chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site was a little sore; Near the brown spots about ½ an inch away there is one red pimple spot.; mild round chicken pox spots brown pin size on breast, legs and back/ I have like 8 to 9 different areas with the brown spots; red spots itches/ the itching last for about 2 days, and it has been more prevalent in the last 2 to 3 days; irritation; I had signs of mild round chicken pox spots. The spots are not like the normal chicken pox-; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had when patient as a child).   On 2nd December 2022, the patient received the 1st dose of Shingrix (intramuscular). On 3rd December 2022, 1 days after receiving Shingrix, the patient experienced injection site pain. In December 2022, the patient experienced red spotty rash, skin discoloration, pruritus, skin irritation and varicella-like rash. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the red spotty rash, skin discoloration, pruritus and varicella-like rash were not recovered/not resolved and the outcome of the skin irritation was recovered/resolved.   It was unknown if the reporter considered the injection site pain, red spotty rash, skin discoloration, pruritus, skin irritation and varicella-like rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-DEC-2022 Reporter's Comment: The reporter was a patient that had the Shingrix vaccine 2 weeks ago.  The reporter reported that patient had chicken pox as a child. The patient had no side effect the next day except the injection site was a little sore. 3 to 4 days after the vaccine patient had signs of mild round chicken pox spots. The spots are not like the normal chicken pox. They were no bigger than a pin head. At the begging it first starts with brown pin head size spots under the breast are and then it had been appearing in other areas of the body.  The reporter reported that near the brown spots about ½ an inch away there was one red pimple spot.  The reporter reported that the red pimple spot itches. The reporter stated that the brown spots do not itch only the red ones.  The patient had like 8 to 9 different areas with the brown spots.  After 28 to 48 hours the irritation disappears.  The spots were more prevalent now in other parts of the body, like the legs and back. The itching last for about 2 days, and it had been more prevalent in the last 2 to 3 days. Not all information was available.  The lot and expiration dates were unknown. The reporter did not consent to follow up.
This spontaneous report as received from a pharmacist ,refers to a patient of unknown age and gender. No information on the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of ZOSTAVAX injection, lot # N020942, expiry date: 26-OCT-2018, for prophylaxis (route of administration was not reported). It was reconstituted with properly stored sterile diluent (lot# N016189, expiry date: 13-AUG-2019). Administered dose of vaccine underwent the 6- hours temperature excursion 6 Fahrenheit degrees to 14 Fahrenheit degrees (10 Fahrenheit degrees). There was no previous temperature excursions noted. Digital data logger was involved. No adverse effects reported. Product quality complaint was not involved.
Dose Number: 3; stomach ache; sore throat; headache; cough; lung pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 23Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Vaccine Administration Time: 03:00 PM), for COVID-19 immunization; Bnt162b2 (Dose Number: 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 23Dec2021, outcome "unknown", described as "Dose Number: 3"; ABDOMINAL PAIN UPPER (non-serious) with onset 23Dec2021, outcome "not recovered", described as "stomach ache"; OROPHARYNGEAL PAIN (non-serious) with onset 23Dec2021, outcome "not recovered", described as "sore throat"; HEADACHE (non-serious) with onset 23Dec2021, outcome "not recovered", described as "headache"; COUGH (non-serious) with onset 23Dec2021, outcome "not recovered", described as "cough"; PULMONARY PAIN (n on-serious) with onset 23Dec2021, outcome "not recovered", described as "lung pain". It was unknown if therapeutic measures were taken as a result of abdominal pain upper, oropharyngeal pain, headache, cough, pulmonary pain.  Additional information: The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Within 10 minutes of the vaccine patient experienced a "near syncope" episode and was noted to have some twitching when EMS arrived to the car. Patient states she felt dizzy, denies shortness of breath, denies chest pain, no rash, no swekking
she was diagnosed with shingles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (she was diagnosed with shingles) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 immunisation.     The patient's past medical history included No adverse event (No medical history was provided.). Concomitant products included WARFARIN and DILTIAZEM for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced HERPES ZOSTER (she was diagnosed with shingles). At the time of the report, HERPES ZOSTER (she was diagnosed with shingles) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included thyroid medications. Treatment medications included valacyclovir.
limping on rt leg onset 9JUN97;MMR given rt leg 6JUN97;
the person who put in the shot injected it into her nerve; she can't feel her arm or fingers yet; She screamed unbelievable; nauseous; pain; It blew up like a balloon; This is a spontaneous report from a non-contactable consumer (patient) via a Medical Information Team. A female patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection) on an unspecified date at 8:00 AM, administered in an unspecified arm via unspecified route of administration at a single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. States her daughter received the first dose of the Pfizer covid vaccine today at 8:00 am, the person who put in the shot injected it into her nerve on an unspecified date. She screamed unbelievable on an unspecified date. EMT was there and told her that the woman put it in her nerve. It blew up like a balloon, she can't feel her arm or fingers yet on an unspecified date.  Not sure what arm. She didn't ask her daughter. The EMT said if she gets a hematoma to go to the hospital. She was nauseous and in pain on an unspecified date. Outcome of events was unknown.     No follow-up attempts are possible as the reporter was non-contactable.
