chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a consumer, describes the occurrence of epistaxis (3 nose bleeds) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jun 7, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 9, 2021, patient experienced epistaxis (3 nose bleeds). At the time of the report, epistaxis (3 nose bleeds) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19  vaccine), intramuscular: unknown. Concomitant product use and treatment information not provided.
She got her vaccine, she only had her arm hurting.  The next morning it itched where she got her shot and then she started breaking out with a rash that continued to get worse.  She went to the doctor today as it was down both arms, on her hands, blotchy with bumps and this morning she started getting spots on her eyelids and the side of her face that started to swell.  She saw a NP today who gave her a steroid shot as her right eye was starting to swell shut.  Told her to continue taking Benadryl and to take Allegra in-between for the itching and to report this to VAERS.   She has been taking Benadryl and the itching, which has helped some but not a lot, but was wearing long sleeves so she wouldn't itch it.  She still has a large red circle at the injection site and that's where she initially scratched her arm.
Employee reported to COVID-19 Bivalent and Influenza Clinic. Employee completed influenza vaccination record form and the nurse administered. A pre-filled COVID-19 Bivalent consent form had been completed by employee and was noted to be incomplete near end of clinic. Nurse called employee and it was discovered that she received influenza vaccine instead of COVID-19 Bivalent vaccine. Employee reported she received flu vaccine at provider's office the week prior.
About 2 hours after vaccine, had sever shoulder pain. Felt similar to a rotator cuff problem. Could not sleep all night. The day after glands or lymph nodes in neck felt swollen, which was noticeable when he tries to open his mouth. Also having calf pain in both legs when using them, which also started the day after and cannot be explained by physical activity.
H1N1 vaccine was injected around 10:20 AM. We waited 10 minutes before leaving. Daycare called around 11:15 AM same day to report that she had bright red hives all over her legs, arms, abdomen, and face. After consultation with public health department, 1/2 tsp of children's Benadryl was given. Hives persisted into the next day (11/3/09). Benadryl continued to be given appr. every 6 hours. She had a fever of 101 degrees the morning of 11/3/09. Motrin was given. She napped from 12:30 PM to 4:30 PM. When she woke up from her nap she had a temperature of 101.7 degrees, the hives where almost entirely gone but she was wheezing and hoarse. More Motrin was given. Fever has not been back over 101 since yesterday evening but is still wheezing and hoarse. 11/10/09 Medical records received for date 11/6/09. DX: Acute otitis media. Presenting SX: fever x4days, nasal discharge, cough. Assessment: Rt.& left ear erythematous.
This case was reported by a pharmacist via call center representative and described the occurrence of blood in stool in a adult male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced blood in stool (serious criteria GSK medically significant), rectal bleeding (serious criteria GSK medically significant) and gastrointestinal disorder. On an unknown date, the outcome of the blood in stool, rectal bleeding and gastrointestinal disorder were unknown. It was unknown if the reporter considered the blood in stool, rectal bleeding and gastrointestinal disorder to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist was reluctant to report and stated that, she was not sure the cause of the issues but wanted to see if it could be SHINGRIX. The patient had gastrointestinal issues. The pharmacist gave limited information and noted she would report on-line if found to be the vaccine. No further questions were asked.
12/16/21 presents to ED for "altered mental status". PMHx of " Osteoporosis, Parkinson's disease, heart murmur"
Within 5 minutes of receiving vaccine began sneezing abdundantly, then became lethargic, which progressed to listlessness and decreased responsiveness. Retracting, wheezing, hypoxic (sats dropped into 60s), arms and face flushed, grunting. Received oxygen, albuterol and atrovent via nebulizer, epinephrine 0.15 mg IM then 0.3 mg IM 10 minutes later, oral dexamethasone, IM benadryl and transported to Emergency Room. By time transported, oxygen saturations had improved to low 90s. Report from ER that was sitting up, alert and interactive within an hour. Kept overnight for observation.
administration of expired vaccine.; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine.). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
I'm paralyzed; Anxiety; chills; Shaking but not fever; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205), via an unspecified route of administration on 06Mar2021 as single dose for COVID-19 immunization. Medical history included hypertension, brain injury (doesn't have a good memory), menopause and menopausal problem. The patient is on a lot of medications (unspecified medication) for her Brain injury. The patient previously received the first dose of BNT162B2 on unspecified date for COVID-19 immunization. The patient had her second dose on 06Mar2021 and had been having bad like chills and shaking too but not fever. The patient was shaking bad (not clarified) there but she doesn't know if it's part of her menopausal problem from my menopause (as reported) but she was shaking. The patient mentioned that she was paralyzed. The patient stated that she was taking some Ativan for anxiety, she has been so anxious; and she had been taking Benadryl. The outcome of the events was unknown.
Information has been received on 02-FEB-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 12-AUG-2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent and severe strain of herpes zoster. Shortly after receiving the ZOSTAVAX, the patient developed shingles on his face, scalp, foot and inside of his ear. Thereafter, he was diagnosed with vasculitis in his legs. On 20-JUN-2016, the patient presented to his primary care physician and was diagnose with Ramsey Hunt Syndrome and continues to suffer from complications of this condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Upon internal review, Ramsey Hunt syndrome was considered to be medically significant. Additional information has been requested.
