chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a other health professional referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with expired dose of ZOSTAVAX vial, subcutaneous (strength and dose not reported). No other concomitant therapies reported. No adverse effect reported. The healthcare worker declined to provide any further information. The outcome of the event was unknown. The causality of the event was unspecified. No PQC reported. Additional information has been requested.
Body soreness; Muscle fatigue; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EN6205, Expiration Date: Jun2021) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Lot Number: EN6200, Expiration Date: Jun2021 MUSC), for covid-19 immunization, reaction: "hive on upper torso, neck and chin". The following information was reported: PAIN (non-serious), outcome "unknown", described as "Body soreness"; MUSCLE FATIGUE (non-serious), outcome "unknown", described as "Muscle fatigue".  Additional information: Shot number 1 adverse event was hive on upper torso, neck and chin. No breathing problems. Shot number 2 adverse events included body soreness and muscle fatigue on 3rd day after shot. No hives.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021196639 Same patient, same drug, different dose, different events
Pt developed a 4" by 6" erythematous area at injection site that was warm and nontender on left thigh.
Myalgia, Fever, Rash, SWOLLEN AND TENDERNESS AT INJECTION SITE
The day shots were administered a fever started of 101 Tylenol would keep it down also trouble breathing, that continued for the next 2 days with a good cough and green snot. On the 3rd day still fevers now hives covering the body controlled by Benadryl, then a full body rash with sores now in mouth on mouth and various places on the body. The doctor at the walk-in would not hear me so she gave an antibiotic to him for viral infections although everytime he gets shots the exact same symptoms occur AND NO ONE WILL LISTEN!!!! When he got his 6 month shots he was hospitalized and they called it RSV we now have to use a nebulizer when he gets shots just to open the air ways! He is a twin and his brother has a milder case but same symptoms! Also he has a 4 yr old brother who had the same problems with shots only a milder version!
severe head and body ache, chills, fever, debilitating fatigue lasting about 40 hours.
Myalgia, Arthralgia, joint pain, neck pain, muscle pain, pain at inj site Narrative:  Other Relevant History:
This spontaneous report as received from an other refers to patients of unknown age. On an unknown date the patients were vaccinated with an improperly stored dose of GARDASIL 9 for prophylaxis which was stored from 9 Celsius degrees (°C) to 25°C. Concomitant therapies included sterile diluent(STERILE DILUENT).  On an unknown date the patients experienced no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9.; Sender's Comments:  US-009507513-1707USA010451: US-009507513-1707USA010526: US-009507513-1707USA010527: US-009507513-1707USA010528: US-009507513-1707USA010529: US-009507513-1707USA010531: US-009507513-1707USA010532:
Swelling and redness to the Left deltoid covering upper 2/3 of upper left deltoid. Reports tenderness initially on 9/3-9/4. Reports tenderness and now swelling have worsened 9/6. Came in for evaluation with med staff. Recommend ice therapy 20-30 min and use of Ibuprofen. Reports taking nasal  wash since injection for sinus infection. 9/10/10 decreased swelling and pain decreased redness. Better movement. Reports had neck & axilla lymph swelling also noted on 9/7 but forgot to mention it on 9/8/10 visit.
Information has been received from the office manager in a doctor's office concerning an 18 year old female patient with penicillin allergy who was vaccinated with a first dose of Gardasil and a second dose of Gardasil. The patient developed fever of 103 F after 8 hours of getting the second injection. She also did not feel well and had "problem breathing". She had no reaction after the first injection with Gardasil. Unspecified medical attention was sought by the patient. The patient recovered. Additional information has been requested.
mom states pt c/o pain lt leg & noticed red area; seen by FNP; had diffuse red warm area lt thigh 11 x 10 cm; no lymphadenopathy; had pharygnitis? sinusitis;
PER PT LATER IN THE DAY AFTER RECEIVING VACCINE THEY HAD DIFFICULTY BREATHING AND DIDN'T FEEL RIGHT, WENT TO THE ER TO SEEK TREATMENT WHERE THEY REPORT THEY WERE FOUND TO HAVE HIGH BLOOD PRESSURE AND WERE GIVEN A TABLET TO HELP THEM BREATHE.  ON 10/23/20 PT CALLED PHARMACY TO REPORT THAT THEY DID NOT FEEL RIGHT AND WERE ASKING IF THEY SHOULD RETURN TO ER.  PT STATED THEIR CURRENT SYMPTOMS WERE FEELING LIGHT HEADED.  WHEN ASKED IF THEY HAD CHECKED THEIR BLOOD PRESSURE THEY STATED IT WAS 150 OVER SOMETHING, THEY DIDN'T REALLY REMEMBER.  ADVISED PT THAT IF THEY WERE NOT FEELING WELL THEY SHOULD SEEK MEDICAL CARE. PT STATED THEY WERE GOING TO EAT SOMETHING AND GO TO FACILITY.
