chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe rash on back which is still there 4  months later. Itching and burning vesicles.
Information has been received on 15-AUG-2017 regarding a case in litigation from a lawyer and a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous in 2010, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving the vaccine, the patient was treated for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Pt called to report the following incident which happened later the same day she received MMR vaccine.  While coaching a ball game "I became dizzy to the point of having to leave the field, and my heart was racing.  My friend said my eyes were completely dilated, one was not focusing, the other was aimed way off to left.  This lasted about a minute, but the racing heart continued.  I felt very cold and had goose bumps afterward.  It has not happened again, and the shot was the only thing different about that day."  Per doctor, pt was instructed this is incident will be recorded and sent to CDC to see if it is r/t MMR, but no knowledge of connection to vaccine administration at this time. This is in follow-up to report (s) previously submitted on 7/25/2008. Information has been received from a licensed practical nurse concerning a 46 year old (also reported as a 18 year old) female with an allergy to codeine and sulfonamide, who on 12-Jun-2008 at 13:15 was vaccinated in the deltoid with a dose of MMR II (Lot # 655123/1216F). The patient was not sick at the time of the vaccination. The patient reported that the symptoms lasted about one minute, but the racing heart continued.  Additional information is not expected.
Fully vaccinated employee with multiple symptoms dizziness, nausea, vomiting and diarrhea.
Received second dose vaccine on 2/16 at 1:50p, on 2/17 around 10pm noticed my top lip was irritated and sore on outside only. Woke up 2/18 with multiple small bumps/blisters on outside of top lip. Lip was also sore, irritated and swollen.
Chills, Extreme Fatigue, Body Aches, 99.7 temperature, nausea, and extreme vomiting. Vomiting lasted about 10 minutes and about 8 episodes. Still experiencing 99.7 temperature.
Information has been received from a emergency medical technician concerning a 38 year old female with a penicillin allergy and no other known medical history who on 7/2/04 at12:45 PM was vaccinated SC in the right upper arm with 0.5ml first dose of varicella virus vaccine live (lot # 645288/0689N). Concomitant vaccination at the same time included a SC dose in the left upper arm of MMR (lot # 647276/0963N), and an IM dose in the left deltoid of diphtheria toxoid (+) tetanus toxoid (lot # TD104). She also had a tuberculin purified protein derivative applied on the same day. There was no illness at the time of vaccination. On 7/5/04, the patient experienced a warm spot at the injection site. The spot was 8cm in size and was red and bruised, not raised or painful. The reporter also noted that the patient experienced a reaction to the tuberculosis skin test which appeared as a 50mm raised mark with clearly defined borders with a 22mm centrally located and raised mark. The next vaccine administration of varicella virus vaccine live had been cancelled on the recommendation of the physician. The area was treated with ice and pain relievers were recommended on an as needed basis. The patient did not actively seek medical attention but was returning for a routine check of a tuberculosis skin test site. No diagnostic laboratory tests were performed. At the time of the report the patient had not recovered. A product quality complaint was not involved. Follow up information was received from the emergency medical technician who indicated that the patient is a healthy woman from another country who came to the physician's office for a required physical exam (which was normal) and an immunization update in order to get a permanent resident card. When the patient returned to the physician's office to have her tuberculin test read, she had a large area (80mm in diameter) of warm erythema at the site of the varicella virus vaccine live injection. It was not painful or pruritic and she had no other symptoms. She had no known prior history of chicken pox, shingles, or vaccination for either. It was noted that the tuberculin test was strongly positive at 22mm induration. There was 50mm of erythema surrounding the indurated area. A chest x-ray was negative. The reaction subsided over the following week and the patient recovered. The patient had no adverse events following prior vaccination. No further information is expected.
Arm was very sore for 4 days. On day 6 arm started to get itchy and it became hot and red. Day 11 day and the redness has spread, itches randomly, and is still warm to touch.
Grandmother states child was fussy after shots, felt warm but did not check temp. States she is fine today.
RAISED AREA OF SKIN WITH PROGRESSING RED RASH OVER 2 DAYS.
Received flu shot 10/25/07 about 1 p.m.-1:30 p.m.  Rash began on lower extremities at approximately 7 p.m. ( 6 hours later), rash continued to spread to trunk, upper extremities by next morning.  Client did experience uticaria, but did not report any other s/s.  Visited ER 10/27/07 and started on oral steroids with diminishing dose schedule to be administered over several days (Medrol pack).  Follow up visit with primary MD,following week, rash almost resolved.  Client did state she had received influenza vaccine for the past few years without adverse response.
Patient reported full body aches causing such a level of pain as to not be able to walk that started the evening of her vaccination. As of the time of this report patient still couldn't ambulate without the help of others.
