chrisvoncsefalvay/vaers-outcomes huggingface dataset:
loss of weight; very ill/sickness/sick; constant nausea; constant vomiting; constant diarrhea; can't eat; can't gain weight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 88-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WEIGHT DECREASED (medically significant), outcome "recovered", described as "loss of weight"; ILLNESS (non-serious), outcome "recovered", described as "very ill/sickness/sick"; NAUSEA (non-serious), outcome "recovered", described as "constant nausea"; VOMITING (non-serious), outcome "recovered", described as "constant vomiting"; DIARRHOEA (non-serious), outcome "recovered", described as "constant diarrhea"; FEEDING DISORDER (non-serious), outcome "recovered", described as "can't eat"; WEIGHT GAIN POOR (non-serious), outcome "recovered", described as "can't gain weight". The patient underwent the following laboratory tests and procedures: Weight: loss. Clinical course: she was still sick and can not even work anymore. She experienced loss of weight, constant nausea, constant vomiting and constant diarrhea for almost 2 years now, got down to 52 pounds, can not eat, can not gain weight. Caller wanted to know the contents of the Pfizer covid-19 vaccine. She also mentioned that her mom (patient) is experienced the same symptoms who also received Pfizer covid-19 vaccine (she was not sure which formulation). Her mom was not going through that and she was 88. Her symptoms were by her daughter checked in the last 3 months.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300202423 Same reporter/vaccine/event, different patient;US-PFIZER INC-202300203422 Same reporter, different patient/drug/event;
Fever; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 24-years-old female non pregnant patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 26Jul2021 12:30 (at the age of 24-years-old) (Batch/Lot Number: FA7485) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included colitis and covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 26Jul2021 17:30 patient experienced fever, muscle pain. patient received treatment as Tylenol. Patient had no other vaccine in four weeks, and no other medications in two weeks, patient has no allergy. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient diagnosed with COVID-19, Since the vaccination, patient not been tested for COVID-19. Outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Swelling, itching, blisters, redness, hardness in arm, hot arm. Prescribed antibiotics for 10 days and did not heal, received additional 5 days of antibiotics. Skin still blistered, healing.
Chills/fever swollen sore tonsils nausea/vomiting lethargy. Symptoms started 10/13/10 am. Doctors appt 10/15/10 am. Symptoms ended 10/16/10 pm.
Patient developed rash 33 hours after vaccines were administered. Rash started on bilateral thighs and spread to trunk, arms, and down legs.  No difficulty breathing, vomiting, or diarrhea.  Patient was also fussier than normal, per Mom. Exam in office reassuring except for rash; notable blanching erythematous plaques with areas of confluence on trunk, arms, and legs, as well as swelling of bilateral feet.  Vital signs were reassuring and normal.
initial and follow up information has been received from a physician,  concerning his 16 year old daughter, with a history of patient ductus arteriosis (PDA) ligation who on 11-JUL-2006 was vaccinated with the first dose of Gardasil, on 23-Oct-2006, with the second dose of Gardasil and on 06-APR-2007 was vaccinated, IM, with the third dose of Gardasil. The physician reported that on 07-APR-2007, the day following the vaccination, his daughter experienced flu-like symptoms, was extremely nauseated, and had severe malaise that lasted for three to four days after the vaccine had been administered and then recovered (approximately 12-MAR-2007).  The patient's sister also experienced flu-like symptoms and nausea and malaise after vaccination with Gardasil (WAES #0704USA05005).   Additional information is not expected.
Patient is a 52 YO F with history of seizure disorder, COPD/asthma, ongoing tobacco abuse, HTN, who was admitted with acute hypoxic respiratory failure due to COVID-19 infection. She was started on decadron, remdesivir. Unfortunately, she developed progressive respiratory failure and ultimately was transferred to the ICU for treatment, once she was requiring HFNC and BiPAP. Further workup with CT angiogram of the chest demonstrated new bilateral lower lobe consolidations without evidence of PE. She was started initially on ceftriaxone/azithromycin, which was later broadened to cefepime/vancomycin for a positive MRSA screen. She was transferred back to the floor once she was of BiPAP, and had subsequent improvement over the next few days with weaning down to 3L NC. She was asymptomatic despite hypoxic. Plan was to continue IV antibiotics to complete a 7 day course for possible MRSA pneumonia. On day of discharge, patient requested immediate discharge. She was resistant to any further delay and was not willing to stay for repeat therapy evaluation. She was set up with home oxygen and home care. Will discharge with 3 more days of doxycycline to complete her antibiotic course. She will follow-up with PCP and pulmonology.
