chrisvoncsefalvay/vaers-outcomes huggingface dataset:
inflammation; shortness of breath; chest pain; inflammation of her heart; The initial safety information received was reporting only non-serious adverse drug reaction(s). Upon receipt of follow-up information on [24Nov2021], this case contains serious adverse reaction(s) and all safety information is processed together.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) (sister) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (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: CARDIAC INFECTION (medically significant), outcome "recovered", described as "inflammation of her heart"; INFLAMMATION (non-serious), outcome "unknown", described as "inflammation"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; CHEST PAIN (non-serious), outcome "unknown", described as "chest pain". Clinical course: Sister genetically similar to reporter. Patient was Clinical pharmacist. She had inflammation. She had shortness of breath, chest pain.  Experiencing that. It states she found out her sister had it for a day, with the 2 vaccines she had inflammation of her heart and it went away after a day, she is a pharmacist specializing in cardiology.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Itching and Redness on the arm down from the injection site; no other allergic symptoms (throat or breathing issues). Within 1.5 hours the itching and redness had stopped; confirmed with patient at 2:00 3/13.
This spontaneous report as received from a Registered Nurse refers to unspecified number of patients of unknown age and gender. On 08-SEP-2014 unspecified number of patients were vaccinated with LIQUID PEDVAXHIB (dose, route, lot # not reported) that had been improperly stored. No adverse event symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not give a consent for contact.
pt recvd 1st dose of HIB/DTP/OPV on 23MAR92 & approx 8 hrs following vax taken to ER w/swelling of the mouth & tongue & swelling @ DTP inject site; lungs were clear & was treated w/ice packs on thigh; pt recovered;
dose 3 years ago, not sure about receiving 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details provided were as follows: Age at vaccination was not applicable for this report. The patient was not sure about receiving the 2nd dose yet. Patient did not recall receiving a 2nd dose. Till the time of reporting, patient did not receive the 2nd dose yet which led to incomplete course of vaccination. So far reporter requested information about possible late 2nd dose and what would happen in case of administration of a 3rd dose. No vaccine administered in current reporter facility at the moment. The reporter did not consent to follow-up.
1st side effect began around 9:30pm w/ fever, body aches, nerve pain down legs and arms, fever broke next day by noon on 1/29/21. Pain in armpit noticed morning 7:00am when patient woke on 1/30/21 w/ nerve pain down to palm of middle finger.
The injection site on my right upper arm is swollen, red, itchy, and warm to the touch.  Measures 4? long and 3? wide and is oval shaped.  I noticed an itch on 1/24/21 @ night and again the next morning and upon close inspection found the reddened oval shape that was warm and swollen.  It continues today on 1/27/21. I am not exhibiting any signs of anaphylaxis.  My concern is whether is is safe form me to receive the second Moderna vaccine on February 9th.
Patient says having "alopecia" (ie bald spots) in his beard, hair is starting to grow back in bald patches but is growing back a lighter color rest of beard is dark - said started after getting flu shot.
PT presented to clinic today for COVID Pfizer vaccine.  Data confirmed Pfizer primary dose given on 10/6/21 @ Pharmacy.  Pfizer # 2 Primary drawn up.    PT greeted and to exam room.  PT asked about concerns over vaccines due to the length of time to get her second Pfizer primary.  PT presents a vaccine card stating this would be her second booster dose.  PT states she is pregnant at six months.  PT asked about pregnancy concerns, advised there are no contraindications and CDC recommends Covid vaccination for pregnant women.  PT also asked about side effects as she usually gets a fever with her Pfizer shots.  I explained side effects to PT and confirmed Fever is one.  I suggested considering a Moderna booster in the future as mixing vaccine brands adds a small increase in protection and she may experience less side effects or more, but worth considering.  PT agrees to move forward with Pfizer vaccine.   Patient tolerated well without any adverse reactions.  PT advised to wait in lobby for 15 mins, drink plenty of water and no physical exertion rest of day.   As I was filling out the PT card, I realized I had given her a Pfizer primary dose, and not the Pfizer bivalent booster.  I reported my mistake to my Manager.  Manager confirmed on CDC the PT should return to facility in 2 months for the Covid bivalent booster.   I asked the PT to return to the exam room with me.  I explained to the PT that I had made a mistake of giving her the Pfizer primary and she should have been given a Pfizer bivalent.  I sincerely apologized for my error and asked if she wanted to speak with my boss.  PT said no, asked if there was a need for concern.  I explained CDC information that PT will be fine, and should return in two months for bivalent booster.   PT asked if her baby would be ok.  I said yes, antibodies would be passed to the baby.  PT was calm and relaxed, but I again offered if she would like to speak with my boss.  No, she understood mistakes happen.  I again reiterated how truly sorry I was.  I gave the PT Facility phone number, Manager's name and my name if she need to callback and ask questions.  PT monitored for 15 minutes post vaccine administration, no s/s reported, no further questions.  Pt contacted OB.  OB confirmed PT and baby will be ok.  To PCP Dr as FYI.
