chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I woke up on the of 02/06/2023 in the morning with a headache.  I took something for it but it didn't go away.  In the afternoon, I started feeling feverish with chills and body aches.  I took my temperature and it was 100.2 degrees.  I put myself isolation.  My primary symptoms were the headache and then the fever. As the day progressed the malaise set in and I was in bed for 4 days and in isolation for 10 days.  On the 7th, I did call my doctor and he immediately prescribed Paxlovid.  Within 24 hours of taking the Paxlovid the symptoms went away except the malaise which lingered for a few more days.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Concurrent conditions, pertinent medical history or concomitant therapies were not reported. The registered nurse stated that an unspecified number of improperly stored doses of PNEUMOVAX23 (lot# K008410, expiration date: 26-FEB-2016) (dose, frequency and route of administration were unspecified) were inadvertently administered to the patients on unknown dates. No adverse events were reported. No product quality complaints were reported. This is one of several reports from the same source. Additional information has been requested.
The patient began to experience hives on 12/03/2001, per her mother's phone call to the doctor's office. The hives, which itched intensely, were on the patient's neck, chest and back. The patient began wheezing on 12/02/2001, but at the time of this report has now stopped. Patient's mother was instraucted by PCP to bring the child in if still symptomatic. Mother gave the patient Benadryl with "fair" results. On 12/07/2001, the mother made a follow up phone call. The PCP wrote out a prescription for Zyrtec and instructed her to proceed with the remaining vaccinations. On 12/18/2001, mother call to state that the patient was still having hives.An appointment has been made to see a dermatologist.
Mom called 2/18/16 to say that patient had redness, hard swollen left arm where injection was given. PROQUAD was given (L) arm. Mom states she called dr office and they told her to give him BENADRYL and apply cold compress to area and if not any better by Friday 2/19/16 to bring the min to MD office, mom to notify DOH of any action taken.
I developed neuritis and systemic polyneuropathy treated pain with Neurotin symptoms noted and 1 week after vaccination initially.    05/03/2007 MR received for multiple neuro consult OVs beginning 10/13/2006 to 3/27/2207 for c/o initially numbness of the lower extremities. Initial PE shows 2+ knee and 1+ ankle relexes and mild sensory disturbance over the ventral aspects of feet. Otherwise WNL. DX: Mild sensory neuropathy ideopathic in nature.  Further F/U show sensory sx now increased and progressing to the arms.  Numbness and tingling now to the mid thigh and left arm.  Legs heavy.  Now noted on 11/16/06 that sx. began after DPT vax.  OV 12/11/06 with development of diffuse dysthetic pain in arms legs and trunk. DX:  Ideopathic neuropathy. Polyneuritis and neuropathy.
Overnight my son developed nausea, headache, body aches and a fever. We didn't have working thermometer but it was easy to recognize the telltale signs, glassy eyes when we woke him up for school at 6am 10/30/2018. These symptoms continued for 36 hours. I did get a thermometer midday on the 30th to take his temperature. At one point it went as high as 103.5, it lasted at 102.8 for most of the afternoon/early evening until some Ibuprofen kicked in around 8pm. The next day my sons temp hoovered just at 99.5 for the day but he looked much better. He still had a headache and body aches on the 31st until about 12 noon. By 4pm, he seemed back to himself with just some minor body aches and fatigue.
Mother scheduled a pediatic pfizer vaccine appointment even though patient is 17. Did not verify age a time of vaccination. Patient requested correct vaccine. Administer adult pfizer vaccine at time and advised of potential side effects.
flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergy to plants (Aloe vera plant allegy).   On 28th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 28th March 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix vaccine on left deltoid. The patient experienced flu like symptoms after receiving 1st dose of Shingrix. For tolerance of 2nd dose, refer case US2019AMR118900.
This spontaneous report as received from a consumer refers to her 15 years old (reported as "16 years old") daughter with no drug reactions/allergies. The patient was vaccinated with dose 1, 2 and 3, 0.5 ml GARDASIL (lot# not reported) on 03-JUN-2011, 15-AUG-2011 and 27-SEP-2011, respectively. No other co-suspects were reported. Concomitant medications included unspecified headache medication. The consumer reported that around the "second week of September", the patient started to experience headaches. The patient was also involved in an automobile accident on 01-SEP-2011. Ever since "the second week of September", the patient had had a headache every day. The patient had seen a neurologist but the physician had not confirmed a specific diagnosis for the headaches. Unspecified headache medication was given for the adverse event. CAT scans and blood work was performed for the patient. The outcome of automobile accidents is unknown. The outcome of headaches was reported as not recovered/not resolved. The patient believed that the headaches my be due to the administration. Additional information has been requested.
