chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had red spots all over both of my arms and my legs; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Had red spots all over both of my arms and my legs) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced RASH ERYTHEMATOUS (Had red spots all over both of my arms and my legs). At the time of the report, RASH ERYTHEMATOUS (Had red spots all over both of my arms and my legs) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   concomitant medication and treatment medication were not reported.
Within 1 day of the administration of IPV, DTaP and MMR developed thigh redness and swelling. Seen in ER, give unknown prescription
He had chills, fever, and left arm from site of injection to elbow, and inner fore arm had redness and some swelling 1+ which was reported as being worse prior to being seen in Employee Health & Safety.
16JAN98 seen by MD for pink eye discharge;given ATB eye drops for conjunctivitis;17JAN98 exp sz;mom noted eyes were deviated to rt;felt very hot to touch;face & neck shaking;sweaty, cough, runny nose, blank stare, sleepy p/event;poss feb sz
Dizzy; fell out of bed could not get up; Shaking; Low grade fever; falling re-injured my back; fell out of bed could not get up; Back pain; Leg pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), FALL (fell out of bed could not get up), MOBILITY DECREASED (fell out of bed could not get up), TREMOR (Shaking) and PYREXIA (Low grade fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Q-Tip up nose) on 07-Apr-2020. Concurrent medical conditions included Chronic back pain since 1985, High cholesterol since 2016 and Depression. Concomitant products included OXYCODONE and GABAPENTIN for Back pain, SERTRALINE for Depression, SIMVASTATIN for High cholesterol, VITAMIN D3, FISH OIL, IRON and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced DIZZINESS (Dizzy) (seriousness criterion hospitalization), FALL (fell out of bed could not get up) (seriousness criterion hospitalization), MOBILITY DECREASED (fell out of bed could not get up) (seriousness criterion hospitalization), TREMOR (Shaking) (seriousness criterion hospitalization), PYREXIA (Low grade fever) (seriousness criterion hospitalization), BACK INJURY (falling re-injured my back), BACK PAIN (Back pain) and PAIN IN EXTREMITY (Leg pain). The patient was hospitalized from 21-Mar-2021 to 26-Mar-2021 due to DIZZINESS, FALL, MOBILITY DECREASED, PYREXIA and TREMOR. The patient was treated with Rehabilitation therapy for Fall; Rehabilitation therapy for Mobility decreased; Rehabilitation therapy for Back pain and Rehabilitation therapy for Pain in extremity. On 21-Mar-2021, DIZZINESS (Dizzy), TREMOR (Shaking) and PYREXIA (Low grade fever) had resolved. At the time of the report, FALL (fell out of bed could not get up), MOBILITY DECREASED (fell out of bed could not get up), BACK INJURY (falling re-injured my back), BACK PAIN (Back pain) and PAIN IN EXTREMITY (Leg pain) had not resolved.            On 07April2020, the patient undergone Q-TIP up nose and tested positive for COVID-19 with no symptoms. Admitted to hospital from 21-mar-2021 to 26-mar-2021 and in rehabilitation till 24-apr-2021.  This case was linked to MOD-2021-060871 (Patient Link).  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-060871 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
6/14/04-Received MMR 7/7/04- Client with report of rash on body, whole body. c/o some slight itching. No c/o hives, c/o glandular swelling. 7/10/04 client went to ER-swelling and numbness of both hands and joint pain. Received Cuycolone and went home. Had N/V. Received Thed. 7/11/04 back to ER, receive an injection and it helped. 7/12/04 Pain and swelling and numbness remain. Has Dr appt today.
Pt recvd MMR; On approx 30JUN90 pt went to ER c/o fever 102, disorientation & grossly edematous eyelids; Pt d/c but not returned to work as of 09JUL90;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 10Mar2023 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Apr2021 at 15:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 10Sep2021 at 15:00 as dose 2, single (Batch/Lot number: unknown), in left arm 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) all with onset May2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 08May2023 to 12May2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300190697 Same patient/vaccine, different dose/event;
This is a spontaneous report from a non-contactable consumer. A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. After reporter got the 2nd shot of the Pfizer COVID-19 vaccine, she had 48 hours of flu like symptoms, aching, extremely fatigued, headache that went away, just like someone opened the blinds, very quickly, 5 weeks from last shot, she got the same symptoms and they lasted for 7 days. Reporter could do nothing, went from the couch to the bed, ached all over. Reporter went to urgent care, had two swabs in 48 hours, negative for COVID-19 swabs one done on Thursday and Saturday went to urgent care and both were negative. Her friend(patient) is experiencing the same thing. Reporter thought maybe she got another bug, patient started to tell reporter that hers came back after 9 weeks after. Patient is 70, she is not doing well, every time she sits down she falls asleep. It's like something gets triggered.  Reporter is going to encourage her friend to report this as well. Outcome for events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Dermatographia (as diagnosed by dermatologist) began roughly 10 days after Moderna booster. It  has continued for three weeks. This is the first time I have ever experienced this condition.