patient felt like her lips were swelling. Patient also felt dizzy and was having problems breathing. patient felt like she had something stuck in her throat. she started feeling better as soon as she was being brought back to med ops 1.  VITALS: laying down time- 12:41,  HR- 77, RESP- 14, BP 123/84, sp02- 100.   sitting up time- 12:50, HR- 67, RESP- 14, BP-118/86, SP02- 99
Two days post vax pt had severe pain in right wrist. Three wks post vax, pt had red rash with hives over entire body. She couldn't write or control the pen. She had a short term memory defect. Her speech was unclear. She had terrible, constant itching and developed rough skin after hives went away. She awoke with eyes swollen shut and face badly swollen. She is almost recovered. Her eyes, skin and short term memory are still slightly affected.
pt recvd vax & later in afternoon arm became sore, was very sore by evening;next day 18OCT95 was tired, arm very sore, noticed rash on upper arm & swollen lymphnode under arm;rash is red extending from upper arm almost elbow & under arm;
I began to notice my left ankle seemed sprained, but I had not injured it . I then began to have a struggle to just stand up and move as if I had aged 25 years since my first vaccine .I had three.
Case number PHEH2014US010527, is an initial spontaneous report received from a pharmacist on 21 May 2014. This report refers to a 26 year old female patient. Pharmacist reported that she administered an expired dose of MENVEO (batch number: A11064, expiry date: Dec 2013), intramuscular to the patient on 21 May 2014. No adverse reaction was reported. No further information was provided.
Information has been received from a physician concerning a 5 year old male pt who on 3/14/00 was vaccinated with varicella virus vaccine live. On 2/17/02, he developed a rash on his shoulder and back in a C2, C3 dermatomal distribution. He presented to the ER on 2/19/02 with a stiff neck and nausea. Other than nuchal rigidity, his neurologic exam was normal. His mother reported him feeling warm to touch at home, however, he was afebrile on admission. Although his mental status was normal and he remained afebrile, he was given a dx of viral meningitis due to VZV and placed on acyclovir. He was immediately placed on respiratory precautions. He improved and WBC returned to normal. He was discharged on 2/26/02. The CDC indicated that this is not a varicella adverse event, but either: shingles and concurrent enteroviral meningitis or possibly enteroviral infection with herpes simplex reactivation. They noted that the skin lesions were never tested and that the physician gave a history compatible with shingles but there was no lab confirmation. PCR analysis was performed at the CDC and the results indicated that the crust of the shingles rash was (+) for Oka strain varicella virus. It was concluded that the child had vaccine-strain shingles and a separate enteroviral meningitis. Additional information has been requested.
back problems; My new teeth are hurting on the top; This is a spontaneous report from a contactable consumer (patient) . A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration on an unspecified date in Jan2021 as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, patient had back problems and new teeth were hurting on top. Patient reported that when it was time to get second dose patient was laid up. Patient figured by the time that they get around to making an appointment for 2nd shot the back would be fine. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Epistaxis, nausea, fatigue, malaise, acne varioliformis.
No adverse event, but when shot was given needle was loose on syringe causing it to not be injected.  Patient was given another dose with good syringe.
I GAVE PATIENT FLUZONE HD  INSTEAD OF PFIZER BOOSTER.  RECEIVED HER FLUZONE HD A WEEK BEFORE.
low grade fever 6hr p/vax;restlessness @ noc-48 hr p/inj blotchy rash, runny nose (next day);no local rxn noted;
THIS IS NOT TECHNICALLY ADVERSE EVENT. 16 Y/O PT RECEIVED 1ST DOSE PFIZER VACCINE ON 05/07/2021 BUT THE FDA APPROVAL FOR THAT AGE GROUP WAS ON 05/10/2021. JUST TO DOCUMENT, ENTERING THE ADVERSE REPORT PER OUR COMPANY POLICY
Developed bumpy rash on LEFT (received injection in RIGHT arm due to being left handed) upper arm/shoulder with smaller rashes on forearm and inner elbow. Does not itch. Minor pain from clothing rubbing it. Taking Advil.
