chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HIVES; This spontaneous report received from a patient via a company representative concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ciu.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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. Concomitant medications included omalizumab. On an unspecified date, the subject experienced hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hives was not reported. This report was non-serious.
Initial reaction started 3-5 hrs. after administration with swollen, red, warm injection site, headache, neck pain, muscle aches all over, fever less than 100.  Down in bed for approximately 30 hrs. then resolved.  On 2/7/2020,  approximately 7pm, started with chills and fever up to 102.4, severe headache, neck pain, nerve pain down legs, eyes hurt with movement, excessive sweating.  Test for influenza in emergency dept. on 2/8/2020 was negative.  Feeling even worse by 2/12/2020, spent most of day in emergency room.  LP, CT of head, and labs done.  All testing was negative.  Over following two days small area of shingles type rash appeared in same area of previous shingles episode years ago.  Primary care physician
Small redness about 6" distal to injection site on 1/20/2021. Redness has grown over the past 3 days, and now covers a section about the size of my hand that is warm, red, and mildly itchy. The injection site was not discernable until yesterday, but now is also red and slightly raised.
Caller tested positive for COVID on Tuesday of last week; Caller tested positive for COVID on Tuesday of last week; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL9269), on 05Mar2021 as dose 2, single (Lot number: EN6198, Expiration Date: May2021), on 17Dec2021 as dose 3 (booster), single (Lot number: 320308D) and on 20May2022 as dose 4 (booster), 0.3 ml single (Lot number: FM9992, Expiration Date: 30Sep2022) at the age of 72 years, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Sep2022, outcome "recovered" (Sep2022) and all described as "Caller tested positive for COVID on Tuesday of last week". The patient underwent the following laboratory tests and procedures: Tests: (unspecified date) Unknown results, notes: They had done a couple tests the week before; SARS-CoV-2 test: (Sep2022) Negative, notes: She almost very quickly tested negative for COVID; (20Sep2022) Positive, notes: Caller tested positive for COVID on Tuesday of last week; (20Sep2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient was 5 foot 6 and a half, she could not say 5 foot 7 anymore. Weight was 200-205 pounds. The patient had "four Pfizer COVID vaccines". The patient was diagnosed with COVID-19 on 20Sep2022 by home test and on 21Sep2022, she started an antiviral Paxlovid. She would like to know how taking Paxlovid may affect COVID vaccination and how long she could wait to get the next vaccine. She wanted to know protocol for getting another vaccine and how does the medicine affect past coverage. In her understanding, it did great and knocked down viral load tested negative on day 5 (almost very quickly tested negative) for COVID-19. As she got COVID-19 after years, hence she was trying to be careful. She got the answer that one could get some resistance when you get COVID and having an antiviral. It affects it in some way where it was not so much an effective deterrent to additional COVID infection.
Had heavyness in left leg and left arm.  tingleing in hands and feet.  Soreness in joints, cranps in legs and toes.  Had blood test and MRI done by local family doctors.
The Tdap injections were stored in a refrigerator in which the temperature gauge malfunctioned. The temperature reached 10 degrees; this incident occurred over a long holiday weekend (1/1/16-1/4/16) the exact date/time of the decrease is unknown.
Patient states that she started to have  head pressure  1 hour after receiving  the vaccine. The headache/ migraine has been continual since then and has cause Nausea and vomiting. The vomiting has led her to have severe abdominal/ uterine  pain that too has been  consistent for the past 4 days. Patient has tried Zofran without any relief and also has utilized her migraine meds ( OTC Excedrin and  Caffeine pills) that have not made any impact on her pain. I have suggested seeing   her  PCP,  patient states that she does not have one at the moment. I advised her to see a clinician  to validate the abdominal and  headaches that she has been having  the last few days. I also advised her to try some meclizine for the nausea and NSAIDS for the migraine.
Pt experienced chickenpox with hundreds of lesions "with blisters". The lesions were "typical vesicular umbilicated lesions". The pt experienced prodromal symptoms prior to rash. The pt stated the lesions hurt, then began to itch. Pt was seen by a physician and subsequently, recovered. There were no reported cases of chickenpox on the island where the pt lived, nor in the school he attended. No further information is available.
