chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient experienced moderate arm pain, which by 27 hours post-dose had reduced to mild arm pain.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 11-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 at 15:30 as dose 4 (booster), single (Lot number: GK1657) at the age of 11 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Eczema" (unspecified if ongoing). Concomitant medication(s) included: QUADRIVALENT INFLUENZA VACCINE taken for immunisation, on 24Sep2022 as dose 1, single. Vaccination history included: Covid-19 vaccine (Dose 3 (Booster), Manufacturer: Unknown), for covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer: Unknown), for covid-19 immunization; Covid-19 vaccine (Dose 1, Manufacturer: Unknown), for covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 23Oct2022, outcome "recovering", described as "Patient experienced moderate arm pain, which by 27 hours post-dose had reduced to mild arm pain.".  Additional information: Reporter was Pfizer employee. Dose was received more than 3. Product: COVID 19 [Brand: Pfizer-BioNTech COVID-19 Vaccine, Is bivalent: True]. Facility type vaccine was Pharmacy or Drug Store. If other vaccine in four weeks: Yes. Other vaccine 4weeks product was Quadrivalent Influenza Vaccine [Other vaccine 4weeks lot number: unknown, Other vaccine 4weeks dose number: 1]. Other medications in two weeks was Daily multivitamins. The vaccine recipient reported to me roughly 27 hours post-vaccination that the morning after the vaccine, he experienced moderate arm pain, which by 27 hours post-dose had reduced to mild arm pain. No other AEs were reported. If covid prior vaccination, was provided as No. If covid tested post vaccination, was provided as No. Known allergies: NKA.  No follow-up attempts are possible. No further information is expected.
Crying, high pitched screaming, pulling hair out, bright red cheeks.  We were told to give him Tylenol.  That did not help at all.  He screamed and cried all night long and into the next afternoon.
Exhaustion; Headaches after the Moderna COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Exhaustion) and HEADACHE (Headaches after the Moderna COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Exhaustion) and HEADACHE (Headaches after the Moderna COVID-19). At the time of the report, FATIGUE (Exhaustion) and HEADACHE (Headaches after the Moderna COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. MOD-2021-025616:patient case
Patient complained of "itching" around injection site. Upon closer examination the area around the injection site was red and warm to touch. Physician was notified and stated to provide an ice pack and continue to monitor in facility. Patient was monitored for any further reaction from vaccination until physician in the building notified parent to use over the counter Benadryl/ ice to help with the reaction. Patient was not seen for further evaluation.
had a terrible time with both moderna shots; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (had a terrible time with both moderna shots) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (had a terrible time with both moderna shots). At the time of the report, FEELING ABNORMAL (had a terrible time with both moderna shots) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication information was not provided. Treatment medication information was not provided.   This case was linked to MOD-2021-168246 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up information received on 25 May 2021.
Pt developed erythema and papulo-vesicular rash circumferential to the Hib injection site.
Client stated itching at back of Lt arm at VZV site given 1-10-12. Area warm to touch. Redness 4 inches in diameter. Advised TYL. q4r prn for pain & BENADRYL 125 mg q6hrs prn for itching. Apply hydrocortisone or BENADRYL cr prn.
ITP platelet count of 32,000; This is a spontaneous report from a contactable consumer (patient, self-reported). A 57-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 11Apr2021 at 01:15 PM (age at vaccination: 56 years), as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included history of ITP last time it was 5 years ago. The patient did not have any known allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ep6955 and expiry date was not reported), via an unspecified route of administration, in Arm, on 21Mar2021 (age at vaccination: 56 years), as a single dose for COVID-19 immunization. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient reported that on 31May2021, she had ITP platelet count of 32,000. The patient did not receive any treatment for the event. Outcome of the event was not recovered.  Information on the lot/batch number has been requested.
I tested positive on Monday for COVID-19. On Tuesday diagram, abdominal pain. I had to be rushed to the hospital and have emergency surgery. Covid attacked my bowels.
Red spot on leg 2.0 inch by 3.0 inch pink and slightly raised. Warm to touch, not tender.
