chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tire easily; Severe cramping for about 15 minutes/cramps for almost 2 weeks; Diarrhoea for about 15 minutes; Stomach ache; Headachecomes and goes; Body aches; Sick all day; Low grade fever; Chills; Ear ringing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhoea for about 15 minutes), ABDOMINAL PAIN UPPER (Stomach ache), TINNITUS (Ear ringing), MUSCLE SPASMS (Severe cramping for about 15 minutes/cramps for almost 2 weeks) and MALAISE (Sick all day) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Chemical sensitivity, Sulfonamide allergy, Allergy to antibiotic and Allergy to antibiotic.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced TINNITUS (Ear ringing). On 05-Mar-2021, the patient experienced PYREXIA (Low grade fever) and CHILLS (Chills). On 06-Mar-2021, the patient experienced MALAISE (Sick all day), HEADACHE (Headachecomes and goes) and MYALGIA (Body aches). On 07-Mar-2021, the patient experienced DIARRHOEA (Diarrhoea for about 15 minutes), ABDOMINAL PAIN UPPER (Stomach ache) and MUSCLE SPASMS (Severe cramping for about 15 minutes/cramps for almost 2 weeks). On an unknown date, the patient experienced FATIGUE (Tire easily). On 24-Mar-2021, DIARRHOEA (Diarrhoea for about 15 minutes), ABDOMINAL PAIN UPPER (Stomach ache), MUSCLE SPASMS (Severe cramping for about 15 minutes/cramps for almost 2 weeks), MALAISE (Sick all day), PYREXIA (Low grade fever), CHILLS (Chills) and MYALGIA (Body aches) had resolved. At the time of the report, TINNITUS (Ear ringing), HEADACHE (Headachecomes and goes) and FATIGUE (Tire easily) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. Treatment information was not provided by the reporter   The reporter assessed the events as possibly related to mRNA-1273
8 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (8 weeks pregnant) in a 27-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 16-Sep-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (8 weeks pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (8 weeks pregnant) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (8 weeks pregnant) in a 27-year-old female patient (gravida 4) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pregnancy.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 16-Sep-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (8 weeks pregnant). The delivery occurred  on 15-Sep-2021. For neonate 1, The outcome was reported as Unknown. At the time of the report, EXPOSURE DURING PREGNANCY (8 weeks pregnant) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2021: No specific follow-up information recorded.  No significant information on follow-up.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2021: No specific follow-up information recorded.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 27-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
No adverse events. Follow-up Information 23-MAR-2009: Outdated vaccine given 3/10/09 - 1430 hrs. No adverse events (effects)
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Mild
sneezing; cough off and on; Itchy eyes; Red eyes; headaches; fever; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (sneezing), COUGH (cough off and on), EYE PRURITUS (Itchy eyes), OCULAR HYPERAEMIA (Red eyes) and HEADACHE (headaches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 15-May-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jun-2021, the patient experienced PYREXIA (fever). On 13-Jul-2021, the patient experienced HEADACHE (headaches). On an unknown date, the patient experienced SNEEZING (sneezing), COUGH (cough off and on), EYE PRURITUS (Itchy eyes) and OCULAR HYPERAEMIA (Red eyes). The patient was treated with IBUPROFEN from 12-Jun-2021 to 14-Jun-2021 for Fever, at an unspecified dose and frequency; ASCORBIC ACID (VITAMIN C ACID) at an unspecified dose and frequency; GUAIFENESIN (COUGH SYRUP E) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) from 13-Jul-2021 to 21-Jul-2021 for Headache, at an unspecified dose and frequency. On 14-Jun-2021, PYREXIA (fever) outcome was unknown. On 21-Jul-2021, SNEEZING (sneezing), COUGH (cough off and on), EYE PRURITUS (Itchy eyes) and OCULAR HYPERAEMIA (Red eyes) had resolved and HEADACHE (headaches) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: significant follow up received and updated vaccine doses information, reporter information, confirmed no medical case,  recovery date provided.
pt recv vax & learned that she was pregnant;pt figured that she was about 3wk pregnant @ time of vax;DEC96 pt had a miscarriage which she felt had nothing to do w/MMR;
Irritable & crying all noc; temp 100.5; 23APR93 irritable but consolable; emesis; nasal congestion; t102 during noc; 24JUN93 t98.9;
hands were swollen; Swollen throat; Had a bad reaction to the vaccine; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (hands were swollen), PHARYNGEAL SWELLING (Swollen throat) and IMMUNISATION REACTION (Had a bad reaction to the vaccine) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Oct-2022, the patient experienced PERIPHERAL SWELLING (hands were swollen), PHARYNGEAL SWELLING (Swollen throat) and IMMUNISATION REACTION (Had a bad reaction to the vaccine). At the time of the report, PERIPHERAL SWELLING (hands were swollen), PHARYNGEAL SWELLING (Swollen throat) and IMMUNISATION REACTION (Had a bad reaction to the vaccine) had not resolved.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No concomitant medications was reported. No treatment drug details was reported.   Reporter did not allow further contact
small rash and joint pain at first, rash started on legs, joint/tendon pain started in elbow and has move and progress to other areas, wrists, biceps hips.  Finally in June the rash become so bad i was covered in hives that medication would not control, my freckles and moles swelled to look like ticks, the amount of rashes and hives were so sever I ended up covered in bruises, I am on LOTS of med to hardly keep it under control at this point, 3 biopsy's have been done and point to drug eruption.  The people who gave me the shot did NOT check my allergies. I DO NOT WANT TO BE on medicine the rest of my life b/c of this vaccine.
