chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Calling regarding PAXLOVID. Caller states she picked up the prescription/has taken both Pfizer Covid vaccines; Calling regarding PAXLOVID. Caller states she picked up the prescription/has taken both Pfizer Covid vaccines; 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 female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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 "Calling regarding PAXLOVID. Caller states she picked up the prescription/has taken both Pfizer Covid vaccines". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Caller stated she was already feeling better and had taken both Pfizer Covid vaccines.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fever up to high of 102.6, chills, headache, body aches. Painful swollen injection site, fatigue.
Parent reported at most recent appt on 12/14/2020 that patient c/o "severe stomach pain and vomiting" the evening of 11/17/2020 after receiving the flu vaccine. Patient was taken to ER by father. ER notes state pt c/o LLQ abd pain, nausea, 3 episodes of vomiting X 3 hrs. Patient left ER after ~ 2 hrs without being seen. Mom reports sx improved by the following day but requested the event be reported.
29SEP93 1800 vax given; 30SPE93 0830 pt nonresponsive to any stimuli; 1OCT93 0300 pt expired; COD hypertensive cardiovascular disease;
Member experienced shortness of breath, migraines, dizziness, nausea and fatigue for 1 week after 2nd dose. Had to take off a week of work.
swollen, red, itchy injection site, swelling, pain in arm, chest tightness, head ache, slight swelling of tongue.  Give Benadryl and albuterol
4/30-Injection incorrectly given high and at an upward angle into the bursa of the left shoulder rather than intramuscular.  Within hours, the left shoulder became painful, tender, with limited range of motion.   5/1- Went to Medical Center and was advised to use NSAIDs and ice to relieve discomfort. 5/3- L shoulder worse, red and swollen with additional pain and discomfort, proceeded to PCP where I was given a steroid taper to decrease inflammation and labs drawn.
15dec89 pt vax hepta B.  after 4hrs pt experienced n/v. 2hrs later experienced severe joint pain, abd pain, stiff neck w/ chills and temp of 101.8f. recovered after 3 days.  no further details.
Patient in left arm for several weeks, now pain in right arm. Pain in both arms (but not at the same time), feeling of my arms being heavy as well. I went to a prompt care location and they felt that it was arthritis coming from by back. I did not return to see a doctor for the continued pain in my arms.
Symptoms began about 15 hours after injection. Nausea and vomiting. Chills and fever of 102.6 for 24 hours following vaccine, swelling, redness, pain at site--swelling and redness was 6 inches in diameter.  Moderate pain in joints lasting 48 hours after injection. Moderate neck, headache and shoulder pain lasting several days. Site of injection still has lump (1.5 inches in diameter)and soreness 19 days after injection.  Neck and shoulder pain are still bothersome.  Extreme fatigue for several days after injection.  I am still not back to my normal self.  Fatigue is still a problem.
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Headache-Severe, Systemic: Hyperventilation-Severe, Systemic: Seizure-Medium, Systemic: Shakiness-Severe, Additional Details: Patient was given Moderna Covid Vaccine in Right Deltoid at 10:50. About 30 seconds later patient slid down from sitting possition and was shaking uncontrollably and reported difficulty in breathing. Patient was given Epi 0.3mg pen IM in right outer thigh and 911 was called.
Upset stomach, weakness, dizziness. Patient drank fluids--broth and Gatorade. Symptoms continued for three days, with severe dizziness reported on third day.
Headache, Myalgia, Fever, inj site sore/tight/red/warm; chills, muscle aches Narrative: Day 1-4 inj sore/tight/red/warm; Day 2-5 fever, chills, muscle aches, headache
Swollen right Calf, right ankle and top of right foot, Symptoms have persisted for 4 weeks.
