chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 1.5-2 weeks after the booster (on 07 Jan 2022) she developed skin writing symptoms (dermatographia).; This spontaneous case was reported by a consumer and describes the occurrence of MECHANICAL URTICARIA (About 1.5-2 weeks after the booster (on 07 Jan 2022) she developed skin writing symptoms (dermatographia).) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced MECHANICAL URTICARIA (About 1.5-2 weeks after the booster (on 07 Jan 2022) she developed skin writing symptoms (dermatographia).). At the time of the report, MECHANICAL URTICARIA (About 1.5-2 weeks after the booster (on 07 Jan 2022) she developed skin writing symptoms (dermatographia).) had not resolved.            No concomitant medication were reported.  It was reported that patient is a woman in her late thirties without any serious health conditi ons.  No treatment medication were reported.
hives all over her body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives all over her body) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced URTICARIA (hives all over her body). The patient was treated with METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]) at a dose of UNK dosage form. At the time of the report, URTICARIA (hives all over her body) outcome was unknown.            Please note, there is no evidence that the patient took Medrol, she was advised again using steroid by her physician friend.  The Concomitant medications were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report was received from a pharmacist via a company representative referring to multiple patients of unknown age and gender. The patients medical history and concurrent conditions were unknown. On an unspecified date, multiple unknown patients were vaccinated simultaneously with ZOSTAVAX (lot number, expiration date, concentration, dose, frequency and route of administration were unknown) and PNEUMOVAX 23 (lot number, expiration date, concentration, dose, frequency and route of administration were unknown). Information regarding concomitant therapy was unknown. On an unknown date, multiple patients experienced flu like symptoms (influenza like illness) cold chills, cold (nasopharyngitis) and nausea. Additionally, it was also reported that the patients sought medical attention. At the time of the report, the outcome of flu like symptoms (influenza like illness), cold chills, cold (nasopharyngitis) and nausea was unknown. The causality between ZOSTAVAX and PNEUMOVAX 23 with flu like symptoms (influenza like illness), cold chills, cold (nasopharyngitis) and nausea was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Diarrhea; Vomiting; dry heaves; This is a spontaneous report from a contactable nurse (patient). A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular (left arm) on 21Dec2020 17:00 at single dose for Covid-19 immunization. The patient's medical history included high blood pressure. Concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced diarrhea, vomiting, and dry heaves on 22Dec2020 (06:00 AM). There was no treatment received for the adverse events. The patient has been tested with COVID-19 since the vaccination. The patient had nasal swab (test) on 22Dec2020 with pending result. The outcome of events was unknown.
Ear felt plugged up; A spontaneous report was received from a consumer concerning a unknown age of male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events ear plugged up.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.and experienced Ear plugged up.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of event(s), ear plugged up was unknown.
immed bright red swelling @ site 4" diameter w/puffiness & unconsolable screaming;>2hrs temp 99, settled down p/2 1/2 hrs & redness gone @ noc;
The pt experienced a 20 cm induration, erythema, warmth to elbow, and general malaise.
Initial and follow up information has been received from a nurse practitioner who initially reported that "over the years" several patients were vaccinated (route unknown) with pneumococcal 23v polysaccharide vaccine (Lot #'s unknown) and subsequently experienced local abscesses. Follow up information from the nurse practitioner indicated that there was only one patient who developed a local abscess following vaccination with pneumococcal 23v polysaccharide vaccine in her office. The nurse practitioner clarified that the patient was a 70 year old retired female, with unknown medical history, who at 10:00 AM on 10-NOV-2005, was vaccinated 9route unknown) in the left arm with a first dose of pneumococcal 23v polysaccharide vaccine  (Lot #650331/0749P). There was no illness at the time of the vaccination. On 12-NOV-2005, at approximately 10:00 AM, the patient developed a large, hot, painful lump, that was deep pink at the injection site. The patient took diphenhydramine hydrochloride (BENADRYL) and applied cool compresses. the patient recovered on 17-NOV-2005. No product quality complaint was involved. Additional information is not expected.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 50-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 4 (booster), single (Lot number: Gh9702) at the age of 49 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, included paxlovid treatment from 21Oct2023 to 26Oct2023. Clinical course: Patient did not have known allergies.; Sender's Comments: Based on the information provided, a causal relationship between the suspected drug and the reported events cannot be excluded,Linked Report(s) : US-PFIZER INC-202300350989 same patient, different drug/AE;
Immun given 24JUN91; pt had inc t102F x 2 days on 26JUN91 pt devel rash that started on arms; 27JUN91 rash has continued to spread & covers pt entire body; Seen by MD; Rash dx as viral & unrelated to immun;
1) Onset of dermatographia, itching and full body hives (trunk, thighs, arms, primarily) 10 days after receiving Moderna booster shots.  2) Patient is healthy 24 male with no prior history of skin issues.  No allergies and history of chronic hives.  No existing chronic conditions or medications taken at time of booster as well. 3) Reactions to first and second doses were unremarkable and within expected guidelines - eg. Fatigue, low fever, muscle pain that resolved within 24hours.  4) Patient is still suffering chronic hives 6 weeks after onset with little sign of symptoms resolving naturally.   Symptoms are kept in check with antihistamines and vitamin D supplements, but patient is very dependent on above medications for relief.
