chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a healthcare worker referring to an 18 year old female patient who was not pregnant and had no pertinent medical history or drug allergies. On 28-JUN-2015, VARIVAX (Merck) (Lot# L006385, expiration date 25-FEB-2017) was improperly stored at an unspecified "high" temperature for an unspecified length of time. On 02-JUL-2015 the patient was vaccinated with this improperly stored dose of VARIVAX (Merck) (dose and frequency not reported), subcutaneously. Then on an unknown date in July 2015 the patient developed swelling at the injection site and pain in the arm in which the VARIVAX (Merck) was injected. No treatment was given for the events and no lab diagnostics studies were performed. The patient recovered from the swelling at the injection and pain in the arm on unknown dates in July 2015. Causality assessment was not provided. Additional information has been requested.
Patient was administered a dosage of 0.3ml instead of 0.2ml. of Pfizer. Patient did wait for 15 minutes after vaccine was administered and had no adverse reaction. Called patient's number on file but person who answered stated it was the wrong number. Therefore I was unable to notify patient's mother or follow up with patient as well as address on file.
rash; still has hives on her legs; I was sick on Saturday (19Jun2021) but worse on Sunday; splotches; did not have the energy to get up; really sick; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) dose 2 via an unspecified route of administration on 18Jun2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported.  The patient's concomitant medications were not reported. Historical vaccine included dose 1 received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on unspecified date as DOSE 1, SINGLE for covid-19 immunization and had nauseous and sick as reactions. On an unknown date, patient stated that, I had a little bit of reaction to the first shot, I was nauseous and sick.  I had vaccination on second last Friday 18Jun2021, was observed for 15 minutes and did not make a connection at first, but the next day, I was really sick. I started getting splotches on me. I was sick on Saturday 19Jun2021 but worse on Sunday 20Jun2021, I did not have the energy to get up.  I still have the rash today 21Jun2021. I still have hives on my legs. I just need to report it. I hope it goes away. The outcome of all events was reported as an unknown.   Information on the lot/batch number has been requested.
Initial unsolicited report received from consumer on 26-Oct-2015. This case involves a female patient (age was not provided) who was vaccinated with a dose of High Dose Flu Shot (batch number, route of administration, site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. The patient felt that she might have had a reaction to the high dose flu shot on an unspecified date after vaccination. Laboratory investigations and corrective treatments were not reported. The outcome of the event was not reported. Documents held by sender: none.
At 9:20am patient fainted after administration of vaccine. Jerking and stiffness of the body noted. Lasting approximately 1 min. Complain of feeling nauseated, blurred vision and dizzy. Skin pale in color. Cool compress applied to head and neck blood pressure monitored. Remained in center until.
Father called 2 days after vaccine stating child had a rash on the arm where vaccine was given. No swelling. Rash hot to touch.
Dizziness and weakness,  "Numbness and tingling;  Hypertoniciy in legs, ringing in ears, riaght hand very numb, loss of bladder contorl, basically every MS exacerbation symptom I've ever had showed up simultaneously."
12 hours post injection intense chills, muscle, full body aches began. 2 hours later joint pain started. No fever was present. Symptoms treated with Tylenol. 24 hours post injection arm where injection occurred became, reddish purple, hot to the touch and slightly swollen. Affected area was from head of the humerus to 4 cm below cubital crease on lateral aspect of the arm. Treated with benadryl without much effect. Chills, body aches and joint pain subsided after 36 hours from onset. Arm of injection site still shows redness, hot to the touch and itchiness in band that is 12 cm wide covering the lower 2/3 of the upper arm.
No reaction at time of vaccine. Several hours later my daughter developed itchy hives all over her body. They would migrate from one spot to another. At first thought it was bug bites but when they continued the next morning we realized they were hives. Used Benadryl tablets and hydrocortisone cream to help with symptoms. Did some research and discovered that many others also developed hives and treated with Zyrtec. Started Zyrtec once a day. Hives would come back nightly as the Zyrtec wore off. After 2 weeks she is able to just take the Zyrtec every other day but the hives come back.
Patient developed cellulitis/? on (L) shoulder. Abscess like hard induration on shoulder. Treated with NSAIDS/Cephalexin 500mg x 3 and issue resolved. She has been examined on 10/9/15 and documented.
After the expected pain at the injection site, I began, about 5 hours later, to feel severe body aches, especially in my head, shoulders and back. By the time I went to bed, I felt as if I had the flu, with body aches and my skin felt "crawly," as if I had a fever, although I did not. The body aches reached their peak throughout the next day, easing up on the third day and I felt back to normal by the end of the 4th day.
pt healthy 930AM 4OCT93 went down for a nap woke 1/2 hr later w/t104 R; no other s&s; 930PM t104.6 R started having runny eyes; scant rhinorrhea & drooled sl; gave bath/APAP; 5OCT t105 R; 2PM woke from nap sweating; fever broke 7PM;
Information has been received from a physician concerning a 5 year old female patient with no pertinent medical history and drug reactions/allergies who in January 2003, was vaccinated with the first dose of VARIVAX (Merck) (lot number, route and site of administration not reported). In April 2007, the patient was vaccinated with the second dose of VARIVAX (Merck) (lot number 656572/0115U) (route and site of administration not reported). On an unspecified date the patient had a breakthrough of VARIVAX. The patient had about 12 lesions. The patient had completely recovered from this event. The patient sought medical attention. Additional information has been requested.