Patient came to pharmacy on 6/27/21 to ask about a rash that appeared late night on 6/26/21. She received her 2nd Moderna COVID vaccine on 6/26/21, around 11am. Patient stated she noticed a tingling sensation on her upper back, at the base of her neck on the evening of 6/26/21. When she awoke on 6/27/21, there was a slight red, raised rash on both arms and legs. When she reported to the pharmacy around 11am on 6/27/21, rash on limbs was not really red anymore but still slightly raised. The rash on her upper back was still present and red, about the size of a half dollar coin. Patient stated that the tingling sensation was still present and went down a few inches form the visible red place, She reported no  itching or pain and  taking no medications to alleviate symptoms. I informed her to continue watching and seek medical attention if things got worse.
About 3 hours after receiving the vaccine, he presented in cardiogenic shock with tachycardia and hypotension. He was found to have severe LV dysfunction and is currently on ECMO. I would like to stress that he did have symptoms preceding receiving the vaccine, but felt that given the clinical decompensation that it should be reported and investigated.
pt recv vax; T to 101.4; apap & swelling of site; excessive drowsy; slept most of the day; improved today;
Upper chest pain; coughing; hurt swallowing food; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 17:45 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, anxiety and known allergy to sulfa drugs. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN) and naproxen (MANUFACTURER UNKNOWN); both for unspecified indications from unknown start dates. The patient previously took trimethobenzamide hydrochloride (TIGAN) for unspecified indication from unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 12:00, the patient experienced upper chest pain that went to back, both sides and hurt with movement, coughing and swallowing food. The adverse events resulted in emergency room or department visit or urgent care. The patient did not receive any treatment for the events. The clinical outcomes of the events chest pain, coughing and swallowing painful was recovering at the time of reporting.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a Nurse refers to a 2 month old infant of an unknown gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 20-MAY-2016 (today), the patient was inadvertently vaccinated with an expired dose of ROTATEQ vial lot # K008140 (expiry date: 30-MAR-2016) (dosage not reported). No adverse effects noted. Additional information has been requested.
Widespread rash starting on the back of the neck and progressing to shoulders, back, chest, entirety of neck, scalp, ears and edges of face. Feels like a heat rash and looks similar. little red bumps, itchy, feels like a sunburn, as well. After 24 hours it has progressed in pain and itchiness.
NONE specified. 1/30/07 T/C to reporter to request missing info from Box 7 on VAERS form.  States patient had local reaction & hives.  Was seen only by her PCP & treated w/steroids & antihistamines & recovered completely within 2 wks.
This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On an unknown date, the patient was vaccinated with a dose of improperly stored Oka/Merck (VARIVAX) injection, lot # M039317 with expiration date 20-SEP-2018 or lot# N030407 with expiration date 30-OCT-2019 (exact dose, frequency and route of administration were unknown), for prophylaxis, reconstituted with properly stored sterile diluent (manufacturer unknown). The vaccine experienced a temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 3 hours and 22 minutes. It was unknown if any previous temperature excursion occurred. The digital data logger was not involved in recording the temperature excursion details. No adverse effects were reported. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1804USA008657:US-009507513-1804USA008658.
acute transient neuropathy beginning 24 hrs p/vax w/numbness in toes gradually spreading to feet & lower legs to knees; 4 days later also had numbness inface & hands & was hospitalized for observation overnight;
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 17-JUN-2016, the patient was vaccinated with an improperly stored dose of oral ROTATEQ (lot # L037924, expiration date 22-JUN-2017, orally; exact doses were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of 48 Fahrenheit degrees for cumulative 14 hours and 50 minutes before administration to the patient. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Reportedly experienced shortness of breath beginning after vaccination between 8/4-8/6. Traveled by car to drop daughter off at college and on the return trip began to feel unwell and stopped in a Truck stop, where he became unresponsive. He was transported by EMS to the hospital where he was pronounced deceased at 23:07 on 8/9/2021.