Extreme weakness and deep aching to sharp pain. Severe sharp pain when moving in some directions. Numbness to outer upper shoulder with intermittent finger tingling
head feels puffy; face feels kind of numb; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (head feels puffy) and HYPOAESTHESIA (face feels kind of numb) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    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 SWELLING (head feels puffy) and HYPOAESTHESIA (face feels kind of numb). At the time of the report, SWELLING (head feels puffy) and HYPOAESTHESIA (face feels kind of numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include cholesterol medication  No treatment information provided   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Received-Non Significant FU-Denies Further Followup
Swelling, hot, and very painful around injection site; more extreme than I have ever encountered with a vaccination in the past. I could barely move my arm and the swelling encompassed my entire upper portion of my right arm. I used ice to kill the pain, heat, and swelling, and it seemed to help a little. 2 days after the vaccination I developed a hives like patch of raised red skin in circular welts about 3 inches from the injection site. They do not itch, and even though the pain has mostly subsided, the hives are still present-a patch about the size of a baseball, but they are not really bothering me the way the pain did for the 1st 2.5 days.
Headache; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Mar2021 11:00 (Lot number: EN6207) at the age of 49 years 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: HEADACHE (non-serious) with onset 12Mar2021, outcome "recovered" (12Mar2021), described as "Headache"; FATIGUE (non-serious) with onset 12Mar2021, outcome "recovered" (12Mar2021), described as "Fatigue".  Additional information: The reporter stated that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. All symptoms Lasting over 24 hrs. After 24 hrs, severe joint pain remains. First dose had a headache and fatigue for a few hrs. 2nd dose fever, headache, fatigue for 6-8 hrs. 3rd dose makes me never want to get a 4th if recommended. Prior to vaccination, the patient diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
no adverse event; VARIVAX has been administered to a total of 13 patients. Temperature excursion; This spontaneous report has been received from a consumer concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.   On an unspecified date between 11-MAY-2022 and 24-MAY-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX)  subcutaneous injection, lot #U039949, expiration date: 16-DEC-2023 (dose, route, vaccination scheme frequency and anatomical location were not provided); along with an sterile diluent, for prophylaxis.  The vaccine underwent a temperature excursion of -14 degrees Celsius (C) up to -10 degrees C for 2 hours (h), 5 minutes (min) and 0 seconds (sec); -10 degrees C up to 8 degrees C for 1 h, 25 min, 0 sec. The involved vaccine had a previous temperature excursion of -14°C up to-10°C (-12C) for 50 minutes 0 seconds. No additional adverse events were reported.
Sore throat; Flu-like symptoms; Sore and itchy; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), INFLUENZA LIKE ILLNESS (Flu-like symptoms) and PRURITUS (Sore and itchy) in a female 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-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), INFLUENZA LIKE ILLNESS (Flu-like symptoms) and PRURITUS (Sore and itchy). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), INFLUENZA LIKE ILLNESS (Flu-like symptoms) and PRURITUS (Sore and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment medication was not provided.
Delayed cutaneous hypersensitivity reaction appeared on 1/25/2021.  Disappeared 24 hours later.  Redness at vaccination site.  No swelling or discomfort.
Information has been received from a physician concerning a 4 year old male who on 19 JUN 2007 was vaccinated with zoster vaccine live (Oka/Merck) (lot # 657558/04610) instead of booster for varicella virus vaccine live (Oka/Merck) (MSD).  No symptoms were reported.  The physician noted that these were cases of human error, not product confusion.  This is one of two reports received from the same source.  Additional information has been requested.
This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 84-year-old male patient who received SHINGRIX for prophylaxis. On 11th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site pain, injected limb mobility decreased and limbs stiffness. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved and the outcome of the limbs stiffness was unknown. It was unknown if the reporter considered the injection site pain, injected limb mobility decreased and limbs stiffness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the lower part of his left deltoid. In 2019, the patients left arm hurts at the injection site and it limits movement. The reporter reported that it hurts a little less than it did initially but has stayed like this for a while. The reporter gave consent to follow up. Reporter was transferred to MI for additional information and indicated that he had not reported this to his physician so he wanted to be sent the letter personally. The healthcare professional also mentioned that, stiffness limiting movement in the affected arm.
