chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient) reported for herself. A 58-year-old (non-pregnant) female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown, expiry date: not reported), via an unspecified route, in left arm, on May 25, 2021, at 15:00, single dose, for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications not reported. She has no known allergies or health issues. The patient did not receive any other vaccine within four weeks. Other medications within two weeks: none. On Jun 6, 2021, at 03:00, when she walked, she had severe pain in her left knee. She never had any knee pain. On the 15 day, now it was in her right knee. It felt like a band around her knee. When she bent down or got up from a sitting position, she had sharp pain. The sharp pain was only in the left knee. She has not yet gone to the doctor. No COVID-19 prior vaccination. No COVID-19 test post vaccination. Patient received no treatment for the event. The outcome of the events: not recovered. No follow-up attempts possible. No further information expected.
Patient received the following shots (PEDIARIX, PREVNAR #13, Influenza). Cried out on the 1st and 2nd then held his breath for a few seconds on the 3rd (Flu) shot. Skin turn slightly pale. Pt mom said this had happened before when pt was hit with a toy. Treatment - pulse ox checked -> 99-100%; Dr. called in to assess pt. which resulted in longer hospitalization.
sore arm; illness; Initial information received on 09-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced sore arm and illness after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 VACCINE   On an unknown date, the patient received a  dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed sore arm (pain in extremity) and illness(unknown latency) following the administration of INFLUENZA VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (sore arm, illness).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event sore arm and was Unknown for the event illness.
adversve reaction from booster only:  numbness in fingers of both hands. worse in right hand. worse in little finger and finger next to it.  dropping things. have trouble turning lamp switches and opening bottle caps.  etc.  never had these symptoms before.
with post-vaccine diarrhea/rotavirus infection;  Information has been received from the authors in a published literature article titled as stated above concerning to a child patient of unknown age and gender who was enrolled in a study to analyze the group A Rotavirus (RVA) genotype prevalence during consecutive RVA seasons (2014-2016). The patient's pertinent medical history, concurrent conditions, drug allergies/drug reactions and concomitant medications were not reported.       On an unknown date the patient was vaccinated with an unspecified dose (1-3) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), (dose, frequency, Lot # and expiration date not provided) oral for prophylaxis.         On an unspecified date in 2016 (season reported as 01-DEC-2015 through 30-JUN-2016), the patient experienced post-vaccine diarrhea (Rotavirus infection) and was hospitalized. A Rotaclone enzyme immunoassay was performed in 2016 by using stool sample or eluted fecal material from diaper which tested positive for Rotavirus of group A (RVA) and unspecified genotype.  The authors reported the importance of continuous RVA surveillance post-vaccine licensure to identify emergent RVA genotypes and other gastrointestinal pathogens causing Acute Gastroenteritis (AGE) and to guide treatment and intervention strategies.   At the time of the report, the outcome of rotavirus infection was unknown.    The reporting authors considered rotavirus infection to be related to Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ).     A copy of the published article is attached as further documentation of the patient's experience.  This is one of several cases from the same article (US-009507513-2104USA006886, US-009507513-2104USA007699).; Sender's Comments:  US-009507513-2104USA006886: US-009507513-2104USA007699:
Report A0323046A (formerly 2000007830-1) describes vasculitis in a 64 year old male who was vaccinated with Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was initially received from the subject and has not been verified by a physician or other healthcare professional. Follow-up information was received from a lawyer. The subject had no relevant medical history. Concurrent medications included vitamins. On 3/15/00, the subject received his third injection of LYMErix. The reporting lawyer stated that the subject had received an injection of LYMErix during the  summer of 2001. Two hours post-immunization, the subject experienced uncontrollable trembling and his body ached. He called the emergency room and was told he was having an allergic reaction. In addition, the pt reported that "strange results were found on blood work." "HLA-DR4" was positive. He stated that he had the "beginnings of arthritis." The subject was treated with Benadryl. Information received on 6/23/00 reported the arthritis as ongoing but the other events as resolved. On 8/16/02, the lawyer alleged that the subject he experienced "vasculitis, diabetes, short-term memory loss, and a whole list of other conditions" following immunization with LYMErix. As of 8/16/02, the outcomes of the events were unknown. The adverse event "vasculitis" is considered medically serious.
