chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received her 1st dose of Pfizer vaccine in her left deltoid. Pt came to the first aid area asking for a new bandaid, and stated that the bandaid was not covering over the injection site. Client fainted and this nurse assisted patient to the floor. This nurse called for additional support of workers to help assist patient to the first aid lying area.  Vital signs were obtained at 1405 and are as follows: 96.6, 63, 143/88, 18, patient denied any pain. Pt reported that prior to fainting she felt dizzy and lightheaded. Pt reported daily medications are vitamin D supplement PO daily and metoprolol PO 10mg daily. PMH includes HTN. Pt was observed in the first aid area for an additional 30 minutes.  Vital signs rechecked at 1424 and are as follows 97.1, 72, 112/73, and 17, no pain. Pt was assisted to an upright sitting position and provided a bottled of water after stating that she no longer felt dizzy or lightheaded. Pt was accompanied by her daughter who will be driving the patient home. Nurse assisted patient to schedule her 2nd appointment for 4/26 at 1pm, and daughter stated that she will be coming with her mother for the 2nd appointment as well.  Patient was assisted to a standing position slowly and patient denied having dizziness or lightheadedness while standing. Patient exited the facility accompanied by her daughter at 1433, vital signs prior were within defined limits.
Crying & t104F by PM of 29MAR91; Consulted family MD by phone tx w/APAP;
This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # M040004 and expiry date: 20-MAY-2018 for prophylaxis. The vaccine was exposed to a temperature frame of 47 Fahrenheit to 77 Fahrenheit for 2 hours. There was a previous temperature excursion of 47 Fahrenheit to 77 Fahrenheit for 3 hours and 10 minutes. The call was because of data logger. No adverse effects were reported. No further information provided. This is one of the several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA009404: US-009507513-1707USA009637:
I developed a soreness in my neck as well as my upper left arm where the shot was given. I lost strength, had severe pain and was unable to grip anything with my left hand. The pain was excruciating and lasted for close to two weeks.
Hive type rash on my right inner thigh and measles/chicken pock rash on my stomach and back. I also have swollen and sore lymph nodes in my left armpit. I also experienced fever and chills.
Threw up 4 times; Had diarrhea 3 times; Tired; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) at 79-year-old via an unspecified route of administration in the left arm on 14Jan2021, 9:03 AM at a single dose for COVID-19 immunization/ because people are dying. The patient's medical history was not reported. Patient however stated he is familiar with cancer, epileptic seizures, and heart attacks (pending confirmation if referring to medical history). The patient lives alone and has nobody. Concomitant medications were not reported. On 15Jan2021, from 2:00AM, the patient threw up 4 times, had diarrhea 3 times, and was tired. The patient recovered from the events "threw up" and "diarrhea" on 15Jan2021 (time unspecified). Outcome of the event "tired" was not recovered. It was reported that the patient was scheduled for his second dose on 04Feb2021 at 3:30 PM.   Information on the lot/batch number has been requested.
Increased stomach pain; Increased headache; Muscle pain in both legs; Pain in the upper part of shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Increased stomach pain), HEADACHE (Increased headache), MYALGIA (Muscle pain in both legs) and ARTHRALGIA (Pain in the upper part of shoulder) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included Gastritis, Stomach mass and Back pain.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Increased stomach pain), HEADACHE (Increased headache) and ARTHRALGIA (Pain in the upper part of shoulder). 16-Apr-2021, the patient experienced MYALGIA (Muscle pain in both legs). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Increased stomach pain), HEADACHE (Increased headache), MYALGIA (Muscle pain in both legs) and ARTHRALGIA (Pain in the upper part of shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Left arm pain; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL0142, intramuscularly in the left arm on 04Jan2021 at 09:45 (at the age of 53-years-old) as a single dose for COVID-19 immunization. Medical history included an allergy to sulfa, from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 04Jan2021 at 09:45 the patient experienced left arm pain. The patient was not treated for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left arm pain was unknown.
