chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left arm pain, redness of skin at site of injection, warm to touch and fever of 101.6F. Treated with cool compresses and Tylenol for pain and lots of fluid. Seen in office on 11/3/00 and was completely resolved.
p/vax pt exp achy muscles, stomach complaints, vomiting x48hr; diarrhea; tiredness; h/a
Lymph nodes under arm are super swollen and painful; Lymph nodes under arm are super swollen and painful; Headache; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6198, Expiration Date: Jun2021), via an unspecified route of administration in left arm, on 27Feb2021 at 11:00 (at the age of 43 years), as dose 2, 0.3 mL, single, for COVID-19 immunization. The patient's medical history included asthma (diagnosed around 5 years old) and polycystic ovarian syndrome (PCOS; diagnosed at 23); both were ongoing. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Lot Number: EN9581) on 06Feb2021 (at the age of 43 years) for COVID-19 immunization (right arm). The patient was calling about the COVID-19 vaccine and reported that she had the vaccine second dose and her lymph nodes under arm are super swollen and painful since 28Feb2021. The patient also has a pretty bad headache that started coming on the afternoon one day before reporting (28Feb2021) and has gotten worse at the day of reporting. The conditions worsened at the day of reporting. The patient had not recovered from the events.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a healthcare worker and refers to 9 unspecified patients of unknown age and gender. The patients' medical histories and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with the improperly stored doses of (Merck) VARIVAX (Lot# L008271; expiration date 11-MAR-2017; dose and route of administration were not reported). No adverse effects were reported. Follow up information was received on 23-OCT-2015 from a certified medical assistant. The medical assistant noted that the number of patients who were vaccinated with improperly stored doses of VARIVAX (Merck) (Lot# L00827) was 8, not 9 as previously reported. Follow-up information has been received on 27-OCT-2015 from the certified medical assistant,. The reporter provided that he patient of unknown age and gender was vaccinated with the improperly stored dose of VARIVAX (Merck) on 17-AUG-2015. It was also reported that the vaccine was 1296 hours out of range. This is one of several reports received from the same reporter. Additional information has been requested. Patient, product and event details and analysis were updated.
07/16/2021: Patient presents to ER with shortness of breath, edema, tachycardia, positive COVID test, and in atrial fibrillation. Acute exacerbation of CHF.  07/17/2021: Diuresis went well and patient back at baseline. Discharged.
Less than hour after shot, burning pain in (L) shoulder area around joint - pain increased, extremely painful with certain movements (dressing, seat belt, lifting arm). Felt like had badly wrenched shoulder. Long lasting pain, impairment of movement. Pharmacist admin. shot high on shoulder, standing while I sat - 2 1/2 mos. later, still painful. Improving very slowly. (Nearly 8 mos later, still residual pain).
Red bumps on torso.  Doctor says they are Pityriasis Rosea.  The bumps are spreading over my arms and front and back of torso.  Also I missed my period, but my pregnancy test is negative.
Approx. 12 hours after 2nd dose of vaccine, woke up with chills that lasted-3 hours.; Rest of the day only symptoms were fatigue and aches; Rest of the day only symptoms were fatigue and aches; This is a spontaneous report from a contactable consumer. A 23-year-old female patient received second dose of BNT162B2 (Pfizer COVID 19 Formulation: Solution for Injection Batch/Lot Number: EL3247 Expiration Date: Unknown) via an unspecified route of administration, administered in Arm Left on 25Feb2021 11:00 (at the age of 23-year-old) as single dose for COVID-19 immunization. Patient previously received first dose of Pfizer COVID 19 vaccine (lot number: EL3247) on 04Feb2021 11:00 administered in left arm. The patients medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received Birth Control medication within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19 and Since the vaccination patient has not been tested for COVID-19. On 26Feb2021 12:00 Approx. 12 hours after 2nd dose of vaccine, patient woke up with chills that lasted for approximately 3 hours. No temperature was taken. Rest of the day only symptoms were fatigue and aches. Outcome of all the event chills was recovered on 26Feb2021 15:00 and rest all events was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
I was not having any symptoms except for back ache and the doctor did blood work and discovered the elevated liver function level.
