chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SWEATING PROFUSELY; ACHES; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported,) dose, start therapy date were not reported 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 subject experienced sweating profusely, aches, and fever. The action taken with covid-19 vaccine  was not applicable. The outcome of the sweating profusely, aches and fever was not reported. This report was non-serious.
After injection, pt complained of feeling light-headed and appeared pale. Pharmacist called for ambulance for pt but refused to go to hospital. Pharmacist consulted pt to sit in chair to rest while pharmacist monitor pt. 10-15 minutes later. pt states he's feeling better ( said he probably was having anxiety because he was already nervous about getting a shot) and wants to leave. Pharmacist again told pt that she can call for an ambulance to have pt monitored, and again, he refused. He states that he is well to leave
Varicella - like reaction (lesion on leg). Follow up states: Do not have lot number for vaccine given.
After the injection my left arm was sore so I took Tylenol for the soreness.  The soreness never went away but became worse on March 11, 2021,  My wife noticed my arm was swollen down to my left hand.  I called pharmacy and they instructed him to take Tylenol and use ice packs.  If the swelling is not down by noon tomorrow, go to clinic or emergency room.
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 02May2022 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "recovering"; COVID-19 (medically significant), outcome "recovering". Paxlovid was taken as therapeutic measures as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, there is a reasonable possibility of a causal  association between the reported adverse events drug ineffective, Covid-19 and the suspect  product BNT162b2.,Linked Report(s) : US-PFIZER INC-202300148530 same patient, different drug/event;
NOT ABLE TO SLEEP; STOMACH ACHE; This spontaneous case report (PVX2019-1692) was received from a consumer on 28-Jun-2019. It describes a 67-year-old elderly male consumer who had stomach ache and not able to sleep, after the administration of Vivotif for an unknown indication.  Case report: The consumer took the first dose of Vivotif on 26-Jun-2019. After 12 hours, he had stomach ache and was not able to sleep. He stated that he never had stomach aches before, and he had no history of gastrointestinal illnesses.  Concomitant medication included Aciphex (rabeprazole), Lexapro (escitalopram), xiidra (lifitegrast), Exforge (amlodipine), oxazepam, Vitamin C (L-ascorbic acid), vitamin D3 (cholecalciferol), and glucosamine chondroitin.  Action taken with Vivotif with respect to the events was unknown.  The consumer had recovered from the event stomach ache on 28-Jun-2019, while the outcome for the event not able to sleep was unknown.  Company's Comment: In this case, it was reported that a male consumer who had stomach ache and not able to sleep, after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, stomach ache is labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that a male consumer who had stomach ache and not able to sleep, after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, stomach ache is labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
This spontaneous report as received from a 71 years old female patient with no drug reactions/allergies and heart murmur who on in July or August 2012, was vaccinated at the local pharmacy with a dose of ZOSTAVAX (dose and lot # not reported). No other co-suspects were reported. Concomitant medications included: CRESTOR, LUMIGAN and CLARINEX. The caller stated she was given the shot in the muscle, not in the fatty tissue of her upper left arm. A couple of days after receiving the ZOSTAVAX shot, the caller developed bruising and itching at the injection site which lasted about two weeks and then went away. The caller was concerned that she was given the shot in the wrong way and wanted to know if she should get another shot. The caller had not talked to her doctor about this but planned to do so. No treatment was given for the events. The patient did not seek medical attention. The relatedness for bruising and itchiness at the injection site was unknown for ZOSTAVAX. Additional information has been requested.
12 hours after shot, developed shaking chills and fever to 101.  Continued with these symptoms along with a headache, muscle aches and continued fever for about 30 hours.