She reports that she feels pain all over her body, reporting that her hands and feet feel stiff and tingly. She reports no weight changes, no cough, shortness of breath, PND, dysuria, swelling.  Patient originally presented to the ED at hospital 3/1/2021 with a generalized body aches and pains of 1 day duration. In the ER, patient was hypertensive and labs showed elevated creatinine of 1.6 (baseline 1.27), BNP >8000.  She describes her symptoms as a sub-acute onset hand and leg weakness. It appears that the leg symptoms started before the arms were affected, after which she developed positive sensory symptoms in the form tingling of the hands and feet. She also admits to negative symptoms in the form of decreased sensation of her feet. She has been unable to stand on her feet since about two days ago. She appears to have some disturbance in time perception as her recollection of the progression of her disease is off by several weeks. she denies bowel/bladder incontinence or saddle anesthesia.
Subsequent to receiving varicella virus vaccine live, the pt presented to a dermatologist with possible herpes zoster. The physician felt that herpes zoster was not related to therapy with varicella virus vaccine live. Additional information has been requested.
This spontaneous report was received from a Registered Nurse and refers to a 4 month old male patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. In July 2018 (reported as "about two months ago"), the patient was vaccinated with the first dose of ROTATEQ orally, and on 19-SEP-2018, he received the second dose of ROTATEQ orally, both for prevention of rotavirus (dose, lot number and expiration date were not reported). In July 2018, the patient vomited immediately after administration of the first dose of ROTATEQ, and then on 19-SEP-2018, he vomited immediately after a second dose of ROTATEQ. It was unknown if the patient received the full dose of ROTATEQ. The patient did not receive treatment for vomiting. The outcome of vomiting was unknown. The causal relationship between the vomiting and ROTATEQ was not reported.
within 6 hrs huge sinus discharge, medicine taste mucus down bck of throat; within 6 hrs huge sinus discharge, medicine taste mucus down bck of throat; fatigue; Not clear minded; Sleep somewhat interrupted; aching legs; This is a spontaneous report from a contactable consumer reporting for herself.   A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FN6199) on 04Mar2021 at 11:15 at single dose via an unspecified route of administration on arm left for COVID-19 immunization. Relevant medical history included chronic diastolic heart failure and hypothyroidism. Concomitant medications included apixaban (ELIQUIS), lisinopril, metoprolol, and levothyroxine. On 04Mar2021 at 18:00 patient started experiencing sinus discharge, medicine taste mucus down back of throat, no fever lasted 4 days lessening each day, then major fatigue set in and has lasted approximately a week.  The patient also presented with not clear minded, sleep somewhat interrupted and aching legs. No treatment was received. At the time of the reporting the patient was recovering from the events.   No follow up attempts are possible,  No further information is expected.
6 hours after the vaccine I developed a very strong headache, specially behind my left eye and left side of my head. I felt a lot of pressure at the back of my head and neck. After 24hrs the pain was just a discomfort. Three days later The same headache and neck pressure came back with addition of rashes near my left eye . Discomfort in my left nostril and left eye muscles. Last nigh, my left eye lid started getting swollen and it is swollen still. The rashes are very itchy and feel like pin needles poking them. I believe these reaction are related to the vaccine due to the same headache and pressure I felt after both doses, with the exception of the rashes
pt recvd Typhoid vax & devel muscle soreness & induration @ the inject site which lasted 3 to 4 days;
Within 2-3 hrs of the shot, started feeling dizzy and lightheaded. Around 11:30pm, started feeling an upset stomach. Around 1am, started having the dry heaves. Within the next 36 hours, had a fever on and off, at times as high as 101.3. During this time, also experienced chills, body aches, sore joints and extreme fatigue and weakness.
redness and swelling at injection site 9cm x 5cm, with central bruising.  Not tender, did not interfere with walking, no fever
Chest pains, migraine, difficulty breathing with mask on, out of breath easily,low grade temp, chills and body aches, runny nose ear pain Started with chest pains 4am 3/26 and lasted about 2 1/2 days
Pain in left arm like a knot. Kind of swollen red - like fever on the knot, hurts when touched.
Acute onset Idiopathic thrombocytopenic purpura 12-14 days after vaccination. Identified by excessive bruising and pinpoint bruises all over arms and legs.
