chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccination site rash; Peripheral swelling; Fever; headache; dizzy; vertigo; A spontaneous report was received from a consumer concerning a 55-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  fever/pyrexia, headache, dizzy/dizziness, vertigo.  The patient's medical history was not provided. Concomitant medications reported were Levothyroxine, Cholesterol medicine for drug use for unknown indication.  On 10 Feb 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 030L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 13Jan2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 039K20A) via unknown route for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced fever/pyrexia, headache, dizzy/dizziness, vertigo.  Treatment details included Ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.   On 10 Feb 2021 the outcome of  fever/pyrexia, headache was resolved. On an unknown date the outcome of dizzy/dizziness, vertigo was unknown.  Based on MSA comment, Rash coded to Vaccination site rash and Peripheral swelling coded to Vaccination site swelling
Pfizer on 3/18 and 4/14. Positive on 10/2
weeks after 2nd dose of pfizer covid vaccine developed thyroditis on same side (LEFT) as vaccine administaration
Aches, flu like symptoms, temp of 100.8 at 1:42 pm on today's dste.
My husband and I were on a trip, and when the trip ended I started with symptoms that was initially diarrhea on Friday, 03/17. My husband tested positive for COVID19 on the 18th and then on Monday the 20th I was cold all day long, couldn't get warm. That evening I started having a post nasal drip. Tuesday morning I did a home test and it was positive. At that point I called Urgent Care and got an appt for that evening. I saw the PA and got a PCR COVID19 test done which came back positive the next morning. I started Paxlovid that night. I had a low grade fever, 100.4. Post nasal drip and a little cough, it was mostly upper respiratory. Better after 24 hours and took all five days of Paxlovid. Finally felt like myself again after about a week total. I also had COVID19 in September of 21 and had to get the Monoclonal Antibodies and it was really bad- this case was nothing like that. Much milder.
Fever, chills, joint pain, myalgia, restlessness, headache, loss of appetite, pain at injection site, frequent urination, back pain, fatigue, weakness.
No adverse event; 1st bivalent booster on 5Sep2022, and 2nd bivalent booster on 3Dec2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (1st bivalent booster on 5Sep2022, and 2nd bivalent booster on 3Dec2022) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059F22A) for COVID-19 prophylaxis.     The patient's past medical history included Heartburn. Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE and BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) on 05-Sep-2022; for Product used for unknown indication: influenza. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) and influenza. Concurrent medical conditions included Hypertension.    On 03-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 03-Dec-2022, the patient experienced EXTRA DOSE ADMINISTERED (1st bivalent booster on 5Sep2022, and 2nd bivalent booster on 3Dec2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (1st bivalent booster on 5Sep2022, and 2nd bivalent booster on 3Dec2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (1st bivalent booster on 5Sep2022, and 2nd bivalent booster on 3Dec2022).    No concomitant medications were reported.   The patient had received unspecified vaccine in the 4 weeks prior to COVID-19 vaccine. The patient did not experience any adverse events.  No treatment details were reported.
Information has been received from a physician concerning a 15 year old female with asthma and penicillin allergy who on 26-Sep-2006 was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot#not provided). Concomitant therapy included hormonal contraceptives (unspecified). On 07-Nov-2006 the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot#6537361/0868F). That same day the patient experienced a migraine with a "blinded spot in one eye", dizziness and was "seeing stars". She was treated with aspirin. At the time of this report it was unknown if the patient had recovered from the event. Additional information has been requested.
Patient had immunization on 5/13/04. On 5/16/04, left leg became swollen the progressed to knee and then to ankle. The area looks like a 3rd degree burn. Temp 104.5. On 5/17/04, mother states she had a fever on 5/15 and 5/16 but didn't have a thermometer. While in hospital she is on Solumedrol 4mg every six hours and Rocephin 400mg IV.  Nurse follow up on 06/21/04 states: "Review of discharge summary indicates diagnosis of cellulitis vs severe immunization reaction.  Additional symptoms were pain due to reaction and vomiting."
COVID-19; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease and Crohn's disease.    No Medical History information was reported.   On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, COVID-19 (COVID-19) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.     It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medication information was reported. No treatment medication information was 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.
Resident has shortness of breath on 1/19/2021 and was transferred to Hospital 1/20/2021
A non-serious spontaneous report of FLUMIST given to two children with asthma was received from a health professional concerning a 11-year-old female. The patient's medical history included asthma. No concomitant medications have been reported for this patient. On 12-Oct-2011, the patient with asthma received FLUMIST. There was on adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Breakthrough case admission after 3 vaccines Pfizer 1/30/21 Lot# EL9261;  Pfizer 2/20/21 Lot# EM9810;  Pfizer 10/2/21 Lot# 30125BA
7cm neck posterior lymphadenopathy on the left side, patient received the vaccine in left deltoid.  Her CT scan showed diffuse matted necrotic lymphadenopathy with the largest one measuring 1.8cm.  Patient is still symptomatic with diffuse myalgias, elevated CRP, SED rate with concern for severe inflammatory reaction.
-Nodule, red (spreading) - ness around vaccine area, warm to touch - within 48 hours.  Runny nose, itchy eyes, sore throat.
