chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient c/o nausea, arm pain, chest pressure after vaccination.  Upon patient examination did not appear to be in acute distress and no labored breathing noted.  Plan discussed with patient and husband to transfer to ED for further workup and monitoring. In the ED patient complained of shortness of breath, and received an ECG and XRAY which were normal. Patient discharged
This spontaneous report as received from a pharmacist refers to a 60 years old female patient. The patient was vaccinated with first dose of VARIVAX (Merck) (lot number, route not reported) two years ago approximately in September 2010 and in the office "today" on 18-SEP-2012 for the second dose. No other co-suspects were reported. No concomitant medications were reported. The patient was not experiencing any known symptoms. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Patient had a mild tiredness and mild diarrhea; Patient had a mild tiredness and mild diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Patient had a mild tiredness and mild diarrhea) and FATIGUE (Patient had a mild tiredness and mild diarrhea) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Patient had a mild tiredness and mild diarrhea) and FATIGUE (Patient had a mild tiredness and mild diarrhea). At the time of the report, DIARRHOEA (Patient had a mild tiredness and mild diarrhea) and FATIGUE (Patient had a mild tiredness and mild diarrhea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  The other Covid-19 vaccines that the patient provided were all Pfizer vaccines.   This case was linked to MOD-2023-746825 (Patient Link).
Opened up her sinuses where she could smell better/rash flare up to a medication which stopped after the vaccine.; lightheaded; big knot on arm near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Opened up her sinuses where she could smell better/rash flare up to a medication which stopped after the vaccine.), DIZZINESS (lightheaded) and VACCINATION SITE SWELLING (big knot on arm near the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Opened up her sinuses where she could smell better/rash flare up to a medication which stopped after the vaccine.), DIZZINESS (lightheaded) and VACCINATION SITE SWELLING (big knot on arm near the injection site). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Opened up her sinuses where she could smell better/rash flare up to a medication which stopped after the vaccine.) outcome was unknown and DIZZINESS (lightheaded) and VACCINATION SITE SWELLING (big knot on arm near the injection site) had resolved.        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.   No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-272991 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Follow-up received contains Non-significant information. HCP contact details updated
Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 18-MAY-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 23-JUL-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
pea-sized lymph node on left collar bone painful when pressed; This spontaneous case was reported by a consumer and describes the occurrence of Lymphadenopathy in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 11M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular route) at an unspecified dose.  On 20-Feb-2021, the patient experienced Lymphadenopathy. At the time of the report, Lymphadenopathy outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Patient received dose #2 of her Moderna COVID vaccine on 2/25/21. Patient called in to work the next day 2/26/21 because she was not feeling well. Patient did not show up to work on Monday 3/1/21 and her supervisor, called the PD to check in on her and she was found deceased in her home.
Patient describes chest pain, shallow breathing, sharp chest pain, patient has previous cardiac problems and could recognize. He also reports feeling fatigued and flushed (hot flashes), body aches, headache mildness, injection site pain
One hour after injections, dry heaves, vomiting and explosive (liquid) diarrhea!  Happened 2-3 times over 4 hours.  Had to use Immodium to stop the diarrhea.
Information has been received from a male physician concerning a male patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot number 1667690/1158Z). The physician reported that on "this week" (on approximately 14-SEP-2010) the patient experienced severe erythema from shoulder to elbow and tenderness. The physician also reported that the patient experienced redness, soreness and swelling. The physician gave the patient steroids and antihistamines. Therapy with PNEUMOVAX 23 discontinued. At the time of the report the patient had recovered. Additional information has been received from a health care professional concerning a male patient with amoxicillin, levothyroxine and LIPITOR allergy and no illness at the time of vaccination, who on an unspecified date was vaccinated with a first dose of PNEUMOVAX 23 and experienced soreness and swelling. The patient was treated with steroids and anti-histamines which calmed down the adverse events. There was no relevant diagnostic test. The patient did not seek medical attention. Follow-up information was received from another health professional who stated that the two lot number 666639/0564Z and 667690/1158Z were both male patients. This is one of several reports received from the same source. Additional information has been requested.
Patient states that arm has gotten swollen and red since vaccination. Patient was informed to contact their primary care dr to discuss reaction and decide if care is required
After a week and a half, where the vaccination was administered I got a large red circled rash about the size of a grapefruit.
17 year old female received the first dose of the Moderna Covid-19 Vaccine; This spontaneous case was reported by a physical therapist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old female received the first dose of the Moderna Covid-19 Vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old female received the first dose of the Moderna Covid-19 Vaccine). On 29-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old female received the first dose of the Moderna Covid-19 Vaccine) had resolved. 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: 016B21A) with no associated AEs.
Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030h21b) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported.  The reporter informed that, the vaccine was used beyond use date of some lot numbers for Moderna that were administered to patients. There was no adverse reaction noted or reported to the reporter ever regarding after administration of vaccine.  It was unknown if the patient was tested positive or diagnosed with COVID-19. It was unknown if acute illnesses at the time of vaccination and up to one month before. And it was unknown if chronic or long-standing health conditions.  No treatment drug details was reported.
p/vax pt devel 2-3mm pink papules on trunk & neck & some small scabs;pt was negative for vesicles;wk before pt felt warm;pt presented to Md w/7 papules on 1/6/99;sl red throat;
Fever of 100.3 orally, diarrhea, vomiting began evening of 9APR92; didn't feel right for a few days; seen by MD 13APR BP 180/96- 130/70- 140/70;
Patient called indicating she went to hospital on 11/4/23 as a result of some sort of reaction. Patient reported to me that she experiencing a rash/hive-like reaction along with throat swelling and some difficulty breathing. Per patient, doctor she had seen in ER had concluded that her reaction was a result of the recent Moderna Spikevax vaccination. Per patient, doctor had put her on a course of Prednisone and also told her to take benadryl. In addition, patient was told by doctor to report this to her pharmacy (me on 11/4/23 after her visit with doctor). I looked at patient's profile, and discovered patient had recieved a moderna spikevax vaccination on 10/30/23. Upon questioning, patient indicated she had not started any other new medications or had changed her diet. Patient also noted she had tolerated all the previous covid-19 vaccinations she had received.
Miscarriage? around 7 weeks pregnant at the time of vaccine, estimated delivery date was 8/19/2021
COVID; COVID; This is a spontaneous report from a Pfizer- sponsored program. A contactable consumer (patient's husband) reported a female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization in Jan2021. The patient medical history was not reported. The patient's concomitant medications were not reported. After the first shot in Jan2021, the patient contracted COVID. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Pt staring into space, hyporesponsive which was alternating with irritability. No treatment. Resolved in 24 hrs and with the discontinuation of Robitussin CF.
tactile fever day p/vax recvd; red swelling to area; discomfort upon walking 2 days p/15cm hot, red swelling around puncture site;
Rapid swelling of arm down to elbow, pain radiating to fingers Symptoms made worse by second injection on 3/30/21. Now months out has ongoing pain in the area with regular shooting pain to left hand fingers. Continues to have a swollen area in upper arm.
PATIENT SAID THAT HE GOT A HEADACHE IMMEDIATELY FOLLOWING THE INJECTION.  IT KEEP GETTING WORSE DURING THE 15 MINUTES HE WAS BEING MONITORED.  HE SAID IT WAS WORSE THAN A MIGRAINE.  HE ALSO WAS FLUSHED IN THE FACE AND SAID HE FELT WARM.  HE WAS SENT HOME FROM WORK WHEN APPROPRIATE.
02/20/22 presents to ED for "AMS". PMHx "recently discharged from hospital with COVID and AKI" "A. Fib on Eliquis"
Patient developed Bell's Palsy on 1/1/2021 and was seen in the Emergency department and started on oral steroids. I saw him 1/6/2021 and he continued to have left sided facial nerve palsy/paralysis.
Suspected vaccination failure/Had it twice, 2nd time after got the vaccine; I've had it twice, 2nd time after the vaccine, milder case; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 03-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient have had them twice. The second time was after he/she got the vaccine. The patient stated that milder case as a result. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
About 5 minutes after the shot, the patient was in the waiting area and started feeling lightheaded and dizzy.  She was sweating and sounded drowsy and said she couldn't see.  She did not report to be hot or itchy.  We had her lie down with her feet elevated and she immediately felt better and could see again.  She remained in that position for 3-5 minutes before she sat up.  She felt normal again at this time.
Treatment of COVID-19; Treatment of COVID-19; Moderna, Date: 14Jul2022 ; Pfizer / BioNTech, Date: 07Nov2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Nov2022 as dose 5 (booster), single (Lot number: GJ3275) at the age of 65 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Mar2021 as dose 1, single (Lot number: 010A21A), in left arm, on 07Apr2021 as dose 2, single (Lot number: 018B21A), in left arm, on 30Nov2021 as dose 3 (booster), single (Lot number: EW0183), in left arm and on 14Jul2022 as dose 4 (booster), single (Lot number: 016B22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Irritable Bowel syndrome" (unspecified if ongoing); "interstitial cystitis" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ibuprofen, reaction(s): "Known allergies:Ibuprofen". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Nov2022, outcome "unknown", described as "Moderna, Date: 14Jul2022 ; Pfizer / BioNTech, Date: 07Nov2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: patient received COVID 19 Treatment: PAXLOVID from 22Feb2023 to 27Feb2023 as Treatment of COVID-19.
