chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1 week after 2nd pfizer shot with erythematous pruritic red patch over injection site.
This spontaneous report as received from a nurse refers to an 11 months 9 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. Additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Resident had no adverse side effects at time of injection and seemed to be doing well overall health wise. Resident goes out for dialysis and is picked up by family for this. On the date resident passed, he went to dialysis as typical but family decided to take him to their home for a get together. When they arrived they stayed only 5 minutes before they decided they would bring him back to the community. Resident was doing well talking and walked to vehicle. During car ride resident suddenly went unresponsive according to family. He was brought to the hospital and was pronounced dead with no further workup.
Exact time not remembered. Tightness in chest, difficulty catching breath, irregular heart rate on day 2, plus poor vision on day 2. Fluvirin 90658 0.5mL
Flu like symptoms. Fever, chills, nausea, muscle weakness, nasal congestion, tiredness.
pt recv vax 5OCT96 & 7OCT96 pt exp urticaria;
74y.o. year old male who presented to the ED 4/9 with weakness. Recent partial R great toe amp at hospital for osteomyelitis. Was seen by ID and discharged 3/11 on ertapenem x 4wks, although discharge summary states linezolid/ceftriaxone/flagyl.  Records reviewed.  Pt taken to OR by podiatry due to foreign body on 4/10 due to displaced antibiotic spacer. preop COVID testing +, Pt did receive Pfizer vaccine x 2  On 2/1, 2/22 O2 sat 94% on 2L, min cough, denies other symptoms
Patient has general malaise  unknown cause . Onsite EMS was called vitals BP 154/91   100% O2 room air Patient Treated, Transported by the EMS to the hospital.
Raised red bumpy rash to (L) thigh/buttock, right thigh, low back.
This spontaneous report was received from a pharmacist refers to a 49 year old female patient. The patient was vaccinated with ZOSTAVAX, (lot number, expiration date and route was not reported) on 17-JAN-2013. No concomitant medications were reported. No adverse event was reported. Additional information has been requested.
Patient received her GARDASIL vaccine on 7/31/18 afternoon. Monitored for 15 mins. No reaction. The next day, she developed fever, headache, chills and myalgias. ER physician attributed this for a reaction to HPV.
Patient started with severe abdominal pain the evening of 01/22/2018. She was crunched over into the fetal position crying and rocking back and forth. Pain continued to increase through the night. Patient was in severe pain for over 3 weeks. Many times begging for someone to take the pain away. She would lay in the fetal position and cry for hours. Multiple days of school were missed.
Developed dizziness in the afternoon after receiving the COVID-19 vaccine on 03/13/21. Developed myalgias & malaise on 03/14/15. On 03/15/15, he woke up with erythema and warmth of his ears. At 7 pm that evening, he developed facial swelling (forehead and cheeks) and erythema around his mouth.
About a week after I received the vaccine I noticed my heart started beating faster than normal. I stopped what I was doing and my heart returned to normal. This comes out of nowhere, I have no way knowing when it will happen. My heart just starts to race, I stop what I am doing then it slows back to normal. I made an appointment with my doctor after four weeks of it happening more frequently. She feels that the second booster may have exacerbated the arrhythmia of my heart.
patient experienced redness  and inflammation at the site of infection, and expanded from the shoulder all the way down to the elbow. her PCP prescribed her Augmentin 875MG.  but symptoms did not improve.
I had arm pain 30 minutes after the vaccine which began to get worse to the point I could not move my arm, on 01/13/22 I woke up nauseous, feeling faint, body freezing but face was on fire, 102.5 fever, dizzy, I couldn't keep my eyes open, I struggled to stay awake it was hard to open my eyes or lift my head long enough to verbally respond, I was shaky, teeth hatter, severe body aches,  continuously my head was dropping my head and felt like I was going to pass out, I felt like I was going to faint several times, I felt really "out of it"
Sever headache  Severe joint and muscle pain  Nausea  Vomiting Diarrhea  Racing heart beat Chills Sever fatigue
Day 1- pain in arm, headache  Day 2- headache, body ache, muscle ache, cold chills, night sweats, nausea, fever
Patient states that he developed high blood pressure about 2 weeks after his vaccine.  He states that prior to the vaccine he never had high blood pressure, but since his vaccine it has been elevated.  Pt states that when he checks it at home it varies wildly, but can be as high as 140s/90s.
COVID-19 Virus test Positive; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID-19 Virus test Positive) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 Virus test Positive). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID-19 Virus test Positive) outcome was unknown.            No ongoing treatments provided by the reporter. Action taken with mRNA-1273 in response to the event was not applicable.   Reporter did not allow further contact
Patient had a fever of 101F and had severe shaking/chills. She couldn't hold onto anything without shaking. She took ibuprofen 400mg and acetaminophen 1000mg at 1:30am on 2-15-19. At 3:00am on 2-15-19, her symptoms resolved and have not recurred (as of 3:00 pm on 3-15-19).
