chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first dose of Shingrix over a year ago / second dose/ not received till 5/18/2021 due to COVID; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose intramuscularly into the left arm over a year prior to the reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not applicable for this report. The patient did not get her 2nd dose until 18th May 2021, the day before reporting due to COVID.   The reporter consented to follow up.
On 10/28/17 at 8:45 am, my son received the flu shot. On 10/29/17 at 7:30 am, we woke to my son convulsing and having erratic breathing. The seizure lasted about 2 minutes. After the seizure, he lost consciousness for about 3 minutes. During the seizure, we called 911. The paramedics arrived a minute into him going unconscious. When he regained consciousness, his eyes were focused in one area for long periods of time. He did not register anyone or respond to my voice or his father's. The paramedics took his vitals upon arrival and they were normal. We were taken to the emergency room. They took his temperature and it was 102 degrees F. They gave him children's TYLENOL rectally. They also did blood work. Everything came back normal. We stayed there for about 5 hours so they could monitor him. His fever went down to normal after 30 minutes and he went back to his normal self. He was very tired and slept most of the time at the hospital. After leaving the hospital, he developed a cough and a cold which lasted about a week. He had a fever on and off for 3 days. We continued giving him TYLENOL every 5-6 hours for 3 days.
3 days post immunization welt formed on shoulder. Swelling started day after injection, painful & red now.
Swollen axillary lymph node. Right side. Fluid filled bumps primarily on hands. Sore left arm (site of injection) - soreness spread to other joints and muscles.
This spontaneous report was received from a medical assistant regarding a multiple unspecified number of patient of unknown age and gender. The patients' medical history, concurrent condition, drug allergies or concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II injection (strength and dose were not reported) (lot # L012481, expiration date 10-APR-2017; lot # L028273; expiration date: 28-JUL-2017) for prophylaxis. According to the reporter, M-M-R II doses were exposed to the following temperature excursions (reported as 82): between 47 degrees Fahrenheit (F) to 77 F, and between 32 F to 35 F, for an unspecified time. No adverse effects were reported. It was unspecified if a digital data logger was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA005263: US-009507513-1704USA005264: US-009507513-1704USA005262.
Walked in with Mom Friday am. In Raised erythema (area of varicella) did not feel good skin temp warm. Advised to go immediately to PMD.
Case number PHEH2013US020428, is an initial spontaneous report received from a pharmacist on 27 Sep 2013 and a follow up report from the pharmacist received on 19 Nov 2013. This report refers to a 62-years-old female patient. Her concomitant vaccine included ZOSTAVAX (batch number: J003360, other manufacturer) on 26 Sep 2013. Accidentally she received only Men C, Y, W-135 liquid component of MENVEO (batch number: X12097), intramuscularly in the deltoid without being reconstituted with Men A lyophilized conjugate vaccine component on 26 Sep 2013. No adverse event was reported following this administration error. Follow up report from the pharmacist received on 19 Nov 2013: Concomitant vaccine was added. The site of MENVEO vaccination was updated.
Mom deep red swelling from site going down to elbow. No pain/ numbness. Itching. Given Keflex as precaution.
Constant pain head, neck, back , limbs, hands and feet go numb, Uncontrolled Body tremor, uncontrollable neck tic, difficulty walking, tripping, loss of grip, loss of muscle, difficulty with speech, memory issues, loss of bladder, stuttering, difficulty making out words
Muscle aches; arm soreness/calf pain; Ankle pain; This is a spontaneous report received from a non-contactable consumer reported for herself. This 34-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced muscle aches and arm soreness after 2nd shot of covid19 vaccine, ankle and calf pain within 30 min of shot. Treatment was received for events. Muscle ache remained 2 days after shot when required ibuprofen (ADVIL) as paracetamol (TYLENOL) did not help. The outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
RASH AND ITCHING COVERING WHOLE BODY LASTING UNTIL THE NEXT DAY.
