chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm; Feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm; Feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm; Feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm; Feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm; Feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm; Feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm; This is a spontaneous report from a contactable nurse (patient).  A female patient of unspecified age started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), unspecified route of administration on 28Dec2020 as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. In Dec2020, the patient experienced feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm, Had same feeling the next day but better compared to the day before. In addition, the nurse reported she woke up to breastfeed. Outcome of the events feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm were recovering.  Information on lot/batch number has been requested.
I started having cramping and bleeding around 9:00 AM on May 27th 2014.  Diagnosis is that I was having a miscarriage.  I started labor and then was given some pain medication to take until a DNC was performed on May 29th 2014.
Redness and swelling at vaccination site inflammation resolved without intervention but nodule was still present at follow up 17/03/2023; Redness and swelling at vaccination site inflammation resolved without intervention but nodule was still present at follow up 17/03/2023; HCP reported that 2 pediatric patients were observed to have a nodule/bump still present at injection site after 2nd dose/ Subcutaneous nodule lasting 2 months on L thigh/  nodule was still present at follow up 17/03/2023; This spontaneous safety report, with reference number 02366699 (Interaction# 02366693), was received by the partner on 05-APR-2023 and forwarded to agency on 06-APR-2023, from a non- health professional.  The case was considered off-label due to Incorrect route of product administration.  The reporter did not assess the causal relationship between Vaxelis and the reported events of "Agency calling on behalf of HCP to report AE for VAXELIS. Agency received information verbally from HCP during meeting on 4/5/23. HCP reported to agency that 2 pediatric patients were observed to have a nodule/bump still present at injection site after 2nd dose."  Due to the nature of the event, the causality between the event "Route of administration reported as IV for Vaxelis" and Vaxelis was not applicable.  Further information is expected.  For reference purposes the case is linked to MCM-004673 (same reporter).  SIGNIFICANT FOLLOW-UP INFORMATION was received on 19-APR-2023 by partner from the physician and forwarded to agency on 20-APR-2023.  Off-label classification was removed as route of administration was reported as intra-muscular.  The reporter assessed the causal relationship between Vaxelis and the event, "HCP reported to agency that 2 pediatric patients were observed to have a nodule/bump still present at injection site after 2nd dose/ Subcutaneous nodule lasting 2 months on L thigh/  nodule was still present at follow up 17/03/2023" as related.  The reporter did not assess the relationship between Vaxelis and the event, "Redness and swelling at vaccination site inflammation resolved without intervention but nodule was still present at follow up 17/03/2023".  No further information is expected.
Began experiencing mild numbness in left side of lip 10/23/16. By mid-morning 10/24/16, whole left side of face was numb with droop eyelid and lip.
Approximately 2 years post vax, pt developed generalized lesions. Physician noted scattered papules of various size and diagnosed chickenpox.  Pt was afebrile. Pt was exposed to shingles 2 weeks prior to onset.
weakness; cough; tired/fatigued; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), COUGH (cough) and FATIGUE (tired/fatigued) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     no medical history information was reported.  The patient's past medical history included No adverse event. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), ALPRAZOLAM for Anxiety, LITHIUM for Depression.   On 12-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, the patient experienced ASTHENIA (weakness), COUGH (cough) and FATIGUE (tired/fatigued). At the time of the report, ASTHENIA (weakness), COUGH (cough) and FATIGUE (tired/fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2021, Body temperature: 96 degree fahrenheit (High) 96 degree Fahrenheit.
pt recv vax 8AUG95 & APR96 pt was exposed to chicknepox in school;22APR96 pt devel mild breakthrough chickenpox w/about 40-50 lesions;pt recovered;
This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Myocarditis in the setting of recent COVID-19 vaccination. Case Rep. 2021     The patient's past medical history included Gastroesophageal reflux disease.   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 MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging heart: abnormal (abnormal) Cardiac MRI supported Myocarditis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Myocarditis) to be possibly related.    This literature reported three patients who presented with chest pain after receiving either the BNT162b2 Pfizer/BioNTech or mRNA-1273 Moderna/NIH vaccine.   Clinical presentation, biomarker supported Myocarditis  Concomitant medications were not reported  Treatment medications were not reported  Company Comment: This is a literature review case concerning a 36-year-old, male patient with medical history of Gastroesophageal reflux disease, who experienced the unexpected serious (hospitalization and AESI) event of Myocarditis. The event occurred after the second dose of Moderna COVID 19 vaccine, unknown time to onset. Clinical presentation, biomarker, and cardiac MRI supported myocarditis. The rechallenge is not applicable. The benefit-risk relationship of Moderna COVID 19 vaccine is not affected by this report.; Sender's Comments: This is a literature review case concerning a 36-year-old, male patient with medical history of Gastroesophageal reflux disease, who experienced the unexpected serious (hospitalization and AESI) event of Myocarditis. The event occurred after the second dose of Moderna COVID 19 vaccine, unknown time to onset. Clinical presentation, biomarker, and cardiac MRI supported myocarditis. The rechallenge is not applicable. The benefit-risk relationship of Moderna COVID 19 vaccine is not affected by this report.
