chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Occurred all at once: muscle ache stiffness in both shoulders (partially frozen), legs (knees), hips, back, arms, elbows.  Severe limitation on mobility especially after sitting or laying down for a period of time.  Still have, recently prescribed Meloxicam 7.5 mg, once a day, which is relieving symptoms about 80%.
On 02/22/2001 the patient presented to the doctor's office with a vesicular rash from his left buttock to his left knee. It was reported that the doctor feels it is herpes zoster. FOLLOW-UP information has been received froma physician who did not feel there was any need to collect isolates. Follow up information from a physician states "no adverse event from vaccine itself, but the patient developed classic dermatomal shingles on the left buttock and left leg". The rash was described as 50 vesicular lesions at the left buttock and left lateral upper leg to the lateral knee". It was noted that the patient was afebrile, had nasal congestion, and was cranky, but consolable. The reporting physician also noted "this is not an adverse reaction to the vaccine. This is primary or secondary vaccine failure". On 03/13/2001 the doctor reported that the patient is improving now. FOLLOW-UP information has been received from aphysician who states Varivax didn't cause his shingles.It was also noted that the physician "did not consider this an adverse event".
Patient states she was watching a play with her husband and daughter when she started to feel "hot and sweaty". Per daughter, the patient then "slumped over" onto her husband's shoulder, was not shaking, but did seem to have her hands curled up in a ball on both sides. Daughter reports she then came to in less than a minute, was a little confused, but was back to her normal self by the time they got her to the ambulance outside the theater. The patient adds she realized she had urinated on herself once she got to the ambulance and that she felt very tired after the episode, but denied any chest pain, shortness of breath, slurred speech, facial droop, or unilateral weakness. The only thing out of the ordinary was that she got a flu shot today.
A subject received an initial instillation of Tice BCG on 09/04/2002 for treatment of bladder cancer.  Within a few hours after, he experienced significant itching, which eventually subsided within less than 1 week.  On 09/11/2002 the patient received a second instillation of Tice BCG, without advising his physician of the significant itching he had experienced after the first treatment.  Within a few hours after, he again experienced severe itching "all over abdomen, back and thighs" and reported a sensation "like his nerve ending were all standing up", with discomfort so severe that he had difficulty standing, lying down or sleeping; no visible rash nor skin abnormality.  Tice BCG was administered with a red rubber catheter and the Tice BCG administration kit, using no Xylocaine as a lubricant.  On 09/12/2002 subject was advised to take Benadryl 25 mg per mouth; it is unknown if this was effective in relieving symptoms.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 51-year-old female patient who received SHINGRIX for prophylaxis. In October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The reporter consented to follow up. This case has been linked to case US2019057191, reported for the dose 2 of the same patient.
Received Flu vaccine at approximately 3:00 PM at clinic. Started not feeling well with Headache, fatigue, increased temperature around 9:00PM. Pt had to stay home with SX of HA, temp 99-102 degrees, pain in all joints, fatigue, felt "like crap" x 1 week until pt started to feel "1/2 way better"
Tingling feeling up and down left arm, shoulder/neck and ear + above eye minutes after shot- 4.5 hours post shot- still feeling it. Not as intense .   Arm tenderness surfaced within 30 min ?Drunk-ish? feeling and neck pain started about 90 min post shot
11/28/21:  presented to ER with complaints of cough, wheezing, increased shortness of breath, abdominal pain, nausea, and tarry stools.  Findings in ER BUN Crt 37/2.4 with eGFR 28, AST 75, ALT 62, WBC 7.1, HH 11.8/39.3.  HR 70s, temp 97.9 F, RR 27, SBP labile 80-100, sat 94% on 4L NC (baseline O2 needs).  CXR bibasilar infiltrates.  COVID positive.  Admitted with COVID PNA, AKI due to dehydration, suspected lower GI bleed.  Given IVF bolus 2000 ml, levophed started at 5mcg and titrated, remdesivir, multivitamin cocktail, IV Cefepime, IV doxycycline, steroids, anticoags on hold d/t possible GI bleed. 11/29/21:  Levophed off.  SBP 95-110.  RR 20s sat 95% on 4L NC remains afebrile.  SOB at rest.  Loose green liquid BMX2 negative for c.diff.   12/1/21:  Hospitalization uneventful.  Discharged to another facility on baseline home O2 4LNC sat 96% SOB with activity back to patient baseline.  HH stable throughout stay with no blood transfusion needed.
parent states pt started stiffening, having szs type behavior-ER MD called states pt very irritable  & to d/c further pertussis
Report adverse event; 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 ADVERSE EVENT (Report adverse event) 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 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 ADVERSE EVENT (Report adverse event). At the time of the report, ADVERSE EVENT (Report adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.
