chrisvoncsefalvay/vaers-outcomes huggingface dataset:
UNEXPECTED BENEFICIAL THERAPEUTIC RESPONSE; PRETTY TIRED; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included hip pain, knee pain, and other aches. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the subject experienced pretty tired. On an unspecified date, the subject experienced unexpected beneficial therapeutic response. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pretty tired on 01-APR-2021, and the outcome of unexpected beneficial therapeutic response was not reported. This report was non-serious.
The patient came into the pharmacy for a booster. He should us his vaccination card which stated that me received moderna on 03/24/2021 and 4/24/2021. When billing his insurance, I received a refill too soon rejection. I looked him up in system which showed that he received Comirnaty from a pharmacy on 9/26/2021. The pharmacy confirmed the vaccination but the patient has not answered his phone
1. Facial Cellulitis -  2 days after shot.  Below right eye on cheekbone.  Hard, swollen, tender and a bit purplish.  Tele-Health Visited with doctor who prescribed antibiotic & probiotic - however suggested I wait to see what happens the next day after using warm washcloth compress before taking antibiotic.  Next day swelling had gone down.  Antibiotics were not taken as it cleared up in 2 days.  Minor scabbing left by day 5.   2.  5 days after shot - Bright Yellow Runny Diarrhea
Myalgia, Fever, LETHARGY, SITE DISCOMFORT AND ITCHING BOTH DOSES
Patient felt weak and developed rash on chest.  Given benadryl and epinephrine where vaccine administered.  Sent to ER.  Observed.  No further reaction.  Discharged from ED
Full body shakes consistent with seizures which lasted less than 1 minute. Pt immediately fell asleep and was somnolent for approximate 10 minutes until woken by parents when EMS arived. Amnesia and postical confusion. Mouth tensed, fists clenched, eyes rolled back, and apnea were also symptoms.
fever; sweats; rash; weak; BP dropped; cold sore; bumps on the roof of her mouth; sore throat; Body aches and pains; brain fog; lots of nausea; itching palms; This is a spontaneous report from a contactable consumer (patient's daughter). A 76-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history included orthostatic issues (we have orthostatic issues in our family (Potts) Her BP dropped from 138 to 119). Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The reporter calling for her mother. The patient got a shot on Saturday. This was her second shot. The first round had a fair amount of side effects and this time she had fever, sweats, rash on an unspecified date. One thing starts and then moves to the next. She has been very weak. She felt heavy headed and felt like she should sit down. We have orthostatic issues in our family (Potts) Her BP dropped from 138 to 119 which was a Potts like reaction and asked side effect you have heard of before. She woke up today with a cold sore, bumps on the roof of her mouth and a sore throat, body aches and pains, brain fog and lots of nausea, and itching palms. She had about a half cup of saltwater that made the nausea go away, but she hasn't been up and around. She took a couple of Tylenol. We our on day 4 1/2. The patient underwent lab tests and procedure included Blood pressure measurement 138 to 119 (normal range 90 to 120) on an unspecified date. Outcome of the event lots of nausea was recovered on an unspecified date and for all other events, it was unknown.  No follow-up attempts are possible; Information about lot/batch number can not be obtained.
Pediatric Engerix administered to a 27y/o; Pediatric Engerix administered to a 27y/o; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 27-year-old male patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device injection syringe for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B ADULT).   On 30th August 2022, the patient received the 2nd dose of Engerix B pediatric 10 mcg/mg and hepatitis B vaccine pre-filled syringe device. On 30th August 2022, unknown after receiving Engerix B pediatric and hepatitis B vaccine pre-filled syringe device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's comment: The registered pharmacist reported that yesterday (the day before reporting) the patient received pediatric dose of Engerix B 10 mcg. No additional details were provided. The pharmacist inquired how to proceed and would this patient need an extra dose of 10 mcg. The reporter did not consent to follow up. Additional Supportive Information: The patient received a pediatric dose of Engerix B, which led to underdose and adult use of a child product.
