chrisvoncsefalvay/vaers-outcomes huggingface dataset:
69 year old male calling about PAXLOVID. Caller added he had all the Pfizer vaccines.The initial 2 doses and 2 Boosters doses.; 69 year old male calling about PAXLOVID. Caller added he had all the Pfizer vaccines.The initial 2 doses and 2 Boosters doses.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "69 year old male calling about PAXLOVID. Caller added he had all the Pfizer vaccines.The initial 2 doses and 2 Boosters doses.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:Male patient calling about PAXLOVID. He finished 8 days, numbness in tongue, lips and throat, wanted to make sure they are related to PAXLOVID. The reason he is calling today is because he talked to his Primary Care Physician and his Doctor suggested to call Pfizer and ask about his symptoms he is experiencing. His Doctor is not familiar with the PAXLOVID product, it is so new. The caller doesn't want to go back and forth. The caller wants to be sure his experience is escalated to the medical team   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
muscle pain; leg muscles; biceps; strange pain in the back of the head; huge lymph nodes at the back of head, clavicle; severe tenderness; back; migrating throughout arms; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (severe tenderness), BACK PAIN (back), LIMB DISCOMFORT (migrating throughout arms), MYALGIA (muscle pain; leg muscles; biceps) and HEADACHE (strange pain in the back of the head) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced TENDERNESS (severe tenderness), BACK PAIN (back), LIMB DISCOMFORT (migrating throughout arms), HEADACHE (strange pain in the back of the head) and LYMPHADENOPATHY (huge lymph nodes at the back of head, clavicle). On an unknown date, the patient experienced MYALGIA (muscle pain; leg muscles; biceps). At the time of the report, TENDERNESS (severe tenderness), BACK PAIN (back), LIMB DISCOMFORT (migrating throughout arms), MYALGIA (muscle pain; leg muscles; biceps), HEADACHE (strange pain in the back of the head) and LYMPHADENOPATHY (huge lymph nodes at the back of head, clavicle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided
pt stopped breathing for a few seconds; then started screaming; fever was 101; mom states lot of saliva coming from mouth;
I have pitted edema present only in my left foot. With the P.E., I have periods of discomfort. When I wake in the morning, the P.E. is mild. As the day progresses, it is more prevalent. This has been ongoing for almost 2 months diagnosis not yet defined as of this date
Severe headache that caused me to wake up, treated with two Ibuprofen. Headache subsided in approximately 45 minutes followed by Tinnitus, louder than ever previously experienced . Tinnitus has continued non-stop since date of occurrence 03/16/2021
Patient called pharmacy on 10/5 to complain of having a very sore arm, achy joints, and cold sweats that have persisted since the day after the vaccine lasting throughout the week. They have not gotten any worse or better. She has not had a fever. She states that she has not received a flu vaccine in about 20 years and had the same reaction back then as well which she classifies as "severe."
Parents reported to Death Investigator that patient complained of body aches, severe headache, and pain in his lower extremities on the evening of 9/22/21 (thee date he received the vaccine).  He was taking Tylenol for his symptoms per his parents.  On Thursday, 09/23/21, he continued with the above symptoms and felt worse per parents.  Mother asked him if he needed to go to the doctor and he said no.  On Friday, 09/24/21, he felt better than the day before but still had symptoms.  Parents last talked with him around 2230 Friday night.  They went to wake him up at 1100 on  Saturday, 09/25/21 and found him deceased in the bed.  EMS was called and he was transported to Hospital Emergency Department DOA.
Otherwise healthy male in shape and active. In a few weeks ends up two hopsitals with substantial Cardiac problems.   I had no prior history of heart issues and testing done by school medical rules out other diseases that sponsor heart failure. My cardiac  heart failure includes sinus tachycardia, ventricular arrhythmia, atrial fib, ventricular dysfunction, bundled branch etc. I had to have a Pacemaker and Defibulator surgically implanted. Cath Review of the heart  showed no blockages or related vascular complications. Congestive heart failure that I feel is likely related to me taking the third shot of the Pizer Covid19 Vaccination.
Directly after shot administered, donor said "I'm feeling light-headed" and with 5 seconds later passed out with eyes rolled back.  LOC about 10 seconds, revived spontaneously.
Vaccinated on Friday, and Monday 3/15 I had blood work done; when I got the results, my platelet count dropped significantly from the results on 3/17 (86 count on the blood test). When I talked to my doctor's office, they wanted me to see a hematologist. I told them I would wait and do my blood work again to see if it was in relation to the vaccine. 30 days or so I went to get another blood work done. Doctor called back and said that it was normal again (150 count), but it was low on the normal range. So called the doctor again, and just did another blood work 11/9 to see if my platelets were still up and made sure that it was okay. I requested these tests. This test came back with 161. My platelet counts in the past have been over 200. I'm in the normal range of 161 but the normal range is 150-400. Scared to get the booster shot because the platelets may drop again. All doctor visits were telehealth/online. Note: all other blood results and levels were normal. Note: all other blood results and levels were normal
Patient was administered vaccine that was improperly stored (in freezer for too long and considered expired by manufacturer at date of administration due to lack of study data). Patient acknowledged recommendation and was revaccinated 6/3/22 at our pharmacy.