Patient called pharmacy after she got vaccine saying blood was pouring from her arm.  She said she was on the way to the urgent care.
No adverse event; a patient was administered a dose of improperly stored VARIVAX; Information has been received from medical assistant referring to a patient of unknown age. The patient's pertinent medical history, concurrent condition and concomitant therapy were not reported.     On 26-AUG-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S004554, expiration date: 14-FEB-2021, strength and route were not reported) for prophylaxis (improper storage of product in use). The vaccine was stored in temperature range from -14 degrees Celsius to -10 degrees Celsius for 18 minutes. The data logger was involved. The excursion was due to calibration for data-logger. There was no previous temperature excursion. No adverse effect reported.
large bruise on the back of the patient's hand covering most of her hand; a small soft lump in the middle of the bruise; This is a spontaneous report from a contactable pharmacist (patient). A 65-year-old non-pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 05Feb2021 (Batch/Lot Number: el3249) as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. The patient has no history of COVID-19 prior to vaccination. Concomitant medications included atorvastatin; metoprolol; sertraline; ergocalciferol (VIT D); all taken for an unspecified indication, start and stop date were not reported (received within 2 weeks). Historical vaccine included BNT162B2 received by the patient on 08Jan2021 for COVID-19 immunization (Brand: Pfizer, lot number: el1284, administration time: 13:00, vaccine location: Right arm, dose number: 1). No other vaccines received in four weeks. On 07Mar2021 15:00, the patient experienced a large bruise on the back of the patient's hand covering most of her hand. There was a small soft lump in the middle of the bruise. She didn't hit anything, and she have never bruised like this, ever. There is no treatment for the events. The patient has not recovered from the events. Facility type Vaccine: Public Health Clinic. The patient has not been tested for COVID-19 post vaccination.   No follow up attempts are possible. No further information is expected.
she had Moderna booster and not had any problems with previous 2 shots.   She stated that about 12 hours later she developed an excruciating headache that would not ease and eventually vomited.   She then broke out in a rash that covered her whole body and she itched like crazy.   The rash lasted for about 4-5 days I believe.  She notified us after the rash resolved and I encouraged her to call her physician and not take any more until she spoke to MD
pt woke up this AM w/swollen rt jaw; no fever or pain; was told to call to see if it was a reaction to shots recvd yesterday;
Patient called next day to inform me that patient had severe abdominal cramps. She also mentioned that her boy also has abdominal cramps even though he didn't get the vaccine. She thinks it might be from the bad clams that they had or the vaccine.
Resident tested positive for COVID 19 on 3/8/21 ... completed vaccination on 2/17/21, suspected exposure on 2/19/21.  Mild symptoms from COVID 19 at this time, Resident did not experience any post vaccinations symptoms.
Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococci have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by >90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year-old trainees and others were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective." According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 17-19 year-old male patient who had received MENOMUNE A/C/Y/W-135 (lot number, route, site and date of administration not reported) and seven months after vaccination developed meningitis, year reported as 2006 (Q 1). Neisseria meningitidis serogroup was determined to be serogroup C. Treatments were not reported. No further information was available at the time of report. Death was reported as "No", however the patient's outcome was not reported. The reporter for this case is the same as for cases 2012-08240, -08242, -08243, -08244, -08245, -08246, -08247, -08248, -08249, -08250, -08251, -08252, -08253, -08254, -08255, and -08256. Documents held by sender: None.
Her breathing is not the same since the Moderna shot; From time to time her chest is hurting; Her blood pressure is high; loss of sleep; agitation; Cough; short tempered; Headaches; Fatigue; Dose-1  June 2021 and dose-2 September 2021; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Her breathing is not the same since the Moderna shot), CHEST PAIN (From time to time her chest is hurting), BLOOD PRESSURE INCREASED (Her blood pressure is high), INSOMNIA (loss of sleep) and AGITATION (agitation) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1  June 2021 and dose-2 September 2021). On an unknown date, the patient experienced DYSPNOEA (Her breathing is not the same since the Moderna shot), CHEST PAIN (From time to time her chest is hurting), BLOOD PRESSURE INCREASED (Her blood pressure is high), INSOMNIA (loss of sleep), AGITATION (agitation), COUGH (Cough), ANGER (short tempered), HEADACHE (Headaches) and FATIGUE (Fatigue). In September 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1  June 2021 and dose-2 September 2021) had resolved. At the time of the report, DYSPNOEA (Her breathing is not the same since the Moderna shot), CHEST PAIN (From time to time her chest is hurting), BLOOD PRESSURE INCREASED (Her blood pressure is high), INSOMNIA (loss of sleep), AGITATION (agitation), COUGH (Cough), ANGER (short tempered), HEADACHE (Headaches) and FATIGUE (Fatigue) outcome was unknown.            No concomitant treatment was provided. No treatment medication was provided. She had also asked about other potential side effects like: short tempered, agitation, fatigue and loss of sleep. She also asked if the vaccine was not authorized and what about the Pfizer vaccine? Her husband had the Pfizer and then had heart surgery. Does the vaccine change your DNA? How long does it take for it to leave your body? At this point she made the agent hold for some seconds and when she came back she could not hear the agent and hung up.
