chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2 , single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Apr2023, outcome "recovered" (2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Apr2023) positive; (02May2023) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: She tested positive for covid on 25Apr2023, received paxlovid on 26Apr2023, tested negative for covid on 02May2023, after not having symptoms from 30Apr2023 to 02May2023.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, a causal relationship between BNT162b2, BNT162b2 omi ba.4-5 and the reported events covid-19, drug ineffective cannot be excluded.,Linked Report(s) : US-PFIZER INC-202300182348 same reporter/patient, different product/AE;
Redness, irritation 12cm below injection site, non-circumferential itching.
Pain in left lower side. Was diagnosed with diverticulitis. Took two rounds of antibiotics (first IV and then oral). Colonoscopy was performed and showed polyps that were removed as well as internal hemorrhoids. Pain continued. Developed cysts in both ovaries and uterus. One burst. Out of work for almost 2 months
neck ache; Fever up to 103 degrees; Loss of Appetite; Thirsty; Chills; Headache; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th January 2021, the patient received Shingrix (intramuscular). On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced neck pain, fever, appetite lost, thirst, chills and headache. On an unknown date, the outcome of the neck pain, fever, appetite lost, thirst, chills and headache were unknown.   It was unknown if the reporter considered the neck pain, fever, appetite lost, thirst, chills and headache to be related to Shingrix.  Additional information was provided as follows: The patient received a dose of Shingrix in left arm and experienced loss of apetite, fever upto 103 degree fahrenheit, thirst, chills, headache and neck ache. The patient was tested negative for Covid test. The reporter did not consent to follow up.
This spontaneous report received from a registered nurse, via company representative, refers to a 13 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 22-SEP-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M009378 (dose, frequency, expiry date were not reported), for prophylaxis. The vaccine was purchased with private funds/ insurance. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
Shingles; Rashes started to appear on the left arm which has already cleared up; Little bump showed up close to the wrist and just went up from there; Pain started on her left arm from the injection site; Right arm hurt bad; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Right arm hurt bad), HERPES ZOSTER (Shingles), MASS (Little bump showed up close to the wrist and just went up from there), RASH (Rashes started to appear on the left arm which has already cleared up) and VACCINATION SITE PAIN (Pain started on her left arm from the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 013M20A) for COVID-19 immunisation.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included VITAMINS NOS for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (Right arm hurt bad) and VACCINATION SITE PAIN (Pain started on her left arm from the injection site). On 09-Mar-2021, the patient experienced MASS (Little bump showed up close to the wrist and just went up from there). On 10-Mar-2021, the patient experienced RASH (Rashes started to appear on the left arm which has already cleared up). On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, PAIN IN EXTREMITY (Right arm hurt bad), HERPES ZOSTER (Shingles) and MASS (Little bump showed up close to the wrist and just went up from there) outcome was unknown, RASH (Rashes started to appear on the left arm which has already cleared up) had resolved and VACCINATION SITE PAIN (Pain started on her left arm from the injection site) had not resolved.            Treatment information included different soaps for rashes, CBD lotion and oil for pain. The patient was prescribed with antibiotics and gabapentin for pain, both to treat shingles. Action taken with mRNA-1273 in response to the events was not applicable.
AE she had to the first dose; Her PCP told her to not take the second shot due to the AE she had to the first dose; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Her PCP told her to not take the second shot due to the AE she had to the first dose) and VACCINATION COMPLICATION (AE she had to the first dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced OFF LABEL USE (Her PCP told her to not take the second shot due to the AE she had to the first dose). On an unknown date, the patient experienced VACCINATION COMPLICATION (AE she had to the first dose). On 21-Jan-2021, OFF LABEL USE (Her PCP told her to not take the second shot due to the AE she had to the first dose) had resolved. At the time of the report, VACCINATION COMPLICATION (AE she had to the first dose) outcome was unknown.            Concomitant medications were not reported. No treatment details were reported. Patient could not receive the second shot as it was canceled.
