chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; a two year old was given the adult dose instead of the pediatric dose.; This spontaneous report as received from a licensed practical nurse referring to a 2-year-old patient of unknown age. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On 10-JAN-2022, the patient was given hepatitis a vaccine, inactivated (VAQTA) (0.5 mL, lot # T036739, expiration date 22-APR-2022; strength, route of administration and anatomical location were not reported) for prophylaxis, which was the adult dose instead of the pediatric dose (incorrect dose administered). No additional adverse event (AE) or product quality complaint (PQC) was reported.
Report describes titubations in a 6 month old female whose mother received Lyme disease vaccine recombinant "early" during the first trimester of pregnancy. The mother's vaccination, drug, allergy, obstetric, and medical histories were not unknown. She received no medications and had no other known disorders or defects. "Early" in the first trimester, the mother received her third injection of LYMErix. When the infant was approximately six months old, in approximately August 2001, tremors were observed in the left arm. Over an unknown period, these gradually involved both arms, then the trunk, causing titubations. As
About 1.5hr p/immun became fussy & warm; Tylenol given 1/2 hr p/immun & again 1.5hrs p/then Q4hrs; Fussiness cont'd & temp taken next day was 104.2(r); TC 1APR91 mom states cough & diarrhea as well as fussiness cont thru today;
Pt recv vax on 8/4/98; on 8/14/98 pt exp joint pain w/ swelling, reactive arthritis, livedo reticularis, erythema nodosum
Lot# not available.  32 hrs after inj 167/69  hb 84 with H/A.
Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 11-SEP-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) VARIVAX (lot # N029634, expiration date 23-OCT-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# R002715, expiration date 20-FEB-2020). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011283: US-009507513-1809USA011743: US-009507513-1809USA011744: US-009507513-1809USA011745: US-009507513-1809USA011746: US-009507513-1809USA011747: US-009507513-1809USA011748: US-009507513-1809USA011749: US-009507513-1809USA011750: US-009507513-1809USA011751: US-009507513-1809USA011752: US-009507513-1809USA011753: US-009507513-1809USA011754: US-009507513-1809USA011755: US-009507513-1809USA011756: US-009507513-1809USA011757: US-009507513-1809USA011759.
From about 8:30pm-1:30 am I experienced chills, fever(99.6), leg aches, outer ear aches, neck aches. General ill feeling. Couldn?t go to sleep. Began to feel horrible.  Cold feet. Took an Advil and within 15 minutes all symptoms went away.
Myocardial Infarction ST Elevation MI -100% Blockage  Treatment-Emergency Angioplasty (permanent stent placed)
cough; tired; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough) and FATIGUE (tired) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, AMLODIPINE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced COUGH (cough) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COUGH (cough) and FATIGUE (tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant and treatment medication include rubinstein calcium.   This case was linked to MOD21-028690 (E2B Linked Report).; Sender's Comments:  MOD21-028690:
Started just feeling tired at about 3:00 pm. By 10 pm I had severe body aches, chills, vomiting & diarrhea
CHILLS; RUNNY NOSE; LOSS OF APPETITE; NAUSEA; HEADACHE; FATIGUE; MUSCLE ACHE; This spontaneous report received from a patient concerned a male of unspecified age. 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, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021, in the right arm, for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced loss of appetite. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fatigue. On MAR-2021, the subject experienced muscle ache. On 20-MAR-2021, the subject experienced runny nose. On 20-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from runny nose, chills, loss of appetite, nausea, headache, fatigue, and muscle ache. This report was non-serious.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
This spontaneous report received from a consumer via social media (J&J Corporate) via a company representative concerned a female of unspecified age and ethnicity. 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, batch number: unknown, expiry: unknown) dose not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient died from unknown cause of death after vaccination. It was unknown if autopsy was performed or not. Reporter stated "So frustrated with the loss of my sister after taking J&J". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). Sender's Comments: V0: 20220853278-covid-19 vaccine ad26.cov2.s-Loss of sister. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH.
Onset 1PM swelling of knee joints, difficulty walking, crying & temp of 102 per mom, mom gave pt APAP & sought ER tx; pt was prescribed Pediaporfen & d/c p/exam;
Pt. developed hives about 12-24 hrs after vaccines (see attached) including large welt at site of PV13 ??? any contraindications to boosters?? Patient is in because of rash that developed to day, and perhaps a little last night. She received her routine vaccinations yesterday, and this morning mom noted a blotch rash on most of her stomach, as well as in the area of the shot on her (L) leg. On the way to the office, she also began breaking out on her face. She had cream cheese and another kind of cheese yesterday for the first time, and also had a little diarrhea yesterday morning. Mom gave her some (purple) acetaminophen after the shot yesterday, before the rash started...one dose. She has had it once before without a reaction. No hx insect bites or previous such rashes.
