chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediately following the vaccine, he compained his throat hurt and it was tight.  He was given water and Dr. checked his throat, nothing noted.  He was given more water and we checked out and left the office.  About 3-5 minutes later, his eyes were swollen almost shut, ears, face and lips were bright red, and lips were swollen as well.  He had a rash from head to toe, and his voice was very hoarse. He was also shaking. We drove back to the Dr. office about 5 minutes later, where the doctor kept him under his supervision until the ambulance arrived.  At the Emergency room, he was given a steroid and Benadryl as well as a prescription for an EPI pen to be carried with him.
Hypotonic episode preceeded by lethargy w/low grade fever 3 hrs post 1st inject; Was hospitalized; Temp inc; DC 9APR90; Seen in office 11APR90 appears well;
Varicella - Information has been received from a man from the massachusetts department of public health concerning a 4 year old female with asthma who on 17 Dec 1996 was vaccinated with one dose of varicella virus vaccine live.  Subsequently the patient experienced less than 50 varicella lesions on the chest, back, and nect.  This was considered a mild case of varicella.  On 12 May 2000 PCR analysis revealed wild type varicella virus.  the patient was otherwise healthy.  The patient was not an oral or inhaled steroide at the time of vaccination or within 42 days thereafter.
Developed chicken pox 20 days after getting the shingles shot. Saw doctor 5/31 and 6/7/13. Titers blood draw 3.9. Took acyclovir 400mg and doxycycline hyclate 100mg.
8 days after receiving the COVID vaccine, pt developed a local site reaction of redness, swelling and itching.
On 1/25/2021 patient reports experiencing vertigo and required a procedure at physical therapy to resolve. On 01/27/2021 patient experienced tachycardia of 175 and was sent to emergency room. ECG showed SVT
Information has been received from a nurse practitioner concerning an 11 year old male patient who on 18 Sep 2006 was vaccinated with a 0.65 ml dose of Varicella-Zoster virus vaccine live. The NP noted that the patient had been given Varicella Zoster vaccine because the vaccine was stored where the varicella virus vaccine live usually is stored. The NP also noted that "this is not a product confusion". Unspecified medical attention was sought and no adverse reaction was reported. No product quality complaint was involved. Additional information has been requested.
Delayed menstrual cycle, no treatment, negative Home pregnancy test on 4/15/21. Date of expected period start 4/8/21. We use natural family planning and my normal mental cycles are regular.
This report is regarding the Pfizer COVID-19 vaccination you received on the above date, which was lot number FD0809. The Public Health District, per guidance from the Department of Health (DH), Centers for Disease Control and Prevention (CDC), and Pfizer have determined that the dose of vaccine that the patient received is valid.
Information has been received from a healthcare worker referring to multiple unknown patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # M026309, expiration date 11-NOV-2018; dose and route were unknown) for prophylaxis. No adverse effects were reported. The excursion temperature was 52 Fahrenheit degree for 17 hours and 30 minutes. There was no previous temperature excursion. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA001267: US-009507513-1612USA010695:
Client presented to the Health Department on 9/15/2014 with c/o onset of rash on 9/12/2014.  Macular-papular lesions present on left arm, concentrated near exterior side of left elbow and left forearm.  2-3 lesions each on ankles, neck, left mid abdomen and upper back. C/o itching. Denies any fever, chills, fatigue, malaise, sore throat, cough or  other prodromal type symptoms.
This spontaneous report as received from a nurse (reported as health care worker) refers to a 67 year old female patient with drug allergies SERZONE and penicillin. The patients pertinent medical history included severe pulmonary hypotension and restrict airway disease. On an unknown date in 2003, the patient was vaccinated with PNEUMOVAX23 (dose and frequency were not reported). Concomitant medications were not reported. On an unknown date in 2003 the patient had a local injection site reaction after being administered PNEUMOVAX23. It was unspecified whether the patient sought medical attention or not. The outcome of local injection site reaction was unknown. The causality of local injection site was not reported. No product quality complaint was filed for PNEUMOVAX23. Additional information is not expected.
