chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had issue with migraine headache after my shot and after a couple of days I developed something of a sore throat and did a telehealth session and showed them my throat. Was given amoxicillin for about 10 days and it cleared up. Still had headaches but that could be from my malformation issue.
COVID 19 Treatment; COVID 19 Treatment; Dose #1: Janssen / Dose #2: Pfizer/ Dose #3: Pfizer.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Dec2021 as dose 2 (booster), single (Lot number: 33130BA), in right arm and on 30Jun2022 as dose 3 (booster), single (Lot number: FK9893) at the age of 52 years, in right arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 10Mar2021 as dose 1, single (Lot number: 1805029), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing). Concomitant medication(s) included: MOUNJARO, start date: Aug2022; MULTIVITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PANTHENOL;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]; PHILLIPS COLON HEALTH; VITAMINE D, LILLY, ALLERGY PILL.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 14Dec2021, outcome "recovered", described as "Dose #1: Janssen / Dose #2: Pfizer/ Dose #3: Pfizer."; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2023) Negative, notes: Tested Negative 10 days after initial positive test; (Aug2023) Positive, notes: Tested Negative 10 days after initial positive test. Therapeutic measures (Paxlovid Treatment start date: 19Aug2023, stop date: 24Aug2023) were taken as a result of drug ineffective, covid-19. Clinical course: Patient tested Negative 10 days after initial positive test, took Paxlovid for 5 days.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300291105 Same reporter/patient, different drug, different event.;
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presented with abdominal pain and nausea  and admitted for anticoagulation (heparin) and monitoring for SMV thrombus. Patient developed fever to 40 degrees Celsius and underwent diagnostic laparoscopy with evidence of recovering ischemia of the jejunum and omental adhesion along the left abdomen. Found to have left upper extremity superficial thrombophlebitis concerning for early suppurative complications in setting of persistent fevers and mild thrombocytopenia. Heparin discontinued when thrombocytopenia developed and platelet counts have increased.
25JAN95 mom called & c/o pt crying 30 mins p/vax given; brought back to clinic seen by NP no unusual findings in areas where vax given; mom states t101;
after over a week became itchy, red and warm to touch.  Area of redness was almost as large as my hand
developed urticaria; This case was reported by a physician via call center representative and described the occurrence of urticaria in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced urticaria. On an unknown date, the outcome of the urticaria was unknown.   It was unknown if the reporter considered the urticaria to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient received 1st dose and experienced urticaria. This case has been linked with case US2020026104, reported for same reporter.
I am reporting my reaction to my first Pfizer vaccination. On April 8, 2021, I experienced dizziness, nausea headache shortly after I returned home.  I slept off and on most of that first day. The next day I still was having the dizziness, nausea, headache and new was muscle pain, joint pain in both arms and legs.  Some weird numbness in one foot/toes.  The third day I noticed that I was starting to feel somewhat better so I was able to go about my normal business. I have a history of sensitivity to most medications going back over fifty years.  Sensitivities internationally and externally.  After blood work many years ago I was told that I have the MTHFR gene mutation.  Which can be associated with my sensitivities. I am concerned about having my second injection next week as I have heard that usually it's the second dose that most people have a reaction to.
erythema & pain @ inj site radiating to axilla & upper shoulder;pt exp localized serum sickness p/vax;now pt c/o lymphedema w/menstrual cycle-(husband & wife recv vax from different lots);
Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a J & J vaccine in March and received a Moderna Booster about 2 weeks ago) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination J & J vaccine in March 2021. Past adverse reactions to the above products included No adverse event with J & J vaccine.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 25 microgram. In December 2021, the patient experienced ACCIDENTAL UNDERDOSE (gave me a 25 mcg dose instead of 50 to 100 mcg) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a J & J vaccine in March and received a Moderna Booster about 2 weeks ago). In December 2021, ACCIDENTAL UNDERDOSE (gave me a 25 mcg dose instead of 50 to 100 mcg) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a J & J vaccine in March and received a Moderna Booster about 2 weeks ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
Extreme pain in left shoulder, upper arm up to neck and across shoulder blade. Pain so severe, needed prescription pain medication (hydrocodone)and Zofran. Level 9 on pain scale. Debilitating pain lasted for approximately  48 hours.
