chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Headache; Arm pain; This is a spontaneous report from the Sponsored Program . A contactable consumer (patient herself) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration on 30Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced chills, headache, and arm pain after the 1st dose on an unknown date in 2021. The outcome of the events was unknown.  Information on the Lot/batch number has been requested.
child;preexisting rash, developed fever and vomiting, morbilli form rash after MMR, varicella
She almost ended up in the emergency room on 12/2/22. She was vomiting every 15 minutes. We took her to her pediatrician office, and they prescribed ondansetron the first day. Then, on 12/12/22, she spiked a fever, and we took her back to the doctor and she tested positive for Influenza A. She went back to school 12/14/22 and on 12/16/22, I had to pick her up from school because she had a fever again. I took her to the doctor, and she tested positive for Strep. She was prescribed amoxicillin for this. She is doing much better now, but she is still dealing with some of these symptoms.
Information has been received from a registered nurse concerning a male who was under 2 years old who in approximately January 2004, late last year or early this year was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient developed chicken pox. There were no complications from the chicken pox. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Nurse administered Varicella in left thigh and within 5mins of receiving vaccine, hard, red area with some swelling, painful with touch. doctor advise mom to give him Benadryl and mom called 2hrs later stating pt was doing fine.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-NOV-2014, the patient was vaccinated with an improperly stored dose of ZOSTAVAX subcutaneously, once, lot # K000326, expiration date: 27-FEB-2015 (dose was not reported). There was no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 38 degrees Fahrenheit for 40 days (reported as 40 days +) since 08-OCT-2014. This is one of several reports received from the same reporter. Additional information has been requested.
pain, swelling, stiffness and burning of joints of hands starting within 24 hours of the first dose.  Pain, swelling, stiffness of fingers persists thru current day.  Pain in fingers will awaken me from sleep.  Joints remain enlarged and joints of hips, knees, and feet are also worse since initial vaccine.
pt recv vax the week of 23JAN97 & 2wk post vax pt exp flu-like sx;
takes my breath away; Sharp pains in chest that come and go; This is a spontaneous report from a contactable consumer (patient). This 16-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0176) via an unspecified route of administration on 01May2021 at 17:00 (at the age of 16-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included asthma, migraines, lactose intolerant, and eczema. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included stool softener and nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine (VITAMIN B-COMPLEX) from unknown dates for unknown indications. The patient did not have any known allergies. On 03May2021 the patient experienced sharp pains in chest that came and went. "Took her breath away." The patient did not receive any treatment for the events. The outcomes of sharp chest pains and took her breath away were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19. The patient received dose 2 of BNT162B2 (lot number EW0180) on 22May2021 at 17:00 as a single dose in the right arm for COVID-19 immunization.   No follow-up attempts are needed. No further information is expected.
I have fever; I have body aches; headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th March 2020, the patient received the 2nd dose of Shingrix. On 11th March 2020, 1 days after receiving Shingrix, the patient experienced fever, general body pain and headache. On an unknown date, the outcome of the fever, general body pain and headache were not recovered/not resolved.   It was unknown if the reporter considered the fever, general body pain and headache to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. On the day of reporting the patient experienced fever, body aches, headache and enquired for how long should it last?
Redness, warm to touch, painful, swollen. Cephalexin prescribed 6/13/08 - will take for 10 days.
Patient noted redness, heat, swelling, and pain to injection site on 11/20 and was seen on 11/21.
Per website child was due for Polio-IPV and DTaP. I mistakenly gave the child Kinrix.
Patient had syncopal episode within 15 minutes of vaccination.  Has occurred with other vaccinations.  Patient released to home.
8/22/2008: 17:17 Mother brought baby to Urgent Care with complaints of baby not feeding for 5 hours, baby pale and limp. During triage it was noted that baby was limp, dusky blue and non-responsive.  o 1720PM: Oxygen applied - Heart rate 87  o 1721PM: 911 was called o 1723PM: Heart rate deteriorated and CPR was initiated o 1728PM: 911 transport arrived   o 1736PM: Baby transferred to gurney and CPR continued during transfer o 1737PM: Paramedics en route to hospital 12/1/08-autopsy report received-COD Sudden infant death associated with acute gastrointestinal illness of unknown etiology. History of vomiting x 2 days unable to keep feeds down. Abdundant loose stoll within small bowel.
