chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE/PQCs reported; Caller reported administration of PROQUAD after product experienced temperature excursion.; This spontaneous report was received from a consumer, referring to a 1-year-old female patient. The patient did not have any known pertinent medical history, drug reactions, allergies or concomitant medications.  On 07-OCT-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, administered in the left vastus lateralis (lot number T015598 which has been verified to be valid, expiration date reported and validated as 02-NOV-2021) (dose and frequency were unknown by the reporter; vaccination scheme and route of administration were not reported) as prophylaxis. The administered dose of the vaccine was stored at a temperature of 15 degrees Fahrenheit (F) to 46 F (23.7 F), during a time frame of 2 hours and 19 minutes, as recorded by a digital data logger. There was no previous temperature excursion. The patient did not seek medical attention. There were no laboratory diagnostic studies performed, and no treatment was given for the adverse event. No additional adverse events were reported in the patient.
This spontaneous prospective pregnancy report was received from a female Registered Nurse of unknown age concerning herself. On an unknown date, the patient became pregnant. The LMP and EDD were not known. The patient had no pertinent medical history or drug reactions or allergies. On 07-MAR-2014 the patient was inadvertently administered a dose of GARDASIL (dose and lot # not provided), intramuscular, instead of the intended TDAP vaccine (manufacturer unspecified). Concomitant therapies included NASALCROM, loratadine (manufacturer unknown) and budesonide (manufacturer unknown). No adverse effects were reported. The pregnancy outcome was pending. The patient stated that she was at the physician's office when this occurred. Additional information has been requested.
Red rash wrists and hands 4-6 hours after shot w/ itchiness; Red rash wrists and hands 4-6 hours after shot w/ itchiness/Severe red rash all over body; Red rash wrists and hands 4-6 hours after shot w/ itchiness; cough; tiredness; muscle and wrist joint pain; muscle and wrist joint pain; feeling unwell; This is a spontaneous report from a contactable consumer (patient himself).  A 66-year-old male patient first dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EN6206, Expiration Date was not reported), via an unspecified route of administration, administered in left arm on 06Mar2021 14:45 (at the age of 66-year-old) as 1st dose, single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (Severe COPD with Chronic Bronchities), drug hypersensitivity (known allergies: Penicillin), bronchitis chronic (Severe COPD with Chronic Bronchities). Concomitant medications included umeclidinium bromide (INCRUSE ELLIPTA, 62.5 mg); salbutamol sulfate (VENTOLIN HFA, 90 ug).  other medications in two weeks Incruse included Ellipta 62.5 mcg, Ventolin HFA 90 mcg. No other vaccine taken in four weeks. On 06Mar2021 07:45 PM the patient experienced, Red rash wrists and hands 4-6 hours after shot w/ itchiness. Severe red rash all over body 12-24 hours after. shot with cough, tiredness, muscle and wrist joint pain, feeling unwell. No treatment taken for ae. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested positive since the vaccination. The outcome of the events was not resolved.  No follow attempts are possible. No further information is expected.
Nerve pain, numbness and soreness in upper left arm with burning and itching.Area is tender to the touch. Symptoms started the day after dose #2 (1/25/2022) and has been continuous.
Patient stated that she had immediate pain. The patient as of 7:20am has pain which makes it difficult to move her arm, as well as a bruise.
50 y/o admitted to hospital with left facial nerve palsy and an EMG documented demyelinating polyneuropathy. LP x 2  with results atypical for GBS (lymphocytic pleocytosis with high protein levels. MRI imaging with nerve root enhancement of the facial nerve and conus nerve roots. Treated with IV steroids, Valacyclovir, IVIG. Etiology of symptoms remains under active medical evaluation.
crying and screaming inconsolable refused food or sleep about 8.5 hours. Note: baby NEVER screamed and rarely cried before this event.
flu-like symptoms; chills; headache; left arm was bruised - still black and blue; Pain in arm; body ache; changes from her lower extremities freezing and sometimes it was her whole body; changes from her lower extremities freezing and sometimes it was her whole body; This is a spontaneous report from a contactable consumer (patient's husband). A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK9231), via an unspecified route of administration in the right arm on 12Jan2021 at a single dose for covid-19 prophylaxis; apixaban, oral from an unspecified date and ongoing at 5 mg, twice daily as blood thinner medication and atrial fibrillation. Medical history was not reported. Concomitant medication included ongoing dronedarone hydrochloride (MULTAQ) for blood pressure and heart beat, ongoing pravastatin for cholesterol, and dronedarone for blood pressure. For the past couple of days, she had had flu like symptoms. She has had a headache, body aches and chills. It changes from her lower extremities freezing and sometimes it was her whole body. Patient also had a pain in arm. Her left arm was bruised - still black and blue. All of these occurred on 13Jan2021. She did not have a fever. Today (20Jan2021), she was ok. When they went through the check in they asked if patient was on a blood thinner and she was. The patient's husband was wondering if the reactions had anything to do with the vaccine and if the blood thinner medication (Apixaban) she was taking would have caused the bruise. The patient was supposed to get the second vaccine 02Feb2021. Reporter was asking if it is ok to get the second dose. The action taken in response to the event for apixaban was unknown. Outcome of event chills was recovered on 19Jan2021, after 6 days; events flu like symptoms and lower extremities freezing and sometimes it was her whole body was unknown while recovering for other events.
