chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Fever; Repeated vomiting; Muscle aches; Felt bad since taking shot; This is a spontaneous report from a contactable consumer. A 71-year-old male patient received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 08:00 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Medical history included brain tumor operation and colectomy. The patient did not take any concomitant medications. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Mar2021, the patient experienced chills, fever, muscle ache, fever, repeated vomiting and felt bad after vaccination. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient received unknown treatment for the reported events. The clinical outcome of chills, fever, muscle ache, fever, repeated vomiting and feeling bad were not recovered.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient states she experienced arm pain and tingling post vaccination that is still occurring 3 weeks later. Her primary physician suspects she has SIRVA and has scheduled an ultrasound to determine if it is an injury such as muscle tear or an allergic reaction.
Patient given both doses over two days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient given both doses over two days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient given both doses over two days). On 17-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient given both doses over two days) had resolved.        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.   No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: clarification on dosing received, Patient only got first dose on 17-JUL-2021, no previous dose.
child was being vaccinated 6OCT97 & during the vax pt moved & some of the vax squirted into the eye of the mom;mom had an unk hx of chickenpox infect;
Local site L deltoid upper region 2" diameter induration; redness.  No fluctuation.  No axillary nodes.  Pain+
After receiving the Moderna booster vaccine, the patient started experiencing swelling in the same arm that they received the vaccine. The state that they did not experience any itching, redness, throbbing, or fever, but their arm was hurting and they had significant swelling around the lymph area.  they did not mention taking any medication, but they did plan on visiting an urgent care if the swelling did not go away as it had already been 4 days.
The pt experienced swelling in the right eye and the right side of face with blotches. The pt also experienced blotches in the right wrist, blurred vision, lightheadedness, and nausea.
pt recv vax & w/in 1hr devel cough gen urticaria, eyelid edema requiring epi & DPH;
cough; painful post nasal drip; headache; feel feverish but have no fever; This is a spontaneous report received from a contactable consumer. A 39-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date was not reported), via an unspecified route of administration, in left arm on 24Mar2021 14:15 as single dose for covid-19 immunization. Medical history included PCOS, ADHD, chronic fatigue, and allergic to penicillin, egg, dairy. Concomitant medication(s) included methylphenidate hydrochloride (CONCERTA), patient received these medications within 2 weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. 6 days later patient experienced a headache, cough and feel feverish but had no fever. Patient also had a painful postnasal drip on 30Mar2021 14:00. Patient not tested for COVID-19 after the vaccination. No treatment received for the reported adverse events. The outcome of the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
- Gastrointestinal hemorrhage, unspecified gastrointestinal hemorrhage type
Lost all my body strength; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose number unknown (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 (primary immunization series complete: unknown manufacturer), for COVID-19 immunization. The following information was reported: ASTHENIA (hospitalization) with onset 05Oct2022, outcome "unknown", described as "Lost all my body strength". The patient was hospitalized for asthenia (start date: 05Oct2022, discharge date: 07Oct2022, hospitalization duration: 2 day(s)). The event "lost all my body strength" required emergency room visit. Therapeutic measures were taken as a result of asthenia.  Clinical course: on Tuesday 04Oct, I received a Pfizer Bivalent inoculation from my local (vaccine facility name). The next day from the time I woke, I lost all my body strength and had to be taken to the emergency room of my local hospital. They admitted me and discharged me the following Friday at noon. They have no explanation for what happened to me on 05Oct.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
At dinner around 6pm, he complained about his upper lip hurting and it looked a little red and swollen. At 12:30am he woke crying because he was having difficulty breathing. He could breathe in ok but breathing out was hard for him and it came out more like a slow, wheezy moan. He also had an occasional deep cough that really hurt him. He fell asleep on my husband so we stayed up with him to monitor his breathing and make sure it didn't get worse. At about 3am his breathing started to improve. The next morning he was doing better but still had an irritated upper lip and some hives on his neck and leg. We took him to urgent care to get him looked at.