At approximately 8:00 pm Paramedic saw pt pass out and he sounded like he was snoring. Paramedic lowered him to the ground and he woke up. This nurse was alerted by employee that someone was in distress.  This nurse noticed patient was awake and sitting up on the floor. Paramedics took his blood sugar and it was normal. pt stated he went home from work got a shower and got in the car and drank one large bottle of Gatorade very quickly on his way to get his 1st Covid shot.. Pt denies any medical conditions. No hx of reaction to any vaccine. 911 was called pt c/o feeling dizzy after put up on the 911 gurney so they lowered it. He states he felt weak and felt a little short of breath. His BP was 113/46. Transported to hospital. At 12:15 am on 4/9/21 this Nurse called hospital and they said pt was just now ok for discharge.
Presented with itching at injections site. within 15 minutes at injection. Within 30 minutes of injection had difficulty breathing. Given Epi injection via Epi-pen x 3 doses within 15 minutes, Solumedrol 125mg IM, transported to Emergency Department.11/26/07-records received for DOS 11/6/07-seen in ED for C/O fullness in throat, itching, throat felt tight. DX-Acute allergic reaction resolved.
Immediately after dizzy spell, faint, tired. That evening high pulse, severe swollen intestines, diarrhea every hour, nausea, unable to eat. Ill for six days, lost 4 lbs. Dr prescribed ZOFRAN for relief which caused more illness by way of impacted defection.
patient developed allergy days after vaccination, area of injection Red, swollen Rash began small enlarged to tricep area
chest pains; with extremely high cardiac enzyme levels; This is a spontaneous report from a Pfizer-sponsored program,  from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2, dose 2 via an unspecified route of administration on 12Apr2021 (Batch/Lot number was not reported) as single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  On 15Apr2021, the patient began having chest pains and was admitted to the hospital with extremely high cardiac enzyme levels. They could find nothing wrong with heart and was discharged the next day. The patient was hospitalized from 15Apr2021 to 16Apr2021. Outcome of the events was unknown.  Information on batch/lot number has been requested.
One day after vaccine developed chills, malaise, fatigue, and erythema/swelling/pain in left upper arm, nausea, chest pain, dry cough, and shortness of breath.  Seen three days later with persistent symptoms.
pt c/o dizziness shortly p/receiving Recombivax HB; laid down @ that time sl pale but conscious; HR60, RR20, BP 112/80; had also gone for 13-14 hrs w/o eating a/this incident; observed for 1 hr p/episode w/o incident;
Patient had fever of up to 101.3 F, one day after the first Moderna Covid-19 vaccine
This spontaneous report was received from a medical assistant refers to unspecified number of patients of unknown age and gender. There was no information about patients' concomitant medications, pertinent medical history, drug reactions and allergies. On unspecified dates, the patients were vaccinated with improperly stored PROQUAD (Merck) (lot # L002419, expiration date 23-JUL-2016, dose, frequency, route and site of administration were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Acute ear ache; flu (early December 2013) and insomnia mid March - April 23.
pregnant patient who got the Fluzone with no reported adverse event; Initial information received on 25-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 30 years old female patient who was pregnant and got the influenza quadrival a-b vaccine [Fluzone Quadrivalent] with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported pregnant patient who got the Fluzone with no reported adverse event occurred at 30 weeks of pregnancy and the patient was exposed to influenza quadrival A-B vaccine at 30 weeks of pregnancy, during third pregnancy trimester for influenza quadrival A-B vaccine.  The date of last menstrual period was reported as 27-Jan-2023. The estimated due date is 03-Nov-2023. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On 25-Aug-2023, the pregnant patient received a Dose 1 of suspect influenza quadrival A-B vaccine Suspension for injection (lot 4T8040NA) (with an unknown dosage, strength, expiry date) via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation) with no reported adverse event (exposure during pregnancy) (latency- same day).  Relevant prenatal testing after exposure was not reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  Additionally, at time of reporting, the pregnancy is still ongoing.
Breakthrough case admission after 2 vaccines Pfizer 4/10/21 lot# Ew0150; Pfizer 5/1/21 lot# Ew0164
Both doses first 2 days no fever but feeling very cold and mild headache. Following 4 days nausea ,unsteadiness and headache . Gradually reducing after 9 days