chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was administered 2/3/11. By the PM of 2/4 my upper right arm was red hot & swollen to the size of a tennis ball. I was feverish (101 degrees) and chilled. My arm was painful. I could not sleep. This faded over about 2 wks.
Worst headache (9/10), nausea, vomiting, upset stomach, felt like I had a fever.
Before the vaccine the patient suffered from fatigue and hot flushes from her menopause, which totally went away after the 2nd dose/the shots were good and made her feel great; Hot flashes returned; This spontaneous case was reported by a nurse and describes the occurrence of HOT FLUSH (Hot flashes returned) and THERAPEUTIC RESPONSE UNEXPECTED (Before the vaccine the patient suffered from fatigue and hot flushes from her menopause, which totally went away after the 2nd dose/the shots were good and made her feel great) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Fatigue (fatigue and hot flushes from her menopause), Hot flushes (fatigue and hot flushes from her menopause) from January 2020 to March 2020 and COVID-19 on 23-Dec-2020. Concurrent medical conditions included Menopause (fatigue and hot flushes from her menopause) since January 2020. Concomitant products included IRON and MULTIVITAMIN [VITAMINS NOS] from 07-Jul-2006 to an unknown date for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced HOT FLUSH (Hot flashes returned). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Before the vaccine the patient suffered from fatigue and hot flushes from her menopause, which totally went away after the 2nd dose/the shots were good and made her feel great). At the time of the report, HOT FLUSH (Hot flashes returned) had not resolved and THERAPEUTIC RESPONSE UNEXPECTED (Before the vaccine the patient suffered from fatigue and hot flushes from her menopause, which totally went away after the 2nd dose/the shots were good and made her feel great) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was available.  Patient informed that after receiving her Moderna 2nd shot, hot flashes were completely gone for three months. However, hot flashes had returned at the time of this report.   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Patient demographics, Concomitant medicine( multivitamin), medical history, event, lab data added.
Pt states he felt nauseous soon after vaccination. Pt has no other complaints. Pt educated on next course of action. Pt has not vomited in our presence. Pt released w/ all questions asked and answered.  Pt states symptoms have become more manageable during observation period.
Injection site bruised; Large red spots with swelling underneath/welts. Upper arm all swollen. Extremely painful.
I started with a scratchy throat on June 18, 2022. On June 19th I was not feeling much worse. On June 20th I was really tired, but I didn't think much of it. That evening I felt kind of nauseas and really tired. When I got home I tested positive for covid. The next day it felt like I had a bad case of the flu. I had body aches and terrible headaches. That day on June 21st I had a telemed appointment with a nurse practitioner. She prescribed me paxlovid, prednisone, azithromycin, and  benzonatate. I only took the paxlovid. I took the first dose of it that evening. The next day I was feeling a lot better. That weekend I was feeling pretty good. I have a little congestion still but not much. I am about 98% recovered.
Moderna Covid 19 Vaccine EUA patient complains of low grade temp 99-100. Had sweating, fatigue, headache, felt like he was  "hit by a truck". Took Tylenol every 6 hours as  needed for symptoms.
Moderna COVID-19 Vaccine  Fever of 103.5F (ear), fatigue, headache, muscle pain, joint pain, chills, and nausea started 12 hours after vaccine and  lasting 24 hours. Fever, headache, and fatigue continue at 32 hours.
Rash with hives on left arm. Spread to face, neck , chest. Burning and itchy. I took Bendryl. Applied Triamcinolobe cream with cold damp cloth to all effected areas.  Did go to urgent care. Was told it was a reaction. Take Bendryl every 6 hours.
A pharmacist reported pt exp agitation, tachypnea and hypotension. Pt was sent to ER and received O2.
Herpes zoster over V facial nerve, facial branch involving forehead, scalp on lt side to midline lt upper lip occurred 2yr p/vax given;
This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (Lot # not reported) on 10-JUL-2012, received the second dose of GARDASIL (Lot # not reported) early on 07-AUG-2012 and the third dose of GARDASIL (Lot # not reported) early on 02-OCT-2012. No symptoms were reported. Additional information has been requested.
pt recv vax 23JAN97 & devel an abscess & soreness @ the inj site w/inc pain until 29JAN97;30JAN97 pt devel fever of 102 & redness @ inj site;presented to MD or ER & tx w/ATB;devel classic fine, red rash on face & arm;
Pt's third pregnancy where dose of TDaP has been given with each pregnancy within a span of 5 years. All normal weight kids. At the last (third) pregnancy, the dose is given at 4pm and patient started experience muscle weakness, pain later that evening around 11 pm. Overnight and the next morning, patient had continued weakness, chills, fevers and unable to move easily.
