chrisvoncsefalvay/vaers-outcomes huggingface dataset:
been in bed for 3 days; has no desire to eat/drink anything; has fallen twice; has not slept in 3 days; nauseated; concerned she might be dead in the next two days with sleep status/not eating; her legs wouldn't hold her up; shoulder is very sore; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) Dose 1 via an unspecified route of administration on 02Aug2021 (Batch/Lot Number: FA7485) as a single dose for COVID-19 immunisation. Medical history included pneumonia from an unknown date and unknown if ongoing , COVID-19 from Jan2021 to an unknown date (Notes: had COVID and was given the antibodies in Jan2021 and was in the hospital). The patient's concomitant medications were not reported. On 02Aug2021, the patient experienced has been in bed for 3 days (medically significant), has no desire to eat/drink anything, has fallen twice (medically significant), has not slept in 3 days (medically significant, nauseated (medically significant), concerned she might be dead in the next two days with sleep status/not eating, her legs wouldn't hold her up, and shoulder is very sore. Consumer received 1st dose of Pfizer Covid 19 vaccine on 02Aug2021. Since then she has been in bed for 3 days, has no desire to eat/drink anything, has fallen twice because her legs wouldn't hold her up (fall happened the first two days), has not slept in 3 days or night. The caller hasn't slept not even 20 minutes. When the caller fell she couldn't get up without help. The caller feels nauseous like she is going to throw up. Patient stated she does not know what to do and thinks she should go to the hospital. It was noted that she is scheduled for her second dose of Pfizer Covid 19 vaccine in two weeks and unsure of guidance. The patient was concerned she might be dead in the next two days with sleep status/not eating and explains that her HCP will not be able to see her. It takes a week to get in. The caller is getting weaker and weaker. The caller is concerned about whether to take the second dose and if she does not get any better then she is going to have to go to the hospital. The caller had to take the nausea pill and that helped. The caller has to walk with help. The patients shoulder is very sore. The patient was recovering from the events, been in bed for 3 days, nauseated, her legs wouldn't hold her up, and shoulder is very sore. The patient had not recovered from the events, has no desire to eat/drink anything, has no desire to eat/drink, has no desire to eat/drink anything, and has not slept in 3 days. The outcome of the events, has fallen twice, and concerned she might be dead in the next two days with sleep status/not eating was unknown.
The patient presents with COVID symptoms. 46 y/o female with a hx of CAD, HTN, COPD, DM presents to the ED with COVID symptoms of increased SOB and chest discomfort over the past two days. Pt sts she tested positive for COVID-19 x2 weeks ago. She sts she had a syncopal episode today while standing drinking tea. Denies any other symptoms.  The onset was 2  days ago.  The course/duration of symptoms is constant.  Location: chest. The character of symptoms is "discomfort".  The degree at onset was moderate.  The degree at present is moderate.  Risk factors consist of CAD, HTN, COPD, DM.
She developed the Shingle infection after the first dose; Patient did not get the second dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (She developed the Shingle infection after the first dose) and PRODUCT DOSE OMISSION ISSUE (Patient did not get the second dose of vaccine) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (She developed the Shingle infection after the first dose) and PRODUCT DOSE OMISSION ISSUE (Patient did not get the second dose of vaccine). At the time of the report, HERPES ZOSTER (She developed the Shingle infection after the first dose) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient did not get the second dose of vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Patient used ointment for Shingle infection.