ROTATEQ, PEDV AX HIB, RECOMBIV AX HB, GARDASIL 9 and VAQTA that went out of range were potentially administered; No additional adverse effect reported; Information has been received from a nurse istant and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history, concomitant medications or drug reactions/allergies.  On unknown dates, the patient was potentially vaccinated with doses of the following vaccines that were out of range: hepatitis b vaccine (recombinant)(RECOMBIVAX HB), lot # R028529 and expiration date of 09-JUN-2021, lot # T004378 and expiration date of 01-NOV-2022 and lot # R021372 and expiration date of 25-MAY-2021, hepatitis a vaccine, inactivated(VAQTA) lot # T020442 and expiration date of 26-JAN-2022 and lot # T014835 and expiration date of 17-JUL-2021, haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # T001208 and expiration date of 09-JUN-2022 and lot # T020615 and expiration date of 13-MAR-2023, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number 1621926 and expiration date of 28-NOV-2021 and lot # 1602284 and expiration date of 26-SEP-2021 (route of administration and anatomical location were not reported) and with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1676322 and expiration date of 21-APR-2021, lot # 1688822 and expiration date of 20-NOV-2021 and lot # 1691301 and expiration date of 12-DEC-2021 per oral route, all for prophylaxis, which were stored in the following ranges: 9 Celsius degrees to 25 Celsius degrees (8.53 Celsius degrees) for 15 minutes and 9 Celsius degrees to 25 Celsius degrees (11.6 Celsius degrees) for 45 minutes.  No previous temperature excursion was reported. No additional adverse effects were reported.  Digital data logger was involved.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2103USA003717: US-009507513-2103USA005236: US-009507513-2103USA005237: US-009507513-2103USA005238: US-009507513-2103USA005240: US-009507513-2103USA005241: US-009507513-2103USA005234: US-009507513-2103USA005233: US-009507513-2103USA005235:
Information has been received from a licensed practical nurse concerning an 8 week old male who was vaccinated with a first oral dose of Rotateq (no lot number was given). Concomitant vaccines included "all the other recommended vaccinations given at 2 months of age." In the late afternoon, after receiving Rotateq, the patient experienced vomiting and diarrhea. Subsequently, the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Information has been received from a certified medical assistant concerning a 21 year old female with dysmenorrhea and no known drug allergies who was intramuscularly vaccinated with 1st, 2nd and 3rd 0.5 ml doses of GARDASIL (1st lot #0250X, 2nd lot #660620/0571X, 3rd lot #661846/1312X) on 23-SEP-2008, 24-NOV-2008 and 23-MAR-2009, respectively. Concomitant therapy included YAZ and FAMVIR. In November 2008, prior to the 2nd dose, the patient experienced sensitivity to wheat. It was reported that bread and pasta products caused severe bloating, a churning feeling in her stomach, and difficult digestion. Then she got either constipation or diarrhea. These symptoms occurred about 15 minutes after any wheat consumption. When she did not not eat those products, she felt much better. At the time of reporting, she did not recover. The patient called the office for medical attention. Additional information has been requested.  5/13/09 medical records received DOS 2/3/05 to 3/26/09 FINAL DIAGNOSIS: GI upset Post vaccination GI upset, nausea, constipation, diarrhea, feels bloated, abdominal pain. ICD-9 codes: 787.3 abdominal bloating, 789.00 abdominal pain, 626.0 amenorrhea, 625.3 dysmenorrhea, 698.9 pruritis. V13.01 HX of Nephrolithiasis, V13.8 HX of Facial Herpes
Patient received ZOSTAVAX vaccination on 4/4/2013 and on 4/11/2013 patient called and stated that "he had rash and swollen at injection site". Patient was told to see doctor for further evaluation.
Severe headache,fever.lower back pain,general all over body pain,coughing,thick secretions and mucus out of lungs[grayish-green color]
she developed a rash on on her arm and chest within 2 hours of the shot; This is a spontaneous report from a contactable consumer (patient's mother). A 14-year-old female patient (reporter's daughter) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0185 and expiry date was not reported), via an unspecified route of administration, on 02Jun2021 (age vaccination: 14 years), as dose 2, single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included Penicillin allergy. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN5318 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on an unspecified date, as dose 1, single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID Since the vaccination. The patient developed rash on both arms 3 days after the vaccination. It lasted for 2 weeks. Her 2nd vaccination was on 02Jun2021, and she developed a rash on on her arm and chest within 2 hours of the shot. The rash persists. The patient took Zyrtec and rash lessens with Zyrtec. Outcome of the event was recovering.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up attempts are completed. No further information is expected.