11:20 AM - GIVEN BENEDRYL 10MG / ITCHINESS AND FULLNESS BACK OF THROAT AND LIGHTHEADED AFTER VACCINE 11:35 - NO CHANGE IN SX, NOT WORSE NO SOB OR GI SX. TALKING COMFOTABLY  P -88 RR-18 O2-98% ON ROO MAIR
This case was reported by a physician via sales rep and described the occurrence of myalgia in a male patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent, the patient experienced myalgia. The patient was treated with ALEVE. On an unknown date, the outcome of the myalgia was unknown. It was unknown if the reporter considered the myalgia to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. The physician stated that every year that he received the flu shot it always makes him had horrible myalgias and he was laid out of several days. The patient currently pre-treating prior to and several days after with ALEVE.
Patient presented reporting continued achy arm following vaccination. Referred to a doctor and at home pain relief remedies ie. cold compress, normal pain relievers.
Information regarding PREVNAR 13 was received from a nurse regarding a patient who experienced swelling at the injection site. The patient received a dose on 04-May-2010. The patient experienced swelling at the injection site in Jun-2010. The outcome is unknown. No additional information was available at the time of this report.
patient started having bells-palsy like symptoms- lips and right side of the face tingled and loss motor control
molar pregnancy; pregnant while taking BNT162B2; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and fetus. This is a maternal report. A 32-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0217), via an unspecified route of administration on 08Jun2021 11:00 AM (at 32-year-old, pregnant at time of vaccination) as dose 2, single for COVID-19 immunization. The patient medical history included allergies and COVID prior vaccination. Concomitant medication included vitamin D NOS. No other vaccines within four weeks. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EE0185), via an unspecified route of administration on 18May2021 11:00 AM (at 32-year-old, pregnant at time of vaccination) as dose 1, single for COVID-19 immunization, and experienced maternal exposure during pregnancy, first trimester. The patient experienced pregnancy fine then turned into a molar pregnancy shortly following second injection on 23Jun2021. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event), congenital anomaly or birth defect. The mother reported she became pregnant while taking BNT162B2. The mother was 7 weeks pregnant at the onset of the event molar pregnancy, 5 weeks pregnant at the vaccination of dose 2. The mother was due to deliver on 07Feb2022. The patient had COVID tested post vaccination, included Nasal Swab: negative on 26Jun2021. Therapeutic measures were taken as a result of molar pregnancy included surgery. The outcome of the event molar pregnancy was not recovered, outcome of the other event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021810841 fetus case
Per witness, patient was sitting in the waiting room post vaccination w/ Pfizer vaccine. Patient's mother got up and walked to counter to make 2nd dose appt. Patient started leaning over in chair and fell to the floor (witness reports patient bumped head). Per witness, mother ran to patient's side. This writer heard someone call for help. This writer was in the back assisting with immunization clinic. Patient was observed lying on the floor w/ mother at her side. Patient appeared confused and was actively trying to sit upright. This writer and patient's mother explained that she had experienced a vasovagal reaction after her COVID-19 vaccine. Patient was instructed to stay in lying position while vital signs were obtained. Patient was able to verbalize name, DOB, and place. Vital signs at 1040 (BP 98/55, HR 61, O2 98% on room air). Patient was diaphoretic and pale. Patient reported eating breakfast this morning. Patient was observed crying stating "I feel like I can't breathe." This writer continued to monitor vital signs (BP 120/72, HR 77, O2 99% on room air). Staff placed several ice packs on patient. She complained of headache and told staff that her head hurt. Mother of patient requested EMS to be called. Staff called EMS. Vital signs at 1050 (BP 101/64, HR 92, O2 98% on room air). Patient reported feeling better and was able to move to sitting upright position on the floor. Patient appeared less diaphoretic and color was returning to normal. Patient was moved to wheelchair w/ assistance from staff. Patient was provided with water and crackers. EMS arrived to the facility at 1050. EMS evaluated patient, but patient declined to be transported. V/S stable. Patient reports history of passing out unrelated to vaccine administration. Staff explained that mother/patient need to inform staff w/ the 2nd dose of vasovagal hx, so patient can receive vaccine lying down. Staff provided mother w/ concussion education and explained what S/S would indicate a need to go to the ER. Patient was also encouraged to f/u with pediatrician. Patient was taken out to car via wheelchair by staff at 1100.
I started having abscesses on my thighs. I though it could of been a staph infection so my primary care physician got me a prescription for it. One of the abscesses got infected so I went to the ER. They said it could of been MRSA so they gave me a stronger antibiotic. I went to a dermatologist and also discovered an abscess in my armpit.  I was given an even stronger antibiotic for it. The dermatologist ruled out that I had MRSA and diagnosed me last Friday with  HS (hidradenitis suppurativa).