Itchiness, slight swelling, red circle, fatigue, soreness at injection site and in bicep of arm
Vomiting; Not able to eat; Lost 18 pounds; A spontaneous report (United States) was received from a Nurse  concerning a 42-year-old, Female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vomiting, Not able to eat, and Lost 18 pounds.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number:  026L20A ) intramuscularly, in left arm for prophylaxis of COVID-19 infection.    On 30 Dec 2020, two hours after taking the vaccine, the patient started vomiting, she was not able to eat and lost 18 pounds. The patient was treated with Zofran (Ondansetron) in order to be able to keep fluids down, but almost had to be hospitalized for these symptoms. Patient is schedule to get the second dose tomorrow and wanted to know if it would be safe.  Action taken with mRNA-1273 in response to the events was not reported.     The outcome of the events vomiting, Not able to eat, and Lost 18 pounds were recovered on 11-JAN-2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
The patient had a large local reaction at injection site. Warm to the touch. Mother of patient said this happened last year, and symptoms lasted for a couple of days. Site was painful to touch but patient was still able to use arm.
Abd feels cold - eyes looks moist. Light headed - Chest CTA HR RRR 78. Laid down ice pack given - resp easy -Parent notified.
51 year old patient was administered Fluzone High Dose with no adverse event; 51 year old patient was administered Fluzone High Dose with no adverse event; Initial information regarding this valid unsolicited non-serious case was received from pharmacist via regulatory authority.  This case involves a 51-year-old female patient who received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Product administered to patient of inappropriate age and Overdose).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. .   On 07-Oct-2020, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Lot number- UJ499AB, expiration date: 30-Jun-2021) via intramuscular route in the left arm for prophylactic vaccination.  This is a case of actual medication error due to Inappropriate age at vaccine administration and Overdose (latency same day).  At the time of reporting, patient had no adverse event. Reporter wanted to know adverse reactions (if any) related to it.  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 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.
Headche, malaise, lightheadedness on day #1 (day vaccine was given). Fever to 102.3 F and presyncope on day #2. Resolution of sx around 4 am on Day #3.
patient called 8 pm 1/26/22 stating had hives starting monday after getting the vaccine. she said its almost scabbing over but not like a scab just very patchy hives from stomach down towards her private parts and also her breasts/ chest and back. it sounded like bad hives patient does not have a primary doctor but plans to show her dermatologist office to look at it and decide if she proceed with another dose. I recommended oral Benadryl if needed.
29JAN93 48 hrs p/receiving Td shot, lt arm around inject site became swollen, red, feverish, hurting; 30JAN93 became more swollen; advised to put ice on arm; red line all around arm, itching;
Headache started approximately an hour after the injection. Chills and fatigue started the next evening after the injection. Sore/painful armpit/lymph node under left arm (same side as injection) started 2 days after the injection.  The headache and chills were relieved by Tylenol.
h/a, neck & back pain, fine papular rash on both arms; used APAP & Motrin
Approximately 1 week after the booster I developed hives that are not subsiding.  Seen in ED and primary. Received Benadryl Pepcid and solumedrol with slight relief. No new know allergens. Seeing allergist March 1st.
neuropathy; Her ankle and both feet, hands, calves, and from the thighs the pain was severe enough; shingles pain; numbness and tingling in feet; trouble sleeping/could not sleep; Nerve pain; Her ankle and both feet, hands, calves, and from the thighs the pain was severe enough; tingling in multiple places in the body; severe ringing of the ears; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient has already reported about the vaccine to her family doctor and will be calling the (Public agency name). She had the first dose of the Pfizer Covid vaccine on Tuesday (unspecified date) and immediately afterwards in the afternoon, about 3 hours later, had severe ringing of the ears and that went in through Wednesday. Then Wednesday she started having tingling and numbness in her feet. That continued to increase to the point by Friday afternoon she was not able to get any sleep because of having nerve pain and tingling in multiple places in the body. It was almost like with someone who has neuropathy or shingles pain, that the nerve pain you would get. Her ankle and both feet, hands, calves, and from the thighs the pain was severe enough that she could not sleep because of it. She has never had or felt anything like that in her life. Knows that it is not the stereotypical symptoms talked about, but she mentioned this to her primary care provider and to the pharmacist. Normally people get the flu like symptoms, but she did not get it, this vaccine did not manifest in her system like that. It was added that she felt she needed to let the company know and everybody know that she is seeing more reports of this and her doctor said that she has a lady that has had this for a while and it is still ongoing. There have been reports of people saying they've had these symptoms 3-4 weeks after getting the vaccine and this is alarming she is not going to lie, but it is doing something to the immune system. Declined to complete report on lady her doctor informed her about stating her doctor had mentioned that this was rare, it's a 1% chance of happening, but she is still having it. No further details provided.  The outcome of the events was not recovered.   Information about lot/batch number has been requested.
