chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CHANGE IN MENSTRUAL CYCLE IT'S 4 DAYS LATE; 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 pre-existing medical conditions included the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-JUN-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 change in menstrual cycle it's 4 days late. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of change in menstrual cycle it's 4 days late was not reported. This report was non-serious.
Soreness in the right shoulder muscle where I was injected; This is a spontaneous report from a contactable 51-year-old male consumer reported for himself. A 51-year-old male patient received second dose of bnt162b2 (Pfizer BioNtech COVID 19 vaccine, Solution for injection, Lot number: EL3247) via an unspecified route in the right arm on 24Feb2021 at 14:00 (age at vaccination: 51-year-old), as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer BioNtech COVID 19 vaccine, Solution for injection, Lot number: EL3247) via an unspecified route in the right arm on 03Feb2021 at 13:45 (age at vaccination: 51-year-old), as a single dose for covid-19 immunization. No allergies to medications, food, or other products were reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 24Feb2021 at 14:30, patient experienced soreness in the right shoulder muscle where he was injected. Patient did not receive any treatment for the event. The clinical outcome of the event was recovering.  Follow-up attempts completed. No further information expected.
Moderna 0.5 cc 02/03/21 Moderna 0.5 cc 03/03/21 Moderna 0.5 cc 10/01/21 Moderna 0.5 cc 10/29/21  Essentially, this gentleman received 2 separate primary Moderna series. The gentleman was not aware this should not have occurred, he was offered the vaccine by a pharmacy (the 2nd round) and accepted; it appears the pharmacy did not confirm prior vaccination dates. Pharmacy erroneously vaccinated him with an additional primary series of vaccine.
Burning and tingling in hands, as well as Numbness in limbs. Severe fevers for three days and heart palpitation.
headache, feverish, burning nose, shortness of breath, extreme fatigue, general feeling of illness, loss of appetite, chills, sweating
Patient presented to the ED with dizziness, fever and heavy vaginal bleeding around 24 hours after receiving her first dose of the Pfizer-BioNTech COVID-19 vaccine. She was tested for active COVID-29 infection via nasal swab PCR and tested positive. Upon presentation labs were drawn and her platelet count was found to be 8 on 5/15. Repeat labs were drawn that day to confirm low platelet count and confirmed diagnosis and thrombocytopenia secondary to an immune reaction to the vaccine was suspected. She was admitted and was started on tranexamic acid, medroxyprogesterone, dexamethasone and IV immunoglobulin (Ig) to help treat low platelet count and vaginal bleeding. As of writing, she is still admitted and her most recent platelet count on 5/17 was 16.
Developed itching, periorbital, swelling following vaccine about 15 minutes. Attempted po Benadryl without success. 2 hours pt cooperation. Gave 25 mg IM followed by relief of itching within 10 minutes.
Swelling of left arm and fever 101 deg. Seen in ER - put on local Rei?? and autibols?.
toothache; body ache; didnt sleep; loss of equilibrium; headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (toothache), PAIN (body ache), PAIN IN EXTREMITY (sore arm), INSOMNIA (didnt sleep) and BALANCE DISORDER (loss of equilibrium) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 18-Mar-2021, the patient experienced TOOTHACHE (toothache), PAIN (body ache), INSOMNIA (didnt sleep), BALANCE DISORDER (loss of equilibrium) and HEADACHE (headache). At the time of the report, TOOTHACHE (toothache), PAIN (body ache), PAIN IN EXTREMITY (sore arm), INSOMNIA (didnt sleep), BALANCE DISORDER (loss of equilibrium) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO concomitant medication provided Treatment included Tylenol   This case was linked to MOD-2021-116598 (Patient Link).
