chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "HBP" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment".  Therapeutic measures Paxlovid  (start date: 03May2023, stop date: 08May2023) were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received other medication in 2 weeks. Patient do not have any known allergies.
14:10 pm Varicella given SC. in upper outer aspect of right arm - 20 minutes after injection pt developed a 1 cm hive with redness, 3/4 tsp Benadryl given at 14:30 pm.
Fevers, severe chills, headaches, nausea, arm pain and swelling of left arm (injection site). Fatigue
Local reaction at site of vaccine. "Bubbles", splotchy red rash, sore arm muscles, body aches for approximately 5 days after vaccination.
Patient received PREVNAR 13 and was not aware that she received PNEUMOVAX 23 at her physicians office during the previous month. She did not have any reactions from either vaccination and did not report any adverse events.
nausea; Bleeding gum; acne like on her face and her back.; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported) via an unknown route of administration on 05Apr2021 at 15:45 (at the age of 38-year-old) in left arm as dose 1, single for COVID-19 immunization. Medical history included penicillin allergy. The patient had no known allergies. The patient's concomitant medications were not reported. The most recent COVID-19 vaccine was administered at pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 05Apr2021 at 15:35, the patient experienced bleeding gum. On 05Apr2021 at 15:45, the patient experienced nausea immediately after getting vaccination. On an unknown date, the patient had acne like on her face and her back and Patient was asked that if needs to report these or is this something related to the vaccine and if needs to follow-up with patient's doctor. No treatment was received for the adverse events. The clinical outcome of nausea was recovered on 05Apr2021 at 16:45 while bleeding gum was not recovered, and acne like on her face and her back was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: 33130BA) at the age of 48 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PREMPRO LOW DOSE oral. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot number: EN6207, Vaccine location: left Arm), for COVID-19 immunization, reaction(s): "Fatigue", "Body Aches", "Fever", "Chills"; Bnt162b2 (DOSE 1, SINGLE, Lot number: EN6205, Vaccine location: left Arm), for COVID-19 immunization, reaction(s): "Chills", "Fatigue", "Body Aches", "Fever". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; CHILLS (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "Body Aches"; FATIGUE (non-serious), outcome "unknown". Therapeutic measures were not taken as a result of pyrexia, chills, pain, fatigue. Additional information: patient experienced the events fever, chills, body aches, fatigue began Approximately 12 hrs post dose and continued for 12-16 hrs. This has happened after each of the vaccination doses. No COVID prior vaccination. Patient was not tested for COVID post vaccination. No known allergies. Patient received the other vaccine in four weeks included Influenza Vac Quadrivalent Prsv Free 3 Yrs + IM) on 16Nov2022, as dose 1, single in the left arm for immunisation. Sender's Comments: Linked Report(s) :PFIZER INC-202201358718 same patient/AE, different vaccine dose; PFIZER INC-202201359445 same patient/AE, different vaccine dose;
Red in the inside lower part of the deltoid area (not where the shot is but below it); The area is tender and warm to the touch; Itches near the bicep area; The area is tender and warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red in the inside lower part of the deltoid area (not where the shot is but below it)), VACCINATION SITE WARMTH (The area is tender and warm to the touch), PRURITUS (Itches near the bicep area) and VACCINATION SITE PAIN (The area is tender and warm to the touch) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Arthritis (Takes paracetamol on a chronic basis for arthritis). Concomitant products included PARACETAMOL (TYLENOL) for Arthritis.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced ERYTHEMA (Red in the inside lower part of the deltoid area (not where the shot is but below it)), VACCINATION SITE WARMTH (The area is tender and warm to the touch), PRURITUS (Itches near the bicep area) and VACCINATION SITE PAIN (The area is tender and warm to the touch). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Red in the inside lower part of the deltoid area (not where the shot is but below it)), VACCINATION SITE WARMTH (The area is tender and warm to the touch), PRURITUS (Itches near the bicep area) and VACCINATION SITE PAIN (The area is tender and warm to the touch) outcome was unknown. Not Provided          The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.   This case was linked to MOD-2021-048145 .
2/2/06 chest tightness, cough. By 1/31/06 cough during night caused gagging and vomiting. Worsened 2/1/06. Seen by physician 2/2/06. Coughing was controlled by Guaifenesin after 4hrs but coughing spells lasted several minutes with stress incontinence and or vomiting. Treated with Guaifenesin/Hydrocodone elixir and amoxicillin.
on 3/23/2021 we discovered the vaccine wasnt properly diluted resulting in the patient only getting a fraction of the intended dose. No adverse reaction reported to the pharmacy.
Rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th September 2019, the patient received Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was   Additional details were reported as follows: The pharmacist reports a patient was in emergency department with a rash on the day of reporting.  The reporter consented to follow up.  The vaccine was given at unknown location, details regarding product were unavailable at time of initial report.