My Menstrual cycle comes every month on the 15th,  In October I never got a menstrual cycle so I took a pregnancy test and it is negative now we are going into November and my period Still hasn?t arrived I?ve been spotty randomly here and there but no actual blood, this is Very rare for me because I receive my menstrual cycle every month and it?s very heavy last about a week so this is definitely new
Large red raised welt that is hot to touch at injection site on left arm extending through about half the length of top portion of arm.
Two weeks after first dose ringing in left ear began, then 2 weeks after that my right ear started crackling then ear ringing started in it as well. Consulted ENT on April 7, diagnosed tinnitus, ears were clear and said to try Flonase and Allegra.  Neither helped. Ringing in both ears has been 24/7.
Narrative:  New to patient reported a new PCP Md had a reaction of numbness due to the influenza vaccine in the past. Md flagged chart with historical ADR. No more info available to report as this is a historical report.
SIDE EFFECT LIKE IF PATIENT HAD COVID-19; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced side effect like if patient had covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effect like if patient had covid-19 was not reported. This report was non-serious.
Information has been received from a pharmacist and a 68 year old male consumer, who on 12-NOV-2012 was administered ZOSTAVAX, 1 injection, "in the shoulder" (lot # H016766). On 17-NOV-2012, the patient called the pharmacist to report he had a rash around the injection site. The pharmacist instructed the patient to call his primary care physician. (No information provided). On 26-NOV-2012, the patient called the pharmacist again and the patient reported, his rash had initially went away, and now it has returned and it was spreading across one side of his back. The pharmacist instructed the patient to call his physician and seek medical attention, however the patient has not called his physician to this date. The pharmacist stated that he was reaching out to the physician to take make him aware of the consumer's adverse experience. No further information was provided. The patient's present status was unspecified by the reported. Additional information is not expected.
Joint pain; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (reporter's son). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), 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 were not reported. The investigation assessment was not provided. The reporter reported that, his son had the COVID vaccine and had joint pain on an unspecified date. The caller stated his son was healthy and fine. Caller declined to complete report. Full details not obtained. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021402260 same reporter/drug/event, different patients
PATIENT CLAIMS TO HAVE MUSCLE PAIN IN HER RIGHT ARM. SHE RECEIVED VACCINE IN OCTOBER 9, 2017, BUT DID NOT REPORT HER ISSUE UNTIL THE THIRD WEEK OF JANUARY. SHE RECEIVED A STEROID SHOT WHICH DID NOT SEEM TO HELP DURING HER DOCTORS VISIT ON 01/26/18. SHE FOLLOW UP ON 01/30/18 WITH THE PHARMACY. SHE CLAIMS THE DOCTOR THOUGHT IT WAS A NERVE ISSUE RELATED TO THE VACCINATION.
Recipient vaccinated @ 0742. Recipient verbalized c/o feeling light headed and feeling woozy with tight chest @ 0750. @ 0803 recipient verbalized feeling better. Kept recipient for 45 minutes and gave water to drink. Recipient verbalized felt better and would be ok to return to work and did not need to be checked out further.
redness at the injection; swelling at the injection; myalgias; fatigue,; headache,; nausea; diarrhea; This case was reported by a physician and described the occurrence of injection site erythema in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 18th November 2022, the patient received the 2nd dose of Shingrix. On 19th November 2022, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, myalgia, fatigue, headache, nausea and diarrhea. On an unknown date, the outcome of the injection site erythema, injection site swelling, myalgia, fatigue, headache, nausea and diarrhea were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, myalgia, fatigue, headache, nausea and diarrhea to be related to Shingrix.     Additional Information: GSK receipt date: 21-NOV-2022 Reporters comment: The physician reported that patient (reporters husband) received the second dose of shingrix vaccine and experienced myaligias, headache, fever, nausea and injection site redness and swelling The reporter consent to follow-up. Additional Supportive information: This case has been linked to the cases US2022AMR173968 reported by the same reporter. The reporter agrees to follow up from GlaxoSmithKline.; Sender's Comments:  US-GSK-US2022AMR173968:same reporter - reporter´s case
Felt muscle pain on left arm. Had a low grade-fever for two days.  Drank a lot of water and had bed rest for two days. Fever and muscle pain were gone on the third day.
