chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I felt my legs like swelling; I had raised rash and both of them on both legs; they were red/I had scratchy redness on my arms; I had scratchy redness on my arms; raised rash; they just felt weird; This is a spontaneous report from a contactable consumer (patient).   A 49-years-old female patient received of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0191), via an intramuscular route on 21Jun2021 (at the age of 49-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history included allergy. Patient allergic to medicines she don't take medicine because she always had a reaction to it like, like Morphine, Oxycodone, Ibuprofen, Tylenol. Patient don't took narcotics. The patient concomitant medications included cetirizine hydrochloride (ZYRTEC) tablet with dose 10 mg for allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Jun2021 (5 minutes after vaccination), the patient experienced felt her legs like swelling that they just felt weird and within that 15 minutes after having the shot leg down and her legs, she had raised rash and both of them on both legs and they were red like red and so then, She had scratchy redness on my arms it's a reaction that she get when she take medicines and she had allergic reaction to them. Patient stated that wanted to have check up she had it last week. It's just the Blood test standard blood panel like CBC all the things just the mix of Cholesterol all that, Annual Blood work and said Yes everything was good. Patient took Diphenhydramine HCL (BENADRYL) tablet 25 mg as treatment. About 25 minutes after she got with the Pharmacist and he finally can get a thing It was about 25 minutes after the shot is when she got the Benadryl and it took about 30 minutes from the Benadryl 20-30 minutes that the redness is at least went down, she still had the raised rash but her legs were not red like red they were and now she was at home and it's pretty much subsided the reaction, she don't have the scratchiness and stuff she had few little spots here and there but not anything. The outcome of the events was recovering.  Time (24hr) of vaccination: Consumer stated, "My appointment was at 2:30 but I think it was about 2:35 time I got it I don't know about 2:35, 2:40 something central time."  Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and white blood cell count increased. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the white blood cell count increased was unknown. It was unknown if the reporter considered the pain in arm and white blood cell count increased to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient was inquired, if SHINGRIX increases white blood cell count. As per patient her white blood cell count had increased, but she was not sure whether SHINGRIX caused it. The patient refrained from providing any further information, and did not want to get involved in reporting the adverse event.
Hives started 24 hours after injection.  she refused to go the the ED, took antihistamines, 48 hours later red puffy eye and hives; hives were gone 50 hours after injection
Last menstrual period approx. 4-26-19, + home pregnancy test "early June."  She was given Varivax, MMR, Tdap on 6-6-19 as required for entry into nursing school.
Pt recvd vax & exp nausea, diarrhea & dark urine; 2MAR93 lab tests indicated elevated alk phos & SGPT;
Patient was scheduled for his 2nd dose of the Moderna Vaccine after arrival to our facility.  Per the patients chart he received dose #1 on 1/19/22.  After administering the 2nd dose  of the Moderna vaccine it was  noticed in his chart that he has previously received a dose on 4/22/21 and 12/2/21.
This spontaneous report as received from a health care worker refers to 2 patients of unknown demographics. The concurrent condition and medical history were not reported. On an unknown date the patients were vaccinated with GARDASIL dose 1m intramuscular. The concomitant medications were not reported. On an unknown date, the patients were vaccinated with the second dose of GARDASIL just 20 days after the first dose. No adverse experiences were reported. Additional information has been requested.
Severe shoulder pain, swelling, red and hot to the touch in a 5 inch radius around injection site.
She was fine with the first injection, she just had a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent  A 45 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "underactive thyroid" (unspecified if ongoing), notes: Verbatim: underactive thyroid. Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism (ongoing).  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "She was fine with the first injection, she just had a sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The report is cross referenced to report ID: # Caller states that she is calling regarding the Pfizer Covid 19 vaccination. While reporting her own symptoms, caller mentioned daughter who had the shot and was sick for 2 days. This was with the second vaccination, she had the Pfizer. She was fine with the first injection, she just had a sore arm. Time the Vaccination Was Given was about 6:30 at night.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
soreness; Redness; swelling near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), ERYTHEMA (Redness) and VACCINATION SITE SWELLING (swelling near the injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. #022M20A) for an unknown indication.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN (soreness), ERYTHEMA (Redness) and VACCINATION SITE SWELLING (swelling near the injection site). At the time of the report, PAIN (soreness), ERYTHEMA (Redness) and VACCINATION SITE SWELLING (swelling near the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Patient presented to the hospital with fevers and he had severe protein calorie malnutrion. He was given MAB treatment of bamlanivimab and he felt great afterwards.
