chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diagnosed with Covid-19, not severe; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (diagnosed with Covid-19, not severe) in a 7-decade-old patient of an unknown gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (diagnosed with Covid-19, not severe). At the time of the report, COVID-19 (diagnosed with Covid-19, not severe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient was in their late 60s. The patient got covid-19, but not as severe. No treatment information was provided.
Fever and vomiting for a period of approximately 24 hours. Dehydrated. He couldn't stand any food or liquid.
pain at injection site; intense pain in lymph node; fever 100-103 degrees- down to 99 with tylenol; severe fatigue; Severe muscle and joint/rib pain, pain at injection site (entire arm) 1st and 2nd shot- worse; Severe muscle and joint/rib pain, pain at injection site (entire arm) 1st and 2nd shot- worse; Severe muscle and joint/rib pain; Severe muscle and joint/rib pain; This is a spontaneous report from a contactable consumer (patient). This 56-year-old non-pregnant female (Not Hispanic Or Latino Caucasian) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0162) via an unspecified route of administration in left arm on 28Apr2021 at 10:30 (at the age of 56-year-old) as DOSE 2, SINGLE for covid-19 immunization. Facility type vaccine reported as other. Medical history included High bp, generalized anxiety disorder, autoimmune history. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient concomitant medications included Bisoprolol, Lisinopril, Xanax for an unspecified indication and Tylenol for pyrexia, start and stop date were not reported. The patient had known allergies for sulfur. No covid prior vaccination. No covid tested post vaccination. The patient did not receive any other vaccines within four weeks. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Ew0151) on unspecified route in right arm on 07Apr2021 at 15:00 (at the age of 56-year-old) as DOSE 1, SINGLE for covid-19 immunization and on 07Apr2021 at 18:00 patient had severe muscle and joint/rib pain, joint/rib pain, pain at injection site and severe fatigue. On an unspecified date, after second dose patient experienced Severe muscle and joint/rib pain, pain at injection site (entire arm) 1st and 2nd shot- worse w/ 2nd dose, intense pain in lymph node (under arm), fever 100-103 degrees- down to 99 with Tylenol, severe fatigue. Treatment received for the event fever 100-103 degrees was Tylenol and for rest of the event patient did not receive any treatment. On an unknown date, patient underwent lab tests and procedures which included body temperature: 100-103 degrees- down to 99 with Tylenol. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
I went for the mammogram and I had an abnormal lymph node it was swollen. When they took it out and tested it it was cancer. First they did a biopsy, then removed it, then I had to do cancer treatment. I get a mammogram every year and never had a lymph node swollen.
pt recvd vax; pt woke up & felt like lt arm was numb & tingling;to MD;x_ray done;Ibuprofen prescribed;sxs cont & went to MD again;arthritic changes in neck (spine); 2mo later, sxs started to subside;
developed chicken pox the day after receiving shot. Doctors office cultured a vesicle and came back positive for varicella.
had fever; couldn't get out of bed; arm swelled up; bright red then turned black and didn't feel good; bright red then turned black and didn't feel good; bright red then turned black and didn't feel good; This is a spontaneous report from a non-contactable consumer (patient himself). A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as 1st dose, single dose and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as 2nd dose single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient got Pfizer's first shot and had fever for 1and 1/2 days. The patient could not get out of bed. On the 3rd day arm swelled up, bright red then turned black and did not feel good. The patient got second shot and had fever again, arm did the same thing, it was a month before that the patient felt like old self. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Varicella and MMR given again.  Father failed to inform us that pt already received shots at Health Department.
Moderna COVID-19 booster vaccine dose administered prior to recommended interval after primary COVID-19 vaccine series. 2nd dose received 8/10/2021.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, between January-February 2014, the patients were vaccinated with 7 doses (unspecified) of GARDASIL (dose and route were not reported) lot numbers:H015555 expiry 13-APR-2015: H021608 expiry 13-AUG-2015: H021861 expiry 09-OCT-2015, that had been stored in January 2014 (starting 16-JAN-2014) at 30 F minimum for a total of 112 hours. No adverse effect reported. This is one of several reports from the same source: 1403USA000542, 1403USA001586, 1403USA001588, 1402USA001587. Additional information has been requested.
24 hour sickness, but adverse reaction has been a growing red circle on my arm. It is raised, itchy, painful, and hot.
Red, hot, swollen, fever @ shot site 2 days out. Went to ER diagnosed(4cm red) Cellulitis, Keflex 250 TID X 10 days.
Fever of 101.7 degrees, vomiting, diarrhea, heart palpitations, aching, mucous in eyes, lethargic, congestion, stuffy nose.  The vomiting and heart palpitations went away after approximately 8 hours. Then the other symptoms continued to progress.  It is day 5 and I still have fever, congestion, stuffy nose, sneezing, aching, and lethargy.  I have missed 2 days of work, not to mention family functions that were previously planned.