2x1 inch rectangle red welt, warm to touch. Tx: Zyrtec, cold compress.
Initial report received from a consumer on 18 August 2010. A female patient, age reported as less than 60-years, completed a post exposure series of Imogam Rabies-HT and IMOVAX Rabies (lot numbers, doses, site and route not reported). Her medical history included thyroid problem, allergy to penicillin, allergy to dust and no illness at time of vaccination. The patient had no adverse event following prior vaccinations. A few days after completing a post exposure series, the patient began having joint pain in her ankles, hips, thighs, fingers and hands. Her eyes feel like they are burning and are watery. She complained of back pain which comes and goes, feeling exhausted and has been having diarrhea. She wakes in the morning feeling tired. The patient required a doctor's visit. The patient had a titer done 2-3 weeks after the IMOVAX series and the level was borderline. The patient was scheduled to have a repeat titer done in 2-3 weeks. Treatment was not reported. The patient did not want to give personal information. The outcome was reported as not recovered. Documents held by sender: None.
This spontaneous report as received from a Certified Medical Assistant (CMA) (also reported as healthcare professional) refers to unspecified patients of unknown age. The healthcare reported that improperly stored PNEUMOVAX23 (dose, route and lot number not reported) multidose vials were administered to an unspecified number of patients, demographics unspecified. No adverse effects were reported. It was unspecified if patients sought medical attention. This is one of several reports form the same reporter. Additional information is not expected.
This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old female patient who received PEDIARIX (batch number L9L2K, expiry date 5th June 2016). Previously administered products included dtap vaccine (dose 1), dtap vaccine (dose 2), dtap vaccine (dose 3 ), ipv vaccine (dose 1), ipv vaccine (dose 2), ipv vaccine (dose 3), hepatitis b (dose 1), hepatitis b (dose 2) and Hepatitis B (dose 3). On 11th November 2014, the patient received a dose of PEDIARIX. On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administration was unknown. Additional information received: On 11/11/14 a new medical assistant to the practice gave 3 patients a dose of PEDIARIX when they were all only due to receive DTaP. All 3 doses of PEDIARIX were from lot# L9L2K (expiration date 6/5/16). They were not due for the other components in the vaccine. The first patient's initials are ND. Their previous doses of DTaP were given on 10/7/13 and 2/10/14. Their previous doses of IPV were given on 10/7/13 and 2/10/14. Their previous doses of hepatitis B were given on 8/6/13. 10/7/13 and 2/10/14. This case is one of the 3 cases reported by the same reporter for the same vaccine.
Mother reports outbreak of chicken pox blisters over-night and morning of 2/14/03. Blisters on back, chest, under arms, and face. No known exposure to chickenpox. Mom has given Tylenol for comfort. Referred her to PCP.
pt recv vax 20MAY97 & 29MAY97 itching @ bedtime;30MAY97 red blotches shoulders scalp, ears, axilla, face, trunk & groin-took DPH 31MAY97: spread to back of knees, legs & top lip became swollen;contacted MD office-advised DPH, cool baths;
Hospitalization for severe hyponatremia likely chronic SIADH, chest pain, COVID-19 viral infection (asymptomatic), metabolic encephalopathy, deconditioned, hypertension on dates 10/17/2023- 10/22/2023.  Treated with vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Developed headache, sore throat, exhaustion, and chills around 1700 on 30 Sep 21. Developed severe chest pain, extreme difficulty breathe, and was in and out of consciousness around 2200 on 30 Sep 21 until around 0230 on 1 Oct 21. The current diagnosis is costochondritis.