This initial non-serious spontaneous case received on 05-Oct-2017, reported by a pharmacist and concerns 74-year-old elderly male patient. The patient's historical condition included "some kind of large prostate". The patient's current conditions included diabetes, high blood pressure, high blood cholesterol. The patient's concomitant medications included: finasteride, JANUVIA, atorvastatin, metoprolol, DEXILANT. On 15-Sep-2017, the patient received FLUAD (TIV) (dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid muscle, batch number: 178701 (as reported), expiry date: April-2018). On 22-Sep-2017, 8 days after administration of FLUAD (TIV), the patient had usual aches and pain in the first two days (after the shot). A week after, he felt there was a burning sensation at the site in the muscle, which lasted about a week and went away. The patient had a dull aching pain in the muscle underneath and surrounding the site. It was reported that, as he touched on it then, he felt a little bit of pain. When the shot was given, he felt the liquid might have damaged the muscle (added by the pharmacist). The outcome of the events was not recovered. The reporter assessed this case as non-serious.
This case was reported by a physician and described the occurrence of diffuse itching in a 77-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included latex allergy and sore throat. On 20 October 2008, the subject received a dose of FLULAVAL (.5 ml, unknown, left arm) and was prescribed Amoxicillin for her sore throat. On 22 October 2008, 2 days after vaccination with FLULAVAL, the subject experienced diffuse itching. The physician reported that the subject came into the urgent care practice complaining of a sore throat. The physician prescribed Amoxicillin 875 mg, twice daily and FLULAVAL was given as a preventative. Two days after receiving FLULAVAL and the amoxicillin was started, the subject developed itching. The itching was diffuse and not just at the FLULAVAL injection site. The physician did not know whether the itching was due to the FLULAVAL or the Amoxicillin. The subject does have a history of latex allergy, but the physician reported he "was told FLULAVAL does not contain latex". The physician did discontinue the amoxicillin on 22 October 2008 and there was a mild improvement in the itching, but the itching had not resolved. No treatment has been required. At the time of reporting, the event was improved.
Had first episode of generalized seizure around 40 hours after vaccination. Temperature was 102'F after the seizure. Patient was brought to hospital by paramedics for evaluation. Fever resolved after another 24 hours with acetaminophen and Ibuprofen. Mild runny nose started same day as the seizure.
FEVER, CHILLS, HEADACHE, MYALGIA  Narrative:  FEVER 100.5; CHILLS AND HEADACHE CONTINUED FOR AT LEAST 3 DAYS
This case was reported by a pharmacist and described the occurrence of elevated liver function test in a 43-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent medical conditions included allergic rhinitis, chromosome abnormality and down's syndrome. The subject was a resident at a state supportive living center. Concurrent medications included PROTONIX, PEPCID, REGLAN and LEVOTHYROXINE. On 15 June 2011 the subject received 1st dose of HAVRIX (1440 iu, site unknown). On 29 June 2011, 14 days after vaccination with HAVRIX, the subject experienced elevated liver function tests, bilirubin increased, jaundice, elevated white blood cells and elevated sedimentation rate. The pharmacist considered the events were clinically significant (or requiring intervention). The pharmacist reported that the intervention required was the monitoring of blood lab work. Relevant test results included negative hepatitis screen on 29 June 2011. At the time of reporting the events of bilirubin increased, jaundice and elevated white blood cells were improved. The event of elevated sedimentation rate was unresolved, and the event of elevated liver function tests was worse. The pharmacist considered the events were probably related to vaccination with HAVRIX.
chest was shaking; chest was really tight; itching on my shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching on my shoulder), TREMOR (chest was shaking) and CHEST DISCOMFORT (chest was really tight) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included APIXABAN (ELIQUIS), LOSARTAN, LEVOTHYROXINE, VITAMIN D NOS and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PRURITUS (itching on my shoulder). On 24-Feb-2021, the patient experienced TREMOR (chest was shaking) and CHEST DISCOMFORT (chest was really tight). On 24-Feb-2021, TREMOR (chest was shaking) and CHEST DISCOMFORT (chest was really tight) had resolved. At the time of the report, PRURITUS (itching on my shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details included None. Concomitant medication also included Ocuvite .   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow up contains non-significant information. Reporter Fax number obtained.
Raised rash over L shoulder and neck, around to L side of back , swollen knot L side of neck, tender to touch.  Headache since taking booster shot. Was visiting parents for Christmas. Mother a FNP. Thinks looks like ?shingles? No fever.