A non-serious, spontaneous report of a three-year-old received full dose of FLUMIST in one nostril was received from a health professional concerning a three-year-old female. Neither medical history nor concomitant medications were reported. On 13-Oct-2010, the patient received a full dose in one nostril. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event was considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Syringe connection issue; Vaccine Underdose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of DEVICE CONNECTION ISSUE (Syringe connection issue) and UNDERDOSE (Vaccine Underdose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no significant medical history).   On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced DEVICE CONNECTION ISSUE (Syringe connection issue) and UNDERDOSE (Vaccine Underdose). At the time of the report, DEVICE CONNECTION ISSUE (Syringe connection issue) and UNDERDOSE (Vaccine Underdose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter asking if he has to repeat the 2nd Dose to the Patient.   Reporter did not allow further contact
Initial information received on 26-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 63 years old female patient who was vaccinated with MENACTRA (lot: U5836BA, expiry date: 18-Mar-2019) via intramuscular route in left deltoid, on 26-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOVAX 23 for Immunisation. It was an actual medication error due to expired vaccine used and inappropriate age at vaccine administration. The patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
UPPER LIP SWELLING; OVERALL UNWELL FEELING; FEVER OF 100.6 F; HEADACHE; This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included graves disease due to hyperthyroidism, penicillin allergy, and sulfonamide allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-JUL-2021, the subject experienced upper lip swelling. On 29-JUL-2021, the subject experienced overall unwell feeling. On 29-JUL-2021, the subject experienced fever of 100.6 f. On 29-JUL-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100.6 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever of 100.6 f on 29-JUL-2021, was recovering from overall unwell feeling, and headache, and had not recovered from upper lip swelling. This report was non-serious.
Very Painful down arm from injection site.  Very swollen and painful  lymph nodes underneath left armpit. Pain in top left shoulder going up to back of head . Also chills fever
Patient received the H1N1 vaccine. Five minutes later she felt lightheaded and dizzy. Her blood pressure was 188/104 and 217/110. Called 911. They took her to ER. ER suspects alcohol swab was the cause.
flu; got really really sick; congestion; cough; sore throat; fever; diarrhea; no appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 48 year-old male patient received bnt162b2 (BNT162B2), administration date 20Oct2021 (Lot number: FF2588) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Verbatim: Diabetes" (ongoing); "Verbatim: high blood pressure" (ongoing), notes: Verbatim: high blood pressure. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st Dose, lot written as PF EL3249), administration date: 14Jan2021, when the patient was 47 years old, for Covid-19 immunization; Bnt162b2 (2nd Dose, lot EN6198), administration date: 22Feb2021, when the patient was 47 years old, for COVID-19 immunization. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "flu"; ILLNESS (non-serious) with onset 14Dec2021, outcome "recovered" (19Dec2021), described as "got really really sick"; NASAL CONGESTION (non-serious) with onset 14Dec2021, outcome "recovered" (19Dec2021), described as "congestion"; COUGH (non-serious) with onset 14Dec2021, outcome "recovered" (19Dec2021), described as "cough"; OROPHARYNGEAL PAIN (non-serious) with onset 14Dec2021, outcome "recovered" (19Dec2021), described as "sore throat"; PYREXIA (non-serious) with onset 14Dec2021, outcome "recovered" (19Dec2021), described as "fever"; DIARRHOEA (non-serious) with onset 14Dec2021, outcome "recovered" (19Dec2021), described as "diarrhea"; DECREASED APPETITE (non-serious) with onset 14Dec2021, outcome "recovered" (19Dec2021), described as "no appetite".  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Diabetes and high blood pressure were diagnosed prior to his Pfizer COVID vaccines. Description of complaint: Report 2 of 2; The report is cross referenced to report ID: GH0TFC9L. Vaccine Supplemental Form completed in additional context. Caller states she came back from Name withheld and both she and her husband both got really really sick and she read this letter and now thought she had COVID but she tested negative for COVID and thinks she and her husband just got the flu and really did get the flu.   No follow-up attempts are possible. No further information is expected.