10/7 - unable to walk, shaking. Had brain MRI and LP - both normal. Tested positive for influenza B and dx of viral cerebellitis. Given IVIG. Followed by Neuro and PT.
Mother stated rash started at site of vaccination and spread all over body, also my brother had the same reaction to MMR vaccine
This non-serious spontaneous case, initially received on 11-Feb-2018, was reported by other non-health professional and concerns a 64-year-old female patient. The patient's current condition included diabetics and allergy to seafood. The patient never had an allergic reaction to a vaccine in the past. On 19-Jan-2018, the patient was administered with AFLURIA (TIV) (dose, route of administration, anatomical location, batch number, expiry date: not reported). On an unspecified date in Jan-2018, the patient developed pain in the vaccinated arm, for which she took self-medication with 2 doses of PANADOL and lidocaine cream. On an unknown date, the patient's arm had swollen (described as a medium size ball in forearm appears to be like a chopped bee) and a red spot near that swollen area. The patient had to visit emergency room. The reaction occurred in the forearm, far away from the site of vaccination. The physician stated, that the event was an adverse reaction to the vaccine and had not suggested any other tests. The outcome of the events was not reported.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2017, the patient was treated for a persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. Additional information has been requested.
Severe headache lasting for weeks, on and off since receiving second dose. In the process of seeing a neurologist. MRI and CT scan planned.
Pt revd MMR 21SEP93 & 2 hrs later became nauseated; by night began to itch & swell slightly around face; upon awakening, swelling on face & chest was worse; no breathing problems; Benadryl 50 mg IM given 22SEP93;
Was seen at a clinic for swelling of upper extremity 4 days after receiving vaccine. On day 11, patient returned to PCP for follow up with mild improvements of signs and symptoms. Patient stated initially after Tdap administration, his left upper arm became painful and very sore along with generalized achiness and a headache; felt like he had the flu. Upon exam at follow up appt, left arm (site of admin) was slightly pinker and warmer to the touch than the right arm without pain. Headache, Myalgia and Rash.
Severe headache (36 hours), Body aches (24 hours), Fatigue (48 hours), nausea (24 hours), Fever (over 100° 24 hours), chills (24 hours) Treatment- tylenol, ibuprofen, rest 60+ hours post vaccine, feeling myself again
APPROXIMATELY 4-5 MINUTES AFTER RECEIVING COVID VACCINE, PT BECAME DIZZY.  HE THEN EXHIBITED SEIZURE ACTIVITY, WHICH LASTED ABOUT 30-45 SECONDS.  PT WAS SWEATING AND HOT.
Uncontrolled violent chills for 4+ hours; chills off and on for more than 12 hours; high fever (over 102) for more than 12 hours; headache for more than 12 hours; body aches for more than 24 hours.
NOT FEELING TOO GOOD; ACHING ALL OVER; VERY UNCOMFORTABLE; MUSCLE ACHES; FEVER OF 99.6; CHILLS; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (NOT FEELING TOO GOOD), PAIN (ACHING ALL OVER), DISCOMFORT (VERY UNCOMFORTABLE), MYALGIA (MUSCLE ACHES) and PYREXIA (FEVER OF 99.6) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (NOT FEELING TOO GOOD), PAIN (ACHING ALL OVER), DISCOMFORT (VERY UNCOMFORTABLE), MYALGIA (MUSCLE ACHES), PYREXIA (FEVER OF 99.6) and CHILLS (CHILLS). At the time of the report, FEELING ABNORMAL (NOT FEELING TOO GOOD), PAIN (ACHING ALL OVER), DISCOMFORT (VERY UNCOMFORTABLE), MYALGIA (MUSCLE ACHES), PYREXIA (FEVER OF 99.6) and CHILLS (CHILLS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported. Treatment medication was not provided.   This case was linked to MOD21-044754 (Patient Link).