Headache, low grade fever, chills, body aches that lasted for 15 hours and stopped once Ibuprofen was taken.
I had fever, chills and severe body aches after the 2nd vaccine which lasted 24 hrs.  The major reaction started as an itchy spot on my back, which eventually, over the course of several weeks,  developed into several red itchy spots.  These spread across the back, buttocks, hips, groin, back of legs, shoulders, and eventually to my chest and stomach. These spots were very itchy and developed a darker brownish color or gray scaly appearance over time.  These have persisted to the present time although the itch has subsided (the discoloration has remained). I visited my primary care physician who referred me to a local Dermatology. Dr. suspected this was a reaction to the Moderna vaccine and had my primary order a quantative covid antibody test. To confirm the diagnosis, two skin biopsies were performed.  Shingles developed on the side of my head, neck and face. on 01/24/2022, This may or may not be related.
Itch in vicinity of shot but did not pay to much attention until I removed my shirt and noticed the rash approximately 10 cm in diameter.
COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's past medical history included high blood pressure, and concurrent conditions included pollen allergy, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 23-AUG-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, the subject experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from covid-19 test positive. This report was non-serious.; Sender's Comments: V0 :  Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Following 15 months vaccinations Pt was lethargic, and non responsive in many areas he formerly interacted in for a week. He then recovered physically, but not mentally. By 2 years of age, he was diagnosed as autistic. Medical Records received stated patient experienced delayed speech and delayed cognition.
The patient received Menactra less than 4 years from a previous dose of Menveo, no AE; Initial information was received on 24-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 15 year old male patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] less than 4 years from a previous dose of menveo (inappropriate schedule of product administration).  The past vaccination(s) included Menveo for prophylactic vaccination.  The patient's medical history, medical treatment(s), concomitant medications and family history were not provided.   On 21-Aug-2020, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6691AA, expiry date: 21-Aug-2021) via unknown route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate schedule of vaccine administered (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Hand & feet feeling ice cold; Severe joint ache that hurt; A spontaneous report was received from a female patient of unspecified age concerning herself who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events hand & feet feeling ice cold and severe joint ache that hurt.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011L20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On an unknown date in Jan 2021, the patient experienced the events hand & feet feeling ice cold and severe joint ache that hurt.  Treatment details included Advil liquid gel 200 mg.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, hand & feet feeling ice cold, and sever joint ache that hurt was  considered recovering.
I got Covid arm; redness; Extremely itchy / itchy soulder and neck; Hot to touch; Bruising at the injection site; Sore throat; Feverish to the touch; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (I got Covid arm), ERYTHEMA (redness), PRURITUS (Extremely itchy / itchy soulder and neck), SKIN WARM (Hot to touch) and INJECTION SITE BRUISING (Bruising at the injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced VACCINATION SITE REACTION (I got Covid arm), ERYTHEMA (redness), PRURITUS (Extremely itchy / itchy soulder and neck), SKIN WARM (Hot to touch), INJECTION SITE BRUISING (Bruising at the injection site), OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Feverish to the touch) and VOMITING (Vomiting). At the time of the report, VACCINATION SITE REACTION (I got Covid arm), ERYTHEMA (redness), OROPHARYNGEAL PAIN (Sore throat) and VOMITING (Vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient was given first dose of Moderna Vaccine at the age of 14.  No adverse effects have been reported.
Body aches; very sore arm; felt bad; This is a spontaneous report from a contactable healthcare professional (patient). A female patient of an unspecified age received her first dose of bnt162b2 (BNT162B2 reported as Pfizer Covid 19 Vaccine; unknown lot number and expiration date), via an unspecified route of administration on Jan2021 at a single dose for covid-19 immunization. Medical history included covid-19 this summer (2020). The patient's concomitant medications were not reported. The patient reported that she got the vaccine last week (Jan2021) and the post op was not very pleasant [pending clarification]. She said that she did not have a fever, but she did have body aches and a very sore arm in Jan2021. The reporter mentioned that she heard that after the second vaccine you can develop high fever and she is hearing that you can from other people. The patient further mentioned that she took the first dose of vaccine and then felt bad afterwards (Jan2021) so she wanted to know more information about the second vaccine for safety purposes. The outcome of the events was unknown.  The following information on the batch/lot number has been requested.