BODY ACHES; SICK; LOW GRADE FEVER; HEADACHES; SHOT HURT LIKE HELL; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, sick, low grade fever, headaches, and shot hurt bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, sick, low grade fever, headaches, and shot hurt bad. This report was non-serious.
After vaccination, about 5 min after and sitting on our bench patient fainted. A technician caught her and kept her from hurting herself. Patient came to within 5 seconds and we gave her some water and she knew she had fainted. Had a store manager come and ask her questions and after sitting 10 more minutes she wanted to go. A technician escorted her out to a car waiting for her with a relative.
Pt states recieved Flu shot on 10/08/2020 and has nit been able to move arm properly since
I experienced a migraine aura within 10 minutes of receiving the vaccine and immediately took 1 capsule of Fioricet. I was driven home and attempted to rest. The migraine worsened with significant head, brain fog, slurring speech, clumsiness and pins and needles on left side of body. I was taken to the Emergency room and seen by a emergency physician who conducted a basic neurological assessment and ordered lab work. I received IV medication cocktail of Toradol, Reglan, and Benadryl for two hours. The migraine subsided, Since receiving the 1st dose of the Pfizer vaccine, I suffer from onset migraines on a nearly daily basis.
tested positive for covid; I tested positive for covid; This is a spontaneous report from a contactable consumer (patient herself) received from a Pfizer sponsored program.  A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 24Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Her second dose was scheduled for Sunday 11Apr2021, however she currently has Covid-19. The patient underwent lab tests which included a positive result for SARs-COV-2 test on an unspecified date. Patient would like to know how to reschedule her appointment for vaccine second dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
I tested positive for COVID-219 on 12/23/22. She had a cough, and wheezing. No other symptoms occurred. We contacted her doctor, and she was prescribed Albuterol. Since testing positive for COVID-19 she has been wheezing a lot and has a lingering cough. She is using an inhaler now.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL3302), in left arm, on 17Feb2021 as dose 2, single (Lot number: EL3302), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: 301458A), in left arm and on 12Apr2022 as dose 4 (booster), single (Lot number: FK9883) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Barrett's oesophagus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was treated with Paxlovid from 10Oct2022 to 14Oct2022 for the treatment of COVID-19.
Flu like symptoms, fever 102 degrees, body ache, very dizziness. Two day in bed.
ACUTE RESPIRATORY FAILURE 11/18/2022 ATHEROSCLEROSIS OF AORTA ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/13/2022 ATHEROSCLEROSIS OF AORTA ACUTE RESPIRATORY FAILURE 11/18/2022 ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/13/2022 ACUTE RESPIRATORY FAILURE
pt recv vax 05/19/97. 2 days p/vax pt devel arthralgia & mild h/a.Pt returned to ER for eval.No further info
Red bump where shot given and hot to touch. Went away after 6 days then has come back same issues after 10 days of the 1st dose.
NEUROPATHY 3/17/2023 ORAL HYPOGLYCEMIC OVERDOSE, ACCIDENTAL, INIT
Information has been received for a case in litigation from information obtained from a published article concerning a female with acne who was vaccinated with a dose of RECOMBIVAX HB. Concomitant therapy included minocycline. Subsequently the patient experienced autoimmune hepatitis. It was reported that the patient had been taking minocycline for approximately 13 months before having an abnormal liver test in August 1997, when she was 40 years old. The reporter felt that autoimmune hepatitis was not related to therapy with RECOMBIVAX HB. It was also reported that "minocycline is know to cause autoimmune hepatitis". This is one of 4 reports from the same source. No further information is available.
Patient stated having a GI problem (Gl Bleed) 2 weeks after the immunization, went to see emergency room doctor and was prescribed pantoprazole, Emergency room doctor do not think   GI bleed is caused by immunization.
Headache, Myalgia, Arthralgia, Fever, Severe headache and back pain, pain in the back of neck, unable to lift Left arm (injection site) pain at injections site, numbness and tingling L side of body.
Although it was fine on 2/24/2021 it became sore on 2/25 and stayed sore. I would see a yellow mark and that was all, but today, I looked in the mirror and there was a rash surrounding the yellow mark.  I don't know how long the rash has been there.