Overall bad feeling; Fatigued; Patient right arm was sore at the injection site; Received Moderna Covid-19 vaccine monovalent pediatric dose, instead of Moderna Covid-19 Vaccine, Bivalent.; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Overall bad feeling), FATIGUE (Fatigued), VACCINATION SITE PAIN (Patient right arm was sore at the injection site) and WRONG PRODUCT ADMINISTERED (Received Moderna Covid-19 vaccine monovalent pediatric dose, instead of Moderna Covid-19 Vaccine, Bivalent.) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   On 12-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 12-Oct-2022, the patient experienced VACCINATION SITE PAIN (Patient right arm was sore at the injection site) and WRONG PRODUCT ADMINISTERED (Received Moderna Covid-19 vaccine monovalent pediatric dose, instead of Moderna Covid-19 Vaccine, Bivalent.). On 13-Oct-2022, the patient experienced FEELING ABNORMAL (Overall bad feeling) and FATIGUE (Fatigued). On 14-Oct-2022, FEELING ABNORMAL (Overall bad feeling) and FATIGUE (Fatigued) had resolved. At the time of the report, VACCINATION SITE PAIN (Patient right arm was sore at the injection site) and WRONG PRODUCT ADMINISTERED (Received Moderna Covid-19 vaccine monovalent pediatric dose, instead of Moderna Covid-19 Vaccine, Bivalent.) outcome was unknown.            No concomitant medications were reported.  The patient was mistakenly given the patient pediatric dose of the regular Moderna Covid-19 vaccine [Monovalent], instead of the Moderna Covid-19 Vaccine, Bivalent.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-659995 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-659995:Crosslinked with MOD22-026790 (Husband's case) same reporter.
Headache, Myalgia, Fever, Diarrhea, FATIGUE, INJECTION SITE PAIN Narrative:  Other Relevant History:
Bright red, heated rash; Bright red, heated rash; Was in so much pain; Could not move; Had a fever; Patient received the 2nd dose 2 weeks after the 1st dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 2nd dose 2 weeks after the 1st dose), RASH ERYTHEMATOUS (Bright red, heated rash), MILIARIA (Bright red, heated rash), PAIN (Was in so much pain) and MOBILITY DECREASED (Could not move) in a 57-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 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 2nd dose 2 weeks after the 1st dose). On an unknown date, the patient experienced RASH ERYTHEMATOUS (Bright red, heated rash), MILIARIA (Bright red, heated rash), PAIN (Was in so much pain), MOBILITY DECREASED (Could not move) and PYREXIA (Had a fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 2 injections. On 15-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 2nd dose 2 weeks after the 1st dose) had resolved. At the time of the report, RASH ERYTHEMATOUS (Bright red, heated rash), MILIARIA (Bright red, heated rash), PAIN (Was in so much pain), MOBILITY DECREASED (Could not move) and PYREXIA (Had a fever) outcome was unknown.            Concomitant medication was not provided.  Additional treatment medication included intravenous (IV) steroids.  Patient Reported that she was in Emergency Room  for 6 hours but not Hospitalised.   Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Follow-Up Received contains NNI.
Hoarse voice, could not swallowing food choked. 10-10-18 still having trouble swallowing and hoarse voice.
Patient's arm is red and and hot only below the injection site. He saw his PCP who presribed KEFLEX and told him it was due to depth of vaccination. Our facility uses 1-inch needles for this vaccination  No pain was reported. This is the second year in a row he has reported a red reaction days afterward.
pt recvd vax; 48 hrs later exp flu-like sxs; unresolved
Pt complained of "very bad" headache and stomach ache. He had a fever of 101.2. Pt napped and when he woke he said the headache was the worse he has ever had and his stomach was both nauseous and he was unsure if he needed to use the restroom. Fever reduced with ibuprofen. Sx completely resolved in 24 hours.
Immunizations given - immediate redness raised area around (KINRIX area) left deltoid - then he began to have flat rash on trunk, head, neck with itchiness. No swelling or respiratory difficulty. He was observed, assessed - Drs. office was called - BENADRYL 25 mg IM was ordered for him. Wt was 38.5#. BENADRYL given @ 11:35 am father was told what to watch for, for further allergic reaction. I called them 3 hours later & mom said he was doing fine.
Narrative:  Patient became hypotension and dizzy following administration of Pfizer covid vaccine. Patient was given juice and water and improved. Patient required no further intervention.
No additional AE reported; that patient received two doses of GARDASIL 9 at the pharmacy on 10/28/2020 and 12/02/2020, that patient actually had received a dose back on 12/07/2019; This spontaneous report was received from other reporter referring to 28-year-old female patient. The patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not provided.    On 07-DEC-2019, 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) in one facility, then on 28-OCT-2020 and 02-DEC-2020, the patient was vaccinated with second and third dose, all three as prophylaxis (concentrations, dosages, routes of administration, anatomical locations, lot numbers and expirations date were not reported). Because the "interval was off," intern inquired if patient should receive a new 3rd dose. No additional adverse events reported (inappropriate schedule of product administration).