Infant received 1st dose of Rotateq on 8/28/06. Mom noticed blood in 2 stools on 8/30/06. No vomiting, no other sx, infant exam nl.
12 hours of extreme vomiting. Fever n chills. Body aches. Severe headaches in multiple locations in head. Diarrhea for 8 hours. Extreme weakness in legs, difficult to stand or walk. Fatigue.
PATIENT STATED AFTER 20 MINUTES OF RECEIVING THE SHOT HER FEET HAD HIVES ALL OVER THEM.  SHE TOOK SOME BENADRYL THAT NIGHT AND IT GOT BETTER AND USING HYDROCORTISONE CREAM TODAY. SAYS IT IS GETTING MUCH BETTER.
no additionalAE's reported; temperature excursion/ vaccine given to patient; This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date between 29-AUG-2021 and 30-AUG-2021, the temperature excursion of the stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # U002533, expiration date 24-JUL-2022) was 8.7 Fahrenheit degree (F) for a time frame of 19 hours and 12 minutes. There was no previous temperature excursion. On 16-SEP-2021, the patient was vaccinated with an improperly stored 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) albumin status rHA, lot # U002533, expiration date 24-JUL-2022 (route of administration were not reported) for prophylaxis. The patient did not report symptoms after the administration of the vaccine. No additional adverse events were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA003187:
a headache and a backache/tested positive for Covid; a headache and a backache/tested positive for Covid; brain fog; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "a headache and a backache/tested positive for Covid"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "brain fog"; LETHARGY (non-serious), outcome "unknown", described as "lethargy ". The patient has had 2 Pfizer shots and 2 Pfizer boosters and she was supposed to get her third on Sunday but she tested positive for COVID. People mostly have the headache as the sign of this strain of COVID. That is why the patient was suspicious when she work up Saturday with a headache and a backache and Sunday morning as well. Even though the patient took 3 Advil and it lessened the effect she took the test and it was positive for COVID. Those are gone now. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive for Covid; Oxygen saturation: fine throughout. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
unable to do ususal tasks for any length of time; joint pain; body hurt all over; weakness; body aches; headaches; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), HEADACHE (headaches), FATIGUE (fatigued), VACCINATION COMPLICATION (unable to do ususal tasks for any length of time) and PAIN (body hurt all over) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sepsis (Acute illnesses at the time of vaccination and up to one month before:) from 27-Dec-2020 to 08-Jan-2021, Lupus pneumonitis (start date 1998) and Thyroiditis (start date 2000). Concurrent medical conditions included Diabetes (start date 2007) and Lupus erythematosus (Start date 1993). Concomitant products included METFORMIN, LISINOPRIL, ATORVASTATIN, CLONAZEPAM (KLONOPIN), ESCITALOPRAM OXALATE (LEXAPRO), MELOXICAM, FOMEPIZOLE, FAMOTIDINE and PARACETAMOL (TYLENOL) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PAIN (body aches), HEADACHE (headaches), FATIGUE (fatigued), PAIN (body hurt all over) and ASTHENIA (weakness). On an unknown date, the patient experienced VACCINATION COMPLICATION (unable to do ususal tasks for any length of time) and ARTHRALGIA (joint pain). At the time of the report, PAIN (body aches), HEADACHE (headaches), FATIGUE (fatigued), ASTHENIA (weakness) and ARTHRALGIA (joint pain) was resolving and VACCINATION COMPLICATION (unable to do ususal tasks for any length of time) and PAIN (body hurt all over) outcome was unknown.            Treatment medication also includes Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: New event added Joint pain having outcome  recovering. Event fatigue, body aches, headache outcome updated to recovering.