Had no reaction during my 30 minute wait after the injection.   That evening at 9:15 started feeling really tired and was chilled feeling which made me shake.   Was nauseated all night long.   I had dry heaves three times.  Had a headache all night.  These symptoms subsided later in the morning and by noon I was feeling fine except for being tired from the night's experiences.  I feel fine now.
After vaccine - normal body aches, headache. 14 hours after vaccine had a syncopal event. Dizziness afterwards, Feeling unwell afterwards with subjective fever and chills.
a sore arm at injection site; FLUZONE HIGH DOSE QIV was inadvertently administered to a 14-year-old patient; FLUZONE HIGH DOSE QIV was inadvertently administered to a 14-year-old patient; Initial information was received on 14-Nov-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 14 years old female patient who experienced a sore arm at injection site and fluzone high dose qiv was inadvertently administered to a 14-year-old patient after receiving influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 vaccine for Immunisation.  On 13-Nov-2022, the patient received 0.7 ml dose of suspect influenza quadrival A-B high dose HV vaccine (unknown formulation, strength)  (expiry date: 30-Jun-2023  frequency: once) (lot:UJ933AC) via intramuscular route in the right arm for Immunization.  On 13-Nov-2022 the patient had a non-serious event a sore arm at injection site (vaccination site pain), fluzone high dose qiv was inadvertently administered to a 14-year-old patient (accidental exposure to product) and (Product administered to patient of inappropriate age) (Latency: same day) following the administration of influenza quadrival A-B high dose HV vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event a sore arm at injection site, was Unknown for the events fluzone high dose qiv was inadvertently administered to a 14-year-old patient.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
temperature excursion / temperature: 37.94 F; Route: IM; This spontaneous report was received from a licensed practical nurse and refers to a 15 months old male patient. There was no information regarding his medical history, concurrent conditions nor concomitant therapies provided.  On 16-AUG-2021, the patient was vaccinated in a public health clinic by the reporter (described also as a trained operator) with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) first dose, intramuscularly into the left thigh, lot # T002847, expiration date 23-JAN-2022 (exact dose was not provided) for prophylaxis; the vaccine was purchased with public funds (product storage error, incorrect route of product administration). The administered vaccine was stored in a temperature of 37.94 degree Fahrenheit (F) for 100 hours. No previous temperature excursion was reported. Digital data logger was involved. No prescription drug treatment for the experience was required.  The reporter stated that the improperly stored vaccine was removed immediately after the reporting and no further vaccine was administered. The patient's parents were notified and the vaccination would be repeated with new vaccine stock.
p/vax pt began w/SOB w/feeling that throat was swelling shut;then noticed arm began swelling from shoulder to elbow became red et hard @ very warm to touch;loss of appetite, fever, diarrhea, sore & swollen throat, loss of voice;to MD;
Approximately 1 week post 1st vaccination became extremely fatigued, extreme sore throat at the suggestion of my doctor I got tested for mono.  Came back positive on the afternoon of Jan 11, 2021 which coincidentally I had received my second vaccination that morning at 0900.  I continued to have these same symptoms which worsened with extreme muscle pain especially in my legs, neck and lower back.  Upon further lab work it was determined that I was in Rhabdo with my CK levels in 4,000, liver enzymes elevated, GFR low.  By the way, this was a reactivation of mono that I had had as a child.  I received over several days approx 10 liter of NS, zofran and toradol. To date, 3.2.2021, I remain easily fatigued by getting better.  Lab work has all resolved to date.
Very heavy menstrual cycle. Numerous clots. Severe cramping. All unusual for me
fever to 103f, R; grunting respirations, sx lasted 1-2 days
pain at site of injection. nausea and lack of appetite. muscle aches. fever. All one day after 2nd injection.
I just want to report that in the evening that I took the Moderna dose #2,  I felt disoriented. My wife took my blood pressure.  The reading was 88/58 and my pulse was 73.  I am wondering if there is an interaction between the vaccine and the high blood pressure medication.  I stayed lied down until I fell asleep.  In he morning of 6/22/21 from 8:03 AM to 8:06 AM, lying down my readings were 99/65 and pulse 61.  Sitting down the readings were 103/67, pulse was 66.  Standing the readings were 103/74 and pulse was 80.  Oxygen was 97.  The last readings at 1:42PM after eating  were 126/75 and pulse was 80.  I am wondering if there is any correlation.