Information has been received from a physician (neurologist) concerning a 15 year old female patient with no drug reactions or allergies and no pertinent medical history who in December 2011, was vaccinated with the first dose of GARDASIL, 0.5 mL, intramuscular in the left deltoid (lot number not reported). There was no concomitant medication. The physician was reporting the patient was referred to her by primary care physician for evaluation on 20-JUN-2012 of persistent left arm paresthesia and muscle weakness following the first dose of GARDASIL in December 2011. The left arm pain diminished after 1 week, but muscle weakness, especially involving the pronator and supinator muscles and paresthesia had persisted. Therapy with GARDASIL was discontinued. There was no treatment given for persistent left arm paresthesia, muscle weakness, especially involving the pronator and supinator muscles and the left arm pain. At the time of the report the patient's outcome was recovering. Vascular studies were performed on an unknown date, with a result of negative for thrombus. The patient sought medical attention via office visit. Therapy with GARDASIL was not reintroduced. Persistent left arm paresthesia, muscle weakness, especially involving the pronator and supinator muscles and left arm pain were considered to be disabling by the reporter. Additional information has been requested.
Patient was riding in a car and began feeling dizzy and passed out, this happened ten times and over the evening and decided to go to the ER the next morning at 7am. These episodes lasted 5 minutes or so and then she was able to regain consciousness.
nausea; vomiting; couldn't get out of bed; couldn't eat; diarrhea; This is a spontaneous report from a contactable physician.   A 48-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 24Feb2021 (Batch/Lot Number: EL9263) as SINGLE DOSE for covid-19 immunisation  .  Medical history included huntington's disease since 1995  Relevant medical history and concurrent conditions:  Structured information(Patient episode name): Huntington's disease  Patient Medical comments: Verbatim: Huntington's Disease.     The patient's concomitant medications were not reported.  The patient received the vaccine 24 FEB 2021, she had 4 days of severe nausea, vomiting and couldn't get out of bed. this patient has Huntington's disease. she was told it was safe, but I don't think they took into consideration that it's a genetic modification and she has Huntington's which is also the genetic modification. The outcome of the events was not reported.  No follow-up attempts are needed. No further information is expected.
felt dizzy; low grade fever (99°F); she felt like if she had the flu; achy all over her body; headache; weak, it was difficult for her to get out of bed; This is a spontaneous report from a contactable consumer (patient). A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Expiry date: Unknown), dose 2 via intramuscular on 06Apr2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced dizzy, low grade fever (99°f), she felt like if she had the flu, achy all over her body, headache, weak, it was difficult for her to get out of bed on an unspecified date. The treatment included Tylenol seems to help with these symptoms, she takes it every four hours. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  No follow-up attempts are needed. No further information is expected.
Chronic Fatigue and Headache. Both fatigue and headache continue since injection intermittently. This is something new that I have not experienced prior to vaccine.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 30-JUL-2015 the patient was vaccinated with a ose of improperly stored PROQUAD (lot # K018144, expiration date 10-APR-2016, dose, dose# and route not reported). There was no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
After 2nd dose of Pfizer (09Jul2021) my period was delayed 14 days; I had a little dark brown spotting right after the 2nd dose for 4 days; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 44-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 44-years), on 09Jul2021 as dose 2, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0180), via an unspecified route of administration, administered in left arm on 16Jun2021 at 16:00 as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccine in four weeks. Patient does not have covid prior vaccination and has not been tested for covid post vaccination. On 09Jul2021, the patient experienced after 2nd dose of Pfizer (09Jul2021) my period was delayed 14 days and i had a little dark brown spotting right after the 2nd dose for 4 days. The treatment was received for the adverse events. The clinical outcome for all the events was reported as unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.
swelling of throat; tongue numbness; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (swelling of throat) and HYPOAESTHESIA ORAL (tongue numbness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Benadryl(diphenhydramine) allergy due to PEG), Food allergy, Milk allergy and Drug allergy (allergies to medicine).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PHARYNGEAL SWELLING (swelling of throat) and HYPOAESTHESIA ORAL (tongue numbness). On 26-Mar-2021, PHARYNGEAL SWELLING (swelling of throat) and HYPOAESTHESIA ORAL (tongue numbness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported. Treatment details were not provided. Action taken with mRNA-1273 in response to the event was unknown
local erythema w/vesicular lesion around the site of inj of varivax;
Pt vaccinated with Meruvax II developed myalgia, lethargy & headache which resolved spontaneously. Treated w/ high-dose steroids.
