chrisvoncsefalvay/vaers-outcomes huggingface dataset:
upon waking at normal time of 5:00 AM - aches from head to toe, total body weakness, chills - cannot get warm, swelling of fingers aggravating arthritis in both hands, flushing of the face as if I had a fever. checked fever with a traditional mercury thermometer twice within 2 hours of each other and fever was normal both times - NO FEVER as of 11:00 AM, 3/17/2020.
Felt faint, pale, dizzy. Rested with legs elevated. Juice and crackers. BP returned to normal. C/O HA, dizzy-called mom to be picked up from school.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical histories and concurrent conditions were not reported. On an unknown date, an unspecified number of patients were vaccinated with an improperly stored doses of VARIVAX , (dose, route, lot number and indication were not reported); no adverse events and concomitant therapies of the patients were reported. Additional information has been requested.
Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient passed out in waiting area 5 minutes after being given vaccination. 911 was called, NP assisted, patient came to and was given water and something to eat. Paramedics checked vitals and patient was okay to leave on her own.
PATIENT SUFFERED DIZZINESS AND APPEARED TO LOSE CONSIOUSNESS ABOUT 5-15 MINUTES AFTER RECEIVING VACCINE AT APPROX.  330PM .   I HAD HER SIT DOWN (APPROX. 345PM) , AND VERY SOON (LESS THAN 1 MINUTE) AFTER SITTING HER HEAD DROOPED AND DIDN'T RESPOND TO ME CALLING HER NAME AND TAPPING HER HAND AND KNEE.  I DIDN'T FEEL A STRONG PULSE BUT HER BREATHING WAS VERY EVIDENT AND DEEP.  AFTER APPROXIMATELY 2 MINUTES SHE AWOKE WITH A SMILE AND MENTIONED THAT SOMETHING LIKE THIS HAS HAPPENED BEFORE.  I STAYED WITH HER UNTIL SHE FELT MORE ALERT, AND HAD HER REMAIN SEATED WITH FEET ELEVATED 6-8 INCHES OFF OF FLOOR.  AS TIME WENT ON SHE BECAME MORE AND MORE CONFIDENT IN HER SITUATION , BUT WE BOTH THOUGHT IT BEST TO HAVE HER HUSBAND COME PICK HER UP.  THIS WAS APPROXIMATELY 430PM.   (NOTE: EMERGENCY MEDICAL TEAM ARRIVED AT APPROXIMATELY 4PM FROM THE MAIN STORE PERSONNEL'S CALL WHEN OBSERVING ME TRYING TO AWAKEN HER)  THEY PROMPTLY OBSERVED AN ALERT PATIENT AND LEFT WITHIN MINUTES.   FOLLOW UP CALL WITH PATIENT A FEW DAYS LATER I LEARNED THAT SHE WAS FEELING FINE EVER SINCE.
This spontaneous report as received from a pharmacist refers to a 65 year old female patient. On 27-AUG-2014, the patient was vaccinated with an expired dose of PNEUMOVAX23 (dose, route of administration and lot # were not provided) (expiration date: 03-AUG-2014). No adverse effects were reported. Additional information has been requested.
Top teeth on roof of mouth feel numb" like when you get novacaine at dentist" also salivating . Starting 20 minutes after getting shot. These symptoms still exit
Patient had a baseball sized bruise.  Denied having fever or chills, not warm to the touch.
1/7/09 Parent called, red puffy (R) leg - local imm. reaction - 1/15/09 Parent called, fever >101 on 1/14/09. Red bumps on face, neck, belly and arm - 1/22/09 Parent called, recovered from chickenpox, only 1 spot on left cheek. Mother reports 9 days after VARIVAX, had 200-300 chickenpox develop. Resolved within 5 days. Symptomatic care.
Pain at site of injection, swelling and hot.  Later, severe joint and muscle pain and headache, some nausea and sleepiness.
I was talking a walk late afternoon and felt a pain on my left leg. I went home and the next morning I had Vertigo. On a Sunday, I went to the ER (Healthcare) and it was not related. I got an ultrasound where they diagnosed the blood clot.
Severe headache, malaise/fatigue, nausea, abdominal cramping unresolved by OTC medications.