Patient had been working all day in her flower gardens.  At 4:30 p.m. she felt like she had double vision and difficulty talking.  She does not remember much of what happened after that, but her husband said she had sudden onset of right arm weakness, leg weakness and drooping of the right side of her face.  Denies having numbness.  He immediately called 911 and EMS took her the Hospital.  She had a CT scan of the head that was negative.  When she arrived at the emergency room her symptoms had resolved, but she had recurrent episode of her symptoms in the emergency room with an NIH score of 5 scoring a point for level of consciousness, best language, and dysarthria and 2 points for facial droop.  She was given tPA and her symptoms resolved.  A CT angio of her head and neck did not show any large thrombus.  She was transferred for ongoing care and neurology evaluation.  Neuro deficits resolved.  Patient was discharged the second day after the event on Aspirin, Plavix and Lipitor.  Hospitalist (Dr) asked me to file VAERS report given recent Janssen vaccine administration.
9 days after injection the patient called the pharmacy to describe a 4 to 5 inch by 3 inch red, warm, itchy spot on her left arm around the site of injection. The patient stated there were little red bumps and the site was itchy.
pt given DTP/OPV on 29SEP92 12noon; mom gave APAP soon p/ took to sitter; mom reports pt started crying hr later could not be consoled;  pt vomited several times & fever rose to 103 something & cont to cry; soreness & sweling @ inject site;
This is a spontaneous report from a contactable consumer (patient herself). A non-pregnant 96-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 3 via an unspecified route of administration, administered in Arm Right, at age 96 years, on 28Sep2021 (Batch/Lot Number: 30135BA) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. The patient medical history was not reported. It was unknown if patient had COVID prior to vaccination. The patient's concomitant medications were not reported. No other vaccine in four weeks. Patient historically received first dose of BNT162B2 (lot number: EL3248)  in the left arm, on 08Feb2021 at age 95 years; and then second dose of BNT162B2 (lot number: EL9262) in the right arm, on 08Feb2021 at age 95 years, both for COVID-19 immunisation. One week after receiving the booster shot on 07Oct2021, the patient experienced Congestive Heart Failure. Patient was admitted to hospital on 07Oct2021 to 15Oct2021 for 8 days. Patient was treated with a diuretic. Facility type Vaccine was Nursing Home/Senior Living Facility. AE resulted in Emergency room/department or urgent care, Hospitalization. COVID was not tested post vaccination. The outcome of the event was not recovered.
Patient says shot felt odd going in.  The next day she could not move her arm and was in a lot of pain.  She had to call an ambulance that took her to the hospital.  She did not have any issue with the first shot in the series.
Pt arrived to ED in respiratory distress and was intubated, became asystolic and did not return. Pronounced at 19:05 March 14.
Sore painful shoulder with some inflammation developed @ 2 am the morning after vaccine and continues to give her discomfort 3 days later. Patient states she has been using ibuprofen. Blisters in inside of lips the day after but has resolved. Shortness of breath starting the day after vaccine but has resolved. Felt like an "elephant on chest" and unable to inhale fully.
