chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 14-DEC-2015 at 05:01, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperature were 5.2 and 4.8 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Exhaustion  minor headache, moderate arm soreness All began around 5 hours after injection Took 400 mg Ibuprofen  and went to sleep, was fine the next day except minor arm soreness
broke out in shingles, diagnosed with shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (broke out in shingles, diagnosed with shingles) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced HERPES ZOSTER (broke out in shingles, diagnosed with shingles). At the time of the report, HERPES ZOSTER (broke out in shingles, diagnosed with shingles) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included chemo therapy infusions and lot of other medications. No treatment medications were provided by reporter.
pt recv vax 5MAY97 & awoke w/5x5cm site rxn, painful, hot to touch, confined to rt deltoid area;
p/vax pt devel full blown chickenpox w/50 to 100 lesions & a fever of 100.8 for two days;pt sought unspecified medical attention;
After flu like symptoms (headache, fever, chills, joint pain) had subsided, which were substantially worse than the previous 2 doses, the next night I woke up with pain and swelling in my knee around 11:50pm. It wasn?t that bad at first and was able to go to sleep again. I was then woken up by it around 2:30am and I couldn?t move my knee or use my leg and the pain was radiating into my ankle and hip. I had to lift my leg with my arms to be able to move it and could only keep it straight.  I could barely limp to get Advil to try and reduce the swelling and pain. I wasn?t able to fall asleep again until around 5pm. If I could have driven (right leg) I would have gone to the hospital. When I woke up next the pain was reduced and centralized at the knee, can limp better but lateral movement creates a lot of pain.
He presented to hospital ED with new onset chest pain.  He reports that he woke up this morning nauseous and he vomited after which he has started developing retrosternal chest pressure and some shortness of breath for which he came to the emergency room for assessment. In the emergency room he was given both a GI cocktail and nitropaste with wheeze the symptoms improved.  He was transferred to a medical center for higher level of care. At present he is essentially symptoms free.  The EKG showed right bundle branch block and all septal myocardial infarction.  The right bundle branch block is new compared to his last EKG.  The initial troponin was mildly increased at 0.18 and BNP was 118. The renal function is normal with a creatinine of 0.8 and the chest x-ray shows bilateral interstitial opacities which might represent pulmonary edema. He remains admitted
Feels like crap; Nausea; Feeling unwell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 04Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "not recovered", described as "Feels like crap"; NAUSEA (non-serious), outcome "not recovered", described as "Nausea"; MALAISE (non-serious), outcome "not recovered", described as "Feeling unwell".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
2 hours after vaccine developed diarrhea x6, headache, body aches and increased temp 102.0. Symptoms improved with BENADRYL. Also had itchy eyes.
redness at injection site; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness at injection site) and INJECTION SITE PAIN (pain at injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (redness at injection site) and INJECTION SITE PAIN (pain at injection site). At the time of the report, INJECTION SITE ERYTHEMA (redness at injection site) and INJECTION SITE PAIN (pain at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
unclear if pt had the adverse event due to Dupixent or flu vaccine pt developed gullain barre syndrome resulting in quadriplegia, requiring trach/PEG
Broke out in hives. First felt itching under arms. Removed shirt and witness rash going across entire back, under arms, up neck and abdominal region. Called nurse on call who recommended urgent care it the mention of swollen feeling in throat. Got to urgent care at 11:00 PM.  Administered 10 mg Dexamethasone Na Phospate 1 Mg 10 mg Intramuscular. Prescribed prednisone 20 mg tablet 3 a day for 3 days.
Got the injection. 5:50pm 2/4 symptoms started next day 2/5. 11:00am  Dry heaves Fever 101.8  Neck and back aches
received expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB02AA, expiry date 28th February 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th April 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 5th April 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-APR-2022 Reporter's Comments: The reporter reported that a patient received expired dose of Bexsero. The reporter did not consent to follow up.
Client reports that she went to emergency 4 hours after receiving immunization on 12/8/10 with symptoms of leg numbness and severe muscle cramping in legs. She also was SOB & reports receiving an inhaler.