Very high fever, severe headaches, nausea, vomiting - lasted for 16 hours nonstop
pt sibling recv vax APR95 & pt devel varicella;the reporter indicated that this is a possible transmission;
swelling around eyes. itchy hives around eyes, forehead, neck on side and back of neck
Started with hot flashes and feeling  ill. Lead to tingling in legs and insomnia. Shortly after the following symptoms occurred and most have been present for over 8 months.: Muscle Fatigue in arms Sore muscles Burning in arms, back and neck Arm falling alseep nightly Muscle tension in back and shoulders- neck sore Ear fullness/ Pain sporatic tingling in feet - especially when seated or lying down Cold feet  Random muscle twitching throughout the body- twitch moves, no consistent in 1 area HR randomly spikes Exercise intolerance Internal shakes Buzzing feeling in legs and feet Nausea Brain fog Occasional Dizziness Fatigue Blood Pressure Spikes insomnia  - High ANA - Positive Biopsy for Small Fiber Neuropathy - Tachycardia
pt started feeling nauseous/hot/sweaty in the after in waiting area and signaled, bench pharmacist made it to chair and guided him to floor, pt was alert and did not hit head. may have lost consciousness for a few seconds while on the floor. elevated his feet with chair. pt opened eyes and we chatted and did breathing exercises. pt states history of fainting w/ IVs and IMZs in the past. declined offer to call someone for him, stated his people were too far away. called emergency medical and they responded, and checked him over. did not check back in with pharmacy, but emergency medical released him and walked out with him.
Flu like symptoms, aches, fever 99.8 , syncope at 2:30 am when up to bathroom. Reported to MD office today. As of time of writing, still symptomatic.
Redness; Heat; Itching; This non-serious case was reported by a nurse via sales rep and described the occurrence of erythema in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced erythema (Verbatim: Redness), feeling hot (Verbatim: Heat) and pruritus (Verbatim: Itching). The outcome of the erythema, feeling hot and pruritus were not reported.   It was unknown if the reporter considered the erythema, feeling hot and pruritus to be related to Shingrix.     It was unknown if the company considered the erythema, feeling hot and pruritus to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-MAY-2023 The reporter reported that the patient received Shingrix vaccine and experienced redness, heat and itching. The reporter did consent to follow up.
After returning home from the clinic where the vaccines were administered, patient noted the left arm (site of vaccination) became painful, hot, red, and swollen. The patient developed fever (up to 103.8 F) and chills. Diagnosed as cellulitis and treated with antibiotics with improvement.
When I got my Vaccine I watched the man giving it to me pull the needle out of my arm while he was still pushing and it squirted on my arm, went down my arm, and dripped on the floor. I said something to the man that gave me my injection. He tried to say it was the alcohol as he wiped my arm. I told him No it wasn't! I watched him pull the needle out of my arm, while still pushing. I watched the stream come out of the needle, roll down my arm & drop off of my elbow to the floor! The man still tried to say it was the alcohol while he wiped on my arm. This is not true. I am a Registered Medical Assistant and given various injections myself in physician's offices over the years so, I know what I saw and I know %100 I did not receive the full vaccine.  I asked to speak to a supervisor. The supervisor. She took my paper and said she would call me in 4 weeks. She said all they could do is offer to run an antibody test in 4 weeks. This supervisor was not there when I was given the vaccine. She came when I asked for a supervisor.   This is the email I received from CDC help - Your vaccination provider will determine whether more than half of the dose was administered. If you received more than half the dose of a COVID-19 vaccine, you do not need to repeat the dose. If less than half of the dose was administered or the proportion of the dose you received cannot be estimated, you should immediately receive the recommended dose in your opposite arm.     If you received too small of a dose of COVID-19 vaccine, your healthcare provider should report this to the Vaccine Adverse Event Reporting System (VAERS). Healthcare providers are required to report to VAERS any COVID-19 vaccine administration errors,    Which I did not receive anything.  This is the response from the Health Department.  From the supervisor that talked to me the day of the vaccine said - Again, we want to apologize that you had this experience. I have since reached out to the CDC and this is the information they pointed me back to. It is not recommended to perform antibody testing at this time to assess for immunity to COVID-19 following the COVID-19 vaccination because the variable sensitivity of tests. If antibody testing is performed following vaccination, additional doses of the same or different COVID19 vaccines are not recommended based on antibody test results at this time. Unfortunately, they are not recommending any further action at this time. Here is the link to the CDC website for further information.  I would like to know what needs to be done.
