chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started by feeling very tired on evening of 11/05/2015. Next day had extreme chills and so tired couldn't get out of bed. Slept for 36 hours straight. Chills all day on 11/06/2015. Woke up on 11/07/2015 feeling somewhat better but still slept. Noticed rash on arm on 11/08/2015. Probably there all along but didn't notice. Rash around injection site and running down arm to elbow. No fever at any time.
P/receiving 4th dose of vax experienced numbness & swelling in a two inch area around the inject site & tingling on the lateral aspect of her arm; Later experienced weakness; Seen by MD dx CNS virus;
OFF LABEL USE; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a health care professional concerned a 17 year old of unspecified sex. 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, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On an unspecified date, the subject experienced off label use, and product administered to subject of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and product administered to patient of inappropriate age was not reported. This report was non-serious.
The rash is a few inches around,rash is not as red anymore but continues to spread; Rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (The rash is a few inches around,rash is not as red anymore but continues to spread) and VACCINATION SITE RASH (Rash at the injection site) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided.).    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced RASH (The rash is a few inches around,rash is not as red anymore but continues to spread) and VACCINATION SITE RASH (Rash at the injection site). At the time of the report, RASH (The rash is a few inches around,rash is not as red anymore but continues to spread) and VACCINATION SITE RASH (Rash at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information included Benadryl.
From telephone contact with reporting physician it was stated that a 7 month old female patient received an IPOL, a Tripedia, a Hibtiter and a Prevnar vaccination on 7/18/01. On 7/20/01, the patient developed a local reaction of redness, swelling and irritability. Patient was treated with Ibuprofen.
18 month imm received DTaP, IPV on 06/21/02. On 06/22/02, pt developed an erythematous rash at DTaP injection site approximately 12x8cm with edema. On 06/23/02 he developed more lesions smaller in circumference over trunk and extremities. By 06/24/02 pt developed pruritis, was taken to clinic for evaluation.
Dizziness, Tachycardia, neck/throat pressure on right side Narrative:
administered dose on 24May2022, expiration date 22May2022; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 67-year-old female patient who received HAV (Havrix) (batch number J95H7, expiry date 22nd May 2022) for prophylaxis.   On 24th May 2022, the patient received the 1st dose of Havrix. On 24th May 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK receipt date 1 June 2022: Reporter's comment: The pharmacist stated that the patient was administered a dose of Havrix, which had an expiration date of 22nd May2022. At the time of reporting, dose was not repeated. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.
Redness of arm approximately 2.5 in. in diameter. Warm to touch.  H/A, body aches sweats from Dec 3rd - Dec 7th
myocarditis, pericarditis, admitted to PICU for monitoring, anti-inflammatory treatment
c/o having numbness to right forearm , mid chest pressure, chest pain, and increase pain with respirations
According to mom the evening of 10-9-04, child developed hives on the site of injection and hives down legs. By Sunday AM, hives on trunk and face. Child also developed wheeze. Mom gave Benadryl and started nebulizer treatment. Mom called Monday 10/11/04. Child better.
On day 8 (from my first injection), experienced significant dizziness/equilibrium issues that persisted for 1/2 day, subsided for 8 hours, and has now returned. I am currently experiencing this feeling and am not sure how much longer is will persist. I have not yet taken the 2nd injection since I am within the 3 week window from the first injection.
Redness at site of Varicella vaccine noted 4/1/08, progressed to heat and pain on 4/2/08.  Seen in office by M.D. 4/2/08, induration 8 x 10cm.  Diagnosed as Cellulitis.  Patient placed on Augmentin.  Seen again in office 4/3/08, swelling decreasing, pain improved.  Follow-up call 4/8/08 - parent reports all symptoms "almost gone".
I?ve had both moderna vaccines in jan and feb - my menstrual cycle was okay in March, however it was 15 days late in April and I am menstruating like I am in my 20s with a heavy flow and large clots.
right eye "floater" -- posterior vitreous detachment, occurred 2 days after 2nd shot of Pfizer Covid-19
Systemic: Fainting / Unresponsive-Mild, Additional Details: RPh asked technician to call 911 and bring Epinephrine. Patient quickly recovered and asked us to cancel and NOT to call 911. After she recovered, she stated she had a similiar previous reaction and should have told me. She was given water and laid on the floor until she felt fine. I asked her to stay in pharmacy for 30 minutes. Her mother can inside the store and stayed with her until that time. She checked in with me before leaving. She said she was fine and apologized a number of times.
nurse/tech diluted the powder vial with sterile water; nurse/tech diluted the powder vial with sterile water; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 14th May 2021, the patient received Menveo. On 14th May 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated with Menveo which was diluted the powder vial with sterile water which led to wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered. The reporter was asked if patient need to vaccinated. The reporter does not have detail of patient or vaccine. The reporter consented to follow up. This case had been linked with case US2021111552, as reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021111552:Same reporter
Vaccine was administer at 1600 with mild c/o of pain at site at 1615 mom called us stating that pt c/o "Head & ears feeling funny" since mom was driving she was around the corner from home. I called her back at 1617 to check how pt was doing. Pt state "my throat feels funny" per dr mom was to take pr to ED. By the time pt was ED there were facial swelling & difficulty swallowing.