Moderna COVID-19 Vaccine EUA Redness, swelling at the injection site, injection site hot to the touch. General side effects
sore arm; pains in joints; nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Aug2021 at 14:00 as dose 2, single (Lot number: FC3184) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sensitive to penicillin" (unspecified if ongoing); "Atrial fibrilation" (unspecified if ongoing); "dextracardia" (unspecified if ongoing); "situs inversus" (unspecified if ongoing); "neuro lyme disease", start date: 2005 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1, Lot: FA7485, Administration time: 1 PM, Anatomical location: Left arm), administration date: 10Aug2021, when the patient was 71-year-old, for COVID-19 Immunization. The following information was reported: NAUSEA (non-serious) with onset 01Sep2021, outcome "recovered" (Sep2021); ARTHRALGIA (non-serious) with onset 01Sep2021, outcome "recovered" (Sep2021), described as "pains in joints"; PAIN IN EXTREMITY (non-serious) with onset 01Sep2021, outcome "recovered" (Sep2021), described as "sore arm".  Additional information: Adverse event 24 hours after the second vaccine I had a sore arm- pains in joints and nausea lasting about a week. After the booster I developed similar symptoms plus a constant feeling of nausea and anything medically that I'd previously had (for example my persistent AFIB had the most pronounced effects as my AFib is generally controlled in its rate between resting in the 80s to 90sbpm) Now its resting at 120s and 130s. I al-so had a sore rib cage on the left side chostrocondritis and now it's so painful plus my breast is so sensitive and sore. It isn't getting better- it isn't worse than the first week but I am extremely concerned about my heart and see a specialist this coming week. Dr withheld, withheld. Prior to vaccination, No COVID. No COVID tested post vaccination
onset of fever 30 minutes post-injection lasting approx. 1-2 hours.  Three days later began w/headache, fever, body aches, fatigue, nausea, diarrhea.
Patient said she has aches and pain around the shoulder area in the arm she had the Zostavax shot.
Pt. woke at night while sleeping to room spinning and dizziness.  The following morning was dizzy and nauseated - Went to chiropractor, who told her she was having a "Toxic Reaction" to the vaccination - as a child she was exposed to measles & received an Immuno Globulin injection (1961)
Information has been received from a nurse concerning a 16 year old patient who on unspecified date was vaccinated with 3 dose series of RECOMBIVAX HB and failed to elicit a positive titer. It was unknown if the patient sought medical attention. At the time of the report, the outcome of the event was not reported. This is one of several reports received from the same source. Additional information has been requested.
Patient received undiluted Pfizer Pediatric vaccine 0.2ml (Father was informed of double dose and told to expect sore arm and injection site redness. Told to ice area, give Tylenol, monitor child and arm, and keep child hydrated)
Patient discharged from (8) day inpatient admission and returned to ED same day for generalized weakness and inability to cae for herself. Requesting home care.  The patient is a 76 y.o. female with a history of chronic diastolic CHF, a.fib on eliquis, HTN, HLD, and GERD admitted on 11/26/2021 with progressive SOB and edema secondary to acute on chronic diastolic heart failure in the setting of diuretic non adnerence. Pt reported dark stool prior to admission as well. +COVID test on admission.  A fib with RVR present at time of admission.    Pt initiated on supplemental O2 and IV diuresis.  Significant COVID pneumonia not suspected given CXR findings, respiratory failure felt to be secondary to CHF instead. Decadron was started, remdesivir held as no significant pneumonia on x-ray and transaminitis. RUQ U/S showed mild increased liver echogenicity, suggesting underlying hepatocellular disease. LFTs down-trended. Recent echo 8/2021 with EF 61%, mild pulmonary HTN. She diuresed well and was weaned to room air. Transitioned back to oral torsemide.   She reported melena on admission so home eliquis held initally. Hemoglobin remained stable without signs of bleeding and eliquis was resumed without evidence of bleeding. PT/OT evaluated and recommended discharge home with assist and HHC.    Patient had stopped taking torsemide at home and she felt it was causing her to feel "unwell". Discharge plans coordinated with cardiology, advised discharge on lasix 40 mg daily with KCl 20meq. She was advised to monitor her weights closely and have follow up labs checked within 5-7 days. Cardiology arranged virtual appointment on 12/6. She was felt stable for discharge on 12/2. She will complete remaining 3 days of torsemide for 10 day course. She was discharged home in stable condition with family.
This case was reported by a healthcare professional via a sales representative and described the occurrence of an unspecified adverse event in a subject of unspecified age and gender who was vaccinated with HAVRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of HAVRIX (unknown). At an unspecified time after HAVRIX, the subject experienced an unspecified adverse event. At the time of reporting the outcome of the event was unspecified. Follow-up received from healthcare professional on 20 April 2011: The subject was a 7-year-old female. On 25 March 2011 the subject received a booster dose of HAVRIX pediatric (intramuscular). On 25 March 2011 within several hours after vaccination with HAVRIX, the subject experienced urticaria with hives, and pain and swelling of her hands and feet. The subject was seen at the healthcare professional's office 48 hours after vaccination with ongoing hives and also a lump on the bottom of her right heel. The events resolved on an unspecified date. The subject had received HAVRIX previously with no adverse reaction.
Information has been received from a health professional concerning unspecified number of unspecified patients. No concurrent or historical conditions were reported. On unspecified dates since 01-NOV-2014, the patients were vaccinated with unspecified number of improperly stored doses of ROTATEQ (lot number, dose and strength were not reported). No adverse effects were reported. This case was one of three cases received from the same reporter. Additional information has been requested.
