chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DEEP VEIN THROMBOSIS; PULMONARY EMBOLISM; This solicited report received from a physician concerned a 56 year old male. 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 and batch number was not reported) dose, start therapy date were not reported, 1 total administered 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 patient experienced deep vein thrombosis and pulmonary embolism, diagnosed approximately 17 days post Johnson and Johnson vaccine. Treatment medications (dates unspecified) included: heparin, and methylprednisolone sodium succinate. Patient was survived. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the deep vein thrombosis and pulmonary embolism was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and deep vein thrombosis, and pulmonary embolism as related. Company causality between covid-19 vaccine ad26.cov2.s, and deep vein thrombosis, and pulmonary embolism was related. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220114526.; Sender's Comments: V0: 20220114454-covid-19 vaccine ad26.cov2.s- deep vein thrombosis, pulmonary embolism. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
This spontaneous report was received from a healthcare worker via a company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL (route of administration, anatomical location, lot number and expiration date were not provided). There were no concomitant medications reported. On an unknown date, the patient developed "chronic" headaches. The outcome of headache was not reported. The reporter did not assess the relatedness of headache with GARDASIL. This is one of several reports from the same reporter. Additional information has been requested.
Pfizer 1st shot: 3/21     2nd shot: 4/11 Post-menapausal Bleeding  - started 3/27 - 4/9
Manufacture's package: Mealses + Mumps + Rubella +Varicella (ProQuad) is for children 12 months to 12yrs of age. Vaccine administered to a child older than 12yrs.
Myocarditis - admission and treatment in Hospital - discharge with treatment ongoing for myocarditis
Started out 5 days later as itching about 2 inches below injection site. Day 6 arm was red, some swelling, and itching, about a 3?x3? spot on upper arm.  Day 7 spread to almost entire upper arm, stinging, and still itching slightly.
No additional AE reported; Nurse reporting an AE for MMRII that was administered after the expiration. No additional AE reported. No PQC.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-MAY-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II), 0.5ml, lot #T012808 was confirmed to be valid, expiration date: 14-APR-2022, administered for prophylaxis (strength, dosing schedule site and route of administration were not provided). (Expired product administered) No additional adverse event was reported.
Patient states that area surrounding site of administration was ~4 inches. It was a red and raised area, it was hot to the touch and itchy. Patient went to her doctor that day. Her physician told her the vaccine was administered too low (site of administration was mid way down deltoid muscle). Patient was instructed to take Ibuprofen and Allegra and the lesion improved. Upon seeing the patient's arm 10/19 @10:30am, it had improved however there was still a visibly red area surrounding the site of administration.
lt arm 1 day post swelling, redness, warm to touch;2 day post same but inc to size of a tennis ball in circumference raised approx 1/4inch;
Rashes all over my body; it's very itchy; Rashes all over my body; it's very itchy; Allergy; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 29Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 administered on an unspecified date for COVID-19 immunization. On an unspecified date the patient experienced rashes all over the patient's body; it's very itchy, and allergy. It was reported that consumer stated, "Patient got second dose of COVID-19 vaccine last Monday, the 29th. This morning when the patient woke up, patient got lots of rashes all over the body and it's very itchy, Patient tried to call the doctor and patient's doctor told that whoever gave the shot, the patient need to call. So, patient asked if that was the right number to call for the shot because patient know, the patient guess, this rashes that the patient had allergy from the adverse reactions from COVID." The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
large red spot on their arm, that was very itchy. It has gotten better but still is irritating having any clothes over the area, it is bothersome; itchy reaction that went away after a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (large red spot on their arm, that was very itchy. It has gotten better but still is irritating having any clothes over the area, it is bothersome) and VACCINATION SITE ERYTHEMA (itchy reaction that went away after a couple of days) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medication history was provided.     On 02-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 PRURITUS (large red spot on their arm, that was very itchy. It has gotten better but still is irritating having any clothes over the area, it is bothersome) and VACCINATION SITE ERYTHEMA (itchy reaction that went away after a couple of days). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (large red spot on their arm, that was very itchy. It has gotten better but still is irritating having any clothes over the area, it is bothersome) and VACCINATION SITE ERYTHEMA (itchy reaction that went away after a couple of days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient provides consent for Safety to follow up with them or their HCP. Patient mentions reading in the computer that some other people had the same itchy reaction that went away after a couple of days. Cases will be crosslinked. This case pertains to the caller. Treated  also with  cold ice pack    Most recent FOLLOW-UP information incorporated above includes: On 12-Mar-2021: No specific follow-up information recorded.