Client presented for second dose Moderna.  After inserting syringe into arm, needle and syringe "exploded" apart and vaccine went all over client and nurse despite being tightened before insertion.  Client was revaccinated per their request without incident. Syringe used was Magellan 3 ml , 25 G x 1 " Lot #028609
Information has been received from a nurse concerning a 61 year old female patient with hypothyroidism, sulfonamide allergy, allergic reaction to AUGMENTIN and drug hypersensitivity to DEMEROL, ALLEGRA, COMBIPATCH, ASACOL and LEVAQUIN who on 02-NOV-2009 was vaccinated intramuscularly with the first 0.5 ml dose of PNEUMOVAX 23 (Lot # 662270/1135Y) in her left arm. Concomitant therapy included SYNTHROID, LIPITOR and alendronate sodium (MSD). It was reported that on 02-NOV-2009 evening, the patient had 2 red raised spots and it was hot on the left arm. The patient tried to ice it and took BENADRYL but she had no relief. The nurse mentioned that at the office visit, it was noticed that 90% of the upper arm was affected. The patient was told to use ice, topical BENADRYL. At the time of the report the patient was recovering. No diagnosis tests were performed. This is one of several reports received from the same source. Additional information has been requested.
4/4 had Hep A #1. 4/8 dx with ITP. Petechiae and bruises. Platelets 10,000. Opted for no Tx for 3 weeks. 9/29 Saw Dr, Tx'd with Wenrhol(?) at hospital. Will have CBC today.
received the Moderna Monovalent Booster instead of the bivalent vaccine; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine).    No concomitant medications were reported. During a Moderna Covid-19 vaccine clinic patient received Moderna COVID-19 vaccine monovalent instead of the bivalent dose for their booster dose. Nurse stated this happened because the monovalent vaccine with the purple border was labeled "booster doses". No treatment information was provided.
I received one jab during my pregnancy. At first I refused but was told it's highly recommended.  After giving birth it was brought to my attention the baby was born with an infection on the placenta. She was givin a spinal tap at 3 days old to make sure infection didn't reach her brain. She was on antibiotics for 10 days. My pregnancy was 100% healthy. She was born 6 pounds 1oz.
Chronic hives on face primarily around cheekbones/eyes. Has been occurring daily since 9/6/2021. No previous history of hives. Antihistamines will temporarily suppress them.
16 year old receiving Moderna; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old receiving Moderna) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old receiving Moderna). On 02-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old receiving Moderna) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old receiving Moderna) to be not related.    No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-201421 (Patient Link).
This is a spontaneous report from a contactable nurse.   A 18-year-old female received TRUMENBA (NDC number: 0005-0100-10; Lot Number: M77282;Expiry date: Jun2017), on 01Mar2017 around noon, at 0.5 ml single for immunisation. Medical history included rheumatoid arthritis. Concomitant medications included ibuprofen for rheumatoid arthritis. On 01Mar2017 patient's arm was red, swollen  and hot, she had a fever of 100, was real achy, nauseated and had chills and muscle ache and could not raise her arm.On  02Mar2017 patient's arm was warm and swollen, there was no redness and patient can only raise it half way. Events muscle ache , could not raise her arm and arm swollen improved but were still ongoing. All other events completely recovered on an unknown date.
A 16 year old patient received two doses of the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient received two doses of the Moderna COVID-19 vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient received two doses of the Moderna COVID-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient received two doses of the Moderna COVID-19 vaccine) had resolved.            No Concomitant drugs were reported. No Treatment information  were reported.  The patient is scheduled to receive her third dose of the Moderna COVID-19 vaccine on 22AUG2021. The reporter confirmed that it has been greater than 28 days since the patient received two doses of the Moderna COVID-19 vaccine.   Reporter did not allow further contact
unusually high number of covid infections in fully vaccinated employees; unusually high number of covid infections in fully vaccinated employees; This is a spontaneous report from a contactable Physician. This Physician reported similar events for 11 patients. This is 3rd of 11 reports.    A patient of unspecified age and gender received the first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on Dec2020 (reported as between 17Dec2020-30Dec2020 (lot number EH9899) and in Jan2021 (between range of 07Jan2021-20Jan2021) (lot number unknown), respectively, both via an unspecified route of administration (age at vaccination unknown), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The physician stated they were seeing an unusually high number of COVID infections in fully vaccinated employees, with second dose plus two weeks, plus well over two weeks.  All of whom received Pfizer and all of whom received their first dose from the same lot. The physician stated they may need an investigation, because they are seeing high viral loads in these individuals and symptoms. The physician reports it is not right. All eleven individuals received their first dose from the same lot: EH9899. They did the standard dosage with the standard vanishing needle. The outcome of the event was unknown.  The patent is not in a study or program.    Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.,Linked Report(s) : US-PFIZER INC-2021392224 same reporter/ vaccine/ event, different patients;US-PFIZER INC-2021445810 same reporter/ vaccine/ event, different patients
Patient states that the afternoon that she received the injection she started feeling really bad. When she woke up the next am she had a fever of 102, severe body aches, diarrhea and nausea. This lasted for 2 days.