0.3ml given as booster instead of 0.25 ml; 9 patients received expired vaccine in November and December; This spontaneous case was reported by a nurse and describes the occurrence of OVERDOSE (0.3ml given as booster instead of 0.25 ml) and EXPIRED PRODUCT ADMINISTERED (9 patients received expired vaccine in November and December) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A, 037C21A and 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .3 milliliter. On 15-Dec-2021, the patient experienced OVERDOSE (0.3ml given as booster instead of 0.25 ml). 15-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (9 patients received expired vaccine in November and December). At the time of the report, OVERDOSE (0.3ml given as booster instead of 0.25 ml) and EXPIRED PRODUCT ADMINISTERED (9 patients received expired vaccine in November and December) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (9 patients received expired vaccine in November and December) to be not related. No further causality assessment was provided for OVERDOSE (0.3ml given as booster instead of 0.25 ml).    Patient's allergies related to medication, food and other product was unknown. It was unknown if the patient has ever been diagnosed with/ tested positive for COVID-19. Acute illnesses at the time of vaccination and up to one month before was unknown. Chronic or long-standing health conditions were unknown. No concomitant medication information was provided. Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination and/ or at the time of adverse event was unknown. The patient had no adverse event with the expired vaccine. The event did not cause the patient to seek medical care. There was no other potential cause. The patient had not experienced similar event in the past. No treatment medication information was provided.   This case was linked to MOD-2022-486834 (Patient Link).
This spontaneous report was received from a R.Ph pharmacist concerning to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant medication were not reported. On an unknown date, the patient did not receive a full dose of PNEUMOVAX 23 due to product quality complaint issue (accidental underdose) 0.5ml, one shot (lot number M040804, expiration date 20-MAY-2018, route was not reported) for prophylaxis, so a new dose of PNEUMOVAX 23 was given with no issues (extra dose administered) (dose, route, lot number and expiration date were not reported). No adverse experiences were reported. Additional information is not expected as there is no consent to contact the reporter.
Gynecomastia b/l day after vaccine (4th dose of Moderna). All labs including estrogens, prolactin, FSH, LH, cortisol, ACTH are normal.
Patient was here in the office today for an acute visit, see office note documented 11/2/17. He received routine 4 year old immunizations: MMR-V and DTaP-IPV around 1200 today. Prior to the administration of the vaccine, he was in good health. Approximately 5 minutes later at 12:05 PM, mother brought him back into the office for coughing, swelling of lips, and increased work of breathing. He was immediately brought back to an examination room for assessment. He was noted to be afebrile, Temp 97.4 axillary and 95% on room air. His HR was 130s. Upon auscultation, he was noted to have coughing with moderate lip swelling and diffuse end-expiratory wheezing. An albuterol sulfate 2.5 mg nebulizer treatment was given and I advised the nursing staff to give BENADRYL 12.5 mg/5 mL PO STAT. He completed the nebulizer treatment without improvement in his respiratory status. Continuous pulse oximetry was obtained and oxygen saturations remained above 95%. He was recognized to having an anaphylactic reaction to the vaccinations. He continued to develop facial edema with diffuse hives from his neck down to his legs. He was able to converse the entire time but seemed increasing somnolent. The emergency response team was immediately activated. Due to his refusal and difficulty swallowing, he was unable to take the liquid BENADRYL. His weight today was 15.5 kg. He was given EPIPEN Jr 0.15 mg IM injection in his right thigh and IM DECADRON 10 mg (0.64mg/kg) in his right bicep. About 1 minute after administering EPIPEN Jr and DECADRON, EMS arrived for assessment. EMT was provided with a detailed account of today's reaction and re-assessed. He continued to be stable on room air, alert although slightly disoriented, and able to tolerate his secretions. He was taken immediately to ED for further evaluation. Both mother and MGM were kept up to date on his status and emergency treatment plan as it was occurring. The family will be contacted later on this afternoon for a status update.