lymph node enlargement; Left breat was heavier than right; If I press around the lining by the chest or sternum, it hurts; Sprain; Felt some swelling on the lining of the brest; This spontaneous case was reported by a nurse and describes the occurrence of LYMPHADENOPATHY (lymph node enlargement), CHEST PAIN (If I press around the lining by the chest or sternum, it hurts), LIGAMENT SPRAIN (Sprain) and BREAST SWELLING (Felt some swelling on the lining of the brest) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On an unknown date, the patient experienced LYMPHADENOPATHY (lymph node enlargement), CHEST PAIN (If I press around the lining by the chest or sternum, it hurts), LIGAMENT SPRAIN (Sprain) and BREAST SWELLING (Felt some swelling on the lining of the brest). At the time of the report, LYMPHADENOPATHY (lymph node enlargement), CHEST PAIN (If I press around the lining by the chest or sternum, it hurts), LIGAMENT SPRAIN (Sprain) and BREAST SWELLING (Felt some swelling on the lining of the brest) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: mmHg Inconclusive. On an unknown date, Computerised tomogram: negative Negative. On an unknown date, Electrocardiogram: Inconclusive. On an unknown date, Fibrin D dimer: high ng/mL (High) The D-Dimer was elevated which indicated a chance for DVT. On an unknown date, X-ray: (Inconclusive) The X-ray taken was unclear.     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 treatment information was provided.  No concomitant medication was provided.
Some tingling and mild numbness in my hand and fingers only; Some tingling and mild numbness in my hand and fingers only; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in arm on 09Feb2021 (at the age of 73-years-old) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported) administered via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. In the arm where the patient received the second dose of the vaccine, she started to get some tingling and mild numbness in the hand and fingers only, not on the arm. The patient was in good health and did not have any conditions that would cause the events. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Headache, chill, body aches, fever, malaise, runny nose, sore throat, loss of taste, night sweats, nausea, diarrhea, chest tightness, dry cough
rash to both arms that is worse on the right arm where the vaccine was given.  spotty with sand paper type rash.  rash itches and burns.
Day 13 after Pfizer vaccine, patient felt a lump below clavicle on R side Saw Dr. 6/5 - per prescriber, ~ 1.5 cm lymph node subclavicle; tender, discrete, moveable No other lymph nodes of concern  As of 6/8 - lymph node still same size
Patient is due for Pfizer Pediactric COVID vaccination, however, the immunizer gave patient the Pfizer Toddler COVID vaccine.  Age inappropriate.
Red rash on torso (not raised). This was my second dose of the vaccine. I experienced the same symptom after the first dose two months ago.  The rash will last a few days.  After my first dose of the shingles vaccine I spoke to my doctor?s office and they indicated that a rash is generally not a reaction to this vaccine.
Pt called stating they have not been feeling like themselves. States arm pain is still there and has rashes and swelling down to the elbow. Has been using Tylenol and ibuprofen. Symptoms have been worsening daily. Was referred to see doctor. If doctor is not available to go to urgent care as symptoms are continuing to worsen. Pt does not take an allergy pill regularly, was recommend Benadryl if an allergic reaction but better to follow up with doctor.
bilateral rash 20 min after shot, R neck/headache and fever for several days, and local induration extending to axilla
Parents report that patient developed itchy rash about 6 hours after receiving vaccine , not like hives/did not come and go, mostly on arms and face.  Some fatigue and mild congestion per parents but no swelling or resp difficulty, no other sxs, no new contacts. Seen in office the following day 12/19/2019 with scattered erythematous macular patches on face and arms, not-urticarial, otherwise nl exam.  No clear etiology. Returned for f/u  12/23,  rash persists with scattered mildly erythematous macules and papules mostly on face and arms, some rough/excoriated, no wheals, not urticarial.  Family leaving next day for extended out of town travel, so no further follow up known.
Patient developed rash below the injection site, macular, some scaling noted. Then developed body aches in arms, back, ankles and legs. Today is feeling fatigued.
Moderna vaccine # 1 caused left arm pain, difficulty moving the arm, unable to drive for 3  days, disabling. LIke a frozen shoulder. Patient recovering partially by day 4. Advised ice, pain meds and mobilizing shoulder
Patient was waiting in car after vaccine and returned to pharmacy at 1:40 (approx. 20 minutes after) stating she was okay now, but she originally felt faint, sweaty, heart racing, and dizzy.  Patient didn't receive anything due to event ending before intervention could occur.