Information has been received from a physician concerning a 19 year old female with a penicillin and cefaclor (Ceclor) allergy who on 19-JUN-2007 was vaccinated with a third dose of Gardasil. On 19-JUN-2007 the patient developed a fever, slight clear nose drainage, and localized pain and redness over the deltoid area. It was reported that on 20-JUN-2007 the patient vomited twice. There was no rash, tongue swelling, or cough. Unspecified medical attention was sought. On 20-JUN-2007 the patient recovered from vomiting and fever. In June 2007, after "several days" the patient recovered from localized redness and pain. In approximately June 2007, the patient recovered from drainage from the nose. Additional information has been requested.
04/04/2022 I began having a headache and I took Tylenol and it did not help. I got up to 6 Tylenol a day, the maximum. I had a negative COVID-19 test at home. I called the doctor a week later via telehealth. He said he wanted to see me in the office. He prescribed me an anti-inflammatory to take. I just got that this past Saturday. The pharmacist said, yesterday, that I can take it 2 times a day, but it gives me nausea and diarrhea. I continue to have headaches that do not go away. I will see my doctor next Tuesday at his office.
Patient stated she "fainted when receiving vaccines." Received vaccine and walked to waiting area. Sat down and became faint at 8:45 am  02 sat 99%; BP 100/80; P 88.  Laid down and was diaphoretic and clammy.  Cool compress applied to forehead and back of neck.  Drank juice and had some water.  Patient .  Stated she felt much better.  8:55 am walked to chair. BP 11/79 P 88.  Stated she was fine.  Left waiting area on her own at 9:00 am.
rash reaction in her arm 3*5 inch area in the injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (rash reaction in her arm 3*5 inch area in the injection) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history was reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced INJECTION SITE RASH (rash reaction in her arm 3*5 inch area in the injection). At the time of the report, INJECTION SITE RASH (rash reaction in her arm 3*5 inch area in the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.
Admitted for Weakness on 9/7/22. Per note, symptoms likely started 1-2 days prior.
Foggy Brain - Decreased cognitive ability, forgetfulness, lack of ability to focus. Fatigue - low energy. Slight constant head pressure that turned into occasional painful headache. Feel exhausted after normal workouts where usually I feel energized and revitalized.
Subsequent to first and second doses of varicella virus vaccine live, laboratory evaluation revealed negative seroconversion.
Red Rash around injection site (approx. 3-4" wide, 4-5" high), pain at and around injection site
CHILLS; FEVER; HEADACHE; FATIGUE; BODY ACHE; LIGHT HEADEDNESS; SLEEPLESSNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body ache, light headedness, sleeplessness, chills, fever, headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, chills, headache, body ache, light headedness, fatigue, and sleeplessness. This report was non-serious.
Arm got really sore and hurt to the light touch. I could not lift my arm up. Next day I got hives on my upper thighs, just a couple of spots and then it has been getting worse. The hives come and go. I'm still getting hives. Woke up last night at 3pm itching all over.
This spontaneous report was received from a registered nurse refers to a 13 year old patient of an unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 09-MAR-2016, the patient was inadvertently vaccinated with a dose of ZOSTAVAX (lot # L029483 and expiration date 06-NOV-2016) (route was not provided) instead of VARIVAX (Merck) (lot number, expiration date and route of administration were not provided). There were no concomitant medications reported. No adverse effects were reported. No product quality issue was involved. Additional information has been requested.
Fever x 2 days, 3 x 5 cm tender, swollen duoerect mata left deltoid at site of Td injection.  when seen 08/15/03 at office.
The  vaccine was stored at room temperature longer than the recommended time. Patient did NOT experience any adverse events but will require another vaccine.
died of SIDS COD per autopsy report 30MAR98;pt recv vax 11MAR98;
Headache, Sluggish, chills, sweating, foggy vision, sharp pain in injection site Narrative:
Information has been received from a physician, via a company rep, concerning her mother, an 89 yr old female who about four years ago, in 2002 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot unk). The physician said her mother had a dose of pneumococcal 23v polysaccharide vaccine about four years ago and her vaccinated arm became swollen and painful. It was reported that the pt had received several doses of pneumococcal 23v polysaccharide vaccine in the past. The pt's present status was reported as recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Received 2 covid 19 shots PFizer; date of 1st: 4/19/21; date of 2: 5/10/21.   on 7/10/21, patient was admitted to hospital due to paralysis of legs and arms. Unable to stand, bare any weight or move limbs on and off initially then progressed to complete paralysis. Admitted to hospital, diagnosed with Guillan Barre Synd. Received IVIG x 5 days than transferred to rehab (expected rehab stay ~ 6 weeks initially then to be re-assessed).   only thing patient had that week is slight diarrhea and complains of muscle/leg cramps
Bacterial Conjunctivis of left eye. Laryngitis. Very sore throat. Coughing up lots of phlegm.
Received Vaccine from a vial having black particles in it; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT CONTAMINATION PHYSICAL (Received Vaccine from a vial having black particles in it) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 13-Apr-2021, the patient experienced PRODUCT CONTAMINATION PHYSICAL (Received Vaccine from a vial having black particles in it). At the time of the report, PRODUCT CONTAMINATION PHYSICAL (Received Vaccine from a vial having black particles in it) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter. No treatment medication was provided by the reporter.