dead arm; debilitating; missed 1 and 1/2 days of work; dry Heaving; vomiting; sore arm on that same day; stomach Pain; nausea; fever; shivering; headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of dry heaves in a 66-year-old female patient who received Herpes zoster (Shingrix) (expiry date 08-JUL-2024) for prophylaxis.   On 11-SEP-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 11-SEP-2023, less than a day after receiving Shingrix, the patient experienced dry heaves (Verbatim: dry Heaving), vomiting (Verbatim: vomiting), pain in arm (Verbatim: sore arm on that same day), stomach pain (Verbatim: stomach Pain), nausea (Verbatim: nausea), fever (Verbatim: fever), shivering (Verbatim: shivering) and headache (Verbatim: headache). On an unknown date, the patient experienced numbness of upper extremities (Verbatim: dead arm), weakness (Verbatim: debilitating) and inability to work (Verbatim: missed 1 and 1/2 days of work).  The patient was treated with acetylsalicylic acid (Aspirin). On 12-SEP-2023, the outcome of the nausea and headache were resolved (duration 1 day). The outcome of the dry heaves, vomiting, stomach pain, fever, shivering, numbness of upper extremities, weakness and inability to work were resolved and the outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the dry heaves, vomiting, pain in arm, stomach pain, nausea, fever, shivering, headache, numbness of upper extremities, weakness and inability to work to be related to Shingrix.     It was unknown if the company considered the dry heaves, vomiting, pain in arm, stomach pain, nausea, fever, shivering, headache, numbness of upper extremities, weakness and inability to work to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-SEP-2023 The case was reported by the patient. The reporter reported that she received Shingrix from her pharmacist in her left arm on Monday at 1 PM and by 11PM- 12AM that evening she was pretty sick experiencing vomiting, dry heaving, headache, shivering, fever, nausea, stomach pain and a sore arm on that same day. The patient reported that her arm hurt so much it felt like a dead arm and she put her arm in a sling until yesterday, 13th September 2023.  The patient reported that the headache was very severe and the headache and the stomach pain were debilitating.  The patient reported that the nausea and the headache lasted until 3 PM on Tuesday, 12-SEP-2023. The patient reported that it took 2 days, until yesterday, 13-SEP-2023 to start feeling better and she took 1 Aspirin (no product information or date provided) to help her tolerate everything.  The patient reported that she missed 1 and 1/2 days of work.  The patient reported that she was over all the adverse reactions at the time of reporting, except her arm was still a little sore if she lifts it above the shoulder.  The patient did not have the lot for the vaccine. The reporter consented to follow up.
Patient stated that she had the normal side effects. The sat following the vaccine she was having joint pain. Shed took Tylenol and they went away. On today She stated that the pain is worst it is in her joints. She stated that she can barely walk.
Stiffness on left side of neck and then when she turned neck she developed numbness on neck that is still present.
1hr p/vax pt became lethargic & sl floppy;low grade temp was also noted per mom for 1min;very floppy, oral secretions coming out of pt's mouth;mom felt immun was result;MD placed pt on apnea monitor x 1wk;
Patient developed symptoms of Bell's Palsy 5 days after receiving 2nd dose of Pfizer/BioNTech Covid vaccine.  Vaccine was given 3/7/21, facial drooping and slurred speech developed 3/12/21.  Patient was evaluated in ED on 3/16/21.  MRI revealed no acute process and she was diagnosed with Bell's Palsy.  Treatment included Prednisone 60mg QD for 7 days and valacyclovir 1000mg TID for 7 days.  Symptoms improved after 2 days of treatment and resolved 3/22/21.  Follow up visit with Primary Care Physician 3/25/21.
After two weeks of receiving the Pfizer vaccine, I got a headache that lasted all day long. I was able to do my regular activities and work. I had the headache on April 30, May 1st, and the second. No headache on the 3rd, but I had a mild headache on the 4th. Like I said before, my lifestyle has not changed or diet.
expired doses of IPOL were administered; Initial information received on 15-Dec-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (consumer).  This case involved a 12-year-old male patient who had administered expired doses of IPV (Vero) Ipol were administered.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a expired dose of dose of suspect IPV (VERO) (lot P1F54, expiry date 07-Dec-2020) via unknown route in unknown administration site (expired product administered).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  The outcome of the event was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Disclaimer: Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
I experienced headache, body aches, fatigue, and pain that spread from the injection site. I contracted COVID-19 on 07/12/2022 with symptoms of body aches, headache, cough, fever, runny nose, congestion, sore throat, and fatigue. I was prescribed PAXLOVID on 07/13/2022. My throat is not as sore today, but it is too soon to say my symptoms are resolving.
