chrisvoncsefalvay/vaers-outcomes huggingface dataset:
08/20/2007-hpv and meningococcal conjugate shot-11/08/2007-hpv and influenza vaccine                                           06/11/2008-hpv shot    after 3rd shot started with diarehha, vomiting,headaches,spotting, aching joints, blurred vision, severe abdominal pain.  Had a colonopsity,upper gi-and ct scan ,blood work, urine test all came back negative. Been on 7 different meds. Now only on celexa thinking its IBS. Not helping.  1/12/2009 MR received from PCP. Seen 7/21/2008 with c/o persistant diarrhea, abdominal pain and nausea. Sx began apprx 2 months ago with acute onset of nausea and then diarrhea. ? medication side effect or IBS. F/u 8/19/08 for ? IBS and tension type H/As. No alternating loose stool with constipation, cramping and nausea. H/A on R side of head/jaw, worse with stress. DX:  IBS.  Tension type H/As. Additional records received. Seen by OBGYN consult re:  pelvic pain and spotting between periods. Exam WNL. Changed OCs and referred to GI. Seen 9/19/09 for 3 mon hx of abdominal pain, and loose stools. Exam WNL. Improvement with 1 dose of prilosec. ? IBS. Seen 10/22/08 for continued hx of vomiting, diarrhea and achiness. Recent onset of joint aches. GI F/U 10/27/09 -no dx made.
He had a low grade fever and figured. the most alarming was the axillary was swollen  and warm to touch by 4 inch by 4inch, next morning the clavicle and next area were swollen and warm to touch the deltoid did develop a rash on the left upper up where the injection was administered. More like a blotchy rash. Did put some corbadasole on it. Generalize myalgia with achiness and stiffness which not common for him. Very uncommon.  As of today the rash is fading but the swelling in the arm pit and left clavicle are still remains.
Pt complained of a large hematoma that formed the day following vaccination (10/19/15). They stated it was painful and very warm to the touch. They showed me Friday 10/23/15 and there was a 4 inch bruise present.
Pt was given pneumovax in Rt Deltoid 11/30/05 while an inpatient at hospital.  Began having redness and swelling that evening which progressed to severe edema in entire Rt arm and hand.  Pt later realized he had pneumovax 10/2002.
Information has been received from a health professional concerning a 12 week female patient who on an unspecified date was vaccinated with the second dose of ROTATEQ (Lot number not reported). Subsequently after one day of vaccination, the patient experienced vomiting and diarrhea and was taken to hospital. During hospitalization the patient was diagnosed with possible severe combined immunodeficiency and was hospitalized. A stool for rotavirus was positive (unspecified strain). At the time of the report the patient's present status was unknown. The reporter felt that possible severe combined immunodeficiency was related to therapy with ROTATEQ. BACKGROUND: Rotavirus vaccines are the only live vaccines recommended for infants. Postmarketing reports have described severe gastroenteritis with vaccine viral shedding in infants who received rotavirus vaccine and were later diagnosed with SCID. Food and Drug Administration recently approved labeling changes for ROTATEQ and ROTARIX contraindicating administration to individuals with a history of SCID. We queried VAERS to characterize reports of SCID after rotavirus vaccination. METHODS: VAERS inclusion criteria included current licensed rotavirus vaccines, report dates from February 3, 2006 to January 15, 2010, and queries for the MedDRA preferred term "combined immunodeficiency" as well as any text containing the terms, "SCID" or "combined immunodeficiency." RESULTS: We identified nine reports of SCID and rotavirus vaccination in infants between 3 and 9 months of age. All but one case presented with diarrhea among other symptoms. All infants were hospitalized and had workups leading to the SCID diagnosis. Stool rotavirus testing was positive in all cases and the virus was identified as the vaccine strain in six cases. Prolonged viral shedding was documented in five cases. No deaths were reported. CONCLUSION: The aforementioned labeling changes were warranted given the risk posed by live rotavirus vaccine to individuals with SCID, as illustrated by these VAERS cases. Although congenital, SCID was not diagnosed in these infants until after rotavirus vaccination. Earlier identification of SCID (e.g., from expanded newborn screening or heightened clinical vigilance) could prevent inadvertent live rotavirus vaccine administration and also potentially result in earlier life-saving stem cell transplants. No further information is available.