Pt was given Varivax lot # T027305 in L arm. After vaccine was given it was discovered that vaccine had expiration date of 08/12/2022. Dr. was made aware of error and examined the pt. Pt was then monitored for 15 minutes. Pt left clinic with father feeling well. Advised to go to ER if SOB, rash, or hives develops. Pt verbalized understanding. Vaccine was pulled from box labeled with lot number U033046 and expiration date 10/21/2023. Vials in box checked afterwards and other vials match box.
whole body feels weak/difficult for her to get around; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (whole body feels weak/difficult for her to get around) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis and Rheumatoid arthritis.  No medical history was provided by reporter.  No concomitant medication reported.   On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (whole body feels weak/difficult for her to get around). At the time of the report, ASTHENIA (whole body feels weak/difficult for her to get around) outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided.
chills; body aches; This is a spontaneous report from a contactable other HCP. This Other HCP reported that a 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported, Expiration date not reported), via an unspecified route of administration on 11May2021 as 2ND DOSE, SINGLE for COVID-19 immunization. The patient's medical history included pre-existing condition of mouth ulceration from an unknown date. The patient's concomitant medication included palbociclib (IBRANCE, 125mg,) taken orally from 31Mar2021 as daily dose (day 1-21 of 28 day cycle) for breast cancer and is ongoing.  The patient experienced chills and body aches on an unspecified date. The outcome of both the events was reported as unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a pharmacist referring to a 52 year old female patient. The patient was allergic to erythromycin, morphine, penicillin, tetracycline, VALIUM. On 29-JUN-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot # K007988, expiration date: 03-SEP-2015; Strength, route and dose unknown) for shingles prevention. There was no information about concomitant therapy. On an unspecified date after administration of ZOSTAVAX, the patient developed a raised rash at the injection site. It was reported that the patient's rash had been present for about a month. The patient had called the pharmacy for medical attention. No treatment was given to the patient. The outcome of injection site rash was reported as not recovered. Additional information has been requested.
Covid-19; A spontaneous report was received from a consumer concerning a female patient who experienced COVID-19/MedDRA PT: COVID-19.  The patient's medical history and concomitant product use were not provided/unknown by the reporter.  On an unknown date the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 30-Dec-2020 the patient tested positive for COVID-19.  At the time of the report the outcome for the events was unknown.   Action taken with mRNA-1273 in response to the event was not provided/unknown.  The outcome of the event were unknown/not reported.   The reporter did not provide causality for the event.; Reporter's Comments: Based on the natural history of COVID-19, and the established information about the mRNA-1273 vaccine, a causal association between the event of tested positive for COVID and the product use is assessed as unlikely,
fever 102.6, body aches, cough, congestion, headache, chills, diarrhea. starting 1/1/2022
Right after receiving the vaccine had a headache in the front of the head which lasted for about 6 hours.  About 24 hours later noticeable amount of dizziness making it difficulty walking. Has not decreased since first appearing. Left arm is sore.  If it does not clear up in the next few days will seek medical attention.
very itchy rash; This is a spontaneous report from a contactable consumer (patient) received. A non-pregnant 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EL9267 and Expiration date: not reported) via an unspecified route of administration, administered on the left arm on 12Feb2021 14:00 (at the age of 45 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history included depression. The patient had no known allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC), calcium, ashwagandha, cyanocobalamin (B12), and ascorbic acid;betacarotene;biotin;calcium;chromium;colecalciferol;copper;folic acid;iodine;iron;lycopene;magnesium;manganese;nicotinamide;pantothenic acid;phosphorus;phytomenadione;potassium;pyridoxine hydrochloride;retinol;riboflavin;selenium;vitamin b1 nos;vitamin b12 nos;vitamin e nos;xantofyl;zinc (CENTRUM SILVER) taken for unspecified indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination. On 13Feb2021, the patient developed a very itchy rash. The rash started on the arm where the injection was and spread under the arm into the armpit area, around the chest area, and onto the other upper arm and armpit area. The patient used hydrocortisone (CORTIZONE, cream) and calamine as treatment. The patient recovered from the event on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Pt received vaccines 8/5/16. He woke up 8/9/16 with severe headache with no additional sx. Pt was seen in office 8/10/16. Phone call to pt's mtr 8/11/16. She states headache somewhat better.
FULL BODY ACHE; PULLED CALF MUSCLE FEELING; LEG PAIN CALF; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced full body ache. On APR-2021, the subject experienced pulled calf muscle feeling. On APR-2021, the subject experienced leg pain calf. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from full body ache, and the outcome of leg pain calf and pulled calf muscle feeling was not reported. This report was non-serious.