I had itching at the injection site; I had pain at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PRURITUS (I had itching at the injection site) and VACCINATION SITE PAIN (I had pain at the injection site) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (I had itching at the injection site) and VACCINATION SITE PAIN (I had pain at the injection site). At the time of the report, VACCINATION SITE PRURITUS (I had itching at the injection site) and VACCINATION SITE PAIN (I had pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided.  No treatment information provided.   This case was linked to MOD-2021-035705 (Patient Link).
my left eye gets very blood shot and a little irritated; my left eye gets very blood shot and a little irritated; Booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 02:15 (Lot number: FF2587) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "high cholesterol" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0170, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 26Apr2021, when the patient was 38 years old, for COVID-19 immunisation, reaction(s): "my left eye gets very blood shot and a little irritated", "my left eye gets very blood shot and a little irritated"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7533, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 05Apr2021, when the patient was 38 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021, outcome "unknown", described as "Booster dose"; OCULAR HYPERAEMIA (non-serious), EYE IRRITATION (non-serious) all with onset 01Dec2021, outcome "recovering" and all described as "my left eye gets very blood shot and a little irritated". Therapeutic measures were not taken as a result of ocular hyperaemia, eye irritation.  Additional Information:The patient had no known allergies. The patient did not receive any other vaccine in four weeks prior to the COVID vaccine. Patient received any other medications in two weeks of vaccination was none reported. Prior to vaccination patient was not diagnosed with COVID-19 and post vaccination, the patient had not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Vomitted dose; Vomitted dose; This non-serious case was reported by a nurse via sales rep and described the occurrence of vomiting in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation. On an unknown date, immediately after receiving Rotarix lyophilized formulation, the patient experienced vomiting (Verbatim: Vomitted dose) and accidental underdose (Verbatim: Vomitted dose). The outcome of the vomiting was not reported and the outcome of the accidental underdose was unknown.   It was unknown if the reporter considered the vomiting to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   It was unknown if the company considered the vomiting to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-OCT-2023 The reporter stated that they had a patient who was given a private Rota but immediately vomited the dose. The provider requested not to repeat the dose until 6 months but that was not a valid dose. The provider asked if that should be documented on the immunization record, as if they did, it would mess up the validity of the next dose in health maintenance or should they cancel the order and consider it as a wasted dose. The patient immediately vomited the dose which led to accidental under dose.
patient were administered expired Fluzone Quad vaccination; Initial information received on 18-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional via Global Medical Information (GMI) (Reference number- 00816469).  This case involves Adult and unknown gender patient who was vaccinated with the expired dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot UJ567AB and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  At time of reporting, 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 by the regulatory authority. 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 nurse refers to an unknown patients of unknown age and gender. No pertinent medical history, drug reactions/allergies and concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot# M028553 and expiry date 07-JUN-2018) (lot# M017290 and expiry date 07-APR-2018) (lot#M023380 and expiry date 11-MAY-2018) (lot# M009767 and expiry date 23-FEB-2018) (lot# M019643 and expiry date 20-APR-2018) (lot# M024677 and expiry date 01-MAY-2018) (lot# M027347 and expiry date 01-JUN-2018) and (lot# M032493 and expiry date 06-JUL-2018) subcutaneously (also reported as depends on the vaccine). The vaccine was exposed to temperature excursion of 1.4C for 21 minutes. No previous temperature excursion was reported. No adverse events were reported. No product quality complaint was filed. This is one of several reports received from the same reporter. Additional information has been requested.
Patient reported having severe headache, severe neck and shoulder pain, mild dizziness and sweating for the past couple of days after receiving the vaccination.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BAYER ASPIRIN), CITALOPRAM and OMEPRAZOLE for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
extreme fatigue leading to frequent  sleep day and night for 2 full days,  lethargic, joint pains, chills, metallic taste, mild cough, no fever - some improvement with paracetamol 500mg QID. Metallic taste remains to date (5/4/21), though improved. I am a physician, if not i would have panicked and gone to the ER.
He woke up the day after his vaccine with neurological symptoms such as  severe depression and agitation.  He then started to have a fever that went from 100 - 103 that lasted a few hours, averaging 101.  He was unable to to eat, having some nausea.  He also started to have severe bloating in his stomach which started  24 hours after the shot, and would burp incessantly for over 48 hours after the shot.
More than 6 months since 1st shot; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received in October (year unspecified)).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 17-JUL-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. It had been more than 6 months after 1st dose. The patient asked how that affected his/her second shot. Additional supportive information: Till the time of reporting the patient did not receive the 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.