chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the 2nd dose kicked my butt; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date (didn't have much of a reaction with the first one)).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and felt it kicked her buttock. The patient stated that hope the second wasn't so bad. Additional supportive information: The follow-up would not possible, as no contact details were available. This case is linked to the case US2022AMR064636, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR064636:Same Reporter
Late for their second dose of Twinrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) (batch number 4KF75, expiry date 03-JAN-2025) for prophylaxis.   Previously administered products included Twinrix (1st dose received on June 2023).   On 12-SEP-2023, the patient received the 2nd dose of Twinrix. On 12-SEP-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late for their second dose of Twinrix).  The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-SEP-2023 The reporter reported that the patient was late for their second dose of Twinrix vaccine. Patient was traveling overseas. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Patient last got the FLUZONE HD shot on Oct. 20, 2015. Today patient still complained of an inflamed arm at site of injection and itchiness.
Patient was seen in Hospital Emergency Room 05/01/2008 for left leg swelling and rednes at injection site.  Diagnosis was Acute Local Large Reaction. Reaction was at the site where Varicella was given.
Female 50y/o  Drove (4 hour drive) with her husband and son. She only ate breakfast and some snacks. Received vaccine at approx. 3:30 pm. She did have a fear of injections but said she was extremely happy because she hardly felt any pain from the injection. Shortly after sitting down for observation she began to feel extremely dizzy.  observed her condition and immediately attended to her. Fanning her to give her air and allowing her to lay her head back. informed of the need for someone to assist. After 15 minutes of the woman still not feeling better we decided to call for paramedics.  Paramedics arrived in 10 minute took vitals. Glucose 132. O2 sat 100%. BP 120/80.  Vitals were all good but patient still extremely nauseous and dizzy. Emt's administered oxygen and ice pack to neck. Woman began to become more alert and was responding better to questions. Due to her positive vitals the emts felt comfortable about leaving her after 15 minutes of oxygen treatment. Her husband and son walked her out.
Red hot swollen area about 8cm in diameter surrounding injection site at shoulder. Pt had fever, chills, night before, T  max 101. Also with pain/mild surrounding left axilla. This began about 48 hours after injection. Has been indurated on day 4. PE is to culture area follow up.
numbness in the extremities. Dizziness and mild vertigo. Flushing about 5 minutes after vaccination. symptoms resolved quickly and on there own . negative  orthostatic  Vitals- BP: 122/73 -  HR:76 -  RESP:14  -  sp02: 98%
The patient reported that on the day of/after vaccination they experienced swelling of the arm around the vaccine site on the arm. On 10/1, after the shot was given on 09/28, the patient reported a rash starting on the left side of the face that progressed and grew larger across the face. It is red and itches, but there is no pain or blisters. The patient tried cetirizine/zyrtec and that did not alleviate any symptoms. The patient was counseled to report to their doctor and follow up. Patient said they would follow up if the situation worsened or did not improve over time. Benadryl was suggested as a nighttime option for itching, and an over the counter steroid cream for the daytime, no longer than x2 weeks, if the itching bothered the patient.
Morbilliform rash started on forearms on 11/12 and over the next 48 hours spread over my body. Nov 17-20th the rash was the most intense. Rash started to resolve 11/23. Rash never itched.
Nausea for 36 hours with one episode of vomiting, Diarrhea for 36 hours, Fever for 8 hours, Body aches for 36 hours, Mild headache for 36 hours. Treated with TYLENOL.
Information has been received from a physician concerning a 14 year old female who "about a month ago" in February 2008, was vaccinated intramuscularly in the upper arm in the deltoid with a first dose of GARDASIL. The physician reported that the patient received the vaccine "in the joint." ON an unspecified date, in February 2008, the patient developed pain. (NOS) and swelling (NOS). It was reported that the patient's mother gave the patient an NSAID (type unspecified). About 12 days ago, on approximately 14-MAR-2008, the patient went to the physician's office and was found to be "infected at the joint". No treatment information was provided. No lab diagnostics studies were performed. Outcome unknown. No product quality complaint was involved. No further information is available.
