chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 01-APR-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J01182 and expiry date: 16-DEC-2014) w01182hich was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Severe Migraines, started having menstrual symptoms with bleeding after I had already had a cycle earlier in the month, lots of cramps that I have never experienced
Thursday, February 11th: Fever, Chills, Nausea, Malayze Friday, February 12th: Severe Chest Pain from sternum to throat, Difficulty Swallowing, Pain in left chest Saturday, February 13th: Itching, Swelling in Left Hand, Welts/Hives on extremities and stomach, Swelling to face, swelling to throat Sunday, February 14th - Tuesday, February 16th: Fatigue Wednesday, February 17th: Difficulty Breathing, Shortness of Breath
High fever and body aches the day after second vaccine.  2 days after, severe Bronchitis and sinus pressure  that does not get better.  It?s been 8 days
Patient stated temp 99 degrees at 12 noon vomited at 7AM drank gatorade and vomited again. No vomiting since approximately 7:30AM. Patient contacted her allergist who advised patient to take BENADRYL and alternate TYLENOL and Ibuprofen. At 5:25pm, patient no longer feverish and stated felt much better.
Injection site soreness; headache (front of forehead across top of head all the way back to ears); sinus ache under eyes; muscle ache across shoulders; hint of nausea; early morning awoke to profuse sweating; tired.
Intense underarm pain, same side as shot.; Stabbing pain in skin andmuscle.; Stabbing pain in skin andmuscle.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old adult non- pregnant female patient received unknown dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE, Lot number: Er8733) via an unspecified route of administration in the right arm on 25Mar2021 at 12:00 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. Medical history included overweight. Concomitant medications were not reported. The patient previously received unknown dose of BNT162b2 (PFIZER- BIONTECH COVID-19 m RNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunisation. Prior to vaccination, the patient had not tested positive for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 13:00, the patient experienced intense underarm pain, same side of shot, had stabbing pain in skin and muscle. There was no visible swelling of area or lymph nodes. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as the result of adverse events. The clinical outcome of armpit pain, skin pain and muscle pain was not recovered.  No follow-up attempts are needed. No further information is expected. .
SHOT GIVEN AT 9:20AM, DIZZINESS REPORTED WITHIN 10 MINUTES POST VACCINATION. AT APPROX. 9:40 AM PATIENT COMPLAINED OF INCREASED OCCULAR PRESSURE. NO SWELLING WAS NOTED. PATIENT ALERT AND ORIENTED X4, BP 128/82 PULSE 64, RESPIRATIONS 18. PATIENT REQUESTED TO STAY TO BE MONITORED LONGER. PATIENT MADE FOLLOW UP APPOINTMENT WITH PCP.
Anaphylaxis.  Swelling of the lips, mouth, throat and hives over 50% of her body.  Started 5 minutes post injection and progressed over the next 5 minutes.  Diphenhydramine 50mg po was administered on site and paramedics were called.  Patient was calm and aware with a good airway and o2 sats.  Paramedics arrived apx 15 minutes following administration.  They evaluated her and decided that she was stable enough for the patent's caregiver to transport her by private car to the nearest ER (2 miles away).
Information has been received on 26-MAY-2017 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 02-JAN-2015 at pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 03-JUN-2016, the patient was treated by a health care professional for a vesicular outbreak that was diagnosed as severe shingles. On or about 25-JUL-2016, the patient was treated again by a physician for ongoing and worsening symptoms of shingles outbreaks that had lasted several months. At that encounter, the patient was then diagnosed with ongoing herpes zoster and post herpetic neuralgia. The patient was prescribed gabapentin (NEURONTIN) for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient got FLUZONE HD shot on Oct. 22, 2015 and complained on Oct. 23, 2015 of inflamed arm and at site on injection.
Pt has local reaction measuring 60mm X 58 mm induration, 72mm X 80mm.  Pt instructed to use cold compresses over the weekend and return for follow-up on 17 May or the E.R. if he experiences any problems breathing or reaction gets bigger. Follow up 5/21/04: Patient has an induration measuring 35mm by 57mm.