This case was reported by a consumer and described the occurrence of skin inflammation in a 48-year-old female subject who was vaccinated with Flu vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. The subject's medical history included erythrokeratodermia variabilis. Concurrent medical conditions included chronic asthma. Co-suspect medication included SORIATANE. Concurrent medications included Albuterol nebulizer, Theophylline, ZYRTEC, Spironolactone, ADVAIR, VENTOLIN, FLONASE, Epinephrine, BENADRYL and Diazepam. The subject started treatment with SORIATANE in August 2010. On an unspecified date in 2010, at 11:00, the subject received a dose of Flu vaccine in the right arm. At 14:30, 3.5 hours after vaccination with Flu vaccine, the subject experienced skin inflammation, skin red, itching like crazy, skin raised and change in skin texture. Skin breakdown was also reported, however, no specific onset time was indicated for this event. It was noted by the subject that these events involved her torso and right hand. She stated that she almost died from the "allergic reaction" from the flu vaccine and SORIATANE combined, however, the subject believed that the flu shot was the main cause because she reported using SORIATANE in the past with no problems. The subject was taken to the emergency room and hospitalized as a result of these events. SORIATANE was discontinued by hospital personnel on an unspecified date in September 2010. The duration of SORIATANE treatment was reported to be 5 weeks. It was not known if the subject ever completed her SORIATANE therapy. It was reported that events of skin inflammation, skin red, itching like crazy, skin raised and change in skin texture had resolved. Outcome of skin breakdown, allergic reaction and possible drug interaction were not specified. Attribution of the events to Flu vaccine and SORIANTANE treatment was not reported except that the subject did indicate that she felt the "allergic reaction" was from the Flu vaccine and SORIANTANE combined.
headache, sore throat, nonproductive cough, chills, diarrhea, ear pain, sinus congestion, post nasal drainage. starting 12/18/21
Red rash developing on back, arms, and thighs.  Rash is visible, but is not itchy. Experienced fever/chills and swollen lymph nodes the day after the vaccination
BLOOD CLOTS (RIGHT HAND AND LEFT LOWER LEG); BLOOD CLOT IN THE LUNGS; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. The patient's past medical history included lung cancer, tumor removal surgery, four chemotherapy sessions, and surgery to remove the blood clots, and concurrent conditions included non-smoker, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: unknown) dose was not reported, 1 total administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-MAY-2021, the patient developed blood clot in the lungs was reported.  On 14-MAY-2021, (three days after) the patient experienced shortness of breath was reported.  On 20-MAY-2021 went to Emergency room (ER) and was subsequently admitted to Intensive Care Unit (ICU).  On 21-MAY-2021, the patient underwent through surgery to remove the blood clots on the lungs along with this on same day patient developed swelling of left leg and right arm was reported.  On 22-MAY-2021, the patient developed blood clot right hand and left lower leg.  On 29-JUN-2021, patient underwent through laboratory test included: Computed tomography (CAT) scan revealed negative for blood clots. It was also stated that patient was on Eliquis (apixaban) for anticoagulation due to blood clots. Treatment medications (dates unspecified) included: apixaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clot in the lungs on 21-MAY-2021, and had not recovered from blood clots (right hand and left lower leg). This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20210702546-Covid 19 Vaccine ad26.cov2.s-  Blood clots in the lungs, Blood clot (right hand and left lower leg). This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Patient was here with 16 year old sibling. RN verified the name, birthdate and the wrong child stepped forward to get the vaccine. Rn noticed mistake and notified the provider and Nurse manager immediately. The RN went to tell the family with the Nurse  manager and mom understood that the 14 year old child will need another Menactra dose when she is of age.
