chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hypersensitive Dermatitis; blood pressure was elevated; Fever of 101 degrees; Pain; Gastric Upset; could not sleep.; rash reappeared on her thighs, arms and her chin; the back of her thighs became Itchy / on her arms / was itching so badly, she could not sleep; This case was reported by a consumer via call center representative and described the occurrence of allergic dermatitis in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on an unkown date refer case id US2020188896). Concomitant products included camphor, levomenthol, phenol (Sarna).   On 1st July 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 7th July 2020, 6 days after receiving Shingrix, the patient experienced rash and pruritus. On an unknown date, the patient experienced allergic dermatitis, increased blood pressure, fever, pain, upset stomach and difficulty sleeping. The patient was treated with PREDNISONE, HYDROCORTISONE (CORTISONE TOPICAL CREAM) and magnesium sulfate (Epsom Salt). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the allergic dermatitis, increased blood pressure, rash, pruritus, fever, pain, upset stomach and difficulty sleeping were unknown.   It was unknown if the reporter considered the allergic dermatitis, increased blood pressure, rash, pruritus, fever, pain, upset stomach and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix (intramuscular) and experienced fever, Gastric Upset, Pain,itchy without rash,Hypersensitive Dermatitis,blood pressure was elevated. The patient tried cortisone cream ,prednisone and sarna for relieving pain and used epsom salt bathtime she reduced prednisone to subdue the Itching.  The dermatologist suggested her starting on a cyclosporine. The patient experienced a fever of 101 degrees, Gastric Upset, and Pain for first couple of days. The patient also experienced after 6 days of vaccination, the back of her thighs became Itchy without rash or redness. The reporter stated that after first week of taking prednisone, the rash on her arms and thighs disappeared, but her thighs still itched intermittently. The rash reappeared on her thighs, arms and her chin on 17th sepetember 2020. The reporter consented to follow up. No further information was available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020188896:Same patient- 2nd dose
PAIN IN RIGHT SIDE OF RIBS; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (PAIN IN RIGHT SIDE OF RIBS) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis and Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate free. On an unknown date, the patient experienced MUSCULOSKELETAL CHEST PAIN (PAIN IN RIGHT SIDE OF RIBS). At the time of the report, MUSCULOSKELETAL CHEST PAIN (PAIN IN RIGHT SIDE OF RIBS) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality of humira as per reporter for event rib pain was no reasonable possibility. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
27 hours later developed chills.  around 30 hours after vaccination vomiting.  headed to urgent care and passed out and hit head.  went to hospital and admitted thursday and left sunday.  no significant findings other that reaction to vaccine.
This is a spontaneous case, initially received from other non-health professional (consumer) on 15-Mar-2019, concerning a 74-year-old, elderly, female patient. On 12-Mar-2019, in the morning, the patient was administered FLUAD TIV [batch number: 250798, expiry date: 31-May-2019, dose, route of administration and anatomical location: not reported] for influenza prophylaxis. On the same day after vaccination, the patient rested for more than 15 minutes, then she had a medical consultation with her doctor, at the same clinic, between 10:00 and 11:30 am (reported as patient could not remember the exact time). After that, the patient left the clinic, and while driving, she passed out and had an accident with the car, around 12 pm (12:29 PM as per the accident report) (reported as almost died). The patient went to an emergency room and received 2 antihistamines (unspecified). Her medical report states that, she had a major allergy reaction', but she was not hospitalized. On 14-Mar-2019, the patient felt better and had recovered from the events. The reporter assessed the case as non-serious.; Reporter's Comments: A 74-year-old, female patient experienced loss of consciousness, hypersensitivity, road traffic accident and near death experience, on the same day after administration of FLUAD TIV. Considering the plausible temporal relationship between vaccination and reported events and lack of any underlying conditions or alternative more plausible causes, the company assessed the events (loss of consciousness and hypersensitivity) as possibly related to suspect vaccine. Despite temporal association between vaccination and events of road traffic accident and near death experience, the course of events suggests that the reported loss of consciousness and hypersensitivity as more plausible explanation for the events. Hence, the company assessed the causality as not related to suspect vaccine. The company assessed the events loss of consciousness and near death experience as serious (medically significant).
Dizziness within the first 15 minutes. Tongue numb and sense of taste affected (this went away after an hour). Left arm very sore and swollen for 3 days. Swollen glands in armpit and neck on left side. Sever fatigue that has waxed and waned for three days. Chills and muscle aches the first two days. Severe vertigo that comes and goes and is ongoing. Have been taking Motrin for aches.
No local rxn of site of injection - 11/10 next day 2:30-Whole body burning, heat, achy requiring a cool shower - lip swelling and red - jaw discomfort sinus pressure - 11/27 GI upset, jaw discomfort still - Patient has been in contact w/Dr sine 11/10.