Numbness and tingling down whole left side of body head to toe (same side of injection).  Mild twitching Ongoing - not treated at time of reporting symptoms . Booked for check at gp clinic  Outcome- unknown
Client became lightheaded and pale s/p first vaccine given (Hepatitia A).  Client was assisted to cot to rest w/head back and cool compress to back of neck.  Client stated he felt better after several minutes.  2 more vaccines were then administered Hepatitis B, and then MCV4.  Client then fainted momentarily, and had twitching of extremities (lasting approx.5-10 seconds).  BP- 100/57, pulse-58.  BP rechecked manually 99/68.  BP rechecked after client  rested approx. 20 minutes 98/70, pulse 60.  Client stated he was feeling better (he drank water and ate a fruit chew snack).  Client stated he only had cereal to eat earlier in day.  Client stated he fainted x1 while donating blood.  After approx. 1/2 hour, client ambulated to waiting room with mother w/out difficulty.
Reported complaints of sternal chest pain beginning the afternoon of vaccination administration. States he was unable to lie flat that night and experienced pain the following day as well. He left work due to the discomfort, but did not seek medical attention. Reported slightly elevated heart rate and blood pressure.
shortly after administering the vaccine, patient felt a numbness on her left arm that radiated to her wrist and she felt a heat rush through her body and her face got red. we placed a cool pack on the back of her neck and another on her forehead off and on for about 2 hours. when she felt better and redness had subsided we told he to walk around the store for a while and to come back before leaving the building. she shopped with her boyfriend for about 45 min and returned and was feeling much better, the redness on her face had gone down a lot but she still was a little red. the rest of her body did not get red, just her face. she felt fine to leave. i told her if she got worse to go to the er. i called her at EOD and she said she had taken a nap when she got home and was feeling better. told her to call me if she had any questions.
Administered Pfizer monovalent to patient. Should have administered  Pfizer Bivalent . No treatment no adverse reaction.
Sore body muscles throughout, for about 30 hours; slight nausea for about 30. Minutes, fever, chills.
4 hours-extreme pain in left shoulder. 12 hours-tiredness. 24 hours-chills, headache and 100 degree fever. 18 hours-slight rapid heartbeat. 48 hours-palm size rash on right front abdominal area no pain or itch on rash at this time.
Fever/Chills 12 hours after shot lasting 4 hours; changed to sweats & racing pulse lasting 30 minutes. Then on/off hot/cold for several hours. 24 hours after shot - heavy sweats and passed out for a few seconds. Very lethargic rest of day. Day 3: lightheaded, fatigued, left arm below shot sight starts to swell with redness & heat - this lasted for 2 days and subsided slowly on the following day. All issues gone by day 6.  Similar event occurred with Phizer\BioN Tech shot EN6198 shot #2 (2/28/21) - that time the sweats/racing pulse after fever/chills ended me in ER, with the diagnosis that I must have had some kind of reaction. Not sure as it was early days if the ER reported the event. And I didn't know there was a reporting system at that time.
Pain behind left ear/left side neck down to shoulder; This spontaneous case was reported by a consumer and describes the occurrence of   in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Fever, chills, severe body ache/muscle fatigue, extreme redness, swelling, blistering and heat at injection site and an approx. 3 inch diameter surrounding site.
Patient developed back pain the following day, along with a buring sensation that wrapped around  to her abdomen. 4 days later a rash developed. Patient sough out medical care and was diagnosed with shingles on 6/26/21
Fever of 102 Painful Softball sized hardened welt on injection site nausea  headache
Pt had been well; no illnesses. Suddenly, on Friday, November 2, 2018, she had a low grade fever. I gave her a dose of Tylenol; and sat down with her on our living room couch. Not even a half an hour later, around 7pm, she began uncontrollably seizing. I immediately placed her on the ground, on her side, and called 911. Pt's full seizure lasted an hour. By the time we got to the hospital, her fever had spiked to over 103. We started our evening at one hospital, but were transferred to another Hospital. Pt spent the night there for observation. The event was diagnosed as a complex grand mal tonic clonic seizure. Due to family history, pt did receive an EEG to rule out epilepsy. The EEG was performed at Hospital a few weeks after our stay. The EEG was normal.
The patient contracted COVID-19 even after being fully vaccinated. The client had nasal congestion and loss of taste and smell.
Wednesday 10/3 2 p.m. - weak and not feeling well and reported symptoms to employee health nurse.  Thursday 10/4 Severe malaise, followed by weakness, high fevers, and followed by severe asthma attacks starting Friday and multiple trips to ER/MD office for evaluation/nebulizer treatments.  Asthma attacks remain mod-severe for weeks following vaccination. Numerous respiratory/steroid treatments required.  Developed bronchitis after asthma flared.