Chills; Soreness at the injection site; generalized body aches/Body aches; Shortness of breath; Asthma attack; Difficulty sleeping; Light headed and dizzy; Nausea; high BP 140's; HR 110's to 120s; Nasal congestion; Swelling of the face; Sore throat; This is a spontaneous report from a contactable nurse.  A 42-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiration date not reported), intramuscular on the right arm on 31Dec2020 at 10:15 AM, at a single dose for Covid-19 immunization.  Medical history included asthma, allergy, hypothyroidism, and some fish allergy. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). Patient previously took ibuprofen and experienced allergy. The patient is not pregnant. On 31Dec2020, after ten-15 minutes (10:30 AM) of receiving the vaccine, she was light headed and dizzy with some nausea. Monitored in the emergency room (ER) with high BP 140's and heart rate (HR) 110s to 120s. After an hour of saline bolus, she was better but she got nasal congestion and swelling of the face with sore throat. On 01Jan2021, after 24 hours, she got some soreness at the injection site with generalized body aches. Also she got some shortness of breath which lead to her asthma attack and difficulty sleeping. On 02Jan2021, after 48hours, she was feeling still light headed with some sore throat, chills, body aches and severe headache which lead her to go to the ER and got herself tested for flu, covid and strep, which came back all negative but her signs and symptoms (s/sx )still after discharge was getting worst especially the headache and generalized body aches. As well as congestion and sore throat. The patient had given "Ivf" for the events. The patient was not diagnosed with Covid prior to vaccination and was not Covid tested post vaccination. The outcome of the events was not recovered. The reporter assessed the events as non-serious.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events.  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 RAs, Ethics Committees, and Investigators, as appropriate.
IST DOSE WAS GIVEN ON 04/28. SHE WANTED SECOND DOSE ON 06/29.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (IST DOSE WAS GIVEN ON 04/28. SHE WANTED SECOND DOSE ON 06/29.) 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 28-Apr-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 DOSE OMISSION ISSUE (IST DOSE WAS GIVEN ON 04/28. SHE WANTED SECOND DOSE ON 06/29.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (IST DOSE WAS GIVEN ON 04/28. SHE WANTED SECOND DOSE ON 06/29.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.
Member recieved Flumist vaccine, and aprox. 1 hour after noticed hives all over body (legs, arms, torso)and itching sensation on legs. At which point member took 25mg Benadryl. 2 Hours later member took second dose due to the fact that the 1st dose had little effect. Member states woke up in AM and syptoms were gone.
Low grade fever; Mild headache; Swollen lymph nodes; Welt; Pain; Itchy injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 23Apr2021 at 12:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 02Apr2021 at 12:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 24Apr2021, the patient experienced low grade fever, mild headache, swollen lymph nodes, welt, pain, and itchy injection site. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events low grade fever, mild headache, swollen lymph nodes, welt, pain, and itchy injection site was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a physician concerning a patient of unknown gender and age. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, route and lot # not provided). The physician reported that on an unspecified date, the patient experienced "an episode of dizziness" following administration of GARDASIL. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
I had pain in my arm. Did not look at it again until I got home from work the next day. Site were shot was given from raised, red, itchy and painful. There was a large orange shaped circle around the injection site. I felt ill went to bed. The next morning I called doctors office and they advised me to come to urgent care. Seen Doctor he diagnosed as a localized reaction. Gave me prednisone and told me to take antihistamines. Swelling was greatly reduced after a few hours of prednisone. Still a bruise and some itching.
After lunch, went to use bathroom, got a shock feeling all over my body, like my body was shutting down, got a intense stunned feeling in middle of chest like I was about to pass out took B/P , it was lower than normal. The feeling lasted about 2 seconds, Got som heart racing for a couple of seconds
Information has been received from a medical assistant referring to an unspecified patient of unknown age and gender. On an unknown date the patient was vaccinated with one dose of improperly stored PROQUAD (lot # L051098, expiration date 17-JUN-2017, strength and route were not reported). The vaccine has been stored under temperature of -10.8 degree Celsius for 48 minutes before back in range. There was no previous temperature excursion and date logger involved. No adverse effects were reported. This is one of several reports received from same reporter. Additional information has been requested.
Itching, redness, enlarged swelling at injection site; 4 days out from injection continuing w/bruising, discomfort and at time of injection did take Benadryl 25mg tablet d/t concern of possible ongoing adverse s/s but no respiratory or cardiovascular arose
Numb right arm from elbow to fingertip, heaviness in arm, stinging  like a bee sting
Patient was given Moderna instead of Pfizer. The check in table asked the patient's parent which vaccine they wanted and gave her the information for the requested Moderna vaccine. The did not realize the patient was only 17 and only eligible for Pfizer. It was not caught until the patient came to receive their second dose. The patient did not state any adverse events from receiving Moderna. She has been checked on once since being given the vaccine series.
PATIENT RECEIVED 2ND PFIZER BOOOSTER ON 4/12/2022 AND DID NOT REPORT ANY ADVERSE EVENTS DURING MONITORING PERIOD. FACILITY REPORTS PATIENTS IS EXPERIENCING CHEST PAIN, AND UNSTEADY GAIT ON 4/13/2022.