chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had a respiratory infection in Apr 2020 consistent with Covid-19. Testing was being rationed at that time and I wasn't tested until later.   Shortly after that illness cleared up I developed new chest pain. This was diagnosed as pericarditis and treated with NSAIDS, eventually a 3-month course of colchicine.   From approximately 3 hours to 36 hours after vaccination I experienced flu-like fatigue, joint stiffness, malaise, and chills without fever. Nothing worse than expected.   On the morning of 2 May I started to experience chest pressure and pain, qualitatively the same as my previous pericarditis. Aspirin at 1:16pm gave some relief, but I switched to ibuprofen for the next dose at 5:36pm.  3 May was fine. Not pain-free but enough that I hoped this was a brief episode.   On 4 May the pain was back. I called my primary care and scheduled and appointment for the morning of the 5th. Resumed ibuprofen.  By midnight that night the pain was breaking through the ibuprofen and I had developed an occasional cough. Presented for an emergency evaluation, spent the night being poked and scanned. Biggest concern on labs was elevated d-dimer and occasional cough suggesting a pulmonary or cardiac infarction, but an angiogram was clean.   Kept my appointment on 5th May. Tested for Covid at that time (negative), advised to watch for additional clotting symptoms, restarted colchicine.  Today is 8th May. Chest pain is somewhat managed with colchicine, but still often at 1/10.
as soon as the pt got the vax her face turned red, forehead and ears were hot.  Her BP spiked.  She stayed  until her face cooled down.  Did not get a BP Reading.  The next day her right arm was very sore and hard around the injection site.  A week later she developed a 3 1/2 x 4 red, itchy rash on her right arm.  She contacted her PCP  and was told to take Benadryl and cortisone.  The redness lasted about 3 days but is now gone but is still itchy.
Pregnant patient received the two doses of the Moderna vaccine; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received the two doses of the Moderna vaccine) in a 31-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Allergic rhinitis. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from 03-Feb-2021 to an unknown date for Allergic rhinitis, ACETYLSALICYLIC ACID (ASPIRIN 81) from 03-Feb-2021 to an unknown date for Hypertension, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 24-Dec-2020 to an unknown date for Pregnancy.   On 27-Dec-2020 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 01-Dec-2020 and the estimated date of delivery was 07-Sep-2021. On 27-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received the two doses of the Moderna vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  On 24-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant patient received the two doses of the Moderna vaccine) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Dec-2020, Pregnancy test: positive (Positive) Positive. On 13-Apr-2021, Ultrasound scan: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Lab data include Glucose tolerance on 01JUN2021 not yet completed .  The patient did not have any complications or acute illnesses during this pregnancy till date.  Treatment for the event was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 22-SEP-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2016, 0.5 ml (route and anatomical location of administration were not reported). The vaccine had three temperature excursions one of 328 hours with a lowest recorded temperature of 29 Fahrenheit (F) (-1.666666667 Celsius (C)), the other one of 264 hours with a lowest recorded temperature of 33 F (0.555555556 C) and the third one of 64 hours with a highest recorded temperature of 48 F (8.888888889C). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning an approximately 22 (at the time of the report 25) year old male patient who on an unknown date (when the patient was a child) was vaccinated with MMR II, (dose, route and Lot# not reported). In approximately 2009 (reported as about 3 years ago) the patient experienced lupus and was hospitalized. Currently the patient was recovered. On 03-MAY-2012 the patient underwent lab diagnostic test: the patient had low antibody titer to Rubella and Measles. Additional information has been requested.
Not feeling very good; Diarrhea; Sore throat; Nausea; Headache; Fever; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included apremilast (OTEZLA) taken for psoriatic arthritis, start and stop date were not reported. On 31Mar2021, the patient developed diarrhea, sore throat, nausea, headache and fever. The patient stated that she went to her HCP and had tests done on Friday 02Apr2021. The patient was not feeling very well on 05Apr2021. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), in arm, on Sep 25, 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for COVID-19 immunisation. The patient developed vaccination site lymphadenopathy (collarbone to the shoulder where there is a gland is bubbled and swollen), onset Sep 2021, with outcome of unknown. Additional information: Patient got her booster shot on Saturday, Sep 25, 2021. The upper part above her collarbone to her shoulder glands on the left-side where she got the shot, bubbled/swollen-up. She wanted to know if this is normal. Informed patient swollen lymph nodes (lymphadenopathy), generally resolved within 10 days, was likely to have resulted from a robust vaccine-elicited immune response. Patient referred back to her HCP. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
I have had heavy lungs since the day after receiving the vaccine. It is hard to breathe, and hard to get a full breath. Their is slight discomfort when I inhale.