I woke up with a red rash about 2"x1" on my left arm below the vaccination site TWO days after getting the shot.  It itched.  There is also very slight bruising on the underside of the same arm.  This DID NOT HAPPEN AFTER MY FIRST SHOT.  I also got flu like side effects with a temp of 100.4 degrees.
Vials were initially stored in refrigerator on 01-Mar-2022, and administered on 30-Mar-2022, which was expired on 19-Mar-2022; Inadvertently administered an expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered an expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Vials were initially stored in refrigerator on 01-Mar-2022, and administered on 30-Mar-2022, which was expired on 19-Mar-2022) in a 42-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 013H21B) for COVID-19 vaccination.     The patient had no known drug allergies. The patient was not diagnosed with or tested positive for COVID-19. Acute illness at the time of vaccination and up to one month before was reported as unknown. Chronic or long-standing health condition was reported as none.     On 30-Mar-2022 at 10:48 AM, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 30-Mar-2022 at 10:48 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered an expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials were initially stored in refrigerator on 01-Mar-2022, and administered on 30-Mar-2022, which was expired on 19-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered an expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Vials were initially stored in refrigerator on 01-Mar-2022, and administered on 30-Mar-2022, which was expired on 19-Mar-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   It was unknown whether the patient took any prescriptions, over-the-counter medications, dietary supplements or herbal medicines at the time of vaccination or at the time of adverse event. The vial was initially stored in the refrigerator on 01-Mar-2022. The vial did not undergo any temperature excursions. The patient did not reported any adverse event. The potential cause was reported as expired moderna vaccine. No treatment information was reported.
I have never had hives before in my life.  On day #8 following the COVID-19 vaccine (Dose #1) I started to breakout with hives.  The breakout is exceptionally bad starting around 5:30pm.  I have now broken out in hives 3 days in a row.  9/9/2021 was day 3 of this side effect.    The breakout occurs on my arms, hands, chest and neck.  I have taken Benadryl to remedy this situation.  Nothing else has changed in my life (i.e., no new perfumes, no change in detergent, no change in diet, etc.).  The only explanation could be the COVID-19 vaccine.
Chills after 2nd shot; Low Grade Fever after 2nd shot; Tired after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills after 2nd shot), PYREXIA (Low Grade Fever after 2nd shot) and FATIGUE (Tired after 2nd shot) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 015M20A) for COVID-19 vaccination. The patient's past medical history included Pulmonary fibrosis. Concurrent medical conditions included Scoliosis and Hypertension. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced CHILLS (Chills after 2nd shot), PYREXIA (Low Grade Fever after 2nd shot) and FATIGUE (Tired after 2nd shot). On 08-Mar-2021, CHILLS (Chills after 2nd shot), PYREXIA (Low Grade Fever after 2nd shot) and FATIGUE (Tired after 2nd shot) had resolved. No Concomitant medications were provided by the reporter.No Treatment information was reported. This case was linked to MOD-2021-385943 (Patient Link).