1/11/21 right after lunch 12:30-1:00 nauseous , body aches, wrist/finger/hip pain, intense headache could not open eyes, pt had to lay down, around 2:00 pt started to vomit throughout the day, later that afternoon pt woke up and missed the whole day rest of the day, pt drank water, 1/12/21 sometime around 1-2 AM patient vomited again, late morning pt tried to drink water and again vomited, pt slept most of the day and not able to consume water, 1/13/21 pt still tried to drink water, headache, body ache, pt was able to eat and then vomited, 1/14/21 pt continued to try drinking and eating light and this was the first day pt did not throw up, patient had to continue to lay down and close eyes, 1/16/21 left foot started to hurt and swell,  1/17/21 pt weighed  and lost 7 lbs, left foot pain continued swelling and blue, top of foot was bruised and really oddly swollen, pt went to doc 1/18-1/19 not sure on date, doc thought maybe pt sprained it, pt stayed in bed sleeping, pt stated it looked like gout, foot pain continued for 8 days, 1/28 pt was able to sit in chair and attend class, pt still cannot put weight on left foot as of 2/17, discoloration is gone, toes are swollen, pt is scheduled to see a podiatrist. Hips/wrist/fingers are sill sore.
None stated  12/28/07 Hospital medical records reviewed which reveal patient experienced irritability, intermittent bouts of inconsolable crying, spitting up, diet refusal, abdominal pain, reduced oral intake & suspected UTI.  Admitted 11/18-11/19/2007.  Peds GI consult done. FINAL DX: none provided, peds GI dx of acute episode of decreased oral intake possibly related to vaccinations & subsequent air travel.
One week post Injection, on 12/28, I noticed a hard lump on my left clavicle  (about 1.5 inches in size)-same side as injection. It was painful and partially mobile.  No other symptoms other than those of headache a few days prior mentioned below. I went to urgent care on 12/29 where CXR and soft tissue ultrasound were ordered. CXR normal. US 12/30 showed cluster of lymph nodes in that area.   Lump appears to be smaller this week and not painful.   Also, I developed a severe migraine on 12/26 (5d post vaccine). So severe that it was debilitating which is unusual for me. It lasted approximately 36 hours.
Blood clot in right leg; pain in leg and was swollen; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A female patient (age reported as 48, unit unspecified) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "Blood clot in right leg; pain in leg and was swollen". The patient had a pain in leg, it went away, then 2 days later in came back and was swollen. The patient had it scanned and there was a blood clot. She then had a hematology work up and a DNA test done that showed no genetic reasoning for the blood clot. It was determined by the hematologist that the cause was very likely the COVID-19 vaccine. The event took place after use of product. events "blood clot in right leg; pain in leg and was swollen" required physician office visit.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient stated that she was having problems breathing, sweating and felt tingling all over. She said she felt she had a tight chest. An emergency response was called and the patient blood pressure, pulse and O2 was checked and was normal. She was given an ice pack to the back of the neck and stopped sweating.  Upon questioning, she had not eaten anything all day and had only drank some pepsi and milk the day. Within 20 minutes she feeling much better and said she was feeling normal again.  She was checked by a provider to make sure everything was ok.
Dizziness, nausea, vomiting x 4  (45 min - 1 hour after shots), headache and shaking.
Recvd vax in am,developed T in pm,mom gave APAP.Pt started"jerking".Mom PC MD gave APAP.TO MD in am R/T "jerky movements" MD states pt was having sz.Pt has cont to have sz.Mom states"developmentally delayed" R/T sz per MD.
Patient said before getting the vaccine that he is afraid of needles and got heartburn from the first dose of the covid vaccine. After receiving the vaccine, the patient went and sat down on a bench. After about 4-5 minutes another patient came and got me and said he had fallen over on the bench and fainted. I went out to the patient and woke him up and he was very sweaty. I got him some water and fanned him. After about 10 minutes he sat up and drank more water. We watched him for another 10 minutes and then he got up and walked around and started feeling better.
This case was reported by a physician and described the occurrence of generalized petechiae in an infant subject who was vaccinated with PEDIARIX, HIB vaccine and PREVNAR. The subject had no history of bleeding. On an unspecified dates the subject received unspecified dose of PEDIARIX , unspecified dose of HIB vaccine, unspecified dose of PREVNAR for month two and month four vaccines. At an unspecified time after vaccination with PEDIARIX. HIB vaccine and PREVNAR, the subject experienced generalized petechiae that subsisted for a few weeks. Upon drawing blood, a low platelet count was found. All other blood type levels were normal. The petechiae lasted a few weeks longer at which point further blood work-up showed a form of platelet aggregation disorder. At the time of reporting the outcome of the events was unspecified.
