chrisvoncsefalvay/vaers-outcomes huggingface dataset:
suspected COVID-19 with symptoms; suspected COVID-19 with symptoms; sore arm; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-Sponsored Program. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) via an unspecified route of administration on 01Feb2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter stated that she "had a sore arm, and today she was experiencing all the symptoms of COVID-19". The clinical outcomes of the events sore arm and suspected COVID-19 with symptoms were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
44-year-old afebrile female patient presents in nontachycardic state with elevated blood pressure for evaluation of possible COVID-19 Johnson & Johnson vaccine related side effects. Patient reports that after her J&J COVID-19 vaccination within 8 hours she developed pain and redness at the site.  She then had a severe headache for 2 days.  That became less severe moderate headache which is persistent.  She reports fever at home to a T-max of 100.8 oral assessment.  She has had extreme fatigue, body wide muscle pain severe low back and pelvic pain.  Abdominal cramping on days 3 4 and 5.  She also is experiencing unexpected early menses. And she reports severe "brain fog " unexpected and early menses
Employee calling to report a reaction after receiving a COVID-19 vaccine.  Vaccine Name -  Pfizer Vaccine Date - ?  08/04/2021 Is this your first or second dose-2nd  Date of symptom onset - ? 08/04/2021 Symptoms - ? Weakness, nausea, headache, cough and sore throat Last day of work and shift - ? 08/04/2021 Home remedies-Advil extra strength 500 mg x 2 tabs Any improvement-"Not really" Recommendation-Keep taking Advil or tylenol or ibuprofen per package instructions; the headache, nausea and weakness are normal side effects of the vaccine; advised her to call if symptoms worsen or new symptoms develop Employee voiced understanding Employee of information ? Yes  Employee voiced any concerns ? No  Employee?s questions answered to employee?s satisfaction -Yes
Abdominal pain, diarrhea, fever, nausea and vomiting. This all has been intermittently happening for over two weeks now.
Patient was given monovalent Pfizer instead of bivalent Pfizer by MA mistake. no adverse reaction was reported
Duplicate report in system is U19990799. It was reported that a 40-year-old female received vax on 09/29/1999. Approximately 10 minutes post vax, the pt experienced an acute anaphylactic reaction. She was treated in the office and went home. Additional information received 10/04/99 includes pt information, timing of events, illness at time of vax and responsible physician information. It was reported that she received vax and within 20 minutes experienced 'throat swelling, swelling lips, horse voice, shaky (shakiness) and shortness of breath.' Pt received 9% NS IV, Benadryl 50mg, oxygen, Epi .4, breathing treatment of Albuterol and Solu-Medrol 125mg. Pt recovered completely.
there was a red dot at the vaccination site, it then turned into a scab that is still there.
The shot was quadrivalent preservative free which I don't see on the list above. Within 20 minutes of the shot I felt a warm flush come over my body and I felt light headed and swimmy in my head.  I have had panic attacks before and this felt much different. I was not nervous in the Dr office and do not mind shots. I was very tired after I drove home feeling like this after the reaction. I noticed anxiety after the reaction seemed much worse than usual. I had heart arrhythmia event on October 18th. After the initial reaction on October 2, I called primary care Dr and cardiologist. After about 6 weeks, anxiety and exhaustion are improving a little. It all started within about 20 minutes of getting the shot.