Tuesday 4/13 9:30-am shot fine until about 11:30 when I get a little tired then around 2pm I start to feel a little achey By 7pm I had what felt like intense full-blow flu symptoms (body aches, fever, fatigue, chills, headaches)  Weds 4/14 and Thursday 4/15 The same as Tuesday evening but slightly more intense.  Headaches were so bad I could not look at a computer/phone screen, etc. Also a bit of dizziness  and some body cramps  Friday 4/16 Woke up feeling measurably better- but symptoms came and went throughout the day and still underlying fatigue  Saturday 4/17, Sunday 4/18 Again better- but symptoms would creep in throughout the day.  Plus a new one: persistent dry cough  Monday 4/19 Cough is the symptom of the day- can not say two words without coughing.  Was otherwise feeling fine-though fatigued.  But now at 6:30pm I feel another fever.  Have tried to report but links I'm sent to report symptoms haven't worked.  Will go to urgent care tomorrow.
Fever (>102F), rigors, severe pain at injection site and polyarticular pain novel to the patient, diffuse myalgia and marked fatigue.  Reported due to fever and rigors.  Treatment was hydration and attempted rest.  Symptoms persisted for approximately 24 hours after first dose, and had it not been a Saturday would have made it impossible to work.
Joint pain; Chills; Congested chest; So bad COVID-19 infection after the 2nd dose; Very sick; A lot of phlegm; Lots of coughing; Congested head/ Sinus infection; Dizziness; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY CONGESTION (Congested chest) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESTRADIOL, PROGESTERONE, ACETYLSALICYLIC ACID (BABY ASPIRIN), ESCITALOPRAM, ROSUVASTATIN CALCIUM (CRESTOR), LORATADINE (CLARITIN [LORATADINE]), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), MAGNESIUM and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced PULMONARY CONGESTION (Congested chest) (seriousness criterion medically significant), COVID-19 (So bad COVID-19 infection after the 2nd dose), ILLNESS (Very sick), PRODUCTIVE COUGH (A lot of phlegm), COUGH (Lots of coughing), SINUS CONGESTION (Congested head/ Sinus infection), DIZZINESS (Dizziness), FATIGUE (Fatigue) and CHILLS (Chills). On an unknown date, the patient experienced ARTHRALGIA (Joint pain). At the time of the report, PULMONARY CONGESTION (Congested chest), COVID-19 (So bad COVID-19 infection after the 2nd dose), ILLNESS (Very sick), PRODUCTIVE COUGH (A lot of phlegm), COUGH (Lots of coughing), SINUS CONGESTION (Congested head/ Sinus infection), DIZZINESS (Dizziness), FATIGUE (Fatigue), ARTHRALGIA (Joint pain) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took Aleve, Mucinex DM to breakup the phlegm, Tylenol, and Pain pill as a treatment medications.  Company Comment : For the event of COVID-19:Based on mechanism of action of mRNA -1273 vaccine, the event is assessed as unlikely related to mRNA-1273.(Moderna COVID-19 Vaccine) For other events: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.   Reporter did not allow further contact; Sender's Comments: For the event of COVID-19:Based on mechanism of action of mRNA -1273 vaccine, the event is assessed as unlikely related to mRNA-1273.(Moderna COVID-19 Vaccine) For other events: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.
TACHYCARDIA; This spontaneous report received from a patient via other manufacturer (Abbvie) concerned a 72 year old female. The patient's weight, height, and medical history were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient previously received two doses of covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, intramuscular, batch number: unknown and expiry: unknown) dose was not reported, 01 total, administered on 01-MAR-2021 and 01-JUN-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26. cov2. s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, batch number: unknown and expiry: unknown) dose was not reported, 01 total, administered on 01-MAR-2022 for covid-19 prophylaxis. Age at time of vaccination 72 years old. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 01-JUN-2022 (3 months after vaccination), the patient experienced tachycardia (dose number in series 2). The patient received non-company suspect drugs included (Skyrizi) risankizumab (form of admin unknown, subcutaneous, batch number: unknown and expiry: unknown) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable and dose of risankizumab was not changed. The patient had not recovered from tachycardia. This report was non-serious.