Left supraclavicular lymphadenopathy; Dose number: 3; This is a spontaneous report from a contactable reporter (nurse). The reporter is the patient.  A 31-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 (Lot number: 33130807) at the age of 31 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Endometriosis" (unspecified if ongoing). Concomitant medications included: ADDERALL; LEXAPRO; DAYSEE and VITAMIN D NOS. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EN6207; Route of administration: Unspecified), administration date: 24Mar2021, when the patient was 30 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0150; Route of administration: Unspecified), administration date: 15Apr2021, when the patient was 30 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021, outcome "unknown", described as "Dose number: 3"; LYMPHADENOPATHY (non-serious) with onset 16Dec2021 at 19:30, outcome "not recovered", described as "Left supraclavicular lymphadenopathy". The event "Left supraclavicular lymphadenopathy" was evaluated at the physician office visit.  Additional information: The patient had no known allergies. It was unknown whether any therapeutic measures were taken as a result of the event. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Less than twelve hours after vaccination, mother noticed patient refusing feed, very drowsy.   There was no fever or edema of the vaccinated sites.  He got vaccinated with Pediarix, ActHib, Prevnar, Rotateq around noon, got one feeding right after that, and refused subsequent feeds until the next morning.  Per mother, she was not able to wake him up at night for feed; his arms and legs were limp.  Patient was seen by me the next day in the morning.  He was sleeping, but woke up for exam, alert and able to breast feed, though not with strong suck.  Exam was within normal limit.  Sites of vaccination had no edema or erythema.  Patient was sent home for observation.  When I talked to his mother over the phone in the afternoon, she said that patient is back to his baseline, feeding well, active, playful.  When I checked back with his mother over the phone on day 3 after vaccination, he remained well.
Dizziness, numbness and nausea. 12 lead ECG, 18g IV, Blood Glucose, Vitals stable, 4mg of Zofran, transported to Hospital
No adverse effects reported; patients received unspecified doses of PEDVAXHIB, MMR II, VAQTA that were improperly stored; This spontaneous report aws received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with an improperly stored, dose of hepatitis a vaccine, inactivated (VAQTA) lot # R021233, expiration date 05-SEP-2019 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 10.9 degrees Celsius for 1 hour 14 minutes.  Data logger was involved. There were no previous excursions reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA003340: US-009507513-1904USA003833:
Eye infection started 2 days after the shot - 4/10/21.  Stye developed and continued for over 2 weeks.  Infection resolved without medication but small redness still present 5/10/21.  Eye infection may not have been related to the vaccine but it was unusual.  I have not had a stye for over 10 years.
Pt recvd 3 doses of Engerix-B & @ the end of JAN92 reported had been suffering muscle weakness, joint pain, h/a, & a stiff neck for 6 months;
Headache, Diarrhea, pain at injection site Narrative:  Employee states: she received the vaccine 1/7/21 had only pain at the injection site for 3 days, then a mild headache began on 1/10/21. On 1/14/21 she experienced another headache which increased in intensity not relieved by OTC pain medication. Still had a headache on Friday, but it diminished by evening. Over the weekend, she began to experience stomach upset and diarrhea tyat persisted through 1/20/21. She was tested by employee health 1/18/21 and received a negative COVID test result.
has high blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (has high blood pressure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (has high blood pressure). At the time of the report, HYPERTENSION (has high blood pressure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Low grade temperature; myalgias; fatigue; neck pain; injection site tenderness; This is a spontaneous report from a contactable physician (patient herself). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) intramuscular (right arm), on 05Jan2021 at 16:00, at a single dose, for COVID-19 immunization. The patient has no relevant medical history and has no known allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular (left arm), on 17Dec2020, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 05Jan2021 at 21:00, the patient experienced low-grade temperature, myalgias, fatigue, neck pain, and injection site tenderness. The patient did not receive treatment for the events. Outcome of the events was not recovered.  Information on the lot/batch number has been requested.
The patient received their vaccine on Thursday Aug 19th. She stated that 24 hours after the vaccine she has had daily headaches and had developed mouth cores.
