chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; chills; migraine; night sweats; diarrhea; loss of taste; loss of smell; This is a spontaneous report from a contactable other healthcare professional, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 21Mar2021 at 16:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic pelvic pain, depression, anxiety, pudendal nerve neuralgia, endometriosis, and Factor V Leiden. The patient previously received prednisone (MANUFACTURER UNKNOWN), LEVOQUIN and CIPRO and experienced drug allergy. Concomitant medications included lamotrigine (LAMICTAL), venlafaxine hydrochloride (EFFEXOR SR), ondansetron (ZOFRAN), topiramate (TOPAMAX) and levorphanol (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: unknown) via an unspecified route of administration in the left arm on 28Feb2021 at 16:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. 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 was not tested for COVID-19. On 02Apr2021 at 14:00, around a week and half after the patient experienced fever, chills, migraine and night sweats, diarrhoea, loss of taste and loss of smell. The night sweats were for approximately 3-4 days after vaccine. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events fever, chills, migraine, night sweats, diarrhoea, loss of taste and loss of smell were resolving.   No follow-up attempts are needed; information about lot number cannot be obtained.
palpitation; Pain in legs; Arm soreness; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (palpitation), PAIN IN EXTREMITY (Pain in legs), PAIN IN EXTREMITY (Arm soreness) and FATIGUE (fatigue) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (palpitation), PAIN IN EXTREMITY (Pain in legs), PAIN IN EXTREMITY (Arm soreness) and FATIGUE (fatigue). At the time of the report, PALPITATIONS (palpitation), PAIN IN EXTREMITY (Pain in legs), PAIN IN EXTREMITY (Arm soreness) and FATIGUE (fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Heart rate: 130 (High) Initially 130 and then dropped to 105.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
My arm is in some real pain and so is my back. My arm had a huge bump and very red
Five minutes after taking the vaccine, patient c/o facial burning, face turning red, facial tingling, and feeling shaky. Admin Benadryl 25 mg PO.  Patient c/o tongue numbness.  B/P 180/94.  HR 70;.  EMS arrived for transport but patient declined.   Symptoms resolved.  F/U with patient confirmed that she went to ER. Admin Decadron
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX dose 1, (dose, lot # and expiry date unknown). On 27-JAN-2011, the patient was vaccinated with improperly stored VARIVAX dose 2 (dose unknown), from lot # 666869/0469Z with expiry date of 31-MAR-2012. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review of records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient had a rash like reaction with swelling with fatigue.  Started on 1/25/2021 thru 2/5/2021.
This spontaneous report received from a consumer concerned a 55 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 not reported, batch number: 206A21A and expiry: 21-SEP-2021) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, atorvastatin, clopidogrel, colecalciferol, and metoprolol succinate.  On an unspecified date, the patient experienced swelling left leg, skin irritation on legs, occasional charlie horses in legs, knots in calves, back pain, chest pain, rapid pulse elevated to 20 bpm for over an hour to two hours, edema, calf pain, and pain left shoulder blade. Laboratory data (dates unspecified) included: CT scan (NR: not provided) negative, Cardiac catheterization (NR: not provided) fine, Diagnostic ultrasound (NR: not provided) detected no clots, and Pulse rate (NR: not provided) rapid. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from edema, had not recovered from pain left shoulder blade, back pain, chest pain, and rapid pulse elevated to 20 bpm for over an hour to two hours, and the outcome of calf pain, swelling left leg, skin irritation on legs, occasional charlie horses in legs and knots in calves was not reported. This report was non-serious.
