chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received the fluzone vaccine on 10/22/2008, (lot # U2757AA,Sanofi Pasteur) IM in my right deltoid.  Throughout the day there was minimal pain in my right arm but no swelling or redness at the injection site.  Approximately 14-15 hours after receiving the vaccine I awoke from sleep with severe pain in both arms, but much worse in the right.  I experienced burning pain throughout both arms, deep in the muscles and in my joints.  The pain was in my wrists, elbows, hands and deep in my right armpit and into my right breast. I took ibuprofen 600 mg every 4-6 hours x 24 hours with little relief.  The left arm pain resolved within 24 hours but the right arm pain continued, and gradually subsided after 48 - 72 hours.
Fully vaccinated and boosted in November.   COVID infection breakthrough and inpatient hospital stay.
Came to office for 11 year check-up. Child is extremely anxious and mom requested shots be given right away before anything else was done. Nurse gave Tdap and Menactra as standing order for 11 year PE. Child had Tdap 3 months previously for an injury. Mom forgot to mention before shot was given.
Child received PEDIARIX/PREVNAR 1/09/2009 at 09:25 per / LPN- 1/10/2009 Mon report swelling, redness at site and thigh swollen 1/12/09 "doing better"
pt recv vax & few hr p/vax pt devel gen wheals & flares, eyelid swelling;sent to ER;
On May 31st I was diagnosed with Chicken pox. I had swollen lymph nodes, headache but no fever.
Fever and rash started 10 days post imms. Had several erythematous (3-7mm) lesions on trunk and chest with central excretion (sloughed vesicle?).
This spontaneous report as received from a other health professional refers to patients of unknown age and gender. On unknown dates, the patiente were vaccinated with VARIVAX lot # N001527 and lot # N007930 for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On unknown dates, the patiente experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event were unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA005004: US-009507513-1708USA011266:
Patient is a 19 y.o. female patient of Dr with an uncomplicated pregnancy who was admitted for maternal tachycardia in the setting of an active COVID infection. On admission patient was tachycardic to the 130s and was given a 1L bolus. EKG showed sinus tachycardia. Required 1L of oxygen overnight due to desaturation to 94%. On discharge, tachycardia resolved, required no oxygen requirement and patient was asymptomatic. An MFM ultrasound was scheduled on 9/5 at 10:30 am. She also has a follow up with Dr on 9/5. She was discharged home with return precautions.      Discharge Diagnoses: * Coronavirus infection Assessment & Plan  Patient is a 19 y.o. G1P0 at 28w3d who presents with with uncomplicated pregnancy who is admitted to hospital with tachycardia in the setting of COVID infection.    Covid w/ Maternal Tachycardia - Tachycardia has resolved in low 110s, NT, AF   - 99% on 1L of oxygen- desatted to 94 when sleeping  - s/p 1,000 mL fluid bolus - Growth US for further fetal evaluation- needs scheduled  - Offered Paxlovid but patient declined.     Fetal wellbeing -cEFM/Toco  -Preg diet  -BMZ: held    Dispo: Continue to monitor. Tachycardia has resolved, deescalate this morning. Oxygen requirement overnight, attempt to wean when patient wakes up. Consider echo if becomes more symptomatic or tachycardia returns.
arm was red, swollen w/knot noticed next day-arm still remains swollen & w/some pain on movement;has used ice on site & has talked w/MD;
The day after her vaccine she began with severe fatigue, body aches, heaviness, and redness and itching to bilateral hands up to wrists.
Participant returned one hour after receiving injection stating feeling lightheaded, queasy, "like I am going to throw up." States, "drank some OJ," has had this feeling before. Skin warm and dry, no chest pain, shortness of breath or dyspnea. No hives, swelling noted. 10:00 AM BP 140/76, pulse 72. Patient states feeling much better, no wheezing noted. 10:15 AM patient states feels fine, no difficulty swallowing. 10:20 AM instructed to return if any further problems.