Within 15 minutes of the injection, I got very light headed and vertigo, sweaty palms and the shakes and then my blood pressure went up to 144 over 97 when it's usually 110 over 70. They gave me Benadryl, called the medics and monitored me for a time - probably an hour. My blood pressure continued to spike for 18 hours, I continued to get the shakes, chills, sweat and get vertigo. I never had a fever. I did have seasonal asthma and a cough at the time that got worse after the injection and 4 weeks later I haven't not improved much. My GP has put me on prednisone because I have not been able to recover. The asthma has gotten so much worse that even symbicort and an emergency inhaler has not done the trick. I never had asthma before this year. I never had a positive covid test, but I do plan to get tested for antibodies this week.
rash 7APR94; resolved 8APR94; did not see personal MD;
Heat, redness, little bit inflamed around injxn. side. Boyfriend called and said it was red/purple and hurt to move. Told them to come in and let me see but if it gets worse to go see the doctor. Told them I had to report it, but wanted to see before reporting.
A report was received on 02/28/2002, concerning a 62 year old male pt who experienced respiratory distress which involved or prolonged hospitalization on 10/22/1998 after receiving fluvirin vaccine on 10/08/1998. It is not known if the pt had recovered at the time of reporting the event. The reporter has assessed the causality as possibly related. No more info was provided.
This spontaneous report was received from a licensed practical nurse regarding unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. Since unspecified dates starting on or after 05-MAY-2016, the patients were vaccinated with an improperly stored doses of VAQTA (dose and route were not reported, lot# L045713 with expiration date 14-JAN-2017). The temperature was 11 Fahrenheit degrees during 11 days (digital data logger). There was no previous temperature excursion. There was no adverse events reported. This is one of several reports received from the same source. Additional information has been requested.
Patient is complaining of swollen injection site, pain, and inability to raise arm above shoulder level.
Patient began to slouch upon sitting in the waiting seat approximately 1-2 minutes after receiving their second dose of the COVID19 (Pfizer\BioNTech) vaccination. Pharmacist immediately assisted patient and instructed for technician to call 9-1-1 immediately. We were able to catch the patient as they were falling out of the seat. Patient then began to seize for 5 seconds. Post seizure the patient was pale but cognizant and able to answer questions correctly (i.e. Name, DOB). Patient then began vomiting profusely. Patient reported no history of seizures, however reported previous an episode of fainting 3 years ago due to heat. Patient was monitored, given bag for emesis, water for rehydration, and ice pack until EMS came.
vaccine administered at 3:07 pm, other complains of feeling sweaty tunnel vision, bilateral ringing of ears 1 minute after receiving vaccine, R 18, HR 49, BP 72/45, o2 99%, Temp 96.8 ... secondary vitals 3:20 pm. R 18, HR 62, BP 116/62, O2 99%, Temp 96.0. 3:34 pm lead nurse made aware. 3:38 pm Md on call made aware. Pt states feels much better. Instructed pt to call 911 if symptoms worsen and put will be driven home by significant other, pt under no distress 3rd vitals 3:35pm o2 99%, Hr 67, BP 110/68, Temp 97.4, R 18. 3:43 MD on call states pt is okay to go home. Pt left in no distress.
Patient received ACTHIB subcutaneously with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Medical Information (Reference number- 00576929) and transmitted to Sanofi on 26-Apr-2021.  This case involves a 2 months old female patient who received a 0.5 mL dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ423AA and expiry date: 20-May-2022) via subcutaneous route in the right thigh instead of intramuscular route (incorrect route of product administration) for prophylactic vaccination on 26-Apr-2021.  Medical history, past medical treatments, past vaccinations and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  It was an actual medication error case due to inappropriate route of vaccination (latency: same day).   The reporter wanted to know whether dose needs repeating.  At the time of reporting, the patient experienced no specific adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report as received from a consumer refers to a 11 year old female patient with mild form of dyslexia and neurofibromatosis. On an unknown date the patient was vaccinated with GARDASIL (Lot # and exp date not reported) (dose, frequency, and route not reported). No other co-suspects were reported. No concomitant therapy was reported. It was reported that two days after receiving the dose, her dyslexia became full blown. The patient rearranged all the pictures in her bedroom, upside down. The patient developed symptoms of amnesia, the patient only remembered immediate family members and could not remember anyone else. The patient also complained of dizziness, headaches, joint pain similar to symptoms of arthritis. The patient lost fine motor skills; she reported to had no strength in her grip. The patient needed to use 2 hands to hold a pencil. The patient reported to had difficulty walking far distances without being exhausted. The patient has been having the symptoms for 1 to 2 months and became depressed and anxious because she has been bullied in school. The outcome of the patient also lost fine motor skills, the patient became anxious, became depressed, the patient reported to have difficulty walking far distances without being exhausted, the patient complained of joint pain, the patient complained of headaches, the patient complained of dizziness, the patient developed symptoms of amnesia and dyslexia became full blown was unknown. Additional information has been requested.
generally not feeling well, joint pain in every joint, wicked headache,100.2 temp (normally 96.8) injection sight painful, 2 day lates visible bruising and red rash in a 4 " diameter, very low energy