chrisvoncsefalvay/vaers-outcomes huggingface dataset:
possibly experienced was a severe allergic reaction; This is a spontaneous report from a contactable consumer. The consumer (patient's mother) reported for patient (reporter's daughter). A 55-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot number: unknown), via an unspecified route of administration on 03Jun2021 as a single dose for COVID-19 immunization. The patient also given Benadryl and other premeds (other premeds not specified), 2 hours before taking the 2nd dose. The patient's medical history was not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot number: unknown), on 02Apr2021 for COVID-19 immunization. The caller stated that, 5 hours after the first dose, her daughter's throat started to close. The caller Immediately called 911 and 911 mentioned that the patient did not require an EpiPen and was not advised to go to the ER. Immediately after receiving the 2nd dose on 03Jun2021, the patient had the same reaction (throat started to close) and her heart seemed to be beating out of her body. The caller stated that her daughter went to urgent care and was currently on oxygen. The caller stated that her daughter has been in the urgent care unit for over 1 hour and 1/2 now. The caller stated that, prior to receiving the second dose, her daughter consulted an allergist, but her allergist urged her to get the 2nd dose. The patient was even prescribed Benadryl and other premeds (other premeds not specified), 2 hours before taking the 2nd dose. The patient also did called CDC to report this event, but CDC did not advise them otherwise. Caller was complaining why should her daughter's doctors (an allergist and immunologist) advised her to get the second dose given the reaction her daughter experienced. The caller was informed as per general pharmacy/medical knowledge, what her daughter could have possibly experienced was a severe allergic reaction post vaccination. The caller enquired about what are the risks of the vaccine and it was reported that, there was a remote chance that the Pfizer-BioNTech COVID-19 Vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Pfizer-BioNTech COVID-19 Vaccine. Signs of a severe allergic reaction can include: Difficulty breathing and A fast heartbeat (similar to what her daughter could possibly experience). The caller was also asking if the vaccinators on the site were employed by Pfizer and why do they not have this information and advised her daughter not to take the 2nd dose given the above-mentioned reactions post vaccination of 1st dose. Caller wanted to know whether her daughter was going to be okay, and she can give her an assurance that this was not going happen when her daughter comes back to home because her daughter was living alone in her apartment. The outcome of the event was unknown.  Follow up attempts are needed, information about lot/batch number cannot be obtained.
14 dead relatives and friends that took that; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 7-Jul-2022 Reporter's Comments: This case was reported by a patient's relative or friend via interactive digital media. The reporter reported that she/he had 14 dead relatives and friends that took that crap poison (Shingles vaccine). Additional Supportive Information:  The follow-up would not possible as no contact details were available. This case is 1 of 16 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR104784:Same reporter US-GLAXOSMITHKLINE-US2022AMR104786:Same reporter US-GLAXOSMITHKLINE-US2022AMR104785:Same reporter US-GLAXOSMITHKLINE-US2022AMR104782:Same reporter US-GLAXOSMITHKLINE-US2022AMR104795:Same reporter US-GLAXOSMITHKLINE-US2022AMR104797:Same reporter US-GLAXOSMITHKLINE-US2022AMR104793:Same reporter US-GLAXOSMITHKLINE-US2022AMR104796:Same reporter US-GLAXOSMITHKLINE-US2022AMR104773:Same reporter US-GLAXOSMITHKLINE-US2022AMR104794:Same reporter US-GLAXOSMITHKLINE-US2022AMR104787:Same reporter US-GLAXOSMITHKLINE-US2022AMR104789:Same reporter US-GLAXOSMITHKLINE-US2022AMR104801:Same reporter US-GLAXOSMITHKLINE-US2022AMR104854:Same reporter US-GLAXOSMITHKLINE-US2022AMR104876:Same reporter; Reported Cause(s) of Death: Unknown cause of death
Pityriasis rosea - Rash appeared as a single 2cm oblong, erythematous scale rash on trunk above left anterior iliac crest.  After 2 - weeks smaller lesions slowly began to develop around first lesion.  Over the next 12 weeks the pruritus rash has continued to spread across entire back, flanks, stomach and upper groins.
The patient's thigh was warm and red in a 9x7 cm area. The patient was treated with Cephalexin.