Patient administered dose of vaccine that had been in the refrigerator longer than 6 hours, which is the longest per manufacturer guidelines.
Child became flushed about 15 minutes after administration.  Progressed to dizziness and became unconscious at home.  Was difficult to arouse, unknown seizure activity.  Prednisione 30 mg was given, and child was taken to Emergency Room, and was evaluated.  Has severe pounding headache, general body aches and very tired.  Has slept excessively.  12/09/09 Immunization records received  12/10/09 MR received for DOS 10/12/09. DX: vaccine reaction to gardasil.  After receiving vaccine, Pt felt flushed, lightheaded, became unresponsive for 10-15 sec, body pain. tx: orapred, motrin.  Pt discharged home in stable condition.
Pt recvd MMR vax on 02MAY90; Immediately following vax, pt exp erythema & swelling (2-3in in size) @ inject site; Swelling & erythema resolved over 24hrs; On 03MAY90, small non-tender nodule was noted @ inject site;
Pt recv vax on 11/12/98; on 11/14/98 pt exp increased eating & sleeping, fever (101.8 - 103.4F); pt hosp; tx=antibiotics
Lump has formed at injection site.  Red in color and itches.  Warm to the touch
Pain over her nerves; Tenderness; Itching; total body rash (chest, back, extremities); This case was reported by a physician via call center representative and described the occurrence of nerve pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2022, the patient received the 1st dose of Shingrix. In July 2022, less than a week after receiving Shingrix, the patient experienced nerve pain, tenderness, itching and generalized rash. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the nerve pain, tenderness, itching and generalized rash were not recovered/not resolved.   It was unknown if the reporter considered the nerve pain, tenderness, itching and generalized rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-JUL-2022 Reporter's comments: The reporter who was a retired dermatologist had reported that a patient who was reporter's friend also in her fifties, had received her first dose of Shingrix about 1 week ago. The patient had developed pain over a linear area over her nerves, and total body rash (chest, back, extremities). The patient had subsequently received steroids even which did not help her. She was also experiencing itching and tenderness.
bad reaction; This case was reported by a pharmacist via call center representative and described the occurrence of adverse event in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 95XF7, expiry date 29th October 2021) for prophylaxis.   On 20th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced adverse event. Shingrix was discontinued. On an unknown date, the outcome of the adverse event was recovered/resolved.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were received as follows: The reporter stated that the patient received first dose of Shingrix and experienced a very bad reaction that took several weeks to recover. The reporter stated that the patient will not be getting the 2nd dose. The reporter obtain permission from the patient for follow up.
headache; Fever; chills; sore throat; tiredness; Dose number: 3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Dec2021 08:30 (Batch/Lot number: unknown) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Brand: Pfizer, Batch/Lot No: Unknown. Unable to locate or read the details), for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Brand: Pfizer, Batch/Lot No: Unknown. Unknown), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021 08:30, outcome "unknown", described as "Dose number: 3"; HEADACHE (non-serious) with onset 14Dec2021 12:30, outcome "recovered", described as "headache"; PYREXIA (non-serious) with onset 14Dec2021 12:30, outcome "recovered", described as "Fever"; CHILLS (non-serious) with onset 14Dec2021 12:30, outcome "recovered", described as "chills"; OROPHARYNGEAL PAIN (non-serious) with onset 14Dec2021 12:30, outcome "recovered", described as "sore throat"; FATIGUE (non-serious) with onset 14Dec2021 12:30, outcome "recovered", described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, pyrexia, chills, oropharyngeal pain, fatigue.  Additional information: No other vaccine in four weeks. No covid prior vaccination. Yes covid was tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Symptomatic for covid-19 06/01/2021 tested positive on 06/08/2021
Patient was complaining of symptoms that started on 8/25 : pain lasting for 5 days, swelling, and itching. She said she felt feverish but she reported a temperature of 98. She used motrin for some relief. I suggested using ice as well, and offered complimentary Benadryl cream for the itching.