Chills through the night; fever; headache; pain in the left arm; body ache (back); This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: EL3247) via an unspecified route of administration in right arm on 30Mar2021 at 11:30 (at the age of 34-years-old), as a single dose for COVID-19 immunisation. Medical history included allergies. Concomitant medication received within two weeks of vaccination included Xyzal for allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: EL3247), via an unspecified route of administration in the left arm on 09Mar2021 at 10:30 (at the age of 34-years-old), as a single dose for COVID-19 immunisation. On 31Mar2021 at 00:00, the patient experienced chills through the night, fever, headache, pain in the left arm and body ache (back). No therapeutic measure was taken for the events experienced. The event neither resulted in doctor or other healthcare professional office/clinic visit nor in emergency room/department or urgent care. The clinical outcome of the events chills through the night, fever, headache, pain in the left arm and body ache (back) was resolved with lasting effects.  No follow-up attempts are needed. No further information is expected.
Pt. received ADACEL and MENACTRA to LD, syncoped and hit head on window sill in room. Received staples for laceration to head in ER. Returned on 10/25 for possible concussion and vaccine reaction to LD. Raised induration 11 cm x 11 cm and warm.
This case was reported by a physician and described the occurrence of hepatitis B surface antigen positive in a 66-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject's medical history included open heart surgery with aortic valve replacement approximately 6-8 months ago. Concurrent medical conditions included type 2 diabetes. The subject's LFT's had never been elevated and she had not been diagnosed with Hepatitis B infection. She has one family member who has active Hepatitis B under treatment. Concurrent medications included Heparin, EPOGEN, and HECTOROL. The subject was on dialysis. On 30 August 2010, 27 September 2010 and 29 October 2010 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (40 mcg, unknown, right arm). On 1 November 2010, 3 days after vaccination with dose 3 of ENGERIX B, 35 days after vaccination with dose 2 of ENGERIX B, 63 days after vaccination with dose 1 of ENGERIX B, the subject experienced hepatitis B surface antigen positive. Relevant diagnostic findings included hepatitis B surface antigenemia identified in a blood sample on 01 November 2010. At the time of reporting the outcome of the event was unspecified. The physician considered the event was possibly related to vaccination with ENGERIX B.
Evening of shot, sore arm and extreme fatigue.  Following day, tired with ?brain fog?.  Third day, brain fog worsens, depression begins. Fourth day, confusion, withdrawal from interacting with others, worsening depression.  Subsequent days, increasing confusion and severe memory problems. Becoming alarmed at inability to respond and ?find words?.  By weekend, (5 days after shot) suicidal ideation, stopped talking to people (I live alone, but would regularly speak to neighbors and family prior to this episode).  This rather alarming condition finally began to lift about 2days ago.    I have a decades-long history of depression and have taken medication for it on and off since my 30?s. I must say I have concerns about getting a second shot next month because of the major depression as well as memory problems. ( I have been experiencing memory challenges for the last few years, and my Mom died of Alzheimer?s.)
CHILLS; BODY ACHE; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022) .5 ml, once a total administered on 05-MAR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) no fever. On 05-MAR-2021, the subject experienced headache. On 05-MAR-2021 14:45, the subject experienced body ache. On 05-MAR-2021 15:30, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache on MAR-2021, chills on 05-MAR-2021 16:30, and headache on 06-MAR-2021. This report was non-serious.
This spontaneous report was received from a pharmacist, referring to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 30-SEP-2015 (reported as "2 days ago"), the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route, lot # and expiration date were not reported). No concomitant medications were reported. On an unspecified date in 2015, the patient developed a "2 by 5 centimeter raised", swollen area" at the injection site that was itchy. The patient sought medical attention by visiting the pharmacist. At the time of the report, the outcome of injection site swelling and injection site pruritus was unknown. The relatedness between injection site swelling and injection site pruritus and the ZOSTAVAX was not provided. No product quality complaint was involved. Additional information has been requested.
1. Headaches pressure 27+ days & continuing 2. Chest pain & pressure 27 + days & continuing  3. Temporary paralysis & unable to speak: 15-20 seconds. One episode
Fatigue, muscle aches, headache, swollen lymph nodes, pain, malaise and fever greater than 102 degrees F. (101-102 degrees for 2 days).  Missed work for 4 days.  All symptoms subsided by 11th day.  Took Ibuprofen and bedrest for 5 days.  Noticed irregular heartbeat for 2 weeks.  Worst days 03/02 to 03/07/2003.
