chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was on my first vacation in three years because of COVID-19. We went out of country on 02/11/2023 using a very small airport. I believe that is where I was exposed. On the third day of our vacation, I was swimming in the pool and noticed pain in my shoulders and I just didn't feel right. I also noticed a large amount of swelling in my stomach. I didn't have any fever or any other symptoms other than being a little stiff. We went home that Saturday, using that very small airport that was very crowded. We were double masked the entire travel time. On Sunday, my wife didn't feel well, but she attributed it to travel. She tested positive for COVID-19 the next day. I then tested positive on Tuesday. We already had prescriptions for Paxlovid and antibiotics in preparation for our travel, so we began taking that. The first day we took it, it was fine, but the next day, I felt awful. My wife called our doctor and they advised that we go directly to the emergency room. I must have been a little out of it, because I don't remember a lot of the events. I do remember that I was having intestinal issues and I vomited around five times. I don't remember everything they did at the hospital, but I did vomit quite a lot more. They could not find me a room for admission, so they sent me to the ICU. I didn't eat or drink for three days. While I was there, I had a CAT Scan and an MRI, and an X-Ray, among other things. They were unsure of my results of everything. They hooked me up to a vacuum cleaner on the wall and it seemed like everything I ate on vacation came out. They were afraid that I had some sort of esophageal bleed because I had a red tone in my vomit. I stayed there through Monday, and they still don't know what is exactly wrong. They put me on a bland diet with no fiber. I'm still having bowel issues. I've been to my doctor twice since being discharged and all of my vitals look great. The only thing that is really still bothering me is my lack of strength from these events. I can't do more than a few things every day before needing a two-hour nap. I'm normally a walker and would walk 3-4 miles a day and haven't been able to do that since these events. My doctor has asked me to start working one food item a day back into my diet and to begin walking again. I am up to 2 miles a day, but I am very tired great.
That same day the patient also received GlaxoSmithKline's SHINGRIX vaccine (Lot # 3Z4KL) in her left deltoid and the original order of PPD (Lot # C5471AA, manufacturer unknown) in her left forearm.  On March 23, 2018, 2 days post-Td administration, the patient was seen at the same facility for interpretation of the TB-PPD skin test and it was confirmed that she did not experience any adverse reactions after Td administration. The reporter indicated that the drug administration error occurred due to a misunderstanding between the nurse and the pharmacist. The nurse requested "PPD, TB" but the pharmacist misunderstood and thought "Td" was ordered. The nurse then did not confirm that the vial provided by the pharmacist was PPD and subsequently administered Td to the patient.; Sender's Comments: This medication error was assessed as non-serious.  The Td vaccine was administered instead of PPD as a PPD skin test. MassBiologics sent a letter containing information regarding this event to the manufacturer of SHINGRIX, GlaxoSmithKline, on May 31, 2018.
This is a spontaneous report from a contactable consumer (patient herself). A female patient, of an unspecified age, received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, Aug 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Patient is calling regarding the Pfizer COVID-19 vaccine. Reportedly, she got the COVID-19 vaccine last Friday. On Aug 19, 2021, patient experienced right leg pain. Since yesterday, she has been having right leg pain. She questioned if she was supposed to go to the hospital. The outcome of the events: not recovered. The lot number for the vaccine, (BNT162B2), not provided and will be requested during follow-up. Follow-up (Oct 1, 2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Initial unsolicited report received from other non-healthcare professional on 20 October 2016. This case involves a 71-year-old male patient who was vaccinated with dose of FLUZONE QIV (batch number: UT5673KA, expiry date: 30 June 2017) intramuscularly in left deltoid on 04 October 2016. Patient's Illness at time of vaccination: none as per reporter and pre-existing physician diagnosed allergies, birth defects, medical conditions includes: Allergies: no known drug allergies as per reporter. Concomitant medication was reported as none. On 04 October 2016, same day following vaccination patient experienced shoulder pain radiating to shoulder blade since received vaccination that continued till (20 October 2016) and it was painful upon movement of the arm. Laboratory data and corrective treatment were not reported. Patient was not recovered from the events. Documents held by sender: none.
Widespread eczema rash started 3 days after the vaccination. Still bothers patient with itching and rash at 6 weeks. Treated with prednisone and topical steroid ointment.
Neck in front began itching, noticed a rash, call Health Dept, was seen by nurse. Applied Cortisone cream to area.
Information has been received from a nurse concerning a 12 year old male with asthma and no allergies who on 25-MAY-1999 was vaccinated SQ with the first dose of VARIVAX (Merck), and the second of VARIVAX (Merck) (lot # 666817/0002Z) on 04-AUG-2010 into the left arm. Concomitant therapy included ADVAIR and albuterol. On 06-AUG-2010 the patient presented with a 3 inch reddened, extremely warm, painful area at the site of injection. There were no laboratory studies performed. KEFLEX 500 mg twice a day was prescribed. The patient had not yet been seen for follow-up (also reported the patient sought unspecified medical attention). At the time of report, the patient's outcome was unknown. Additional information has been requested.
exacerbation of chronic graft versus host disease; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "haematopoietic stem cell transplantation (HSCT)" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19  vaccine (manufacturer unknown, Dose 1), for COVID-19 immunisation. The following information was reported: CHRONIC GRAFT VERSUS HOST DISEASE (medically significant), outcome "unknown", described as "exacerbation of chronic graft versus host disease".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event: "Chronic graft versus host disease" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.,Linked Report(s) : US-PFIZER INC-202200611693 Same reporter/product/event, different patient
Parasthesias, radiculoneuropathy, burning sensation in back.  All symptoms began the day after vaccine administration. ? Guillain Barre Syndrome.