3/17/07 pt called to report reaction to Pneumovax, developed pain, redness, and swelling at injection site, noted red streaks. Pt referred to ER as office closed on weekends.
Patient experienced 2-3 inches of swelling, redness, and infection at the site.   Patient presented to the ER for treatment on 11/9/19.  She was prescribed prednisone and cephalexin to treat the reaction.
Redness in the arm after second vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness in the arm after second vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003F21A and 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced ERYTHEMA (Redness in the arm after second vaccination). At the time of the report, ERYTHEMA (Redness in the arm after second vaccination) was resolving.            Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Received 3rd dose of Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated the patient received 3rd dose of Shingrix, which led to extra dose administered. The reporter stated the third dose was done two years from the first series and wanted to know what should the patient expect in terms of side effects. The follow-up would not be possible as no contact details were available.
Pentacel dual vials - only the diluent/liquid was administered. It was not reconstituted with the HIB portion of the vaccine duo.   There was no adverse medical event for the patient.  The full vaccine dosing was given on 4/20/2022 without medical event
Vaccine was given after expiration date (Product expired on 13-Oct-2021, product administered on 16-Nov-2021.); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was given after expiration date (Product expired on 13-Oct-2021, product administered on 16-Nov-2021.)) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was given after expiration date (Product expired on 13-Oct-2021, product administered on 16-Nov-2021.)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was given after expiration date (Product expired on 13-Oct-2021, product administered on 16-Nov-2021.)) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Vaccine was placed in refrigerator on 01-MAR-2022.  Vaccine had not undergone any temperature excursion, No Adverse events were reported  No concomitant medications were reported  No treatment medications were reported   This case was linked to MOD-2022-491837 (Patient Link).
pt recvd 1st dose of Hep B vax on 31JAN92; pt exp stinging pain @ the inject site; pain persisted for a few seconds;
A spontaneous report had been received from a Physician concerning a male patient of unknown age. Medical history of patient included severe headaches. The patient had received FLUMIST quadrivalent (intranasal), 0.2 millilitres, unknown frequency started on an unknown date. It was reported that the patient experienced spontaneous carotid dissection of both carotid arteries. Action taken with the suspect drug of FLUMIST quadrivalent was unknown. The outcome of the event of spontaneous carotid dissection of both carotid arteries was unknown. The company physician assessed the event of spontaneous carotid dissection of both carotid arteries to be serious with the seriousness criteria of important medical event. The reporter considered that the event of spontaneous carotid dissection of both carotid arteries causally unrelated with the suspect drug of FLUMIST quadrivalent and company physician agreed with that.
NEUROPATHY AGGRAVATED; This spontaneous report received from a patient concerned an 8 decade old elderly male of an unspecified ethnicity. The patient's weight was 250 pounds, and height was 74 inches. The patient's past medical history included: concussion (in college), broken 22 bones, and several operations, and concurrent conditions included: cats allergy, alcohol user (a little bit), non-smoker, blood pressure, and neuropathy in both hands, and other pre-existing medical conditions included: Patient had no history of drug abuse or illicit drug usage. The patient had not had any internal issues like heart or kidney issues, just structural before vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on an unspecified date in 2021 for covid-19 prophylaxis. Age at time of vaccination 8 decade old. The batch number was not reported and has been requested. Concomitant medications included olmesartan for blood pressure, and apixaban.  On an unspecified date in 2021, few weeks after vaccination, the patient experienced paresthesia on the right side of his face and ear. Patient reported that he was experiencing tingling, crawling, paresthesia on the right side of his face. He stated that it comes and goes but it seems like now it was here to stay and it was aggravating (neuropathy aggravated). He spoke with his physician about it and physician was going to refer patient to a neurologist. Patient reported that he thinks that the paresthesia on his face/ear might be related to his vaccine and if he put his hand on the right side of his head, that was about the normal area, that was being affected by the paresthesia. It was on the side of his head covering his eyebrows going through his ear and cheek. Patient stated it was not a burning sensation and it had never been painful but it was getting to where it was painful. When patient spoke with his physician about the complaint, his physician gave him cortisone injections in his hands and got him some hand braces, neither of which did anything. Patient stated that he did not get a cortisone injection to his face or ear as he had not had a cortisone injection above his shoulders since he had a concussion in college. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neuropathy aggravated. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230302319-Neuropathy aggravated. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: MEDICAL HISTORY. Therefore, this event is considered inconsistent with vaccine administration.
still get the shingles even if you have the shot.I have had them 2times/Suspect vaccination failure; still get the shingles/I have had them 2times; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were provided as follows: The case was reported by patient itself. The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient got 2 times Shingles after vaccination. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.
12/27/08 - Presented with 3 weeks nonproductive cough, treated with AZITHROMYCIN.  Patient still with symptoms as of 02/15/2009.