chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is an instance of breakthrough COVID-19 after which death occurred.   The individual was vaccinated with the Moderna product on 03/26/2021 and 04/23/2021.  The individual had left nursing home against medical advice on 09/06/2021. They were brought to emergency department via ambulance on ____   with a primary complaint of shortness of breath. They tested positive for COVID-19 on 10/08/2021. They were brought to emergency department via ambulance on 10/08/2021 with primary complaint of shortness of breath. They were admitted to hospital 10/08/20201 and discharged 10/12/2021. They were found to be hypoxic and to have COVID-19 pneumonia. They were brought to emergency department again on 10/14/2021 a with a primary complaint of shortness of breath. They became non-responsive during the ambulance ride. They died on 10/17/2021 (it seems from the clinical notes that they did not regain consciousness). It was determined they suffered cardiac arrest.
Recurrent, spontaneous itching at random places on body. Red rash that occurs spontaneously every evening on different parts of the body. Symptoms resemble hives.
Information has been received from a physician concerning a 47 year old male who on approximately 03/15/2001 was vaccinated with hep b vaccine recombinant. Two weeks post vaccination, on approximately 03/30/2001, the pt experienced chronic urticaria. The physician stated that no other symptoms were noted. Unspecified medical attention was sought and the pt's outcome was unknown. Additional info has been requested.
BODY ACHES; CHILLS; TIRED; SEVERE HEADACHES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-MAR-2021 11:30 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 MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced tired. On MAR-2021, the subject experienced severe headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches, tired, severe headaches and chills was not reported. This report was non-serious.
This spontaneous report as received from a Registered Nurse refers to a 5 year old female patient. On 18-MAR-2013 the patient was vaccinated with a dose of (Merck) PROQUAD (lot no. 0404AA, expiration date 16-MAR-2013, dose no. not reported), 0.5 ml, subcutaneous in the left leg. The reporter stated child was vaccinated with expired (Merck) PROQUAD. No adverse effects reported. No other information provided. Additional information has been requested.
My adverse event started on 01/2022 in mid day. I had severe headaches which then progress to migraines. I started experiencing migraines after my 3rd dose. As of today I am experiencing vertigo and migraines. I went to the hospital and emergency room few times regarding this problem. I have a follow up with my doctor today at 2:00PM. I also went to a Neurologist on 01/18/2023 at 10:00AM they did MRI where it showed some spots but I had no cancerous cells. They are not sure what it is. I also did a CT which was good. My doctor and my Neurologist prescribed me with meclizine, ZOFRAN, IMITREX, and ADVIL, for my vertigo and migraines. I also took over the counter DOLOVENT. They just prescribed me with a new medication called NURTEC ODT I haven't started yet.
arm soon became sore; Felt weak; Ache; my arm was squeezed/pinched; This is a spontaneous report from a contactable consumer (Patient, Self-reported). A 71-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date was not provided) via an unspecified route of administration as a single dose for COVID-19 immunization. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), first dose (lot number: EL9261 and expiry date: not provided), via an unspecified route of administration, in Arm Left, on 30Jan2021, 01:15 PM as a single dose for COVID-19 immunization. The patient experienced felt weak, arm soon became sore, ache and my arm was squeezed/pinched. The patient said that, his second dose was as expected. Administered by the same nurse as the first. He was very much felt the needle. It was somewhat painful. His arm soon became sore and was sore for about two days. he felt weak and aching all over like he was getting the flue. he felt fine after one day. At that point he questioned whether he actually got the first injection. At both events he told the nurse my arm is so small that a needle inserted too far would hit the bone. The second injection my arm was squeezed/pinched for the injection, not so on the first. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
This spontaneous report was received from a pharmacist refers to a currently 60 years old female patient. The patient's concurrent condition included asthma and diabetes mellitus. The patient's medical history and concomitant therapies were not reported. On 22-APR-2017, the patient was vaccinated with ZOSTAVAX 19400 PFU, 0.65 ml, subcutaneously, with a lot # of M019645 and 18-JUL-2017 (anatomical place of vaccination was not provided), for prophylaxis.  Other suspect therapies included sterile diluent which had a lot # reported as "N003193", an expiration date of 02-JUL-2019. Approximately in April 2017, the patient developed swelling and redness near the injection site. No rash was reported. Therefore, the patient seek for medical attention by calling the pharmacist. Nevertheless, no treatment was provided for the adverse events. At the time of reporting, the patient did not recover from injection site swelling and injection site erythema. The reporter did not provide a causality assessment between ZOSTAVAX, sterile diluent and the events. Additional information has been requested.