Moderna COVID19 Vaccine EUA  Admitted inpatient for planned total joint replacement, no complications
Around May 31st, a month after my vaccine I noticed some pain in my legs but mostly in the left leg accompanied with swelling of the left foot. I went to the emergency room and they did a couple of blood test and a ekg of my leg and saw that I had developed symptoms of DVTs. I was there for about 8 hours and received my prescription for Eliquis and returned home. The following days I immediately felt and saw results and have not had a problem since.
BUMP ON UPPER LIP; ITCHINESS AROUND VACCINATION SITE (LEFT ARM); This spontaneous report received from a patient concerned a 23 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-JUN-2021, the subject experienced bump on upper lip. On 21-JUN-2021, the subject experienced itchiness around vaccination site (left arm). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bump on upper lip, and itchiness around vaccination site (left arm). This report was non-serious.
TOOK SECOND DOSE ONE DAY LATE; This spontaneous case report (PVX2019-2785) was received from a consumer on 11-Nov-2019. It described a 29-year-old adult male consumer who "took second dose one day late" (PT: Inappropriate schedule of product administration), while being on Vivotif for an unknown indication.  Case report: The consumer took the first dose of Vivotif on 07-Nov-2019. Then, he took the second dose on 10-Nov-2019 instead of on 09-Nov-2019   Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took second dose one day late" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took second dose one day late" was considered as not applicable.
diarrhea; slight body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 24Mar2021 12:30 (Lot number: EN6207) at the age of 63 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1; Lot # EN6201; Time of administration 12:30), administration date: 24Feb2021, for Covid-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 26Mar2021, outcome "not recovered", described as "diarrhea"; PAIN (non-serious) with onset 25Mar2021, outcome "recovered" (25Mar2021), described as "slight body aches". Therapeutic measures were taken as a result of pain.  Additional information: Patient had her second dose of vaccine on 24Mar2021 and ever since then, every morning she had diarrhea. There were no history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. Not require a visit to emergency room and physician office due to any adverse event. No reported prior vaccinations (within 4 weeks). Patient mentioned that she had a sore arm  after getting a flu shot every season, patient said it was not bad, it was tender in area where they gave it. Patient that the first day after the second dose she had slight body aches. They went away after she took some Motrin. She states that the Motrin, knock it right out. The body aches lasted maybe not even an hour. No further information provided. No relevant Tests were reported.   No follow-up attempts are needed. No further information is expected.
Information has been received from a nurse practitioner referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. The patient had two doses of GARDASIL (dose detail, route of administration, lot # and expiration date were not reported) administered in 2016 or earlier, and the patient was vaccinated the third dose in the series on 25-OCT-2018 (lot #: J009243, expire date: 23-APR-2016, intramuscularly; dose detail and strength were unknown) (inappropriate schedule of product administration, expired product administered). No adverse effects were reported for the patient. Information about treatment given for the event, lab diagnostics/studies and medical attention was not provided.
Tongue sensation/metallic taste Narrative: Patient received first dose of COVID-19 vaccination on 2/4/21. Mild reaction, tongue felt funny, metallic taste, watery eyes, 911 called but he refused to go to the ER for evaluation, RN stayed with him for an hour with EMS, vitals remained stable provider contacted and the patient daughter. He was ok before the RN left).
Pt was given the wrong COVID vaccine. Since he was not 18 yr at the time of the first administration, he should have gotten pfizer, but was mistakenly given the Moderna. Pt/parent was notified. Provider also notified and told us since he got the 1st dose of Moderna to given him the @nd dose on 08/04/2021. Pt did not have any adverse reactions to either of the 2 moderna injections,.
Moderate chest pain lasting 12 hours and hot/cold flashes, generalized achyness starting at 4 pm day of vaccine. Following lasted started day after vaccine and lasted 24 hours: fever, fatigue, achyness, hot/cold flashes, headache, sore arm, burning nose. Took Tylenol, left work early, went home slept on 1/29/21  additional 5 hours from 3 pm until 8 pm. Back to bed 12 am to 8 am following day
16 year old received moderna vaccine; A spontaneous report received from a Consumer concerning, 16-year-old female patient who received Moderna COVID-19 vaccine /MedDRA PT: [Inappropriate Age].   The patient's medical history was not included/ unknown. Patient's concomitant was not included/ unknown.    On 13-JAN-2021, the patient received their first of two planned doses of mRNA-1273 in her left arm (Batch #: 012L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 10-FEB-2021 patient's mother stated that her 16-year-old daughter received the first dose of the Moderna COVID-19 vaccine. Mother stated that her daughter was scheduled to receive the second dose on 10Feb2021. The local health department denied patient the second dose and advised patient to reach out to the Moderna clinical trial so she could receive the second dose.  Treatment information was not provided/ unknown.   Action taken with mRNA-1273 in response to the event was not provided/unknown.   The outcome of the event was unknown/not reported.; Reporter's Comments: This case concerns a 16 year old female who received their first of two planned doses of mRNA-1273 (Lot number: 012L20A) intramuscularly for prophylaxis of COVID-19 infection. There were no reported adverse events associated with this event of  product administered to patient of inappropriate age.