pt recvd vax & t105.9 lt ear & 103.6 rt ear; mom states ran fever off & on since shots; dx sl ear & throat infect;
Patient returned for 2nd Shingles vaccination on 6/28/2021 and indicated he experienced a headache on the left side of his head that went into his eye and into the temple area.  He also indicated he experienced blurry vision.  He went to see an eye doctor who prescribed an unknown antibiotic eye drop and will follow up with the eye doctor in a week.  He indicated he thought they were connected, as he received his vaccine in his left arm and the side effects occured on the left side of his head.
shortness of breath; This is a spontaneous report from a contactable consumer (patient's father). A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, via an unspecified route of administration in Apr2021 (Batch/Lot number was not reported) single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the Pfizer Covid 19 shot about 2 weeks ago (Apr2021), his first shot. About 4-5 days after the covid vaccine shot, he developed shortness of breath that is almost debilitating. He can barely move; he always lays down. His shortness of breath has lasted 4-5 days, and the patient can barely breathe. The reporter knows the answer is to have him see his doctor or an ER (emergency room), but he is in federal prison. The reporter inquired if he could get a letter stating the patient needs to be seen by a physician. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Parent reported fever of 102 degrees F and increased fussiness for 3 days following vaccine.
Case number PHEH2013US021419 is an initial spontaneous report received frrom a pharmacist on 10 Oct 2013. This report refers to an 11-year-old female patient. She was vaccinated with FLUCELVAX, (batch number: unknown) intramuscularly on 09 Oct 2013. No adverse event was reported following medication error (inappropriate age at vaccine administration).
Fatigue, headache, eyes hurting, joint pain and body aches, chills and fever
Narrative: A 41yo, male reported with historical ADR of Pfizer Covid -19 vaccine induced rash. It was reported as observed on February 24, 2021 and classified as moderate, by the patient's Psychiatrist who reported it on March 19, 2021 Per February 19, 2021 Psychiatry note, his PMH included HTN, HLD, Anxiety and PTSD No other detailed information in the Facility system was provided, including where it was administered, lot# or adminitering personnel
multiforme rash and pain in rash area; A spontaneous report was received from a consumer concerning a 82 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rashes in the body.  The patient's medical history included incontinence and crohn's disease. No relevant concomitant medications were reported.   On 2 JAN 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 025L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 5 JAN 2021, the patient experienced rash and pain in the rash area. Patient had consulted HCP on 18 JAN 2021 and was prescribed methylprednisone and other medication changes. No laboratory details were provided Treatment information:  18JAN2021 med center Self-administered: Benadryl and Aloe plant Rx: Mathylprednisone 4mg. pack started 18JAN2021 Toviaz incontence Generic Tolterodineer 4mg. (stopped) Action taken with mRNA-1273 in response to the events was not reported.   At the time of the report, the outcome of the event rash was unknown.
This spontaneous report was received from a pharmacist referring to a 27 years old female patient with rubber sensitivity. On 25-AUG-2016, the patient was vaccinated with PNEUMOVAX 23 injection lot # M020521 (strength,dose,expiration date were not provided). Concomitant therapies included METADATE, ethinyl estradiol, JOLESSA and FLUZONE. On 25-AUG-2016, 12 hours after receiving PNEUMOVAX 23,she developed pain at the injection site. The primary reporter stated that the patient's pain continued to worsen and the patient now had pain,swelling, and a rash that extends to the elbow. The pharmacist also reported that the patient now was unable to use her arm, due to the pain, and that her arm was  in a sling. The Pharmacist stated that the patient had not recovered and would seek medical attention form her physician. No laboratory tests were performed. The outcome of the events was not resolved. The relationship between the events and the PNEUMOVAX 23 was unknown. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient's medical history and current condition are not reported. It was reported that on 03-SEP-2014 the patient was vaccinated with RECOMBIVAX HB and PEDIARIX, intramuscularly. Also reported that the patient received PEDIARIX instead of the LIQUDI PEDVAXHIB. No adverse effects reported. Product quality complaint was not involved. The outcome of the event is unknown. Additional information has been requested.