Felt sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt sick) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ILLNESS (Felt sick). At the time of the report, ILLNESS (Felt sick) outcome was unknown.            No Concomitant medications were provided  No treatment information was provided   This case was linked to MOD-2021-018537 (Patient Link).   Reporter did not allow further contact
Pt experienced a syncopal episode 10 minutes after vaccine administration. Pt reported dizziness and lightheadedness before syncope and was alert again after 10 seconds w/ low blood pressure. Pt evaluated by MD and felt better after legs being elevated and being given juice and crackers. Pt BP improved and pt was discharged home w/ follow up visit w/ PCP scheduled for later date.
strange bruises on both of her arms, mainly on the arm that was injected; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, administered on 27Jul2021, as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, after the first dose of vaccine, the patient experienced strange bruises on both of her arms, mainly on the arm that was injected. Patient was due for the second on 07Aug2021. She may not take her second dose, as she got complication from first dose. Patient was hesitant with the first because she doesn't trust it. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extreme nausea, vomiting, fast heart beat, dizzy, weak feeling, tingling feet, headache, ringing in ears. On and off heavy chest
LOCAL PAIN; NECK, BACK, AND SHOULDER STIFFNESS; This spontaneous report received from a patient via a company representative concerned a 44 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: Unk) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On 07-MAR-2021, the subject experienced local pain. On 07-MAR-2021, the subject experienced neck, back, and shoulder stiffness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from local pain, and neck, back, and shoulder stiffness on 09-MAR-2021. This report was non-serious.
Pt was given MMR vaccine in Right thigh (IM) and within about 3 min pt. had localized redness, swelling with white spots over red area, appeared to be in great deal of pain (localized).
Dizziness, Headache, Myalgia, NauseaVomiting, chills, fatigue, appetite loss Narrative:
Rash and bump at area of injection site.  Itchy.  Resolved in 2 days.
fast heart beat; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration on 19May2021, as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The next day vaccination on 20May2021 at 12:45, patient had a fast heart beat. No serious reported. Caller states she received the first does of the Pfizer COVID-19 vaccine on 19May2021 and the next day had a fast heart beat, per Safety occurred at 12:45, she would like to know this is a common side effect. She was asking what is Polyethylene glycol. She was asking what is the efficacy after the first dose. she was told the second dose is stronger than the first. Is this true. she was trying to figure out if she should get the second dose of the vaccine. she had a side effect after the first dose of the vaccine.  Should  get the second dose. The outcome of fast heart beat was unknown.  Follow-up attempts are needed. Information about lot/batch number is requested.
This case meets vaccine breakthrough criteria review. SxS headache, nausea, poor oral intake, SOB, cough
This spontaneous report was received from a pharmacist via employee and refers to a male patient in his early sixties. Concomitant medications, pertinent medical history and drug reactions/allergies were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). On an unknown date (unspecified time after receiving ZOSTAVAX) the patient's unspecified physician diagnosed him with shingles. The patient sought medical attention and visited his physician. The pharmacist reported that at the unspecified time that the patient was speaking with her, he was not "currently active". No product quality complaint (PQC) was reported. The outcome of shingles was not reported. Relatedness between shingles and ZOSTAVAX was not reported. Additional information has been requested.
Arm got red and swollen. Patient got a tingling all over his body. The next day a fever began and he felt sick all over his body. Pneumococcal vaccine 0.5 ML once.
Note - The above two shots were given in patients right arm. They are documented as given in RD, however patient points to location they were given as approx. 2-3 inches above her right olecranon.   Patient presented to clinic on 1/6/2020. Complained that symptoms began in the middle of the night (late night 1/3--early am 1/4). States her arm became swollen, red, hot and extremely painful. Reports being unable to use/move the right arm over the weekend. Reports using ice helped decrease swelling. At time of evaluation provider reports:  Skin - redness from 13cm proximal and 10.5cm distal to olecranon process. redness on dorsal surface, with sparing of the ventral surface including antecubital fossa. Area is mildly warm to touch, mild swelling in area - no joint swelling appreciated. Injection sites not visible.  Ortho - mildly decreased elbow flexion and shoulder abduction and IROM due to pain. No swelling in elbow joint." Assessment and Plan (per chart note): T50.Z95A Adverse effect of vaccine, initial encounter  (primary encounter diagnosis): suspect inflammatory reaction to vaccination- unclear which one as she received both in the same arm.  Less likely infectious, as her symptoms are improving with use of ice.  Advised her to continue ice 15-20 minutes TID, use naproxen BID x 1 week.  Needs to be seen asap for any worsening of sx- increased pain, redness, swelling, fever.   Plan : ? NAPROXEN 500 MG TABLET - Take 1 Tab by mouth            2 (two) times daily with a meal   M79.89 Swelling of arm Plan : ? NAPROXEN 500 MG TABLET - Take 1 Tab by mouth            2 (two) times daily with a meal
Pain; Swelling; Redness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site pain, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were received as follows: The at vaccination was not reported.  A pharmacist reported that after receiving Shingrix, patients complained of redness, swelling, and pain at the injection site. He stated that the reported patients stated the symptoms resolved in 2 to 4 days. The reporter consented to follow up. The pharmacist estimated that approximately 10 patients experience the symptoms. The pharmacist also reported that he experienced the symptoms after 2 doses of Shingrix but declined to file a report for his AE.