The morning after I received the injection,  my elbow on my left arm was extremely swollen and painful.  by the end of the day my entire elbow was dark purple/black which spread down to my lower arm.
COVID positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID positive) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     no medical history was reported by reporter.  Concomitant products included METOPROLOL SUCCINATE (TOPROL), HCTZ, VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID positive). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID positive) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, SARS-CoV-2 test: positive (Positive) tested positive for covid.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medicines include Steroid, antibiotic, inhaler
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No information about medical history concurrent conditions and concomitant medications was reported. On an unknown date the patient was vaccinated with ZOSTAVAX (frequency, route, indication, dose strength was not reported) and the patient developed red area at the injection site that was warm to touch and persistent the next day. The reporter stated that patient informed that she did not have rash and believe that reaction is still present. The outcome of red area at the injection site and warm to touch was reported as not recovered/not resolved. No product quality complaint was involved. Additional information is not expected.
Initial information received on 22-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to 2019SA056156 and 2019SA056122 (same reporter). This case involves a 18 years old female patient (also reported as 18 year 7 months) who received a 0.5ml single dose of vaccine FLUZONE QUADRIVALENT prefilled syringes batch number: LB549, expiry date- 30-Jun-2019 via intramuscular route in unknown administration site on 11-Jan-2019. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included was TRUMENBA. It was an actual medication error due to incorrect product storage. (FLUZONE QUADRIVALENT had temperature excursion in Jan2019). No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. Follow-up information received on 25-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. No new information was reported. List of documents held by sender: none.
Chills 2nd day:  Sciatica seizing up hips area. Joint pain in both knees
Painful swelling and redness to area of injection the next day. Area stayed red for 3 weeks.
Burning sensation similar to neuropathy in hands and toes, facial burning, burning at injectionsite and burning in the neck. The sensation spread from left to right across the chest .  Complaint of immediate lathery  and difficulty concentrating and focusing to answer questions in the ER.
Pt given 2nd dose of Engerix-B one month p/first; Six months later (recently) given third dose; M.D. did not seroconvert p/the third dose.
Fever of 100.7; throbbing Sinuses; severe Headache; generalized Achiness/Soreness; injection site Soreness; Myalgia; This case was reported by a consumer and described the occurrence of injection site pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd December 2020, the patient received the 2nd dose of Shingrix (intramuscular). In December 2020, less than a week after receiving Shingrix, the patient experienced myalgia. On 23rd December 2020, the patient experienced injection site pain, fever, sinus pain, headache and generalized aching. On an unknown date, the outcome of the injection site pain, myalgia, fever, sinus pain, headache and generalized aching were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, myalgia, fever, sinus pain, headache and generalized aching to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix intramuscularly on left arm and had severe headache, throbbing Sinuses, fever of 100.7, generalized achiness, and injection site soreness that started the day of the vaccine and continued. The reporter consented to follow up. All information was not available.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date during 2006, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-JUN-2016, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Child went to school after shots. School nurse states lips puffy, temp 101. tired, flushed and wheezing. Symptoms resolved by end of school day.
Received 1st dose, 02/27/2020. Received  2nd dose: 02/12/2021. I noticed moderate worsening of tinnitus a few(3 maybe) after 2nd dose.  I have inquired with an ENT doctor whom I work with about being worked up about condition. I'm working in state for summer and hope to have an appointment in the fall some time.  I wanted to let CDC know about the symptom in case others have noticed it as well.  It's a difficult symptom to make a definitive diagnosis. But I have definately noticed an increase in the tinnitus. Wonder if the vaccine could play a role.
Tested positive for Covid-19; Tested positive for Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL8982), in left arm, on 19Feb2021 as dose 2, single (Lot number: EL9266), in left arm, on 29Sep2021 as dose 3 (booster), single (Lot number: 301458A), in left arm and on 18Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing); "dystonia" (unspecified if ongoing); "Known allergies: Sulfas" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jun2022, outcome "unknown" and all described as "Tested positive for Covid-19 ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jun2022) Positive; (21Jun2022) Negative; (26Jun2022) Positive; (03Jul2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Rebound Covid-19. Tested positive for Covid-19 on Wed 15Jun and started Paxlovid same day. Tested negative on 21Jun. Tested positive on 26Jun after bronchitis-like cough. 03Jul tested negative (still had cough). No treatment received for rebound Covid-19.