Headache, Myalgia, sore throat Narrative:  Employee reports symptoms of sore throat, headache, and body aches, which reportedly began approximately 1.5 hours after receiving second dose of vaccine. Per report, employee took "XL3" for symptoms. No further information provided.
At this time (20:45), only has upper lip swelling. I'm treating with steroids and Benadryl.
no adverse event; she was scheduled to receive her third dose ofGARDASIL 9 in October 2019 but that she was unable to receive her third dose due to "Covid-19 outbreak; This spontaneous report was received from a 43 year old female patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided.   On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(strength, dose, frequency, lot # and expiration date were not provided) for prophylaxis. Patient stated she was scheduled to receive her third dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) in October 2019 but that she was unable to receive her third dose due to "Covid-19 outbreak." Patient wanted to know if she was able to proceed with her third dose or if she needed to take her first and second doses again. Patient stated her insurance won't pay for her to get her first and second doses again. No additional adverse event was reported.
Middle chest hurt/chest pain appear again; Middle chest tight like when something is stucked on her throat; Bad rash on trunk/Bad rash on palms/Bad rash on eyes/Rash appear again; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Middle chest hurt/chest pain appear again), CHEST DISCOMFORT (Middle chest tight like when something is stucked on her throat) and RASH (Bad rash on trunk/Bad rash on palms/Bad rash on eyes/Rash appear again) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066K21A, 014F21A, 011A21A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Sulfur), Allergy to antibiotic (Erythromycin), Hypothyroidism (chronic illnesses) and Anxiety (chronic illnesses). Concomitant products included SERTRALINE for Anxiety, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, the patient experienced CHEST PAIN (Middle chest hurt/chest pain appear again), CHEST DISCOMFORT (Middle chest tight like when something is stucked on her throat) and RASH (Bad rash on trunk/Bad rash on palms/Bad rash on eyes/Rash appear again). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, CHEST PAIN (Middle chest hurt/chest pain appear again), CHEST DISCOMFORT (Middle chest tight like when something is stucked on her throat) and RASH (Bad rash on trunk/Bad rash on palms/Bad rash on eyes/Rash appear again) had not resolved.            Patient had never tested positive for Covid-19 and Patient did not received any other vaccine within 1 month prior to Moderna Covid-19 vaccine.  Patient received first dose, second dose, first booster dose and second booster dose. It was reported that on 15-Apr-2022 patient again experienced symptoms of rash and chest pain.  Patient did not seek for medical care attention for events. Patient took Benadryl for symptoms and symptoms went away.   This case was linked to MOD-2022-541551, MOD-2022-541804 (Patient Link).
patient received wrong pneumonia vaccine- should have received the pnuemovax 23 already received the prevnar 13 in 2016
56 adults patients received doses after its expiration date Jul 13, 2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022).    No concomitant medications were reported.  It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that "the CDC had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case (1 of 56 patient)
Patient reported redness, pain, and swelling at the site of injection. She had tingling feelings in her fingertips and her legs felt weak. She had fever & chills which were treated with TYLENOL. She missed work 1 day. She noticed the pain the morning after the shot & it lasted for 6 days. She took BENADRYL and on the 7th day reported feeling much better.
Given 5th DTaP to RALT. Developed redness affect of 3/4 of whole right thigh. Patient has no lump, no pain, no fever. Patch is slightly warm to touch but not tender.
For fever, took Tylenol and Pedialyte, For chills, took Tylenol.  Some spasming, stretched.  Injection site reaction: Tylenol.  For achiness, Tylenol.
Headache started on the evening of October 13th (one week after 1st dose of Pfizer.  Thursday morning turned headache into migraine that was so severe meds did not work.  Had projectile throw up, which has never happened before.  Had to be taken to hospital by ambulance as I could not walk or hold myself up.  Was treated in the ER with a cocktail of drugs to ease my pain.  Received prescriptions for Ibuprofen (800mg 3 x a day), Acetaminophen 1000mg 3 x daily and cyclobenzaprine.NE 10mg 3 x a day for 10 days.