THE PATIENT WOKE UP A MONTH AFTER VACCINATION & COULDN'T SEE OUT OF LEFT EYE, SHE WAS SEEN BY OPHTHAMOLOGIST & WAS TOLD THAT SHE HAD A MILD STROKE THAT PROBABLY ORIGINATED FROM A THROMBUS IN THE CAROTID
Red lump at site, sick to stomach Sunday, body aches, nasal congestion; headaches
patient received his first GARDASIL 9 (lot N004798 & 10/31/19) on 6/29/2017 and the second GARDASIL 9 (lot 1602283 & 8/16/21) on 6/17/2019; No adverse effect reported; The office did not have any GARDASIL 9 in stock; This spontaneous report was received from a nurse referring to a 14 years old male patient. Information about concurrent condition, concomitant medication and medical history was not provided.   On 29-JUN-2017 the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # N004798, expiration date 31-OCT-2019; strength, dose and route were not reported) for prophylaxis. On 17-JUN-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1602283 expiration date reported as 16-AUG-2021, but upon internal validation established as 18-AUG-2021; strength, dose and route were not reported) for prophylaxis (inappropriate schedule of product administration). In 2018 when the patient was at the age of 14, the office did not have any hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) in stock.  The outcome of product availability issue was unknown. The causality assessment was not provided.
He received the covid vaccine. He did not have any complications, other than some joint pain.; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced some joint pain. The patient stated he did not have any complications, other than some joint pain. The outcome of event was unknown.  Information on the lot/batch number has been requested.
A continuous pain feeling in the center of chest. Chest area also had a somewhat constricted and general tightness feeling. On the 3rd-5th days after the shot, had a few brief periods of dizziness and high anxiety, lasting less than a minute or so each. Symptoms improved pretty quickly from there, and by about day 7 or so the chest pain was gone and felt completely back to normal. No significant fatigue, fever, or problems breathing at any point. Have not had any symptoms at all since.
Patient had a fainting episode and urinated herself at about 4:45pm. We layed patient down took vitals once patient was stable we lifted her up to the sitting position and gave her some juice to drink. This was about 4:55pm.
No additional AE information; HCP (nurse) called to report TE for VARIVAX (lot: W031813 expiration: 10/05/2024) that occurred on 05/11/2023 but she was not made aware until today (06/26/2023).  The product was stored at 10.8F for 8 hours, 23 minutes and 0 seconds with; This spontaneous report was received from a Nurse and refers to a 5-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On 05-JUN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #W031813, expiration date: 05-OCT-2024, administered for prophylaxis (anatomical location, strength, and route of administration were not provided). The product was stored at 10.8F for 8 hours, 23 minutes and 0 seconds with a supported temperature excursion (TE) stability evaluation. There were no any previous excursions. No adverse outcomes or side effects were reported.  This is one of the nine reports from the same reporter.; Sender's Comments:  US-009507513-2306USA012702: US-009507513-2306USA012560: US-009507513-2306USA012315: US-009507513-2306USA012318: US-009507513-2306USA012351: US-009507513-2306USA012355: US-009507513-2306USA012732: US-009507513-2306USA012753:
5.5 x 5.5 cm area of redness & induration 2 days p/immun, t99.5, lt thigh exam shows local rxn;
Moderna COVID-19 vaccine EUA.  Approximately 10 hours after the vaccine, severe chills, fever, headache and inability to sleep.  The symptoms subsided approximately 18 hours after onset.
Nerve pain from right upper arm to fingers; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received the second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) at 11:00AM 12Jan2021 at right arm for COVID-19 immunisation. The first dose was received on 23Dec2020 10:30 AM at right arm. The patient had no medical history, no known allergies and had no Covid-19 before vaccination. The patient had not received other medications in two weeks and no vaccine received in four weeks. At 11:15 AM after the second dose, the patient experienced nerve pain from right upper arm to fingers. Pain was with usage of hand and fingers. Patient had not received treatment for the event. The patient had not tested after vaccination. The event was resolving at the time of reporting.  The reporter considered that the event was non-serious.   No follow-up attempts are possible. Information on lot number, batch number could not be obtained.