Had a headache, congestion and a deep cough, took the Home COVID-19 test and it was slightly positive. Called doctor and was advised to go the Emergency Room. At the Emergency Room I was given a PCR COVID-19 test and it was negative. Had congestion for at least a couple of weeks afterwards. Finally felt a little better and took another Home COVID-19 test and it was negative.
high blood pressure, dehydration, diarrhea, vomiting, nausea, fatigue
Recieved TD injection in right deltoid on 4/2/06 at ER with treatment of L index finger laceration. Erythema at injection site appeared on 4/3/06. patient presented on 4/4/06 for evaluation.
Left deltoid mild erythema mild edema.  difference between arms.  Slight warm to touch.  Mother states symptoms improve from 01/08/04.
Varicella vaccine given 4/28/14 at approx 2:30pm. Started to have throat pain at approx 4pm on 4/29 left upper arm with redness, pain and swelling.
hot, tender, large inflamed area 10 inches below the injection site; hot, tender, large inflamed area 10 inches below the injection site; hot, tender, large inflamed area 10 inches below the injection site; The doctor believes the injection may have been given Subcutaneously; This case was reported by a physician via call center representative and described the occurrence of skin warm in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 16th March 2020, the patient received the 2nd dose of Shingrix (subcutaneous). On 16th March 2020, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On 17th March 2020, the patient experienced skin warm, skin tenderness and skin inflammation. On an unknown date, the outcome of the skin warm, skin tenderness, skin inflammation and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the skin warm, skin tenderness and skin inflammation to be related to Shingrix.  Additional details were reported as follows: The patient received 2nd dose of vaccine and next day developed a hot, tender, large inflamed area 10 inches below the injection site. The doctor believed that the injection might have been given Subcutaneously which led to Intramuscular formulation administered by other route. The vaccine was given at an unspecified pharmacy. The reporter consented to follow up.   Follow up information received from nurse on 23rd April 2020: The patient's demographic details were updated. VAERS details were updated. The reporter considered the skin warm, skin tenderness and skin inflammation to be related to Shingrix
Developed redness and swelling at injection site that evening. 12/25 developed fever of 103 degrees, poor appetite and vomiting. Continued to have fever off and on through 12/31 ranging from 101-103. Poor appetite and vomiting only lasted 24 hours. No other symptoms noted. Redness and swelling at site resolved by 12/31.
Dizziness, Thirst,   B/P 108/ 78  @ 12:04P
BODY PAIN FROM HER NECK TO ALL THE WAY  TO THE BACK OF HER SHOULDER ON THE LEFT SIDE OF HER BODY/SHOULDER; BODY PAIN FROM HER NECK TO ALL THE WAY  TO THE BACK OF HER SHOULDER ON THE LEFT SIDE OF HER BODY/SHOULDER; BODY PAIN FROM HER NECK TO ALL THE WAY  TO THE BACK OF HER SHOULDER ON THE LEFT SIDE OF HER BODY/SHOULDER; This spontaneous report received from a patient concerned a female of unspecified age. 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: 201AZIA expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced body pain from her neck to all the way to the back of her shoulder on the left side of her body/shoulder. On 09-APR-2021, the subject experienced body pain from her neck to all the way to the back of her shoulder on the left side of her body/shoulder. On 09-APR-2021, the subject experienced body pain from her neck to all the way to the back of her shoulder on the left side of her body/shoulder. Treatment medications (dates unspecified) included: menthol, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body pain from her neck to all the way to the back of her shoulder on the left side of her body/shoulder, body pain from her neck to all the way to the back of her shoulder on the left side of her body/shoulder, and body pain from her neck to all the way to the back of her shoulder on the left side of her body/shoulder. This report was non-serious.
Early this morning  I rolled over on my right side and I had pain in my right arm and is swollen. It's like my shoulder is swollen.  The pain has down some. It is still swollen.