Follow up information was received that provided vaccine information, test results and outcome and medically confirmed this report. This case was considered medically important. Information regarding PREVNAR was received from a consumer and physician regarding a 12 month old male patient who received a dose on 25 Mar 20101 and experienced swelling of three inches in diameter in the thigh area at the site of injection that was painful to touch. Medical history: None. Indication for PREVNAR was immunization. Product was administered on 25 Mar 2010. Dose regimen was 1 dose 1 time per day. The vaccine had been stored as per manufacturer instructions. Concomitant therapy: None. On 25 Mar 2010, the patient developed swelling of three inches in diameter in the thigh area at the site of injection that was painful to touch. Treatment included TYLENOL. On an unspecified date, the patient recovered. Test results: Physical examination (results: The patient's language/speech, emotional/social, fine/gross motor skills and cognitive thinking developmental milestones were with normal range. The patient's physical growth has been normal) was done on an unspecified date. No additional information was available at the time of this report.
runny nose; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose) and OROPHARYNGEAL PAIN (sore throat) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (runny nose) and OROPHARYNGEAL PAIN (sore throat). At the time of the report, RHINORRHOEA (runny nose) and OROPHARYNGEAL PAIN (sore throat) outcome was unknown.      No concomitant medications were reported. No treatment details were reported.
About 20 mins after I received the vaccine.  I started to feel a little nauseous.  I decided to go home and did not feel. I started to vomit and had horrible headaches.  About the second week of having these symptoms I went to the doctor and he did a COVID-19 test and a Flu test.  They came back negative.  He prescribed me two medicines for nausea.  After a few weeks I started to feel better.  I have also had symptoms with my blood pressure.  I know the vaccine has messed with my pancreas.  My blood sugar only has slowly started to go back to normal.  I have diabetes but I have had a hard time getting my blood pressure to get back to normal.  I was recommended not to get the 2nd vaccine.  I felt the worst I have ever felt in my life after this vaccine.  The vaccine messed with my overall wellness.
No adverse effects were reported; the patient was inadvertently administered a fourth dose of GARDASIL 9; the patient was administered the second dose on 08/08/2016 and the third dose on 10/24/2016; This spontaneous report was received from a pharmacist and refers to a 14-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 01-JUL-2016, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, route of administration, lot # and expiration date were not reported), on 08-AUG-2016, she was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, route of administration, lot # and expiration date were not reported) and on 24-OCT-2016, she was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, route of administration, lot # and expiration date were not reported), all for prophylaxis. On 15-JUL-2019, the patient was inadvertently vaccinated with the fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported.
COVID Arm- raised red welt about 2? in diameter at vaccination site. Hot, itchy and tender. Lasted for five days before disappearing.
Pt got red and blotchy on bilateral arms. Not itchy, no swelling any where. Convient care provider in to check on patient. Kept any additional 20 minutes and then released.
Several months after the vaccine was administered, I had fatigue, headache, major sore throat, slight feverish. I took a COVID-19 home test on 7/23/22 and the results were positive. I was traveling and I called a provider and was prescribed Paxlovid. It took me about 8 days to recover.
16mar90 pt vax hepta B.  pt devel induration and erythema at inject site.  04apr90 pt complained of soreness at inject site.  pt remained under treatment
On 09/03/2001 the patient found it hard to swallow and breath, had extreme hot and cold spells, generalized weakness, dry mouth and shortness of breath. On 09/06/2001 the previous symptoms worsened and the patient also had a headache, sore throat and dizziness.
Pt vaccinated with Engerix-B developed mild dizziness, felt feverish but no fever, swollen glands, joints generalized ached, general feeling of weakness, achy, flu like symptoms.
Fever; Flu-like symptoms; Muscle aches; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced fever, influenza-like symptoms and muscle pain. On an unknown date, the outcome of the fever, influenza-like symptoms and muscle pain were unknown.   The reporter considered the fever, influenza-like symptoms and muscle pain to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient herself. The age at vaccination was not reported. In 2020, the patient had fever, muscle aches, and flu-like symptoms.  The reporter did not consent to follow up.
Patient waited in pharmacy for 15 minutes after receiving vaccine and was fine. Approximately 30 minutes after administration she began experiencing throat tightness described by the patient to feel like an anaphylactic reaction. She immediately took oral Benadryl and returned to normal.
Vaccine was administered subcutaneously instead of intramuscularly. Patient was called and told of the medication error and hs been prompted to call of any adverse reaction.