Patient started developing a fever the evening of the vaccine. Fever was 104 degrees and broke about 3am. Patient had extreme fatigue the next day, felt better 2 days after.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 61-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 60 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "Known allergies: Crab anaphylaxis" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE oral; EXCEDRIN MIGRAINE oral. Past drug history included: Phenergan, reaction(s): "Known allergies: Phenergan rash". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jan2023) Negative; (unspecified date) Positive, notes: Treatment of COVID-19; (27Jan2023) Positive, notes: Symptoms began 1:00 am 27Jan2023. Tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.
8/18/99 fussy;8/19/99 onset bloody, mucous diarrhea x 6; no emesis, no fever; 8/20/99 ER; brought to hosp via air ambulance; tx w/barium enema-resolved;
Pain and swelling in left arm at point of injection. Still painful 2/10/2013. Met with physician.
Miscarriage of baby at 7 weeks. 12/04/09 Antenatal records received for 06/24/09, 05/12/09. 12/14/09 Medical record received for DOS 11/25/09, 11/30/09
1st day of COVID symptoms, and positive rapid antigen test, was 26Apr2022.; 1st day of COVID symptoms, and positive rapid antigen test, was 26Apr2022.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Lot number: ER8729), in right arm and on 01May2021 as dose 2, single (Lot number: EW0172), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight but not obese" (unspecified if ongoing), notes: Overweight but not obese; "Depression" (unspecified if ongoing), notes: treated with bupropion.; "ADHD" (unspecified if ongoing), notes: not treated. Concomitant medication(s) included: BUPROPION. The following information was reported: SARS-COV-2 TEST POSITIVE (medically significant), VACCINATION FAILURE (medically significant) all with onset 26Apr2022, outcome "not recovered" and all described as "1st day of COVID symptoms, and positive rapid antigen test, was 26Apr2022.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Positive; (09May2022) Positive. Therapeutic measures were taken as a result of sars-cov-2 test positive, vaccination failure.  No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse referring to a patient of unknown age and gender. On 09-NOV-2015, ROTATEQ was stored under 32 F for 39.5 hours. Then on 09-DEC-2015 the patient was vaccinated with the improperly stored dose of ROTATEQ (lot # K007246, expiration date 17-MAR-2016, dose and route unknown). No adverse effects were reported. There was no previous temperature excursions and it was not called because of a "data logger". This is one of several reports received from the same source. Additional information has been requested.
other also had similar problems, edema in brain; This case was reported by a physician and described the occurrence of brain edema in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced brain edema (serious criteria GSK medically significant). On an unknown date, the outcome of the brain edema was unknown.   It was unknown if the reporter considered the brain edema to be related to Shingrix.  Additional Information: GSK Receipt Date: 26-JAN-2023 Reporter's Comment: The reporter reported that other people (patient) also had problems similar to his (edema in brain). He accepted the contact from the pharmacovigilance sector only by postal mail. Additional Supportive Information: The case had been linked to US2023008033, reported by the same reporter.; Sender's Comments:  US-GSK-US2023008033:same reporter - reporter´s case
This spontaneous report was received from a 23 year old female patient and refers to herself. The patient's medical history and concurrent conditions were not reported. On an unspecified date in 2011, the patient was vaccinated with the first and only dose of GARDASIL (frequency, route, lot # and expiration date were not reported). No concomitant medications were reported. On an unspecified date in 2011 (reported as two days after the administration of GARDASIL) the patient was bedridden with a terrible pain and flu like symptoms, which worsened as time went on. She stated that she spent the past four years (unspecified dates) working to heal her body and relying on her mother and husband for full support, and that the GARDASIL changed her health and life forever and not because it had protected her. She also stated she lived in chronic pain (since an unspecified date) every moment of her life, with continuous health fluctuations, despite the progress she made. At the time of the report, the outcome of chronic pain, flu like symptoms and quality of life decreased was not recovered. The reporter considered chronic pain, quality of life decreased and flu like symptoms to be related to GARDASIL. Upon internal review, chronic pain and quality of life decreased were considered as disabling events. Additional information is not expected because no contact details were provided.