Developed shingles about two weeks after 2nd shot. Not immune compromised. Received anti viral medications about 3 days into episode, which seemed to help resolve the outbreak.
A few days after receiving my booster shot I started with Swelling in my right armpit and had pain. I also noticed a mass just above my right elbow that later was determined was enlarged Lymph Nodes. For several weeks in the evening I would experience Body aches and chills. Fatigue.
This case was received on 01 May 2009, via another manufacturer (document number 956545). The event occurred to a subject enrolled in a study. Subject identification number: 361540. A child received a DTaP vaccine (manufacturer and lot not reported), and experienced severe erythema during study week 24. The reporter assessed the event as definitely related to the vaccine. The subject also experienced another serious adverse event while enrolled in this study, which is captured in case number 2009-01942.
Site of injection is large red and swollen, itchy and warm to touch. Still uncomfortable 6 days after the shot (2/15/21).
5/9/03: Nurse notified DPH of possible reaction to vaccine. Pt was noted to have large amount of swelling and redness of right upper arm/shoulder on 5/8/03. Ice pack applied. Was arranged for pt to go to MD. Saw MD. Area measured 2" x 3". MD monitoring.
A few minutes after the administration of Tdap and Menactra, patient had syneapal attack and fell on the floor. Recovered completely after few minutes.
This case was reported by a consumer and described the occurrence of arm tingling in a 37 year old male subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The reporter is the subject. A physician or other health care professional has not verified this report. The subject's medical history included "altered sensation of the left side since 28 May 1995." The subject had no concurrent illness at the time of vaccination with Fluarix. Concurrent medications included Naproxen for an unspecified indication. On 15 November 2005 at 2:55 p.m., the subject received 1st dose of Fluarix in the left deltoid (lot AFLUA120AA). "Immediately upon receipt of the injection" of Fluarix, on 15 November 2005, at 2:55 p.m., the subject experienced left arm tingling and feeling of arm and hand falling asleep. The reporter stated that, the subject received "no treatment." The outcome of the events was not reported. Follow up received states - This case was reported by a consumer and described the occcurrence of arm tingling in a 37-year-old male subject who was vaccinated with FLUARIX, GlaxoSmithKline. The initial reporter is the subject. This case was subsequently confirmed by a nurse practitioner. The subject's medical history included arthritis and an "altered sensation of the left side since 28 May 1995." The subject had no concurrent illness at the time if vaccination with FLUARIX. Concurrent medications include Naproxen for arthritis. On 15 November 2005 at 2:55 p.m. the subject received 1st dose of FLUARIX in the left deltoid (Lot AFLUA120AA). "Immediately upon receipt of the inhection" of FLUARIX, on 15 November 2005, at 2:55 P.M., the subject expereinced left arm tingling, feeling of arm and hand falling asleep, and numbness and tingling of the tongue "without any oral swelling." The subject was treated with BENADRYL on 15 November 2005. The events resolved on 16 November 2005. The nurse practitioner considered the events to probably be related to vaccination with FLUARIX and also related to his medical history.