I had a positive test on the morning of 18Jun2022. I began my Paxlovid on 18Jun2022; I had a positive test on the morning of 18Jun2022. I began my Paxlovid on 18Jun2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jan2021 at 15:00 as dose 1, single (Lot number: EL1283), in left arm, on 02Feb2021 at 14:00 as dose 2, single (Lot number: EL9262), in left arm and on 23Sep2021 at 12:00 as dose 3 (booster), single (Lot number: FC3183) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jun2022, outcome "not recovered" and all described as "I had a positive test on the morning of 18Jun2022. I began my Paxlovid on 18Jun2022". The patient underwent the following laboratory tests and procedures: Body temperature: (27Jun2022) 100.3; SARS-CoV-2 test: (18Jun2022) Positive; (22Jun2022) Negative, notes: I tested negative again on the 22nd at 8am; (27Jun2022) Positive; (29Jun2022) Positive, notes: Still testing positive on a home rapid test; (21Jun2022) Negative, notes: I tested negative at 6:45pm (I have the documents) . Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient did not have known allergies. The patient had a positive test on the morning of 18Jun2022. She began Paxlovid (lot no: ga2851) on 18Jun2022. Felt better by Monday 20Jun2022. The patient had  PCR test on Tuesday the 21st. She had tested negative at 6:45pm (She has the documents). Then she finished her Paxlovid on wed 22nd. The patient tested negative again on the 22nd at 8am. The patient had no symptoms or fever. The patient started feeling bad on Sunday night 26Jun2022. She tested on Monday the 27th and she was positive. She was running a fever of 100.3 had a runny nose and headache. No cough or trouble breathing, just like a sinus infection. On Wed 29Jun2022, She was better with a low grade fever. Still testing positive on a home rapid test. Her doctor gave her a prescription for Tamiflu but she has not taken it yet. She was hesitant because she was doing better. She has no underlying health problems.  She was doing work out regular.
It has been a month since getting the vaccine and my arm is still painful to the point of limited movement. The first few days after the shot, I was not concerned about the soreness, I knew it was a normal side affect. But at this point I am more concerned and do feel it is an  issue to be reported. This may keep me from getting the vaccine in the future.
onset of rash 2 days ago, other than being a little more irritable, she has been eating and sleeping well, does not seem pruritic.
I tested positive for COVID-19 on 1/2/23. I had a cough, shortness of breath, nausea, vomiting, diarrhea, fever of 104, and fatigue. I had severe symptoms for about 2 weeks. I contacted my doctor and was prescribed 5 days' worth of PAXLOVID and ondansetron. It took me about 2 months to fully recover.
Chills, fever, cold sweats, nausea, dizzy,head ache, fatigue, night mares. Lasted two days.
Later that night, 10 yo taken to ER bec. in pain & emesis. Diagnosed w/ UTI & given antibiotics.
The following date 1/29/2021, I began bleeding  from my Uterus as if I had started my period again, when I had just had it 15 days prior. Since then today is 2/16/2021 and I yet to stop bleeding. I do not have any underlying issue, pregnancy test came out negative, and I am not on birth control.
pt was given tdap instead of dtap.  pt had no sx.pt will be followed up with a Dtap.
Clinical deviation of Pfizer mixed with Moderna.  Patient received "booster" of Pfizer after Hx of Moderna Dose #1 1/9/21 & Moderna Dose #2 2/6/21.  Not considered immunocompromised.  F/U with patient on 9/27/21 and patient verbalized no S/S.
No additional adverse events reported; improperly stored doses of VARlVAX that was administered; This spontaneous report as received from a nurse and an other reporter and refers to a 17-year-old female patient. No information regarding the patient's medical history and concomitant medications was provided. The patient had no illness at time of vaccination and had no pre-existing allergies, birth defects or concurrent medical conditions. There was no concomitant vaccines administered.   On 17-FEB-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, subcutaneously (SQ) in the left arm (LA) for prophylaxis (lot # S006021 was verified to be valid, expiration date reported and established as 27-FEB-2021).  It was reported that the excursion occurred on 11-FEB-2021 and lasted for 1 hour and 6 minutes, the temperature reached -6 Celsius degrees and the freezer returned to range. The excursion was notced on 19-FEB-2021. The patient did not experience any additional adverse reactions after administration of the vaccine. The vaccine was used according to the instruction and the operator was trained. The improper storage was recorded by digital data logger.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2102USA007657:
Soreness in armpit on injection arm (sore lymph-node). It has lasted 2 days as of now.