progressed to pimple all over his chest; temporary diagnosed with intertrigo; rash under his arm, back of his head; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (progressed to pimple all over his chest), INTERTRIGO (temporary diagnosed with intertrigo) and RASH (rash under his arm, back of his head) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 021B21A) for COVID-19 immunisation.     Concomitant products included VITAMINS NOS and SIMVASTATIN for an unknown indication.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced ACNE (progressed to pimple all over his chest), INTERTRIGO (temporary diagnosed with intertrigo) and RASH (rash under his arm, back of his head). The patient was treated with HYDROCORTISONE (topical) for Rash, at a dose of 2.5 %; MUPIROCIN (topical) for Rash, at a dose of 2 %; DOXYCYCLINE for Rash, at a dose of 100 milligram and KETOCONAZOLE (topical) for Rash, at a dose of 2 %. At the time of the report, ACNE (progressed to pimple all over his chest), INTERTRIGO (temporary diagnosed with intertrigo) and RASH (rash under his arm, back of his head) outcome was unknown.            Concomitant medicines include vitamins and Simvastatin Treatment drugs Concomitant medicines include hydrocortisone cream 2.5%, mupirocin 2%,doxycycline 100mg,ketoconazole 2% The action taken with mRNA-1273 (Moderna COVID-19 vaccine ) was not applicable   This case was linked to MOD21-091922, US-MODERNATX, INC.-MOD-2021-148669 (E2B Linked Report).; Sender's Comments:  MOD21-091922: US-MODERNATX, INC.-MOD-2021-148669:
Same day in the evening sore arm, headache. Woke up next day with a lump in the neck the size of a coin. Hives began on the following day. After that I would get hives periodically. I saw a rheumatologist in July, and she concluded it was due to the vaccine.
Significant chest pain, shortness of breath, and extreme fatigue after little to no activity whatsoever. I am still experiencing these symptoms five (5) days after receiving my second dose of the Pfizer vaccine. Additionally, I can assure anyone reviewing this report that I absolutely did not exhibit these symptoms (or anything similar) prior to Saturday, 22 May 2021.
Local reaction more extensive than usual. Significant swelling at deltoid. Tissue firm and sore. Redness and swelling extended down anterior bicep area. Began eve. 3/20 (date of injection).
Red blotchy area on both lower legs. On 12/07/2012 complained of burning on legs and red blotchy areas spread to groin and buttocks. Never totally cleared but became better with prednisone and Benadryl. On 01/04 2013 red raised area now on waist areas and continued on legs. Rash is now painful to touch and some scabbed areas. Dr. diagnosed it as Henoch-Schonlein Purpura
constant seizures which lasted for 1.5 hours; chest pain; trouble breathing; body was very hot and sweaty due to fever; body was very hot and sweaty due to fever; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (constant seizures which lasted for 1.5 hours) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    In September 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced SEIZURE (constant seizures which lasted for 1.5 hours) (seriousness criterion medically significant), CHEST PAIN (chest pain), DYSPNOEA (trouble breathing), HYPERHIDROSIS (body was very hot and sweaty due to fever) and PYREXIA (body was very hot and sweaty due to fever). The patient was treated with OXYGEN for Adverse event, at an unspecified dose and frequency. In September 2021, SEIZURE (constant seizures which lasted for 1.5 hours) had resolved. At the time of the report, CHEST PAIN (chest pain), DYSPNOEA (trouble breathing), HYPERHIDROSIS (body was very hot and sweaty due to fever) and PYREXIA (body was very hot and sweaty due to fever) outcome was unknown.            Treatment medications were not reported. Concomitant medications were not reported. The reporter stated that the patient received the 2nd dose of Moderna vaccine last week and had immediate reaction. Within a minute following vaccination and patient developed constant seizures which lasted for 1.5 hours and chest pain, trouble in breathing and patient body was very hot and sweaty due to fever and they put icepack all over patient body. Patient was seen by 3 doctors and nurses at the clinic, but patient refused to go to Emergency room for further monitoring. Patient was on oxygen and monitored patient vitals, Patient contacted her HCP and was told could not be seen until 14 days because she was shedding or has COVID-19 and patient uses nebulizer and inhaler PRN for asthma.  This case concerns a 41-year-old female patient with concurrent medical condition of asthma, who experienced unexpected events of seizure, chest pain and dyspnoea. It was reported that the events occurred within a minute following the second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. Concurrent medical conditions of asthma remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 41-year-old female patient with concurrent medical condition of asthma, who experienced unexpected events of seizure, chest pain and dyspnoea. It was reported that the events occurred within a minute following the second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. Concurrent medical conditions of asthma remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.