Chest pain (achy, sometimes sharp, all-over chest but mostly middle and left; radiates into left arm (numbness), ribs, back, neck).  Chest palpitations, anxiety attacks, pins and needles down back. Insomnia. Head zaps Pain in neck (left side) felt like straining Difficulty driving Extreme muscle tension in back, neck, chest and legs Knots in neck on left side  Leg pain (achy, hurts where leg meets torso) Dizzy feeling Headaches Muscle twitching TMJ/tinnitus  After Booster: Rapid heartbeat Feel heartbeat in left arm Pain/achy left arm Prickly feeling in head Headaches Sharp pain in chest with rapid heart beat Sharp pain in fingers and achy wrists
Joint inflammation; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Joint inflammation) 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 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 ARTHRITIS (Joint inflammation). At the time of the report, ARTHRITIS (Joint inflammation) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported. No treatment medications were reported.
This non-serious spontaneous case, initially received on 27-Nov-2017 from a pharmacist, concerning a 64-year-old, female adult patient. The patient had no medical history and was not under any concomitant medications. On 27-Nov-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 179804P, expiry date: not reported), that was stored at a maximum temperature of 53 F, about 10 hours. It was reported that, no adverse event was occurred after the vaccination. Follow up received on 03-Jan-2018: Indication (influenza vaccination) of the suspect product was updated.
Wed eve 9/30/09 pt started to feel as if getting "the flu' achey, swollen glands below ears, back of head. Thur & Fri was v. weak and ached all over. Pt reports going for a brisk walk Fri eve. Entire face, especially eyes were very swollen and puffy. Pt came into the pharmacy on Mon 10/5 - and reported to me extreme swelling itching and irritation, especially on left side. Her face was very red on left side and eye was puffy and swollen, with large bag under her left eye and some spots near ear and into scalp. Pt did not remember any blisters - just extreme itching. She reported no vision changes except for swollen, puffy skin may have interferred with vision. I encouraged her to call her Dr to report occurrence as this reaction was not what we expect from a shingles vaccine.
SHE SAID SHE IS ITCHING FROM WITHIN. I ADVISED HER TO CONSULT HER DOCTOR BUT SHE REFUSED.  IT SHOULD BE NOTED THAT PATIENT ALSO TOOK FLUZONE HIGH DOSE ( LOT # UJ904AB ) ON THE SAME DAY.
pt recv vax 1NOV95 & 29MAR96 pt devel gen chicken pox;the nursed reportedly discussed the self-defrosting cycle of the office freezer & questioned the ability of the freezer to maintain appropriate temp;
This case was reported by a healthcare professional and described the occurrence of petechial rash on arm in a 36-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). The subject's medical history included allergy to amoxicillin. Previous vaccination included Salmonella typhi Vi capsular polysaccharide vaccine; manufacturer unspecified; oral given on 20 April 2010. On 5 May 2010 at 14:50 the subject received 2nd dose of TWINRIX (1 ml, unknown route, left arm). On 16 May 2010, 11 days after vaccination with TWINRIX, the subject experienced petechial rash on left arm. At the time of reporting the event was resolved. The healthcare professional considered the event was probably related to vaccination with TWINRIX. Follow-up information received from healthcare professional on 06 August 2010: The healthcare professional reported that there were no concurrent illnesses. The immunization series with TWINRIX was discontinued. The reporter considered the events could have been associated with the subject's medical history (not specified), and indicated that there was no other possible causes.
No adverse reaction occurred. Patient presented with consent form listing date of birth signed by legal guardian requesting to receive first dose of Pfizer COVID-19 vaccine . Per policy, the legal guardian who signed the consent form was contacted prior to administration to confirm consent and consent was documented on 8/31/21. Patient received vaccine.  As there was no profile in the database for patient with name and DOB combination, a new profile was entered. Prior to appointment for the second dose scheduled for 9/21/21, a staff pharmacist determined that a database profile existed for a patient with the same name and a different date of birth. As the Pharmacy Manager, I contacted the patient's legal guardian and received a return call from the patient's grandfather. When asked to confirm the patients date of birth , he stated false birthdate. Because two entries existed in the database, I asked that he bring proof of the patient's date of birth to the appointment for validation. He stated he would not be able to do so in time for the appointment and I asked him to reschedule and provide proof prior to administration. The pharmacy was not contacted again and no appointment was rescheduled. Suspect that date of birth might have been falsified on consent form and that Pfizer COVID vaccine was administered to a 9 year old.
