chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 02-JUL-2016, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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.
ACCORDING TO DAUGHTER & SISTER: THE DECEASED HAD NO RECENT COMPLAINTS. THEY HAD A HISTORY OF HTN FOR, WHICH THEY WERE TAKING MEDICATION, BUT NO KNOWN CARDIAC ISSUES. THEY WERE AT WORK WHEN THEY HAD "SEIZURE-LIKE" ACTIVITY & COLLAPSED TO THE GROUND. EMS WAS CALLED. SHE WAS NOTED BY EMS TO BE IN ASYSTOLE AND ACLS BEGAN. EMS ADMINISTERED 3MG OF EPINEPHRINE AND CONTINUED COMPRESSIONS UNTIL THEIR ARRIVAL TO ED AT 11:38AM ON 8/22/21. WHILE IN THE ED, SHE RECEIVED MAGNESIUM SULFATE, AMIODARONE, CALCIUM CHLORIDE, SODIUM BICARBONATE, AND ADDITIONAL DOSES OF EPINEPHRINE. BEDSIDE CARDIAC US REVEALED NO CARDIAC WALL MOTION. A CENTRAL VENOUS CATHETER WAS PLACED AND tPA WAS ADMINISTERED. CPR WAS CONTINUED. DESPITE ALL EFFORTS, SHE REMAINED IN ASYSTOLE. REPEAT BEDSIDE CARDIAC US AGAIN REVEALED NO CARDIAC WALL MOTION. SHE WAS PRONOUNCED AT 12:11PM.
The normal signs of inflammation, slight redness and pain was evident within 24 hours.Warm compress was applied with some relief. On 10/30 the area around the injection site was circular in shape, red and firm to touch, in addition to warm compress, neosporin ointment was also applied with little success. On the morning of 10/31, the swelling was more inflamed, injection site warm to touch and painful. I took Motrin which was helpful, Benadryl did not help the itching. The circular area measured 3 inches and my skin looked and felt like it was burning. I stopped the warm compress and the neosporin because it was not effective. On 11/1, the rash appears to be spreading down and to the back of my arm. due to previous commitment I could not seek medical attention and thought it would improve because the pain decreased in intensity and my arm movement improved on 11/2.  As of today my arm is returning to it's natural color, the citcular shape is visible, however there is a slight lump at the injection site and some residual itching that remains, using Cetaphil lotion which is helpful. attached pictures will follow.
Extreme fatigue, joint pain, chest aching, headache, dizziness, blurred vision for 2 wks after receiving 1st dose of Anthrax. Seen by PCP; dxed w/ sinus infection and given antibiotics.
Lower (L) humerus soft tissue fiery red and warm to touch - Cellulitis non- infective treated with KEFLEX 500mg QID for 7 days.
Covid monitoring documentation. PT admitted 10/22/21 documented to have positive covid. PT received Moderna 1/8/21 Lot 011L20A for dose 1. Dose 2 was Moderna given on 2/5/21 Lot 028L20A.
Patient developed left arm numbness, tingling, pain and redness from above elbow to mid-forearm. Pt says that it constantly hurts, is worse with movement. Symptoms are unchanged over past few months. No injuries. Pt saw PCP ortho and neurologist about this. They thought she could have had cellulitis, tendonitis, carpal tunnel, blood clot, or nerve damage, but nothing determined.
He developed tinnitus in ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101689631 (Pfizer). A 54-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 19Mar2021 (Lot number: ER2613, Expiration Date: Jul2021) at the age of 54 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: TINNITUS (non-serious) with onset 21Mar2021, outcome "not recovered", described as "He developed tinnitus in ears". The event "he developed tinnitus in ears" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus.  Additional Information:  Time the Vaccination was early afternoon. Received call from consumer regarding Pfizer Adult dose COVID 19 vaccine. After Patient had 1st shot, 2 days later. The patient was not hospitalized. Prior Vaccinations (within 4 weeks) , list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was none. Relevant Tests was none. AE(s) following prior vaccinations was none. Patient reports onset of tinnitus after primary dose Pfizer vaccine 19Mar21, second dose 09Apr21.   Follow-up attempts are completed. No further information is expected.
DTAP vaccine was given to the patient in error (TDAP was ordered by provider but DTAP was given by MA). Patient/provider aware. No further action at this time per current vaccine guidelines.
This spontaneous report as received from a physician assistant refers to a 26 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 13-JUN-2018, the patient was inadvertently vaccinated with one dose of PROQUAD (strength and route of administration were unknown) with lot # R001541 and expiration date of 15-JUL-2019 for prophylaxis. No adverse effects were reported.
