chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she developed small round rashes in the back; This is spontaneous report received from a contactable consumer (patient's husband). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on an unspecified date (Lot Number: EN6206) as single dose for COVID-19 immunisation. Medical history included diabetic, high blood pressure. The patient's concomitant medications were not reported. The patient developed small round rashes in the back on 19Mar2021. The outcome of event was unknown.    No Follow-up attempts are needed. No further information is expected.
Mother calls reporting fever starting at 6 pm the evening of the vaccination and has it the next day. Fever- 101 degrees Significant swelling at site of injection and patient is complaining that his arm hurts and he doesn't want it touched, not moving it normally He was tired at 11:30 this morning/never tired then and then slept from 1:30-4:30/never sleeps 3 hrs Tired and lethargic and only wanting to sleep x 2 days No respiratory distress Day 3 after vaccination swelling better and patient less tired/lethargic
This spontaneous report as received from a pharmacist refers to an 82 year old female patient. The patient has no drug reactions/allergies. On 08-NOV-2013 the patient was vaccinated with ZOSTAVAX lot number J002865 expiry date 07-JUN-2014, 1 vial, via subcutaneous route in the upper left arm to prevent shingles. On an unknown date in approximately November 2013 after vaccination, the patient developed a rash and severe pain on her right upper thigh. The patient was diagnosed with shingles during an office visit with her physician on 15-NOV-2013 and was prescribed Percocet, Ibuprofen (manufacturer unknown) and Valacyclovir (manufacturer unknown). On 21-NOV-2013, the patient had an office visit with another physician who had prescribed Valacyclovir (manufacturer unknown), Neurontin and a higher strength of Percocet. The patient continued to have severe pain especially at night time. The outcome of events shingles and rash was reported as resolving. The outcome of severe pain on her right upper thigh was not resolved. Additional information has been requested.
Pt developed raised red rash 2 x 2 1/2" over left deltoid within 24 hours.
Patient was administered Pfizer vaccine on 5/22/21 even though they had been given Johnson and Johnson brand 3 months prior.  Patient's note on the consent form was not seen by the Pharmacist during pre administration consultation and the vaccine was administered. Error was noticed later during processing. Patient was contacted and he confirmed he did get the J&J and he said  "he was not happy with the J&J vaccine" and that his dr advised him to get the Pfizer in 2 to 3 months. Patient was advised by the pharmacist that the J&J brand provides full immunization against covid and subsequent immunization we not neccessary and this was against CDC guidelines. Patient had no symptoms. Patient was informed that we would notify his Dr and the national ADR line the following business day. Patient was contacted again on 5/24/21 to follow up -No unusual symptoms were reported. His Dr was contacted and incident was reported on 5/24/21.
It was reported that a 2 month old male pt received a Tripedia, a Comvax, an IPOL and a Prevnar vaccination on 12/1/00. Reportedly, 3 days later, the pt had a grand mal seizure that lasted for 20 minutes. The pt did not develop a fever. File to be completed. Follow up info reported that the pt's grand mal seizure lasted for 20 seconds not 20 minutes as previously reported. An MRI and EEG are pending. Reportedly the pt recovered from this experiences. N further info is available.
Pt developed hive within several minutes after receiving vaccines 4mls of BENADRYL administered PO.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION and PAIN in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 VACCINATION COMPLICATION and PAIN. At the time of the report, VACCINATION COMPLICATION and PAIN outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported No concomitant medication was reported
pt recvd vax & exp stiff rt posterior neck, rash-red raised, t101, swollen nodes under rt arm, nausea; sx persisted for 2 days;
numb on left side of face due. slight bell's palsy.  No treatment given was told by my Doctor that it should correct itself in time. as of today I still have numb feeling on the left side.  with very little face drip and drooling.
I got shingles - I thought it was poison ivy. Neck, shoulder, chest and back - all on my right side. It blistered in about two days and I called the dermatologist - and she gave me medication for it - pills and creams.  It took awhile and I think I still have some spots but they don't itch. I took a week off of work.