Information has been received from a physician concerning a female who was vaccinated with Gardasil. Three to four days after she received the vaccination, she experienced nausea, vomiting and fever. The physician felt that the nausea, vomiting and fever were not related to therapy with Gardasil. He noted that he had a lot of patients with the flu. Additional information has been requested.
Case number PHEH2013US014818 is an initial spontaneous report received from a nurse on 09 Jul 2013: This report refers to an adolescent female patient. She was vaccinated with MENVEO (batch number: M12123) intramuscularly on 08 Jul 2013 and began experiencing severe pain in the upper arm at injection site, and dizziness throughout the evening. Outcome of the events was reported as ongoing. No further information about causality and seriousness was reported.
Per EMS report:  ED was dispatched to the vaccination clinic at city hall for a female having an adverse reaction. When we arrived the patient was found sitting in an upright position on a chair; she was conscious and alert. We were informed by medical staff on scene(EMT) the patient had developed some redness on her chest and had been given 50 mg Benadryl prior to our arrival. Patient informed us she has a history of adverse reactions to vaccines so she was expecting something to happen. She said she had initially gotten a feeling of warm/flushing from her feet and up into her body and then developed the redness. She also said her tongue had been feeling numb but she denied any shortness of breath or chest palpitations associated with her symptoms. According to the patient and provider on scene the redness was improving after the Benadryl. Patient also said her tongue was feeling normal again. The patient did not want to be transported to the hospital as she said she was feeling better. Health department staff on scene was going to be sending Benadryl with the patient in case she needed more. Patient signed medical release and ED cleared.
Patient received her second COVID vaccine (Moderna) on 06/21/21. She says 12 hours after her vaccine she developed nausea, vomiting, and low grade fever. The vomiting became persistent and patient developed severe flank pain. She was taken to an ER. 24 hours post vaccine. Patient says she was given IV boluses and Zofran which helped resolve the vomiting, she was discharged later the same day. Her fever lasted 4-5 days, t-max 100.0 with intermittent Tylenol dosing. Since discharge she says she continues to have consistent nausea but denies vomiting. She admits she has little appetite and has not felt hungry. She denies diarrhea. Her flank pain is "constant" and she felt it was starting to effect her bladder. Patient denies burning and stinging; however, describes back pain prior to voiding. She says she does not feel she can fully empty her bladder despite having urgency to do so. She denies gross hematuria. She says she does not feel well in general and has no energy. She feels her flank pain is becoming worse and Tylenol is no longer giving her relief. Her brother says the family wanted to ensure there was no complications involving her kidneys considering her history.  The renal team did not feel patients symptoms were related to a kidney/bladder issue but rather a reaction to her second COVID vaccine. Her case was discussed with rheumatology and infectious disease. She received ondansetron for nausea, Naproxen for pain, and encouraged her to remain well hydrated. She was  prescribed a short course of prednisone.
fever 102, very fussy, constant crying, irritability;pt adm to hosp for observation;found to have nl WBC, RSV negative, CXR showed bronchitis;MD specified DTAP for immun but DT was given by error;
11 hours after 2nd shot, severe skin burning sensations moving around various body parts. No fever or headache. Common, expected strong muscular aches. Skin burning areas were not red nor swollen. So strong I could not sleep the first night. Lasted for about 4 days, then slowly decreased to disappear on day 7. However, on April 14, same skin burning feelings reappeared, accompanied with itchy sensations in spots where not "burning". Again, no redness nor swelling. GP indicated vaccine probably triggered immune system which response activated nerves. Still going on today (April 16, but not worse). Areas affected move from scalp and face (mainly itching and tingling) to jumping any place over the body, like here and there, now and then, all the way down to feet.
pt recv vax & exp severe swelling of arm & residual discomfort in the muscles where vax was given;the discomfort persisted for months p/vax & @ the time of report pt exp were still being treated;
Feeling not well; Shivering; Headache; Nausea; This case was reported by a consumer and described the occurrence of feeling unwell in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of no adverse event (1st dose received on an unknown date, did not have these side effects with the initial dose).   On 9th January 2021, the patient received the 2nd dose of Shingrix. In January 2021, less than a day after receiving Shingrix, the patient experienced feeling unwell, shivering, headache and nausea. On an unknown date, the outcome of the feeling unwell, shivering, headache and nausea were unknown.   It was unknown if the reporter considered the feeling unwell, shivering, headache and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but was captured as an adult as per vaccine indication. The patient received Shingrix vaccine and that night started feeling not well. By the next morning, in the less than a week after vaccination, the patient experienced shivering, headache and nausea. The patient did not have these side effects with the initial dose of Shingrix. The patient asked question regarding continuation.