Narrative: 79yo male previously at rehab facility was admitted to hospital for endocarditis on 6/30/21. Pt died on 7/26/21 at hospital (outside facility). Pt had received one dose of covid vaccine - moderna on 3/2/21. Vaccine is not related to pt's death.
Overall unwell feeling, chills, nausea, chest discomfort, unable to take full deep breath and fever.
Pt felt nauseous and lightheaded about 15 min after receiving 2nd dose of moderna.  Pt taken to urgent care on site, given Zofran, symptoms resolved.
Information has been received from a female consumer who on "last Tuesday" approximately 01-APR-2008 was vaccinated once with 0.65mL of zoster vaccine live (Oka/Merck). Subsequently, the patient developed a raised, red, "quarter sized hard lump" at the injection site. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information has been received from a physician concerning this 60 year old female consumer with sulfonamide and seasonal allergies, depression, reactive airways disease and irritable bowel syndrome who on 08-APR-2008 was vaccinated SQ in the left arm with a first dose of zoster vaccine live (Oka/Merck) (659763/1875U). There was no illness at the time of vaccination. Subsequently, the patient developed a local reaction of bumps at the injection site (per the patient's report). It was noted that the patient was not seen in the office and there were no lab studies performed. The patient recovered on an unspecified date. Additional information is not expected.
This case was reported by a physician (also the subject's father) and described the occurrence of chest palpitations in a 19-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), HAVRIX. On 7 August 2012 the subject received a dose of BOOSTRIX (.5 ml, unknown route) and on 13 August 2012 the subject received 1st dose of HAVRIX (details unknown). On 19 August 2012, 6 days after vaccination with HAVRIX, 12 days after vaccination with BOOSTRIX, the subject experienced chest palpitations and less than a month after vaccination with HAVRIX and BOOSTRIX, the subject experienced premature atrial contraction. The subject developed the palpitations on 19 August 2012. The subject "has undergone test which revealed atrial premature contractions (APC) and will have a 24 hour Holter monitor and 2-D echo as well as blood tests". The physician considered the events were disabling. At the time of reporting the outcome of the events was unspecified.
Patient had a fever 11-8-13. Later in day had a 5 minute seizure at dinner. EMS called, went to ED. Vomited once, febrile 39.3, tachycardic given 150 mg TYLENOL, observed. Short post-ictal period. No further seizure, dx: Febrile seizure, time of admit to ED 18:02, time of discharge to home 20:56.
Chills; Believes the vaccine exacerbated Fibromyalgia possibly; Arm has a knot in it; Muscle ache; Arm red, swollen, and itching; Arm red, swollen, and itching; Arm red, swollen, and itching; Arm sore; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FC3180) via an unspecified route of administration, administered Left deltoid on 30Aug2021 at 18:00 as dose 1, single for COVID-19 immunization (age at vaccination 61 years). The patients medical history included ongoing fibromyalgia Diagnosed 40 years ago believes the vaccine exacerbated this possibly. Concomitant medications were not reported. No vaccination was administered 4 weeks Prior Vaccination. History of all previous immunization with the Pfizer vaccine considered as suspect, additional vaccines administered on same date of the Pfizer suspect was none. On 30Aug2021, the patient experienced arm sore. On 01Sep2021, had muscle ache, arm has a knot. On 31Aug2021, arm red, swollen, and itching. On an unspecified date, had chills, believes the vaccine exacerbated fibromyalgia possibly. It was reported that on Monday evening she had the vaccine and her arm is still sore, red, swollen, and she has a knot in it. She also had chills after the vaccine, muscle aches, and all that stuff which has gotten better. Arm Sore, she noticed the night she went to bed. It also did not help this was the same side she sleeps on. Arm swollen, red, and itching: She started to notice this the following day when woke up. Arm has a knot in it, confirmed it is not as prominent, it is better now. She mentioned she had to leave work yesterday early because she was hurting so bad. The adverse event did not require a visit to emergency room visit or physician office visit. Treatment/Intervention was she took Tylenol, Gabapentin, and used ice pack on arm. She later clarified the Tylenol is technically Acetaminophen, Mipap, Lot: 544785CS7 Exp: Aug2021. Treatment received for the events as Tylenol, Gabapentin, and used ice pack on arm. She later clarified the Tylenol is technically Acetaminophen, Mipap. The outcome of the events was reported as recovering for arm sore, muscle ache, arm has a knot in it and the outcome as not recovered for arm red, swollen, and itching and the outcome as unknown for chills and believes the vaccine exacerbated fibromyalgia. The patient provided information regarding the reported adverse event with the use of the product and consider the Pfizer product had a casual effect to the adverse event.  No follow-up attempts are needed. No further information is expected.