Cold compress day of vaccine around 8pm for arm soreness. Painful Sore arm, body aches on day after vaccine as of 9am.  600 Ibuprofen taken around 12pm, and 1-2 hour nap around 3pm
period type Nausea feeling; 1st dose on 26-May-2021 and 2th dose on 9-June-2021; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (period type Nausea feeling) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 26-May-2021 and 2th dose on 9-June-2021) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS, Anxiety, Blood pressure high, Asthma and Penicillin allergy.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 26-May-2021 and 2th dose on 9-June-2021). On an unknown date, the patient experienced NAUSEA (period type Nausea feeling). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Nausea, at a dose of UNK dosage form. On 09-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 26-May-2021 and 2th dose on 9-June-2021) had resolved. At the time of the report, NAUSEA (period type Nausea feeling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.   This case was linked to MOD-2021-364860 (Patient Link).
56 y.o. male with a history of HTN, HIV+,proteinuria being admitted for AKI. Acute Renal Failure on CKD. High AGMA. HTN. HIV+. Electrolyte abnormalities. Normocytic Anemia.  Covid + infection. Vaccinated with Moderna 2/12/21 and 3/11/21.  No booster yet. O2 sat 97-100% on room air.   CXR lungs clear. Possible exposure to co-worker recently Covid + + Low grade fever; sx onset on 12/17
Rigors, chills, body aches, fatigue, night sweats, golf ball sized mass at injection site- tender and painful to touch.
pt recv vax 7FEB97 & had light case of chickenpox 6wk later 21MAR97 per mom;
Sore arm for two weeks. Muscle pain in back and shoulders. Advil, resolved 4 months post vaccine. Body aches and tiredness every few days for 7 months post vaccine. Neuropathy in hands and feet started at 6 weeks post vaccine, then moved to entire body (small fiber neuropathy). This is still persisting (taking nortriptyline).
Received PNEUMOVAX 23 in left deltoid.  Left arm distal to deltoid and proximal from elbow became red and inflamed.  Swelling and symptoms disappeared in 3-5 days.
Symptoms: 3/6: nausea, dizziness, fatigue, headaches (school missed for three days); 3/9: hives, rash, fatigue, headaches, dizziness; 3/11: rash goes away, continuing with fatigue, headaches, dizziness.
Patient said she was fine after receiving the vaccine and only experienced sore arm the night of receiving the vaccine. Patient said the next day (tues. Sept. 12th) was when she developed rashes all around her neck and welts on the side of her back. She said she took an antihistamine and applied cortisone which helped.  Patient says that the rash was extremely itchy. Patient came to the pharmacy on Thursday September 14th and said that her condition was improved.
By the following evening I was breaking out in hives all over my body, Sunday morning I was covered in an itchy rash that looked like a sunburn all over my body, in my ears and hair.
Client reports starting 05/13/2021 she experienced burning, aching in injection site, difficult to move; chills, fever, headache, fatigue, and muscle aches which are still ongoing. Client had 2 seizures today, previously seizures were well controlled and client reports these seizures today were not like previous seizures as she did not have aura prior to them. Client reports she did call neurologist who told her stay hydrated, not drive, and call the health department.   Recommended to client to be seen by physician today as symptoms are progressing and vaccination was ~ 6 days ago.
Positive PCR with symptoms; Positive PCR with symptoms; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Dec2020 at 13:00 as dose 1, single (Lot number: EK9231), in left arm and on 22Jan2021 at 13:00 as dose 2, single (Lot number: EL3249) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Menieure's" (unspecified if ongoing). The patient did not have any known allergies. Concomitant medication(s) or other medications the patient received within 2 weeks included: BETAHISTINE, start date: 13Apr2022, stop date: 15Apr2022; ROPINIROLE, start date: 13Apr2022, stop date: 15Apr2022; TRIAMTERENE/HCTZ, start date: 13Apr2022, stop date: 15Apr2022; MUCINEX, start date: 13Apr2022, stop date: 15Apr2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "not recovered" and all described as "Positive PCR with symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive, notes: Positive PCR with symptoms; (18Apr2022) Negative, notes: Salivary PCR; (25Apr2022) Positive, notes: Salivary PCR; (22Apr2022) Negative, notes: Rapid antigen, Salivary PCR; (25Apr2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid. The adverse event was treated with Paxlovid from 13Apr2022 to 17Apr2022 after positive PCR with symptoms. Negative salivary PCR was on 18Apr2022. Negative rapid antigen was on 22Apr2022. The symptoms returned on 24Apr2022. Positive salivary PCR and rapid antigen test was on 25Apr2022. The patient remained symptomatic. The device date was reported as 28Apr2022.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out.