Localized rash, severe pain- diagnosis Shingles (Herpes Zoster) Prescription Medication(s): Valtrex 1 gram tablet
Information has been received from a woman in a pharmacy concerning a 61 year old retired white female with an allergy to red peppers resulting in hives, who in November 1999 and September 2001 was vaccinated with pneumococcal vaccine 23 polyvalent (this does not comply with the recommended dosage schedule). It was reported that the patient forgot that in November 1999 she had received a dose of pneumococcal vaccine 23 polyvalent at her physician's office, and subsequently received a second dose in September 2001 at a pharmacy. The patient had no illnesses at the time of vacinations. On 12/13/01 the patient subsequently developed a swollen arm and an itchy rash that lasted for about one week. Medical attention was sought and the patient was treated with a corticosteroid. Conflicting follow up from a pharmacist reported that in September 2001, (previously reported as 12/13/01) the patient developed swelling at the site of the injection to almost twice normal size, and a fever of 100 to 101 which lasted for two days. The patient was seen by her physician (office visit only) and was given samples of fexofenadine (Allegra). It was reported that all symptoms resolved within one week and there was no effect on CNS or breathing. No further information is expected.
Pfizer-BioNTech COVID-19 Vaccine EUA  102 degree fever, extremely weak and tired, with an extreme headache.
Patient was administered incorrect vaccine dosage. Patient received pediatric dose of Pfizer COVIID vaccine rather than adult dosage.  Patient waited in observation for 15 minutes without adverse reaction.
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 73-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included ophthalmic herpes zoster. Concomitant products included amitriptyline and Eye Drops. On 5th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced tiredness, general body pain, fever and muscle discomfort. On an unknown date, the outcome of the tiredness, general body pain, fever and muscle discomfort were recovered/resolved. It was unknown if the reporter considered the tiredness, general body pain, fever and muscle discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient reported that he felt the vaccine going into his muscle, that evening he had a little fever and felt tired, was sore all over and after 4 days the events resolved.
Not received 2nd dose yet; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (received 1st dose when patient was 5).   On an unknown date, the patient did not receive the 2nd dose of Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incomplete course of vaccination (Verbatim: Not received 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 24-JUL-2023 The nurse stated that a patient received her first dose of Havrix when she was five.  The patient is now 19 and the second dose has not yet been given. The nurse enquired how to proceed with the second dose and what dosage should be given. Till the time of reporting, the patient did not receive 2nd dose of Havrix which led to incomplete course of vaccination. The reporter did not consent to follow up.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 4:29 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 4:29 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 90.69.  Concomitant products were not provided.  On 20-Mar-2021, excursion time was 09 AM and 10 AM and temperature was 34 and 37 respectively, total doses given for the day was 184, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vial was moved to clinic on 20-Mar-2021. Vaccine BUD date was 08-Apr-2021.  Vial was stored on cooler 1 , on 20-Mar-2021, Excursion duration At, 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM : 44, 2 PM : 44, 3 PM: 44, 4 PM: 44 and 5 PM : 43.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
I developed a red rash at the injection site that was about 3 inches in diameter. I noticed it on 3-11-2021 and it cleared up on 3-16-2021
Gave the patient a flu shot and she did really well. As I was giving the mother her flu shot, she said, "mom that wasn't bad" and then when the mother bled a little and the daughter saw and passed out. She passed out, fell and hit her head. She regained conscience right away, and the mother started asking her questions to make sure she didn't have a concussion. She was able to recall everything. I offered to call 911 but the mother said that wasn't necessary. Ice was provided and she sat for a bit while the mother and I talked. The daughter had never gone through this before but the mother has experienced this where she faints at the sight of blood. We asked patient if it was because it was the sight of blood that caused her to faint and she said yes. The mother carried her and she felt better. I reached out later in the day to see how patient was doing and the mother said she was resting and was going to give Tylenol for the bruise on her head. Expressed that her family consists of multiple healthcare professionals and they had everything under control.