Patient presented to the ED on 6/22 with left-sided weakness, facial droop and dysarthria likely due to acute CVA. His family member reported he had obtained the covid vaccine previously on 6/21, unknown where and which vaccine.
No treatment, but I got really sick (flu). Got hives on neck, fever (103), arm was swollen for 7 days (hives for 2 days).
Client complains his nose hurts, his nose is stuffy and hard to breathe through nose.
Child received immunizations as noted at clinic at bedtime that evening MOC noted that his right arm was very swollen, red and hot from neck to shoulder to elbow level. child was complaining of no pain and not dyspneic. On 4/28/04 she phoned his doctor with no response received; then clinic applied ice. No antihistamines . Given Motrin at bedtime. Condition improved on 4/29/04 with only blotchy redness noted in affected extremity.
Patient was seen in the office of Dr. with c/o chest pain for 1 week.  Placed on observation status for evaluation and treatment.  Patient was diagnosed with Covid.  Patient was evaluated by cardiology and released from there care.  Patient chest pain was treated with pain medication and patient was discharged home 1/13/23.
Pt recvd 3rd dose of vax & missed 6 months of work due to severity of illness; 5JUN93 had not been in remission since getting ill; pt also found to be neg for anti-HBs;
Angioedema; Generalized urticaria (hives) all over trunk, arms, buttocks; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8737; Expiration date was not reported) on the left arm on 06Apr2021 (13:15) as a single dose, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store. Medical history included type 2 diabetes, hypertension (HTN) and obesity. Concomitant medications included atenolol, amlodipine, metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET) and simvastatin. The patient previously took buproprion (WELLBUTIN), and had drug allergy. On 07Apr2021 (14:00), the patient had angioedema and generalized urticaria (hives) all over the trunk, arms and buttocks. The events had resulted into doctor or other healthcare professional office/clinic visit. The patient had received methylprednisolone (MEDROL) as treatment for the reported event. The outcome of the event was not recovered. The patient did not have COVID-19 prior to vaccination, and had not been tested post-vaccination.
Hypotension (extreme drop of blood pressure); Dizziness; This is a spontaneous report from a Pfizer-sponsored program from a contactable physician.    A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, at single dose, for COVID-19 immunization. Relevant medical history and concomitant medications were unknown. The patient previously, on an unspecified date, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose, for COVID-19 immunization. On an unspecified date, in Feb2021, the patient experienced hypotension (extreme drop of blood pressure) and dizziness. She had episodes of hypotension to approximately 60-70 systolic over 40, dizziness and extreme drop of blood pressure that lasted for about an hour that was not associated with chest pain or shortness of breath. These hypotensive episodes never happened to her before. Clinical outcome of the adverse events was unknown at time of this report.    The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Hypotension and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
23OCT flu vax c/o sore throat later in PM;24OCT hives @ inj site in AM progressing to hands & feet, fatigue, sore arm, inc throat pain;25OCT unable to talk diff swallowing, gen urticaria;went to an ED given IV DPH, solumedrol, tigan
pericarditis w/fever & arrhythmias (PVC's) 4 wks duration until complete recovery;
CHILLS; FEVER; HEADACHE; NAUSEA; FATIGUE; FOGGY FEELING IN HEAD; BODY SORENESS/MILD PAIN; DEHYDRATION; SORE ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight was 140 pounds, and height was 65 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 12-APR-2021 16:00 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 12-APR-2021, the subject experienced sore arm. On 13-APR-2021, the subject experienced foggy feeling in head. On 13-APR-2021, the subject experienced body soreness/mild pain. On 13-APR-2021, the subject experienced dehydration. On 13-APR-2021, the subject experienced fever. On 13-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced fatigue. On 13-APR-2021 03:00, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from foggy feeling in head, body soreness/mild pain, dehydration, chills, fever, headache, nausea, and fatigue on 13-APR-2021, and was recovering from sore arm. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Information has been received from a registered nurse concerning an approximately 31 year old male pt who was vaccinated with a two dose series of varicella virus vaccine live according to the recommended schedule. In approximately 2002, the pt was tesed for seroconversion using the herpes zoster ABS serology test. The pt's test was negative (did not show seroconversion). The registered nurse was not sure if the serology test was appropriate to show seroconversion for varicella virus vaccine live. Unspecified medical attention was sought. Additional info has been requested.