chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in arm where injection occurred; Headache; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 15Apr2021 at 15:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received unspecified medications within two weeks of vaccination. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) on an unknown date for an unspecified indication and experienced drug allergy. On 15Apr2021 at 15:00, the patient experienced pain in arm where injection occurred and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events pain in arm where injection occurred and headache were resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Skin on arms and legs began to tingle, like skin was crawling, then began itching and burning like sunburn. Neck area became red and blotchy like hives. Last about 2 days, took Rx Antihistamines since allegric to Benadryl.
Information has been received from a registered nurse concerning her 4 year old son with no known drug allergies who was born at 3 weeks gestation and has a history of herpes simplex type 1 requiring ventilator assistance at 4 weeks of age who on 27APR1999 was vaccinated SC with first dose of varicella virus vaccine live. There was no concomitant medication. In April 2001, the patient developed shingles for the first time and for the second time in April or May 2002. On 29JUL2003 the patient's mother reported that her son was currently having an outbreak. She reported that his rash is always on his upper back on the right side and this was the third time he developed shingles since receiving varicella vaccine live. It was reported that the patient was recovering with sequelae. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Pressure on both sides if the skull and back of skull. Like a constant pressure type of headache. I manage the discomfort  with Tylenol. This started approximately a week ago from today and I have never suffered from headaches or this illness before.
pt recvd vax;on 17nov mom called w/ c/o pt irritable; fussy; dec appetite since 15nov; had arm tremors am 18nov;to ofc, face turned blue;mom shook x 2; pt cried & coughed; final dx: gastroespongeal reflux;
Patient had a slightly swollen arm and soreness complained of arm feeling tight. Patient stated that it got better overnight. The arm did not look infected. Suggested using ibuprofen, BENADRYL, ice, and keeping the arm mobile. Recommended the patient keep an eye on the arm and to see if the swelling started to expand indicating possible infection or allergic reaction and to contact the doctor if there was any of these symptoms.
pt was taken to ER w/resp difficulties & required immed attention;no sx of illness prior to immun;mom has reported it late, but wants to have it in registry for f/u & to share info;
This spontaneous report was received from a nurse regarding unknown number of patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients received unknown number of doses of RECOMBIVAX HB lot# M020926 with expiry date: 11-AUG-2018, lot# L048848 with expiry date: 09-AUG-2018 following temperature excursions to -1 C for 30 minutes and 9C for 13 minutes for prophylaxis (dosing details not reported). There was no previous temperature excursion. The call was due to data logger. No adverse effects were reported in any patients. No product quality complaint was involved. This is one of the several reports due to the same reporter. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a 10 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 29-NOV-2016, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (manufacturer unknown), lot # M015735 with expiration date of 30-MAR-2018 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 63 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA014053.
Dry heaves, difficulty breathing. No output in ileostomy or fistula, chills, fever started Sat. Continued through tues went to ER MVH
TIA/Seizure 2 days later.  Extreme dizziness, diplopia and memory problems still persists.  Had before due to brain stem  surgery in 2018, now progressively worse since the TIA.
Redness and slight swelling. Warm to touch.  Started out about the same size as small round bandaid 24 hours after vaccine.  By 48 hours after vaccine was 2-3 inches in diameter and hot to touch.  At 72 hours after, still 2-3 inches in diameter and warm to touch.  Is itchy to patient and now has scratch marks.  Patient otherwise does not seem too bothered, though complained "it hurt" for first 24-48 hours.
This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of raised red bump at injection site in an adult subject of unspecified gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date in September 2011 the subject received a dose of FLULAVAL (unknown route, unknown deltoid). On an unspecified date in September 2011, the same week after vaccination with FLULAVAL, the subject experienced raised red bump at injection site. The bump covered most of the deltoid. At the time of reporting the outcome of the event was unspecified. The healthcare professional reported 3 subjects who experienced raised red bump at injection site after vaccination with FLULAVAL. This is case 1 of 3 (see case IDs A0947997A, A0947999A for details of the other reports). The healthcare professional had reported the cases to VAERS.