This spontaneous report was received from a consumer via pharmacist refers to a female patient of unknown age. The patient's concurrent conditions, medical history, historical medications, concomitant medications and drug reactions/allergies were not reported. On an unknown date in March 2018, the patient was vaccinated with GARDASIL 9 shot (dosing details, route, lot # and expirations date were not reported) as prophylaxis, but had not had her second dose yet (at the time of this report) (circumstance or information capable of leading to medication error). The patient planned to administer the remaining two shots this year. No adverse experience reported. Product quality complaint was not involved.
Narrative: COVID infection following COVID vaccine series 03/24, Pfizer, dose #1 04/14, Pfizer, dose #2 12/27 COVID swab, result: detected 12/17 pt cc: nausea, headache exposure: unknown
Information has been received from a physician, for VARIVAX (Merck) and GARDASIL, Pregnancy Registry products, concerning a 14 years old female patient. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot number not provided) and the second dose of GARDASIL (dose, route and lot number not provided) on 05-JUn-2012. The patient was also vaccinated with other suspect therapies including BOOSTRIX and MENACTRA on 05-JUN-2012. No concomitant medications were reported. Subsequently, the patient became pregnant. The Last Menstrual Period (LMP) or her gestational age and Estimated Date of Delivery were not known. Additional information has been requested. Update (10-FEB-2014): The patient's doctor was contacted in order to obtain follow-up regarding the patient's pregnancy outcome. However, the doctor informed that the doctor did not see the patient since the vaccination, and the doctor has no information on the pregnancy, delivery or OBGYN. Additional information is not expected.
the patient was administered an improperly stored dose of vaqta; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions/allergies were not reported. On 19-DEC-2019, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated(VAQTA) with lot number S010727, expiry date 26-JUL-2019 (dose, strength and route of administration were not reported) for prophylaxis (product storage error). The storage temperature was reported as 48.5 degree Fahrenheit in time frame of one hour. There was no previous temperature excursion. There was no product quality complaint (PQC). The outcome of the event was unknown.
This case was reported by a consumer and described the occurrence of autism in a female patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed and hepatitis B vaccine recombinant. The reporter is the mother of the patient. A physician or other health care professional has not verified this report. On an unspecified date, the patient received a dose of Infanrix. On an unspecified date, the patient received a dose of Engerix. At an unspecified time following the administration of Infanrix and Engerix, on an unspecified date, the patient developed autism. The outcome of autism was not reported. Autism was assessed as medically serious by manufacturer (OMIC).
Very sick the first day he got the shot; The nurse at the  store in  spilled it on his arm.; The nurse at the  store in  spilled it on his arm.; Fever; Headache; Felt very achy on the left arm; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of ILLNESS (Very sick the first day he got the shot), UNDERDOSE (The nurse at the store in spilled it on his arm.), DEVICE CONNECTION ISSUE (The nurse at the  store in  spilled it on his arm.), PYREXIA (Fever) and HEADACHE (Headache) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was not provided by reporter.  Concomitant products included VITAMIN C [ASCORBIC ACID], ERGOCALCIFEROL, RETINOL (VITAMIN A + D) and ZINC for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Very sick the first day he got the shot), UNDERDOSE (The nurse at the store in spilled it on his arm.), DEVICE CONNECTION ISSUE (The nurse at the store in spilled it on his arm.), PYREXIA (Fever), HEADACHE (Headache) and VACCINATION SITE PAIN (Felt very achy on the left arm). At the time of the report, ILLNESS (Very sick the first day he got the shot), UNDERDOSE (The nurse at the  store in  spilled it on his arm.), DEVICE CONNECTION ISSUE (The nurse at the store in spilled it on his arm.), PYREXIA (Fever), HEADACHE (Headache) and VACCINATION SITE PAIN (Felt very achy on the left arm) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable  Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 23-May-2021: Outcome of events changed from unknown to recovered, new events such as device connection issue and under-dose were added.
Information has been received from a physician concerning a (bottle fed) patient who was vaccinated PO with his first dose of ROTATEQ and vomited immediately after receiving the dose. The patient sought medical attention at the physician's office. The physician stated he did not want to file a report and said the event was unrelated to therapy  with ROTATEQ. The patient had just received a bottled feeding which caused the vomiting. No other details. There was no product quality complaint. No further information is available.