Client verbalized itchy throat after receiving the vaccine.  Client was evaluated by onsite  Fire Rescue and released at 10:54 am for home.  Per Fire Rescue no further evaluation needed.  Symptom resolved.
Started out as a little knot and now it is red and swollen at the injection site and hot. It is almost 6 inches in Diameter.
Patient reports having a bruise and soreness after over a month has passed. No signs of infection.
Adverse side affects started 4 days after vaccination. I started light bleeding that intensified each day. Cramping also accompanied the bleeding. I presented for an early pregnancy ultrasound on 11/5/21 to find a fetus that was at the appropriate gestational age, with no detectable heartbeat. This tells me baby was growing at least until the time of  Covid vaccine injection. Estimated delivery day was June 24,  2022. However, that is no longer as the vaccine most likely killed my growing baby.
Numbness on both of her leg and arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness on both of her leg and arm) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced HYPOAESTHESIA (Numbness on both of her leg and arm). At the time of the report, HYPOAESTHESIA (Numbness on both of her leg and arm) outcome was unknown.            No Concomitant medication were reported. Treatment medication was not provided.
Pain at injection site left upper arm noted the evening of 3/27/12. Pain with lifting arm up.
Rash on entire tricep and radiating around toward bicep on right arm. Itchy, warm to touch, red circular spots around tricep, injection site hard/firm to touch.
I received the High Dose Flu Vaccine 2015-16 SYR Lot #UI428AB on Friday, Sept 25. On the following Tuesday, I noticed a rash appearing under my right breast. Eventually a rash also appeared on the right side of my back with accompanying pain on skin. I went to a doctor on October 8, and was diagnosed with shingles. I had been given the shingles vaccine in January, 2012. I received a prescription for valacyclovir which I am currently taking. The rash is slowly going away, but I still have pain and sensitive skin in the area of the rash. Prior to receiving the flu vaccine I was in good health and was not stressed.
Patient was at the clinic for his 2nd dose of Moderna. Pfizer was accidentally administered instead of Moderna.
Have been in menopause for 2 years with no menstruation (with 2 years prior to that of erratic periods).  Have had hormones checked and the low numbers also foot with menopause.  And 10 days after my first dose of the Pfizer Covid Vaccine, I got my period.  And it was very very heavy, heavier than any time in my life and made it hard to even leave the house for two days because of the constant need to deal with all of the blood.  It lasted 7 days and then went away.
(L) arm immediate redness. Pain 8 days later. 10 cm patch warmth, redness 2 cm tender nodule diffuse dermatitis on back.
Refrigerator containing Fluzone went down to 29.1F. After that excursion, vaccine administered to patient / no AE; Initial information received on 07-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2020SA038344, 2020SA032577, 2020SA038302, 2020SA038467, 2020SA038474, 2020SA038473, 2020SA038466, 2020SA038472, 2020SA038471, 2020SA038470, 2020SA038469, 2020SA038468, 2020SA038351, 2020SA038348, 2020SA038349, 2020SA038345, 2020SA038343, 2020SA038347, 2020SA038350, 2020SA038352 and 2020SA038344.  This case involves a four months old female patient who received 0.5 ml dose of IPV (VERO) [IPOL] (lot number PIF541M and expiry date 07-Dec-2020) via unknown route in the left thigh for Prophylactic vaccination on 15-Jan-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  It was an actual medication error case due to Product storage error temperature too low.  It was reported that refrigerator containing Fluzone went down to 29.1F and the vaccine was given to the patient in spite of being compromised (product storage error).  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Temperature was 101.8; Felt a little warm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Temperature was 101.8) and FEELING HOT (Felt a little warm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included COPD since an unknown date. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN), METHADONE, DILTIAZEM, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and VITAMINS NOS for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Temperature was 101.8) and FEELING HOT (Felt a little warm). At the time of the report, PYREXIA (Temperature was 101.8) and FEELING HOT (Felt a little warm) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.8 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021 and was forwarded to Moderna on 07-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Temperature was 101.8) and FEELING HOT (Felt a little warm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included COPD since an unknown date. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN), METHADONE, DILTIAZEM, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and VITAMINS NOS for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Temperature was 101.8) and FEELING HOT (Felt a little warm). At the time of the report, PYREXIA (Temperature was 101.8) and FEELING HOT (Felt a little warm) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.8 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information for the event was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sore muscle; Little bleeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 10 year-old male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) 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: MYALGIA (non-serious) with onset 2021, outcome "recovering", described as "Sore muscle"; VACCINATION SITE HAEMORRHAGE (non-serious) with onset 2021, outcome "unknown", described as "Little bleeding".    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a other health professional refers to a 1 year old female patient. On 11-FEB-2013, the patient was vaccinated with the first dose of VARIVAX (merck) (LOT# H017243) subcutaneous (dose unspecified by reporter). No other co suspects were reported. No concomitant therapy was reported. On 24-FEB-2013 also reported as 10 days after the vaccination VARIVAX (merck), the patient experienced redness, swelling and rash at site of injection with fever of 102.6 F per 2 days. The outcome of redness, swelling, rash and fever was reported as recovered / resolved on 27-FEB-2013. Additional information is not expected.