mom states pt's hands & arms became cool & purple & had tremors; took to NP to be evaluated; t103.4; pt sl shaky as was being awakened; 19SEP92 red rash devel;
TWO HEART ATTACKS; CONGESTIVE HEART FAILURE; STROKE; This spontaneous report received from a patient via a company representative concerned a 63 year old male of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient has a past medical history of 2 heart attacks and heart issues of congestive heart failure, concurrent conditions included moderate to severe ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) with frequency time 1 total, dose and start therapy date were not reported for Covid-19 vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included Humira (adalimumab) for moderate to severe ulcerative colitis.  On APR-2021, the patient experienced stroke. On an unspecified date, the patient experienced two heart attacks and congestive heart failure. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke, and the outcome of heart attack and congestive heart failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20211021607-COVID-19 VACCINE AD26.COV2.S-stroke, two heart attacks,  congestive heart failure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
3 patients received 1 original monovalent and were due for their 2 dose, received the Bivalent dose from dark pink cap vial instead of the Blue cap vial with grey border; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of WRONG PRODUCT ADMINISTERED (3 patients received 1 original monovalent and were due for their 2 dose, received the Bivalent dose from dark pink cap vial instead of the Blue cap vial with grey border) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (3 patients received 1 original monovalent and were due for their 2 dose, received the Bivalent dose from dark pink cap vial instead of the Blue cap vial with grey border) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (3 patients received 1 original monovalent and were due for their 2 dose, received the Bivalent dose from dark pink cap vial instead of the Blue cap vial with grey border) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (3 patients received 1 original monovalent and were due for their 2 dose, received the Bivalent dose from dark pink cap vial instead of the Blue cap vial with grey border).    It was unknown patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  No treatment information was reported.   This case contains information for patient 2 out of 3.   This case was linked to US-MODERNATX, INC.-MOD-2023-733923 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733923:Master case
Rash on lateral breasts/felt a bit of itching.; blotchy rashes; Itchiness on Scalp; broke out in hives/welts came up on right ear and behind neck/welts under buttocks and behind knees, welts were large and red; Slight chills; Tenderness in injection arm; was just a little cold; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: PAA156571), via an unspecified route of administration in left deltoid on 28Dec2020 10:00 at 0.3 mL single for covid-19 immunization; sulfamethoxazole, trimethoprim (BACTRIM DS), at twice a day for 10 days for perineal cyst. The patient was on her last day of sulfamethoxazole, trimethoprim on the day she got the COVID-19 vaccine (28Dec2020). Medical history included perineal cyst, COVID-19 in Apr2020 with no problem, only had a cough. Husband had COVID-19 and had loss of taste and smell, had fever, but he was not serious. Both her and her husband got tested for antibodies and were positive. Family medical history was none. The patient had unspecified flu vaccine (Lot: UJ428AB) on 18Dec2020 injected in left deltoid in two weeks prior to COVID-19 Vaccine.  Checked with three different people who stated the Flu vaccine would not interfere with COVID-19 Vaccine. Checked with two pharmacists who stated Bactrim DS would not affect her taking the COVID-19 Vaccine. She received COVID-19 Vaccine through her work in a nursing home.  There were no additional vaccines administered on same date of Pfizer suspect. On 28Dec2020 about 7 to 8 hours after vaccination, patient had slight chills and tenderness in her arm: was just a little cold. Thirty-six hours after injection, midnight on 29Dec2020, her scalp itched like crazy, broke out in hives. On 30Dec2020, rash developed on both lateral sides of her breast, welts came up on right ear and behind neck. On 31Dec2020, welts under buttocks and behind knees, welts were large and red. Rash on lateral breasts: felt a bit of itching. The patient had blotchy rashes, rash up in her hair above her neck and back of ear, had intense itching; which subsided. It was a little pink on her chest, little itching on her head. Her ear was better.  Symptoms were most mild because she was still able to function. Clarified as not serious.  The patient was taking diphenhydramine (BENADRYL, Lot: SMF011, Exp: May2022) at 25mg every 3.5 to 4 hours, cortisone cream 10 Maximum Strength (Lot: 20K434, Exp: Sep2023) for rash and welts; and doing tepid soaks. It was tolerable and faded. Rash had subsided, but was a little red.  Her greatest concern was what to do in regards to the second dose in three weeks. The reporter considered events were related with COVID-19 Vaccine. The action taken in response to the events for sulfamethoxazole, trimethoprim was unknown. The outcome of events was unknown.
I received my first dose of the COVID19 Pfizer vaccine on 12/30/20. At this point I was 4 weeks pregnant. I received my second vaccine dose for the series on  1/22/21. At this point I was 7 weeks pregnant. On 2/18/21 I was diagnosed with a miscarriage due to no fetal heartbeat on ultrasound. I now have to undergo a D&C in the operating room.
Pt developed subjective, transient choking sensation x 1 episode 2 wks post vax. Pt also had difficulty breathing per mother. Pt was not seen or treated by MD.