Pt recv vax on unspecified day; post vax pt exp auto immune like rxn  Information has been received from a registered pharmacist concerning a female who was vaccinated with RECOMBIVAX HB. The patient sought medical treatment. Subsequently the patient experienced an "auto-immune like reaction". Additional information has been requested. Additionally it was noted that another patient (WAES 99010987) experienced a similar reaction. No further information is available.
Info has been received from a physician concerning a 9 year old male who was vaccinated with a SC, 0.5 ml dose of varicella virus vaccine live. It was reported that the pt presented to the office with a breakthrough case of chickenpox, with about 100 generalized lesions. The lesions were treated with Benadryl and calamine lotion. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. Additional info has been requested.
Thirty to 45 min. after heart rate and resp. rate started to drop. She was on a apnea monitor. She didn't act right and the next 24 hrs feeding, crying a lot Nov 3 she was taken back to Dr. jerking ? and legs and dismissed. Seizure disorder.
sick (malaise); fever; chills; couldn't get out of bed (Weakness); This case was reported by a consumer via call center representative and described the occurrence of malaise in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (13 years ago). Previously administered products included Zostavax (received the approximately 13 years ago).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced malaise, fever, chills and weakness. On an unknown date, the outcome of the malaise, fever, chills and weakness were recovered/resolved.   It was unknown if the reporter considered the malaise, fever, chills and weakness to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for herself. The patient was diagnosed with Shingles 13 years ago and when the rash went away, she received the Zostavax vaccine (approximately 13 years ago). The concomitant medication includes blood pressure lowering medicine and cholesterol lowering medicine. The patient received 1st dose of Shingrix vaccine and was sick (malaise), fever and chills and couldn't get out of bed (weakness) and it lasted 2 days (malaise, fever, chills, weakness are resolved). The call center representative referred her to speak with her doctor about her medical concerns. The patient said she might seek legal representation. The reporter consented to follow up. For tolerance to 2nd dose, refer case US2021AMR202920, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202920:Same reporter
This vaccine was inadvertently administered despite him being 17 years old and vaccine not fully approved.
Patient received 2 dose of Pfizer COVID vaccine on 3/17/21. Patient drove ~3 hours for vaccine. Several days later he noted swelling in hs right leg that progressively worsened. He denies injury to leg. He presented to PCP office on 4/5/21 due to swelling. Extensive acute DVT extending from calf to groin was identified via ultrasound. Patient was placed on blood thinner.
upper thigh where immun given w/secondary scaring w/hypopigmentation @ site & some retraction muscle lt thigh;
Initial day was fine, went to sleep and kept waking up throughout the night. Had a hard time falling back to sleep, once I did, I woke up at 4am to body aches with my heart racing. I wear a Fitbit and my BPM was 120-133 most of the day. I had body aches, and a low grade fever of 100.3- that didn't resolve after taking an aleve. This went away following the next day. The first dose, my injection site was sore and only had a small circle. After the second dose, I have a large circle on my arm that is warm to the touch- it still is.
Well so, I had really bad cold symptoms the morning of the 10th of July. I had headache, runny nose, sore throat, fever, diarrhea. I went for a rapid covid test at the ER that day. I stayed out of work that weekend, and worked from home on Monday. On Tuesday my work asked me to work from home and I have been working from home since, it is the 30th now. I went to my PCD on Monday the 19th and had blood panel and again a covid test. I got doxycycline as well but still today the cough is ongoing and I am not feeling well.
Measles like rash-no temp starting 9-10 days p/vax;
Patient having low grade fever on and off since the vaccination. Body ache. Below the waistline right side abdominal pain on and off.
AFTER 15 MINUTES, PATIENT HAD SWOLLEN LIPS, PERIORAL CYANOSIS, LETHARGY, WHEEZING. TREATED WITH EPINEPHRINE, DECADRON, OXYGEN, ALBUTEROL NEB. WITHIN FIRST 10 MINUTES AND TRANSFERRED TO EMERGENCY ROOM AFTER 20 MINUTE FOR TREATMENT OF ANAPHYLAXIS.  WAS THEN GIVEN IV FLUIDS, IV BENADRYL , AND SOLUMEDROL. TRANSFER TO PICU AND OBSERVED OVERNIGHT AND DISCHARGED IN GOOD CONDITION. Information from Medical record sttes hearing impairment. msv
Rash all over her upper body, arms and thighs. She did not get a fever. Rash has been present for tow days, has no gone away.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: carries APIS tablets which she uses if feels like have an anaphylactic episode. Waited an hour and left with no complications
Pt had instant swelling on arm. Woke up in the am with hot sweats, body aches, and sore throat. Felt like chest tightening possibly due to asthma and anxiety.  Did not seek medical attention, just used ibuprofen,
SEVERE TINNITUS DEVELOPED 24 hours a day, 7 days a week ringing in the ears Both ears have it
Development behavioral changes, mood swings which mother believes began after 1st HPV, given 2/5/08. Ultimately hospitalized and diagnosed with Oppositional Defiant Disorder and Mood Disorder.