Received smallpox vax 3/20/03. Developed hives around site, back arms buttocks and chest. 3/30/03 Instructed to take Benadryl. If worsen go to ER. 3/31/03 Hives have intensified and spread to legs. Ref to MD.
Developed shingles on 12/23/20- went to urgent care on 12/24/20, was given Prednisone and Acyclovir prescriptions.  Rash sites dried on 12/28/20.
I developed sudden onset of bilateral arm-fingertip pain, numbness, tingling with diagnosis transverse myelitis 5-6 months following 3 AVA and repeat smallpox vaccination.  I also developed red streaking and redness to smallpox site 7 days post vaccination.  6/29/07 Received Clinical Summary from HC which reveals patient experienced streaking & redness at smallpox vax & redness at anthrax vax sites 7 days s/p vax.  Seen in ER & dx w/allergic reaction to smallpox & anthrax vax.  Completed anthrax series & was deployed.  Developed sudden bilateral arm-fingertip pain, numbness, tingling approx 5-6 mos s/p vax.  Admitted to local ER then transferred to higher level of neurologic care for 7-10 days.  Tx w/high dose steroids x 5 days w/improvement.  Completed several weeks of intensive PT & was able to return to normal ADLs w/mild constant dull ache w/numbness & tingling from bilateral triceps to fingertips.  Grip strength weak, fatigues quickly, coordination difficulties, muscle spasms & jerking while asleep which were felt to be as resolved as possible & had begun disability process. FINAL DX: Transverse Myelitis w/cervical cord lesion C4-5 & C5-6, affecting both arms w/partial recovery.
I had a shingles vaccination on Thursday 24th in my left arm - on Sunday 27th I noticed a significant lump on my right hand forearm - there is no associated pain, and the lump is still on my arm today (28th).
Influenza A; Initial information received on 21-Dec-2022 regarding an unsolicited valid social media serious case received from a consumer/non-healthcare professional (hcp).  This case involves an unknown age and unknown gender patient who experienced influenza A after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, route, dose: unknown) (lot number and expiry date: not reported) in unknown administration site for Prophylactic vaccination (Immunisation).  On an unknown date, the patient Got his/her flu shot and just spent 3 days in the hospital with Influenza A (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.   It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.   Action taken with INFLUENZA VACCINE was not applicable.  It was not reported if the patient received a corrective treatment for the event (Influenza A).  At time of reporting, the outcome was Unknown.   Seriousness Criteria: Hospitalization for the event Influenza A.; Sender's Comments: Sanofi company comment dated 27-Dec-2022: This case involves an unknown age and unknown gender patient who experienced influenza A after receiving vaccine INFLUENZA VACCINE. Based upon the reported information, the role of vaccine cannot be assessed. Additional information regarding additional risk factor, concomitant medications, medical treatment and family history, underlying medical history excluding other predisposing etiologies would be needed for complete assessment of the case.
nausea within 20 minutes, lasting approx 3 hours. migraine started approx 14-15 hours later, migraine caused blurred vision, light sensitivity, and nausea. lasted approx two hours. Took Excedrin Migraine an hour after migraine started to relieve symptoms. unsure if migraine will reoccur when Excedrin wears off
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot # K010339, expiration date 22-JUL-2016, dose and route unknown). This is one of several reports received from the same reporter. Additional information has been requested.
I was having some complications and I went to see my Dr. and she recommended that I see a cardiologist.  I am still going through this at this time.