I received my second COVID vaccine at 1030 on 4/21/2021.  By about 1230-1245, I began to not feel well.  My symptoms on 4/21 included: Nausea, fatigue, lightheadedness, resting tachycardia (heart rate 120-130s while sitting for extended periods of time), palpitations, mild shortness of breath, chills (without fever), & headache.   Into this evening (4/22), the symptoms that have remained are: Fatigue, resting tachycardia (heart rate 110-125s), shortness of breath (now using Albuterol MDI as needed), chills (without fever), & headache.  Nothing seems to help improve them at this time (i.e. hydration, Motrin, & rest).
Headache, Myalgia, EXTREME FATIGUE Narrative: "body aches and extreme fatigue, those are the big ones" above symptoms were more pronounced and occurred the very next day after receiving vaccination.
Chills without a fever, severe headache, dizziness, brain fog, nausea, vomiting from 7 am until 1:30 pm, then slow return to "normal" at ~ 7 pm on 3/30/21.
Rapid onset of nausea and dizzy / lightheaded feeling shortly after standing up from chair within  2 minutes after vaccination. Immediately sat back down to place my head between my knees, and completely blacked out, fallout out of the chair and hitting my head and knee on the floor and  nearby fixtures. Regained consciousness on floor about 30 seconds after fainting and immediately felt much better. Pharmacy staff were on hand and promptly called 911, instructed me not to move and took my pulse and monitored me until EMS arrived within 5-10 minutes. Vital signs normal including BP 120/90, 100% o2 levels, normal blood sugar and EKG. EMS assisted in getting me back to seated position and monitored for another 10-15 minutes. Declined transport and had family member drive me home where I rested for a few hours and woke up feeling fine. Very minor bruising / bump on head with no lasting sign of concussion or other trauma. 24+ hours post vaccine no other notable vaccine reactions aside from sore arm / muscles on injection site.
found to have received  two boosters - one on 6/22/2022 and one on 7/18/2022.  No side effects noted at this point
The next day I started my period. Normally not a weird occurrence, but it was 4 days early and a lot heavier than what I'm used to. I've never taken any feminine birth control and have always had a very, very regular and reliable period. But this go around I was experience heavy bleeding and cramps right away rather than a few days in. Even now after five days, I my period would normally be tapering off and the blood would be changing to light pink in color. Yet, I'm still experiencing bright red blood.
Patient stated that she feels her throat closing and a heavy chest. Epi pen 0.3mg administered. Patient went to the hospital for further evaluation.
Initial report received from the patient on 1/24/2006. The 68 year old female patient with a medical history of glaucoma, had received an injection of Fluzone SV 2005-2006 USP, lot number not reported, in the left deltoid on 11/01/2005. One day later, her face swelled up and she developed red blotches on her face. Her eyes were red and swollen. She also developed a sore between her eyes, which became painful and itchy. She was seen by her eye specialist two to three weeks later and was treated with Benadryl and steroids. The patient reported that she now has a deep scar between her eyes and cannot wear glasses because of her puffed eyes. She has not recovered from these events.
Information has been received from a 22 year old female, for GARDASIL, a Pregnancy Registry product, concerning herself with no pertinent medical history and no known drug reactions/allergies who in March 2009, was vaccinated with the first dose of GARDASIL. In November 2009, the patient was vaccinated with the second dose of GARDASIL. There was no concomitant medication. On unknown date, the patient was seen in the emergency room with stomach pains. Urine and blood tests were done and revealed pregnancy. The date of last menstrual period was 27-SEP-2009 and the estimated delivery date will be on 04-JUL-2010. Therapy with GARDASIL was discontinued. At the time of reporting, the patient's outcomes were unknown. She had an appointment to see her physician on 14-DEC-2009. Unspecified medical attention was sought. Additional information has been requested.
received 1st dose on 23Aug2021, forgot and then received again on 13Sep2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 27PA5, expiry date 3rd February 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 13th September 2021, the patient received the 2nd dose of Shingrix. On 13th September 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 22-Jul-2022 Reporter's comment: The pharmacist reported that 67 year old male patient received 1st dose of Shingrix series  at a different pharmacy, forgot he received the dose, and then came in to their facility on 13th September 2021 and received another dose.   The reporter did not had lot number / expiration date information for the 1st dose.   At the time of reporting, the patient had not received a repeat dose. The reporter consented to follow-up. Additional supportive information: The patient received 2nd dose of Shingrix earlier than the recommended interval, which led to shortening of vaccine schedule.