I received a seasonal flu shot on 10/14/2009. On 10/16/2009, after eating a seafood Cobb salad for lunch at a restaurant, I went into anaphylaxis and was taken by ambulance to the emergency room at hospital. Blood tests run at the hospital allergy clinic on 10/20/2009 came back positive for an egg allergy. I have never a food allergy before. I am wondering if there is any chance that the flu shot I had two days prior to this episode could have triggered something that caused this sudden allergic response to eggs. 10/16/2009 was the first time I ate eggs or anything containing eggs after the flu shot. I tested negative for seafood and cheese allergies - the other potential allergens in the lunch I ate prior to going into anaphylaxis-.   11/25/09 Medical records received for DOS 10/16/09.  Final DX: Allergic reaction  C/O throat closing/throat tightness s/p eating seafood. Facial erythema.  Mild uvular edema. Difficulty swallowing. Jittery. Relieved by steroids. D/C to home.
Narrative: The patient received a second dose of J&J vaccine on 8/18/21 even though he had already received this vaccine on 7/8/21.
Fever of 105 F on 8-31-07 Two days later developed purpura of upper thighs. No treatment given
This spontaneous report was received from a healthcare business professional concerning a patient of unknown age. No information about the current condition, medical history or concomitant therapy was reported. There was previous temperature excursion of varicella virus vaccine live (oka/merck)(VARIVAX) and it was noted from 6 F to 14 F (5.7 F) for 11 minutes on 19-DEC-2021. On 20-DEC-2021, varicella virus vaccine live (oka/merck)(VARIVAX) was stored at 5.9 F for 13 minutes. On 21-DEC-2021, the patient was administered improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (dose and route were not reported; lot # U020244, expiry date: 28-JUN-2023) as prophylaxis (product storage error). The patient did not experience any adverse effects after this vaccine.
left under arm along side of breast pain and swelling. swollen lymph node on left side of neck.
Bells Palsy of left face 2 days following Pfizer covid-19 booster
Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 19-Apr-2022; Patient received expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 19-Apr-2022) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 19-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 19-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that when the vaccine received to pharmacy on 23-Feb-2022, the pharmacy staff member looked up the expiration date and came up with expiry date of June 2022. However, the correct expiry date for lot was 01-Apr-2022.  The vial was initially stored in refrigerator on 04-Apr-2022 and the vial did not undergo any temperature excursions.  No treatment information was reported.
Subsequent to receiving vax, the pt was determined to have elevated liver function test results. Medical history is significant for household exposure to hepatitis A, the the pts father.
nausea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (nausea). At the time of the report, NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant was reported. Patient treatment information was not provided.
Received vaccine on 4-9, same day experienced chills, fever, light headedness, and soreness around injection site.  Symptoms persisted throughout weekend.  On 4-17, broke out in hives on arms, neck, and backs of hands.
Patient's mother reported that a few hours after his 2nd Hepatitis A vaccine, patient started experiences dizziness, headaches, weakness, fatigue. The symptoms were reported to be exacerbated during football practice. Patient consulted and was seen by internist and lab results and examination were determined to be withing normal limits. Patient was given an excuse to refrain from football practice due to his decreased ability to participate. A few days later he reported that symptoms had resolved and he asked for another note to return to football practice. No further contacts to the clinic from the patient or mother since then.
BioNtech covid vaccine was taken on 8/24/2021 administered by local Pharmacy and after injection And noted the following symptoms 1st day fatigue, eye pain and pressure. The 2nd day continued eye pressure, fatigue, arm pain, and slight swelling and redness at injection site.
Pfizer Covid-19 vaccine booster dose administered around 90 beyond syringe expiration time (i.e., past the 6 hour window after vaccine mixed).
Last wk baby given HIB-Titer/DTP; @ HIB site, redness & sl blotchiness which persisted for about 1 wk; Baby was fine otherwise;
Patient came in to receive first dose of Moderna at 1623. Approximately 1645 patient began to complain of itching within the right arm where the injection site was. Also complained of itching on the right side of the face, back, chest, into the left leg. Some erythema developed on the right side of her back. PO 25mg Benadryl was given around 1652. Spoke with on-call allergist and relayed information regarding patient's allergies. Asked to monitor for 30 minutes more after medication to see if there is any improvement. RN called, patient improved and was okay to discharge patient home.
Right deltoid IM DTAP reaction 14x10cm redness and swelling. Tx: Benadryl, Tylenol
Got shot on Thursday woke up Friday 2am with achy arm, by 7am full body aches and mild temp of 99.4 Friday all day arm ached,small rash developed right of injection site , brainfog, dizziness. Symptoms went away by Saturday Morning just had a achy arm until Sunday. still expierencing Brain fog . Also experienced Brain fog and dizziness with first dose
On Sunday I started with a severe headache. When I woke up on Monday morning I couldn't lift my head. The headache was intense. I could not open my left eye. I had facial paralysis on the right side of my face. I had slurring of speech. When I walked I was dizzy. I fell asleep all day long, and woke up each time completely disoriented.
