chrisvoncsefalvay/vaers-outcomes huggingface dataset:
JAW PAIN WITH LITTLE PUFFINESS; HIVES ON FOREHEAD; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced hives on forehead. On 12-APR-2021, the subject experienced jaw pain with little puffiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from hives on forehead, and jaw pain with little puffiness. This report was non-serious.
This spontaneous report as received from a doctor of medicine refers to a 25 years old female patient with no pertinent medical history and sulfa allergy, penicillin allergy, ibuprofen allergy and aspirin allergy. The patient was vaccinated with first dose GARDASIL (lot # 672193/1524AA) on 28-JAN-2013. There was no concomitant medications. On 29-JAN-2013 the patient developed confusion, malaise and numbness in the arm where she received the GARDASIL. The patient did not receive treatment. No lab diagnostics studies were performed. The patient sought unspecified medical attention. At the time of reporting, the patient's outcome was not recovered. Action taken and the relatedness for all events and GARDASIL were both unknown. Additional information has been requested.
p/vax pt exp acute onset of chills; vomiting & flu-like symptoms; had chest pain; shortness or breath; tx benadryl & ibuprofen; lymerix was discontinued
This lot #/vaccine was incorrectly updated to my medical records, as I have not received a vaccine through facility. I am not a patient of facility, nor have I visited their clinics. I am unable to obtain the vaccine through my own dr due to this incorrect information registered to my medical records.
Hives, soreness left arm sore throat, dizzy, fast heart rate. Still having symptoms as of this date. Saw Doctor on this date.
myocarditis; severe pain in my left shoulder, radiating down my left arm all the way to my fingertips; severe pain in my left shoulder, radiating down my left arm all the way to my fingertips; severe pain in my left shoulder, radiating down my left arm all the way to my fingertips; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration at the age of 43-years-old, administered in Arm Right on 26Mar2021 12:30 (Lot Number: EA8732) as single dose for COVID-19 immunization. Medical history included allergies, asthma, genetic predisposition to heart disease. Concomitant medication included unspecified medications. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 43-years-old, administered in Arm Right on 05Mar2021 12:30 (Lot Number: EN6199) as single dose for COVID-19 immunization. The patient reported, "I had severe pain in my left shoulder, radiating down my left arm all the way to my fingertips. The pain was severe enough to be admitted to a hospital, where they performed an angiogram and MRI, resulting in a myocarditis diagnosis. The doctors suspect that these symptoms may have been at least partially triggered by." The patient experienced myocarditis and severe pain in my left shoulder, radiating down my left arm all the way to my fingertips on 28Mar2021 18:00. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for the events for 3 days. The patient underwent lab tests and procedures which included angiogram: myocarditis diagnosis on 28Mar2021, MRI: myocarditis diagnosis on 28Mar2021, SARS-CoV-2 test: negative on 02Mar2021. Therapeutic measures were taken as a result of the events which included Ibuprofen, Colchicizine, and Metoprolol. The outcome of the events was recovered/resolved with sequel on an unspecified date. No other vaccine in 4 weeks. Not diagnosed with COVID prior vaccination.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 21-SEP-2015 the patient was vaccinated with a dose of improperly stored PROQUAD 0.5 ml once subcutaneous lot # L023113 and expiry date of 24-DEC-2016. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
My arm starting absolutely killing me the night of the  second vaccine which was on Wednesday. Today is Saturday and my arm is still as painful. There is no rash, not itchy, didn?t seem to be swollen or red but I have a high pain tolerance living with migraines and I can barely use my arm. I?m starting to get a little concerned.
Information has been received from a physician concerning himself (age unknown) with no drug allergies, who on 01-JAN-2008 was vaccinated intramuscularly with a dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. On 01-JAN-2008, the patient developed redness, pain, local heat, weakness and nausea a short time after being vaccinated. The patient did not seek medical attention. No laboratory diagnostics were performed. The patient recovered on an unspecified date. No product quality complaint was involved. This is one of three reports from the same source. Additional information has been requested.