This spontaneous report received from a male patient of unknown age refers to himself. Medical history and concurrent conditions were not reported. On 29-OCT-2013 the patient was vaccinated with ZOSTAVAX (dose, frequency, lot#, expiry date and indication were not reported) and ever since he got the vaccination his skin has been burning and breaking out into rashes. Concomitant therapy was not reported. The outcome of the skin has been burning and breaking out into rashes was unknown. The relatedness between ZOSTAVAX and skin burning, breaking out into rashes was unknown. PQC was not involved. Additional information is not expected.
This spontaneous report was received from a licensed practical nurse (L.P.N) refers to a 19-year-old male patient. On 06-JUN-2008 the patient was vaccinated with dose 1 VAQTA (lot# and route not reported) 25 Units (U). No concomitant medications were reported. On 14-NOV-2012 he received dose 2 VAQTA (lot# and route not reported) 25 Units (U). No adverse effects had been observed or reported. No additional information currently available. Additional information has been requested.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 79-year-old male patient received BNT162b2 (BNT162B2), on 06Jan2021 at 14:00 as dose 1, single (Lot number: Eh9899), in left arm, on 06Feb2021 at 14:00 as dose 2, single (Lot number: El1284), in left arm, on 23Sep2021 at 13:00 as dose 3 (booster), single (Lot number: 3013584), in right arm and on 18Apr2022 at 11:00 as dose 4 (booster), single (Lot number: Fp4554) at the age of 78 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "Double bypass heart surgery" (unspecified if ongoing), notes: Other medical history: Double bypass heart surgery and diabetic; "diabetic" (unspecified if ongoing), notes: Other medical history: Double bypass heart surgery and diabetic; "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs. Tetracycline. The patient's concomitant medications were not reported. Past drug history included: Tetracycline for Known allergies: Tetracycline, notes: Known allergies: Sulfa drugs, Tetracycline. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 26Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 26Apr2022, outcome "recovering" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Paxlovid had a rebound effect approximately 10 days after testing negative; (26Apr2022) Positive, notes: Tested positive for Covid on 26Apr. Therapeutic measures were taken as a result of Covid-19. Clinical course: Other medication in 2 weeks was reported as unknown.
pt recvd vax 21JUL-synd of fever, red throat; rapid strep positive late in illness; ? mild carditis; ? mild atypical RF
This spontaneous report was received from a pharmacist referred to a female patient of an unknown age (college student). The patient's concurrent conditions, medical history, historical drugs, drug allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with two doses of M-M-R II (default route subcutaneous) (strength, formulation, frequency, lot# and expiry date was unknown) for prophylaxis. On an unknown date, the patient was diagnosed with multiple sclerosis. Outcome of multiple sclerosis was unknown. Causality assessment was not provided. Product quality complaint (PQC) was not found. Upon internal review, the event multiple sclerosis was determined to be medically significant.
my brother has a friend who is paralyzed now after getting vaccinated; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARALYSIS (medically significant), outcome "unknown", described as "my brother has a friend who is paralyzed now after getting vaccinated".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
High Fever, 106+, convulsions, trouble breathing, pnemonia,   Ive never been so ill in my life.  I nearly died.
it was rpt pt recv 1dose varivax on 5/23/95 & in 5/12/98 devel chickenpox w/80-100 lesions.
Large, red, itchy, hard lump surrounding injection site. Started on day 7 after injection. Spreading larger.  Using hydrocortisone topical ointment.
Herpes Zoster; Postherpetic Neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the prevention of shingles and routine health maintenance. On an unspecified date, the patient experienced painful blistering rash on the back, then diagnosed with postherpetic neuralgia and herpes zoster. The outcome of the events was not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX). The reporter considered the events to be disability.   Additional information has been requested.
1.5 inch round raised welt at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 21Mar2021 at 15:00 (at the age of 16-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included ethinylestradiol; norgestimate (TRI-LO-SPRINTEC) and biotin supplement (MANUFACTURER UNKNOWN); both on unknown dates for unknown indications. The patient had no allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Apr2021, the patient experienced 1.5 inch round raised welt at the injection site. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event 1.5 inch round raised welt at the injection site was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
On day 9 after the vaccine, a red spot showed up near the injection site of the vaccine.  It was a little larger than a silver dollar and was red/itchy.  It lasted about 4-5 days, then disappeared.