After receiving the Moderna vaccine the patient was observed in the monitoring area (he was designated 30 minute in pre screening).  He complained of fainting symptoms and described past similar episodes related to vasovagal type stimulus (IV insertion) as well as panic attacks.  The patient was placed supine, vitals signs were monitored and IV normal saline bolus administered by on site paramedics.  The patient rapidly improved and refused transport and further care against medical advice.  He was advised to seek immediate medical evaluation at a hospital and advise his physician and he was picked up by another party and di not drive.
Vaccine administer after the 12 hours recommended by CDC and 24 hours after the manufacturer stability.
last night at work i experienced extreme sleepiness, but thought it was just lack of sleep after shot before returning to work as i only got four hours of sleep yesterday, also was cold, but thought that was just because of the weather.  slept all day today, but when woke up this evening to prepare for work, experienced chills when i got out of bed, then in the bathroom, i experienced dizziness and weakness, and moderately loose stool. sat on the floor for a little while, while regaining my composure, then went back to the bedroom and called in to work that i would not be coming in. have been experiencing chilling. weakness went away, chilling lasted longer.  was told that some other people called in today due to symptoms from same shot
joint pain and I'm talking about hand pain foot pain; joint pain and I'm talking about hand pain foot pain; joint pain and I'm talking about hand pain foot pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "joint pain and I'm talking about hand pain foot pain".  Additional information: I received the Pfizer vaccine sometime in March. Since then I haven't felt myself physically. (withheld) just tired and now I have some latent joint pain that I can't explain I'd like to know a little more about your vaccine can you let me know what's in the ingredients (see subsequent REQ for handling of ingredients inquiry) and is joint pain and I'm talking about hand pain foot pain etc as part of the list of side effects  The lot number for bnt162b2 was not provided and will be requested during follow up.
"Moderna COVID-19 Vaccine  Symptoms:  chills, Fever 101, joint pain, headache, loose stools
Fever, fatigue, headache, nausea....flu like symptoms  lasting day 3.
feeling achy, sore in neck, lt arm swollen, red & warm @ shot site;this started 4-5 days p/shot & lasted 4-5 days;(not sure of date of onset);PS neck sore & stiff, hard to hold head up;
body aches; heat/pain at injection site; nausea; skin sensitivity; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Mar2021 (Lot number: Unknown) as DOSE 1,SINGLE for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN (non-serious) with onset Mar2021, outcome "recovering", described as "body aches"; VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "recovering", described as "heat/pain at injection site"; NAUSEA (non-serious) with onset Mar2021, outcome "recovering", described as "nausea"; HYPERAESTHESIA (non-serious) with onset Mar2021, outcome "recovering", described as "skin sensitivity".  Additional Information: Pfizer has permission to contact you about this report. Pfizer does not have permission to contact your/the patient's healthcare provider about this report. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Unknown if treatment received for the adverse event. Prior to vaccination, Unknown if the patient diagnosed with COVID-19.Since the vaccination, Unknown if the patient been tested for COVID-19.  Follow-up (06Apr2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of below mentioned query. The response included: Please provide a response to the below request as soon as possible so the regulatory compliance of AE reporting could be met. The Pfizer US Drug safety unit recently received the attached report submitted by you via Pfizer safety reporting.com. Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events. Also, Is patient report this event to you?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Cluster of 5 adult patients (no individual patient identification provided) had 6-7 cm redness with 2-3 cm "knot" under skin at the injection site after intramuscularly receiving Adacel (lot number and date of administration not reported), received from a nurse on 31 July 2007. The vaccine was given as a 5 year booster. It was reported that a 23 gauge 1 inch needle was used.
This is an incorrect vaccine error. Patient signed up for the Moderna Bivalent pediatric dose and received the pediatric monovalent series. Patient did experience fever and missed 1 day of school due to it.
Possible that patient did not received full 0.5 ml dose of vaccine, due to draw up issue.
Immediate pain, decreased range of motion. Attended physical therapy for approx 6 weeks w/little improvement. Cortisone injection x 2.
Pfizer-BioNtech Covid-19 Vaccine. Patient reported dizziness, headache, and lightheadedness right after receiving the vaccine. He had to lie down for 20 minutes to recover from this symptom.
Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: sore throat-Severe, Systemic: Weakness-Severe, Additional Details: Pt has been having these symptoms since he has received the J&J vaccine. Pt's mother called the pharmacy 4 days after he has gotten the vaccine, stating pt's symptoms are worse. Recommended to take him to the hospital for a check-up. Tried calling the patient but lost follow-up.
many people who got the shot and got shingles/Suspected vaccination failure; Got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: many people who got the shot and got shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2023 This case was reported by a consumer via interactive digital media. The shingles shot did not work if you got the shingles shot, you would get shingles or very sick after the shingles shot.  The reporter knew many people who got the shot and got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.