fever; extreme nausea; fatigue; joint pain; sick; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), NAUSEA (extreme nausea), FATIGUE (fatigue), ARTHRALGIA (joint pain) and ILLNESS (sick) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), NAUSEA (extreme nausea), FATIGUE (fatigue), ARTHRALGIA (joint pain) and ILLNESS (sick). At the time of the report, PYREXIA (fever), NAUSEA (extreme nausea), FATIGUE (fatigue), ARTHRALGIA (joint pain) and ILLNESS (sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
My daughter has experienced substantial hair loss since having the GARDASIL series of immunizations. She has always had a thick beautiful head of hair and now at the age of 19 she has areas of the scalp with very little hair. It is devastating to her emotional well being. She has also experienced extreme fatigue. She never seems to get enough sleep and spends a lot of time in bed.
patient received expired dose of pentacel with no adverse event; Initial information received on 30-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a 6 months old female patient who had expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered)  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  The patient's medical history included Pre-Term birth.  It was unknown if the patient had any additional medical history, concomitant disease or risk factor.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) and HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B) (lot numbers and expiration date not reported) for prophylactic vaccination.  On 03-Nov-2021, the patient received a third dose of suspect PENTACEL (lot UJ393AAA and expiration date: 12-Oct-2021) via intramuscular route in the left thigh for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  It was unknown if the patient experienced any additional symptoms/events.   It was unknown if there were laboratory data/results available.  It was reported "One of the study participant received the 3rd dose of vaccines (6 months of age) on November 3rd 2021, the Pentacel dose that was administered was taken from the initial lot that was provided to the sites, with an expiry date of Oct 12 ,2021 instead of the new lot."  No adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient with history of Lupus. She presented to the ED by EMS on 3/5/23 with report of fever and shortness of breath for the past several days. She additionally reported chills, diaphoresis, cough, headache, dysuria, shortness of breath, lightheadedness, and abdominal pain. A COVID PCR test performed in the ED resulted positive. Ultimately she was admitted 3/5/23 - 3/7/23 for COVID-19 infection and sepsis. Of note, the patient has received the primary COVID vaccine series and three boosters.
Patient was later determined to be only 15 years old, an unauthorized age group for this vaccine.  No adverse reaction identified.
All vaccines administered without issue on 12/5/2017. However, after patient left clinic, it was realized that the Hepatitis B dose was incorrect. A child's (0.5 mL) dose was given to the patient instead of the full adult dose (1.0 mL). The patient came back on 12/7/2017 for the other half of the adult dose. After the patient left, it was realized that the correct dosing should have been to give a full 1.0 mL instead of the second half as has been done in the past. Upon review with the hospital pharmacy and review of CDC information (noting no risk for overdose with Hepatitis B or other risks) - the patient is scheduled to return on 12/11 to receive the correct full 1.0 mL adult dose.
Passed out; Bruising her head; Dizziness; A spontaneous report was received from a 58-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event passed out/loss of consciousness, bruising her head/contusion and dizziness.  The patient's medical history included diabetes mellitus, blood pressure and cholesterol. Concomitant medications included glyburide, cholesterol medication and blood pressure medication.  On 24 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot#: unknown) in the right arm for prophylaxis of COVID-19 infection.  On 24 Mar 2021, the patient experienced dizziness, passed out and bruised her head. Treatment for the event, bruised her head included applying ice.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events; passed out, bruising her head and dizziness was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
she got her last Pfizer Covid 19 booster dose on 14Oct, then got Covid; she got her last Pfizer Covid 19 booster dose on 14Oct, then got Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "she got her last Pfizer Covid 19 booster dose on 14Oct, then got Covid". Therapeutic measures were taken as a result of drug ineffective, covid-19. She was prescribed Paxlovid, lot number GH5752.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Metallic taste in mouth after injection; dizziness; nausea; confusion; cold tingling hands and feet. Pt states he felt really bad and had the urge to defecate.
Covid arm red, swollen area at injection site.  Approx 3in by 3.5 in. Present since approx 24 hours after 2nd vaccine
On the date listed i noticed significant swelling under my armpit that was very tender, its no longer tender but its still there. Also the night of the shot I had to sleep semi sitting because my asthma actually bothered me alot, I havnt had this happen to me in quite sometime.
Body itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Body itchiness) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PRURITUS (Body itchiness). At the time of the report, PRURITUS (Body itchiness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported years ago when she took zyrtec, she had a reaction. No concomitant medications reported. No treatment reported.
On 3/26/2022 I received my Covid-19 vaccine shot. Approx. 20 days after it affected my back and jaw. I had trouble eating. I had an inflammatory process in back right back hip area and left jaw. Took about 6 months to feel relief however pain still insists. I took MRI of jaw. Results from MRI shows degeneration and arthritis.
Pain in chest, blurred vision and speech, rapid heartbeat, weakness, pain in left shoulder.  Went to ER and subsequently had an Overnight stay in hospital diagnosed as "Hospitalized with an Ischemic Stroke"
Initially, vomiting and vertigo.  Vertigo has continued for the past 11 days, and not resolved yet.