A consumer report as been received. The report concerns a 44 year old, female consumer, who had been receiving FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on an unknown date. The patient experienced rash on hands and forearms. The outcome of the event of rash on hands and forearms is unknown. The report was considered to be non-serious.
Site: Pain at Injection Site-Medium, Systemic: pain radiating down,tingling,hurts to move, hard to open jars-Medium, Systemic: Weakness-Medium, Additional Details: Patient was vaccinated and had a sore arm. Five days later had pain radiating down arm and has been constant since. Patient states the arm tingles and sensitive to touch. She stated it hurts to move her arm and difficult to open jars. I informed patiet to immediately follow up with her primary physician. Patient has been traveling out of the country during this time and just arrived back.
This is a spontaneous report from a contactable consumer (reporting on himself) from a Pfizer-sponsored program. A 71-year-old male patient of an unspecified ethnicity received PREVNAR 13 via an unspecified route of administration at single dose in Mar2017, and via an unspecified route of administration at single dose in Mar2018, both for immunisation, pneumonia pneumococcal. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced pneumonia on lower right lobe due to infectious organism (as doctor wrote on the report) with outcome of unknown, fatigue with outcome of unknown, residual cough from the pneumonia/coughing without producing phlegm with outcome of unknown, running a temperature/fever with outcome of recovering, tightness in the chest with outcome of unknown, overall body aches with outcome of unknown. Course of events: Before pneumonia diagnosis, he was running a temperature for 2 days and tightness in the chest and coughing without producing phlegm. He had overall body aches. He ended up going to his GP. He did Xray and overall exam on 27Mar2018 and that was when came back with Pneumonia. The 1st pneumonia shot was back in 2-3 years before and then he had another shot in Mar2017. He thought it was the PREVNAR shot in 2017. He was given another one at the end of Mar2018. He believed it was the PREVNAR one. It was different from anything else he had ever had. Tightness in chest and the fatigue. He knew this could be very serious. They gave him antibiotics: azithromycin (pill form) for 5 days, TYLENOL to reduce fever, lots of liquids. He still had fatigue and residual cough from the pneumonia. They lasted a good week or so after my diagnosis. No follow-up attempts are possible. No further information is expected.
1 1/2 hrs p/receiving vax pt c/o severe h/a, pain in legs, refusing to walk, shaking, chills, disoriented; 2 1/2 hrs p/vax t102;
Fever ranging from 100 degrees to 102 degrees (more hours of 102 degrees) from 11PM, 3/15 to 3PM , 3/17. Intense chills, front torso and down front of legs Body aches Headache
Patient was giving pfizer 2-11 year olds instead of the Adult pfizer 12+
Pt states that the PREVNAR 13 that she was give 10/29/15 in the left deltoid had a reaction. Her deltoid was bruised with redness and burning down the arm for 1 week. She also stated it caused burning in her left lower quadrant x 1 week. Pt never called or come in for us to visualize this reaction. Pt had no reaction in clinic.