Asthma Attack; A spontaneous report () was received from a consumer for a 67 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced asthma attack.  The patient's medical history was not reported. No concomitant product use was reported.  On 24 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 25 Feb 2021, next day after receiving the vaccine, the patient experienced an asthma attack and used a rescue inhaler (albuterol) and the asthma responded. She then had a severe asthma attack same evening, went to emergency room about midnight and was treated with albuterol breathing treatment and given a cortisone shot.  Action taken with mRNA-1273 with respect to the event was not reported.  The outcome of the event was recovered on 26 Feb 2021.  The reporter did not provide the causality assessment for the event.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Information has been received from a consumer concerning her husband, a 69 year old male with blood pressure high, sulfonamide allergy and WELLBUTRIN allergy who on 29-JUL-2010 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included omeprazole, oxybutynin ER, naproxen, NIFEDIAC CC and ATACAND. On 31-JUL-2010 the patient had this rash on the left side underneath the waistline that just won't go away and believed it might be shingles. The patient had not been in to see a doctor. There were no lab diagnostics studies performed. At the time of the report, the outcome was unknown. Follow up information was received which reported that the 69 year old retired male patient with hypertension, dyspepsia, arthritis and a history of chickenpox who at 10:30 am on 22-JUL-2010 (previously reported as 29-JUL-2010) was vaccinated into the left deltoid with a dose of ZOSTAVAX (Merck) (lot # 665528/0710Z). The patient had no illness at time of vaccination nor any recent exposure to chicken pox and herpes zoster. On 24-JUL-2010 (previously reported as 31-JUL-2010) the patient developed rash in groin area, abdomen, under bilateral arms, right side of chest and bilateral legs. The patient felt itchy but no pain. On 02-SEP-2010, "skin, left abdomen, punch biopsy" was performed which consisted of an ovoid portion of tan skin measuring 0.2 cm in greatest dimension. The microscopic description: The sections showed a superficial and mid moderately perivascular mixed inflammatory infiltrate composed primarily of lymphocytes and scattered eosinophils and neutrophils. There was slight parakeratosis with mild spongiosis of the epidermis. The diagnosis was compatible with popular urticaria (dermal hypersensitivity reaction). The differential diagnosis included one of figurate erythemas, viral exanthema or a drug reaction. Clinical correlation was recommended. The pre-op/clinical diagnosis was hypersensitivity reaction. Other lab tests were performed on 27-SEP-2010 including complete blood cell counts, differential  and platelet counts and Comprehensive Metabolic Panel. Results were within normal range except serum glucose (107, high) and absolute neutrophil count (0.6, high). At the time of the report, the patient was still on medication. Additional information has been requested.
Rash (maculo-papular) started around mouth, 10 days post vax, and spread on to body. Fever to 101F and rhinorrhea.
24 hours after dose - experienced fatigue, headache, muscle aches, arm soreness.  Swollen lymph node in elbow started several days after vaccination.
UNSPECIFIED ADVERSE REACTION; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes.The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 2021 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 mrna 1273. On 2021, the subject experienced unspecified adverse reaction. The action taken with covid-19 vaccine  was not applicable. The outcome of unspecified adverse reaction was not reported. This report was non-serious.
Lt. arm swollen, red, rash. Temp. 100. Patient instructed to see a doctor. Pt. states she passed out 2/25/10. Pt went to Dr. & was given steroids & states she feels better.
Gave Two Patients who are Under 18 Years Old; Initial Report Received on 13-Dec-2021  A registered medical assistant reported that a 17 year-old male patient (race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported. The patient had no known drug allergies.  No relevant concomitant medications were reported.    On 13-Dec-2021, the patient, who was under 18 years-old, received a dose of HEPLISAV-B (Lot # 934975, expiration date 13-Aug-2022, and NDC # 43528-003-01) in the right deltoid from the registered medical assistant. The wrong vaccine was chosen instead of the pediatric vaccine. It was a "human error." The patient had no adverse reactions at the time of the injection and there were no other adverse events associated with this event.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
BAD BODY ACHE; THREW UP; CHILLS; EXHAUSTED/FATIGUE; NAUSEA; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 39 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042a41a, expiry: not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced bad body ache. On 07-APR-2021, the subject experienced threw up. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced exhausted/fatigue. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad body ache, chills, fever, headache, nausea, exhausted/fatigue, and threw up. This report was non-serious.
Itchy tongue that lasted for 12 hours, followed by swollen tip/middle of my tongue. Oral Benadryl was able to help the symptoms and I did not have trouble breathing so chose not to go to the hospital