Patient reports numbness on left arm (injection arm), positive PMS. Visual inspection reveals no significant abnormalities.
Driving in car, patient's eyes rolled back and became unresponsive, then saliva came out of mouth and a choking sound. Total time lasted about 3-4 minutes.
redness (vaccination site); Arm pain; Swollen arm; Swollen neck; Dry Mouth; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness (vaccination site)), PAIN IN EXTREMITY (Arm pain), PERIPHERAL SWELLING (Swollen arm), SWELLING (Swollen neck) and DRY MOUTH (Dry Mouth) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L2U9) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included AMLODIPINE for Blood pressure abnormal.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness (vaccination site)), PAIN IN EXTREMITY (Arm pain), PERIPHERAL SWELLING (Swollen arm), SWELLING (Swollen neck) and DRY MOUTH (Dry Mouth). The patient was treated with ACETAMINOPHEN for Pain, at an unspecified dose and frequency.   At the time of the report, VACCINATION SITE ERYTHEMA (redness (vaccination site)), PAIN IN EXTREMITY (Arm pain), PERIPHERAL SWELLING (Swollen arm), SWELLING (Swollen neck) and DRY MOUTH (Dry Mouth) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  For mRNA-1273 (COVID 19 Vaccine Moderna) administered intramuscularly, the reporter did not provide any causality assessments.
Sore arm, red circle around injection site, about an inch wide., and it?s hard.  Arm is hot, both  at the injection site, and  in the area immediately surrounding the injection site-probably extends about 4-5 inches in each direction.  This was patient's second meningitis vaccination and these symptoms did not occur with the first. However, he had a very similar reaction(but worse!) in his thigh when he got the TDAP when he was about 4  or 5 years old. OF NOTE-I was forced to select a manufacturer above but I DO NOT KNOW what manufacturer it was. Contact the provider please!
Got Covid after receiving both vaccines; Got Covid after receiving both vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 87 year-old male patient received bnt162b2 (BNT162B2), administration date 11May2021 (Lot number: EW0169) at the age of 86 years as dose 2, single and administration date 20Apr2021 (Lot number: ER8731) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 19Dec2021, outcome "unknown" and all described as "Got Covid after receiving both vaccines". The patient was hospitalized for vaccination failure, covid-19 (start date: 19Dec2021, discharge date: 22Dec2021, hospitalization duration: 3 day(s)). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive.  Clinical course: Caller (patient) clarified that he got two shots, he ended up in the hospital for two weeks with a blood clot, he couldn't walk, then he went through months of rehab. Stated then he got Covid.   No follow-up attempts are possible. No further information is expected
Fever, body aches, chills, cold sweats, headache, nausea, joint pain
Tachycardia.   Pt presented with c/o rash that once she saw she said it made her more anxious. She has anxiety disorder and being in the line waiting she became more anxious. This culminated upon the shot being given and once she saw the rash she became more anxious. Her vitals were B/P 148/100, Pulse 108 and SaO2 was 99%. She started to become more calm. No Chest pain SOB or dizziness. Her current B/P is 122/77 pulse 84 and SaO2  99%. She felt better and was discharged after 30 minutes observation
Mom (Parent) reported that child was noted to be woken from sleep at 3AM post day of vaccine with "Full body shaking, heavy breathing" for about 5 minutes. No loss of weakness, no SOB. Returned to sleep. 9PM next day noted to be "starring". Mom reported event to Immunology office 2 days past vaccine.
BODY RASH; SINUS CONGESTION; RUNNY NOSE; COUGH; SWOLLEN TONSILS.