Patient had 4 doses of Imovax. Symptoms Low back pain, Leg stiffness(could not use legs).
Numbness in her finger; Injection site pain; This spontaneous case was received on 07-Nov-2023 from a pharmacist via agency (reference number: SEQW23-04095) and concerned a 65-years-old female patient.  The patient's medical history and concomitant medications were not reported.  On 18-Oct-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for influenza immunization for patients over 65 years of age. The batch number reported was 371640 and expiry date was 30-Jun-2024.   On unspecified date in 2023, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced injection site pain and some numbness in her fingers. Treatment measures associated with event included Tylenol extra strength (paracetamol).   The outcome of the events of 'vaccination site pain' and 'numbness in fingers' was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 65-years-old patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving the suspect vaccine, the patient experienced hypoaesthesia and vaccination site pain. Causality for event hypoaesthesia is unassessable, due to unclear temporal relationship. Causal role of the suspect vaccine cannot be excluded for event vaccination site pain, due to anatomical plausibility and is assessed as possibly related.; Sender's Comments: A 65-years-old patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving the suspect vaccine, the patient experienced hypoaesthesia and vaccination site pain. Causality for event hypoaesthesia is unassessable, due to unclear temporal relationship. Causal role of the suspect vaccine cannot be excluded for event vaccination site pain, due to anatomical plausibility and is assessed as possibly related.
15mins post vax broke out w/fine, red, itching rash on upper trunk & upper extremities; c/o pricking sensation; No SOB or resp distress;
Patient was given the Moderna Covid 19 vaccine, sometime between 9:30 and 9:45am with no incident.  At around 10am the pharmacist was called to the front of the store to assist a patient who has fainted. The pharmacy assisted the patient into a chair, by this time the patient was alert and talking. It was reported by another customer that patient was unconscious on the floor when he found her.  The decision was made to call an ambulance. The EMTs took patient blood pressure which was low, for the safety of patient and her unborn baby, it was decided the patient would be taken to the hospital for further evaluation. A phone call was placed to the patient the next day but there was no answer.
Four days after injection developed symptoms of labyrinthitus - slight nausea, light headedness, dizziness and vertigo.  Started acutely then got better but continue now for 31 days.  Took flu injection 14 days before the Covid-19 injection.  Previous viral labyrinthitus years before with lingering symptoms for months.  On receiving Covid injection  healthy.  More info on injection EVDS vac number VP4WNUAHLAJ9  Symptoms may be related or nonrelated to Covid injection. Symptoms getting better but still present.  Use antihistamnine on occasion without real effect.
A couple of days after the vaccine she developed chills, vomiting, tremors and had difficulty eating for 3 weeks. She called her physician and then went in to see her. The physician suggested not to receive the flu vaccine in the future.
Approx 5 mins after pt rec'd Var #2 & MENACTRA vaccines pt got up from exam table was talking to dad then fell face forward onto the floor. LOC x 30-60 secs.
Immunizations given on Monday 8/16/21. Patient stated that the next day Tuesday 8/17/21 his right arm was swollen and red and he took some ibuprofen and applied ice that next night. Stated on Wednesday 8/18/21 the swelling was worse on upper right arm and he applied ice and took ibuprofen. On Thursday 8/19/21 he stated the swelling was down. He came back into the clinic on 8/19/21 and saw the provider. He was to continue the ice for 20 minutes at least a  couple times of day and continue taking the ibuprofen and monitor the redness and swelling, and if it goes beyond the line that was drawn he is to notify us.
Fatigue; Headache; Body Aches; Chills; Fever; Brain Fog; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PREVACID; ASPIRIN [ACETYLSALICYLIC ACID]. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer.), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; PAIN (non-serious), outcome "unknown", described as "Body Aches"; CHILLS (non-serious), outcome "unknown", described as "Chills"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Brain Fog".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Same evening as having recieved MMR, DTP, and Polio vaccines, patient began running a fever.  She was very fussy waking up multiple times during the night.  Fever continued during the next two days. The next day, patient broke out in the hives, which persist still three days later.  Additionally, she has needed an extra 4-6 hours sleep each day since receiving the shots, and continues to be much more agitated and fussy than usual.
Vaccine was give after we were aware of new vaccine recommendation. Pt had no reaction to the vaccine
This spontaneous report as received from a Nurse refers to multiple unspecified patients. On unknown dates the patients were vaccinated with improperly stored ROTATEQ (lot number, expiration date and dose unknown, oral) for prophylaxis. No adverse effects reported. The vaccine was exposed to 47 Fahrenheit (F) to 77 F (47.5F) for 888 hours. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010320: US-009507513-1708USA010402: US-009507513-1708USA010400: US-009507513-1708USA010401:
Hot, red, hard large circle of skin on arm around injection site. Itching and tight ?like a sunburn? about 4 inches in diameter. Possibly ?Covid arm? allergic reaction. Appeared 2 days after 2nd moderna shot (not experienced after first shot). Still experiencing 3 days out... Female and breastfeeding