Chills; Headaches; Stomach issues; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 29Mar2021 at 09:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have any allergies to food, medications, or other products. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 31Mar2021 at 17:00, the patient experienced chills, headaches, stomach issues. For 8 days, the patient had chills headaches stomach issues. The patient did not receive any treatment for events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care visit. The clinical outcome of the events chills, headaches, stomach issues were not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
On 11/5/15, 19 yo F was brought to clinic for an annual exam. During visit, pt was ordered to receive inluenza vaccine and dose #2 of HPV vaccine quadrivalent IM (GARDASIL). Pt tolerated the influenza vaccine without incident. At 1106, pt was administered the HPV quadrivalent vaccine 0.5 mL in right deltoid (Manufacturer: Merck & Co. Inc, NDC: 0006-4109-01, Lot #L026034). After the injection, the pt passed out briefly. Pt's blood pressure was checked and found to be 84/58. Pt was provided with apple juice & allowed to rest for a unreported period of time. BP recheck at 1120 was back WNL at 112/68. Pt did report that she had eaten prior to appointment. Pt recoved completely and was discharged in stable condition.
This spontaneous report as received from a physician via a company representative, refers to an elderly (reported as "above the age of 65") male patient. The patient's concurrent conditions and medical history were not reported.  On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (strength, dose, anatomical location, lot number and expiration date were unknown) for prevention of shingles. There were no concomitant therapies reported. It was reported that, on an unknown date, the patient got sick with herpes zoster. At the time of reporting, the outcome of herpes zoster was unknown. The causality between ZOSTAVAX and the event was not provided. Additional information is not expected as no permission to contact the physician was provided.
pt presented with worsening SOB, cough, fever since 8/27; tested positive for COVID on 8/30; supplemental O2 started via NC and proceeded to BiPAP; diagnosed with AKI and COVID pneumonia; pt's condition worsened and he expired in the hospital
Patient passed away 2 days after a healthy well baby check up at the office, was found unresponsive, taken to ER where he was declared deceased. Results of pathology still pending.
short of breath; could not even walk 3 feet; feel weak; lightheaded; lost their appetite; aching in their legs; are aching in their arms; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (short of breath), GAIT DISTURBANCE (could not even walk 3 feet), ASTHENIA (feel weak), DIZZINESS (lightheaded) and DECREASED APPETITE (lost their appetite) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 037A21B and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fistula (complications due to their "internals being in a bad shape, intestines were messed up, and developed fistulas an have an ostomy bag. They had those before , 8-9 years ago too) in 2014 and Hospitalization (for 3 and half months) in July 2021. Concomitant products included HYDROCODONE and ACETYLSALICYLIC ACID (ASPIRINE 325 MG) for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced DYSPNOEA (short of breath), GAIT DISTURBANCE (could not even walk 3 feet), ASTHENIA (feel weak), DIZZINESS (lightheaded), DECREASED APPETITE (lost their appetite), PAIN IN EXTREMITY (aching in their legs), PAIN IN EXTREMITY (are aching in their arms) and CHILLS (chills). At the time of the report, DYSPNOEA (short of breath), GAIT DISTURBANCE (could not even walk 3 feet), ASTHENIA (feel weak), DIZZINESS (lightheaded), DECREASED APPETITE (lost their appetite), PAIN IN EXTREMITY (aching in their legs), PAIN IN EXTREMITY (are aching in their arms) and CHILLS (chills) outcome was unknown.            No treatment medications was provided by the reporter.  Patient reported that they have not being diagnosed with any heart conditions or had covid-19 before and took several medication but will not provide that information at this time. Also,took 325mg of aspirin a day as a blood thinner and wondering  they should go to the hospital for their symptoms.
herpes zoster; Information has been received regarding a case in litigation from a lawyer and the patient (pt) on 09-SEP-2020, referring to a 63 year old pt of unknown gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 10-APR-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot# and route unknown) for long-term prevention of shingles and zoster-related conditions. The pt suffered the following injuries as a result of the zoster vaccine live (ZOSTAVAX) vaccine: herpes zoster. The outcome of herpes zoster was unknown. The causality assessment between herpes zoster with zoster vaccine live (ZOSTAVAX) was reported as related.