Information has been received from a physician concerning a male patient who on an unspecified date was vaccinated with a dose of Zostavax. Three weeks after vaccination, the patient was diagnosed with shingles. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
No symptoms - was exposed on 4/4/21. Pt is requesting monoclonal antibodies.
Soreness and aching in upper arm where administered. NUPRIN, regular dose, still hurting three days after injection.
injection-site soreness; radiating pain up neck; lymph node swelling; migraine; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Apr2021 (Lot number: ER8730) at the age of 47 years as dose 1, single and administered in arm right, administration date 08May2021 (Lot number: EW0185) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hemiplegic migraines" (unspecified if ongoing). Concomitant medication(s) included: PROBIOTICS; PRILOSEC [OMEPRAZOLE]. Past drug history included: Demerol, reaction(s): "Known allergies: Demerol". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "not recovered", described as "injection-site soreness"; NECK PAIN (non-serious) with onset 2021, outcome "not recovered", described as "radiating pain up neck"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "not recovered", described as "lymph node swelling"; MIGRAINE (non-serious) with onset 2021, outcome "not recovered", described as "migraine"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "fatigue". Therapeutic measures were not taken as a result of vaccination site pain, neck pain, lymphadenopathy, migraine, fatigue.  Additional information: Dose received: 3, Most recent dose details: product=COVID 19, brand=Pfizer, Brand unknown=False, lot number=F51620, lot unknown=False, administration date=13Dec2021, administration time=03:00 PM, dose number=3, vaccine location=Left arm. Reported Event: 1st dose - injection-site soreness, radiating pain up neck, lymph node swelling, migraine, fatigue. 2nd dose - 1st dose - injection-site soreness, radiating pain up neck, lymph node swelling, migraine, fatigue 3rd dose ; 1st dose - injection-site soreness, radiating pain up neck, migraine, fatigue, chills/sweats, arthralgia (esp in knees), leg and foot cramping, tingling in injection arm for 1 day. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Shots given on 11/3/15, had vomiting and diarrhea and chills that evening. The next day felt fine. On Nov. 5th, he developed swelling in his wrists and knees. Dr. saw patient in the office on 11/20/15. Patient given Prednisone.
Received vaccine at 4pm-observed for 15 minutes in office. At 8pm she started having trouble breathing, sore throat, tingling, numbness of left leg and the next day morning woke up with a headache and dizziness. By 10 am today 03/24/2011-she did not have any of those symptoms.
Vaccine Administration Error: 15 y/o individual given Moderna COVID-19 vaccine. No adverse events during 15 minute observation period.
Coughing, sneezing, runny nose, congested, bodyaches, teeth pain, jaw pain, neck pain, headache, chest pain, fever, chills/sweats, loss of appetite, fatigue????, sore throat, painful swallowing? All symptoms started approximately five hours after receiving the vaccine, after receiving the vaccine within seconds I got incredibly lightheaded and dizzy, almost like a drunk feeling?
Complains of redness, swelling right arm deltoid.  Tender to touch, small red bumps; itchy area outside of injection and over deltoid area.  Hard area at site of injection.
rash from head to toe started on the 28th of May and I still have it two month later Aug 5
Within a few minutes post vax her arm became swollen, red and hot to touch and very sore.