she feels like she has Covid and the caller already took 5 doses of the Pfizer Covid Vaccine; she feels like she has Covid and the caller already took 5 doses of the Pfizer Covid Vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "she feels like she has Covid and the caller already took 5 doses of the Pfizer Covid Vaccine".  Clinical course: Caller is going to have the covid vaccine on Thursday 26Jan and right now she feels like she does have a covid and wants to know if she can take the vaccine on Thursday. It will be her 6th dose. The caller also wanted to know what would be the side effects if she will take the covid vaccine on Thursday. Created Manual AE form because the caller said she feels like she has Covid and the caller already took 5 doses of the Pfizer Covid Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pediatric (ages 5 - 11 yrs) dpse of Covid-19 Pfizer vaccine administered. Patient is 12 yuears of age. Patient monitored for 15 minutes for adverse reactions. Mother of child informed of error. Advised mother 2nd dose of vaccine will be the adult pfizer vaccine (12 years and older).
Immediately after the shot I was very tired. The next morning I woke up about 6am, I felt out of sorts. I got very light headed and dizzy. I had a headache and noticed I had a 101.2 fever so I took Tylenol. I also had body aches. All day I was very weak. Later in the day about 4pm I became nauseous and threw up. Symptoms carried over into the next day. I am tired with a bad headache and nauseous.
Local reaction; Rash; Chills; Headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Local reaction), RASH (Rash), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced VACCINATION SITE REACTION (Local reaction), RASH (Rash), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (sore arm). On 11-Jan-2021, CHILLS (Chills) and HEADACHE (Headache) had resolved. On 17-Jan-2021, VACCINATION SITE REACTION (Local reaction), RASH (Rash) and MYALGIA (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.   This case was linked to MOD-2021-116965 (Patient Link).
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. On 21-OCT-2013, the patient was vaccinated with an expired dose of ZOSTAVAX (Lot # J001729, expiration date 20-OCT-2013) subcutaneously. No adverse effect was reported. Additional information has been requested.
3:30 shot, 4:02pm itchy throat, trouble breathing 97.8degrees, 103bpm, 99sp02, itchy throat worsening. 4:05pm albuterol hfa 2 puffs. 4:08pm EpiPen right leg, 97%sp02 110bpm. 4:12pm 2liters of oxygen placed on patient nos. 4:13pm EpiPen left deltoid. 4:18pm 155/102mmHg.
Feeling weak; Shakiness/ shaky after going up the stairs; Lightheadedness / dizziness; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shakiness/ shaky after going up the stairs), DIZZINESS (Lightheadedness / dizziness) and ASTHENIA (Feeling weak) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included Anxiety. Concurrent medical conditions included Drug allergy (experienced a very bad reaction to Prilosec).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced TREMOR (Shakiness/ shaky after going up the stairs) and DIZZINESS (Lightheadedness / dizziness). On an unknown date, the patient experienced ASTHENIA (Feeling weak). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) for Sinusitis, at an unspecified dose and frequency. At the time of the report, TREMOR (Shakiness/ shaky after going up the stairs), DIZZINESS (Lightheadedness / dizziness) and ASTHENIA (Feeling weak) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.
found "a knot under my bicep"; bright red; itchy; didnt feel right; itchy; Arm swelling; Arm pain-feels someone kicked me on the arm; Arm hot to touch; rash around the shot area about 3 inches wide. The rash kept spreading and spreading,; really tired; exhausted; slept the whole day; slightly raised temp (3 degrees highter than normal); nausea; diarrhea; Normal vaccination soreness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swelling), PAIN IN EXTREMITY (Arm pain-feels someone kicked me on the arm), VACCINATION SITE WARMTH (Arm hot to touch), DIARRHOEA (diarrhea) and MASS (found "a knot under my bicep") in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced DIARRHOEA (diarrhea), VACCINATION SITE PAIN (Normal vaccination soreness ) and NAUSEA (nausea). On 09-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm swelling), PAIN IN EXTREMITY (Arm pain-feels someone kicked me on the arm), VACCINATION SITE WARMTH (Arm hot to touch), ERYTHEMA (bright red), PRURITUS (itchy), FEELING ABNORMAL (didnt feel right), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE RASH (rash around the shot area about 3 inches wide. The rash kept spreading and spreading,), FATIGUE (really tired; exhausted; slept the whole day) and PYREXIA (slightly raised temp (3 degrees highter than normal)). On 11-Jan-2021, the patient experienced MASS (found "a knot under my bicep"). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 11-Jan-2021 at an unspecified dose and frequency. On 03-Jan-2021, DIARRHOEA (diarrhea) and NAUSEA (nausea) had resolved. At the time of the report, PERIPHERAL SWELLING (Arm swelling), PAIN IN EXTREMITY (Arm pain-feels someone kicked me on the arm), VACCINATION SITE WARMTH (Arm hot to touch), PRURITUS (itchy), FEELING ABNORMAL (didnt feel right) and VACCINATION SITE RASH (rash around the shot area about 3 inches wide. The rash kept spreading and spreading,) had not resolved and MASS (found "a knot under my bicep"), ERYTHEMA (bright red), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (Normal vaccination soreness ), FATIGUE (really tired; exhausted; slept the whole day) and PYREXIA (slightly raised temp (3 degrees highter than normal)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Sore arm (R arm of injection); Sore back; when lying down could not relax muscles; felt her entire body was with electricity; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE DISCOMFORT (when lying down could not relax muscles), FEELING ABNORMAL (felt her entire body was with electricity), PAIN IN EXTREMITY (Sore arm (R arm of injection)) and BACK PAIN (Sore back) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced MUSCLE DISCOMFORT (when lying down could not relax muscles) and FEELING ABNORMAL (felt her entire body was with electricity). On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm (R arm of injection)) and BACK PAIN (Sore back). At the time of the report, MUSCLE DISCOMFORT (when lying down could not relax muscles), FEELING ABNORMAL (felt her entire body was with electricity), PAIN IN EXTREMITY (Sore arm (R arm of injection)) and BACK PAIN (Sore back) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       herbal products used as a Concomitant medication. Patient take 13mg of Magnesium tablet  for very effective muscle relaxer in treatment Medication.