Vaccine was administered to pt., and upon exiting the interior clinic door, pt. collapsed onto waiting room floor and hit head. Pt. was found responsive but diaphoretic, weak, pale and reporting feeling nauseated. Pt.'s vital signs initially were 90/55, 72, 96% on RA and glucose 83. Pt. was able to roll over and sit up and was escorted back to an examination room where she improved quickly, was able to sit up and was given a neurological examination by physician. Pt.'s B/P improved to 100/76. Pt. tolerated PO fluids, and left clinic with grandmother.
Pt had swelling, pain, and redness at injection site. Pt states she had fevers on and off. Given KEFLEX to treat.
An hour after I got the vaccine I got a feeling of itching all over my body. I went back to the hospital  which is my workplace and they gave me some Benadryl.  They observed me for 15 minutes and then I was fine. I took a Benadryl the next day and did not have any more symptoms. I did not have this happen with the first dose.
4/29/21 - Fever of 102.0F, sweats, chills. Sever body aches. Could hardly get out of bed and walk.  4/30/21 - Fever reduced to 99.5F, sweats remained at night while sleeping. Body aches, joint aches persisted. 5/01/21 - Fever gone. Sweats remained at night. Brain fog began. Hard to focus and concentrate. Body aches, joint aches slightly better, but persisted.  5/02/21 - Sweats reduced at night, but still present. Brain fog remains. Arthritis-like joint aches persist. 5/03/21 - 5/19/21 - Sweats return occasionally. Brain fog remains, and gets worse at times. Arthritis-like joint aches persist. Have in-person doctors appointment today at 1:40p because the joint-pain and related aches are still not going away.
The Moderna vaccine with lot # 003C21A that was sent out on 11/24/21 to our clinic should have the absolute expiration date of 12/17/21 and not 12/24/2021.
The patient returned for her 2nd Pfizer vaccine after 2 weeks (14 days) instead of 3 weeks. This wasn't noticed until after the shot had been administered and her vaccination record card was being filled out. Patient was monitored for 15 minutes after and no adverse event were observed
Patient was laying on her side asleep and her left hand began to shake. Then the shaking spread to her left arm at which point I picked her up and attempted to arouse her. She did not readily rouse from her sleep but I yelled and shook her gently at which point she did wake. She was not completely alert right away and took about 30 seconds to protest at being awakened as she normally would. She seemed fine about a minute after this episode and we thought nothing of it. The following week she had seizure that shook her entire body and required hospitalization where she received an EEG and MRI and was diagnosed with Epilepsy.
Within one hr. of vaccine, patient complained of throat pain going towards ears. This quickly resolved. patient then said her throat "felt funny". By this she meant her throat and cheeks felt numbs. She was in no distress and had no trouble breathing. We recommended she go to ER. While at ER, all symptoms resolved without treatment.
HEADACHE; This spontaneous report received from a consumer 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache. This report was non-serious.
DVT Lower Right Leg; This is a spontaneous report from a non-contactable consumer (patient). A 58-year-old male patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), via an unspecified route of administration in the left arm on 04Mar2021 16:15 (lot number: EN6199) as a single dose for covid-19 immunization. The patient's medical history concomitant medications were not reported. The patient was not diagnosed with covid prior vaccination. On 13Mar2021, the patient had DVT lower right leg which resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the adverse event which included Warfarin/Enoxaparin. The patient has not been covid tested post vaccination. The outcome of the event was not recovered.  No follow up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacist refers to a 43 year old male patient with asthma and without any drug reactions/allergies. The pharmacist reported that the patient was in the hospital for an unspecified simple surgical procedure, and before hospital discharge on 18-NOV-2013, the patient was administered PNEUMOVAX23 lot # J010654, "25 Micrograms", intramuscular in the right arm. Concomitant medication included unspecified inhalers for asthma. The patient returned to the hospital on 21-NOV-2013 with cellulitis on the right upper extremity, redness and swelling at the site of PNEUMOVAX23 injection and fever. The patient was admitted to the hospital and is currently being treated with Vancomycin (manufacturer unknown). Unspecified blood cultures were performed. Result were not provided. The outcome of cellulitis of the right upper extremity, redness and swelling at the site of PNEUMOVAX23 injection and fever were reported as not recovered/not resolved. No reporter causality provided. The pharmacist requested that a lot check for this PNEUMOVAX23, lot # J010654, expiry date 17-OCT-2014. Additional information has been requested.