Pt vaccinated with OPV developed fever, diarrhea & anorexia; Unable to walk because of lt leg paralysis. Polio Type II confirmed
Patient received the first Pfizer dose at approximately 5:13 PM.  At 5:44 PM, the patient developed slight hand tremor and was complaining of chest pain (patient was asked to stay within sight of the pharmacy for 30 minutes due to history of anaphylaxis).  9-1-1 was called approximately 2 minutes after initial complaint.  At 5:45 PM, 1 dose of 0.3mg epinephrine injection was given on the right anterolateral thigh.  At 5:47PM, a blood pressure was recorded at 113/87 with heart rate of 124 bpm.  At 5:50 PM, paramedics arrived and took over care.
Fast heartbeat for about 15 minutes, chills/shivering for about 10 minutes, and fatigue after that lasting the rest of the evening.
The patient stated that 12 hours after the flu shot she started getting a fever. The fever then continued for 11 days. During their time she also experience vomiting, headaches, shakinen, chills and the fever ran 99 to 102.4. Her doctor gave her a COVID 19 test it came back negative. Blood test showed SA elevated numbers.
Patient felt dizzy. When moves to a private room, she collapsed while two staff members supported her. She land on her back and regained consciousness. EMS was called and evaluated here. She was walked out to her car.
Immediately after receiving vaccine client got headache. Client received pain at injection site approx. 12 hours after injection. Both H/A & pain at site are resolving at this time. Resolving.
Stomach cramps; Throwing up; Chills; Hot flashes; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17 year-old female patient received bnt162b2 (BNT162B2) (Lot number: ER8733) at the age of 17 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "Stomach cramps"; VOMITING (non-serious), outcome "unknown", described as "Throwing up"; CHILLS (non-serious), outcome "unknown", described as "Chills"; HOT FLUSH (non-serious), outcome "unknown", described as "Hot flashes".  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Narrative "The patient did not receive any medication within two weeks of vaccination." was removed. 2. Final sentence was updated.  No follow-up attempts are possible. No further information is expected.
Loose BM, pounding headache, body aches, nausea, fatigue, sore arm,  chills , eyes hurt-sinus.
This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, past drug history and concurrent conditions were not reported. On an unknown date in May 2016 (reported as either 05-MAY-2016 or 06-MAY-2016) the patient was vaccinated with first dose of RECOMBIVAX HB) (lot # L039660, expiry date 04-FEB-2018) dosing details and route unknown as injection. Concomitant medications were not reported. It was reported that the RECOMBIVAX HB had previously undergone a supported temperature. As of 06-MAY-2016, it was unknown if the patient continues to take RECOMBIVAX HB and the outcome of receiving a vaccine that had undergone a temperature excursion was unknown. This is one of the five reports received from the same reporter. Additional information has been requested.
Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: TINNITUS (non-serious), outcome "unknown". Additional information: Patient had two Pfizer vaccine Covid shots. Patient had been diagnosed with tinitus and would like to know if there is a class action suit for this.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
large hives broke out on buttocks and have persisted for 10+ days traveling to flanks; Fever for 2 days after booster; Vomiting for 2 days after booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Nov2021 15:30 (Lot number: FH8028) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0170, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 23Apr2021, when the patient was 35 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8734, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 02Apr2021, when the patient was 35 years old, for COVID-19 immunization; Flu vaccine vii, administration date: Oct2021, for Immunisation. The following information was reported: PYREXIA (non-serious) with onset 06Nov2021 02:00, outcome "not recovered", described as "Fever for 2 days after booster"; VOMITING (non-serious) with onset 06Nov2021 02:00, outcome "not recovered", described as "Vomiting for 2 days after booster"; URTICARIA (non-serious) with onset 07Nov2021, outcome "not recovered", described as "large hives broke out on buttocks and have persisted for 10+ days traveling to flanks". The events "fever for 2 days after booster", "vomiting for 2 days after booster" and "large hives broke out on buttocks and have persisted for 10+ days traveling to flanks" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pyrexia, vomiting, urticaria. Included Anti itch cream, pill. Waiting on steroids.  Additional Information: Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination.  No follow-up attempts are possible. No further information is expected.