I started feeling pain in my arm about 6 pm the day of the vaccine.  During the night I woke up with body aches.  By morning I had chills, nausea, and severe body aches.  My neck and head hurt a lot- it was hard to move.  My whole body hurt and it was hard to get out of bed.  I was very sick.   By morning I was much improved, mostly weak, slightly achy and nauseas still.  The headache was gone.
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-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 (fever). At the time of the report, PYREXIA (fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 101f (High) 101F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication not provided. Concomitant medication not provided.
pt rcvd vax; pt had history of hives & positive skin test (as a child) to grass & horse hair; pt exp itching & broke out hives on arm w/in 7 hrs of vax; pt had rash; MD dx pt w/ allergic reaction to vax; MD recommended vax series be cancel;
Somewhere around 6 days after the first shot, I got a small (1-2 cm diameter), very hard, itchy lump at the injection site (completely hidden under a tattoo on my arm).  After the first reaction, my arm got very hot, and the lump started to swell.  By day 9, the reaction was >10 cm in diameter, still very hot, and the swelling could be seen past the tattoo.  That is when I realized the large swelling was a red rash. For the most part, the arm never hurts. Sometimes the lump is itchy though. It is always very hot.
fever - 101 degrees for 2 days severe coughing weakness chills head congestion
He has blood clots in his lungs; Cough; shortness of breath; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on (01Sep2023), this case now contains all required information to be considered valid.   This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: GL3248) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "factor V Leiden mutation", start date: 11Jul2014 (ongoing), notes: Had a basket ball pole fall on his right foot in August. Clot found in December also found factor V Leiden mutation. Concomitant medication(s) included: AMLODIPINE (ongoing); LOSARTAN oral (ongoing); SIMVASTATIN oral (ongoing); VITAMIN D3 1000 (ongoing). The following information was reported: PULMONARY EMBOLISM (medically significant), outcome "recovering", described as "He has blood clots in his lungs"; COUGH (non-serious), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath". The event "he has blood clots in his lungs" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of pulmonary embolism: on blood thinner.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300272236 Same patient, reporter, same drug, different dose and event.;US-PFIZER INC-PV202300150289 Same patient, reporter, same drug, different dose and event.;
Extremely, endless, runny nose, coughing and scratchy throat. Unable to sleep. My home test was positive. I went to an urgent care office in my neighborhood where I tested positive again. I requested and received  a prescription for Paxlovid, which I received from a nearby pharmacy.  I started taking the pills that night, 9/4/22.  I started getting better every day and finished the pills on the morning of 9/9/22. I have been feeling fine since then.
Got very, very ill; Weakness to where it was hard to get out of bed; Trouble breathing; Fever of 103 F; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Got very, very ill), ASTHENIA (Weakness to where it was hard to get out of bed), DYSPNOEA (Trouble breathing), PYREXIA (Fever of 103 F) and NAUSEA (Nausea) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history was reported).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Got very, very ill), ASTHENIA (Weakness to where it was hard to get out of bed), DYSPNOEA (Trouble breathing), PYREXIA (Fever of 103 F), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, VACCINATION COMPLICATION (Got very, very ill), ASTHENIA (Weakness to where it was hard to get out of bed), DYSPNOEA (Trouble breathing), PYREXIA (Fever of 103 F), NAUSEA (Nausea) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient came up to the desk post vaccine from waiting area. Reported symptoms of queasiness, dizziness. Patient sat down. He was diaphoretic, pale & clammy. Sternal rubbed & patient came back around. Provided Gatorade. Sat in the clinic for further observation.
On 2/22 I woke up with  and went to the ER, it was determined that I have Bells Palsy.