Very sore arm; For 3 Days - Slight fever; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19), MYALGIA (Very sore arm) and PYREXIA (For 3 Days - Slight fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A, 016B21A and 030H2IB) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis.    No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2022, the patient received fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 14-Oct-2022, received fifth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form.  On 25-Nov-2022, the patient experienced COVID-19 (COVID-19).   On an unknown date, the patient experienced MYALGIA (Very sore arm) and PYREXIA (For 3 Days - Slight fever). At the time of the report, COVID-19 (COVID-19), MYALGIA (Very sore arm) and PYREXIA (For 3 Days - Slight fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.     No concomitant medications were reported. No treatment medications were reported. On an unknown date, the patient reported worse side effects with Moderna and no reaction at all with last Pfizer vaccine. On 26-Nov-2022, the patient became very ill with COVID-19. The patient was sure the booster dose was effective.
p/vax pt devel cellulitis;pt adm to hosp recv unspecified tx & recovered;
Received vaccines on 4/19/21, shortly after developed a blistery rash on bilateral thighs. Two weeks later patient has a papular, itchy rash on bilateral thighs.  Differential diagnosis: irritant contact dermatitis
Patient stated that she had arm pain approximately 25 minutes after injection. Patient then stated she was having chest pain, achy arms, lightheadedness, slight nausea. EMS was called and patient left the center and was taken to the ambulance, where she decided she did not need further medical treatment. Donor states she does have a slight rash under her breasts currently. No further actions taken.
Numbness spead to entire left side of face. Possible bells palsy. Mouth slightly drooped. Went to primary dr. Getting better but still numbness in front teeth area today.
On 12/1/00, the pt developed several varicella lesions on face and trunk. No known sick exposures.
I had leg weakness, feeling like both legs going to give out about 15 minutes after vaccine, later feeling of fatigue and unwellness.  Couple of days later had dysphagia, food getting stuck in throat, throat tightness,  feeling of phlegm, severe leg  spasms  in both legs,  I could see spasms/jerking  through pants,  then had arm and hand tremors/spasms and leg weakness/feeling of legs going to give out.  I had to go to ER and then had relapse of same symptoms week later.   I still have dysphagia, unable to swallow solids,  food and pills stuck in throat, throat tightness, weight loss of 12lbs, leg weakness and pain, excessive fatigue.
Patient reported localized rash to injection site and upper chest/arms starting within minutes of receiving vaccine. With history of anaphylaxis to bee stings, case was transported via ambulance to  Hospital ED. Case received Benadryl PO during transport. Upon evaluation at ED, case received steroids and amlodipine, case declined use of epinephrine. Denied breathing or airway difficulties. Rash turned into full body rash once at ED. Case experienced pain at injection x 1 week. Case was not admitted to hospital and was discharged home. Case followed up with her physician who recommends second dose with steroid use prior to receiving.
On 4/14, had a series of rashes on left side of face - eye lid, eye brow, forehead and well into the scalp.   Following a visit to Dr,  He confirmed this to be Shingles and referred me to the Ophthalmologist as the Shingles had affected eye surroundings. I have been prescribed and taking Valacyclovir, Gabapentin, and Prednisolone eye drops to treat the Shingles.   Into week 3, Shingles rashes have all healed, blisters have all crusted out and cleared, however nerve pain continues in the head and around the eyes. The ophthalmologist suspects this to be post-Shingles effect, i.e., Postherpetic Neuralgia. My current condition results in Insomnia during various nights, and itchiness/tingling sensations, for which I have to apply cold/wet compress and Calamine Lotion to provide temporary relief.  As a result of above following the 1st COVID vaccine, I have postponed my 2nd COVID-19 (Pfizer) vaccine to 5/22. However, my confidence level to proceed and get this 2nd vaccine on 5/22 is low at this time, until CDC is able to let me know whether there is a link between the COVID-19 vaccine and this causing Shingles in rare cases, to help me avoid a repeat of the stressful experience after the 1st COVID-19 shot.  I would greatly appreciate a callback or an email.