Pt reported sharp, pinching 2/10 pain in chest.  Patient reported nervousness and a history of similar episode when stressed.  Pt vitals assessed. BP 164/78, HR 56, 98% SpO2.  Patient denied itchiness, rashes, hives, and difficulty breathing. Pt given water. Pt advised to stay for further observation. Pt reassessed at 1625. BP 162/78, HR 59, 97% SpO2. Pt denied difficulty breathing, itchiness, rashes, and hives. Patient offered transportation. Patient declined transportation. Patient left facility at approx. 1630 with steady gait and unlabored respirations.
Large red, hot to touch, itchy blotch below injection site. 3-4? in diameter
Immediately after shot given felt hot couldn't breath fading by. No loss of consciousness, nausea, blurry vision, confusions. Diff-on nausea throughout the day Severe chills around dinner time to midnight then sweating that resolved by morning
Pt reported feeling "euphoric" about 30 minutes after had vaccines.  "Vision seemed cloudy and hearing was fuzzy".  Episode lasted perhaps thirty minutes and symptoms resolved after drinking some fluid and taking a snack. Follow up call on 12/24: pt felt fine.  No further trouble.
Red patch at vaccine site the size of palm. slight itching but no soreness. Appeared two days post vaccination and is fading at current (six days post vaccination).
Roughly 40 mins after shot, case was working, noted his face was hot, hand were cold and he felt lightheaded and nauseated.
Tinnitus, hearing loss in left ear, and vertigo all happened on 3/23/2021 at 3:05pm. By 3:30, the vertigo attack had become severe with vomiting lasting until 8:30pm. Tinnitus is still present today (4/20/2021). Hearing loss in left ear resolved after a second severe vertigo attack on 4/13/2021 (vomiting lasting 10 hours). Saw PCP and referred to ENT for further testing (upcoming) after first vertigo attack.
Arvexy administered to preganant patient instead of other RSV vaccine; Arvexy administered to preganant patient instead of other RSV vaccine; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: Arvexy administered to preganant patient instead of other RSV vaccine) and wrong vaccine administered (Verbatim: Arvexy administered to preganant patient instead of other RSV vaccine). The outcome of the vaccine exposure during pregnancy and wrong vaccine administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 2-Nov-2023 Nurse would like to know if there were any studies in pregnant ladies for Arexvy.  The reporter stated that the pregnant patient received Arexvy instead of the other RSV vaccine (did not know the name), which led to vaccine exposure during pregnancy and wrong vaccine administered. The reporter stated that the patient already called in and reported to GlaxoSmithKline but was informed her health care professional would need to call for data so this was most likely a duplicate. Note, most likely given patient was pregnant, there was a good chance this was administered under approved age indication but did not confirm on call with nurse so did not add as adverse event detail. Did not consent to follow-up.
That evening I started getting a sore arm. The next morning I woke up w/ a slight headache and just did not feel right. As the day progressed I started having body aches, chills, extreme fatigue, still sore arm. I could not stand for long periods of time or I would start to fell like I was going fall right there in the floor.
CHILLS AND BODY ACHES, AND WEAKNESS; INDIGESTION AND NAUSEA; LEG CRAMPS ON BOTH CALVES, AND NEURITIS ON LOWER EXTREMITIES; UPPER THIGT CRAMPS WHICH STARTED WITH RIGHT SIDE THEN INSTANT MIGRATION ON LEFT THIGH THAT WAS TOO TIGHT AND SEVERE I COULDN'T MOVE FOR 10-15 MINUTES OR SO. I STILL HAVE WEAKED AND CRAMPED FEELING ON MY LEGS.