Shingles  - zoster  Headache , rush , severe pain , blisters in  right side of torax, fatigue, diarrhea, sensitivity to light
Patient fainted immediately after vaccination, and was described as having seizure-like activity.  Patient felt better after resting and drinking juice; refused transport to hospital and was released to home.
pt recvd vax; pt exp'd headache & nausea; also devel full-body rash w/ draining pustules & pruritus;
her upper face was swollen, clarifying more on the left side, and mostly around her eyes.; her upper face was swollen, clarifying more on the left side, and mostly around her eyes.; her eyes are a little red; This is a spontaneous report from a contactable consumer(patient). A 61-year-old female patient received BNT162B2 via an unspecified route of administration at Deltoid Right on 22Dec2020 14:00 at the 61 years old at single dose for COVID-19 immunization. The medical history included Type 2 diabetes mellitus from 1995 and ongoing(diagnosed about 25 years ago, controlled diabetic with a Hemoglobin A1C of 5) and Blood pressure high from 1995 and ongoing (diagnosed with high blood pressure about the same time as her diabetes, clarified as 25 years ago. She stated she has controlled blood pressure). The concomitant medications were not reported. The patient previously received a flu shot in Oct2020. On 23Dec2020 the patient reported her upper face was swollen, clarifying more on the left side, and mostly around her eyes. She said her eyes were a little red, too. She said she does not have any swelling around her mouth. The patient reported the facial swelling had slightly improved. She said she keeps looking at her face, so it was hard for her to tell, but her boss said her face was swollen. The patient reported she took a generic Benadryl 30 mg tablet this morning. She said she normally takes a Benadryl 30 mg tablet every night along with Melatonin for sleep. She said she has a big bottle of the generic Benadryl 30 mg at home and the bottle is almost empty. She said she rather take the Benadryl and Melatonin. The outcome of the events upper face was swollen and mostly around her eyes was Recovering, the event eyes were a little red was Not Recovered.  Information about batch/lot number has been requested.
pt recvd vax 27OCT93 following day felt achy & weak; 1NOV presented in ER w/fatigue, weakness, rapid pulse, dizziness & jaundice; hospitalized dx Coombs' negative hemolytic anemia (exact cause undetermined); still in hosp 9NOV93;
Been longer than 6 months since 1st dose; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received more than 6 months before the date of reporting).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 7-Apr-2022 Reporter's comments: Doctor of medicine reported that it had been longer than 6 months since the patient got first dose of Shingrix and wanted to get 2nd dose. The reporter asked did this patient had to restart the series. The healthcare professional did not know exactly when the first dose was given. Only that it had been more than 6 months. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Day 1 (4/5/21) was a Monday and I felt okay. Tuesday I felt okay. Wednesday and on I?ve had mild headaches and fatigue. Today (4/13/21)  I had strong fatigue and needed to rest after work for at least an hour. In addition, last night (4/12/21) I experienced slight pain in my lower to middle right  leg.  It went away after a while.  I?m a kidney transplant patient so there are many variables to take into consideration.
Information has been received concerning a 14 week old female with no medical history of illnesses or fevers who on 1/17/01, was vaccinated with the 1st dose of haemophilus b conjugate vaccine + hepatitis b vaccine recombinant (yeast). Concomitant therapy included the 1st dose of streptococcus pneumoniae vaccine (Prevnar) IM, the 1st dose diphtheria toxoid/pertussis/tetanus vaccine (Acel-Imune), and the 1st dose poliovirus vaccine. On 2/20/01, the pt experienced a seizure and fever of 103F. She was taken to ER. The seizure was considered a "Significant Medical Event". Follow-up was received from a healthcare professional. She was treated at the ER with Rocephin. An LP was offered but was refused by the parents. The pt was discharged from the ER. On 2/21/01, the pt was seen for follow-up in the pediatrician's office. She was given Rocephin 700mg again. On 2/22/01, the pt was in the pediatrician's office for another follow-up visit and it was documented that the pt was "alert, active and doing great". The CBC came back with elevated WBC's. The pt's ears were red, and the final dx was a urinary tract infection. The last visit for the pt was 3/14/01, at which time she received her 2nd dose of haemophilus b conjugate vaccine + hepatitis b vaccine recombinant (yeast). The decision was made to not give the pt a 2nd dose of Streptococcus pneumoniae vaccine (Prevnar). No further information is available. This was originally reported by a physician.
I had the first dose of Shingrix vaccine for Shingles prevention on 5/7. Early the following morning, I woke with severe gastrointestinal issues - diarrhea and vomiting - that lasted about 5 hours. I also experienced significant joint pains in my knees. This lasted about 24 hours and the side effects seem to have abated.
pt rcvd vax; pt devel fever, diarrhea, weakness & flu-like symptoms for over 78 hrs; pt was seen by MD & recovered;