No adverse reaction, sxs, or signs at time of administration or currently. DTAP-IPV component of PENTACEL not mixed with a HIB component. Pt injected with DTAP-IPV only. Pt will be given HIB inj 10/11/13.
Patient received 0.5 of FLUZONE and should have received 0.25 due to his age. Patient did not have any issues with the vaccine.
Received vaccine 1/8/21 with small welt on Left arm and soreness. On 1/11/2021 received depo injection on same left arm. On 1/18/2021 red rash erupted on Left arm where both vaccines were given. Itchy rash and expanding.
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The nurse reported that the patients received improperly stored (temperature excursion: 21.1 C, time frame: 16 hours) doses of VARIVAX (Merck) of lot/batch L042267, expiry date 27-OCT-2017 and lot/batch L036831, expiry date 24-SEP-2017 (dose, dose number, vaccination site and route of administration not provided) since 01-MAR-2016. There was no previous temperature excursion. Concomitant therapies were not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of two reports from same reporter link. Additional information has been requested.
Took Paxlovid from 20Aug-24Aug. Tested negative on 26Aug. Rebound symptoms began on 28Aug and tested positive.; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 17Feb2021 at 09:00 as dose 1, single (Lot number: EL3247), in right arm, on 10Mar2021 at 09:00 as dose 2, single (Lot number: EL3248), in right arm, on 21Oct2021 at 09:00 as dose 3 (booster), single (Lot number: FF8839), in right arm and on 04Apr2022 at 09:00 as dose 4 (booster), single (Lot number: FL3197) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LIPITOR, start date: 07Aug2022, stop date: 13Aug2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant) with onset 28Aug2022 at 08:00, outcome "recovering", described as "Took Paxlovid from 20Aug-24Aug. Tested negative on 26Aug. Rebound symptoms began on 28Aug and tested positive.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Aug2022) Negative, notes: Took Paxlovid from 20Aug - 24Aug. Tested negative on 26Aug; (28Aug2022) Positive, notes: Rebound symptoms began on 28Aug and tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence. Clinical course: The patient was treated with Paxlovid from 20Aug2022 to 24Aug2022 for COVID-19.
Patient received the MMR(V) Vaccine at her 12-month checkup. 3 days after, she was crying and screaming and seemed to be in pain. She was inconsolable. The following morning, patient woke up and was acting sluggish and confused. Around 1:30 p.m. patient went into a seizure and her eyes were staring off. Upon arriving at in the Emergency Room, she was rushed back and Respiratory was rushed in. She was put on Oxygen for about 30 minutes before she opened her eyes. We were transported to another Hospital for an overnight observation.
Enlarged lymph node by clavical; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 16-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Jan2022 (Lot number: FJ5682) at the age of 16 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: ER8735; Route of administration: Unspecified; Anatomical location: Right arm), administration date: 08May2021, when the patient was 16 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0178; Route of administration: Unspecified; Anatomical location: Right arm), administration date: 29May2021, when the patient was 16 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 16Jan2022, outcome "unknown", described as "Dose received: 3"; LYMPHADENOPATHY (non-serious) with onset 17Jan2022, outcome "recovering", described as "Enlarged lymph node by clavical". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 injection, lot # L029306, expiration date: 26-MAR-2017, (dose, route of administration and injection site were not reported). There were no concomitant medications reported. It was stated that the vaccines underwent a temperature excursion of 54.9 degrees Fahrenheit for 2 hours and 40 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning a student (patient) who in the past was vaccinated with Varivax. Subsequently in the past few weeks, the patient developed chicken pox. It was reported, the patient was in grade one. The patient sought unspecified medical attention. The nurse reported that the physicians have reported this to the state health department. At the time of the report, it was not reported if the patient recovered from chicken pox. The registered nurse had reported on 2 other students (patients) who were vaccinated with Varivax in the past and recently, in the past few weeks, have had chicken pox. Additional information has been requested.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It mentioned that the vial was placed in the refrigerator on 14-Oct-2021, the vial did not undergo any temperature excursion and patient did not experienced any adverse events. No treatment medications were reported.
Extreme fatigue, low grade temp for 2.5 days, intermittent headaches that shifted and moved to different areas and intensity