Patient recieved expired vaccine with no reported adverse event; Initial information was received on 23-Sep-2021 regarding an unsolicited valid non-serious case received from a other healthcare professional and non-healthcare professional via MI (Medical Information- 00782588).  This case involves a 1-years old female patient who was vaccinated with an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (Expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  On 22-Sep-2021, the patient received a 0.5ml fourth {total} dose of suspect HIB (PRP/T) VACCINE (lot number LUJ401AA and expiry date 23-Aug-2021) via intramuscular route in the left thigh for prophylactic vaccination.  It was reported "they would like to know if they need to revaccinate or can that vaccine count towards the series of shots for the patient?"  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Event outcome was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Left arm from shoulder 15cm down toward elbow slightly swollen, red, warm to touch. Improved, per patient, since yesterday.
SHE FELT ANXIOUS AFTER RECEIVING THIS DOSE. ON SITE EMS RESPONDED. HER VITALS ARE BELOW. IN TYPING THIS UP FROM AN EMS REPORT, I FOUND IN THE DATABASE, THAT SHE HAD HAD 2 PREVIOUS DOSES BEFORE THIS DOSE ON 3/26/21. THE 1ST DOSE ON 2/26/21 HERE AT THIS FACILITY. THE 2ND IN ANOTHER TOWN CALLED ON 3/20/21 AND THEN BACK AT OUR FACILITY ON 3/26/20 WHERE SHE GOT ANXIOUS AT.  I HAVE REACHED OUT TO HER AND LEFT HER A MSG TO PLEASE CALL ME BACK ON 4/22 AND 4/23. AS OF 4/26 NO CALL BACK. NOTE: I WAS WONDERING IF THE VACCINE ON 3/20 IN MIGHT NOT BE HER, THAT IT WOULD BE ENTERED ACCIDENTLY UNDER HER FILE.
2 month old baby got Kinrix; Kinrix instead of Infanrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 20-APR-2023, the patient received Kinrix. On 20-APR-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 2 month old baby got Kinrix) and wrong vaccine administered (Verbatim: Kinrix instead of Infanrix). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were 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: 02-MAY-2023 The mother called on behalf of her 3 month old patient (daughter) who was the consumer.  The mother stated that her pediatrician office contacted her and stated that her patient received Kinrix when the intended vaccine should had been Infanrix.  The reporter consented to follow up.  The patient received Kinrix instead of Infanrix at inappropriate age, which led to inappropriate age at vaccine administration and wrong vaccine administered.
SOB, aches p/flu shot; thickening of phlegm, unable to cough up phlegm-lasted approx 2 wks p/shot;
Mild myalgias and headache the day after.  On Saturday, January 23rd, I had an hour+long episode of Atrial fibrillation. While I have had other cardiac dysrhythmias throughout my adult life, this is the first time I have had diagnosed Afib. I took one dose of my PRN Propranalol (10mg) orally after a few minutes of the abnormal rhythm. When it didn't convert, I did go to the Emergency Department. My heart converted to normal sinus rhythm while on the monitor but before any other interventions were needed. I have a follow up appointment with my cardiologist tomorrow to determine further care as needed.
Dehydration as evidenced in stools.   Passing mucus and blood.   Lightheadedness.
Left arm pain.  Seen on 11/13/2018 ; PT 2x per week for 4 weeks recommended
One day after the vaccination, I felt all the problems in the pamphlet the nurse gave to me but after the 5th day, a red rash shows up and my arm feels hot but the rash dissappeared after 3 days.