Patient noticed after the first vaccine about 2 weeks later red spots appeared. The spots became darker. The spot was about the size of a quarter. It appeared on the side of her arm. 3 weeks after the second vaccine a red spot appeared under her breast. The spot had  a white center and was the size of an orange.  The spots never itched or burned. The Dr prescribed a cream and it helped a lot. The Dr said that she had a reaction to the vaccine.
Arm sore for over a week. She could not lift her arm for a week. A week after the injection developed sore throat, body aches, chills, headache, nonproductive cough, sinus pressure and pain.
Information has been received on 04-JAN-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2015, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In 2016, the patient was treated by a physician at a clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
Patient fully vaccinated (Moderna), but not boosted, admitted to the hospital on 1/10/2022 with COVID-19 and associated hypoxia. Patient was discharged on 1/13/2022.
Patient had coffee in the nothing by mouth duration; A spontaneous report was received from a nurse practitioner on 03NOV2022. It described a 41-year-old male patient who "had coffee in the nothing by mouth duration" (PT: Wrong technique in product usage process). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient consumed coffee during the duration after administering a dose of Vivotif but could not confirm the timeframe of when he had coffee after taking Vivotif. Additionally, it was reported that the patient completed the course of Vivotif on 27OCT2022 and did not experience any side effects. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a patient had coffee in the nothing by mouth duration (wrong technique in product usage process). Considering the nature of the event, the causality of wrong technique in product usage process is assessed as not applicable to Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a patient had coffee in the nothing by mouth duration (wrong technique in product usage process). Considering the nature of the event, the causality of wrong technique in product usage process is assessed as not applicable to Vivotif. The case is considered non-serious as per medical assessment.
This case was reported by a other health professional via call center representative and described the occurrence of fever in a 55-year-old female patient who received SHINGRIX (batch number M77B4, expiry date 8th February 2021) for prophylaxis. On 31st August 2018, the patient received SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced fever, erythema of extremities, skin warm and welts. The patient was treated with ibuprofen and Acetaminophen. On an unknown date, the outcome of the fever, erythema of extremities, skin warm and welts were unchanged. It was unknown if the reporter considered the fever, erythema of extremities, skin warm and welts to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on an unknown arm. The healthcare professional who was also the patient reported that she developed a larger than golf-ball sized red, hot to the touch welt on her arm after receiving a dose of SHINGRIX. The patient also reported that she had a consistent fever with max temp of 102 (F) which had been controlled with the administration of ibuprofen and acetaminophen. No further information reported regarding the adverse reaction.
Pt received 4th anthrax injection, felt nauseated 30 minutes afterward and went to sleep. She did not take any meds for it. She woke up the next day, nauseated, this time vomiting to the point of dry heaves. She reports that was 6 hours after her injection. The symptoms eventually went away on their own. No meds were administered.
thigh muscle weakness / something strange/e had something strange happen to his fingers unable to move his thumb; got worse/Before vaccine he had some thigh muscle weakness which got worse; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (thigh muscle weakness / something strange/e had something strange happen to his fingers unable to move his thumb) and CONDITION AGGRAVATED (got worse/Before vaccine he had some thigh muscle weakness which got worse) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Muscle weakness (muscle weakness of thigh.).    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 MUSCULAR WEAKNESS (thigh muscle weakness / something strange/e had something strange happen to his fingers unable to move his thumb) and CONDITION AGGRAVATED (got worse/Before vaccine he had some thigh muscle weakness which got worse). At the time of the report, MUSCULAR WEAKNESS (thigh muscle weakness / something strange/e had something strange happen to his fingers unable to move his thumb) and CONDITION AGGRAVATED (got worse/Before vaccine he had some thigh muscle weakness which got worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       after 2 wees of vaccine patient had something strange happen to his fingers and  unable to move his thumb. Before vaccine he had some thigh muscle weakness which got worse,  leg muscle got worse after his second dose and they diagnosed him with ALS.  no concomitant medications are provided. treatment to the events not provided.   This case was linked to MOD-2021-240745 (Patient Link).
Patient received first Gardasil vaccine on 3/7/07 and second Gardasil vaccine on 5/9/07.  Patient developed a DVT in the right upper extremity subclavian and axillary veins on 6/23/07.  At the time, she was also on oral contraceptives.  She was subsequently found to have thoracic outlet syndrome in the same extremity. 1/24/08-records received for DC DX: Deep vein thrombosis, right arm. Depression. One day prior to admission noted dull pain in right shoulder, swelling developed of right shoulder and arm, then discoloration of distal arm. Treated with anticoagulant therapy.