ARM SORE, RIGHT ITCH ARM, BODY ACHES, STRONG HEADACHE DURING 3DAYS, NAUSEA, CHILLS, TREMOR, SHAKING, FEVER FATIGUE, SORE THROAT, COUGH, SMALL CHEST PAIN
shingles; Decreased breast milk supply; Decreased breast milk supply; Decreased breast milk supply; This is a spontaneous report from a contactable consumer. A 28-year-old female patient (non-pregnant) received BNT162B2 (BNT162B2, PFIZER BIONTECH, COVID-19 Vaccine, Solution for injection: Batch/Lot number: EN6203, and expiration date: Not reported), via an unspecified route of administration, administered in Arm Left on 07Mar2021 as DOSE 2, SINGLE (age at vaccination 28-year-old) for covid-19 immunisation. The patient medical history included hypothyroidism, Tree Nuts allergy. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]) taken for an unspecified indication, start and stop date were not reported; levothyroxine taken for an unspecified indication, start and stop date were not reported. The patient historical vaccine includes BNT162B2 (BNT162B2, PFIZER BIONTECH, COVID-19 Vaccine, Solution for injection: Batch/Lot number: EL9266, and expiration date: Not reported), via an unspecified route of administration, administered in Arm Left on 14Feb2021 at 11.30AM as DOSE 1, SINGLE for covid-19 immunisation. other vaccine in four weeks: No. covid prior vaccination was No. covid tested post vaccination was No. It was reported that happen only after my second dose of the vaccine. I have a few close friends (2-3) who are also breastfeeding, and they also reported changes in breastmilk supply to the point that they switched to formula. Thankfully, I was able to pick up my supply again through pumping a ton, but they reported not being able to get back to their normal supply after the vaccine, also was diagnosed with shingles on 01Apr2021, 3.5 weeks after my second vaccine. I'm not sure if this has been reported by anyone else, but I think it's pretty bizarre that I got the shingles at such a young age and in less than 4 weeks from getting the vaccine. Therapeutic measures were taken as a result of shingles, decreased milk supply. The outcome of the event was suppressed lactation and herpes zoster was recovering.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021423510 same reporter/drug, different event/Patient  (baby case)
This is a spontaneous report from a contactable physician via a Pfizer representative for a female patient (patient initial unknown). An adolescent female patient aged between 16 to 18 years, of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at 0.5 ml, single. The patient medical history and concomitant medications were not reported. The patient experienced hives reaction on an unspecified date with outcome of unknown.
I woke up scratching a rash under my left breast. It was a cluster of bumps that itched but were painful to scratch.
severe headaches; muscle spasms mainly in her legs; if she sits down she will fall asleep; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EL9267) 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: SOMNOLENCE (non-serious) with onset 22Feb2021, outcome "unknown", described as "if she sits down she will fall asleep"; HEADACHE (non-serious), outcome "not recovered", described as "severe headaches"; MUSCLE SPASMS (non-serious), outcome "not recovered", described as "muscle spasms mainly in her legs". Therapeutic measures were not taken as a result of somnolence, headache, muscle spasms.    Additional information: No treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 21-JUL-2017 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot number M044032 expiration date: 03-JUL-2019) for prophylaxis (digital data logger). No adverse effects reported. Sender's Comments: US-009507513-1708USA002800.
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's concomitant medications included sterile diluent (MERCK), lot# and expiration date were not provided. The patient's medical history and concurrent conditions were not provided. On 02-APR-2018, the patient was vaccinated with an improperly stored dose of VARIVAX injection, lot # N020016 with expiration date 17-JUL-2019, for prophylaxis (route and anatomical location were not provided). The administered doses of the vaccines experienced a temperature excursion in the range between -9 degrees C to 8 degrees C during 1 minute as recorded by a data logger. The vaccines also experienced a previous temperature excursions in the range between -9 degrees C to 8 degrees C for 5 minutes. There were no adverse effects reported.
1/18/2010 red color in urine, 1/23/2010 out of breath, 1/24/2010 medical diagnosis was hemolytic anemia, 1/25/2010 condition became worse, 1/25/2010 admitted to hospital, surgery to take out spleen, 1/26-2/1/2010 kidneys failed, heart attack with death on second heart attack.