Nausea; Fatigue; Head fog; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included the patient already had Covid 'more than 90 days ago'. The patient's concomitant medications were not reported. The patient experienced nausea, fatigue, head fog on an unspecified date. The outcome of the events was unknown. Information on Lot/Batch number has been requested.
Information has been received from a pharmacist concerning a male "between the ages of 40 and 50" with hypertension and a history of a myocardial infarction and no drug reactions/allergies who between 1989 and 1992 was vaccinated with the first, second, and third doses of hepatitis B virus vaccine or hepatitis B virus vaccine plasma-derived (the patient could not remember what vaccine he received). Concomitant therapy included hydrochlorothiazide. Subsequently the patient experienced thrombocytopenia and a positive core antibody. He did not have symptoms at the time of vaccination. Unspecified medical attention was sought. The outcome was reported as not recovered. No additional information was available. There was no product quality complaint. The pharmacist indicated that these events are possibly related to vaccination with hepatitis  virus vaccine rHBsAg (yeast) or hepatitis B virus vaccine plasma-derived. Additional information has been requested.
feel muscle aces all over body, bad headace,.wheezing ,trouble breathing. shortness of breath., feel like I have to throw -up, Flu like symtons, weakness, chills, but I do NOT have fever. was vaccinated May 6th 2021, seven days ago
Information has been received from registered nurse (R.N.) concerning a male child patient who on unspecified date was vaccinated with a dose of VARIVAX (Merck) (Lot number unknown). The nurse reported that the child received a booster dose of the vaccine and had chicken pox. At the time of report, the patient's outcome was unknown. The patient sought medical attention at the doctor's office. Additional information has been requested.
Positive antigen tests for COVID-19/ had 2 Pfizer/BionTech vaccines-has COVID; Positive antigen tests for COVID-19/ had 2 Pfizer/BionTech vaccines-has COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jan2022, outcome "unknown" and all described as "Positive antigen tests for COVID-19/ had 2 Pfizer/BionTech vaccines-has COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200035829 Same reporter/RA, Different patient/AE
after 24 hours, had chilling, joint stiffness, fatigue, nausea, dizziness.  this resolved after 12 hours of rest.
Two days after receiving the vaccine (3/14/21), I got a fever ranging from 99.0-100.5 degrees F. I had muscle aches, a headache, and a runny/stuffy nose. This persisted for 2 days. Four days after the vaccine (3/16/21), I no longer had a fever, but I still had sinus pressure and I had a stuffy nose and was sneezing and felt generally groggy/tired. By seven days after receiving the vaccine, I had extreme sinus pressure and my symptoms had been 'passed on' to my finance. We both took a covid test on 3/19/21 and we both came up covid positive.
The patient reported having significant pain, redness, and swelling at injection site within a day after administration. She stated that a large hard nodule about the size of her fist developed below the site of injection and traveled down her arm toward her elbow. She also developed severe mouth sores, similar to canker sores that are very painful. She states that her doctor told her it is related to the herpes zoster virus, and treated her with valacyclovir.
BODY ACHE; NO SLEEP; FEVER; HEADACHE; CHILLS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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: Unk) dose was not reported, administered on 10-MAR-2021 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 an unspecified date, the subject experienced body ache, no sleep, fever, headache, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache, body ache, chills and no sleep was not reported. This report was non-serious.
Said he had a headache after second dose of vaaccine; This is a spontaneous report from Pfizer Sponsored Patient Support Program from a non contactable male consumer (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient previously received  bnt162b2 (BNT162B2) for covid-19 immunization.The patient said he had a headache after second dose of vaaccine on an unspecified date.  Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
6-13-19 Client reports "large knot" on Right deltoid that has decreased in size but noticed redness of RD this AM - 6-19-19. Oblong area of redness of RD of about 2cm x 3.5cm. No swelling noted by Nurse. Client reports pain in right arm gong down outside of arm. 6-21-19 Called & spoke with client. Stated arm is much better. Just very small area of redness & very small knot
Pt broke out in hives about 60 seconds after receiving Hep A #1. BENADRYL given and hives stopped and began to clear up. Pt sent home and mom to give BENADRYL in another 6.