Patient received both vaccines in left thigh on 9/9/19. She returned to office on 9/20/19 with large swollen lump on left thigh. No fevers. Area with no redness or tenderness. Ultrasound obtained, result suggested cellulitis with small amount of free fluid. Patient started treatment with keflex on 9/23/19.
This spontaneous report as received from a pharmacist refers to a 42 year old male patient. The patient's medical history, concurrentt conditions and concomitant medications were not reported. The nurse reported to the pharmacist that on 22-APR-2015 (also reported as "three weeks ago") the patient was vaccinated with PNEUMOVAX 23 lot # K012424, expiry date: 05-JUN-2016, in the unspecified arm. On the following day (estimated date: 23-APR-2015) the patient range the medical office and reported the upper arm swelling, redness and tenderness extending from the shoulder to the elbow of the arm where he received the vaccine. He was advised to seek a medical atttention at the emergency room in the hospital where he received an unspecified injection as a treatment. The patient was discharged from the emergency room to home with no further issues. Lot check of the PNEUMOVAX 23 was requested by the physician. The outcome of the events was unknown. The causality between the events and PNEUMOVAX 23 was not provided. Additional information has been requested.
pt recv vax 19MAR96 & 4OCT96 & pt devel a generalized rash w/over 50 lesions;rash consisted of minute maculopapular lesion, some w/vesicles & was located 4 to 5 on back & around face;
patient presented to clinic 7/12/2021 at 2:00pm for 2nd COVID vaccine.  Patient completed the COVID 19 vaccine screening and consent form  and said she was here for her 2nd dose.  Nurse, RN asked her if her first dose had been Moderna and the patient said yes.  Nurse administered the Moderna vaccine and then the client presented the nurse with her vaccine card which listed Pfizer as the first dose Lot #ER2613 administered by mobile vaccination bus on 5/22/2021 .   Nurse informed patient of this.  Patient had no adverse reactions and left after 15 min monitoring time.
Patient received first dose of Pfizer series. At approximately 18:20 she felt faint and given a bottle of water. She became unresponsive and lowered in Trendelenburg position with feet elevated. EMS called. Respirations regular but shallow. HR 81. BP 122/90. Unarousable to sternal rub and smelling salts. Per parents, she has a history of fainting with vaccinations. She took prescribed propranolol prior to coming today. EMS arrived at 18:40. Patient still not verbally responsive but opened eyes. She was taken to hospital with EMS.
This case was reported by a physician via a sales representative and described the occurrence of not responding to therapy in an unspecified number of adult subjects of unspecified gender who were vaccinated with Engerix B (GlaxoSmithKline), Havrix (GlaxoSmithKline), or Twinrix (GlaxoSmithKline) for prophylaxis.  The subjects' medical histories included HIV infection.  The physician reported that "some" HIV positive subjects received Engerix B (1 ml, unknown), Havrix (1 ml, unknown), or Twinrix (1 ml, unknown), and did not seroconvert for hepatitis B and/or hepatitis A.  Some of the subjects received booster doses after hepatitis titers were performed.  At the time of reporting the outcome of the event was unspecified.
Sore arm; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age (reported as 70, unit not provided, pending clarification) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 24Jan2021, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced sore arm from the injection in Jan2021. The patient was concerned as she stated that her shot did not even take a sec, it was quickly administered and she saw in the TV that it was given slowly. The patient wanted to know if it takes 2 weeks for the antibodies to be made after the first dose, wanted to know about new strain and if its covered by the vaccine, if she should continue to wear mask and social distancing after the vaccine, and how many ml/mg is the medication. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Fever & irritable on days 12-113 - on 6-14-12 tonic seizure lasting 5 minutes approximately 12N - another seizure at 4pm - 'seen' at ER labs normal - transferred to hospital - febrile seizure ruled out - Third seizure occurred 6/21/12 - body aching stiffening & tremors lasting 1-2 minutes - Neurologist saw patient 6-21-12 - DIASTAT prescribed - diagnosed - reaction to pertussis no further pertussis vaccine to be given - stagger vaccines.