pt recv vax & exp local rxn-erythema, induration lt arm elbow to shoulder;
Ischemic Stroke 21Nov2021; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Oct2021 13:00 (Lot number: FF2589) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Crohn''s Disease" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Doxycycline, reaction(s): "Allergy_Doxycycline". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FF2589, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 26Sep2021, when the patient was 48 years old, for Covid-19 immunization. The following information was reported: ISCHAEMIC STROKE (medically significant) with onset 21Nov2021 11:30, outcome "recovering", described as "Ischemic Stroke 21Nov2021". The event "ischemic stroke 21nov2021" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of ischaemic stroke.  Clinical Course: The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had tested since the vaccination.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available, the causal relationship between the reported event and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Nausea, Vomiting, and chills beginning on 11/16 and remaining for 4 days. Headache beginning on 11/17 and progressing toward migraine symptoms. Visited an eye doctor and was diagnosed with ocular migraines. Experienced them daily for three weeks, then 2 to 3 times weekly thereafter. Still experiencing them. Ophthalmologist educated on early warning and prevention of ocular migraines.
pt stated she had developed a rash over entire stomach area and bottom of both feet were itching after of hours of getting the Shingles Vax.   Pt stated she was very sick and said she had a case of the shingles.
About 14.5 hours after injection, I began to experience chills, some shivering, and some muscle aches.  I took some generic Tylenol and got under the blankets.  Symptoms subsided after a couple of hours.
Patient called 2 days post-immunization to report warmth, redness, swelling and a mild rash.
24 hours after receiving the flu shot, I had difficulty breathing, tightness in the throat and chest, itching, and a rash on the left arm.  I went to a local Patient First, where I received a shot to stop the itching, and a shot of steriods for the breathing difficulties.  In addition, I was given a 6 day steriod pack to take beginning on 11/2/06.  The flu shot was received on 10/31/06 at appox noon, the reactions begin on 11/01/06 at appox 5 PM.
Developed faint unrasised rash to trunk within 5 minutes of vaccination v/o from NP to adm 1 tsp Benadryl po No other symtpoms
Pain, redness and warmth at injection site. Feeling achy, tired and maybe feverish. All was back to normal in 36 to 48 hours.
patient came in for second dose of vaccine, the pfizer pediatric was taken out by a technician and when I the pharmacist got to it, I forgot to dilute the vial and gave the child 0.2ml of the non diluted vaccine. patient waited 15 min and left and I did not notice until they were gone that the vial was not diluted. called the patients mother she said he was doing fine. we called pfizer before and they informed us that there could be systemic reaction which i told the mother about and informed her if she could please call us with an update tomorrow.
This case was reported by a nurse via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, chills and injection site pain. On an unknown date, the outcome of the fever, chills and injection site pain were recovered/resolved. It was unknown if the reporter considered the fever, chills and injection site pain to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The case was reported by the registered nurse for herself. The patient had fever, chills and the site was painful when pressed. Lot and expiration date was not available. The patient informed that the 2nd dose of SHINGRIX had her a worst reaction that the 1st dose that was fever, chills and painful when pressed. For tolerance refer case US2018211886.
Chest tightness; hard to breathe; Vomiting; This is a spontaneous report from a contactable consumer. A 23-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in Arm Left on 25Feb2021 11:00 (Batch/Lot Number: EL3247) as single dose, for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported.  The patient previously took codeine and experienced drug hypersensitivity. Patient received first dose of bnt162b2 for covid-19 immunisation on 04Feb2021 01:00 PM (Lot number: EL3247) in left arm. On 26Feb2021 01:45 AM, patient experienced chest tightness to the point it was hard to breathe and vomiting also occurred. Outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  Patient age was reported as 30 years and 1 months.   It was reported that vaccine was administered beyond use date to patients. There was no adverse reaction noted or reported regarding these administrations. Vaccine number 1 NDC code was reported.  No treatment drug information was provided.