Severe virtigo and intractable nausea requiring ER admission. Sxs ameliorated with Ativan, meclizine, Metachlopramide in ER.  Persistent sxs of virtigo, decrease hearing, nausea resolving over several days treated with meclizine, ativan, phenergan,  Virtigo improved but still persisting when moving quickly or looking up or down  Left frontal discomfort and sinus congestion; hearing returned to near baseline after 10d Steroid 5d dose pack and Augmentin started 2/13 Still unsteady (untrustworthy gait), excess fatigue and fatigability, wt loss, head pain Has not had fever
Cortisone administered after one week of vaccination; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC PRODUCT EFFECT DECREASED (Cortisone administered after one week of vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC PRODUCT EFFECT DECREASED (Cortisone administered after one week of vaccination). At the time of the report, THERAPEUTIC PRODUCT EFFECT DECREASED (Cortisone administered after one week of vaccination) had resolved.     Company comment: Causality for this event is not applicable; Sender's Comments: Causality for this event is not applicable
they are like water blisters inside the lymph of my mouth and inside of my lips; headache; water blisters on roof of mouth that pop and have a slight blood discharge; water blisters on roof of mouth that pop and have a slight blood discharge; have a little bit of sore arm; This is a spontaneous report from a contactable consumer or other non hcp.    An 82-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 20Feb2021 14:00 as 2nd dose, single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease, COPD, he takes Symbicort for that, dose says 160/4.5. caller said that this was diagnosed 20 years ago, type 2 diabetes mellitus and takes Onglyza and Glipizide for this. Caller said he had that probably 30 years. Concomitant medication(s) included budesonide; formoterol fumarate (SYMBICORT) taken for chronic obstructive pulmonary disease; saxagliptin hydrochloride (ONGLYZA) taken for type 2 diabetes mellitus; glipizide (GLIPIZIDE) taken for type 2 diabetes mellitus. It was Reported that, the patient experienced headache on 21Feb2021 with outcome of recovered, water blisters on roof of mouth that pop and have a slight blood discharge on 20Feb2021 with outcome of unknown, have a little bit of sore arm on 20Feb2021 with outcome of unknown, they are like water blisters inside the lymph of my mouth and inside of my lips on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included blood glucose fluctuation: 108 on 24Feb2021. Therapeutic measures were taken as a result of headache (headache).  Information on the lot/batch number has been requested.
Since my first vaccine shot on March 3, 2021 I have required a tremendous amount of sleep, and tired all the time.  In addition, I have had headaches twice for 5 days in a row.  The fatigue that necessitates sleeping for 12 hours a night is ongoing. Ironically, an approximately 54 year old friend received the Moderna vaccine and is experiencing the same persistent fatigue and headaches.  She's in very good health except for a Shingles episode 4 and a half years ago.
Fever, chills, and hysterical crying/ screaming for 24 hours +.  We tried everything to calm her and nothing worked.  It was aheart breaking event resulting in no more of this vaccine . We called to doctor, but there was nothing he could do.
experiencing joint pain; inflammation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), in Feb2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious) with onset Feb2021, 2 days after the suspect product(s) administration, outcome "not recovered", described as "experiencing joint pain"; INFLAMMATION (non-serious) with onset Feb2021, 2 days after the suspect product(s) administration, outcome "not recovered". The events "experiencing joint pain" and "inflammation" required physician office visit.  Additional information: After patient received the Pfizer-BioNTech COVID-19 Vaccine, Monovalent (gray cap), in Feb2021, he had been experiencing joint pain and inflammation, and it was getting worse. The symptoms started the day after receiving the vaccine. The had consulted the case with doctors. They had investigated for rheumatoid arthritis and auto immune diseases but found nothing. Reporter wanted to know if it had been reported before. Patient's symptoms were getting worse. The case was reported as non-serious.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On second day experienced muscle aches over body and extreme fatigue. Slept most of the day and was fine the next day. Also muscle soreness in arm for approximately three days.
78 year old female with severe CAD was admitted for Covid-19 pneumonia and NSTEMI. Cardiology signed off with recommendations for NOAC. Her pulmonary status continued to worsen. She became unresponsive and was DNR. Renal function declined and determined to be due to cardiorenal syndrome. She became unresponsive. She passed away this morning at 1055 hours.