Mother called from car after shots. Child had blotchy face. Could have been heat. Mom was concerned. Child better.
This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm was sore as heck), FEELING ABNORMAL (Feels like crap), DIZZINESS (Feeling dizzy), OROPHARYNGEAL PAIN (Sore throat) and DYSPHONIA (Voice is shot) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included LEVOTHYROXINE and ARIPIPRAZOLE (ABILIFY) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore as hell). On 12-Mar-2021, the patient experienced DIZZINESS (Feeling dizzy), OROPHARYNGEAL PAIN (Sore throat), NAUSEA (Nauseous), CHILLS (Chills) and PYREXIA (Slight temperature). On 13-Mar-2021, the patient experienced FEELING ABNORMAL (Feels like crap), DYSPHONIA (Voice is shot) and FATIGUE (Fatigued). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency. On 04-Mar-2021, PAIN IN EXTREMITY (Arm was sore as heck) had resolved. At the time of the report, FEELING ABNORMAL (Feels like crap), DIZZINESS (Feeling dizzy), OROPHARYNGEAL PAIN (Sore throat), DYSPHONIA (Voice is shot), NAUSEA (Nauseous), CHILLS (Chills), PYREXIA (Slight temperature) and FATIGUE (Fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Another treatment medication was cough drops.
Pt vaccinated with DTP/OPV developed fever 102.0F; screaming Episode lasting greater than 3 hrs.
Initial report was received 27 January 2011 from a health care professional. A pregnant female patient who at 22 weeks gestation had received an injection of ADACEL and FLUZONE (unspecified) vaccines on 26 January 2011 (lot numbers, routes and sites of administration were unknown) and six hours later, she developed joint and muscle aches, a headache, fever and chills. The events required a doctor's visit. Her dates of last menstrual period and expected delivery were not reported. Her past medical and obstetrical histories were unknown at the time of the report. At the time of the report, the patient had not recovered. Documents held by sender: None.
Patient complained of lips burning, tingling then itching. Experienced facial swelling.  Denies shortness of breath or wheezing.  Reported no evidence of reaction at the site of injection.  Went to Immediate Care and was diagnosed with Angioedema.  Prednisine 40mg, Zantac and Claritin ordered.  Spoke with her primary physician.  Discontinued Prednisone dus to Diabetes and elevated blood sugar.  Continues with Zantac and Claritin.  10/20/15 reports doing "fine and facial swelling almost gone."
Husband reported weakness in left arm the evening of vaccination. Patient's health has declined. She now needs assistance with moving from chair to bed. She can walk once she is on her feet, but cannot get to her feet by herself.  Just very week.
From initial info received on 2/26/03 from physician's office regarding an adverse event, it was reported that an elderly female pt received Fluzone (U0906AA), on an unspecified date. Sometime after vaccination the pt tested positive for influenza type A. No additional info is available at this time.
Later on after being vaccinated I felt chills, body aches and fatigued and then two days later I produced a dry cough and then on oct 7th the cough got worse on friday on oct 8th the cough got productive and hurt my ribs and then on 10-13 I had a visit with my dr and she gave me and albuterol inhaler for my cough and breathing.
Non-febrile seizures within 15 minutes of injections. Multiple seizure episodes occurred over the course of three days. The evening after the injections, patient began a high-pitch screaming, flailing of arms, and sleep became erratic and infrequent.
I noticed a large lump in my breast but also nausea on the same day. (Aug 5th - 6 days after vaccine). Pain got worse in stomach - especially Monday until it was unbearable. We went to the emergency room and found that I had appendicitis (August 9th.) I had my appendix removed by Dr.
No additional adverse effect reported; Patient received a dose of improperly stored ROTATEQ; This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender.  The patient's pertinent medical history, concurrent conditions, concomitant medication, previous drug reactions or allergies were not reported.  On 28-OCT-2019, the patient started therapy with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 1 dosage form for prophylaxis (lot number 1660112 has been verified to be a valid number; expiration date reported and validated as 18-OCT-2020) (concentration, route of administration, frequency of vaccination scheme and anatomical location of vaccination were not reported).  On 21-FEB-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (product storage error). The nurse reported that the Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) underwent multiple temperature excursions below 2 degrees Celsius (1.28 degrees Celsius) for a time frame of 2 hours and 30 hours, as recorded by the data logger. There were not any other temperature excursions.   No adverse effects were reported for the patient.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-2003USA005901: US-009507513-2003USA005908:
Large local reaction, hot to the touch, 4 inches in diameter, red mark with ring around center mark, persisting for over 16 days.
Injection site RUE erythema & induration 5 x 3.5 cm 8/18/11; increased to 8.5 x 9cm 8/19/11. No systemic complaints.