Tinnitus started  three days after vaccination in both ears. Audiogram shows no  hearing loss. Tinnitus has  persisted for six months.
started developing a rash. Like red patches on her arms/showed up on her stomach, chest and thighs. They flare-up.; It's a little bit itchy; This is a spontaneous report from a contactable consumer (patient) reported that a 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EC8982), via an unspecified route of administration on 21Jan2021 at a single dose for Covid-19 immunization. Medical history included blood pressure high, thyroid disorder (reported as thyroid), and cholesterol high. Concomitant medications included lisinopril and hydrochlorothiazide both for blood pressure high, levothyroxine, and atorvastatin for cholesterol high; all were taken from an unspecified date. On 26Jan2021 afternoon, the patient started developing a rash. Like red patches on her arms, she put the Cortisone on her arms and it went away. But then it showed up on her stomach and chest and thighs. They flare-up. It's a little bit itchy. The outcome of the events was not recovered.
Difficulty breathing, tried, weak, heart racing slight, lasted for 30 minutes then went back to sleep.
Vaccine reaction and Uvular swelling.    Shot site remained sore, swelling on left side of throat and tongue.  Treated with Diphenhydramine and Methylpredisolone sodium succinate injections at 5:27 p.m., March 26th.  Prescribed famotidine, 20 mg and methylpredisolone, 4 mg.  Recommended benedryl, 25 mg, every 6 hrs.  Recommended follow up with primary doctor.  Doctor did not want second covid  shot administered.  Relief immediate from treatment.
Post vax the patient developed redness and swelling at the immunization site and complained of itching.
Localized rash on arm below injection site; patient will take diphenhydramine and ice the affected area.
2nd dose given too early, 1st dose 1/15/21, 2nd dose 2/5/21
Erythema shoulder to elbow, hot to touch, nausea, malaise x2 days.
red welts on chin & cheeks next day; spread into big circles 2nd day on cheeks; eyes swollen on 3rd day on cheeks; eyes swollen on 3rd day; t104; seen in ER:
Covid infection positive; Covid infection positive; This is a spontaneous report from a contactable consumer. A 40-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 12Mar2021 (Batch/Lot Number: EN6207) as dose 1, single and via an unspecified route of administration on 02Apr2021 (Batch/Lot Number: EKC734) as dose 2, single for covid-19 immunisation. Age at vaccination was 39 years old. The patient's medical history and concomitant medications were not reported. No other vaccines received within 4 weeks prior to COVID vaccine. On 21Oct2021, the patient experienced covid infection positive. The events were reported as non-serious. The patient underwent lab tests and procedures which included RT-PCR (nasal swab): positive   on 21Oct2021. No treatment was given. The event resulted in doctor or other healthcare professional office/clinic visit. The patient was recovering from the event.
Date of Admission: 10/21/2021 ý Date of Discharge: 10/30/2021  69 yo female h/o of past smoking, moderqte COPD/emphysema, HTN, gout, pre-DM, vit D deficiency. She was vaccinated x2 with Pfizer vaccine, admitted on 10/21/21ýwith severe sepsis with mild acute hypoxic respiratory failure from COVID-19 PNA.  ý ý Plan: 1)Severe sepsis and acute hypoxemic respiratory failure due to COVID pneumonia. Symptom onset on 10/18/21COVID positive on 10/19/21.  - Patient required oxygen via nasal cannula and received Decadron 6 mg daily during hospitalization and Remdesivir 200mg IV x1, followed by 100mg IV daily until clinical improvement (last day on 10/26/21). Patient received course of PO Levofloxacin which was started on 10/22/21 for possible superimposed pneumonia. I discussed with inpatient pharmacist on 10/27/21 and plan for last dose on Thurs 10/28/21.; patient will need follow up CXR in 6 weeks Patient received DVT prophylaxis with Heparin 5,000 units SQ q12h during hospitalization.  I discussed patient with doctor of Pulmonary on 10/28/21 who recommended Prednisone taper on discharge (30 mg PO daily for 3 days, then 20 mg PO daily for 3 days, then 10 mg PO daily for 3 days, then stop). Patient was hypoxic with 02 sat decreased to 87% RA during ambulation on 10/29/21. ý It has been arranged for home 02 with instructions to use 2 liters with activity. ýPatient will have follow-up with Home Health and econsult sent for follow-up oxygen clinic. placed referral for COVID Transitions team follow-up. Isolation through 11/7/21. ý ý2) s/p AKI (Cr increased to 1.51 on 10/21/21); on Lisinopril as outpatient which was held during hospitalization. Cr improved to 0.97 on 10/30/21. It has been arranged for Home Health to draw follow-up chem 7 in 2-3 days. ý 3) HTN; On Lisinopril as outpatient which was held during hospitalization in setting of AKI. Patient continued on Amlodipine 2.5 mg PO daily.  