Information has been received from a physician concerning a male who on 05-Aug-2002 was vaccinated with a dose of varicella virus vaccine live (lot #639432/0787L). In July 2003, the patient presented with chickenpox and recovered without treatment. In January 2004, the patient experienced zoster and was treated with acyclovir. It was noted that the zoster was localized to his right trunk. Unspecified medical attention was sought. Subsequently the patient recovered. There was no product complaint involved. The reporter also indicated that the patient's sister (WAES #0402USA01326) had similar experiences following exposure to varicella virus vaccine live. Additional information has been requested.
pt recv Td vax instead of PPD & w/in 2 days site swollen up like a large mosquito bite;elevated, red & itchy area about 2 inches in diameter;itching dec significantly;there was still a raised area;yellowish-white & skin shiny;
HEMORRHAGIC STROKE; HIGH BLOOD PRESSURE; This spontaneous report received from a patient concerned a 53 year old female. Initial information was processed along with the additional information received on 13-JUL-2022. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 16-FEB-2022) dose was not reported, 01 total administered on 05-APR-2021 for prophylactic vaccination. Age at time of vaccination 53 years old. No concomitant medications were reported. On 24-AUG-2021, the patient experienced hemorrhagic stroke from high blood pressure. The reporter reported that the stroke had nothing to do with blood clots. The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855194, expiry: 06-SEP-2022) dose was not reported, 01 total administered on 29-NOV-2021 to the upper left arm for prophylactic vaccination. It was unknown if patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hemorrhagic stroke and high blood pressure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint number 90000241924. The suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria) based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20220724260.; Sender's Comments: V0: 20220724456- COVID-19 VACCINE AD26.COV2.S-hemorrhagic stroke, high blood pressure. 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). Therefore, this event(s) is considered unassessable.
1/4 vaccination. Discomfort in arm couple hours later. By evening time, started to feel 'flu like symptoms'. Achiness, not feeling well, fever?; ibuprofren. Symptoms lasted 24 hours. Unable to eat. Diarrhea but unsure if related to IBS.   *COVID + November 27, 2020 *I have not had a lot of energy since having COVID + and voice coarseness.
Acquired PCP approval prior to giving due to history of significant allergies. Vaccine given at 1354. Observed pt in clinic following vaccine. Pt reports tingling and throbbing in extremities one hour after vaccine. Facial flushing noted. Reports difficulty swallowing 90 minutes after vaccine. Anaphylactic protocol initiated. Pt refused epi as she states "I do not like the way it makes me feel". Pt remains vitally stable with O2 sats above 98%. No dyspnea noted, talking without difficulty. Pt does have elevated BP but reports not taking antihypertensive medication this AM. Pt seen in ED, given Benadryl, prednisone. Symptoms resolved, pt discharged to home. Pt reports hives the next morning 3/30 continuing to take Benadryl per MD order.
induration, swelling, purulent drainage, heat, pain starting 3-4 days after injection on 5/5/21 with development of subjective fever/chills
Patient had a few pinpoint papillae red in color, on arms. Vital signs stable. The doctor on site gave 10 mg of Zyrtec. No wheezing, no dyspnea. Has a history of hives and throat closing up but does not have his own epi pen.
Decreased activity and restlessness 10/30/07. Seen 11/1/07 in ER see enclosed note
On 7/25/01, MMR and Varivax given. Returned on 8/4/01 with localized erythema and edema at Varivax site. Pt had facial and trunk rash, conjunctivitis and red throat (looked like measles).
Breakthrough case admission after 2 vaccines  Moderna 4/17/21 lot# 045B21A;  Moderna 5/20/21 lot# 023C21A
Information has been received from a consumer concerning a 14 year old family member who on 4/21/00 was vaccinated with "the final dose" of Hep-B vaccine. "Soon afterwards, the pt experienced arm soreness "deep in the muscle" and twitching. The pt sought unspecified medical attention. Additional information has been requested.
Information has been received from a licensed visiting nurse concerning a 12 month old male with no previous medical history and no drug reactions/allergies who on 25-APR-2007 was vaccinated subcutaneously with a 0.5 mL dose of Proquad (lot# 657264/0294U). There was no concomitant medication. On 08-MAY-2007 the patient developed a fever of 1010 F and a rash on his torso. The patient sought unspecified medical attention. The patient's outcome was not reported. There was no product quality complaint involved. Additional information has been requested.
The day I received my 2nd dose, Wednesday,  my arm was extremely painful. I took aleve and was still in a lot of pain, had trouble sleeping due to the pain. My arm was throbbing from shoulder to fingers. The following day the pain was still uncomfortable but improved from the previous day. I also felt a little ?out of it? and tired, minor headache. I was back to feeling 100% by Friday.
Red, raised rash on stomach and back. Lasted 3 hours. Not itchy, could have occurred overnight while sleeping.
Slept all day; Extremely Tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept all day) and FATIGUE (Extremely Tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 immunisation.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced FATIGUE (Extremely Tired). On 07-Mar-2021, the patient experienced HYPERSOMNIA (Slept all day). On 07-Mar-2021, HYPERSOMNIA (Slept all day) and FATIGUE (Extremely Tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.