Noted 1 day after vaccine DTaP/IPV, left upper arm, area red, swollen and warm to touch. No pain. Brought to ER 5/18/05 and told to follow up with PMD. Brought into clinic 5/19/05; treated with cool compresses and Benadryl for itching. Motrin for pain.
Started with vomiting, then fever. Took to pediatrician. Vomiting and fever stopped after a couple of days. Then sore throat which has been persistent. Then, clogged nose and cough that hasn't gone away.
psychotic break down; Became very depressed/went down like a rock with the worst depression; didn't want to do anything at all, answer the phone, or leave the house; gone from depression over to some sort of mental break; arm was a bit sore; This spontaneous case was reported by a consumer and describes the occurrence of PSYCHOTIC DISORDER (psychotic break down), DEPRESSION (Became very depressed/went down like a rock with the worst depression), PAIN IN EXTREMITY (arm was a bit sore), DECREASED INTEREST (didn't want to do anything at all, answer the phone, or leave the house) and MENTAL DISORDER (gone from depression over to some sort of mental break) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included TSH in 1966. Previously administered products included for Cholera: Cholera; for Diphtheria: DTAP; for Flu: Flu shot (Patient haves flu shot every year.); for Pneumonia: Pneumonia; for Yellow fever: Yellow fever; for Shingles: Shingles; for Smallpox: Smallpox; for Typhoid: Typhoid; for Typhus: Typhus; for Polio: Polio. Concurrent medical conditions included Allergy to plants (Allergy to Juniper plant). Concomitant products included ESTROGENS CONJUGATED (PREMARIN) for Hysterectomy, L-THYROXINE [LEVOTHYROXINE] for Thyroidectomy.    On 05-Feb-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was a bit sore). On 09-Feb-2021, the patient experienced DEPRESSION (Became very depressed/went down like a rock with the worst depression), DECREASED INTEREST (didn't want to do anything at all, answer the phone, or leave the house) and MENTAL DISORDER (gone from depression over to some sort of mental break). On an unknown date, the patient experienced PSYCHOTIC DISORDER (psychotic break down). At the time of the report, PSYCHOTIC DISORDER (psychotic break down), DEPRESSION (Became very depressed/went down like a rock with the worst depression), PAIN IN EXTREMITY (arm was a bit sore), DECREASED INTEREST (didn't want to do anything at all, answer the phone, or leave the house) and MENTAL DISORDER (gone from depression over to some sort of mental break) outcome was unknown. Not Provided      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.   Patient  took the J&J Covid-19 on May 4, 2021, and had not a whisper of a side effect , not even a sore arm.  No treatment medication information was provided    Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Non significant follow up received on 18-may-2021, and contains no new information. On 25-May-2021: Follow-up received and HCP phone number updated, state updated, patient demographics, medical history updated, vaccine facility information, concomitant medications updated, Events added On 22-Jul-2021: No new information was received.