Broke out with rash 5/26/09. Mild fever began 5/27/09. Denies any other problems. Denies difficulty breathing, swelling around lips/throat or hives. Rash is small, red bumps per pt description "measles like". Reviewed VIS form 3/98. To MD if develops moderated or severe problems.
After receiving influenza vaccination patient felt dizzy and had to sit down. Patient was very nervous about getting shot and had not eaten any food that morning or had anything to drink. Vaccination site was not swollen or red and respiration was normal and B/P 84/50. Client was given juice and crackers to eat and felt better
Client reports has felt like heart fluttering and like he is going to pass out several times since he received the vaccine yesterday morning, client advised to see Primacy Care Physician for further evaluation/treatment promptly, client verbalized understanding.
2 daughters were vaxed w/varicella on 19JUL95 & mom devel some papules on abd;mom recovered;1 daughter devel fever (WAES95080254) & 1 daughter devel 5 papules (WAES95080509);no further details were provided;
Mom states after vaccines she went to sleep. Woke up with rash and "knots" at vaccines. Was given "high dose steroids" at ER per mom.
This spontaneous retrospective pregnancy report as received from the patient's mother refers to a 18 year old female patient. The patient had no pertinent medical history and no drug reactions or allergies. On unknown dates (reported as "when she was in 8th grade"), the patient received the first and the second dose of GARDASIL (dose, route, lot# and expiry date were not reported). On 29-SEP-2015, the patient was vaccinated with the third dose of GARDASIL (dose, route, lot# and expiry date were not reported). No concomitant medications were administered. The patient became pregnant with last menstrual period (LMP) of 01-SEP-2015 (menstruation through 07-SEP-2015) and estimated date of delivery (EDD) of 07-JUN-2016. Initial exposure to GARDASIL was at 4 weeks (it was also reported by the patient's mother that "she could be 2-3 weeks pregnant"). On 29-SEP-2015, the patient performed multiple pregnancy tests, but the results were inconclusive, because the line was "so faint". On 30-SEP-2015, the patient was seen by the nurse practitioner and the pregnancy test was performed with a positive result. On 04-OCT-2015 (reported as "yesterday"), the patient was taken to the hospital (but per patient's mother she was not admitted to the hospital) due to vaginal bleeding and cramping. General hematology, general chemistry, urinalysis and other laboratory studies were performed in the hospital (results were not provided). The patient's hormone levels were also measured and they were very low, so the physicians thought that the patient lost the baby. Therefore the pregnancy outcome was spontaneous abortion unspecified date in 2015. Fetal outcome was not reported. On an unknown date in 2015, the patient developed urinary tract infection and unspecified medications were prescribed at the hospital for the treatment. At the time of report, the patient was still experiencing bleeding and cramping and the urinary tract infection was not completely resolved. The outcome of abortion spontaneous was unknown. The relatedness between the events and GARDASIL was not reported. Upon internal review the events of spontaneous abortion was considered to be medically significant. Additional information has been requested.
Information has been received from a 62 year old male with no pertinent medical history reported and no known drug allergies, who on 21-FEB-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot number not reported). Concomitant therapy included TENORMIN, MAXIDE and AMBIEN. On 15-APR-2009, the patient experienced paralysis of his right upper arm. The patient could not raise his right arm above his head. He also lost strength of his bicep. Electromyography (EMG) study showed there are some interferences of transmission of the nerve impulses in the muscle of the upper arm. An MRI was also performed (results not provided). The patient sought unspecified medical attention. Upon internal review paralysis of his right upper arm was determined to be an other important medical event. Additional information has been requested.
Moderna COVID-19 Vaccine EUA  Body aches, chills, sore injection site. Started this morning and despite Tylenol 1000 mg still feeling poorly.
On the 2nd day after this vaccine a flat red rash appeared all over my neck, chest, torso and arms. Also, it was more pronounced on the injection arm at the site of injection than on the opposite arm. I want to note that this is a regular reaction for me when I get sick. And it was especially bad when I got my shingles vaccine last year. It's slightly itchy/prickly, and tends to go away in 3-4 days, based on past experience.   Also, on the 1st day after the vaccine, additional side effects were an extremely sore arm at the injection site, and general mild flu symptoms - chills, body ache, lethargy. These mostly went away the next day.