Pt recv vax on 10/29/98; post vax pt exp headache, dizziness, dry mouth, eye pain, breaking out around neck
a 12 month old was given PROQUAD and VARIVAX togerther; This spontaneous report was received from a nurse practitioner and refers to a 12-month-old patient of an unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 27-AUG-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, route of administration, lot # and expiration date were not reported) together with varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route of administration, lot # and expiration date were not reported), both for prophylaxis.  The outcome of inappropriate schedule of product administration was unknown.
Coughing on 1/23 pm started.  Temp 103 started on 1/24. Came to ED, chest x ray showed pneumonia.
9FEB92 pt devel h/a & fever 100.6 po; no other signs or symptoms on exam but on 12FEB92 mom reports h/a & fever were gone on 10FEB92 but arm was hard & swollen that day;
Guillian Barre syndrome; Ascending paralysis; 2nd dose in 2022; This serious case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (The patient had the 1st dose of Shingrix in 2020.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: Guillian Barre syndrome) (serious criteria GSK medically significant), paralysis ascending (Verbatim: Ascending paralysis) (serious criteria GSK medically significant) and drug dose administration interval too long (Verbatim: 2nd dose in 2022). The outcome of the guillain barre syndrome and paralysis ascending were not reported and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the guillain barre syndrome and paralysis ascending to be related to Shingrix.     It was unknown if the company considered the guillain barre syndrome and paralysis ascending to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-APR-2023 The patient received both doses of Shingrix, however patient received the 2nd dose in 2022, which led to drug dose administration interval too long. A few weeks after vaccination, patient developed guillian barre syndrome and developed ascending paralysis. Patient was sent for a lumbar puncture however Doctor does not know results of puncture as of today. The reporter consented to follow up.
immediatley lethargic, medium grade fever, persistent unconsulable and high pitched painful cry, not able to sleep at night, severe diahrea that included an ER visit and many Dr. visits that lasted for 2-3 weeks long. He stopped talking during this time and has never regained speech. He has regressed in fine motor and gross motor skills as verified by an occupational therapist. Now has major gastorintesitnal problems and undergoing many tests.
Pt test positive for COVID 7/8/21 s/p being fully vaccinated w/ 2 doses of Moderna
Patient had two previous live births and two spontaneous abortions at 10 and 8 weeks prior.  Reported lack of fetal movement in the last few days (not quantified).  Provider note ruled as a pregnancy loss at 19 weeks of gestation.
pt stated he felt some immune response but no fever after receiving.  Pt said he developed a painful rash under left armpit.  He contacted his PCP and he was told to use cortisone and send her a picture of it tomorrow to see if it needs further treatment.
Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and NAUSEA (Nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jul-2021, the patient experienced HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, HEADACHE (Headache) and NAUSEA (Nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information was provided.
pain was sever and tender to touch.; fever with temperature of 99.4; chills; arm pain, couldn't move or lift his arm above 45 degrees; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain, couldn't move or lift his arm above 45 degrees), INFLUENZA LIKE ILLNESS (flu like symptoms), TENDERNESS (pain was sever and tender to touch.), PYREXIA (fever with temperature of 99.4) and CHILLS (chills) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain, couldn't move or lift his arm above 45 degrees), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever with temperature of 99.4) and CHILLS (chills). On an unknown date, the patient experienced TENDERNESS (pain was sever and tender to touch.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm pain, couldn't move or lift his arm above 45 degrees), INFLUENZA LIKE ILLNESS (flu like symptoms), TENDERNESS (pain was sever and tender to touch.), PYREXIA (fever with temperature of 99.4) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Body temperature: 99.4 (High) temperature of 99.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
Headache, Myalgia chills Narrative: Employee took sick leave, continuing to monitor symptoms
Anaphylaxis reaction immediately post-vaccine; Difficulty speaking; hoarseness; tightness in throat and chest; tightness in throat and chest; dizziness; disorientation; This is a spontaneous report from a contactable consumer (patient). A 66-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 08Mar2021 17:30 as single dose for covid-19 immunization in an hospital. Medical history included reaction to preservatives in foods, products, and medications from an unknown date. The patient's concomitant medications were not reported. The patient previously took sodium metabisulfite and experienced anaphylaxis. No other vaccines taken in four weeks. No COVID-19 prior to vaccination. On 08Mar2021 18:00 the patient experienced anaphylaxis reaction immediately post-vaccine, difficulty speaking, hoarseness, tightness in throat and chest, dizziness, and disorientation. The events required emergency room and physicians office visit and were considered life threatening by the reporter. The patient was treated with Epinephrine, Benadryl, Prednisone, and Pepcid. The patient was tested for COVID-19 via nasal swab post vaccination on 08Mar2021 with a negative result. The outcome of the events were recovered with sequel.   Information about lot/batch number has been requested.
Patient complained of left lower lobe of lung pain, which she stated has been causing her symptoms prior to Moderna vaccine administration. Asked patient if she needed treatment and she stated no and she just wanted to let us know.
Patient received a Pfizer Booster vaccine lower than Deltoid muscle/Wrong injection site. On 12/01/2021, patient reported mild Covid-19 symptoms, specifically mentioning subjective fever and ?migraine? her concern today is that yesterday she noticed redness & swelling to her left upper arm.  About 2.5 cm erythema & swelling to the left lateral posterior upper arm , no tenderness, flu ear, nor increased warmth from of left upper extremity.  Patient advised to seek medical attention  if the area of the erythema and/or swelling increased outside of the marking.  Provider recommended Tylenol 650mg every fours as needed. And to apply cool compress to the area.