Fever, chills, nausea, headache, insomnia, injection site pain, diffuse arm pain, large circular red rash in left armpit, vomiting (twice) the next day, couldn't keep water down. Shot received at 4:30 p.m. and bulk of symptoms experienced between 11 p.m. that day and 11 p.m. the next day. Rash in armpit remained for 3 days accompanied by slight discomfort in area
stroke involving basilar artery and a small pontine infarct; Information has been received from lawyers referring to a male patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On or around 20-DEC-2019, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for routine health maintenance and the prevention of shingles (herpes zoster).    On an unknown date in December 2019 (three days after vaccination), the patient experienced dizziness, aphasia and generalized weakness. The patient was diagnosed with a stroke involving basilar artery and a small pontine infarct. The patient did not recover from the event. As per the reporter, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The event was disabling.  The reporter considered the event was related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event was determined to be medically significant.
I'm I'm pre-menopause and haven't had a period in months. Today they've come back. I've also got severely swollen lymph nodes in both armpits and have to take  Motrin so I'm able to sleep at night.
Pt recvd vax & devel thrombocytopenic purpura & was  hospitalized;
This case was reported by a physician and described the occurrence of sick in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date, the subject received 2nd dose of ENGERIX B (unknown route and injection site, batch number not provided). At an unspecified time after vaccination with ENGERIX B, the subject became sick. At the time of reporting, the outcome of the event was unspecified. No further information was provided.
shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 29-APR-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a health care provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Left great toe redness, pain and swelling. Intermittent. Today, May 3 remains present
After getting the MMR, Hep A, and Varicella vaccines my daughter woke up the next morning with her right eye looking red and half closed.  It took 3-4 days before her eye started looking normal.  She also had a fever for 4 days.  The highest that I know it got was 101.3.
Received an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired dose) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired dose). On 02-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.
A few hours after receiving the vaccination, the patient had palpitations and presented to the ER. She was noted to be in sinus tachycardia rate 126 with T wave inversions. Symptoms improved with fluids
Redness, stiffness and pain around the injection site.  Also, warmness around the injection site.
Headache, vomiting, nose bleed  12/7 3am-2pm Vertigo, neck pain, migraine, fatigue 12/19-ongoing
skin rashes on both arms, groin area and legs .  Patches of itchy bumps and area of raised, red itchy hives.  Still have thse bumps today 10/12/2021  Fever over 100 degrees the following day 10/7/2021.   gnawing  headache for 4 days 10/7/2021 to 10/10/2021
I received the booster on 12/16/2021. On the evening of 2/8/2022, I experienced mild symptoms (cough, body aches) on 2/8/2022. I received a test on 2/9/2022, which came back positive. Most of the symptoms were gone by the time I got tested. After the result, I self-isolated for five days.
November 16 in am had intensive itching and was scratching it got worst and on Wednesday it got so bad, and I was in tears and on my arms, under my breast and after scratching, it was red and flare and Thursday, I called off work because it was bad. The doctor saw me on 18 Nov2021 oral and medicines. It went away but still slight itchy. No reacting to other vaccines. I feel that I am a little anemic, but nothing came back unusual. Headache because of the medication for the rash.
eyes are all swollen; rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 55-year-old male patient received BNT162b2 (BNT162B2), in Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE: 1), for COVID-19 immunization; Covid-19 vaccine (DOSE: 2), for Covid-19 immunization; Covid-19 vaccine (DOSE: 3), for Covid-19 immunization. The following information was reported: EYE SWELLING (non-serious) with onset Jun2022, outcome "not recovered", described as "eyes are all swollen"; RASH (non-serious) with onset Jun2022, outcome "not recovered".  Additional Information: The reporter stated that her husband (55 years) has had an awful reaction to the 4th vaccine of the Pfizer COVID vaccine back in the beginning of Jun. He has a lot of symptoms of COVID and an awful rash. His eyes are all swollen, it was a horrible mess. They have been told that the 4th booster shot was changed and apparently that was the one that gave him the awful reaction. [After confirming when the bivalent booster dose was authorized] He did not get this recent booster; he got the booster vaccine that came out in about Mar or Apr. He was still dealing with the situation now in Nov. The reporter enquired what was it in the mRNA that was changed for the new booster dose. She enquired if the first 3 doses did not contain this change of the DNA strand of the virus is that. The reporter asked if the mRNA breaks down when the vaccine breaks down or does the mRNA stay in the body forever and how long would the immune system continue to produce antibodies also would the antibodies show up in the blood test.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt. came in with 2 lumps on his thigh and a rash on 4/18/12. Pt. saw Dr. who believed the lumps to be a reaction to the vaccines he received. They were not painful to the pt. She also "believed the rash to be secondary to the varicella vaccine".