Mother reports seizure activity (unresponsive, eyes rolled back, extremities stiff x 3-5mins. Drove to ER, sx resolved mother did not bring into ED.
On the 9th of April about 3:40pm about 10 minutes after the vaccine I felt faint and waived the Doctor over because of my allergy to contrast dye I was in a section of people to be watched but I called my Dr. before the vaccine and he said I could get the vaccine. So I waived someone and they put me on a stretcher and I was in and out of consciousness for around 90 minutes so I fainted and from that point I experienced Alice In Wonderland Syndrome for the next 3-4 weeks. This is something I have since I was a child but I only get it when i have a fever so the difference is that I had no fever and was stuck in Alice In Wonderland mode so it wasn't safe to drive. The next day april 5th and I started having diarrhea and haven't had a regular bowel movement until this day. It hasn't gone away. That day also April 10th I started having breathing problems where my breathing was very shallow and it was the first time i called my Dr and asked for an appointment but at that time there wasn't enough lab work to know what was going on. Later that week around 12/13th I started having extreme fatigue and dizziness with trouble going up and down the stairs and stuck in Alice In Wonderland mode so i fell down a lot. I had trouble walking and walking my dog and started getting migraines without head pain with little lights flashing and circles that expanding, having a lot of those for several weeks but no head pain so it was odd. My last symptom before my second vaccine between 23/26 I started to feel that my limbs were really heavy and I was sleeping a lot and had a really hard time getting up in the morning and short of breath and still tired after sleeping 11 hours and that's when I got my 2nd vaccine.
A pharmacist reported that a 33 year old female received an injection of Flu Shield on 12/6/02. *On 12/7/02,* she developed severe back pain. She was hospitalized on 12/12/02 because of her complaints of severe back pain, severe abdominal pain, and severe headache. She was worked up for "some sort of neurological problem," but as of 12/16/02, were unable to determine the cause of her severe pain. The reporter noted that the pt had neither a fever, nor any local reactions to the vaccine. *She recovered.* No further info was available as of the date of this report. *F/UP report on 2/12/03: Info received from the reporter indicated that the PT recovered and that the first symptom onset was 12/7/02.*
I started having chills, fever, nasal, head congestion, sinus infection and body aches, I used my home COVID-19 test that came back positive. I called my doctor and had a telehealth visit and was prescribed a Z-PAK that I started today, 12/14/2022.
Complaining of shortness of breath; laid back on table and became blue (cyanotic) around mouth and stopped breathing; CPR administered and Epi-pen injected; immediate response. Given epinephrine. Episode lasted approx. 4 minutes, no further incidence.
had the 2 shot-series several years ago; shingles; vaccination failure; This spontaneous report was received from a patient of unknown age and gender reporting on theirself via manufacturer.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) administered as prophylaxis (formulation, dose, strength, lot #, expiry date, and route of administration were not provided). The patient received the dose, then was told it was not good enough, so the patient had the 2 shot-series several years ago (Extra dose administered).  On an unknown date in 2022 (reported as "over the weekend"), the patient developed shingles and "it was miserable" (vaccination failure). The outcome of the events of shingles and vaccination failure were not reported.  The event of vaccination failure was determined to be related to zoster vaccine live (ZOSTAVAX). The causal relationship between shingles and zoster vaccine live (ZOSTAVAX) was not reported.
Received 1st shot on 24Feb and went COVID-19 positive; Received 1st shot on 24Feb and went COVID-19 positive; This is a spontaneous report received from a Pfizer sponsored program from a contactable consumer (wife). A male patient of an unspecified age, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 24Feb2021 as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. On an unknown date in 2021 after receiving the first dose, the patient was COVID-19 positive. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
I felt ok the day after receiving the vaccine. On 12/29/2022 my lymph nodes under my left armpit began to swell and hurt. I used only hot compress to relieve the pain. I had these symptoms for two days.
Broke out in shingles on right side (underarm, trunk) approximately 3 days post vaccine.  This has occurred since 2nd COVID Pfizer vaccine. Outbreak milder but in larger area. Second recurrence of shingles 8/2/2023.
Pain in hand started on Friday then on Saturday was out of town and went to an urgent care there. He had hives, itching and swelling to L hand and abdomen.
Information has been received from a nurse practitioner, concerning a 15 year old female who in "summer 2008", which was in approximately July 2008, was vaccinated with the first dose of GARDASIL (total daily dose and route not reported).  An hour after the first dose of GARDASIL, the patient developed a mild fever of 102F (also reported as the patient was "warm" and fever temperature was not determined).  An hour after the fever started the patient developed a severe headache and dizziness lasting 24 hours and the patient was unable to go to school.  At the time of the report, the patient recovered from mild fever, severe headache and dizziness.  It is not known if the patient sought medical attention.  Additional information has been requested.
12yr old male received first does of Pfizer on 3/17/2021  Mother came back for second does and was advised the minor could not receive the second dose due to Pfizer not having an EUA for minors under the age of 16. Mother's name and phone number were taken and she was advised once Pfizer received the EUA she could bring her son back for the second dose