Herpes Zoster, treated with Valacyclovir 1000mg PO qhs x7 days
get sick as a dog; Initial information was received on 29-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves a patient (unknown demography) who get sick as a dog (illness), while the patient received vaccine INFLUENZA VACCINE.  This case is linked to cases 2020SA307387, 2020SA307451, 2020SA307452, 2020SA307939, 2020SA307940, 2020SA307941, 2020SA308033, 2020SA306301 and 2020SA302198 (same source).  The patient's past vaccination(s) included INFLUENZA VACCINE. Medical history, medical treatment(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious get sick as a dog (illness) (about a month later) following the administration of INFLUENZA VACCINE.  It was reported that, if patient not take flu shot get a mild case of flu if at all that's why patient was not taking flu  shot from last 33 years.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
swollen lymph node under my armpit on the same side of the injection; This is a spontaneous report from a contactable consumer(patient). A male patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced swollen lymph node under his armpit on the same side of the injection on 22Jan2021. The outcome of the event was unknown.   Information on the Lot/Batch number has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a male patient who received Shingrix for prophylaxis. On 20th June 2018, the patient received the 1st dose of Shingrix. In June 2018, less than a week after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the fever to be related to Shingrix. Additional details were received as follows: The age at vaccination was not reported. The healthcare professional reported that the patient experienced fever of 102 to 103 degree F for 2 to 3 days. On 23rd June 2018, the healthcare professional stated that the information was reported to GlaxoSmithKline and VAERS.
Redness, swelling, arm hot 1/2 down, pain, fever, chills, wheezing, arm itching & raised areas, headache, lasted 1.5 weeks.
After 2nd shot on 3/31/2021, near the end of April I began having shortness of breath. I got a new inhaler 5/18/21, but was more easily winded than usual even with the inhaler. Was prescribed a daily inhaler in June with no improvement. Went to the emergency room 6/30/2021, because I could not breathe. Admitted to Hospital 7/1/2021 with bilateral blood clots in the lungs and a blood clot in my L leg. Clots were said to be so large that Drs. could not use clot buster drugs. I also had anemia. I was hospitalized for a week. Subsequent tests did not turn up a cause. I have had extensive bood tests during and after my hospitalization. I have had cancer screenings with no problems. I am seeing a Hemotologist, a Pulmonary doctor and my GP. My lung function is good. I am on xarelto since my hospitalization.  I read a pdf of VAERS reporting that showed dpeople with problems up to 120 days later, so I am reporting my experience.
localized skin infections; Swollen lymph nodes/swelled lymph nodes; Chills; Site of vaccination painful/local sore arm where COVID-19 vaccine injected; This spontaneous case was reported by a consumer and describes the occurrence of SKIN INFECTION (localized skin infections), LYMPHADENOPATHY (Swollen lymph nodes/swelled lymph nodes), CHILLS (Chills) and VACCINATION SITE PAIN (Site of vaccination painful/local sore arm where COVID-19 vaccine injected) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced CHILLS (Chills) and VACCINATION SITE PAIN (Site of vaccination painful/local sore arm where COVID-19 vaccine injected). On an unknown date, the patient experienced SKIN INFECTION (localized skin infections) and LYMPHADENOPATHY (Swollen lymph nodes/swelled lymph nodes). At the time of the report, SKIN INFECTION (localized skin infections) and LYMPHADENOPATHY (Swollen lymph nodes/swelled lymph nodes) had not resolved and CHILLS (Chills) and VACCINATION SITE PAIN (Site of vaccination painful/local sore arm where COVID-19 vaccine injected) was resolving.            Concomitant product use was not provided by the reporter. The patient had localized skin infections and swelled Lymph nodes causing by SKYRIZI. This had happened three times already so they were switching her. Patient had to be taken off SKYRIZI & switching her to Tremfia. After covid-19 vaccine she had chills and local sore arm where injected. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of LOCALIZED SKIN INFECTIONS and SWELLED LYMPH NODES with  SKYRIZI(RISANKIZUMAB) was a reasonable possibility. The reporter's causality for the event(s) of CHILLS and LOCAL SORE ARM WHERE COVID-19 VACCINE INJECTED with SKYRIZI(RISANKIZUMAB) was no reasonable possibility.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
w/i 24 hrs after admin. of Tdap, had large, erythematous area  distal to vaccine site which was hot to touch.  Also had erythema around vaccine injection site. + achy muscle
2 hours after vaccine my face felt weird and numb from jaw up to forehead. Felt like when numbing is wearing off after dentist. It lasted for approximately 2.5 hours.
102 FEVER CHILLS ONLY- SOAKED IN COLD TUB AND TOOK MEDICATION FOR PAIN AND FEVER PER EMPLOYEE. FLU S/S PER EMPLOYEE.