Lot of side effects; I was in bed for 36 hours; Muscle pain; Chills; Fever; Nausea; Headache; Body was aching; fever continued till next day; Feeling tired; Weak; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Lot of side effects), BEDRIDDEN (I was in bed for 36 hours), MYALGIA (Muscle pain), CHILLS (Chills) and PYREXIA (Fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, LISINOPRIL and METOPROLOL for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Lot of side effects), BEDRIDDEN (I was in bed for 36 hours), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache), MYALGIA (Body was aching), PYREXIA (fever continued till next day), FATIGUE (Feeling tired) and ASTHENIA (Weak). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, ADVERSE EVENT (Lot of side effects), BEDRIDDEN (I was in bed for 36 hours), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache), MYALGIA (Body was aching), PYREXIA (fever continued till next day), FATIGUE (Feeling tired) and ASTHENIA (Weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
He said 2 hrs after the vaccination he felt something unusual and it lasted for 19 days. He did not call pharmacy or physician regarding this discussed with MD & RPh on 4/8/13.
Extreme joint pain; fever; blurry eyesight; confusion; severe sensitivity to light; migraine headache; sore muscles; extreme tiredness; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: en6200) via an unspecified route of administration, administered in Arm Left on 18Feb2021 16:30 (at the age of 41-year-old) as single dose for COVID-19 immunization. Medical history included migraines. The patient had allergies to medications, food, or other products such as Penicillin, pineapple, gold, lanolin, hair dye. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received other medications (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: el8982) via an unspecified route of administration, administered in Arm Left on 25Jan2021 09:15 (at the age of 41-year-old) as single dose for COVID-19 immunization. Since 19Feb2021 04:00, the patient experienced extreme joint pain, fever, blurry eyesight, confusion, severe sensitivity to light, migraine headache, sore muscles, extreme tiredness lasting 3 days. Joint pain subsided after 30 hours. The reporter assessed the events as non-serious. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events was recovered with sequelae in Feb2021.  Follow-up attempts completed. No further information expected.
Dose #1:  Extreme fatigue, headache, injection site swollen, hot, hard red.  After taking my Repatha injection 3 days later, BP went up to 164/112.  Dose #2:  Extreme fatigue, headache, injection site swollen, hot, hard, red.  10 hrs later:  hands & feet freezing cold, shivering, sweating as temperature rose to 101.8, body aches, joint pain.
70 year old PT comes to observation presenting a persistent cough when sitting down, refers to feeling a sensation of heat on the neck, face and ears. Taking his vitals presents  P. 79, T. 36.7c, BP. 180/70, RESP. 20, Right. 379mg/dl.
Redness; cramps; bowel issues, feel sick to her stomach; inflammation which is spread around the injection site; headaches; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), MUSCLE SPASMS (cramps), ABDOMINAL DISCOMFORT (bowel issues, feel sick to her stomach), INJECTION SITE INFLAMMATION (inflammation which is spread around the injection site) and HEADACHE (headaches) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0530M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE and SIMVASTATIN for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced ERYTHEMA (Redness), MUSCLE SPASMS (cramps), ABDOMINAL DISCOMFORT (bowel issues, feel sick to her stomach), INJECTION SITE INFLAMMATION (inflammation which is spread around the injection site) and HEADACHE (headaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Redness), MUSCLE SPASMS (cramps), ABDOMINAL DISCOMFORT (bowel issues, feel sick to her stomach), INJECTION SITE INFLAMMATION (inflammation which is spread around the injection site) and HEADACHE (headaches) had not resolved.        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.
This case was reported by a other health professional via call center representative and described the occurrence of crying in a 2-month-old female patient who received ROTARIX (batch number A41CB568A, expiry date 17th October 2017). On 10th November 2016, the patient received ROTARIX (oral). On 10th November 2016, less than a day after receiving ROTARIX, the patient experienced crying, vomiting and underdose. On an unknown date, the outcome of the crying, vomiting and underdose were unknown. It was unknown if the reporter considered the crying and vomiting to be related to ROTARIX. Additional details were provided as follows: The GlaxoSmithKline had not been previously contacted about any adverse event for this patient. This case was not associated with product complaint. After the ROTARIX vaccine was administered the patient received other intramuscular injections, began to cry and threw up the ROTARIX, which led to underdose.