Initial report received from a consumer who is a physician on 25 January 2011. A male patient (date of birth not reported) had received in a hospital setting a dose of Influenza vaccine (reported as FLUZONE) on an unknown date. The lot number and route of administration were unknown. Per the patient, the vaccine was administered at an incorrect site and was administered into the nerve. Following vaccination he developed paralysis of the injected arm. Per the patient, an adverse event report was completed by the hospital but he had no other information regarding that report. The patient did not wish to be contacted. No further information is expected. Documents held by sender: None.
No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 2-year-old male patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 20-NOV-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S007770; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
She had the first dose before she was 19 years old/ boosted dose 0.5 ml; She had the first dose before she was 19 years old/ boosted dose 0.5 ml; no adverse events; After giving the vaccine I noticed it expired on 01/09/2021; This spontaneous report was received from a medical assistant and refers to a female patient of unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, before the age of 19 years old, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) (exact dose, route of administration, lot # and expiration date were unknown) for prophylaxis. On 03-FEB-2021, the patient was vaccinated with the second booster expired dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 ml, lot # S034296 with expiration date on 09-JAN-2021 (route of administration was unknown) for prophylaxis. No adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S034296; expirationdate: 09-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
symptoms and subsequent confirmation diagnosis of Mondor's disease; This is a spontaneous report from a contactable healthcare professional (patient). A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 08Jan2021 15:30 (Batch/Lot Number: EL3246) as single dose for covid-19 immunisation. The first dose was received on 18Dec2020 15:30 (lot number: EK5730) intramuscular on the left arm at age 26 years old. Medical history included hyperadrenergic postural orthostatic tachycardia syndrome. There were no concomitant medications (no vaccine in 4 weeks and no other medications in 2 weeks). The patient previously took bactrim and experienced allergies. Soon after the second dose, patient had symptoms and subsequent confirmation diagnosis (20Jan2021) of Mondor's disease. At the time, patient had thought maybe it was related, but chalked it up to a coincidence and did not decide to report until patient had recently heard of a possible blood clotting relation to the COVID-19 vaccine. The event was experienced on 09Jan2021 and resulted in physician's visit. Outcome of the event was recovered. Treatment was NSAID (unspecified) for 6 weeks. Patient was not diagnosed with covid prior to vaccination and had not been tested post vaccination.
1/14 received vaccine. Presented to clinic 1/19 with headache and dizziness. Blood presure at home 157/80, took an additional 5mg amlodipine and tylenol and came to work. Headache and dizziness returned, BP in clinic 168/90. She ended up taking a leave of absence from work and is currently complaining of neuropathy and headaches, has been referred to neurology.
cerebrovascular accident (lt hemisphere) in pt, 10 days p/vax w/fluvirin; pt was vaxed on 14OCT91 & died 25OCT91; no other clinical info available;
Information has been received from a 61 year old female nurse who on 28-JUL-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 664630/0837Y). On approximately 08-SEP-2010 (6 weeks after receiving the vaccination, also reported as 28-JUL-2010), the patient contracted a case of shingles. This was treated with antivirals (dose, frequency, manufacturer, and name of drugs were not specified). On 21-FEB-2011, it was reported that she again, contracted a case of shingles which was also treated with the same course of antivirals (dose, frequency, manufacturer, and name of drugs were not specified). The patient sought unspecified medical attention. At the time of this report, the outcome of the patient was not reported. Follow-up information was received from the nurse indicating that she had her vaccine through a public health clinic not at a doctor's office. No further information is available.
(L) arm pain, redness, chills tender, SOB located from (L) deltoid to (L) forearm. Started 6/27/15 to current. Advised antihistamines and OTC PEPCID x 2 days.
Patient received first Moderna COVID vaccine on 2/11/2021 and second on 3/12/2021. She was tested and diagnosed with  COVID-19 on 6/16/21.