A little over two weeks after booster I began to get extreme itching on my scalp and my skin became hypersensitive to touch and would break out into hives when contacted. If I scratch anywhere on my body it becomes a swollen painful rash that lasts about 20 mins. Never had any skin issues and was fully healthy. Had these symptoms now for 6 days
pt recvd vax & pt did not feel well; denies chest pain; phone call from family @ 345; pt having trouble breathing; instructed to call 911 or transport to ER arrived ER 444PM; PO2 48.8, Co2 46.0; K 3.3; creact 5; resp sx cont to worsen;
Pfizer lot #FJ6369 with temp excursion. Reported to Pfizer company and ok'd for use. Instructed by staff to report eac dose given in this system.
Pt at 34w 2d IUP was inadvertently administered Gardisil vaccine instead of influenza vaccine, as the vial was in the same location as the infuenza storage location.
Fever; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and HEADACHE (Headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PYREXIA (Fever) and HEADACHE (Headaches). At the time of the report, PYREXIA (Fever) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant and treatment medications were provided.
I had chest pain, as if a heavy foot were pressing on my chest, that lasted for hours and required me to lie in bed. Now, I believe it must have been the kind of heart inflammation that is being reported. It went away eventually. I have no idea whether it caused any permanent damage.
immediate metallic taste in mouth, followed by dizziness, dry mouth.  Twenty minutes later fatigue and headache.
1st Shingrix Vaccine dose on September 13th, 2020 / 2nd dose / on April 12th, 2021 / second dose of Shingrix vaccine 7 months after receiving 1st dose; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 13th September 2020).   On 12th April 2021, the patient received the 2nd dose of Shingrix. On 12th April 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The case was reported by the patient himself. The patient received 2nd dose of Shingrix on right arm later than recommended schedule, which led to lengthening of schedule. It was stated that patient was administered second dose of Shingrix vaccine 7 months after receiving 1st dose. The reporter did not consent to follow up.
Information has been received from a consumer's husband concerning a 35 year old, not pregnant, female patient with penicillin drug reaction/allergy and a history of Lyme disease and shingles 5 or 6 times in the past 6 years. On 03-APR-2012 the patient was vaccinated with ZOSTAVAX (lot# not reported) injection (dose, route, frequency not reported). Concomitant therapy included CRESTOR and XANAX. On 04-APR-2012 the patient experienced a hard, sore, burning sensation at the injection site. The patient was prescribed an unspecified high dose steroid. There was Lyme titer performed and with no result provided. About 2 weeks after receiving ZOSTAVAX, appropriately on 17-APR-2012, the patient recovered. The patient sought medical attention by visiting the doctor's office. Product Quality Complaint (PQC) was not involved. Follow up information has been received from a physician concerning the female patient (occupation reported as clerk) with anxiety and depression who was vaccinated with ZOSTAVAX. It was reported the patient's husband demanded vaccine because the patient felt she had zoster rash twice already and they felt it might help the patient attenuate any future event, even though they knew it wasn't indicated under age 50 due to no formal testing at this level. Since then the husband was upset that his insurance didn't cover the cost, and he was on a mission to find something wrong with it. There was a 2cm area of redness at the injection site. The AE onset date 05-APR-2012 and recovery date 06-APR-2012 was contradict to the former report (AE onset date 04-APR-2012). It was reported that the patient didn't sought medical attention. Follow up information has been received from physician, who stated the patient developed 2 cm size area of redness on her arm, at the injection site, after receiving ZOSTAVAX in April 2012. Additional information is not expected.
bright red spot where the injection was; I can still the heat and it is still a little swollen, at injection site; I can still the heat and it is still a little swollen, at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 28Jul2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, she had no problems with he 1st dose), for COVID-19 immunization, reaction(s): "no problems".  The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset Aug2021, outcome "not recovered", described as "bright red spot where the injection was"; VACCINATION SITE WARMTH (non-serious) with onset Aug2021, outcome "not recovered", VACCINATION SITE SWELLING (non-serious) with onset Aug2021, outcome "recovering" and all described as "I can still the heat and it is still a little swollen, at injection site". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site warmth, vaccination site swelling.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Woke up with a rash on legs, which spread throughout the day to arms, stomach, chest, neck, face, and ears.
First course of this vaccine only had injection site pain.  Second shot started with injection site pain which moved to whole body pain, chills and sleeplessness.  One day after, body pains continue and some intestinal issues have been noted, chills have subsided.  OTC ibuprofen (600mg) took the edge off the discomfort so I could work but I've been feeling quite uncomfortable all day.
