chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic itching; Heart racing; Diarrhea; Feels like she has flu; No sleep; Feels dehydrated; Both eyes watering; Achy muscles; Chills; Nausea; Low grade fever of 99.8F; Headache; This spontaneous case was reported by a health care professional and describes the occurrence of PRURITUS (Systemic itching), PALPITATIONS (Heart racing), DIARRHOEA (Diarrhea), INFLUENZA LIKE ILLNESS (Feels like she has flu) and INSOMNIA (No sleep) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy (Allergic to cotton trees when they are blooming.). Concomitant products included DIAZEPAM for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced HEADACHE (Headache). On 02-Mar-2021, the patient experienced PRURITUS (Systemic itching), PALPITATIONS (Heart racing), DIARRHOEA (Diarrhea), INFLUENZA LIKE ILLNESS (Feels like she has flu), INSOMNIA (No sleep), DEHYDRATION (Feels dehydrated), LACRIMATION INCREASED (Both eyes watering), MYALGIA (Achy muscles), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Low grade fever of 99.8F). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever and Headache, at a dose of UNK dosage form. At the time of the report, PRURITUS (Systemic itching), PALPITATIONS (Heart racing), DIARRHOEA (Diarrhea), INFLUENZA LIKE ILLNESS (Feels like she has flu), INSOMNIA (No sleep), DEHYDRATION (Feels dehydrated), LACRIMATION INCREASED (Both eyes watering), MYALGIA (Achy muscles), CHILLS (Chills), NAUSEA (Nausea), PYREXIA (Low grade fever of 99.8F) and HEADACHE (Headache) outcome was unknown.        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.
The evening of the vaccine she went home and started getting Headaches and body aches 12 hours after the vaccine. She treated it at home with Tylenol, Zinc and vitamin D. After meds symptoms went away.
I develop a temperature of 102; Headache; I am sick/I am really not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Jun2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 14Jun2023, outcome "unknown"; PYREXIA (non-serious) with onset 14Jun2023, outcome "unknown", described as "I develop a temperature of 102"; MALAISE (non-serious) with onset Jun2023, outcome "unknown", described as "I am sick/I am really not feeling well". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, headache, malaise. Additional information: Consumer stated, "I took Pfizer BioNTech yesterday and last night I develop the temperature of 102 (degree) and I have a headache so I am calling find out do I need to go to the hospital or just take Tylenol or something?" Consumer stated, "Yes, I have a temperature and a headache, so I don't know I should go in to the hospital or should I just take some Tylenol because the information, it said if we have one of these side effects call, so that is why I am calling." As for lot, Consumer stated, "Well this person pen writing is trouble it looks, I cannot read this. It looks like 0253270. I am not even sure if that is, they have troubled penmanship. All of them it just looks like scribbled, it appears to be 0253270, I am reading it but I am not sure if that is the one. I got the vaccine yesterday 14Jun2023 (Further date and month could not be appropriately clarified) and then it has my patient number, my date of birth, it has no expiration." Consumer stated, "The LOT# that I just read to you, Pfizer BioNTech and it is a 2 and then the other number appear to be 0213270, I am not sure if that is correct because I am unable to read the penmanship." As for treatment, Consumer stated, "No, I called the number for the information. I do not take medicine."  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Flu shot was given around 1:45 AM and at 5:30 PM, began having itchy, swollen eyes, swollen throat with difficulty breathing. Pt. stated she took Tobamax in the AM and IMITRIX that evening. POA headache, she stated she had a hamburger and lemonade prior to shot and only H2O after. Pt. wanted to sleep so she took Nyquil. This AM still had  itchy eyes with some swelling. Pt. stated had any appt. with Dr. today.
Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications was reported.   This case was linked to MOD-2021-370033 (Patient Link).
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. On unknown dates the patients received RECOMBIVAX HB (dose and route not reported, lot # K020216 with expiration date 17-SEP-2016 that had been improperly stored. No adverse effects were reported. Additional information has ben requested.
Rash on bilateral arms. Reports itching inside. No breathing concerns/throat swelling/angioedema. No anaphylaxis.
Information has been received from a health professional concerning a female who was vaccinated with Gardasil. On approximately 18-FEB-2008 the patient experienced hives. The patient's outcome was not reported. Additional information has been requested.
Dose administered after 30-day Use By Date or after manufacturer date of expiry; Expired dose administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 69-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator :14 Mar 2022. Vial did not undergo any temperature excursion. No concomitant medication was reported.    No treatment information was reported.