BP's have been stable on Amlodipine and patient was instructed to hold Lisinopril on discharge and PCC has arranged for HHRN for BP check and patient to follow-up with doctor to discuss with patient if Lisinopril should be resumed ý 4) H/o COPD; stable. Continue Stiolto and Rx for Albuterol MDI PRN shortness of breath/wheezing ý ý 5)H/o prediabetes; stable. ýPrior HbAIC 6.0% from 5/20/21. ýPatient not on medications as outpatient.  ý 6) History of gout; stable. ýOn Allupurinol ý Primary Procedures:  None ý Secondary Procedures: 10/21/21 XR Chest ý ý Reason for Hospital Admission (Admitting Diagnosis):  Severe sepsis and acute hypoxemic respiratory failure due to COVID pneumonia
pt recvd all doses of vax;to allergist who had antibody titers to DTP;all were in protective range;has no antibody titer to HIB;
Vaccine reaction, probably to DTAP.  Left thigh swelling, erythema.  Induration - no fever.
pt recvd vax;exp high fever 108 Rt then sz; in er t 106.7 & hypoxic but not apnic;severe shock;init arterial ph=6.84 primarily metabolic acidosis;recovered now w/ significant CNS deficits;all cultures & studies nl except EEG;still hosp;t nl
Redness, pain, tenderness and swelling at injection site, R deltoid fatty tissue.
Patient had redness and swelling in the injection arm. She went to the emergency department and was told she was not having an allergic reaction to the immunization but was likely having a reaction to one of the components in the immunization. She brought in a prescription for KEFLEX from the emergency department prescriber.
Patient received vaccine after published expiration date. Moderna Company analyzed lot 007B21A and indicated vaccine maintained activity necessary to protect against covid 19 at time of administration. Patient also did not call in with adverse event.  This is administration error without adverse event.
pt cried all noc, arm hurt & was red & swollen; no fever; Tues-arm still sore but ate & slept well; 5AUG94 pt devel cough & runny nose - to ER; treated for acute URI; broke out in rash all over body; little fever;
This case was reported by a consumer via call center representative and described the occurrence of pain in a 62-year-old female patient who received SHINGRIX (batch number L9CS4, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (received 1st dose refer case US2018GSK141017). On 17th August 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The SHINGRIX vaccine was administered by a pharmacist. The VAERS details were updated. The patient experienced some soreness for two full days, but after that nothing, she did not experience the rash at all. This case has been linked with the case US2018GSK141017 reported by the same reporter for the same patient.
ITP, presented with undetectable platelets. No bleeding event to date. Remains hospitalized but responding to dexamethasone and IVIG.
Information was received from a office manager referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 14-JUL-2016 the patient was administered a dose of improperly stored (Oka-Merck) PROQUAD injection (lot # L040415, expired on 13-APR-2017) (dose and route unknown). The vaccine was exposure under 32.9 Fahrenheit degree (F). There was no previous temperature excursion. No adverse event was reported. Additional information has been requested.
Information has been received from a physician concerning a 11 year old female pt with no known allergies who on 03/09/2001 was vaccinated with the second dose of hep b vaccine recombinant. On 03/25/2001 the pt developed a pruritic red rash, plaque like blisters that were diffused. The rash was on her face, arms, and trunk. She developed fevers of 101-102F, chills, and joint aches/pains. On 03/26/2001, the pt presented to the physician's office with a rash that was blotchy, raised, urticarial, with a few vesicles, that had no target lesions, and no mucosal lesions. There were some small lesions on the hands and feet. On 03/26/2001, laboratory values were as follows: PT normal, platelets normal, AST 216, ALT 268, alkaline phosphatase 513, and total bilirubin of 1.8. The pt did not have a coagulatiion disorder. It was initially thought since the pt had a subconjunctival hemorrhage from coughing and a large hematoma after blood was drawn, but the PT and platelets were normal. The pt was not hospitalized. Since the pt tested negative for hep a,b, and c, the physician felt the pt could have had an atypical viral syndrome. The pt was treated with prednisone and was improving. The pt will not be receiving the third dose of hep b vaccine recombinant. The pt's liver enzymes will be followed until normal. Additional info is not expected.