She didn't want to get sick again because she was sick; She has pain in the joints of her arms and her legs/joint pain in her fingers/have a history of joint pain but this is worse; This is a spontaneous report from a contactable consumer (patient) from medical information team. A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EP6955, expiration date was not reported) via an unspecified route of administration, in left arm, on 23Mar2021 (at the age of 44-years-old), at dose 2, single for covid-19 immunization. Medical history included arthralgia and covid-19; she was infected with the Covid 19 virus on an unspecified date. There were no concomitant medications. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6202, expiration date was not reported) via an unspecified route of administration, in left arm, on 02Mar2021 (at the age of 44-years-old), at dose 1, single for covid-19 immunization and had the joint pain. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. On 25Mar2021, the joint pain came back, and patient experienced she has pain in the joints of her arms and her legs/ right arm and right arm joints she had pain/ joint pain in her fingers; her right arm is bothering more, joints are hurting more; patient had a history of joint pain, but this is worse. It was reported that, on an unspecified date the patient infected with the Covid 19 virus before, and she didn't want to get sick again because she was sick. Therapeutic measures included Tylenol. There were no investigation assessments. The outcome of the event joint pain was not recovered, and outcome of the other event was unknown.  No follow-up attempts are possible. No further information is expected.
injected a bivalent booster instead of first primary series.; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (injected a bivalent booster instead of first primary series.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (injected a bivalent booster instead of first primary series.) and NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (injected a bivalent booster instead of first primary series.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (injected a bivalent booster instead of first primary series.).    No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
This case was reported by a nurse via sales rep and described the occurrence of seizure in a patient who received BOOSTRIX. Co-suspect products included MENACTRA. Concurrent medical conditions included autism (underlying neurological disorder). On an unknown date, the patient received BOOSTRIX .5 ml and MENACTRA at an unknown dose. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced seizure (serious criteria GSK medically significant) and fever. On an unknown date, the outcome of the seizure and fever were unknown. It was unknown if the reporter considered the seizure and fever to be related to BOOSTRIX. Additional details were received as follows: the age at vaccination was not reported. the reporter stated that, the patient received a dose of BOOSTRIX along with MENACTRA and experienced the events. the reporter did not have any patient information or lot number and expiry date of the product.
Felt really sick; About to faint; Lost her taste; Lost her smell; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt really sick), PRESYNCOPE (About to faint), AGEUSIA (Lost her taste) and ANOSMIA (Lost her smell) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In August 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced ILLNESS (Felt really sick), PRESYNCOPE (About to faint), AGEUSIA (Lost her taste) and ANOSMIA (Lost her smell). At the time of the report, ILLNESS (Felt really sick), PRESYNCOPE (About to faint), AGEUSIA (Lost her taste) and ANOSMIA (Lost her smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  The treatment information was  not provided.   Reporter did not allow further contact
Red, itchy rash on arm began 2 days after vaccine administration.  Rash began as red, raised, discrete blisters at the injection site, then developed into more diffuse, migratory redness that reached about 4 inches from the injection site. Has started to fade after 9 days.
Information regarding PREVNAR 13 was received from a physician regarding 2 month old patients who experienced high fevers "around 104.0" within 48 hours of receiving PREVNAR 13 and PENTACEL for first immunization in the series at 2 month well baby visit. The patients received the first dose on unspecified dates. Relevant medical history was not provided. Additional suspect medication included PENTACEL. Concomitant medications were not reported. The patients experienced high fevers "around 104.0" within 48 hours of receiving PREVNAR 13 and PENTACEL for first immunization in the series at 2 month well baby visit. Outcome was unknown. No additional information was available at the time of this report. Laboratory test (results: negative septic workup) and body temperature (results: around 104.0) were done on an unspecified date. The reporter was unable to specify the number of patients who experienced this event. Additional reports will be generated when identifying information is provided.
Engerix-b expired dose administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a adult patient who received HBV (Engerix B) (batch number H2T35, expiry date 29th May 2022) for prophylaxis.   On 16th June 2022, the patient received Engerix B. On 16th June 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 16-Jun-2022 Reporter's Comments: The reporter stated that a nurse gave by error an Engerix-B expired vaccine to a patient. The reporter had no information about the patient at the time of reporting. The reporter consented to follow up via email. Additional Supportive Information: The patient received Engerix B, which was already expired in 29th May 2022, which led to expired vaccine administered.