Red, swollen, warm to touch, and itchy at site of injection. About 1.5" X 3" area. One tablet of Benadryl taken. Red and itchiness went away. Still swollen and warm to touch. Also, eyes were dry and nose was runny.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced a rash for 9 days, a low grade fever for 2 days, some spots and a mild illness.
Rash Narrative: Developed quarter sized rash around injection site immediate afterwards, described as swollen, erythematous and painful. No warm and unknown if indurated. After resolution, this then recurred at the same site, was the same size, and with the same associated complaints. No other adverse effects noted. No therapies tried or applied.
tested for COVID-19/tested positive with symptoms; tested for COVID-19/tested positive  with symptoms; This is spontaneous report from a contactable consumer (patient). This consumer reported similar events for himself and his wife. This is a 1st of 2 reports. A 75-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was due to receive the second dose on 14Feb2021. He was asked to go get tested for COVID-19. He tested negative that day, but he also tested positive the next day on 15Feb2021. He specified he had "minor coughing, headaches and fever". He added he was in quarantine for 14 days. The outcome of event was unknown.     information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021168265 same reporter/drug/event, different patient
Patient has 17.5cm long by 9cm high induration with erythema to right lower deltoid/upper arm. Area tender to palpitation. Right shoulder with reduced range of motion. Malaise/Myalgia.
low iron; incontinence; memory loss; dizziness; felt sick/thinks she might have passed out; anemia; headache; vomiting; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of anemia in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 16th August 2019, 1 days after receiving Shingrix, the patient experienced anemia, headache, vomiting, diarrhea, dizziness and feeling unwell. On 18th August 2019, the patient experienced memory loss. On 19th August 2019, the patient experienced incontinence. In September 2019, the patient experienced iron decreased. On an unknown date, the outcome of the anemia, memory loss and iron decreased were unknown and the outcome of the headache, vomiting, diarrhea, incontinence and dizziness were recovered/resolved and the outcome of the feeling unwell was recovering/resolving.   It was unknown if the reporter considered the anemia, headache, vomiting, diarrhea, memory loss, incontinence, dizziness, iron decreased and feeling unwell to be related to Shingrix.  Additional case details were reported as follows: The patient felt sick with headache, dizziness, vomiting and diarrhea.  On 18th August 2019, 3 days after receiving Shingrix, the patient was very sick and did not remember that evening at all.  Four days after receiving Shingrix, when the patient woke up around 3 to 4 am, her nightgown was soaked in urine and she thought she might have passed out. In September 2019, the patient had her routine physical with her doctor and standard blood tests showed her iron levels were down to 10 ng.   The patient was diagnosed with anemia.
raised bumps at the the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE MASS (raised bumps at the the injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE MASS (raised bumps at the the injection site). At the time of the report, VACCINATION SITE MASS (raised bumps at the the injection site) outcome was unknown.            No relevant concomitant medication was reported. Treatment information was not provided.   This case was linked to MOD-2021-218901 (Patient Link).
12/11/09 became dizzy and had headache rested in car symptoms went away, drove home. 12/12/ dizzy, bilateral weakness in hands and lower arms, went away after awhile then went shopping 8-9 PM this day, nausea, went away. 12/13/dizzy at church, went away then went shopping. 12/14/09 4 AM awoke with heart palpitaions, dizzy, bilateral weakness hands and lower arms. made doctor appointment. 2 PM today went to doctor, recommended Tylenol for headache, Benadryl and Xanax to sleep. 12/15/09 good day. 12/16/09 heart palpitations, dizzy, bilateral weakness in hands and lower arms goes away and able to do usual activity. 12/17/09 good day. 12/18/09 heart palpitation, bilateral weakness hands and lower arms. She is the care taker for elderly ill parents and works part time.
FELT PAIN SIMILAR TO STRAINED MUSCLE LOWER RIB CAGE AND HIP MUSCLE SAME SIDE; BODY ACHES; BY 48 HOURS APPETITE GONE; CHILLS DEVELOPED FOR 3 TO 4 HOURS; TOTAL LACK OF ENERGY; FEVER (99 PLUS) FOR 3 TO 4 HOURS; DULL LONG LASTING HEADACHE; This spontaneous report received from a patient via a company representative concerned a 74 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: patient was above average health and did not take daily meds. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced felt pain similar to strained muscle lower rib cage and hip muscle same side, body aches, by 48 hours appetite gone, chills developed for 3 to 4 hours, total lack of energy, fever (99 plus) for 3 to 4 hours, and dull long lasting headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99 plus. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt pain similar to strained muscle lower rib cage and hip muscle same side, chills developed for 3 to 4 hours, and fever (99 plus) for 3 to 4 hours, was recovering from by 48 hours appetite gone, and total lack of energy, and had not recovered from body aches, and dull long lasting headache. This report was non-serious. This case, involving the same patient is linked to 20210427557.