No additional AE reported; RECOMBIVAX HB had been involved in multiple low temperature excursion and was administered; This spontaneous report has been received from a medical assistant referring to a 9 months old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication were not provided.  Hepatitis b vaccine (recombinant)(RECOMBIVAX HB)had been involved in multiple low temperature excursions on 03-NOV-2021(35 degree Fahrenheit(F) for 0.25 hour), 04-NOV-2021(35 F for 0.75 hour), 05-NOV-2021(35 F for 0.5 hour), 12-NOV-2021(35 F for 0.25 hour), 15-NOV-2021(35 F for 1.5 hour), 16-NOV-2021(33 F for 4.25 hour), 17-NOV-2021(34 F for 2.25 hour) and 18-NOV-2021(34 F for 1.25 hour), respectively. The previous excursions were unknown.  On 19-NOV-2021 the patient was vaccinated with the improper storage hepatitis b vaccine (recombinant)(thimerosal-free)(RECOMBIVAX HB) (lot # T028933, expiration date 03-NOV-2022; strength, dose, frequency, route and anatomical location were not reported) for prophylaxis(product storage error). No additional adverse event (AE) was reported, and no further information provided.
This spontaneous report as received from a doctor of pharmacy refers to a 67 year old female patient with amoxicillin allergy. On 01-nov-2013, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # J004269, expiration date 12-JUL-2014) subcutaneously in the left arm. On the same date, the patient also was vaccinated with a dose of PNEUMOVAX23 (dose, route and lot # not reported) in the right arm. The pharmacist reported that on an unknown date, the patient experienced intermittent pain on her left arm at injection site of ZOSTAVAX. The patient stated that the pain was most noticeable at night, when she was lying down. There were no Lab diagnosis or studies performed. The outcome of intermittent pain on her left arm at injection site was reported as not recovered/not resolved. Additional information has been requested.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE FOCAL MOTOR SEIZURE EPILEPSY, UNSPECIFIED ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
2 days, post vax, the pt had erythematous swelling of 5cm X 5cm in diameter noted with induration at left thigh.
Immediate fever, slowly degenerated over weeks time. Language disappeared and regressed over the next six months. many fevers and viruses. On 12-99 roseola. 01/01 hand, foot, mouth. 01/01 scarlett fever, roseola rash has never disappeared on arms, face, thighs. His behavior became aggressive.
FEELING HOT/FEVER 104.8; This spontaneous report received from a parent concerned a 25 year old female. 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) dose was not reported, administered on 07-APR-2021 around 8:00 or 9:00 vaccinated on left deltoid 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 07-APR-2021, the subject experienced feeling hot/fever 104.8. Treatment medications included: ibuprofen. On 07-APR-2021 21:00, Laboratory data included: Body temperature (NR: not provided) 104.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling hot/fever 104.8 was not reported. This report was non-serious.
Flu Vaccine: case resulting in allergic reaction Patient received Afluria Quadrivalent Influenze Vaccine on 10/7/23. Pt admitted to ED with possible allergic reaction after receiving seasonal flu vaccine. Pt reports experiencing symptoms such as burning sensation on the roof of her mouth and feeling a lump in her throat with a slightly hoarse voice. She denied any difficulty swallowing, shortness of breath or trouble breathing. She reported no tongue/lip swelling nor intraoral/throat swelling. Patient denied nausea, vomiting, and diarrhea. She experienced no rashes, and does not have a history of reaction to the flu vaccine. Pt recieved children's benadryl. No harm came to patient.
Administered pediatric concentration of Pfizer vaccine, diluted with 1.8ml normal saline instead of adult concentration.  Patient contacted once error recognized and asked to return to Clinic to receive adult dose as recommended.  Patient has not returned to facility yet.
Starting on Saturday early morning, had severe chills and was very tired. Had a fever of 101 and slept off an on all day. Could not keep my eyes open and went to bed very early. I woke up the next morning (Sunday) feeling soso even though the day before I drank a bottle of gatorade, a bottle of water and 1/2 of a jug of a 3  gallon water. My legs were sore, like a feeling of being dehydrated, not flu like and my arm swelled up like a balloon, my eyes were very swollen, hands and feet as well. The swelling lasted until this past Saturday, April 10 and had a bunch of water weight on my body (4 extra pounds, which I have shed 2 of). I have a lot of memory loss as well as I ended up with my period, which I have not had in approximately 9 years.  I had a headache for the first four days.
Sudden problem in throat at point of esophagus (sp?) which then became sore.  This followed by severe shaking/shuddering, despite heavy layering of clothing and blankets.   Could not get warm.  This followed by fever, followed by diarrhea then general nausea.  Became very weak, could not face food for next three days - intermittent fever throughout.