Drug Allergies: Pneumococcal Vaccine - Edema; Drug Allergies: Pneumococcal Vaccine - Edema; This is a spontaneous report from a contactable physician for a patient enrolled in a Pfizer-sponsored program Pfizer RXPathways. A 54-year-old female patient received Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced drug allergies: pneumococcal vaccine - edema on an unspecified date with outcome of unknown.    Pfizer is a marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] has submitted the same report to the regulatory authorities.
About 10 minutes after the injection, patient passed out and fell face down onto concrete floor. Pt stood up to get someone's attention and dropped.
underarm swelling (from day of first injection continuing still); stomach bloating and discomfort about 10 days after second dose; stomach bloating and discomfort about 10 days after second dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient (not pregnant) received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), administered in arm right, administration date 10Mar2021 09:15 (Lot number: EN6204) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "depression" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: ACIPHEX; CRESTOR; DESVENLAFAXINE; LEVOTHYROXINE. Past drug history included: Azithromycin, reaction(s): "Allergies: Azithromycin"; Xanax, reaction(s): "Allergies: Xanax". Vaccination history included: Bnt162b2 (LotEL9266, time09:30AM, location Right arm, Dose1, fatigue resulting in sleeping 14 hrs+/day for 3 days), administration date: 17Feb2021, when the patient was 72 years old, for Covid-19 immunisation, reaction(s): "fatigue resulting in sleeping 14 hrs =/day for 3 days", "fatigue resulting in sleeping 14 hrs =/day for 3 days", "Muscle pain", "Joint pain", "underarm swelling". The following information was reported: SWELLING (non-serious), outcome "not recovered", described as "underarm swelling (from day of first injection continuing still)"; ABDOMINAL DISTENSION (non-serious), ABDOMINAL DISCOMFORT (non-serious) all with onset Mar2021, outcome "not recovered" and all described as "stomach bloating and discomfort about 10 days after second dose". Therapeutic measures were not taken as a result of swelling, abdominal distension, abdominal discomfort. Clinical course: Patient reported underarm swelling (from day of first injection continuing still), stomach bloating and discomfort about 10 days after second dose, continuing still. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was at a Public Health facility. Since the vaccination, the patient has not been tested for COVID- 19.  No follow-up attempts are possible. No further information is expected.
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 13 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in a cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Information has been received on 15-NOV-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information 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 2012, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In 2013, the patient was treated by the patient's healthcare provider at a community hospital 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 unknown. The causality of the events is related. Additional information has been requested.
3 DAYS AFTER RECEIVING THE H1N1 VACCINE I STARTED SPOTTING, WHICH THEN TURNED INTO BLEEDING AND RESULTED IN A MISCARRIAGE AT 7 WEEKS.  EVERYTHING WAS PERFECT AT MY PRENATAL CHECK UP ON 12/16 AND I HAVE ALREADY HAD ONE SUCCESSFUL PREGNANCY/BIRTH.  CAN'T UNDERSTAND WHAT CAUSED MY MISCARRIAGE.  I NEVER TYPICALLY GET FLU SHOTS, HOWEVER, WAS HIGHLY ADVISED BY MY OB-GYN TO GET IT.  I LATER FOUND OUT THAT THEY DID NOT KNOW WHAT WOULD HAPPEN TO A PREGNANT FEMALE WHO RECEIVED THE VACCINE.  NOT GOOD.
Bloody diarrhea, chest pains, bruising and swelling in same arm shot was given