Persistent headache x 23 days unrelieved by NSAIDS and antibiotics (given to treat sinusitis).
tenderness in armpit; swollen lymph node from collarbone to ear; experienced sore arm; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness in armpit), LYMPHADENOPATHY (swollen lymph node from collarbone to ear) and VACCINATION SITE PAIN (experienced sore arm) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 immunisation: COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (patient received his first dose of the Johnson and Johnson COVID-19 vaccine on 07-APR-2021 in the right non dominant arm and on an unknown date, the second dose was received as well. Date and lot and expiration date was unknown) on 07-Apr-2021.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (tenderness in armpit), LYMPHADENOPATHY (swollen lymph node from collarbone to ear) and VACCINATION SITE PAIN (experienced sore arm). At the time of the report, TENDERNESS (tenderness in armpit), LYMPHADENOPATHY (swollen lymph node from collarbone to ear) and VACCINATION SITE PAIN (experienced sore arm) had not resolved.            No concomitant medications were reported.  Treatment information was not provided. The patient received a booster dose in the right non dominant arm.
Pt reported feeling an "awareness" of a tongue & tingling of tongue. No other symptoms Tingling decreased after Benadryl 12.5 mg
Shortness of Breath upon waking in the morning that required use of my Pro Air/ Albuterol inhaler. Diarrhea for 21 hours. Vomitted once. Some brain fog, confusion only last a few seconds. Come and go.
cardiac issues; fatigue; hearing issues; vision issues; balance issues; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a currently approximately 82-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 17-DEC-2012, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) for the long-term prevention of shingles and zoster-related conditions at physician's office. Subsequently, on an unknown date, the patient was treated by a healthcare provider for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: cardiac issues, fatigue, vision issues, hearing issues and balance issues. The outcome of the events was not provided. The reporter considered those events to be related to zoster vaccine live (ZOSTAVAX).
The patient received a vaccine that had been stored in the freezer too long and was expired .  Patient has not suffered any side effects to this date
bloody stools; This is a spontaneous report from a contactable consumer (parent). A 13-year-old female patient (not pregnant) received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 21Jul2021 at 10:00 (Lot Number: FA7485) at the age of 13-year-old as single dose for COVID-19 immunization. Medical history was none. No other vaccine in four weeks. COVID prior vaccination was none. COVID tested post vaccination was none. Known allergies none. Concomitant medications included  multi vitamins, vitamin c [ascorbic acid] and vitamin d [vitamin d nos]. On 22Jul2021 at 21:45, the patient had bloody stools a total of four times on different days after she received her first shot of the Covid-19 Pfizer shot. First bloody stool was Thursday 22Jul2021.  After that day she had bloody stool with less blood each time on Saturday 24Jul2021, Sunday 25Jul2021, Monday 26Jul2021, and Tuesday 27Jul2021. The event resulted in doctor or other healthcare professional office/clinic visit. The patient used suppositories for three days as treatment. The outcome of event was unknown.
Fever, Crying, Vomiting - Information has been received concerning an 18 month old Causcasian female who on 25 May 2000 was vaccinated with varicella virus vaccine live IM in the right, thigh.  On 26 May 2000 the patient experienced fever a fever of 104.8 degrees F. crying, and vomiting.  At the time of the report, the patient's vever had decreased to 100 degrees f.  and the patient had recovered from the vomiting.  Medical attention was sought.  The patient recovered from the symptoms on 28 May 2000.