Guillain-Barre syndrome; patient was crippled - Difficulty in walking; Initial information received on 19-Jul-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves patient of an unknown age who experienced Guillain-barre syndrome, while he/she received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a serious guillain-barre syndrome and patient was crippled (gait disturbance) following the administration of INFLUENZA VACCINE. This event was assessed as serious as per IME list.   (Other relevant tests included no lab data.)  Final diagnosis was Guillain-barre syndrome.  It was not reported if the patient received a corrective treatment.  The outcome of the event was reported as Unknown.  Information on the batch number was requested  Documents held by sender: none.; Sender's Comments: This case concerns a patient of an unknown age who presented with guillain-barre syndrome and gait disturbance after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is not known. There are multiple possible etiologies of Guillain Barre Syndrome and the causal relationship with the vaccine cannot be ascertained without ruling out the other causes of this event. Based upon the reported information, the role of the vaccine cannot be assessed.
Information has been received a registered nurse referring to a patient of an unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or drug reactions/allergies. On 03-JAN-2019, the patient was vaccinated with an improperly stored dose of VARIVAX with lot number N028715 and expiration date on 13-OCT-2019, administered for prophylaxis (strength, dose, dose number, route of administration and anatomical injection site were not reported). The vaccine was reconstituted using a properly stored sterile diluent. It was reported that on unknown date, the vaccine was exposed to a temperature between 15 Fahrenheit degrees and 46 Fahrenheit degrees (25.7 F degrees) for 4 hours and 30 minutes. There was no previous temperature excursion. The call was placed because of a Digital Data logger report. No adverse effects were reported.
PAIN ON INJECTION SITE/ Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (PAIN ON INJECTION SITE/ Injection site pain) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product LEUPRORELIN ACETATE (LUPRON DEPOT) for an unknown indication.    No Medical History information was reported.   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started LEUPRORELIN ACETATE (LUPRON DEPOT) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (PAIN ON INJECTION SITE/ Injection site pain). At the time of the report, VACCINATION SITE PAIN (PAIN ON INJECTION SITE/ Injection site pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not reported.  On 23-Jul-2021, Patient received 1st dose of Moderna COVID-19 Vaccine.  On an unknown date, the patient experienced Pain on injection site.  Treatment information was not provided.  It was unknown if he was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of Pain on injection site with LUPRON DEPOT(LEUPROLIDE ACETATE DEPOT) was a reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
It looked like it was getting better but then sevne days later it; now my arm started to swell; the area was red had a knot hot and sore; the area was red had a knot hot and sore.; rash came out on the site; "baseball" sized welt; (welt) sore; redness; local inflammation at the site; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (It looked like it was getting better but then sevne days later it), PERIPHERAL SWELLING (now my arm started to swell), VACCINATION SITE WARMTH (the area was red had a knot hot and sore), VACCINATION SITE INFLAMMATION (local inflammation at the site) and URTICARIA ("baseball" sized welt) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Allergic reaction to drug and Allergic reaction to food. Concomitant products included ESTRADIOL for Hysterectomy, VITAMIN D NOS and PROBIOTICS NOS for an unknown indication.    On 05-Mar-2021 at 8:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 05-Mar-2021, the patient experienced VACCINATION SITE INFLAMMATION (local inflammation at the site) and VACCINATION SITE ERYTHEMA (redness). On 12-Mar-2021, the patient experienced URTICARIA ("baseball" sized welt) and PAIN ((welt) sore). On an unknown date, the patient experienced CONDITION AGGRAVATED (It looked like it was getting better but then sevne days later it), PERIPHERAL SWELLING (now my arm started to swell), VACCINATION SITE WARMTH (the area was red had a knot hot and sore), VACCINATION SITE PAIN (the area was red had a knot hot and sore.) and VACCINATION SITE RASH (rash came out on the site). At the time of the report, CONDITION AGGRAVATED (It looked like it was getting better but then sevne days later it), PERIPHERAL SWELLING (now my arm started to swell), VACCINATION SITE WARMTH (the area was red had a knot hot and sore), VACCINATION SITE INFLAMMATION (local inflammation at the site), URTICARIA ("baseball" sized welt), PAIN ((welt) sore), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE PAIN (the area was red had a knot hot and sore.) and VACCINATION SITE RASH (rash came out on the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: Non significant follow up received on 16-MAY-2021, event added, medical history updated On 21-Jun-2021: Non significant follow up received on 21-JUN-2021, no new information