Per Dr.'s office visit notes 8/24/18-"Adverse reaction to bacterial vaccines - Patient appears to have had a local reaction to the pneumococcal vaccination. It is erythematous and slightly warm to the touch. I am going to start the patient on a medrol dose pack to help with inflammation and erythema. In case this is a cellulitis I am going to start her on a low dose of bactrim for the next 5 days."
patient called and reported that arm was significantly swollen (more than would be expected with a vaccine) and that should could not move her arm.  Said pain was spreading to her back and was becoming so severe that should could not move her arm or walk. Advised patient to follow up with primary care physician to seek their treatment recommendation.
w/in 1 hr of vax devel starring episodes lasting approx 1 minute occuring every 1-2 hrs;
allergic reaction; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The patient had all allergic reaction to dose 1 of Shingrix. No other information was available. The reporter refused to provide any further information and hung up abruptly from the call.
no additional AEs; CMA calling to report concomitant administration of PROQUAD and VARIVAX to 1 year old patient on 12/22/2022. Caller states that patient received each vaccine in different thigh. No further information provided, no additional AEs, no PQCs reported.; This spontaneous report was received from a medical assistant referring to a 1-year-old female patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 22-DEC-2022, the patient was vaccinated with concomitant administration of varicella virus vaccine live (oka/merck)(VARIVAX) (0.5ml/once, lot # U015687, expiration date 18-MAY-2023; route was not reported)) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live ((recombinant Human albumin) rHA) (PROQUAD) (0.5ml/once, lot # W024547, expiration date 31-JAN-2024, route was not reported) for prophylaxis (overdose). The patient received each vaccine in different thigh. No additional adverse event was reported.
Extreme Agitation; Anxiety; Extreme Agitation and Anxiety but most disturbing are the vivid dreams; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EP6955) via an unspecified route of administration in the left arm on 18Mar2021 at 16:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EW0150) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. Medical history of the patient included none. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 00:00 the patient experienced extreme agitation and anxiety but most disturbing were the vivid dreams. The clinical outcome of the events extreme agitation, anxiety and vivid dreams were not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Mother of patient called approximately 2-3 hours after vaccination appointment to inform us that patient was experiencing hives "all over body" and that he is allergic to BENADRYL. Patient was referred to nearest ER.
pain in her joints after getting her first dose; This is a spontaneous report from a contactable consumer (patient herself). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration on 24Mar2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced pain in her joints after getting her first dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Medical assistant received an order from provider to administer engeryx Hep B.  Medical assistant administered Men B - Bexsero
freezing and I am hot at same time; head hurts; ache all over; This is a spontaneous report received from a contactable consumer (patient) from . The 76-years-old female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EP6955; Expiration date: not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The medical history of patient included Diabetes, blood pressure and had 2 stents on the lower part of heart. The concomitant medications included Metformin 500 mg, twice a day, blood pressure medicines, Carvedilol 25 mg and Nifedipine 25 mg. Historical vaccine included: first dose of BNT162B2 (lot number: EN6204) via an unspecified route of administration on 11Mar2021 as single dose for COVID-19 immunization. The patient reported that she had vaccine may be 5 hours ago and took temperature and it only has '1' degree (Further clarification was unknown) but she was freezing and hot at same time and her head hurts and ache all over. She took Tylenol. Patient took her second shot. When paraphrased the concern, the patient stated, she had been in bed and took 2 Tylenol and somebody told her to take Benadryl. She was not running a high fever, she just felt bad enough to be in bed. When she went in the garbage to find something, she thought she might fall and so she thought maybe somebody could get something through the drug store and get something to help. On Dec2020, the patient had laboratory tests and procedures included: sugar was 6.3, it was below 7 (rest of her blood tests were normal). Patient stated that she was not sick before she got the vaccination. The patient did not receive any treatment; she just take her morning medicine and eat breakfast and drink a lot of water and rest. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
7/18/22 ~3:30PM - started feeling congested 7/18/22 ~8:00PM - took home COVID test, returned postive result 7/19/22 - symptoms worse, body aches, sinus congestion, chills.  No fever though 7/19/22 afternoon - started paxlovid 7/20/22-7/22/22 - symptoms lessened each day 7/23/22 - took home COVID test, postive (VERY faint line) 7/25/22 - took home COVID test, negative 7/29/22 - took home COVID test, negative 8/1/22 - took home COVID test, negative Symptoms mostly gone.  Some muscle ache and sore left elbow, but not sure if related to COVID.  8/2/22 ~12:15PM - recived call from CDC Vsafe Reg asking me to submit this form.