Seven days after vaccine I started feeling very tired, achy,  headache and lethargic.  Went to bed at 5:00 pm and slept until 8:00 am the next day.  Was still tired and achy for a second day, gradually reducing feelings as the day progressed.  Third day after onset of reaction I was back to feeling normal.
Mother state patient awoke 5/12/12 with Nausea, severe headache, Dizziness, and fever.  States she also noted "twitching" in patient's thumb and back.  And noted swelling and redness to injection areas.  Was given Ibuprofen which gave little relief.  Saw private MD on 5/14/2012.
vertigo/ extreme episode of vertigo; lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo/ extreme episode of vertigo) and DIZZINESS (lightheadedness) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 631M20A and 026A21A) for COVID-19 vaccination.     No medial history was reported.  Concomitant products included METOPROLOL, MULTIVITAMIN [VITAMINS NOS], ESCITALOPRAM OXALATE (LEXAPRO), APIXABAN (ELIQUIS) and GLUCOSAMINE for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced VERTIGO (vertigo/ extreme episode of vertigo) (seriousness criterion hospitalization) and DIZZINESS (lightheadedness) (seriousness criterion hospitalization). The patient was treated with PROMETHAZINE HYDROCHLORIDE (METHAZINE) for Adverse event, at an unspecified dose and frequency and SCOPOLAMINE [HYOSCINE] for Adverse event, at an unspecified dose and frequency. At the time of the report, VERTIGO (vertigo/ extreme episode of vertigo) and DIZZINESS (lightheadedness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Computerised tomogram: normal (normal) Normal. In February 2021, Magnetic resonance imaging: normal (normal) Normal.         It was reported that the patient had seen an ear, nose, throat health care provider and test were run, everything had come back as normal.  The patient was hospitalized for about 3 or 4 days. The patient had a MRI and CT scan and everything came back normal.  Company comment: 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. Further information has been requested.; Sender'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. Further information has been requested.
Presents for SOB x1wk & cough, chills, body aches. Admit for COVID pneumonia. Tx: O2, decadron, zinc, singulair.  DC home.
Information has been received from a pharmacist concerning a 66 year old female with diabetes and penicillin allergy who on 09-FEB-2008 was vaccinated with 0.5ml Zostavax (Oka/Merck) (lot # 658861/1822U).  On 12-FEB-2008 the patient experienced fever, and an injection site reaction that was a half dollar size swollen area with a hard center.  Unspecified medical attention was sought in the pharmacy.  There was no lab studies performed.  At the time of the report the patient's status was unknown.  There is not product quality complaint involved.  Additional information has been requested.  This is one of several reports from the same source.
Slightly elevated temperature / Fever; Swelling about 2 &1/2 to 3 inches around the injection site; Soreness about 2 &1/2 to 3 inches around the injection site; Redness about 2 &1/2 to 3 inches around the injection site; Headache; Muscle pain; Aches; Chills; Tiredness; Fogginess; This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma and immune system disorder.   In October 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 9 months after receiving Shingrix, the patient experienced fever, injection site swelling, injection site pain, injection site erythema, headache, muscle pain, general body pain, chills, tiredness and foggy feeling in head. On an unknown date, the outcome of the fever, injection site swelling, injection site pain, injection site erythema, headache, muscle pain, general body pain, chills, tiredness and foggy feeling in head were recovered/resolved.   It was unknown if the reporter considered the fever, injection site swelling, injection site pain, injection site erythema, headache, muscle pain, general body pain, chills, tiredness and foggy feeling in head to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in left arm and had fever, swelling, soreness and redness about 2 &1/2 to 3 inches around the injection site, muscle pain, aches and chills. The patient also reported tiredness and fogginess. The patient did not had lot number or expiration date information to provide for either dose of Shingrix. For tolerances of 2nd dose, refer case US2020124819, reported by same reporter for the same patient. This case linked with US2020AMR125326 and US2020AMR125327, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR125326:Husband's case 2nd dose US-GLAXOSMITHKLINE-US2020AMR125327:Husband's case 1st dose US-GLAXOSMITHKLINE-US2020124819:same reporter
First chills and aches which accelerated until I was shaking violently and temp dropped to 94.4.  This violent shaking lasted several hours.  I finally warmed up with feet and hands in hot water.  Temp then went to 103.3.  Joints hurt.  Was nauseous and dizzy.  Took 3 Ibuprofen at 9pm and 3am. Norm temp 7am.
Redness and hotness and swelling the size of the palm of the mom's hand to her finger tips-  She gave Benadryl and Tylenol
patients have been administered doses while the temperature excursion assessment was ongoing; patients have been administered doses while the temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing) in a 45-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  The reporter stated that, their facility had not been able to download the digital data logger, they had been put on hold by the state at the moment. There had been no power outages that would have impacted the Moderna vaccine.  It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  No treatment information provided.