Flulike Muscle/joint aches, mild headache  (similar to reaction to first shot on 11/24/19)
had the shot and still got them/suspected vaccination failure; got them; painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included normal birth (had two babies natural childbirth).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had the shot and still got them/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got them) and pain (Verbatim: painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 24-Mar-2023 The case was received from the patient via interactive digital media. The patient had the shot and still got them. The patient this was more painful. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
My right eye (white of the eye) became irritated and swollen; My right eye (white of the eye) became irritated and swollen; It continued to be swollen until about 7:00am. It is currently inflamed but no longer swollen; This is a spontaneous report from a contactable consumer. This 46-year-old male consumer (patient) reported for himself.  A 46-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number and expiration date unknown), via unspecified route on left arm on24Feb2021 at 10:15 (patient was 46-year-old at the time of vaccination) at a single dose for COVID-19 immunisation. The patient's medical history included allergies to bananas, walnuts. The patient's concomitant medications included atorvastatin, lisinopril, metformin, Farxyga. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 25Feb2021, at 9:30 pm the patient experienced right eye (white of the eye) became irritated and swollen, It continued to be swollen until about 7:00am and currently inflamed but no longer swollen. The patient received treatment with Benadryl, ibuprofen. The outcome of the event eye irritation and eye inflammation were recovering while, eye swollen was recovered at 26Feb2021, at 07:00.  Follow up #1 (03Mar2021): This is a follow up-spontaneous report received from a contactable Other HCP. This Other HCP reported for himself that: This is not part of a study/SAE/AE form. This is personal experience, self-reporting of use of PFE product. I received the Pfizer vaccine on 24Feb. On 25Feb, I experienced the swollen eye issue, so yes that is the first moment an employee of Pfizer was aware.  Information about lot/batch number has been requested; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a temporal relationship. 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.
2/11/21:sore arm 2/12/21: swollen lymph glands in neck, slight sore throat, in evening fever 100.6 F maximum 2/13/21: swollen lymph glands in neck, slight sore throat, afebrile, generalized rash over trunk and anticubital area 2/14/21: swollen lymph glands in neck, slight sore throat, afebrile, rash mostly faded 2/15/21 to 2/18/21 swollen glands in neck, slight sore throat, afebrile, no rash 2/19/21 (today): swollen lymph glands in neck, slight sore throat (improving), afebrile, no rash
Patient experienced joint stiffness, pain, covid arm, disorientation, chills, diarrhea, and vomiting.
Loss of appetite; Extremely nausea; Diarrhea; Headache all the time; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Mar2021 at 18:15 (at the age of 43-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 43-years-old), both as a single dose for COVID-19 immunisation. Medical history included asthma, bipolar, depression, and anxiety. The patient had known allergies to medications (unspecified). The patient did not receive any medication within two weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 19:00, the patient experienced "extremely nausea", loss of appetite, diarrhea and headache all the time between shots 1 and 2. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events extremely nausea, loss of appetite, diarrhea and headache was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I was having random chest pains possibly related to stress for around 3 to 4 months before I took the first dose. After the first dose (05/15/21 at 4:00pm) I started to have racing heart later that evening. That has become on and off ever since. The day after I recieved the second dose (06/06/21 at 4:00pm) I became very sick with flu-like symptoms. The next day  (06/07/21) the chest pains I was experiencing before I got the shots became intense, frequent, and started radiating to my upper left back.
This is a  spontaneous report from a contactable consumer. This 74-year-old female patient received a single dose of pneumococcal vaccine via an unspecified route of administration in the left arm on 21JAN2015 around 11 AM. The patient medical history and concomitant medications were not reported. On 21JAN2015 within an hour after the vaccine was administered the patient experienced itchiness at injection site. In the evening her left arm had swelled, she stated she felt tightness in her left upper arm, rather than pain, a weird feeling. She stated that at time of reporting, her arm was not longer so swollen, but it as though the chemical had moved from the injection site. There was right redness, under her left arm, about an inch or two below her armpit, that was spread about 1 quarter inch across her chest from left to right and moved up toward her neck. She had a temperature of 99.7 degrees Fahrenheit around 8 PM on 21JAn2015. She had called the triage nurse and she was advised to take for increased body temperature ALEVE which sh did, she took 2 tablets by mouth. She believed that fever had gone, although she had not retake her temperature. She was concerned, and she asked if it would affect her heart and how long the reaction would last. The final outcome of the reported events was recovered. Follow-up attempts completed. No further information expected. Follow-up (20MAR2015): New information from contactable consumer includes event outcome. No follow up attempts possible. No further information expected.
Muscle pain. Red, hard, swollen and warm to touch at injection site (upper arm)  down to elbow. Healthcare provider prescribed Allegra 180 mg twice a day for 3-5 days. Pain in mouth area, numbness on the right side of face.
Throat swelled up; Mild food allergic reaction.; This is a spontaneous report from a contactable consumer(patient). A 26-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EW0153), via an unspecified route of administration, administered in Arm Left on 06Apr2021 11:45 as DOSE 1, SINGLE for COVID-19 immunization (26 year when vaccinated). Medical history included food allergy (Had an allergic reaction after eating watermelon last year but otherwise nothing else that I'm aware of). Concomitant medication included fexofenadine (FEXOFENADINE). The patient was not having covid prior vaccination and has not been covid tested post vaccination. 06-APR-2021 13:00 patient reported that Throat swelled up, but not enough to go to the hospital or ER. Felt similar to having a mild food allergic reaction. No treatment was received for the adverse event. The outcome of the events was recovered on an unknown date.  No follow-up attempts are needed. No further information is expected.
A report has been received from a Health Professional concerning, subject of unknown gender, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 09-Dec-2014. The patient was administered expired FLUMIST on 09-Dec-2014. The outcome of the event of EXPIRED FLUMIST ADMINISTERED is unknown. The report was considered to be non-serious.