pain in her whole arm; numbness in right cheek/numbness in arm/hand; Swollen lymph nodes; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 30Dec2020 12:12 at SINGLE DOSE at right arm for covid-19 immunisation. Medical history included SVT this was recognized at least 20 years ago, around the age of 30, she started to deal with high blood pressure, allergic to penicillin. The patient's concomitant medications were not reported.  The patient previously took codeine, levothyroxine: allergic to codeine, levothyroxine. The patient also previously took Tylenol with Codeine and that was horrible and she can't ever take it again, when she was around the age of 40 years old. The patient received the COVID vaccination around Wednesday 30Dec2020 at 12:12 p.m. She was perfectly fine until late Thursday afternoon 31Dec2020, around 3:30-4:00 pm. She started to have swollen lymph nodes. It was only a little bad at first and then she started getting more and more swelling. She spoke with her facility's RN who suggested she use some cold and warm packs/compresses and also take some Tylenol to deal with it. She has had the swelling for this many days now. It's not bad swelling but she her lymph nodes are still so swollen. She thought it was a regular reaction, but now it's been too long. Her lymph nodes are not swollen humongous. There is no redness. Her lymph nodes are not hard, just swollen. The swelling was a little bit better on Friday and Saturday but yesterday, it started bothering her again. She has had pain in her whole arm on an unspecified date. On 03Jan2020, her face also started to feel funny. She clarifies by "feeling funny", she meant she started to experience numbness in her right cheek, only her cheek, like when one gets a vaccination when they go to a doctor's office/dentist office and it starts working and one can feel it getting numb. She also experienced numbness in her arm. She clarifies when she puts pressure on her arm (like putting her arm on the desk), she feels numb in her hand. She verifies the numbness in both her cheek and arm started occurring on 03Jan2020 around 7-8pm. She is fine today and then she'll start to feel the numbness again in her cheek and arm. She clarifies the numbness comes and goes. It comes in the morning and then goes away and then the numbness starts again. She started to feel numb in her face and cheek, like when one gets a Novocain at the dentist office and it starts working- it's like the same feeling. The outcome of the events Swollen lymph nodes and numbness in right cheek/numbness in arm/hand was not recovered, while unknown for the other event.   Information on the lot/Batch number has been requested.
The arm the vaccine was given in developed slight tenderness, small bumps, some redness, itches  and a has a hard area on or just below the injection site. These conditions did not begin until approximately 10 days after the vaccine. I visited with a nurse at our local health clinic. She, ironically, developed the same symptoms and said hers lasted almost until her second shot. Other than Benadryl cream to alleviate the itching, no treatment was recommended. I have had the above symptoms for five days and although they are slightly improved, they are not gone.
I had an appointment scheduled online to get a Flu shot. The tech didn't ask my name or ask my birth date before she gave me the shot. Afterwards, she gave me a vaccination record sheet indicating she had given me the Covid 19 booster shot. I told her I was supposed to be getting a flu shot. They discovered that she had the wrong record--another person with a very similar name. Since it was a Friday afternoon, I was told to go to an urgent care or the emergency room if I had side effects. So far--the next day--I have no side affects.
Left arm pain with touch and movement.  Patient unable to move arm out from body more than 20 degrees.
Rec'd DTAP # 5 and IPOL #4 L arm on 5/31/06. Mom brought to office 6/2/06 with complaints of L arm redness and swelling. Dx'd with early cellulitis. Prescribed antibiotics.
Dizziness, vertigo, dull taste and headache continue after 11 days.
Pt. had swelling and redness at the site x 5 days. Started the next day.- (R) thigh
pt recvd vax;approx 2 wks later had swollen lymph nodes in the groin;reporter instructed pt to go to MD;sxs has not resolved;
HCP states that this specific patient experienced swelling of her arm,; an arm rash; bruise-like discoloration of whole arm; This patient also reported experiencing tongue swelling.; This spontaneous report has been received from a pharmacist, referring to a 79-year-old female patient. The patient's medical history, concurrent conditions,  and concomitant medications were not provided.  On 17-NOV-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter intramuscular injection (lot number W021636 has been verified to be a valid lot number, expiry date 01-OCT-2023) (strength, and frequency were not reported) indicated as prophylaxis.  On an unknown date, the patient  experienced swelling of her arm (peripheral swelling), an arm rash (rash) and bruised like discoloration of whole arm, not just the injection site (skin discolouration). The patient also reported experiencing tongue swelling (swollen tongue). The reporter states that the patient sought medical attention on 18-NOV-2022  The outcome of the events was reported as recovering.  The causality assessment was reported as unknown.; Sender's Comments:  US-009507513-2211USA006955:
Patient felt "shivery stuff" during the day after receiving the first dose of the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of CHILLS (Patient felt "shivery stuff" during the day after receiving the first dose of the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Patient felt "shivery stuff" during the day after receiving the first dose of the vaccine). At the time of the report, CHILLS (Patient felt "shivery stuff" during the day after receiving the first dose of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.