On about 9th day post vaccine very sore arm. Large red hot welt.  Continued for over 2 weeks. The first few days it kept getting larger and hotter. Then stayed same for about a week.  After that slowly stared to fade.  I can faintly still see  just a title red.  Never fever or anything.  Just arm very hot, swollen raised rash, itchy, painful.
initial subjective fever, onset of wheezing & cough 12 hrs post vax; CXR-hyperinflation; Exam-alert, afebrile, HEENT WNL; Lung RR 64, Bilat wheezing, moving air well;
This spontaneous report was received from a nurse practitioner refers to a patient of an unknown age. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were not reported. Nurse practitioner reported that patient was scheduled to receive VARIVAX (Merck) and M-M-R (circumstance or information capable of leading to medication error). On 25-JAN-2016, the patient inadvertently received VARIVAX (Merck) and PROQUAD (Merck) (overdose) instead of intended M-M-R. Nurse practitioner did not have patient's chart and could not provide lot # and expiry date for vaccines administered. No adverse effects reported. Additional information has been requested.
Approximately 24 hrs after vaccine administered, pt went to ER with redness, swelling, hardness around injection site. Pt was treated with prednisone & released.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 16-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.
almost felt like she was hallucinating; felt very weak; had bizarre  dreams; was very thirsty; had no appetite; This case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix (intramuscular). In September 2019, 10 hrs after receiving Shingrix, the patient experienced feeling abnormal, weakness, bizarre dreams, thirst and appetite absent. On an unknown date, the outcome of the feeling abnormal, weakness, bizarre dreams, thirst and appetite absent were recovered/resolved.   It was unknown if the reporter considered the feeling abnormal, weakness, bizarre dreams, thirst and appetite absent to be related to Shingrix.  Additional details were received as follows: The patient received the first dose of Shingrix on 28th September 2019 or 28th September 2019, around 2 PM. Around midnight or 1 AM she started experiencing side effects.  The patient felt very weak and had bizarre  dreams. She said it almost felt like she was hallucinating. The patient was very thirsty and had no appetite. She was in bed for 2 days because of the symptoms.  The symptoms were resolved after about 2 days. The reporter consented to follow up.
Heart palpitation, difficult breathing, soreness, muscle aches, weakness, paleness, dizziness.
This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), AXILLARY PAIN (sore armpits), PYREXIA (fever), FATIGUE (very tired) and LYMPHADENOPATHY (swollen and inflamed armpits) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: Pfizer on 14-May-2021 and Pfizer on 04-Jun-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concomitant products included ETHINYLESTRADIOL, ETONOGESTREL (NUVARING) for Contraception, FLUVOXAMINE MALEATE (LUVOX [FLUVOXAMINE MALEATE]) and TRAZODONE for an unknown indication. On 14-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna booster administered to 15 year old child). In January 2022, the patient experienced ASTHENIA (Weak), AXILLARY PAIN (sore armpits), PYREXIA (fever), FATIGUE (very tired) and LYMPHADENOPATHY (swollen and inflamed armpits). On 14-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna booster administered to 15 year old child) had resolved. At the time of the report, ASTHENIA (Weak), AXILLARY PAIN (sore armpits), PYREXIA (fever), FATIGUE (very tired) and LYMPHADENOPATHY (swollen and inflamed armpits) outcome was unknown. Patient did not take any Treatment medication for symptom relief.
Fatigue; Headache; Fever; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), FATIGUE (Fatigue), HEADACHE (Headache) and PYREXIA (Fever) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020 and Fatigue (Experienced for 2 weeks and thought that he might have been infected) in March 2020.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN (Soreness). On 17-Jan-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache) and PYREXIA (Fever). On 18-Jan-2021, PAIN (Soreness), FATIGUE (Fatigue), HEADACHE (Headache) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 antibody test: positive (Positive) Positive.         No concomitant and treatment medications were reported.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD-2021-020728 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up information received on 22-JUN-2021 contains no new information.
1st 2 days-extreme fatigue. 3rd day headache/nauseousness/then pain in stomach/achy. 4th-5th & 6th day rash on lower face canker sores in mouth, wheezing, coughing. Still a little weak. 1 symptom at a time.
A non-serious spontaneous report of administration of H1N1 vaccine to a patient above 50 years old was received from a pharmacist concerning three patients above the age of 50 and of unknown gender. No past medical history or concomitant medication was reported for these patient. In 2009, these patients received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Fever, chills, myalgia, headaches, nausea, vomiting.
I have had my period 3 times in 2 weeks  and extremely heavy. Really bad cramps and hormone swings. I have broken out all over my face due to the hormone changes. This is something that never happens. I did have a headache and extreme fatigue as well, but the intense hormones and constant heavy bleeding are the worst.
Sneezing all day; Runny nose all day; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Sneezing all day) and RHINORRHOEA (Runny nose all day) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced SNEEZING (Sneezing all day) and RHINORRHOEA (Runny nose all day). On 22-Mar-2021, SNEEZING (Sneezing all day) and RHINORRHOEA (Runny nose all day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: TCR received and contains No New Information.