his case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 78-year-old female patient who received SHINGRIX for prophylaxis.  The patient's past medical history included viral infection (hospitalised to rule out stroke, about one year ago from the date of reporting). Concurrent medical conditions included diabetes. Concomitant products included doxycycline and levocetirizine hydrochloride (Levocetirizine). On 4th June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced injection site swelling, dry mouth, appetite lost, injection site bruising and tiredness. The patient was treated with medication unknown (Ice Pack (Nos)). On an unknown date, the outcome of the injection site swelling and injection site bruising were recovered/resolved and the outcome of the dry mouth, appetite lost and tiredness were not recovered/not resolved. The reporter considered the injection site swelling and injection site bruising to be related to SHINGRIX. The reporter considered the dry mouth and tiredness to be possibly related to SHINGRIX. The reporter considered the appetite lost to be unrelated to SHINGRIX. Additional details were provided as follows: This case was reported by the patient who is a nurse practitioner. She experienced swelling at the site of injection to about twice normal size as well as bruising.  She used ice packs and those resolved within about 10 days. The patient also stated that, since the injection, she had noted increased tiredness, loss of appetite and dry mouth. The patient was concerned whether the symptoms are similar to what she had experienced about an year ago when she was hospitalized for possible stroke and was finally diagnosed with a viral infection. The patient was unsure if these symptoms are related to the SHINGRIX vaccine.
Information has been received from a medical assistant referring to unspecified number of unspecified patients. Information regarding medical histories and concurrent conditions was not reported. On unknown dates the patients were vaccinated with doses of VAQTA (dose, frequency, route and lot# were not reported) which underwent a supported temperature excursion. No adverse experiences were reported. This is one of three cases (MARRS# 1504USA003190, 1503USA005652 and 1504USA003189) from the same reporter. Additional information has been requested.
Syncope, fainting, clonic seizure activity within 5 min of immunization.
Vaccine given on 9/7/2023, but vaccine expired on 8/31/2023
This spontaneous report was received from a Registered Nurse regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with improperly, stored PNEUMOVAX23 (dose strength and route was unknown) (incorrect product storage). No concomitant medication was reported. Patient experienced no adverse event. No product quality complaint was involved. The outcome of the event was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Autoimmune flare lasting seven weeks. Unable to function for seven weeks.  Neuro: head pressure, blaring tinnitus,leg numb/heavy/spacticity, tingling extremities and face, cognitive dysfunction, extreme noise sensitivity,. Musculoskeletal: joint pain both hips, body aches,. Cardiac: blood pressure fluctuations to very low, low grade fevers 5 weeks after shot
Member c/o tenderness and induration began approx 24 hrs post Anthrax #3. Today presents with red, indurated "lump" approx 4.5 cm across with associated pain / tenderness. No lymph node swelling noted.
Medical Assistant gave patient 2 Immunizations,  TDaP, Menactra. Patient was fine after vaccines, he walked out of room with mother when PSR called my name and asked for help,  I got to the patient he was hallway in front on check out station he was lying on the floor passed out with his mother at his side.  Patient woke up a few about 15 seconds later, he was confused and stated that he had a headache, asked if he knew where he was he stated "at the hospital" I placed the 02 monitor on patients finger for a few minutes which read 99% 02  and 72 for his pulse. APRN, carried  patient to one of his exam rooms to monitored him. APRN then asked if the patient could walk to see how he was doing he has some weakness in legs Mother was informed by APRN that patient should get checked out by ER, mother declined ambulance and stated that she wanted to take him herself to ER. Nurse to follow up on patient condition
No adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a 49-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Aug-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    No relevant concomitant medications were reported.  No treatment information was provided.
Shingles; Pain; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles was unknown and the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. The reporter reported that the patient got shingles shortly after the vaccination. The reporter stated that the symptoms and pain went away within 2 months. The follow-up would not possible as no contact details were available. The case was linked with case US2022AMR006312, reported by same reporter.
History of Bell's palsy first episode 25 years ago most recent episode November 15, 2019 was seen in urgent care. In March, 6 days after receiving second dose of the Phizer COVID-19 vaccine, developed recurrence of Bell's palsy on the left side of face. Initially had significant pain and progressively lost function of left side of face, numbness, and some slight eye lid drooping. 10 day prednisone treatment. Symptoms decreased and majority of face functions returned within two weeks.
Information has been received from a nurse referring to unknown number of patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (therapy type: rHA, lot# L009214, expiration date 17-MAR-2017; lot# K021152, expiration date 02-JAN-2016; strength, dose and route unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.