415 OV 97% BP 188/81 PULSE 81, PATIENT COMPLAIN OF DIZZINESS 416 STATES HE HAD A SMALL BREAKFAST ONLY TODAY.  SNACKOFFERED AND ACCEPTED 430 STATES HE IS FEELING BETTER AFTER SNACK 440 BP 178/91 HR 71 445 STATES HE WILL TAKE MEDS AFTER EATING DINNER, DRIVEN HOME BY FRIEND
induration 1.5 to 2cm @ site, entire arm warm, more @ induration;
An hour after the hep B shot was given to my child, he dropped limp in my arms and was lethargic. We were unable to wake him. He had shallow breathing with a fast heart rate. A week afterHep B shot, He had cold like symptoms, Stuffy nose, cough, sneezing. He also continues to have brief lethargic states with blank stares.
Narrative: ADMISSION DATE: 27OCT2021 DISCHARGE DATE: 07NOV2021 DISCHARGE TYPE: Death PRINCIPAL DIAGNOSIS (Reason for admission after study): COVID 19 pneumonia ADDITIONAL DIAGNOSES: Acute hypoxic respiratory failure Cytokine release syndrome grade III Hypercoagulable DIC COVID-19 encephalopathy Diabetes mellitus type 2 Diabetic retinopathy History of colostomy Chronic kidney disease stage IV with acute kidney injury, prerenal History of bowel obstruction Currently with ileus History of hepatitis B History of hypertension Anemia of chronic disease Hypernatremia Moderate protein calorie malnutrition Possible superimposed bacterial pneumonia, organism unknown HISTORY OF PRESENT ILLNESS: (per H&P) Presented to the ED for the second time in 5 days complaining of nonproductive cough and mid back pain. He had multiple back surgeries. On evaluation in the ED, T = 101.5, COVID-19 positive, BUn = 69, creatinine = 5.3, Hgb = 9.7 and admission was requested. The patient was noted to have worsening mental status and respiratory status, with agitation and requiring continuous BiPAP. He was transferred to the intensive care unit 05NOV: Overnight the patient has had no improvement in his mental status, he is responsive only to nausea stimuli. We had increase his FiO2 this morning for hypoxia to the 80s. His renal function has continued to decline despite IV fluids. 07NOV: The patient began to quickly decline around 0800. HIs family was informed. The patient passed at 0822.
Swollen deltoid with redness extending down to the elbow and warm to the touch. Significant Muscle soreness with throbbing pain the first evening. Itching.
-arm red hot with bullseye and hard knot - very sore - low fever, headache, fatigue
This initial spontaneous case, was received from other health professional (nurse) on 06-Nov-2017, concerning a patient of unspecified gender and age. This case refers to 18th out of 18 reports. The patient's medical history and concomitant medications were not reported. It was reported that most of the patients received the vaccine on 09-Oct-2017 (as reported), the patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number, expiry date: not reported) (explicitly coded to expired vaccine used). It was reported that, the patient had no reaction/had not experienced any adverse event after vaccination. The reporter assessed the events as non-serious.
Redness at and around the injection site greater than 2 inches in diameter. No other symptoms. No treatment provided.
pt recvd vax 1APR94 & had high fever that noc (was not taken in ER), vomited x 1-kept fever 2 days; devel rash on face 4 days p/shot; not itching-still was sl rash 12APR94;
Flu like symptoms; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007MZ0A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.    This case was linked to MOD-2021-369017 (Patient Link).
Headache, Arthralgia, NauseaVomiting, Fatigue Narrative:
Mild to moderated headache immediately following injection.  At approximately 1:30 the next morning I awoke with a stabbing headache on my left side top of head and stabbing pain in my abdomen. Similar to when I was hospitalized for covid in October.  I threw up and had dry heaves for 8 hours.  Took phenegren, Tylenol , ibuprofen and sudafed (as I was congested too) after the 8 hours of dry heaves I was able to take small amounts of electrolyte drink And keep it down. Deep joint pain and body aches in addition to fatigue continue.
Pt reported abdominal pain after taking the vaccine by oral route- which subsided after several hours. Did consult with CDC Info whom reported that this has been a reported adverse reaction in the past. Discussed with patient to discontinue vaccine and continue probiotic/hydration. Pt states that the symptoms have subsided by phone call this afternoon. Pt is aware if symptoms return to seek care from ER. Did follow up with patient by phone.