Pt had nausea after 2 hours and felt tired/heavy feeling.  Took Ibuprofen.    On day later, experienced more nausea and lack of appetite, and then had a terrible headache.  It got worse and she experienced neck stiffness and her blood pressure was 175/95 at 4pm on 1/8.  She rested and felt better about 24 hours later.  She felt normal again after a few days.
swelled up my left side of face that had the Botox ,Kind of like paralysis but I was fine; fatigue; headache; muscle pain; joint pain; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelled up my left side of face that had the Botox ,Kind of like paralysis but I was fine), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) in a female patient of an unknown age 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.     The patient's past medical history included Eye injury (had a history of an eye injury (from a bad car accident several years ago).), Nerve damage (trigeminal nerve damage(and takes Botox)) and COVID-19 (Patient did have COVID two years ago) on 21-Jan-2020. Concurrent medical conditions included Asthma (had asthma but not a medical condition). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), PARACETAMOL (TYLENOL [PARACETAMOL]) and BOTULINUM TOXIN TYPE A (BOTOX) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (swelled up my left side of face that had the Botox ,Kind of like paralysis but I was fine), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills) and NAUSEA (nausea). At the time of the report, SWELLING FACE (swelled up my left side of face that had the Botox ,Kind of like paralysis but I was fine) had resolved and FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2020, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative, negative (Negative) Negative and negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was reported that about a week and a half later all the Botox were off.  Patient took three test at the times and came back negative (Dec 26/31/ Jan4)  The patient had to have a prosthetic lens in one eye   This case was linked to MOD-2022-547079 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2022: Follow up received contains no newinformation.
feeling very bad today; body ache; pounding headache; sore injection arm/sore injection shoulder; fever; tired; shivering/chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling very bad today), PAIN (body ache), HEADACHE (pounding headache), VACCINATION SITE PAIN (sore injection arm/sore injection shoulder) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A and 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, 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 experienced FEELING ABNORMAL (feeling very bad today), PAIN (body ache), HEADACHE (pounding headache), VACCINATION SITE PAIN (sore injection arm/sore injection shoulder), PYREXIA (fever), FATIGUE (tired) and CHILLS (shivering/chills). At the time of the report, FEELING ABNORMAL (feeling very bad today), PAIN (body ache), HEADACHE (pounding headache), VACCINATION SITE PAIN (sore injection arm/sore injection shoulder), PYREXIA (fever), FATIGUE (tired) and CHILLS (shivering/chills) had not resolved.            Concomitant medication was not provided. Treatment information was not provided.   This case was linked to MOD-2021-304616, MOD-2021-313559 (Patient Link).
Serum sickness reaction, fever 104 degrees x 4 days, myalgias, arthralgias, nausea. L arm swelling 15cm x 8cm x 2 wks. Hives at site and legs.
Soreness of arm, within 2 hours of injection. Fever 100.5, 15 hours after injection Mild nausea On-going as of 24 hrs after injection
she wanted to get the 2nd dose of the vaccine; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (she wanted to get the 2nd dose of the vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Tuberculosis NOS (Treatment during 1 year (unspecified)) in January 2021.    On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (she wanted to get the 2nd dose of the vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (she wanted to get the 2nd dose of the vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (she wanted to get the 2nd dose of the vaccine).    Patient wanted to get the second dose of the vaccine, patient was not able to do it since patient was taking treatment for tuberculosis during 1 year (unspecified medication). It was unknown if caller experienced any adverse event after the vaccine was given.  Treatment medications were not reported.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022) in a 39-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.  On 11-Mar-2022 at 12:21 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 11-Mar-2022 at 12:21 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022) outcome was unknown.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Dosage text was reported as additional dose.  The patient received vaccine past its 30 day expiry date on 11-Mar-2022 at 12:21:42 PM.  Vaccine went into 2 to 8 degree Celsius thaw state on about 24-Dec-2021. The vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.  Treatment information was not provided.   This case was linked to MOD-2022-542869 (Patient Link).
nausea; Fatigue; slight headache; This is a spontaneous report from a non-contactable consumer, the patient.  A 43-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER BIONTECH mRNA COVID 19 VACCINE) (batch no: EL3247) on left arm as a single dose on 15Mar2021 at 10:00 AM for COVID-19 immunisation. The patient also received first dose of BNT162B2  on left arm as a single dose on 22Feb2021 at 10:00 AM for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not allergic to medications, food, or other products. Patient is not enrolled in clinical trial. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, has the patient had not been tested for COVID-19.  On 15Mar2021, patient experienced fatigue, slight headache, and nausea. The clinical outcome for these events were given as recovering. The patient did not received any treatment for these event. No follow-up attempts are needed. No further information is expected.
Hoarseness, slight cough; mild at first; fever 1-2 days later; became secondary infection (respiratory); required antibiotic.