1/20/04 Complained of shooting pains down right arm, numbness, tingling right fingers x 3 weeks. Tx for RT myositis/bicep tendonitis results not back from MRI (some heat).
I had of congestive in my throat, running nose, diarrhea, cough, SOB, and low-grade fever.  I also lost my smell.  These symptoms are still ongoing except for the congestive and fever.  I did a home Covid-19 and went to the hospital for a Covid-19 test on Dec 19th.  Both came back positive for Covid-19.
FEVER OF 102 F; HEADACHE; This spontaneous report received from a parent concerned a 48 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced fever of 102 f. On 06-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever of 102 f, and headache on APR-2021. This report was non-serious.
Possibly given compromised vaccine (vaccine reconstituted and administered with sterile water instead of manufacturer's diluent). No reported adverse health events by patient in subsequent visit to the Immunizations clinic. Patient revaccinated on 19JUL2019 with Yellow Fever, Lot #: UI933AA. Revaccination determined by local medical team with advice from the following medical professional. *Item 5 was filled due to form requirement but it is unknown if patient has experienced an adverse health event. This VAERS form is being filled out for documentation and education purposes. 22JUL2019.
p/vax pt ran a fever of 100;had sore arm & SOB that lasted 12hr;
increasingly severe tinnitus, mostly in the left ear, but often loud enough that both seem to be ringing. It's getting louder and does not go away.
patient came in on 5/20 to receive second dose of COVID (pfizer) vaccine and her mother called on 5/21 in the morning to inform us that her daughter was having swelling in her face from the eyes down but not involving her mouth, tongue or throat.  She had given her daughter ibuprofen and benadryl.  I recommended she take her to the ER for further evaluation.  She said she would and would contact me later to let me know how she was doing.
Information has been received from a nurse concerning a 15 year old male with no pertinent medical history who on 25-OCT-2000 was vaccinated subcutaneously with one 0.5 mL dose of VARIVAX (Merck) (LOT# not reported). In July 2010, the patient was diagnosed with shingles. Unspecified medical attention was sought. No further details were provided at this time. Additional information has been requested.
Patient developed cellulitis in the right arm  the same day they got the Pnemovax23 in that arm.  Pt went to urgent care on 09/20/20 and received antibiotic treatment.
10/7/14 family member reported c/o less hurting; stomach hurting; and tiredness, encouraged to see doctor.
Pt recvd 2 doses of Hep B vax JUL91 & AUG91 following 2nd dose lab eval revealed sl inc in serum bilirubin;
Arm swelled size of baseball below injection site, reddened and black and blue discoloration
lethargic; dizzy; stayed asleep until around 6:30-7:00AM the next morning; This is a spontaneous report received from a contactable consumer.  A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 16Apr2021 10:00 (Batch/Lot number: unknown) at the age of 57 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "high blood pressure" (ongoing). The patient took concomitant medications. Vaccination history included: BNT162B2 (dose 1, Batch/Lot number: unknown), administration date: 26Mar2021, when the patient was 56 years old, for COVID-19 immunisation, reactions: "lethargic". The following information was reported: LETHARGY (non-serious) with onset 16Apr2021, outcome "recovered" (18Apr2021), described as "lethargic"; DIZZINESS (non-serious) with onset 16Apr2021, outcome "unknown", described as "dizzy"; SOMNOLENCE (non-serious) with onset 16Apr2021, outcome "unknown", described as "stayed asleep until around 6:30-7:00AM the next morning".  Additional information: Concomitant medications included blood pressure medication every day taken for high blood pressure. The events did not require visit to emergency room of physician office.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient woke up in the middle of the night with hives over several parts of his body. He started getting worse so his wife called 911. He passed out once the ambulance got there. They gave him benadryl on the way to the hospital. Once he got to the hospital he was found to be dehydrated and his kidneys were compromised.
The initial spontaneous case, was received from other health professional (nurse) on 06-Nov-2017, concerning a patient of unspecified gender and age. This case refers to 16th out of 18 reports. The patient's medical history and concomitant medications were not reported. It was reported that most of the patients received the vaccine on 09-Oct-17 (as reported), the patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number, expiry date: not reported) (explicitly coded to expired vaccine used). It was reported that, the patient had no reaction, had not experienced any adverse event after vaccination. The reporter assessed the events as non-serious.