A very strong odor; coming from my genitals and its more complicated than that; from my penis head like from the skin there; A very strong odor; coming from my genitals and its more complicated than that; from my penis head like from the skin there; I suffer with something called Smegma; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed; unknown manufacturer), for COVID-19 immunization.  The following information was reported: GENITAL ODOUR (non-serious), SKIN ODOUR ABNORMAL (non-serious), outcome "unknown" and all described as "A very strong odor; coming from my genitals and its more complicated than that; from my penis head like from the skin there"; SMEGMA ACCUMULATION (non-serious), outcome "unknown", described as "I suffer with something called Smegma". The events "a very strong odor; coming from my genitals and its more complicated than that; from my penis head like from the skin there" and "i suffer with something called smegma" required physician office visit. Therapeutic measures were not taken as a result of genital odour, skin odour abnormal, smegma accumulation.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
At 2 days after the vaccine patient says he experienced a rash that started on lips, then to the back of his hands, and also to his groin and left leg.  Patient took benadryl and used alcohol topically to dry out bumps for 10 to 12 days
Felt feverish 4 hours after the injection. Followed by pain, tenderness on L arm.  Had an episode of runny nose in the afternoon. In the evening, felt fatigue, mild headache. Took tylenol. Felt achy all over the day after, temperature of 101. Resolved with tylenol. Still with L arm tenderness,  headache, achy joints. + swelling on L arm injection site.
It was about 5 minutes after my shot and I started feeling dizzy and going to passout.  I got a nurse and my blood pressure and oxygen levels went down.  They laid me on the floor and put a ice pack on while I'm breaking out in a sweat. They called the parmetrics to monitor me.  They didn't like my reading and took me to the ER to monitor me.
Tongue Tingling; Felt a little off; had trouble breathing; started trembling and shaking; neck in both sides is sensitive to the touch, sore; voice is raspy; blood pressure was high; felt warm heat throughout the whole body; Dizziness; heart skyrocketed; A spontaneous report was received from a consumer concerning a fifty-one-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced feeling of warmth, dizziness, heart skyrocketed, tongue tingling, blood pressure was high, felt a little off, had trouble breathing, started trembling and shaking, neck in both sides is sensitive to the touch, sore and voice is raspy.   The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 (BATCH# 025L20A) on 14 Jan 2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Consumer received the Moderna COVID-19 vaccine on 14 Jan 2021 around eight-thirty am (ante-meridian) in the left arm (non-dominant) and immediately after getting vaccine felt warm heat throughout the whole body and dizziness, heart skyrocketed and tongue tingling. Paramedics attended to them. Once she got the shot it was not even a minute until she felt warm, people talked to her and they felt far away. Their blood pressure was high and heart rate elevated from sixty-two to one-hundred and twenty-two. Consumer stayed for forty-five minutes in the facility and then felt better and drove home. Took Benadryl and slept the whole day and night. On 18 Jan 2021 consumer felt a little off, and going to work had trouble breathing, tongue tingling, feeling dizzy, started trembling and shaking. Reporter took some more Benadryl while they waited for ambulance, at the hospital received Benadryl injection. 18 Jan 2021 their neck in both sides is sensitive to the touch, it is sore, and voice is raspy.  Treatment for events included Benadryl.  Action taken with RNA-1273 in response to the event was unknown.  The outcome of the events was unknown.  The reporter did not provide an assessment for the events, feeling of warmth, dizziness, heart skyrocketed, tongue tingling, blood pressure was high, felt a little off, had trouble breathing, started trembling and shaking, neck in both sides is sensitive to the touch, sore and voice is raspy.  Follow-up received on 14 Jan 2021 included, reporter stated they reported adverse event after getting vaccine.; 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.