9/24- began with fever of 101.8. 9/25- fever continued after alternating Tylenol and Motrin every 4 hours. Inconsolable crying. Decreased appetite. 9/26- saw pediatrician, told it was a virus. Fever continued, even with Tylenol and Motrin given. Still inconsolable. Appetite almost nonexistent. Only 7oz of similac go and grow all day. Refusing any and everything else by mouth. Around 730pm, pinkish/light red rash began on face. Called pediatrician, advised was most likely a virus again. Given option of taking her to the ER or bringing her to the office in the AM. Fever has been consistently between 101.4-101.8 (rectal temperature). 9/27- rash worse on face but as day went on slowly less noticeable but more visible on chest, abdomen, and back, with rash starting to appear on upper extremities as well.
bruising at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (bruising at injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M70A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ESTRIOL, SIMVASTATIN, OMEPRAZOLE, ALPRAZOLAM (XANAX), VALACICLOVIR HYDROCHLORIDE (VALTREX), ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN D3, ZINC, VITAMIN C [ASCORBIC ACID], COENZYME Q10 [UBIDECARENONE] and CALCIUM for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE BRUISING (bruising at injection site). At the time of the report, VACCINATION SITE BRUISING (bruising at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include Multivitamins. No treatment medication was reported.
Soreness at injection and redness; Soreness at injection and redness; Rash under arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness at injection and redness), INJECTION SITE ERYTHEMA (Soreness at injection and redness) and RASH (Rash under arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for an unknown indication.  No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced INJECTION SITE PAIN (Soreness at injection and redness). 09-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (Soreness at injection and redness) and RASH (Rash under arm). At the time of the report, INJECTION SITE PAIN (Soreness at injection and redness), INJECTION SITE ERYTHEMA (Soreness at injection and redness) and RASH (Rash under arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter. Treatment included hydrocortisone cream
Approximately 30 minutes after receiving vaccine, pt. started complaining of feeling short of breath, lightheaded, and fatigued.  No other symptoms noted at this time. Assessed per health professionals.   Blood pressure: 153/103, heart rate: 91, and O2 sats: 100% on room air.  No Benadryl or Epinephrine given.  Pt. requested to be seen by emergency room - friend came and picked pt. up and took to emergency room.
Did fine after shot  on Friday until Saturday about 12 hours later  had onset of shaking " it was awful " Abdomen , arms , legs all shaking all at night, he could not get up The next time it occurs she may have to call EMS.   Gave him fluids, He is fine now
Daughter of client reported that her mother had 2 "seizures" with loss of consciousness 24 hours post vaccination. No history of seizures. Patient reportedly had COVID with significant "brain fog" 1 month prior to 1st dose of vaccine.
Information has been received from a healthcare worker concerning her 25 year old daughter who in July 2009, was vaccinated with her third dose of GARDASIL (lot # not reported). In approximately July 2009, after patient received her third dose of GARDASIL, she began to have adverse experiences which led to an emergency room visit and hospitalization. She started pain in the neck and back, nerve pain, autonomic dysfunction, chronic low blood pressure, gall bladder disease and possible gall bladder removal, vaso/vago syncope, and migraines. These adverse effects have been debilitating with her job. It was also reported that during the patient's hospitalization, her blood pressure "bottomed out", and her heart rate "skyrocketed". Unspecified laboratory tests were performed (results not provided). At the time of the report the patient was on a machine to monitor blood pressure. The patient was being treated by a cardiologist and by a nurse practitioner. The reporter stated that "these adverse events are still going on but have improved slightly". The reporter considered pain in the neck and back, nerve pain, autonomic dysfunction, chronic low blood pressure, gall bladder disease and possible gall bladder removal, vaso/vago syncope, and migraines to be immediately life-threatening, disabling and other important medical events. Additional information has been requested.
Patient reported that she noticed "red dots/patches"  all over her legs, back, breast/stomach area after getting the second dose of the Pfizer vaccine which have not gotten better.
Seasonal flu mist given instead of H1N1 mist (dispensed by pharmacy - packaging very similar)
Case number PHEH2014US024367, is an initial spontaneous report received from a nurse on 02 DEC 2014, with a follow up report received from the nurse on 19 JAN 2015. This report refers to a 79 year old female patient. Historical condition and concomitant medication were not reported. her past vaccinations (unspecified) were well tolerated. The patient was vaccinated with the initial application of FLUVIRIN 2014/2015 (batch number: 14511P, expiry date: MAR 2015) intramuscularly in right deltoid at a dose of 0.5 ml on 13 NOV 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. Patient did not experience any adverse event. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided. Follow up report received from the nurse on 19 JAN 2015: Updated vaccination history, recent vaccination site and reporter's statement.
extreme fatigue; I had 104.5; extreme chest pain; sob; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (extreme chest pain), DYSPNOEA (sob), FATIGUE (extreme fatigue) and PYREXIA (I had 104.5) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced CHEST PAIN (extreme chest pain) and DYSPNOEA (sob). On an unknown date, the patient experienced FATIGUE (extreme fatigue) and PYREXIA (I had 104.5). At the time of the report, CHEST PAIN (extreme chest pain) and DYSPNOEA (sob) had not resolved and FATIGUE (extreme fatigue) and PYREXIA (I had 104.5) outcome was unknown.            No concomitant medication was provided No treatment information was provided.
Six days after receiving Janssen vaccine at approximately 4:00 pm, left hand experienced numbness. As the evening wore on, weakness spread through the left side of body and speech began slurring. The next day, after no improvement, went to hospital to find from CT scan that he had suffered a stroke. He had no precursors that would lead to being prone to strokes.