Five hours after no reaction to the vaccine chills commenced, nausea, vomiting, loss of appetite and severe muscle weakness; unable to ambulate even with walker; lost control of bowels and bladder functions; fatigue.  Was bedridden for 36 hours .  At about 28 hours upon recommendation from oncologist, took one Benadryl and within 2 hours started to improve.  Took 1 Benadryl every six hours for next 48 hours and was feeling better except for residual whole body weakness.  Would have been helpful to know about Benadryl before hand.  Will take Benadryl 30 minutes prior to getting 2nd shot on March 5.  Thanks.  Hope this information is helpful to others.
2 doses of IPOL were give to two different patients , doses were given on 11Feb2022 and 1Mar2022 with no adverse event; 2 doses of IPOL were give to two different patients, product was no longer viable with no adverse event; Initial information received on 11-Mar-2022 regarding an unsolicited non-valid  non-serious case received from a other health professional.    This case involves two patients of unknown demographics for whom it was reported that 2 doses of ipol were given to two different patients, product was no longer viable with no adverse event and doses were given on 11-Feb-2022 and 01-Mar-2022  with no adverse event while receiving IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Feb-2022 and on 01-Mar 2022, the patients received a dose (Twice Drug Treatment Duration) of suspect IPV (VERO) (dose, strength, formulation, route, administration site: unknown, lot U1C571 expiry date 17-Jun-2023) for Immunization.   On 11-Feb-2022 it was reported that 2 doses of ipol were give to two different patients, product was no longer viable with no adverse event (poor quality product administered) (Latency: same day). On 01-Mar-2022 it was reported that doses were given on 11-Feb-2022 and 01-Mar-2022 (inappropriate schedule of product administration) (Latency:21 days)  Action taken was not applicable.  Outcome: unknown    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Dizziness; Heart palpitation; Hand tremo; Sore; Head felt hot; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PALPITATIONS (Heart palpitation), TREMOR (Hand tremo), PAIN (Sore) and HEAD DISCOMFORT (Head felt hot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history 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 DIZZINESS (Dizziness), PALPITATIONS (Heart palpitation), TREMOR (Hand tremo), PAIN (Sore) and HEAD DISCOMFORT (Head felt hot). At the time of the report, DIZZINESS (Dizziness), PALPITATIONS (Heart palpitation), TREMOR (Hand tremo), PAIN (Sore) and HEAD DISCOMFORT (Head felt hot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Extreme difficulty urinating.   Onset: 7 days after first dose, 24 hours after second dose Duration: 3 days after first dose, 1 day after second dose
medical assistant administering the dose was cut on her hand from the broken edge.; Syringe number one broke at the finger flanges during administration/the dose was cut on her hand from the broken edge; product quality complaint; Syringe number one broke at the finger flanges during administration; THE NEEDLE APPEARED CROOKED; This spontaneous report was received from a pharmacist referring to a female patient of unknown age, who was not pregnant. No concurrent, conditions, medical history or concomitant therapies were provided.  On 18-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route were not provided) for prophylaxis. Lot No. S012245 has been verified to be a valid lot number for [pneumococcal vaccine, polyvalent (23-valent)], expiration date reported as 09-FEB-2021, and upon internal validation established as the same.  On this same date, during the vaccine administration two vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringes out of a carton of ten broke.   The first syringe broke at the finger flanges while using it, but there was no initial crack on the syringe. The finger flanges broke up after the administration of the shot (product quality issue). The medical assistant was administering the dose and was cut on her hand from the broken edge (skin laceration; accidental exposure to product). The patient who received the vaccine reported no adverse effects. There was no difficulty trying to attach the syringe needle to the syringe, but the needle appeared crooked (needle issue). The medical assistant saw the physician and the physician cleaned up the cut and bandaged it. The outcome of skin laceration was reported as resolved on 20-SEP-2019.  The second syringe broke at the luer lock while the medical assistant was sliding the safety tip off of the needle. It was stated that it broke after administration while attempting to put the safety mechanism on after administration. No patient was involved.   The outcome of product quality issue, accidental exposure to product, needle issue and syringe issue was unknown.     The reporter did not provide a causal relationship between the events and the Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23).
2 days after flu vaccine was administered, the area around injection site was swollen, red and hot. Also had streaking of red down her arm and around injection site. Saw physician and started on Keflex