This spontaneous report was received from a other health care professional regarding a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and drug reactions/allergies were not reported. Concomitant therapy included properly stored sterile diluent. On 03-JAN-2019, the patient was vaccinated with improperly stored VARIVAX (strength, dose, frequency and route of administration not reported) lot # R010468 and expiry date: 10-APR-2020 (product storage error) for prophylaxis. No adverse effects were reported. The temperature at which the vaccine was stored was reported as 6 °F to 14 °F (7.41 °F) with a time frame of 20 minutes (multiple excursion). There was no previous temperature excursion reported. Digital data logger was present.
pt recv vax 12JUN96 1030AM;2PM pt began screaming & thrashing uncontrollably;pt could not be comforted & would not eat;6PM screaming stopped;mom denies fever, any sz activity or soreness @ vax site;3 doses of APAP given;no more pertussis
Right after receiving the vaccine I had extreme nausea, diarrhea and a scratchy throat for three days. I took some Zofran and loratadine and it went away. I then started feeling extreme chest tightness, shortness of breath and extreme sore throat a week after receiving my vaccine. I saw my NP on Tuesday, May 24, 2022 and was tested for COVID-19 that came back positive, she prescribed Augmentin and steroids as of today May 31, 2022 I am feeling much better.
Experienced a huge hot red lump/Hot lump on injection arm; Fever; Red lump on injection site; Chills; Angioedema to her face; swelling of tongue; hot red lump at vaccination site/Huge red lump on injection arm; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (Angioedema to her face) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Poison ivy rash. Concomitant products included PREDNISONE for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced ANGIOEDEMA (Angioedema to her face) (seriousness criterion medically significant), SWOLLEN TONGUE (swelling of tongue), VACCINATION SITE WARMTH (hot red lump at vaccination site/Huge red lump on injection arm), PYREXIA (Fever), INJECTION SITE ERYTHEMA (Red lump on injection site) and CHILLS (Chills). On 14-Apr-2021, the patient experienced INJECTION SITE INDURATION (Experienced a huge hot red lump/Hot lump on injection arm). On 13-Apr-2021, ANGIOEDEMA (Angioedema to her face), SWOLLEN TONGUE (swelling of tongue), PYREXIA (Fever) and CHILLS (Chills) had resolved. On 27-Apr-2021, VACCINATION SITE WARMTH (hot red lump at vaccination site/Huge red lump on injection arm), INJECTION SITE INDURATION (Experienced a huge hot red lump/Hot lump on injection arm) and INJECTION SITE ERYTHEMA (Red lump on injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment was not reported.  It was noted swelling started 45 minutes after vaccination and went down one hour after. Additionally, the event huge, red, hot lump came and went for two weeks on and off.  Company comment: 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.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Additional information received included update to event outcome; 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.
Aprox 45 minutes following the vaccine had bilateral ascending LE paresthesias and RUE arm tingling. This all lasted several 6+ hours. Did resolve by the next day. 24 hours following the vaccine has intense midsternal chest burning that worsened as I was supine. Not really resolved by PPI administration. This too resolved in about 10 days following the vaccine. Was advised not to receive the second dose.
pain started day of injection, swelling, heat, redness started next morning and has been increasing in size to 5.5 inches in diameter.
Had a sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Linked case(s) involving the same patient:US2022AMR081015   Additional Information: GSK Receipt Date: 16-MAY-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient got the 2 dose shingles vaccine. The patient only had a sore arm with the first one. Additional Supportive Information: The follow up would not possible as no contact details were available. For tolerance of 2nd dose, refer case US2022AMR081015.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR081015:Same reporter
This spontaneous report was received from a registered nurse referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-JUN-2017, the patient was vaccinated with an expired dose of GARDASIL (dose, frequency and route of administration were not reported) lot # K016966, expiration date 10-MAY-2017 for prophylaxis. No adverse effects were reported. No further information was provided. A product quality complaint was not involved. Additional information has been requested.
DEVELOPED SHINGLES 13 YEARS LATER 6/24/2017, symptoms, rash and pain right upper quad abdomen and back, treatment famciclovir 500 mg 7 days, hydrocodone 5 mg /acetaminophen325 mg 4 x day, time course not complete.
Information has been received from a registered nurse concerning a 13 year old female patient who on an unspecified date was vaccinated with a dose of PROQUAD (Merck) (Lot # not provided), "back to school dose required by the state", instead of VARIVAX (Merck). It was reported that the patient had not experienced any known symptoms. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.