From the beginning I felt that the injection was given too high and not in the deltoid muscle. It was injected just below the shoulder. My arm was sore within an hour of injection at 1 pm and got progressively more sore so that by 6 pm the  left arm felt weak and heavy and hard to move up above my head.  I became light headed and weak and went to bed at 7 pm.  I took an advil at 8:15 pm and did sleep quite well for several hours, but the arm still was sore and weak.  Occasionally, I would get a  quick  sharp 'quiver' up the left side of my neck. In the morning I had a headache and took another advil. I was able to eat, not so weak and the arm felt a bit stronger.  I did a search regarding what could happen if a shot was given too high in the arm. I drove to pharmacy and talked with the pharmacist about my experience which I had never had with the high dose flue shot for over 65.  She didn't seem too concerned and advised to continue drinking lots of water and return if symptoms continued.  I rested most of the day and the pain and movement did improve   though still sore. I slept quite well and was able to function on Sep 11, the next day.
Information has been received from an office worker in a physician's office concerning her 13 year old daughter, who on 18-APR-2007 was vaccinated with a first dose of Gardasil and developed cellulitis. She went to the Emergency Room (E.R.) and received an anti-biotic. The patient was recovering. Additional information has been requested.
Macular rash on neck, face and digit faint redness of trunk and limbs, mother giving Tylenol advise discontinue and discontinue new foods stated this week.
new onset tachyarrhythmia associated with SVT confirmed by Holter monitor associated with palpitations and elevated heart rate which was noticed at rest and with exercise.
Patient had Dtap and phemonia shot. He can?t move his legs. Won?t walk at all.  Is in pain when I try change diaper.
low grade temp, body aches, headache 48 hours after vaccine which lasted 24 hours 1 week after the vaccine, hard, red swollen lump at the injection site
Long lasting muscle pain that slowly lessens.  Pain still there after 2 months of vaccine injection.
Started with chills about 10.5 hours after shot. Took temperature and noted a fever of 101.1F at the 12 hour mark along with a headache and fatigue. Improved moderately with taking ibuprofen and rest, fever ended after 24hours post vaccine. Lingering headache for the next 12 hours.  Completely resolved at 36 hours.
Tiredness; This case was reported by a nurse via sales rep and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were provided as follows: Patient was employee at practice. The age at vaccination was not reported. The patient reported that after immunization they were tired for 1 to 2 days. This case has been linked with case US2019AMR097190, US2019AMR097048reported by the same reporter.
Expired Twinrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 22-year-old male patient who received HAB (Twinrix) (batch number X239D, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st September 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 1st September 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 01-Sept-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Twinrix, which led to expired vaccine used. The case was linked with case US2022126915 and US2022126900, reported by same reporter.; Sender's Comments:  US-GSK-US2022126915:Same reporter US-GSK-US2022126900:Same reporter
Information has been received from a consumer concerning her 23 year old daughter who in August 2008, was vaccinated with the first dose of GARDASIL. In August 2008, after vaccination, the patient experienced swollen nodes in her armpit since then. It was reported that the swelling started in her left armpit and then went away, and reappeared in her right armpit. At the time of the report, the swelling was in the left armpit. Additional information has been requested.
urine's color is like an iced tea; chills; chilling with fever; terrible headache; got sick; body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHROMATURIA (urine's color is like an iced tea), ILLNESS (got sick), MYALGIA (body aches), CHILLS (chills) and PYREXIA (chilling with fever) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (First dose and Lot number CC) on 17-Mar-2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE.    On 19-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Dec-2021, the patient experienced ILLNESS (got sick), MYALGIA (body aches), PYREXIA (chilling with fever) and HEADACHE (terrible headache). On 21-Dec-2021, the patient experienced CHROMATURIA (urine's color is like an iced tea) and CHILLS (chills). At the time of the report, CHROMATURIA (urine's color is like an iced tea), MYALGIA (body aches) and CHILLS (chills) had not resolved and ILLNESS (got sick), PYREXIA (chilling with fever) and HEADACHE (terrible headache) outcome was unknown.            No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
patient began complaining of throat burning, lungs burning that feels like after she is running.  She also has a dry cough.  No fever.  Asked mother to just monitor symptoms, and let us know if they don't resolve or they get worse.