SORE ARM; HEADACHE; SLIGHT INCREASE IN TEMP 99.6 -99.8; TIREDNESS; CYST IN ARMPIT FROM AN INFECTED HAIR FOLLICLE; This spontaneous report received from a patient concerned a 36 year old of unspecified sex. 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: 202A21A and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: diphenhydramine hydrochloride, ibuprofen, and paracetamol.  On 09-APR-2021, the subject experienced cyst in armpit from an infected hair follicle. On 09-APR-2021, the subject experienced slight increase in temp 99.6 -99.8. On 09-APR-2021, the subject experienced tiredness.  Laboratory data included: Body temperature (NR: not provided) 99.6 -99.8 F. On 10-APR-2021, the subject experienced sore arm. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight increase in temp 99.6 -99.8, had not recovered from sore arm, headache, and tiredness, and the outcome of cyst in armpit from an infected hair follicle was not reported. This report was non-serious.
A 33 year old female reported that she received an injection of Tetanus Toxoid Adsorbed, Ultrafined on 5/26/00. On 6/7/00, she developed hives. She was seen by her physician who prescribed Claritin and Benadryl. Allergy testing was reportedly positive for tetanus. The hives persisted and she was treated with prednisone on 7/5/00. On 8/10/00, the physician prescribed Tagamet and an unspecified antihistamine along with the Claritin previously prescribed.
This case was reported by a consumer and described the occurrence of chills in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of chills (1st dose received refer case US2018GSK173995). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills, fever, general body pain, influenza-like symptoms and bone pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the chills, general body pain, influenza-like symptoms and bone pain were unknown and the outcome of the fever was not recovered/not resolved. It was unknown if the reporter considered the chills, fever, general body pain, influenza-like symptoms and bone pain to be related to SHINGRIX. Additional details were provided as follows: The patient was just sharing information, and she did not want anything. The age at vaccination was not reported, the patient received the first dose of SHINGRIX and a few hours after the patient experienced chills, fever and it ached all over, the patient felt like had the flu, the bones ached and was okay after 12 hours. This case has been linked with case US2018GSK179197 reported by the same reporter for the same patient.
This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site reaction, erythema, swelling and pruritus. On an unknown date, the outcome of the injection site reaction, erythema, swelling and pruritus were unknown. It was unknown if the reporter considered the injection site reaction, erythema, swelling and pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter did not consent to follow up. This case has been linked to the case US2019032533, reported by the same reporter.
I have had a cold and cough ache  and headache and vomiting from coughing, since 05/01/2021 it  started with a scratchy throat then went into a bad cold and cough, it appeared like it was starting to go away and then it started all over again with the scratchy throat and quickly back into the cold symptoms cough and headache and coughing so hard I vomit again.  As of today after taking antibiotics, prednisone robitussin dm , fluticasone propionate nasal spray and benzonate capusules.  I am not getting any better.
Shingles. Onset 3/23/21 at 4 pm. Treatment with Acyclovir started 3/29/21
PUFFY EYES; ITCHY EYES; BLOWING NOSE; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included menopause, and headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: unknown) dose was not reported, administered on 12-APR-2021 15:30 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced puffy eyes. On 13-APR-2021, the subject experienced itchy eyes. On 13-APR-2021, the subject experienced blowing nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from puffy eyes, itchy eyes, blowing nose, and headache. This report was non-serious.
Anaphylaxis; low blood pressure; experienced flushing; nausea; A spontaneous report was received from a consumer concerning a 39-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events anaphylaxis, flushing, nausea, and low blood pressure.  The patient's medical history included allergy to medications (information not reported). Concomittent meds included Xyrem  (for narcolepsy/cataplexy) and Adderall (narcolepsy)   On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 27 Jan 2021, 20 minutes after the vaccine the patient experienced flushing. nausea, low blood pressure (reading unknown). Patient was premedicated with Benadryl and Xyzal because of known history of allergy to medications. Treatment details were not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events were reported as resolved.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
pt recvd vax & exp swelling, soreness & redness @ inj site;No further details were provided;
At 18:36 pt chief complaint is dizziness, pt assessed to be sweating and shaking. Pt denies feeling cold. Pt vitals taken at 18:36 are Temp-97.8 HR-106 RR-20 BP-140/100 O2-100%. Pt transitioned to laying down position. Pt denies any additional symptoms. Pt monitored by observation RN. Pt vitals taken at 18:46 are Temp-97.7 HR-97 RR-16 BP-121/100 O2-99% Pt observed to still be shaking. Pt offered EMS call, pt denies. Pt observed to still be shaking at 19:00 with no reported resolution of dizziness. Observation RN called EMS. 19:10 EMS arrives on scene to assess pt. EMS reports normal heart rhythm, BP-130/82, with all other vitals within normal limits. Pt refused to go with EMS and signed AMA waiver from EMS. Pt suddenly reports feeling better and walked out with her husband at 19:35.
Vertigo, presyncope, migraine, menstruation, back ache, nausea, tingling In the fingers,  tinnitus