Beginning to get swelling and swelling eventually become the size of like half a golf ball, hard as rock, hot as fire and it was almost gone that day but there is still a little soft lump; I am sick with it; In the last few days I have noticed my blood sugar is a little higher than normal; swelling and swelling eventually become the size of like half a golf ball, hard as rock, hot as fire; Having this rash on and off ever since and yesterday the rash was back again really strong on my arms; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6201; Expiration Date: 30Jun2021, NDC number and UPC number: unknown) via an unspecified route of administration on 04Mar2021 at 10:20 (at the age of 79-years-old) as a single dose for covid-19 immunization. Medical history included blood pressure high, type 2 diabetes mellitus both from an unknown date and unknown if ongoing. The patient had covid-19 last year in March, April, and half of May. Concomitant medication included lisinopril (LISINOPRIL) and triamterene (TRIAMTERENE) both taken for an unspecified indication, start and stop date were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on an unspecified date for covid-19 immunization and had no problem. The patient reported that after taking the vaccine there was no problem for the first part of that day but after lunch, she took a nap for like 4 hours. She went to bed at 8'o clock that night and slept all through Friday, Saturday and Sunday (clarification unknown) and by the time on Friday she had or beginning to get swelling and swelling eventually became the size of like half a golf ball, hard as rock, hot as fire and it was almost gone that day but there was still a little soft lump developed, she had this on and off. She had covid last year and was sick with it. She had rash on and off. The rash was back again really strong on her arms. She took Benadryl as treatment and it subsided somewhat. She asked if it was a normal reaction. She reported that her blood sugar was a little higher than normal, it was 127. It had been under control with diet. The patient underwent lab tests and procedures which included blood glucose: 127 on an unknown date in 2021. The outcome of the events swelling, feeling hot and rash was recovering and for all other events was unknown.  No follow up attempts are possible. No further information is expected.
sent to the emergency department with confusion and weakness and fever. Treated with dexamethasone. Covid positive on 12.28.23.
expired dose of Daptacel was administered, with no reported adverse event; Initial information received on 15-Mar-2022 regarding an unsolicited valid non-serious case received from other health professional.   This case involves an unknown age female patient who received expired dose with no reported adverse event while receiving diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 14-Mar-2022, the patient received dose 0.5 ml once a day of suspect diphtheria-15/tetanus/5 ac pertussis vaccine (strength: standard;  route, formulation, batch number: C5706AA, expiry date:11-Mar-2022) at left Deltoid administration site for Immunization.   On 14-Mar-2022 the patient developed a non-serious event as expired dose of daptacel was administered (expired product administered) (Latency: same day).  Action taken was not applicable.  Outcome was Unknown.   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 guidelines. 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.
Community member, Dose #2 During post vaccination observation, lightheaded & elevated HR to ED with headache & anxiety, improved & discharged to home
This spontaneous report as received from a other health professional refers to a 73 year old male patient. On 04-AUG-2017 the patient was vaccinated with PNEUMOVAX 23 lot # N010109 dose 1, .5 ml for prophylaxis. On AUG-2017 the patient experienced injection site erythema, injection site warmth and injection site swelling. The outcome of injection site erythema, injection site warmth and injection site swelling was reported as recovering/resolving.