The injection site has swollen and is continuing to swell. It?s red and warm to the touch. It?s hard and there are hives on the swelled area and it itches.
Pain shooting down (R) arm & fingers hurting started 8pm 4-26-11, 4-27-11 morning noticed (R) hand cold & cold to touch, c/o knuckles swollen & can't bend to a fist w/o pressure & pain, c/o (R) palm tingling & (R) 3-5 fingers numb & tingling.
c/o 3 days of wheezing & severe h/a commencing 14OCT93; went to ER 17OCT93; dx bacterial pneumonia; tx Biaxin;
Pt's daughter called saying pt's arm was approx. 3" "down" from site. Very red, very sore. Gave her daughter BENADRYL 25mg once q 4-6 hours prn redness and to call Dr. if further prob.
A week after she had the shot, Patient became ill.  She thought she had a cold - was suddenly short of breath and had difficulty speaking.    By Wednesday of that week, she tried to go to the doctor, but they wouldn't see her without a test.  She had a quick COVID test that came back negative, but the doctor insisted on the long test.  Thursday morning, she was coherent, but stumbling when she rose from bed.  Thursday afternoon her husband found her unresponsive and called 911.  She had vomited a black substance.  EMTs were able to get a heart beat back, but were unable to keep it and she was announced dead at the hospital about 9 PM March 26.  Her husband thought an autopsy had been done, but they had only taken blood for testing.  When her autopsy came back 3 months later, they indicated the cause of death was her heart stopping. She did not test positive for COVID.
Pt has a neg titer,revcd 1st series of hep B vax 1987,1st dose being given on 16Jul87 following day pt exp the sensation of being on a rollercoaster&it dropped.The sensation reoccurred occasionally for approx 1 yr.Now 100 times a per day.
Seizures; dazelike stance for many days; forgetfulness; Feeling like sleepwalking; Memory loss; This is a spontaneous report received from a contactable consumer (patient) . A adult no pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 21Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation  .  The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID    The patient's concomitant medications were not reported. On 21Mar2021 the patient experienced seizures, dazelike stance for many days, forgetfulness, feeling like sleepwalking and  memory loss The adverse events resulted_in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.No treatment received for the events.The outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19   Information about the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
After Gardasil #2, pt c/o nausea x 12 days, vomited x 4, comes and goes. Pt had office visit with doctor on 8/7/07 - given Rx for Phenergan/follow up as needed. Pt had some nausea after Gardasil #1 for a few days.
Tested positive for Covid Wednesday, pulmaory and monoclonal infusions. Bad head cold Tuesday night. I could smell and taste, major running nose. ER on 7Oct2021.
This spontaneous report was received medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was reported. On 13-JUN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II with lot # L029266, expiry date: 04-AUG-2016 (route and dose not provided). The vaccine was exposed to temperature excursion of 47 F for 9 hours on 13-JUN-2016. It was reported that the vaccine was exposed to 47 F for a total of 22 hours. The nurse stated that the refrigerator back in range. No adverse effects were reported. No previous temperature excursion was reported. The call was because of a data logger. This is one of several reports received from the same reporter. Additional information has been requested.
15JAN98 during pre operative screening pt noted to have sl elevated WBC count;9 days post vax WBC count was 5% higher;WBC count on 16JAN98 was 13.46 & on 21JAN98 it had inc to 17.6;16JAN98 neutrophils 26.5;dx chronic lymphocytic leukemia;
Patient reeceived Pfizer 6mo-4yrs bivalence vaccine as the second dose of the series rather than the monovalent vaccine. Patient has not reported an adverse effects related to the vaccine.