Myalgia, body aches, sore throat, fatigue, and generalized itching on 5/12/15. Reported at office visit on 5/13/15. Also at visit on 5/13/15 noted by dr that pt "feels better today." he does c/o nasal congestion, but sire throat and muscle aches, head aches are better. Advised by dr to mother via phone consultation 5/15/15 to monitor him over the week and mother agreed to see if further evaluation was needed.
extreme electric shocks down both arms and legs; racing heartbeat/High heart rate; stomach pain and contractions; involuntary muscle contractions of hands so extreme I couldn't move them; involuntary muscle contractions of hands so extreme I couldn't move them; Chills; itching; numbness in hands and feet; High blood pressure; felt dizzy; nauseous; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: ER2613) via an unspecified route of administration in left arm on 22Mar2021 at 12:00 (age at vaccination 47-year-old) as 1st dose, single for covid-19 immunization at Health Clinic/ facility. Patient medical history included allergies, asthma, reflux, osteopenia. Patient was allergic to Chickpeas, adhesives. Patient received other medications within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021, at 12:15 patient Immediately felt dizzy and nauseous. Sat for 15 mins and felt a bit better, but off. Within 5 mins of driving experienced extreme electric shocks down both arms and legs, racing heartbeat, stomach pain and contractions, and involuntary muscle contractions of hands so extreme that she could not move them. Rushed to emergency room by ambulance. Chills and itching occurred, numbness in hands and feet. High blood pressure and heart rate. Adverse events resulted into Emergency room/department or urgent care. Treatment given for adverse event was 50 mg of Benadryl which did nothing, added IV of. Fluids and Pepcid, lidocaine with Maalox. Stayed over four hours before anything helped. Still having symptoms on day of reporting. The patient underwent lab tests and procedures which included blood test: unknown on 22Mar2021, electrocardiogram: unknown on 22Mar2021. The outcome of the events was not recovered at the time of reporting.  No follow-up attempts are possible. No further information is expected.
The wrong vaccine was pulled from the refrigerator. There is one basket with two compartments, a front and a back compartment. There are two labels in the front of the basket to indicate two different vaccines, but the vaccine was pulled from the front compartment, rather than the back.
sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received meningococcal group b rlp2086 (TRUMENBA), administration date 25Aug2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "sick". Additional information: The reporter stated that the patient received the vaccine the week of the report and that he is shortly exhibiting some symptoms (further not clarified) and the reporter was not sure if they are side effects that are common from meningococcal group b rlp2086 or if he is sick with something else. The reporter was looking for some information and read the pamphlet insert with meningococcal group b rlp2086 saying that there is the adverse reaction listed there pain at the injection site, fatigue, headache and muscle pain and wanted to know if there are any other common adverse reactions that are common for meningococcal group b rlp2086.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT REPORTED FEELING NAUSEOUS, DIZZY AND LATHARGIC AFTER VACCINE ADMIN ABOUT 5 MINS AFTERWARD. PATIENT HAD A HARD TIME VERBALIZING AND RESPONDING HOW HE WAS FEELING BUT WAS AWAKE AND ALERT. PHARMACIST CALLED FOR EMS. EMS SUGGESTED TRANSPORT BUT PATIENT DECLINED,
Provider summary "92 year old male with PMHx significant for CKD 3, who presented to the ED on 11/19/21 for evaluation of right leg weakness. He reported last three days of intermittent neurologic changes starting with left arm numbness that resolved after a few hours and bilateral leg weakness. The CT of the brain did not show an acute infarct but showed chronic atrophy. His CTA head and neck showed 50% stenosis of the left MCA and 75% stenosis of the right PCA. His MRI did not show evidence of acute ischemic changes but showed chronic lacunar infarcts. In the emergency department he was found to be COVID positive despite being fully vaccinated. His condition improved throughout his hospital stay however on 11/20 had some difficulty swallowing but SLP evaluation was normal. He was accepted to an outpatient acute rehabilitation facility, however had to wait 10 days for placement due to being COVID positive. By 11/23 he had returned to baseline and was discharged home with PT and OT home care and was sent home with prescriptions for aspirin and Lipitor. Recommendations if this were to occur again would be to start Plavix."
pt recv vax & mom reported pt w/hives starting around 10:00 mainly on legs-more on arms this morning;given DPH @ home;
Pt presented with hard, red lump at inj site and red rash along upper arm. Advised pt to take BENADRYL. Area was also very tender. Followed up with pt on 1/4/15-Area much improved.
Fever of 102 degrees F. or higher  (temp was 102 degrees  2 hours after taking ibuprofen), shaking chills, headache, nausea, severe generalized body aches.