No other adverse events reported; Caller reports that an expired MMR II was administered to a patient on 27Oct2022; This spontaneous report was received from a medical assistant referring to a patient of unknown gender and age. Information of the patient's pertinent medical history, concurrent condition and drug reactions/allergies was not reported. Concomitant medications included sterile diluent.  On 27-OCT-2022, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (1 dose, lot #T029550, expiration date upon internal review was established as 01-SEP-2022, strength and route were not reported) for prophylaxis (expired product administered).  The reporter confirmed that the dose was properly stored up through administration. The reporter was unable to provide sterile diluent lot/expiration date used with dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) but confirmed that it was not expired. No other adverse events reported (no adverse event).
Increased edema to the vaccine site with erythema. The area was also warm to the touch. Advised to continue cool compresses, and elevation of the affected limb. Recommended antibiotic therapy if s/s worsen in 2 days.
Chills, fatigue started first. Then after I went to bed I began to feel lethargic. The next day I was in pain throughout my whole body while for two straight days running a fever up to 103 degrees on Friday night (12/03/10). I continued to run a fever until 12/06/10. I went to urgent care on 12/5/10. I was unable to use my arm until 12/5/10 due to the injection site being red, inflamed, blotchy and severely sore.
Patient started with a low-grade fever on 8/10 (101) that turned into a high fever by 8/11 (103) that wouldn't drop below 102 even with medication. His fever spiked to 104 at 2 AM on 8/12 and finally broke and didn't return by 4 AM. He then broke out in a rash mainly covering his torso area on 8/14 and still has it.
Numbness to arm that was vaccinated.  VS WNLs, symptoms improved after 30 minutes and pt cleared by medical provider.
Information has been received from a nurse referring to a patient of unknown age and gender. On 04-DEC-2015 the patient was vaccinated with a dose of expired M-M-R II lot # J014876, expiration date: 21-NOV-2015, (dose, dose #, route and application site were not reported). No adverse effects reported. Additional information has been requested.
Chills, fever of 100.5-101 degrees, sweats, congestion, headache that came and went for about 24 hours
This spontaneous report as received from a nurse refers to an unspecified number of unspecified patients. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M002064, expiration date 12-JAN-2016. No adverse effects were reported. Additional information has been requested.
After influenza vaccine given on 11-7-05. At 4 pm on 11-9-05 developed generalized rash with extreme itching during night hours. On Friday and into Friday night on 11-11-05 experienced generalized ache.  Saturday night experienced onset of tingling in arms, "every joint hurt" with stiffness.  Sunday, nov. 13th, temperature of 99.6; pain more severe with difficulty walking - joints more painful and reddened.  Seen by nurse practitioner who made diagnosis of flu vaccine reaction.  Prescribed Naproxen 275 mgm - 2 tabs am and pm; Tramadol 50 mgm - 1-2 tabs q 4hrs.  Had better day on the 14th (Monday), but experienced painful joints and sleeplessness Monday night.  Back of neck and particularly joint in right arm painful - continued on Tuesday, the 15th. Returned to work on wednesday, Nov. 16th, right arm pain continued.  Report from lab work done was within normal limits.
The patient has had no adverse effects according to the child's father as of 12/12/2021
After initial reaction body felt very heavy and very tired. Approximately around 5:30PM completely drained and body started shaking all over. Muscle pain through out and chills. Did not take temp. However felt warm. Right arm high level of pain. 10/04/2011 started vomiting and right arm was very hot and red rash or bumps had appeared. Could not move arm without extreme pain. Swelling, redness, and pain spread to fingers, armpit to 1/4 of right breast.
Sore and tender in upper arm where shot was administered by the end of the day. Slightly tender throughout the next day and back to normal the 2nd day after the vaccination.
felt like collapsing; not good feelings; felt very uncomfortable; cramping mouth; breathing got deeper; felt like sick; Allergy; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (felt like collapsing), FEELING ABNORMAL (not good feelings), DISCOMFORT (felt very uncomfortable), ORAL PAIN (cramping mouth) and DYSPNOEA (breathing got deeper) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included Cholesterol medicine and High blood pressure medicine for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PRESYNCOPE (felt like collapsing), FEELING ABNORMAL (not good feelings), DISCOMFORT (felt very uncomfortable), ORAL PAIN (cramping mouth), DYSPNOEA (breathing got deeper), ILLNESS (felt like sick) and HYPERSENSITIVITY (Allergy). At the time of the report, PRESYNCOPE (felt like collapsing), FEELING ABNORMAL (not good feelings), DISCOMFORT (felt very uncomfortable), ORAL PAIN (cramping mouth), DYSPNOEA (breathing got deeper), ILLNESS (felt like sick) and HYPERSENSITIVITY (Allergy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.   Reporter did not allow further contact
11DEC94 knees gave out;15DEC94 fell again;dx GBS;arms & hands got extremely weak;totally helpless;neurologist verified dx;pt in wheel chair several months;p/4mo of GBS, autoimmune hepatitis followed;GGT inc;wt loss;fatigue, appetite loss;