These have occurred repeatedly since since my first reaction -    Prickling, stinging in your fingers, toes, ankles or wrists -    Weakness in your legs that and upper body -    Unsteady walking and inability to walk or climb stairs -    Dizziness -    Severe pain that may feel achy, shooting or cramp  -   Difficulty bowel function  -   Rapid heart rate  -   Difficulty breathing  -   Profuse bleeding from nose  -   Severe continuous headaches in front temporal region
Patient was pregnant at time of vaccination but may not have been aware of pregnancy. She was asked at time of immunization, and she answered "No" to pregnancy question on consent form.
Had chicken pox. Per follow up: Broke out with chicken pox type lesion 1 wk prior to shot.
first dose on 2019, never got 2nd dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 23rd August 2019, batch number AC79X, expiry date 17th October 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The health care professional reported that, the patient received 1st dose of Shingrix and never got the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up. This is one of 2 cases, reported by the same reporter.
Cried non-stop for at least an hour.  Le were red/swollen no special rx given but pt given TYLENOL in office & advised to ice X 24 hours
pt recvd vax; redness at site about 50 cents size w/ extreme itching;
Noticed pain and itching to injection site immediately but noticed whole body itching by the evening, without noticeable rash.
Body aches and congestion, started Saturday morning. It is now Monday morning, and I am still having body aches, and congestion.
Fever starting within four hours of immunizations, lasting 7 days (>101), anorexia, weight loss (secondary to dehydration) and oral aphthous ulcers.
Patient woke up the next morning following her 2nd dose of the vaccine (17SEP) with a 7/10 unilateral headache on the left side. Patient went to the ER on the same day (18SEP). Patient was given naproxen and told to hydrate. Patient then returned to ED on 02OCT with complaint of headaches presenting in the morning on a daily basis since the vaccine was administered. Patient states the headache cause left sided neck pain, left eye pressure and lacrimation. Headache lasts 45-60min and is relieved with ibuprofen and a hot shower. Once symptoms subside then headache dose not return until following day
Hard to breathe; A fast pulse, my heart felt like it was pounding out of my chest; nightmare; I had body aches; Nausea; Diarrhea; My palms felt strange/They felt very light weight; Cold sweat; Tingly; hands felt clammy; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 38-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: ER8730), via an unspecified route of administration, administered in left arm on 24Mar2021 13:45 (age at vaccination was 38 years) as dose 1, single for covid-19 immunization. The patient medical history was not reported. The patient was allergic with NKA. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 24-MAR-2021 Immediately after receiving the vaccine the patient experienced her palms felt strange. They felt very light weight, cold sweat, and tingly. On 01Apr she had sudden nausea and diarrhea. 02Apr she had body aches. 03Apr2021 early morning she called the paramedics because she woke up in the middle of the morning from a fast pulse, her heart felt like it was pounding out of her chest and it was hard to breathe. Only lasted for about 10 minutes and then it was gone. The paramedics said she had a nightmare, but she did not remember anything. She was not sure if this was because of the vaccine. The patient underwent lab tests and procedures which included blood pressure measurement: unknown results, investigation: unknown results on unspecified date in 2021, sars-cov-2 test: negative on 04Apr2021. The patient received treatment for the events hard to breathe, a fast pulse, my heart felt like it was pounding out of my chest, nightmare and recovered on 03-APR-2021, hands felt clammy was recovered with sequelae and other events were recovering.  No follow-up attempts are possible. No further information is expected.
Pt recvd 3 doses of Engerix-B vax & it was determiined that pt did not seroconvert; 4th dose of Engerix-B was administered;
Moderna COVID-19 vaccine EVA  extremes migraines, Right side occipital cortex infraction, vision loss
Forgot to get dose 2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-FEB-2023 Reporter's Comment: The reporter was a patients husband. The reporter reported that his wife received 1st dose of Shingrix vaccine in January 2022. The reporter stated that he does not know the exact date or location site of injection. The reporter stated that they moved and forgot to get the second dose The reporter did not consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. This case had been linked with US2023019046 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023019046:Same reporter.
Varicella rash appeared 10 days after vaccine administration - classic scattered varicella lesions (papules/vesicles) to face, trunk, arms and legs. Supportive measures recommended.