and warmth, tenderness.
Itching, swelling and hardening at site of injection one week after shot.  Has subsided, but still some heat and itching