Initial report received on 28 July 2008 from a health care professional.  An 18-year-old female patient, with "unknown" past medical history was exposed to a cat (date not provided) that was known to have rabies and she subsequently received a first dose of IMOVAX, and a first dose of IMOGAM on 18 July 2008 in the morning hours.  The Lot numbers, routes and sites of administration were "unknown".  At an unspecified amount of time later, on the same day, reported as in the morning, the patient became confused and was angry.  She "returned to the hospital" and was admitted.  A lumbar puncture test was performed; however the results of the test were not provided.  The patient was released from the hospital the following day.  It was "unknown" if the patient had fully recovered.  It is worthy to note, the patient subsequently received a second dose of IMOVAX on 21 July 2008 and a third dose on 27 July 2008 and experienced back pain and a headache after each dose.  These adverse events are reported in case 2008-02453.
feeling like she was about to break out in hives but she never did; itchy; feeling like she was about to break out in hives but she never did; itchy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (feeling like she was about to break out in hives but she never did; itchy) and PRURITUS (feeling like she was about to break out in hives but she never did; itchy) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced URTICARIA (feeling like she was about to break out in hives but she never did; itchy). On an unknown date, the patient experienced PRURITUS (feeling like she was about to break out in hives but she never did; itchy). On 16-Mar-2021, URTICARIA (feeling like she was about to break out in hives but she never did; itchy) outcome was unknown. At the time of the report, PRURITUS (feeling like she was about to break out in hives but she never did; itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
pain in injection site (left); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in injection site (left)) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain in injection site (left)). On 12-Mar-2021, VACCINATION SITE PAIN (pain in injection site (left)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was included antiviral medication.   Treatment information was not provided.
Information has been received from a pharmacist referring to an adult patient of unknown age and gender. The patient's concurrent condition and medical history were not reported. On an unknown date the patient was vaccinated with a dose of PROQUAD (Merck) (lot#, expiration date, dose, frequency and route were unknown) (Inappropriate schedule of vaccine administered). No adverse events were reported. Additional information has been requested.
The vaccine was adminestered three days after the stated expiration date. There was no adverse reaction  from the client. No need for any action or treatment. 06/21/2023 03:50pm
I had a fever of 101.4 was the max and I had a cough and chest congestion. I was whizzy and I lost my taste and smell. I would get short of breath doing things. I also was getting nauseous. O2 saturation 93 percent.
blood clot; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Lot number was not reported) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced blood clot (life threatening) on an unspecified date. Event as reported: Patient had a blood clot due to our vaccine. The outcome of the event was unknown.   Information about lot/batch number has been requested.
Superficial vein thrombosis - right leg; This is a spontaneous report received from a contactable female consumer. A 34-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8737) via an unspecified route of administration, in right arm on 29Mar2021 09:15 as 1st dose, single for covid-19 immunisation. Medical history included the patient previously took bactrim for drug hypersensitivity. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Concomitant medications were not reported. Other vaccine details include second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0176) via an unspecified route of administration, in right arm on 29Mar2021 as 2nd dose, single for covid-19 immunisation. The patient did not receive any vaccines within four weeks prior to the vaccination. On 26May2021 18:00, the patient experienced superficial vein thrombosis on right leg. Adverse event result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Outcome of event was recovering.
Fever; Body ache; Heaviness; This case was reported by a physician via call center representative and described the occurrence of fever in a 26-year-old female patient who received Rabies NVS (RabAvert) (batch number ARBA181A, expiry date 30th September 2022) for prophylaxis.   On 1st October 2020, the patient received the 2nd dose of RabAvert. In October 2020, less than 3 weeks after receiving RabAvert, the patient experienced fever, general body pain and sensation of heaviness. On an unknown date, the outcome of the fever, general body pain and sensation of heaviness were recovered/resolved.   It was unknown if the reporter considered the fever, general body pain and sensation of heaviness to be related to RabAvert.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 25 or 26 year. The reporter stated that the patient presented with fever, body ache and heaviness after administration of Rabavert. The reported batch number ARDA1818 was not available in sales datasheet, hence updated as ARBA181A. The reporter did not consent to follow-up.