From initial information received on 09/Dec/2003 from a health care professional regarding an adverse event occurring in the USA, it was reported that an 11-year old female patient received her first dose of TD ADS adult, lot number U0831AA, administered intra-muscularly in the left deltoid on 23/Jun/2003. Two days later, the patient developed a lump on her arm that was reddened and tender to touch. Warm soaks, Tylenol and Benadryl were advised. The child was taken to the emergency room. Mother called on 26/June/2003 and stated that the child was diagnosed with cellulitis vs allergic reaction. The patient was given Keflex 500 mg three times a day. The patient's concomitant medications include Advair, Albuterol nebs, Singulair, and Zyrtec. Her pre-existing medical history included asthma, seasonal allergies, and local cellulitis vs allergic reaction after flu vaccine (case #U2002-01023). Reportedly, the patient recovered from these events.
NO LONGER ABLE TO DONATE BLOOD BECAUSE IT APPEARS TO BE RH SENSITIZED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Due to the rarity of A- blood type patient donates blood regularly. Patient had never been pregnant nor had a blood transfusion before vaccination. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced no longer able to donate blood because it appears to be rh sensitized. Laboratory data (dates unspecified) included: Rhesus antibodies (NR: not provided) Positive, Blood appears to be Rh sensitized. The action taken with covid-19 vaccine was not applicable. The outcome of no longer able to donate blood because it appears to be rh sensitized was not reported. This report was non-serious.
Not being able to walk; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (Not being able to walk) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0041c21a and 043b21a) for COVID-19 vaccination.     Concurrent medical conditions included Spinal cord compression (Compressed vertebra).   On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GAIT INABILITY (Not being able to walk). At the time of the report, GAIT INABILITY (Not being able to walk) outcome was unknown.            Patient was using many concomitant medications. Patient was unable to walk since March . Treatment information was not provided.
Reports waking in night with increased heart rate, lower blood pressure, temp 95.2, diaphoretic, vomiting, dizziness, muscle weakness, itchiness at injection site. Continued through the night.  She was seen by, PA on 7/2/18 and prescribed ZOFRAN for the nausea.
Started with 1 on abd Sunday pm 7/14/13 then Monday - underarm, chest, back.
the patient received an improperly stored dose of VARIVAX; This spontaneous report was received from a pharmacy technician referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported.     On 03-JAN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose, lot # S024366 with expiration date reported as "02-MAR-2021", for prophylaxis (route of administration and anatomical location were not reported). Concomitant therapies included sterile diluent(MERCK STERILE DILUENT) which was properly stored. It was reported that the vaccine was exposed to a temperature of -14°C to -10°C for 2 hours 30 minutes and -9°C to 8°C for 5 hours 40 minutes. No previous temperature excursion was reported. A digital data logger was involved.  Lot # S024366 was determined to be a valid lot # for varicella virus vaccine live (oka/merck)(VARIVAX), expiration date was reported as "02-MAR-2021", but after internal review, it was determined as 06-AUG-2021.
I had spotting mid-cycle for 5 days and now my period is over 10 days late.  I am not pregnant.
I was on a Zoom meeting and around 2 PM I suddenly had a severe pounding at the base of my skull on the right side and it radiated to my forehead. It was so severe I had to get off my meeting and lay down. After about 5 mins the intensity remained so I asked my husband to take me to the emergency department. I was seen at the ER and my blood pressure was very elevated. My labs and CT were all normal but despite treatment for my head pain and a BP medication, my blood pressure remained elevated. The head pain finally abated by the next morning. However, my BP reamined elevated over the period of several months. I checked my BP periodically and it ranged from 140's/88-89 and finally on 4/13/22 my blood pressure went back to normal and has stayed around 105/71 - 112/70 range.