Hands and feet just itch really bad; slight redness on palms and feet and in between fingers and toes.
Developed rash on Sunday 11/24/13 upper body front and back and both arms deltoid region. Saw on 11/25/13. Received steroid shot. Client was also given steroid pills to start Friday.
Shoulder pain and soreness. Nothing helps, cold compress or heat does not help. No medications help. Constant pain and now weakness is in my skin. Loss of strength. I will never take this shot again.
Back surgery; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 07Apr2022 as dose 4 (booster), single (Lot number: FJAA43) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "High Blood pressure" (unspecified if ongoing); "Heart disorder" (unspecified if ongoing); "Prosthetic knee" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: ENTRESTO taken for cardiac disorder; NYQUIL taken for hypertension; TYLENOL taken for joint prosthesis user, arthritis. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot number: EN6208), administration date: 11Mar2021, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot number: EWA53), administration date: 08Apr2021, for Covid-19 Immunization, reaction(s): "Accident happened", "She had a disc that was ruptured", "She had a bruise", "Bang on the elbow and knee", "Elbow was losing strength"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot number: 330308D), administration date: 02Dec2021, for Covid-19 Immunization; Pneumonia shots, for Immunisation. The following information was reported: SPINAL OPERATION (medically significant) with onset Jul2022, outcome "recovered" (2022), described as "Back surgery". Clinical Course: She doesn't take flu shots, she has only taken pneumonia shots, she doesn't get sick, very seldom she gets sick, if she feels anything like a scratchy throat or runny nose she usually take that Blood pressure cold medicine Coricidin, she will take a couple of those and feel fine. No details were provided on patient's other conditions and investigations. Patient's weight was 160lbs-175lbs.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300109929 same patient and product, different dose and events;
Pain at injection site x 72 hrs, severe insomnia x 48 hrs, muscle spasms causing left ankle to freeze and prevent inversion/eversion.
Tongue and lips started tingling, felt hot and flushed, for about two minutes. Five minutes later left hand started tingling, lasted an hour. Then face went numb for a couple of hours, is starting to ease. Right leg shin pain for about an hour, like painful tingling. Mid-back tingling is easing up. Mild sore throat. Sore left arm at site of injection.
My son began experiencing increased acid reflux that broke through his PPI. It was normally controlled by it. He kept spitting up profusely. Also, he had choking episodes. Lastly, the blood in his stools increased significantly as well as his eczema, which was already very bad but become uncontrollable.
On eight day, developed red, patches of itchy, warm skin by injection site. Lasted about three days. Had a stronger reaction that lasted longer after second dose, which was given 5/1/21 at same CVS, Moderna Lot #045B21A. I think this is called "COVID Arm"?
This spontaneous report as received from a physician refers to a couple of patients of unknown age. The patients were vaccinated with VAQTA on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patients experienced positive serology post vaccination. It was unknown if the patients sought medical attention. The outcome of the patients was unknown. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Shot one was just sore arm for a few days.   On June 22 nd, I received shot two and my left side of my face went numb right away.   3 days after second shot, numbness and tingling on left side, working its way up to left arm, to neck.  It continued to spread to full body into hands, armpits, neck pain,  causing me to have shooting pains and terrible nerve issues.   I felt as if i was going to have a heart attack for the first few weeks, I was doing nothing and it was in the 150s, then heart rate would fall into the 50's while doing nothing.    It is now super low when i sit down.   I have horrible head aches, sensitive to light.
11/9/2007 - FluMist given.  She received vaccine about 12 noon, then returned to wk.  Approximately 8 pm she began to sneeze.  The next day she had sniffles, sneezing worse and diffuse aches (like a cold).  The next day, Sunday, she had a cough.  She went to Urgent Care on Monday c/o temp 101, stuffy head, congestion, cough and treated for URI w/meds and given NFW for 2-3 days.  Symptoms lasted 2 weeks.
p/vax pt c/o pain, swelling;itch& redness to inj site also;MD dx erysipelas;under tx w/PCN;