The afternoon on 11/22/14 after pt got her flu shot, her whole arm went numb and hand painful. She says it's slowly going back to normal.
Day of shot (4/9), experienced a potential vasovagal reaction and bleeding in the arm. 10 days after shot, on 4/19,  began to feel very weak and faint, and movement became effortful, along with chills and muscle aches and soreness. This continued into 4/20. Vitals were checked and found to be normal, and by 4/21 symptoms mostly subsided, except for remaining occasional chills and muscle-aches.
Child started breaking out with lesions on 5/29/01, came into office on 6/1/01 for verification of varicella breakout.
developed shingles on 09/17/2020.  Pain and itching for at least two months. I still itching quite a lot but without pain.
Pain, swelling  and Redness at injection site. Fever, body ache , fatigue , headache  , nausea, vomiting and chills lasted till 5 pm ( 6/4/22)
This spontaneous report was received from a Nurse referring to a 67 year old female patient. The patient's concurrent conditions included hypertension. The patient did not have drug reactions or allergies. On 08-JAN-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # N020688, expiration date on 09-MAR-2019 (strength, dose number and route of administration were not provided) for prophylaxis. On 08-JAN-2018, the patient experienced a large localized reaction a couple hours after receiving PNEUMOVAX 23. The nurse reported patient had two red spots on deltoid where injection was administered that traveled to outer aspect of breast into axilla and was painful and warm. It was reported that treatment unspecified was given. At the time of the report, the outcome of erythema, injection site erythema, injection site discoloration, injection site reaction, axillary pain and feeling hot was reported as not recovered; however the nurse reported patient was doing better but reaction was still painful and now pink in color. The reporter did not assess the relatedness between erythema, injection site erythema, injection site discoloration, injection site reaction, axillary pain and feeling hot and PNEUMOVAX 23.
Initial and follow-up information has been received from the Merck pregnancy registry via a registered nurse concerning a 22 year old female smoker with a history of depression with no treatment medications, 2 previous pregnancies, 1 full term delivery at 38 weeks, 1 elective termination, and a cousin with open neural tube defect, who on 24-JUL-2007 was vaccinated IM, into the left deltoid, with a 0.5 ml first dose of GARDASIL (lot # 658822/0927U).  It was reported that a pregnancy test was negative at the time of vaccination.  Subsequently, the patient became pregnant.  The patient's last menstrual period was 14-JUL-2007 and the estimated date of delivery was 19-APR-2008.  On 13-AUG-2007 the patient was started on VITAFOL-B, once a day.  On 17-SEP-2007 an ultrasound was performed for routine viability source and dating, and the results were intrauterine pregnancy and a positive fetal heart.  On 10-OCT-2007 the patient showed to be positive for Coxsackie B titers.  On 15-OCT-2007 the patient was vaccinated with a 0.5 mL dose of influenza virus vaccine (unspecified).  On 12-NOV-2007 a Maternal Serum Alpha-Fetoprotein Screening was performed for genetic screening, and the results were within normal limits.  On 15-NOV-2007 a level II ultrasound was performed for genetic screening and fetal anatomy, and the results were within normal limits.  On 18-DEC-2007 a fetal echocardiography was performed and was within normal limits.  On 31-JAN-2007 at 28 weeks gestation the patient received a 300 microgram dose of globulin, immune because she was Rh negative.  Unspecified medical attention was sought.  At the time of the report, the patient's outcome was unknown.  On 12-APR-2008 the patient gave birth to a female infant at 39 weeks.  The infant weighed 6 pounds 3 ounces, was 18.5 inches long, had an apgar score of 8/9, and a head circumference of 32cm.  The infant was normal with no congenital anomalies, complications, or abnormalities.  The patient experienced Leukocytosis, Bandemia, and positive Coxsackie B titers during pregnancy.  At the time of the report the patient had recovered from leukocytosis and bandemia.  The outcome of the positive Coxsackie B titers was unknown.  Additional information is not available.
Low grade fever 100.7 degrees, and increased fussy through next 12 hours, with increased fussy following 12.  Injection site looks normal.