Information has been received from a physician concerning a 19-year-old female patient, who on 09-OCT-2008 received a third dose of 0.5 ml GARDASIL (lot # 660618/0572X, injection site not reported) via intramuscular route.  Concomitant vaccination included a dose of FLUZONE (preservative free).  The patient had previously received her first dose of GARDASIL (lot # 658556/1060U), together with a dose of MENACTRA and DTAP on 22-FEB-2008; and her second dose of GARDASIL (lot # 658556/1060U) on 13-APR-2008.  On 09-OCT-2008, within 5 or 10 minutes after administration of the third dose of GARDASIL, the patient reported that she felt dizzy and lightheaded and sunk to the floor.  Loss of consciousness was suspected.  She was very "confused, pale, color poor and limbs cold."  The patient was placed on exam table.  She did not have a palpable pulse; her heart rate was in 40's via stethoscope and her blood pressure was 80/50.  She was diaphoretic.  The patient was given some apple juice and condition monitored.  According to the patient, she had not eaten breakfast.  After given more juice, the patient's heart rate improved and her blood pressure rose to 90/60.  After being observed for a while she was sent home.  The patient also had a similar episode a few weeks ago after running at a track.  On a follow up phone call from the doctor on 10-OCT-2008, the patient was fine.  Additional information has been requested.
Feeling of warm and burning sensation in the forearm; Feeling of warm and burning sensation in the forearm; This case was reported by a consumer via call center representative and described the occurrence of skin warm in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th February 2020, the patient received the 1st dose of Shingrix. In April 2020, between 1 and 3 months after receiving Shingrix, the patient experienced skin warm and burning sensation. On an unknown date, the outcome of the skin warm and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the skin warm and burning sensation to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. In April 2020, the patient started noticing a feeling of warm and burning sensation in the forearm, It was on the same arm where patient received the vaccine but not exactly at the injection site, but more on her forearm. The patient said that the feelings are intermittent. The reporter consented to follow up.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 1:13 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 1:13 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was reported as 58.60.  Concomitant products were not provided.  On 03-Apr-2021, Temperature Excursion at 9 AM the temperature was 34 degrees Fahrenheit, Total doses given for the day was 210, Condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic on respective dates. Vaccine BUD date was 29-Apr-2021.  Vial was stored in cooler 1, on 03-Apr-2021, Excursion duration, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM : 41, 3 PM: 40, 4 PM: 40 and 5 PM : 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Pt recv vax on 4/5/99; 10 min post vax pt exp red/ raised are on right thigh
Pain, swelling and redness that is spreading slightly. Warm to the touch and itches. As of today the pain and swelling are getting better but it?s been 4-5 days. My first dose was typical with pain a swelling gone within 2-3 days.
DEVELOPED INTENSE LOWER BACK PAIN/MUSCLE SPASMS THAT HAVE LASTED SINCE 11/28/2021. HE COMPLAINS OF IT BEING DIFFICULT TO WALK DUE TO THE PAIN.
Patient states arm was extremely sore and hurt to move with radiating pain to shoulder and back. Patient still experiencing pain about 20 days after the vaccine. Patient states she was going to urgent care to be checked out.
COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 24Mar2021 at 13:00 as dose 1, single (Lot number: ER2613), in left arm and on 14Apr2021 at 13:00 as dose 2, single (Lot number: ER8729) at the age of 48 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Dec2021 at 15:00 as dose 3 (booster), single (Lot number: 012H21B), in left arm and on 10Oct2022 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Dec2021, outcome "not recovered"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Positive; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: Patient took Paxlovid, felt better, tested negative.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300199926 same patient, different drug, different event;
No adverse effects; patient received improperly stored VARlVAX; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.   On 10-SEP-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (strength, dose, route, frequency, were not provided) for prophylaxis; the Lot No. S003864 has been verified to be a valid lot number for [Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live], expiration date reported as 08-AUG-2020, and upon internal validation established as the same.   The medical assistant reported that the vaccine dose was administered to the patient and the vaccine was improperly stored (incorrect product storage). The vaccine presented a temperature excursion with a temperature of 6°F to 14°F (7.7 degrees F) for 30 minutes. And no adverse events were reported.   Moreover, it was stated that the sterile diluent that was used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was properly stored. The Lot was No. S016519 and the expiration date reported as 01-APR-2022.
Abdominal pain on day of shot (3/29), subsided that evening.  Intense abdominal pain on 3/31 beginning at 7 PM, continuing into 4/1. Went to urgent care, CT scan showed inflamed appendix, referred to ER and surgery performed at 8 PM on 4/1.
My son developed a rash all over his chest and back a couple of hours after receiving the vaccine.  He also developed a sore throat
pt seen 2 days p/inject recvd erythema 7x8 cm in size, some pain on palpation, pos inc color; given DPH;