Tested positive for Covid-19; Tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old adult male received COVID-19 immunisation with the first dose of intramuscular BNT162B2 (solution for injection; Lot EL3247 expiry information not provided) as a single dose in the left arm on 28Jan2021 (at 45-years-old); and the second dose of intramuscular BNT162B2 (solution for injection; Lot EL3247 expiry information not provided) as a single dose in the left arm on 18Feb2021 (at 46-years-old). Relevant medical history included Type 2 diabetes and no known allergies. The patient received unspecified concomitant medications. The patient denied being diagnosed with COVID-19 prior to receiving any vaccine. The patient denied receiving any other vaccine within four weeks of these vaccines. The patient reported that on 05Jan2022 he tested positive for COVID-19. The patient explained that on 04Jan2022 he underwent Covid test post vaccination with SARs-COV PCR via nasal swab which was negative and on 05Jan2022 another Covid test post vaccination with SARs-COV Antigen via nasal swab was positive. There was unspecified treatment received for the events. The outcome of the events Tested positive for Covid-19 was recovered on an unspecified date in Jan2022.
sweats; arm hurt; lump in the front part of my breast left side; swollen arm; crease; cant sleep at night; i cant move it; arm is still killing me (injection site); chills; fever; bodyache; enlarged lymph node; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats), VACCINATION SITE PAIN (arm hurt), BREAST MASS (lump in the front part of my breast left side), PERIPHERAL SWELLING (swollen arm) and SKIN WRINKLING (crease) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B(8)2 (Z)1A and 030A2(Z)1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No specified medical history has been reported.  Concomitant products included VITAMIN D NOS, LEVOTHYROXINE and LISINOPRIL for an unknown indication.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-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 HYPERHIDROSIS (sweats), VACCINATION SITE PAIN (arm hurt), BREAST MASS (lump in the front part of my breast left side), PERIPHERAL SWELLING (swollen arm), SKIN WRINKLING (crease), INSOMNIA (cant sleep at night), MOBILITY DECREASED (i cant move it), VACCINATION SITE PAIN (arm is still killing me (injection site)), CHILLS (chills), PYREXIA (fever), MYALGIA (bodyache) and LYMPHADENOPATHY (enlarged lymph node). At the time of the report, HYPERHIDROSIS (sweats), VACCINATION SITE PAIN (arm hurt), BREAST MASS (lump in the front part of my breast left side), PERIPHERAL SWELLING (swollen arm), SKIN WRINKLING (crease), INSOMNIA (cant sleep at night), MOBILITY DECREASED (i cant move it), VACCINATION SITE PAIN (arm is still killing me (injection site)), CHILLS (chills), PYREXIA (fever), MYALGIA (bodyache) and LYMPHADENOPATHY (enlarged lymph node) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-264071 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: follow up received contain reporter details, patient demographics, event details
Administerd 8 doses to 8 patients from a vial punctured 24 hours ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administerd 8 doses to 8 patients from a vial punctured 24 hours ago) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administerd 8 doses to 8 patients from a vial punctured 24 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administerd 8 doses to 8 patients from a vial punctured 24 hours ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender's Comments: This report refers to a case of 'expired vaccine administered' for mRNA-1273, lot number unknown with no associated AEs. Causality for this medication error is not applicable
This spontaneous report as received from an office manager (medical assistant) refers to a patient of unknown age and gender. On 13-DEC-2013 the patient was vaccinated with the third dose of ROTATEQ. The ROTATEQ was improperly stored. It was exposed to temperatures of 32F for 32 minutes on 02-DEC-2013, then 32F for 24 minutes on 03-DEC-2013, then on the same day 03-DEC-2013 at 31F for 8 minutes, then 33 F for 19 minutes on 04-DEC-2013. No adverse effects reported. This is one of four reports received from the same reporter. Additional information has been requested.
Had both shots, still feel them, Suspected vaccination Failure; Still feel them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had both shots, still feel them, Suspected vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: Still feel them).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported by the patient via interactive digital media. The reporter reported that he or she had both shots could still feel them but a friend had shingles they hurt longer. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
This is a spontaneous report from a contactable nurse via Pfizer sales representative. A female patient of an unspecified age (reported as Age: 18, Year: Unspecified) received TRUMENBA; (batch number unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had a fever of 104 degrees on an unspecified date which took place after use of product. The outcome of the event was unknown. Information on the batch number has been requested.
SICK NOW; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a consumer via a company representative via social media (J and J Corporate) concerned a female of an unspecified age, race and ethnicity.   The patient's weight, height, and medical history were not reported. The patient previously received 2 doses of covid-19 vaccine (dose number in series 1) (unspecified manufacturer) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse event following 2 doses of covid-19 vaccine (unspecified manufacturer) (dose number in series 1). The patient additionally received third dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis which was a revaccination with different covid-19 vaccine (dose number in series 2). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced sick (dose number in series 2). It was reported that, "My ENTIRE fam has had 1,2,3x's. On my side my brother, his wife- ALL jabbed- All sick now". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sick now, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious. This report was associated with product quality complaint: 90000261955. The suspected product quality complaint has been confirmed to be voided (no product quality issue and there was no timeline for date of vaccination to contracting covid and no confirmatory test reported) based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20221210980, 20221210598, 20221210446, 20221210961 and 20221211116.