Nausea; I am nauseous; Headache; Dizziness; I''m dizzy; I feel really weird like I threw up; This is a spontaneous case received from a contactable consumer (Patient) via Pfizer sponsored program. A 61-year-old patient of unspecified gender received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 04Oct2021 as dose 1, single for COVID-19 immunization; oxycodone (OXYCODONE), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 10 mg, 4x/day for an unspecified indication; lisinopril (LISINOPRIL), route of administration, start and stop date, batch/lot number and dose were not reported for blood pressure measurement . The patient medical history included hearing disability. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced nausea, headache and dizziness and reported that felt really weird like threw up. It was reported that, patient felt really weird like threw up yesterday and hadn't thrown up, patient didn't remember the last time had thrown up like that, patient was nauseous, dizzy, it was just really affected the patient. Patient wanted to know if it was okay to get the second shot and took 3 other medications, took blood pressure medication Lisinopril and took Oxycodone and Morphine. So patient wondered if anything had a reaction with that. Patient was little hard of hearing, and took them due to disability and was very scared to get the COVID-19 vaccine. The action taken in response to the event(s) for oxycodone and lisinopril was unknown. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Multiple swollen and tender lymph nodes on left side of neck and collar bone found week after injection.
Pt called on 4/20/01 at 10:30 and stated her right arm was red and blotched and complaining of mild difficulty breathing. She was told to see MD. She stated she was going to MD and was to call clinic with results. Also, given another telephone # to call. Tried to call pt on 10/23/01 and only answering machine picked up, so left a message for her to call clinic.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Aug2021 as dose 1, single (Lot number: EN6203), in right arm and on 03Mar2022 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "ALK lung cancer" (unspecified if ongoing), notes: Other medical history: ALK lung cancer; "Known allergies: Pennicillan" (unspecified if ongoing), notes: Known allergies: Pennicillan. Concomitant medication(s) included: ALECENSA, start date: 01Oct2017; NP THYROID, start date: 15Dec2020. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro"; Keflex, reaction(s): "Known allergies: Keflex"; Levaquin, reaction(s): "Known allergies: levaquin"; Iv phenegqan, reaction(s): "Known allergies: Phenegqan". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The event "treatment of covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Dec2022) Positive, notes: Dr. appointment for COVID test, went in on the 09Dec2022, test came back Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not receive any other medications within 2 weeks of vaccination. On 07Dec2022, patient had an earache and sinus drip, made a Dr. appointment for COVID test, went in on the 09Dec2022, test came back Positive. Patient was given prescriptions for dexamethasone 4MG tab / azithromycin 500MG tab / Paxlovid. Patient received Paxlovid, from 09Dec2022 to 14Dec2022 for the treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
diarrhea; muscle pain; joint pain; chills; nausea and vomiting; nausea and vomiting; fever; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills) and NAUSEA (nausea and vomiting) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced DIARRHOEA (diarrhea), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea and vomiting), VOMITING (nausea and vomiting), PYREXIA (fever), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, DIARRHOEA (diarrhea), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea and vomiting), VOMITING (nausea and vomiting), PYREXIA (fever), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Pt taken to ED as awakened in night C/O "feeling odd" fever at home. Vomiting and diarrhea at home. Mother relates child C/O seeing things not there: lights on clock w/o any light. Labs and CXR w/o concern. Child ill 10/22 and not ill 10/23.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Abdominal Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Medium, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Vomiting-Medium
Pt recvd 4 doses of Engerix-B & exp failure to convert;
swelling at the site of his Shingrix injection; warmth at injection site; itching at the site of his Shingrix injection; redness at the site of his Shingrix injection; rash at the site of his Shingrix injection; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In AUG-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). In AUG-2023, 2 days after receiving Shingrix, the patient experienced injection site rash (Verbatim: rash at the site of his Shingrix injection), injection site erythema (Verbatim: redness at the site of his Shingrix injection), injection site swelling (Verbatim: swelling at the site of his Shingrix injection), injection site itching (Verbatim: itching at the site of his Shingrix injection) and injection site warmth (Verbatim: warmth at injection site).  The outcome of the injection site rash, injection site erythema, injection site swelling, injection site itching and injection site warmth were not resolved.   It was unknown if the reporter considered the injection site rash, injection site erythema, injection site swelling, injection site itching and injection site warmth to be related to Shingrix.     It was unknown if the company considered the injection site rash, injection site erythema, injection site swelling, injection site itching and injection site warmth to be related to Shingrix.   Additional Information: GSK receipt date: 31-AUG-2023 The patient called to ask if his rash, redness, swelling and itching at the site of his Shingrix injection was a sign of a serious allergic reaction.   The patient received his 1st Shingrix dose about one and a half weeks ago.   Two days later these symptoms began and still remain. No consent as he had not discussed this with his doctor yet.  The patient referred to his health care professional (HCP). The reporter did not consent to follow-up.