broke out into hives in my face and neck; short of breath; Exhaustion; This is a spontaneous report from a contactable Other Health Professional (patient). A 36-year-old female patient received first dose of BNT162B2 (Pfizer BioNTech COVID-19 EUA30, lot# EL1284), via an unspecified route of administration in left arm on 28Dec2020 08:45 at single dose for covid-19 immunization.  Medical history included Allergies: Penicillin, Bactrim (sulfamethoxazole, trimethoprim), tomatoes.  The patient's concomitant medications were not reported.  After 25 minutes of getting the first dose of the vaccine, the patient broke out into hives in face and neck. Hives continued for days. By day 3, the patient was checked into the hospital for short of breath, hives and exhaustion. A week after dose 1, the patient still had hives and slight shortness of breath. Pregnant at the time of vaccination: No. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. AE treatment: COVID test and steroids. If COVID prior vaccination: No. If COVID tested post vaccination: Yes. Covid test post vaccination: Nasal Swab on 01Jan2021, Negative result.  Facility where the most recent COVID-19 vaccine was administered: Hospital. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: NO. The outcome of all the events was not recovered. Serious: no. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: no. Seriousness criteria-Caused/prolonged hospitalization: no. Seriousness criteria-Disabling/Incapacitating: no. Seriousness criteria-Congenital anomaly/birth defect: no.
Case number PHEH2015US025172, is an initial spontaneous report received from a consumer on 01 Dec 2015. This report refers to a patient of unknown demographics. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly and DTP vaccine (manufacturer and batch number: not reported) on an unknown date. On 3 Nov 2015, the patient experienced extreme pain and right shoulder tendinitis. Final outcome of the events was unknown. Seriousness and causality of the events was not reported. Seriousness of the events was upgraded based on information available in the source document.
Patient had an episode where he stiffened and eyes rolled back, lasted 10 sec. Mother denies color change, no shaking. Pt returned to baseline after episode and then went to sleep.
Pt presents with swollen area of left thigh 35cm X 40cm in size at 16:00. Mom complained that pt has cried since receiving injection at 11:30. Area has no redness or heat. Mom calls on 4/9/01 and states that pt is better.
Approximately 2 hours post vax the patient developed a big knot at the injection site. The area was very red and itched. That evening the arm was very swollen to the elbow, red, hot to touch and itched. The patient could not remove her rings and her ankles were also swollen. The patient was treated with Benadryl and cold compresses.
Injection site - tenderness Fatigue Chills, which led me to take temp. Temp - for 3 days, starting on 4/3/2021.  100.0 - 100.2
3 Days after shot tightness in chest occurred, on the 4th morning patient went to Hospital and was admitted with myocarditis and pericarditis following x-rays, ekg, and bloodtests showing elevated troponin and white blood cell count. Next 24hrs patient was monitored, given Indomethacin, and lovenox. Patient responded well with no continued chest tightness and was discharged 5 days after initial vaccine.
This is a spontaneous report from a contactable consumer received via a sales representative.  A 12-month-old patient of an unspecified ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain at the injection site that is more painful compared to other vaccines (non-serious) on an unspecified date with outcome of not recovered. The information on the batch number has been requested.
02/20/23 presents to ED for "diarrhea, cough, fever, chills". PMHx of "diabetes, asthma, OSA and hypertension"
ached badly all over,  terrible headache, vertigo, brain fog, nausea,  tiredness
(L) erythema to injection site instantly. 70cm x 45cm area inflamed, whelped. Area on opposite arm inflamed from tourniquet. 45 min area still inflamed. Decreasing in whelp. No SOB. Anthrax (L).
weakness and paresthesia of bilateral lower extremities and bilateral hands, areflexia of bilateral lower extremities. Suspicious for Guillain-Barre Syndrome
Patient developed redness around the injection site beginning on 7/21/19 around mid-day. Patient previously experienced reaction with first dose so patient drew a line around the redness that evening and it became worse the next morning. States that she had fever, chills, headache, aches, and tired. She was seen at urgent care on 7/22 where she was diagnosed again with cellulitis and given a course of antibiotics.
Rash. skin warm, firm, erythematous diffuse about 8 X 11 cm.
pt c/o site of TD being sore, red, swollen;site had 1 1/2cm red & hard knot in deltoid
She didn't have an adverse event but she should have received bivalent and got the original Moderna.