2 patients received a vaccine that were first punctured yesterday; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 patients received a vaccine that were first punctured yesterday) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 patients received a vaccine that were first punctured yesterday). On 29-Jun-2021, EXPIRED PRODUCT ADMINISTERED (2 patients received a vaccine that were first punctured yesterday) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information not provided. List of concomitant medication were not given.
Headache started about 2 hours after flu shot. I gave my daughter Advil.  She went to bed about 2 hours after the Advil. When she woke this morning, she was complaining that she still had a headache. I felt her head and she was warm so I took her temperature and it was 102.2. I gave her tylonal.  Fever and headache subsided. Around 1pm she was complaining of a headache again. Took her temperature and it was 101.4. Gave her more tylonal. Symptoms subsided again. Around 7 she started complaining of a headache again. When we took her temperature it was 103. We gave her tylonal and she went to bed.
C/o myalgias x 6 wks post injection. Was uncomfortable, hard to be still or sleep. TYLENOL/MOTRIN no effect. Discussed at 6/19/13 visit. Joints burning sensation entire body.
Syncope; This is a spontaneous report from a contactable nurse (patient). A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 17Apr2021 11:30 (Batch/Lot Number: ER8735) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced syncope on 17Apr2021 11:45. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of syncope. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available and the close temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported 'syncope' cannot be completely excluded. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Information was received from a physician via an internet article regarding cases in litigation concerning female patients of unknown age, who received vaccinations with GARDASIL (lot numbers, dates of vaccination, dosages, and routes of administration not reported). It was reported that between May 2009 and September 2010, 16 deaths occurred after GARDASIL vaccination (causes of deaths not reported). It was unknown if autopsies were performed. Upon internal review, 16 deaths was determined to be medically significant. This is one of several reports from the same source. Additional information is not expected.
Pt received second dose of Pfizer vaccine in Jun and did not get her period for the month of Jul. For Aug she had 2 heavy periods.; Pt received second dose of Pfizer vaccine in Jun and did not get her period for the month of Jul. For Aug she had 2 heavy periods.; This is a spontaneous report from a contactable consumer. An adult non-pregnant female patient received second bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration on an unknown date in Jun2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration as dose 1, single for COVID-19 immunization. On an unknown date in Jun2021, the patient had received second dose of pfizer vaccine and had not got her period for the month of July2021 and had 2 heavy periods in Aug2021. The patient received no treatment for the events. It was unknow whether the patient had received any other vaccine within 4 weeks. It was unknow whether the patient had not been diagnosed with COVID-19 prior to vaccination or had been tested since the vaccination. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderna on 1/26 and 2/19. Positive on 9/27
Office found box with one extra diluent left in box unable to differentiate who may have gotten only the powder. She has been revaccinated for MENVEO 3/7/2023
terrible burning; also in her 'upper respiratory tract'; This is a spontaneous report from a contactable consumer. A 79-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), via an unspecified route of administration on 10Feb2021 as dose 1, single for covid-19 immunisation. Medical history included acid reflux disease, asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, Caller received the 1st dose of the Pfizer vaccine 10Feb2021, however on that night she had terrible burning also in her upper respiratory tract. Caller would like to know whether she should get the 2nd dose of the Pfizer covid vaccine and would like to know how much she is covered after 1 dose of the Pfizer covid vaccine and would like to know whether she could switch between 2 different brands of the covid vaccine. The outcome of events was unknown.  Information about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Patient had swelling, redness, skin warm to the touch at injection site.  Soreness in muscle/joint pain began day after vaccination (1/7). Injection site became very swollen and painful on 1/14/21.
Headache, fatigue, fever, body aches, lightheaded and swollen lymph node in armpit of arm shot was injected in.   She has been taking ibuprofen and outcome still undetermined as it?s been 39 hours since she was administered shot and still not feeling well.
L arm numbness, L arm heaviness, chest tightness, itchy throat-cleared by EMS