Case number PHEH2014US003751, is an initial spontaneous report from a pharmacist received on 20 FEB 2014. This report refers to a 16-year-old female patient. The patient's medical history and concomitant medications were not reported. This patient under the age of 18 years was vaccinated with FLUCELVAX (batch number: 010031A) intramuscularly on an unknown date in DEC 2014. No adverse event was reported following this medication error. No further information was provided.  Following an internal review on 18 AUG 2014, a significant correction wad done for the information received on 20 FEB 2014, it was identified that the BPI labeling of the event "inappropriate age at vaccine administration" was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.
Next day had rash at injection site, 3 - 4 inches in length. Filled with blisters. Called pharmacist who gave no recommendations. Still has headache.
Moderna COVID vaccine given which is only indicated at 18 years of age or older. Patient experienced a sore arm and fatigue for one day, then resolved and well.
Severe chills (temp was 97.3), uncontrollable shaking (shivering, muscle seizures). I wrapped up in a blanket, made some hot chocolate, sat in a chair to wait it out. Symptoms lasted 45 minutes. After the symptoms improved, I had weak/achy muscles. Even the soles of my feet were achy. A headache followed, so I took 2 aspirin.
This spontaneous report as received from a consumer who was a 69 years old female patient. The patient was vaccinated subcutaneously with a dose of ZOSTAVAX on 14-JAN-2013 (reported as today). The patient questioned the efficacy of the product today. The vaccine was kept for 35 to 40 minutes after being reconstituted and administered. She stated she was not having any side effects only wanted to be sure the product was good. She also stated the vaccine was kept on ice. The patient did not seek medical attention and no treatment was given to patient. At the time of report, the patient's status was unknown. Additional information has been requested.
This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown age and gender. In 2016 (after 29-MAR-2016), the patients were vaccinated with improperly stored doses of ROTATEQ lot # L008034 with exp. 10-MAY-2017 and lot # L037726 with exp. 10-MAY-2017, (route and doses were not provided). The vaccines were exposed to 15C for 24 hours between 18-MAR-2016 and 29-MAR-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt received flu shot and seemed ok, but later returned to the clinic and said that his tongue was numb, and had a headache and felt stiff. 911 called but no treatment was given.
severe chest pain during breathing, dull pain between shoulders blades;tx w/motrin dx pericarditis;
Chickenpox clinically 05/24/04.  Vaccine x2 seems to have been ineffective.
The pt experienced extreme swelling of complete upper left leg. Refusal to walk on day 1 post vax.
71 y/o male, BMI 36, PMHx of DM, HTN, and Afib, admitted for weakness and fall on 9/6/21. Pt complains of left leg weakness. Chest x-ray shows multifocal pneumonia and pt was diagnosed with Covid19 in the ER. Covid19 treated with Remdesivir, Olumiant, and supportive care. Pt discharged home on 9/13/21.
2 cm area of erythema and warmth and mild induration on the upper right arm.
Reports excessive bleeding from site, then bruising, pain. Now at 2 months s/p injection, has tissue loss and deformity to deltoid muscle, skin discoloration and intermittent pain.