Fever up to 100 degrees, severe body aches, dizziness, nausea, chills, chest pain, acid reflux, bladder pain and frequent urination, general malaise and restricted to bed
soreness @ inject site-swollen tender to touch-warm-rash @ inject site approx 2 cm;
PATIENT CONTRACTED COVID DESPITE BEING FULLY VACCINATED AT TIME OF EXPOSURE- SYMPTOM ONSET 8/11/21 OF LOSS TASTE/SMELL, SORE THROAT, AND NASAL CONGESTION.  POSITIVE COVID PCR TEST ON 8/16/2021
rashes that itch; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rashes that itch) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (rashes that itch). At the time of the report, RASH PRURITIC (rashes that itch) outcome was unknown.            No concomitant and treatment medications were not provided.
Starting on 04/02/2021, the injection site on my left arm and about 2 inches below it became very red, swollen, and itchy. It?s slightly painful to the touch.
Received vaccine in the morning, started to have pain (left arm) with chills same day in the afternoon noticed redness, swelling on affected arm, consulted a doctor antibiotic was started and no improvement-ended up to ER and admitted to hosp and treated with IV antibiotic-TYGACIL 50 mg Q12 hours (Aug 01, 2010).
Received a third Moderna dose of 0.5 ml instead of the booster of 0.25 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Received a third Moderna dose of 0.5 ml instead of the booster of 0.25 ml) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 24-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Received a third Moderna dose of 0.5 ml instead of the booster of 0.25 ml). On 24-Oct-2021, ACCIDENTAL OVERDOSE (Received a third Moderna dose of 0.5 ml instead of the booster of 0.25 ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was reported.    This case was linked to MOD-2021-365290 (Patient Link).
Developed rash around injection site. Patient's arm swelled and flu-like symptoms. Patient went to ER for treatment.
Patient vaccinated with Flu vaccine on 10/29/08 and developed syncope on 10/30/09 and passed-out. CT scan of head was negative, probably not a seizure per Emergency Room MD but rather a vasovagal reaction.
Information has been received from a nurse practitioner referring to multiple unknown patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates, the patients were vaccinated with improperly stored M-M-R II lot # M010426, expiration date: 01-MAR-2018; lot # L040961, expiration date: 19-OCT-2017; lot # L037356, expiration date: 28-SEP-2017; lot # L036851, expiration date: 23-SEP-2017; dose and route unknown) for prophylaxis. It was reported that the M-M-R II improperly stored vaccines from lot # L040961 were administered on 15-FEB-2017, 16-FEB-2017, 21-FEB-2017 and 22-FEB-2017. The lot # M010426 was administered on 23-FEB-2017. The M-M-R II was stored under temperature between 33.44 Fahrenheit (also reported as 32°F) and 36 Fahrenheit for 44 hours. There was no previous temperature excursion. It was unknown if there was a digital data logger involved. No adverse effects reported. No product quality complaint was involved. This is one of several cases received from the same source. Sender's Comments: US-009507513-1703USA002539: US-009507513-1702USA012115.
This case was reported by a nurse and described the occurrence of injection site rash in a 64-year-old female patient who received SHINGRIX (batch number Z9RR4, expiry date 15th November 2020) for prophylaxis. Concurrent medical conditions included adhesive tape allergy (the patient avoid adhesive). On 11th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 13th June 2018, 2 days after receiving SHINGRIX, the patient experienced injection site rash, erythematous rash and raised rash. On an unknown date, the patient experienced tiredness. On 24th June 2018, the outcome of the injection site rash, erythematous rash and raised rash were recovered/resolved. On an unknown date, the outcome of the tiredness was recovered/resolved. It was unknown if the reporter considered the injection site rash, erythematous rash, raised rash and tiredness to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX, the patient experienced red, raised rash coming down from the site of injection 3 and half inches round. Less than a year after receiving SHINGRIX, the patient experienced tiredness. The patient iced and rested.
Systemic: Allergic: Itch Generalized-Medium, Additional Details: Administered second dose on right arm. Client reported no reaction after first dose except for sore arm. No history of allergies or adverse reactions from vaccine. Reported generalized itchiness. Gave 50 mg Benadryl. Client's husband drove her here and back home. First dose of vitals: 97.7 degrees F, 82 bpm, 98% O2, 130/94 BP, RR 16 at 1756. Second dose of vitals taken 1815: 72 bpm, 98% O2, 97 degrees F, BP 120/80. Client left approx. 1830 reports decreased generalized itchiness.