I went to get the covid shot and i went to the waiting area in about 15 mins while sitting i got vertigo. When someone came to check on me and i told them i didn't feel good and i started to get the tingles they went from one area to another all over the body , my heart started pounding out of my chest. They took my blood pressure and my temperature. They asked me if i was exposed to covid. I said no i said that i had to go to the bathroom when i got up to go to the bathroom i almost passed out. I got in the car and 30 mins later i was still feeling the same. They told me that i needed to go to the hospital. I went to the er and they gave me Benadryl, and iv fluids. They thought i could be dehydrated.  I am still suffering from heart palpitation and racing pulse without high blood pressure and did not get my second shot. They put me on a steroids' and it attacked my GI system so i stopped taking that.
Case number PHHY2011US26134 is an initial spontaneous report received from a nurse on 29 Mar 2011. This report refers to 11 years old female patient. She was vaccinated with MENVEO vaccine (batch number 100022) on 20 Mar 2011. The vaccine was given intramuscularly. She did not receive the MenA lyophilized conjugate component of MENVEO vaccine. No other adverse reaction was reported. The final outcome of the event was not reported. Follow-up report received from a nurse on 12 Apr 2011: The patient did not present any adverse event.
No adverse reactions - a fourth dose was administered as the patient did not disclose previously receiving the third/booster Pfizer dose the year prior.
Immediately following vaccination, I began to have mild headaches that could be treated with Tylenol up until the evening of Friday April 9. My head began to hurt so bad I thought I might be having an aneurysm. I was losing my sight and had blurred vision. I pleaded with my husband to take me to the hospital and he would not. I literally thought I was going to die. After about 3 hrs it finally stopped and I began to feel better. The next day I had tinnitus in my left ear, the same side that most of my head pain was on. I have had tinnitus ever since.
Patient hospitalized due to COVID-19. Patient is fully vaccinated. Placed on BiPAP in hospital and moved to ICU. Patient died due to COVID-19.
Sore throat; Sporadic headache lasting 4 hours; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Sporadic headache lasting 4 hours) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026a21a) for COVID-19 vaccination.     The patient's past medical history included Cancer (Of vocal chords since 4-5 years).    On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Sporadic headache lasting 4 hours). On 16-Mar-2021, HEADACHE (Sporadic headache lasting 4 hours) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore throat) outcome was unknown.            Concomitant product use was not provided by the reporter.   Treatment information was not provided
THE MODERNA ADMINISTERED   HAS BEEN STORED IN THE FRIDGE  FOR MORE THAN 30 DAYS AS REQUIRED BY THE MANUFACTURER
worsening generalized weakness that has limited her ability to move about her home. Over the past few days she has had poor appetite and has been able to eat, she additionally endorses intermittent shortness of breath diffuse chills.
CHILLS AND FEVER ON 1ST DAY AFTER VACCINE. MUSCLE ACHE, HEADACHE, NAUSEA AND TIREDNESS ON 2ND DAY. TOOK TYLENOL AND IBUPROFEN
onset 2 1/2 hrs p/dose; hard screaming, refusal of feedings; awoken scream uncontrobly & then go back to sleep; t100;
After 10minutes of receiving Pfizer, patient complained of dizziness, a blurry vision, and fatigue. Paramedic came and checked patient out and took patient to ER
The evening of the 12th, employee started to experience fever, chills, sweatiness, lightheaded, nausea and abdominal cramping (Tylenol was taken that night). Next morning felt lightheaded, aches and pains, nausea (employee did not eat either that morning or night before) Ibuprofen was taken and felt better on her stomach without food. Sore throat for one week. Unable to swallow food or water. Employee not very hydrated. Redness and soreness to injection site first three days. Employee mentioned continued fevers, sore throat, body chills and aches and slight tenderness to touch over injection site.
No other AE; a dose of MMRII was administered to a patient after the expiration date; This spontaneous report was received from a customer and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 25-MAY-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) 1 dose, lot # s015092, expiration date 15-MAY-2021 (exact dose, dose number, vaccination site and route of administration were not provided) for prophylaxis. No other adverse event (AE) reported.  The customer also stated that on 15-APR-2021, the vaccine underwent a temperature excursion (TE) of 7.28 degrees Fahrenheit for 45 minutes. However, that temperature was within the recommended storage range for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and no TE occurred.