I have soreness and sharp pain in the left arm- this is the arm that the shot was given
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I am writing to you during the 90-day comment period on the anthrax vaccine. My husband is fighting overseas right now and yet he doesn't have the freedom to say no to the anthrax vaccine. As I've been reading about the anthrax vaccine and AVIP, some of the symptoms and diagnosis are frightening me, because my husband is already suffering from these symptoms. After three anthrax vaccines, he suddenly has headaches that incapacitate him. He never used to get headaches. These headaches are so bad that when he called the other night, he was only able to talk for a minute. Because of the headache, he was unable to eat that day. As a wife and a mother, I am very concerned about the anthrax vaccine. If this problem is effecting my family, then it most be effecting someone else's family. Maybe they aren't so lucky. Maybe its worse than bad headaches for them.
This spontaneous report as received from a medical assistant (other health professional) refers to unspecified number of patients of unknown age. Pertinent medical histories and concomitant medications were not reported. On an unknown date in April 2017, the patient was vaccinated with improperly stored PEDVAXHIB, 1 DF Intramuscular injection for prophylaxis (incorrect product storage). Temperature excursion 32 to 35 degree Fahrenheit for 5 minutes and 47 to 77 Fahrenheit for 17 minutes. No adverse reactions (no adverse event) per primary reporter. NO further information to report. This is one of the several reports from same reporter. Additional information has been requested.
After 1st shot had ache and pains. Had 2nd shot feb 11, 2021. 3 days later went in the hospital with a fib
Pt was nervous about getting the COVID-19 IMZ. After the shot she was sitting next to her mom and told her she was feeling thirsty.  Her mom then put her arm around the patient who then fainted.  The mom held her up and gently laid her on the floor and raised her legs up on the chair.  I got the patient a bottle of water and the color came back into her face.  She laid on the floor for about 15 minutes and then waited another 15 minutes after that and was feeling fine after that and she went home with her mom.
I got the shot at 5PM and at 2:00Am I had a fever of 104degrees My blood pressure was high, and my heart rate was elevated. I was taken by ambulance and they monitored me and gave me Tylenol. I was discharged after four hours. The fever was down, and my blood pressure was normal. I had been having a headache and chill the evening of the vaccination.  I still had a headache for three days.
Immediately following injection, patient became non-verbal and started shaking. (4:55 pm), Patient did not loose consciousness but was moved to the floor (mother had brought blanket for patient to lie on in case something like this happened as she expected). (5:00 pm). Ice pack applied to injection site at this time. Patient remained on floor lying down for 10-15 minutes before sitting up. Patient moved to chair at 5:20 and left with mother on his own legs.
Took both Shingrix last year, got a mild case of Shingles this year (a year later)/suspected vaccination failure; Got a mild case of Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 1 year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 03-Sept-2022 Reporter's comment: The case was received from the patient via  interactive digital media. The patient took both Shingrix vaccinations (shots) last year (in 2021) and got a mild case of shingles this year (a year later). Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Moderna COVID-19 Vaccine EUA- Patient is 12 years of age and received 0.5mL dose. This was his first COVID-19 vaccination.
2nd dose two weeks after 1st dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number KK3KM, expiry date 25th September 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 17th November 2022, the patient received the 2nd dose of Shingrix. On 17th November 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional Information: GSK Receipt Date: 17-NOV-2022 Reporter's Comments: A pharmacist reported that a female patient received the 2nd dose of shingrix only two weeks after the 1st dose. The patient received 1st dose either in October or November 2022. The reporter did not consent to follow-up. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Developed (L) arm swelling and redness on 9/20 - 9/20. Vaccine was given on 9/19. Pt ordered Triamcinolone tropical cream 2 times a day.
Pt came back to pharmacy on 9/15 complaining of tightness and pain in his right arm. Also was concerned with the "heat" in his arm. He said he only slept about 1.5 hours the night he had the injection.
Tired within a couple of hours of injection. Injection site became red, warm and sensitive the following morning (about 3.5? x 2?) on left arm.
Patient claimed that the vaccine was injected by the pharmacist at the back of the shoulder close to the joint  and he experienced pain afterwards.