Thigh swelling and pain.  Per mother patient had trouble walking and would not let her touch his leg.  Fever to 102 today at home, no other complaints.  DIPHENHYDRAMINE--PO 12.5MG/5ML ELIX -  GIVE 2 TSP (10ML) EVERY 6HRS FOR RASH OR ITCHING #1   IBUPROFEN--PO 100MG/5ML SUSP - GIVE 1.5 TSP (7.5ML) EVERY 6HRS PRN FOR PAIN  AMOX/CLAV(AUGMENTIN*ES*EQ)-PO 600/5ML SU - 5 ML PO BID F 10 DAYS
2/10: fatigue 2/12 @ 1900: SOB, wheeze, rhonchi, decreased SpO2. Tylenol, 2L NC applied, duoneb, IM Solumedrol, ST CXR, mucinex 2/12 @ 22:00 SpO2 70's, transfer to Hospital via EMS @ 22:30
Events happened about 5 mins after shot was given. Patient experienced lightheadedness, loss of consciousness for a couple seconds, uncontrolled urination, hot flashes, headache. Patient was given water and a snack to consume. After about 10 minutes of resting and consuming food, she feeling better afterwards, said it could have been to fear of getting injections, and was able to go home with her family.
This spontaneous report as received from a pharmacist refers to a 57 year old female patient. There was no pertinent medical history and no drug reactions or allergies. On 07-DEC-2014, the patient was vaccinated with ZOSTAVAX lot # J013138 expiry date 17-JAN-2015 (dose and route not reported). Concomitant therapies included levothyroxine sodium (manufacturer unknown), LAMICTAL and MYRBETRIQ. It was reported that the patient stopped taking VALTREX prior to the administration of ZOSTAVAX. Pharmacist reported patient inquired of she could continue taking VALTREX again since patient "felt like a herpes outbreak is about to happen (on an unknown date in December 2014). No lab diagnostics performed. At the time of the report, action taken regarding therapy with ZOSTAVAX was not reported. The outcome of the event was reported as not recovered. Additional information has been requested.
OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTRATION; This spontaneous report received from a health care professional concerned a 69 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 211A21A expiry: 14-DEC-2021) dose was not reported, administered on 27-SEP-2021, and dose was not reported, administered on 15-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-SEP-2021, the patient experienced off label use. On 27-SEP-2021, the patient experienced inappropriate schedule of vaccine administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate schedule of vaccine administration was not reported. This report was non-serious.
MMR 11/14/01. On 11/25/01 seen in ER for increase diarrhea temp 11/21/01-11/23/01 to 102.5 (max) and viral exanthem noted in ER. Seen in office 11/26/02. Pt had history of chronic diarrhea x mos and had been previously seen by ped GI specialist-worse after vaccine initially parents feel he has been pickier eater/less wiling to eat textures since. Is diagnosed with sensory integration. No at this time.
He developed shingles in left T4 distribution 4 days after his vaccine. No sick relatives or contacts. Wife had same vaccine and had no rash. Hx of varicella in his youth.
This information has been received from a licensed practical nurse concerning a 12 month old patient of unknown gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. The nurse stated that on 22-JUN-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 with lot number N001007 and expiration date on 19-SEP-2018 (dose, dose number, route of administration and anatomical location were not provided) administered for prophylaxis. The nurse stated that the physician ordered PNEUMOVAX 23 instead of PREVNAR 13 for this patient. The nurse confirmed that this event was a result of human error, not product confusion. No adverse effects were reported.
This case was reported by a nurse via sales rep and described the occurrence of extra dose administered in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB39AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (1st dose received on 23rd March 2021 at a local pharmacy) and Bexsero (2nd dose received on 30th June 2021 at a local pharmacy).   On 2nd December 2021, the patient received the 3rd dose of Bexsero .5 ml and Bexsero Pre-Filled Syringe Device. On 2nd December 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered 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 details were provided as follows: The patient inadvertently received 3 doses of Bexsero, which led to extra dose administered. The patient was unaware that she had received menB vaccine previously and the nurse office didn't have documentation of previous vaccination. The patient's mom was aware and called nurse office when she learned of the additional dose. Nurse stated that while in the office the patient did not report any adverse events. The patient's mom also stated that the patient did not currently had any adverse events following vaccination. The patient's mom was advised to call the office if any adverse events developed. The reporter stated that the GlaxoSmithKline could follow up on the maladministration.
A few seconds after receiving immunizations, infant stopped breathing for 15-20 seconds.  Exhibited posturing with head to R.  Responded when air blown into mouth, began crying.  Had 2 more apneic episodes, responded to stimulation. Skin pale at time of 1st event.  approximately 10 minutes after initial event, color pink, crying.
Received Previnar13. Muscle weakness, pain, shoulder very painful joint with limited range of motion. Ongoing since initial injection. Now getting physical therapy.