no additional adverse events; caller reports a temperature excursion with administration of GARDASIL 9 during the excursion; temperature 1.8 C; This spontaneous report was received from a medical assistant and refers to a 12-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 23-OCT-2020 (reported as during the excursion), the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot # S022599 , expiration date 25-FEB-2022 (route of administration was not provided). There was no adverse event reported. Administered dose of vaccine was stored in an inappropriate temperature of 1.8 degrees Celsius for 7 hours and 25 minutes.   Digital data logger was not involved. No previous temperature excursion occurred. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S022599; expirationdate: 25-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
injection site became swollen; hard and red for 3 days; had a flush of chills; was extremely tired every day; This is a spontaneous report from a contactable consumer (patient). This 54-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Batch/lot number: unknown) on an unspecified date in Apr2021 at 15:30 via an unspecified route of administration in right arm as DOSE 2, SINGLE for covid-19 immunization. The patient other medical history included: High triglycerides. No known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination neither COVID tested post vaccination. The patient took other medications: Fenofibrate, Multi-Vitamin, and Fish Oil within two weeks of the vaccination. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Batch/lot number: unknown) on an unspecified date in Apr2021 at 14:00 via an unspecified route of administration in right arm as DOSE 1, SINGLE for covid-19 immunization. On an unspecified date in Apr2021 after second dose the patient experienced injection site became swollen, hard and red for 3 days, had a flush of chills, and was extremely tired every day for about 3 days after that. The patient did not receive any treatment for the events. The outcome of the events was resolved on an unspecified date in 2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
About thirty minutes after getting my booster I started getting a sore arm. About mid afternoon I was feeling body aches. By 4:00PM I was having chills and severe body aches. Around 9-10PM I had a horrible headache that lasted for 24 hours, medication was not helping, and I was so out of it and in so much pain from this headache I was stuck in bed other than shuffling to the bathroom. This is not normal for me as I am generally healthy. I was a little better the next day but was still very dizzy and weak. I did have headaches but not as bad as that first one. Those lasted through Monday. I slept a lot and even got a COVID-19 test about five days after the vaccine to make sure I did not have COVID-19. About two weeks after that I went to my doctor, they did a neurological exam, a body exam, my abdomen was tender. We did blood work, Liver Enzymes. Checked thyroid, CBD, Liver panel. It came back that my liver enzymes were very high, about five times as high as normal as they would be. They were still elevated a month later and I am now seeing a Hepatologist next month. My doctor also concluded I should not get a Moderna vaccine again and we are holding off on a second booster due to this as well even though I did well with my first and second dose of Pfizer.
4 hours post vaccine - arm pain (rated 10/10), temperature 106, chills and headache
Patient received vaccine (DTAP) on 08/11/17. Sates that swelling started 48 hours ago (08/15/17). Also stating that woke up in middle of night w/pain and this morning with pain from injection site. Large area of erythema noted to right deltoid, swelling, pain w/movement. Referred to clinic.
She has an artificial knee and after she got COVID, she has now pain in her knee that continues; extreme tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "artificial knee" (unspecified if ongoing). Concomitant medication(s) included: CLONIDINE HCL; SPIRONOLACTONE; LIPITOR. Past drug history included: Amlodipine for Blood pressure, notes: What I was on before, the last medicine I took for blood pressure, Amlodipine. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization. The following information was reported: ARTHRALGIA (non-serious), outcome "not recovered", described as "She has an artificial knee and after she got COVID, she has now pain in her knee that continues"; FATIGUE (non-serious), outcome "unknown", described as "extreme tiredness". Additional information: She has an artificial knee and after she got COVID, she has now pain in her knee that continues. She has extreme tiredness like she has been doing a marathon.  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.
Headache, slight dizziness and stomach cramping started later that day of vaccination. Stomach cramping and Headaches continued intermittently. I took Excedrin as needed for symptoms. Itchiness started after a week and rash developed on 1/14/2021. I am waiting for return call from my Primary Doctor. I started taking Benadryl 25mg for rash/itchiness as needed.
Cellulitis vice local erythema.  Layer erythema area under right upper arm. Cellulitis at site and urticaria entire area. Pt given antibiotic and responded. Pt was administered vaccine correctly.
Patient narrative -  "On Friday, I went to a pharmacy to get my second COVID-19 booster. The staff was very friendly but one person's skills in giving shots needs improvement. My arm is still quite sore - much sorer than any of the previous shots.  The gentleman held the syringe like a dart, counted down to one, and almost tossed it like a dart as well. His aim was off, the needle found its mark at the top of my arm near the shoulder joint. Instead of letting it stop there, he ran it even deeper. Immediately, I could feel it hit the bone or the joint itself and intense pain radiated down to my wrist. I stated very frankly, "That's going to hurt for a while." He apologized.  Luckily, it was on a Friday afternoon, so I could recuperate over the weekend. I didn't sleep at all that night because of the extreme discomfort. And at present, I am still having mobility issues. This didn't happen as badly with the three previous vaccinations. A sore arm is expected, but not so much and not for so long.  Please give your pharmacy staff more guidance on how and how not to administer vaccines. It would save a bunch of suffering. I feel I may have to seek service at another location when I need any further vaccinations."   Follow up w/ patient - I followed up with the patient by phone. He said the pain in his arm is continuing to improve. I apologized for the incident and assured him that the intern who administered the vaccine would receive further instruction before any further administration. He seemed understanding and was hopeful that he would fully recover quickly.
shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. The patient's medical history, concomitant therapy and concurrent condition were not provided.  In 2014 the patient was inoculated with zoster vaccine live (ZOSTAVAX), as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated for shingles. The outcome of event was unknown.  As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Mucous cough, swollen, watery eyes, clear nasal discharge hives back of neck and upper back. Pt. was checked by doctor. 0.15 ml epinephrine 1:1000 given subq. Benadryl 12.5 mg given IM. O2 sets 94-97%. Respirations 20. Pulse 160-120. Discharge to home with prescription for Prenisolone & oral Benadryl.
Client received the Pfizer injection by Nurse, arrangements for injection was given at doctors office.  Pt received the injection at 13:00 and about 15 minutes after the injection the Pt noticed tingling of her tongue and a tingling in the back of her throat.  at this time, she was given 25 mg p.o. of Benadryl. and then she was sent to the ER for evaluation.   About one hour in the ER, she could not breath and was given an epi pen and symptoms improved.  1345 IV was strted and IV fluids were infused, 125 Solu-Medrol, 50 o f Benadryl were given IV .  Symptoms improved.  14:10: Pt's symptoms worsened and Epi 0.5mg IM given due to chest pressure, dyspnea, tingling of the mouth, lip swelling/numb feeling.  14:15 Symptoms improving. and 16:30 symptoms completely resolved.
Right thigh where vaccine was administered was reddened, swollen and had a rash with raised vesicles similar to chickenpox.  Symptoms started 7 days after vaccine administration.  Within 11 days the rash was on back chest and both legs. Rash on back, chest and other areas of legs did not progress to vesicles.
Pain during injection. Immediate injection site pain, lasting all evening. Injection site discomfort.
shingles; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th March 2019, the patient received the 1st dose of Shingrix. In May 2019, less than 3 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter confirmed that shingles case occurred after 1st dose of vaccine (the shingles was determined in May 2019). The reporter was consented to follow up. The reporter declined to leave patient demographics stated that they report to VAERs.
Awoke 10/04 with erythema, swelling and warmth surrounding site of MenQuadFi injection site. Entire size approx 4 inches round.
He was fine the day of,  2/19/2020 a bit fussy and tired but to be expected.  Fine through the 2/ 25/2020. Until about dinner then he wouldn?t eat and was fussy. He was fussy throughout the night and next day. He wouldn?t eat breakfast, or much of his lunch or dinner and was fussy all day and he cried when he had to walk and was crying help. Fever at dinner time with diarrhea into next day.
No additional AE information; temperature excursion; Information has been received from an administrator referring to a 12 years old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 01-MAR-2021, the patient was administered improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1687290, expiration date: 06-SEP-2022, strength, dose, frequency and route unknown) for prophylaxis (incorrect product storage). No adverse effects were reported.  The stored temperature was 1.48 degree Celsius. The time frame was 0.35 hours on 01-MAR-2021. There was no previous temperature excursion. The temperature excursion was detected by a data logger.  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2105USA006116: US-009507513-2105USA006117: US-009507513-2105USA006118: US-009507513-2105USA006119: US-009507513-2105USA006120: US-009507513-2105USA006121: US-009507513-2105USA006122: US-009507513-2105USA006123: US-009507513-2105USA006124: US-009507513-2105USA006125:
Horrible itching mainly on back; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In JUL-2023, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced pruritus (Verbatim: Horrible itching mainly on back). The outcome of the pruritus was not resolved.   It was unknown if the reporter considered the pruritus to be related to Shingles vaccine.     It was unknown if the company considered the pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-AUG-2023 This case was reported by a patient via interactive digital media. The patient reported that what is the shingles, certainly he or she had these symptoms and he or she received the second vaccination just three days ago. The patient stated he or she hoped that now the horrible itching mainly on his or her back and will go away. Follow-up would not possible as no contact details were available.