A non-serious spontaneous report of wheezing and fever has been received from a nurse concerning a four-year-old male subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient had no history of wheezing. The patient received the first dose of FLUMIST on 01-Sep-2008. Approximately nine to ten hours after receiving FLUMIST, the patient developed a fever and wheezing. The patient was given acetaminophen. The outcome was not reported.
HIGH FEVER OF 103 FOR 6 HOURS, SEVERE CHILLS, MUSCLE AND JOINT PAIN AND SEVERE HEADACHE THAT LASTED FOR 12 HOURS
Student reports noticing rash on back and chest 1 day after receiving 2nd Hep B injection. No symptoms after 1st injection. 5/17/01 T 98.7, BP 100/60, P 72
Presented on 4/26/2021 to the Medical Center ER with chest pain.  CTA showed 1. Examination limited by patient motion artifact. There are likely small  bilateral segmental pulmonary emboli.   2. Trace effusions.   3. Mild groundglass interstitial prominence could relate to atypical  infectious etiology or edema.   4. Severe colonic distention again demonstrated and is incompletely assessed.
Lady called Saturday 10-24 and stated she had received a Flu shot Thursday 10-24 ( Flucelvax was given ). Says since then has had hives on body including on eyes. Is allergic to eggs, as she stated on her VAR and said she last had a flu shot "about 15 years ago". She was looking for an antihistamine. Helped her and then said we would document her reaction and report it accordingly
On 1/16/00, the pt developed a "rash on her trunk, neck, arms and legs. The lesions were widespread but were not counted. The pt had a low-grade fever. On 1/18/00, it was reported that the pt is better today with no new lesions." The pt sought unspecified medical attention. Additional information has been requested.
No additional AE reported; that vaccines were previously short dated for 1 month after excursion and then were administered after the short date; This spontaneous report was received from a medical assistant and refers to a male patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On 01-NOV-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T032321, expiration date 22-SEP-2022 (short expiration date reported as 15-OCT-2021) for prophylaxis (dose, anatomical location and route of administration were not reported). It was reported that that vaccines were previously short dated for 1 month after excursion and then were administered after the short date.  The vaccine was stored at the temperature that was reported as 55.9 degrees of Fahrenheit for 30 minutes. There was no previous temperature excursion reported. The date of excursion was provided as 15-SEP-2021.
Pt recv vax on 11/4/98; on 11/7/98 pt exp fever, red/hot/painful arm; tx=Keflex; dx=cellulitis
Patient got a fever Sat 12-4-10 early afternoon of 101.3. I began giving her Tylenol every 4 hours. Around 3:00am she threw up twice. At 5:30pm Sun 12-5-10 her fever was 102.8. I took her to the Hospital right away and within an hour she had a seizure. They ran blood tests and did an xray and determined it was a febrile seizure.
Lump on neck; This spontaneous case was reported by a consumer and describes the occurrence of NECK MASS (Lump on neck) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044AZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced NECK MASS (Lump on neck). At the time of the report, NECK MASS (Lump on neck) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment medication was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: TCR Received-AE Outcome and patient gender provided
An attorney alleged that a male infant received Tri-Immunol vaccine on 8/18/94. Within hours of receiving the vaccine, the infant suffered neurological illness. It is alleged that, as a result of Tri-Immunol administration, the infant suffered severe and permanent harm, including but not limited to, a seizure disorder, convulsions, encephalopathy, mental retardation, hypotonia, coordination problems, ataxia, lethargy, developmental delay, physical and mental pain, suffering and emotional distress.