Bell's palsy in left side of face; This is a spontaneous report from a contactable consumer (patient).   A 26-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 16Mar2021 09:00 (Lot Number: ZP7534) single dose for covid-19 immunisation. First dose was administered on 18Feb2021 3:00PM left arm, lot# ZL9267.   The patient medical history was not reported. No concomitant therapy received within 2 weeks of vaccination. 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. The patient experienced Bell's palsy in left side of face on 26Mar2021. Treatment received for the adverse event included anti inflammatory drugs. The outcome was recovered.    No follow-up attempts are possible. No further information is expected
This spontaneous case, initially received on 31-Oct-2016, was reported by a non health professional and concerns a male patient. Weight: not provided; Height: not provided. Past medical history included low thyroid levels and pneumonia. Drug history includes carboplatin (reaction: pneumonia, low red blood cells, low white blood cells) and ABRAXANE (reaction: pneumonia, low red blood cells, low white blood cells). Concomitant medication: methylphenidate hydrochloride and salbutamol. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN). Dose regimen: Not reported, Route of administration: Not reported, Batch number: Not reported. Non-company suspect drugs: On 18-Aug-2016, the patient received KEYTRUDA for non-small cell lung cancer. Dosage regimen: 100 mg once every three weeks. Route of administration: Intravenous. Batch number: Unknown. Next dose due 04-Nov-2016. Adverse reactions/events and outcomes: On an unknown date, the patient experienced being more tired, less active, joint pain in his knees and joint pain in his 3 fingers on right hand and a loss of appetite starting on an unspecified date. The patient states that when he comes home after receiving KEYTRUDA he goes right to bed and sleeps. The patient states that he does feel better the next morning because he is less tired and reports worsening neuropathy since starting KEYTRUDA. Outcome for all events: not recovered/not resolved. The patient sought medical attention by visiting a physician. Treatment was given for the adverse event. Lab diagnostic studies performed: blood tests. Additional information was received on 11-Jan-2017: On 09-Nov-2016, the patient received his third infusion of KEYTRUDA. He continued to feel tired since the starting of KEYTRUDA. The joint pain in his knees and joint pain in his three fingers on the right hand had improved. He continued to lose appetite but was not losing weight. His oncologist prescribed him with levothyroxine because his thyroid level was low and his TSH was high. He had a cough and had been coughing up phlegm since 'last week'. His oncologist also prescribed him Z-PAK for a lung infection and he was feeling better. His oncologist started him on an unspecified inhaler a, morphine and prednisone for cough and to ease the pain from coughing. He got over the cough after taking the unspecified inhaler, morphine and prednisone. On 21-Dec-2016, the patient received sixth infusion of KEYTRUDA. He continued to feel tired, nauseous and no appetite since starting KEYTRUDA. When he ate, he started feeling sick and was not hungry. His last CT scan showed that the tumors were shrinking. The thyroid medication had not helped with his tiredness. It was hard for him to breath and he wheezed. On 23-Nov-2016, he started taking prednisone 10 mg, daily as suggested by his oncologist, for the difficulty breathing. He reported that the more he rested, the less energy he had.
Fever 101.8 Dizziness Nausea Headache  Tylenol 650 mg q4hrs PRN Ibuprofen 400mg q6hrs PRN if nausea controlled Push Fluids Office Visit if not controlled
difficulty thinking "Spacey"; sweats; severe diarrhea; severe body ache; chills; A spontaneous report was received from a consumer concerning a 78-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events severe body ache, severe diarrhea, sweats, chills and difficulty thinking.  current condition of patient include lung cancer. No relevant concomitant medications were reported.  On 5 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 5 Mar 2021, the patient experienced the events, severe body ache. severe diarrhea, sweats, chills, difficulty thinking spacey.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  Seriousness of events not reported. Event difficulty thinking(mental impairment) upgraded to medically significant based on IME list.  Events Pain, hyperhidrosis, chills,  diarrhea was considered to be recovered/ resolved on 7 Mar 2021.The patient recovered from the event difficulty thinking (mental impairment) on 8 Mar 2021.; Reporter's Comments: This case concerns a 78-year-old male on chemotherapy for lung cancer, who had a serious unexpected event of mental impairment along with events of unexpected pain, diarrhea, hyperhidrosis and expected chills. Event onset occurred the same day after the first dose of mRNA-1273. Treatment not reported. Events resolved. Based on 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.
Pt devel arm sore, red, indurated x 4 days; some mild nausea x 2 days;
Other complications following immunization, not elsewhere classified, initial encounter on 2023-05-13.
Dizziness, vomiting, partial loss of hearing starting around 5:00 pm. Uncontrollable shaking around 9:00 pm until around 10 pm. Tried to sleep but would wake up gasping for air which continued all night. Periodic vomiting, confusion until around 8:00 am. Still weak at this time.
Received 2nd flu vaccine dose when already received on 11/01/07.  No reaction noted.