Itching at injection site within 1 hr of receiving on 10/22/15. Rash, swollen and raised on 10/24/15.
Stiff, painful neck (next day) sore arm (L) extending down body to thigh and back. Sore tingly middle fingers (R) hand. Hurts to get up and to walk.
This is a spontaneous report from a contactable physician reported that: A 29-years-old female patient received BNT162B2 (BNT162B2), dose 2 intramuscular, administered in deltoid Left (Arm left) on 08Jan2021 17:00 (Batch/Lot Number: EL3249) as 1Mx2 single dose for COVID-19 immunization. Medical history included, drug hypersensitivity (allergic to penicillin). The patient's concomitant medications were unknown. The patient provide information to you regarding the reported adverse events with the use of the product, considering. the Pfizer product had a causal effect to the adverse event. On an unspecified date, the patient experienced extreme fever, rash, body aches. Outcome of the events were unknown.
This case was reported by a consumer and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 14th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain in arm, incomplete course of vaccination and product availability issue. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the incomplete course of vaccination and product availability issue were unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient hurt like heck and arm was sore for 3 days. She put the reminder on phone for 1st June 2018 following her monthly hike only to discover the back order she was told to check on 1st July 2018. She was told to call daily to find out if it was in. And after calling several sources and researching online, that was the only answer available, which could lead to incomplete course of vaccination and product availability issue. The patient realized that she was fortunate to be an active over 50 year old which she meant she had better things to do with time than investing in the anxiety-producing process of call daily to be told no. The patient felt it far worse for older people who do not have where with all to even do the daily process, much less endure the daily slog through phone calls and rejections.
over 65 and had gotten the FLUZONE QUAD and not the FLUZONE HD QUAD with no reported adverse event; Initial information received on 17-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves Elderly female patient who was over 65 and had gotten the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and not the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no reported adverse event.  The patient's past medical history, medical treatment(s), Concomitant medication, vaccination(s) and family history were not provided.  On an unknown date the patient developed a non-serious event of over 65 and had gotten the fluzone quad (dose, strength, formulation, route, administration site, batch and expiry date was unknown for prophylactic vaccination) and not the fluzone hd quad with no reported adverse event (wrong product administered) (latency: Sam day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE and INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.. She wants to know what she should do at this time..  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Red swollen area at location of vaccine - noticed 1-2d post vaccination. Mildly tender, central clear approximately 2 in x 2 in diameter.
broken out in hives; having a pretty bad allergic reaction; hands and feet swollen; chills; muscle spasms; hard to breathe; front of my chest was sore; dizziness; could not walk; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (muscle spasms), DYSPNEA (hard to breathe), CHEST PAIN (front of my chest was sore), DIZZINESS (dizziness) and GAIT DISTURBANCE (could not walk) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 038A21A,) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DOMPERIDONE, RANITIDINE HYDROCHLORIDE (NEUTRAL [DOMPERIDONE;RANITIDINE HYDROCHLORIDE]) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 30-Apr-2021, the patient experienced MUSCLE SPASMS (muscle spasms), DYSPNEA (hard to breathe), CHEST PAIN (front of my chest was sore), DIZZINESS (dizziness), GAIT DISTURBANCE (could not walk) and CHILLS (chills). On 01-May-2021, the patient experienced URTICARIA (broken out in hives), HYPERSENSITIVITY (having a pretty bad allergic reaction) and PERIPHERAL SWELLING (hands and feet swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form. At the time of the report, MUSCLE SPASMS (muscle spasms), DYSPNEA (hard to breathe), CHEST PAIN (front of my chest was sore), DIZZINESS (dizziness), GAIT DISTURBANCE (could not walk), URTICARIA (broken out in hives), HYPERSENSITIVITY (having a pretty bad allergic reaction), PERIPHERAL SWELLING (hands and feet swollen) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable   This case was linked to MOD-2021-101581 (Patient Link).