Swollen Lymph Node on collar bone. Pain from lump going up my neck and down my arm. Ongoing for the past 2 days. Still experiencing pain.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: pt says redness/itc started in 1 arm then went to other to hands-Mild
Face on the side of the injection was noticeably numb with a dull ache feeling; Face on the side of the injection was noticeably numb with a dull ache feeling; Face on the side of the injection was noticeably numb with a dull ache feeling; Cheek and jaw feeling tight and numb; Sensitivity to touch; This spontaneous case was received on 13-May-2021 from other non-health professional (consumer)(reference number: SEQW21-01316) and concerned 39-year-old, male patient.  The patient's medical history and concomitant medications were not reported. The patient received flu vaccines in the past with no issues other than a sore arm (see case 202102435).   On 28-Sep-2020 at 03:00 p.m., the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose: 0.5 ml, anatomical location and route of administration: not reported) for influenza prophylaxis. The batch number reported was P100229091 and expiry date 25-May-2021.  On the same day, within an hour after receiving Afluria Quadrivalent, the patient's face on the side of the injection was noticeably numb with a dull ache feeling. The feeling was similar to getting Novacaine (procaine) at the dentist office with his cheek and jaw feeling tight and numb. Also, he had sensitivity to touch and did not experience a rash or any swelling. Nurses recommended the patient to monitor and contact medical attention if symptoms got worse. This same feeling continued until the patient woke up the next morning.   On 29-Sep-2020, the patient recovered from the events and had been fine since then.  The reporter did not provide causality assessment.   The case was assessed as non-serious.   The case is linked to case 202102435 (the same patient).  Company comment: A 39-year-old, male patient was vaccinated with Afluria Quadrivalent. On the same day, within an hour after receiving Afluria Quadrivalent, the patient's face on the side of the injection was noticeably numb with a dull ache feeling. Reportedly, the feeling was similar to getting Novacaine (procaine) at the dentist office with his cheek and jaw feeling tight and numb. The patient had sensitivity to touch. Based on plausible chronology and no alternative aetiology provided, causality is assessed as possibly related for all events.; Sender's Comments: A 39-year-old, male patient was vaccinated with Afluria Quadrivalent. On the same day, within an hour after receiving Afluria Quadrivalent, the patient's face on the side of the injection was noticeably numb with a dull ache feeling. Reportedly, the feeling was similar to getting Novacaine (procaine) at the dentist office with his cheek and jaw feeling tight and numb. The patient had sensitivity to touch. Based on plausible chronology and no alternative aetiology provided, causality is assessed as possibly related for all events.
Information has been received from a health professional concerning a 8 year old female patient who on 11/30/1998 was vaccinated with a dose of varicella virus vaccine live.  Subsequently, on approximately 04/22/2004, the patient developed breakthrough chickenpox with 50 to 500 lesions.  Follow up information indicated that there was not a single report of adverse reaction following varicella vaccination.  The reporter indicated that 49 other patients developed breakthrough cases of chickenpox.  No additional information is expected.
24hr p/vax pt devel acute sciatica of the rt leg;foot still numb p/3 months;
This spontaneous report was received from a license vocational nurse and refers to an unknown number of patient of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB (dose, route of administration, lot number and expiry date were not reported). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
incomplete dose of Boostrix due to a leakage of the vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 75-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number LP2G2, expiry date 19-SEP-2025) for prophylaxis.   On 22-MAY-2023, the patient received Boostrix. On 22-MAY-2023, an unknown time after receiving Boostrix, the patient experienced incomplete dose administered (Verbatim: incomplete dose of Boostrix due to a leakage of the vaccine). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 22-MAY-2023 The vaccine administration facility was the same as Primary Reporter. The reporter consented to follow up.  The reporter informed that earlier that day a patient received an incomplete dose of Boostrix due to a leakage of the vaccine, which led to incomplete dose administered.
Redness at injection site. Noticed few days after injection. Redness seems to be getting lighter, but spreading. About 2 1/2 inch in size.
about 23 hours after the short I fell tired, weak, I got chills and a fever. That night while sleeping I woke up to a pain under my arm (armpit) on the same arm as the injection. Later the next morning I had a red splotch on my arm (same as injection but not the same spot). The splotch is warm to the touch, and has a bump or hardening under the skin, it is also a little painful.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received SHINGRIX (batch number 9779K, expiry date 11th October 2020). Concomitant products included simvastatin and hydrochlorothiazide, olmersartan, hydrochlorothiazide, olmersartan, BENICAR HCT. On 3rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 3rd May 2018, 4 hrs after receiving SHINGRIX, the patient experienced injection site pain and general body pain. On an unknown date, the outcome of the injection site pain and general body pain were not recovered/not resolved. The reporter considered the injection site pain and general body pain to be related to SHINGRIX. Additional details were reported as follows: The pharmacist reported the case on behalf of the patient. The patient came back to the pharmacy the day after receiving SHINGRIX and stated that she was experiencing injection site pain and body aches. On the day of reporting, the symptoms were worse.
strong reaction; aches; chills; fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (strong reaction), PAIN (aches), CHILLS (chills) and FATIGUE (fatigue) 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.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced VACCINATION COMPLICATION (strong reaction), PAIN (aches), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, VACCINATION COMPLICATION (strong reaction), PAIN (aches), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.     No treatment medications were reported.   This case was linked to MOD-2021-403265 (Patient Link).
mom reported t102-105 relieved by APAP & bathing in lukewarm water; loud crying, fussy; wouldn't move leg for 2 days; swelling of rt upper leg; no drainage; seen by MD 29AGU92;
pt recv vax 12JAN99 & CXR performed 25JAN99 revealed a left basilar recurrent or chronic infiltrate;pt hosp w/dx of pneumonia;no cult were performed & the causative organism was not identified;this is 1 of 5 pt exp pneumonia p/vax;