Received 4 year vaccines on 8-20-09.  Mom noticed L arm swollen on 8-22-09 and on 8-23-09 patient arm was swollen, she complained of itching and pain. she had a runny nose and also complained of itching on chest and other arm. mom took patient to ER on 8-23-09 and ER MD prescribed Benadryl, Ibprophen, and Cefporzil antiboitic.  Today on 8-24-09, patients arm still swollen and she is still itching, no rash noted to skin.
Shingrix 3 years ago and developed GBS; This case was reported by a consumer via other manufacturer and described the occurrence of guillain barre syndrome in a female patient 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 guillain barre syndrome (serious criteria GSK medically significant and other: serious as per reporter). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-Jan-2023 Reporter's Comments: The patient had the Shingrix vaccine 3 years ago from reporting and developed Guillain barre syndrome.
Patient called the pharmacy about 1 1/2 hour after vaccine. Symptom left arm hurt all the way to her hand and had started on her neck, primary care was called. Staff said Dr would tell her to go to ER.
?Covid Arm? A hard lump at the injection sight, red and itchy, not painful. Showed up around 7 days after I got my first shot.
Expired vaccine was stored and then administered/Vial refrigirated after expiry; Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered/Vial refrigirated after expiry) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered/Vial refrigirated after expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered/Vial refrigirated after expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported. HCP stated that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.Date the vial placed in refrigerator was on 29 Oct 2021. Vaccine did not undergone any temperature excursion. No adverse events were reported for patient. No treatment information was reported.
Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant  medication was not provided. On unknown dates the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # L015047, expiration date 29-APR-2017, dose and route unknown). The temperature of exposure was 6.8F and time frame was 8 hours. There was no previous temperature excursion. No adverse effects reported. Additional information has been requested.
This spontaneous report was received from a pharmacist via a company representative and refers to a 65-year-old female patient. The patient had no medical history, concomitant therapies and concurrent conditions. On an unknown date in November 2018, "one to two weeks ago" from the reporting time, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (exact dose, frequency, route of administration, lot# and expiration date were not reported) as vaccination. On an unknown date in 2018, the patient developed a rash on her face and all over her body. The patient planned to make an appointment and visit an unspecified physician for treatment. The outcome of rash generalised was unknown. The causality assessment was not provided.
Information has been received from a company representative concerning his child's piano teacher's daughter a 20 month old female who in the end of March 2008 was vaccinated with  VARIVAX (Oka/Merck) and another unnamed vaccine. On 26-APR-2008 the patient experienced a rash all over her body. The patient was seen by her doctor who diagnosed it as chicken pox. The patient's symptoms persisted. The was no product quality complaint. No further information is available
This 24-year-old received her 3rd anthrax immunization about 9 am on 12 July 2004.  Later that evening, she noted the site was mildly red and swollen with generalized itching.   The next morning she returned to Immunization Clinic for evaluation of increased swelling, redness and itching.  She denies any headaches, lymph node swelling, fever, paresthesia, arthralgia, and myalgias.  She did do repetitive motions with both arms yesterday evening (5-6 pm) cleaning her bathroom shower.  Three days earlier (07 June 2004), she was given her typhoid vaccine #2 to the left deltoid, a PPD skin test to the left forearm (negative results), and Hepatitis B #2 IM to the right deltoid.  She reports no adverse reaction with anthrax #1 except for a small-reddened area that lasted a few days.  Anthrax #2 caused a dime size knot with redness that lasted for a few days.  She experienced an acute onset "temporal headache" that occurred about 2 weeks after the vaccination. This headache was nothing like her headaches in the past. Normally her headaches would occur once every 3-4 months, if then, and go away on own without medication.  She describes this headache as non-radiating, throbbing, sharp pain that was felt in both temples.  She denied any increase in pain with position changes, visual disturbance, photophobia, mental changes, paresthesia, speech impediments, musculoskeletal pain or any other concerns.  She took 2 Regular Strength Tylenol at onset of this headache, fell asleep, woke up 3 hours later with the headache persisting, took 2 more Tylenol and slept for the night.  When she awoke the next morning, the headache was gone without reoccurrence to date (July 12, 2004).  She stated her eating pattern was different that day and associated the headache with a "hypoglycemic" event.
Approximately 15 minutes following the injections, patient had syncopal episode lasting less than 1 minute.  After episode, patient reports not having had anything to eat or drink all day.  Patient's blood sugar = 85.  Patient given granola bar and H2O.  Stated that she felt much better.  Discharged home with mother.  No injury reported.  Physician aware.