Evening after shot: 11 hours sleep Day 1 after shot - fatique and headache.  I took 325mg acetaminophen.  Later that day, I was achy, so I took 200mg ibuprofen before bed. Day 2 after shot - My teeth started to hurt, then my gums were very sore, and by the end of the day, my gums started to bleed.  I added hydrogen peroxide to my normal waterpik routine, took acetaminophen 325mg, and went to bed. Day 3 after shot.(today) My gums still hurt, but not as bad as yesterday, and they are not bleeding.
Paged at 9PM that the site of her vaccine reaction is raised and red and tender. It feels hard, red, and warm and measures 3 inches. She is afebrile and acting normally, but not wanting to walk on her leg or to have her leg touched. Appt is made for tomorrow to evaluate it, but as long as she is AF and acting normally, this is likely a localized vaccine reaction. Comfort measures with Motrin.
Expired First Dose Administered; Initial Report Received on 16-Oct-2023  A pharmacist in the reported that a 39-year-old male (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history was reported.  No relevant concomitant medications were reported.  On 16-Oct-2023, the patient received the first dose of HEPLISAV-B (Lot #938794, expiration date: 09-Oct-2023, NDC #43528-003-05), route not reported.  The dose given was expired.  No adverse events were reported.  No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.   ?
The area of induration started last night. The area is a 4.5 x 6 inch erythematous lesion on the right upper anterior thigh, slightly swollen, no significant warmth, good capillary refill of Right toes, +2 dorsalis pedis pulse. To use cool & warm compresses, Benadryl prn
first dose September 24th 2021 second dose October 23rd 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number kz455, expiry date 4th February 2023) for prophylaxis.   Concurrent medical conditions included immunocompromised (immunocompetent). Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 23rd October 2021, the patient received the 2nd dose of Shingrix. On 23rd October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: On 24th September 2021, the patient received first dose of Shingrix. The patient received second dose of Shingrix earlier than recommended interval, which led to shortening of vaccination schedule. The reporter did not consent to follow-up.
Longer than normal menstrual cycle.  This period lasted longer than 10 days when I normally bleed for 5 days max. This was the first period to follow my 2nd dose of the covid 19 vaccine. I normally bleed 5 days max and have had regular periods for 20 plus years ( since the age of 10).
Semi arthritic pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Semi arthritic pain) and HEADACHE (Headache) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 026821A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Semi arthritic pain) and HEADACHE (Headache). At the time of the report, ARTHRALGIA (Semi arthritic pain) and HEADACHE (Headache) had resolved.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
My son's  COVID-19 infection symptoms started on 01/14/2023 in the morning as soon as he woke up. He had a dry cough,  chest congestion, phlegm, pressure on the face,  low grade fever, and fatigue,  I did the home COVID-19 test on 01/16/2023 which was positive. I called my sons doctor's office on 01/18/2023 and left a detailed message but got no answer. I called back after 4 hours the call center of the doctors office send an email to my son's doctor informing that he was positive for COVID-19 infection. They called me back an hour after my second call and advised  me to give my son Tylenol. Since , my doctor prescribe me with a cough medication called Benzonatate I shared my medication with him because I also was positive for COVID-19. The cough medication helped my son with his cough.
Patient received immunization on Fri and started to experience pain and numbness in the immunized arm that evening around 6pm.  The pain and numbness worsened throughout Saturday and Sunday with an increase of right leg pain on Sunday.  On Friday,  April 9, the patient noticed a numbness and drooping of his face which progressed to his eye not being able to close.  Today, April 15, he presented with two prescriptions for prednisone and erythromycin eye ointment.
No other AEs or PQC reported; vaccine administered after temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 25-SEP-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U015689, has been verified to be a valid lot number, expiration date was reported as 13-MAY-2023, but upon internal validation established as 18-MAY-2023, 0.5 milliliter, strength was not reported) subcutaneously (SQ) for prophylaxis.         The vaccine administered after temperature excursion. Administered varicella virus vaccine live (oka/merck) (VARIVAX) were stored at 25.9 degrees Fahrenheit (F) for 1 hour and 30 minutes. There was no previous temperature excursion reported. No other adverse events reported.
Developed a fever shortly after immunization and had a seizure on 06/22/2011 & was taken to Hospital.