Patient feels a lot of pain and inflammation signs on the injection site. Also  signs of haemorrhages at the injection site
felt light headed; arm was just sore initially; Wasn't feeling well; I have the Corona; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt light headed), PAIN IN EXTREMITY (arm was just sore initially), MALAISE (Wasn't feeling well) and CORONAVIRUS INFECTION (I have the Corona) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ZINC and AMLODIPINE for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, 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 experienced DIZZINESS (felt light headed), PAIN IN EXTREMITY (arm was just sore initially), MALAISE (Wasn't feeling well) and CORONAVIRUS INFECTION (I have the Corona). At the time of the report, DIZZINESS (felt light headed), PAIN IN EXTREMITY (arm was just sore initially), MALAISE (Wasn't feeling well) and CORONAVIRUS INFECTION (I have the Corona) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative. On 05-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.         Treatment details included Honey with tea.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: FollowUp Received on 01-JUL-2021: second dose details are added, events outcome was changed from unknown to Recovering/Resolving.
Patient presented to employer health clinic complaining of persistent bleeding from a cat scratch on his right upper arm, bleeding gums, was sent to the ER were was found to be severely thrombocytopenic,  subsequently  diagnosed with HLH as of 09/30/21
Late 04/12/2002 or early 04/13/2002 pt complained of itchy rash, about 20 mosquito bite like raised, red, some with blisters. Size about 1/4" or less. Location trunk and extremities. Mother of pt denies of any fever and fatigue. Pt was somewhat "hyper" Friday evening. Pt continues to have this rash today. May go to pmd's if no improvements.
Starting at 4am the following morning of vaccine, sweats, aching arm at injection site(no pain prior), sore throat on right side when swallowing(possibly swollen right lymph node), sore muscles including neck,shoulders and back, headache.
This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED HEALING (Delayed healing of wound) and COVID-19 (COVID-19) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced IMPAIRED HEALING (Delayed healing of wound). The patient was treated with POTASSIUM at an unspecified dose and frequency. At the time of the report, IMPAIRED HEALING (Delayed healing of wound) outcome was unknown and COVID-19 (COVID-19) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication were reported. It was reported that the daily dose of Moderna COVID-19 Vaccine given as (1 in 1 Once) and for co-suspect Humira was reported as CF PEN. It was reported that the primary reporter did not have the lot number information, because the packaging was discarded. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter causality for the events of LEG INJURY TAKING A LONG TIME TO HEAL unknown onset, COVID, NECK PROBLEMS, LEG INJURY TAKING A LONG TIME TO HEAL unknown onset and MUSCLE TIGHTNESS with HUMIRA (ADALIMUMAB) was no reasonable possibility (Not Related). Company comment: This spontaneous case concerns a 73-year-old female patient with relevant medial history of treatment with Adalimumab for Rheumatoid arthritis, who experienced the unexpected non-serious AESI Covid-19, after receiving a dose of mRNA-1273 vaccine on an unspecified date. Latency unknown as the onset date was not specified. Details of symptoms, Clinical course, investigation reports and treatment were not provided. The outcome was reported as resolved. The current pandemic situation of Covid-19 could be a confounder. Elderly age of the patient and treatment with Adalimumab could be risk factors. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 73-year-old female patient with relevant medial history of treatment with Adalimumab for Rheumatoid arthritis, who experienced the unexpected non-serious AESI Covid-19, after receiving a dose of mRNA-1273 vaccine on an unspecified date. Latency unknown as the onset date was not specified. Details of symptoms, Clinical course, investigation reports and treatment were not provided. The outcome was reported as resolved. The current pandemic situation of Covid-19 could be a confounder. Elderly age of the patient and treatment with Adalimumab could be risk factors. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Patient received Gardasil vaccine dose #1 on 3/2/2009, Gardasil #2 on 6/9/2009, and Gardasil #3 on 9/30/2009.  She reports having a seizure in May, was seen by a neurologist and had a negative workup, and was told she has pseudoseizures and was prescribed Xanax 0.25 mg.  She reports her last seizure was 9/2/2009.  Approximately 5 minutes after receiving her third Gardasil dose today at 2:15 PM, she complained of "not feeling well" and then began to have a seizure that lasted approximately 5 minutes in duration.  She took 0.25 mg of Xanax at the onset of the seizure.  She did not suffer any injuries during the seizure and was awake, alert, and responsive during the event.  She was ambulatory upon leaving the office and had no complaints.  She did admit to not having eaten either breakfast or lunch today.
ITP within 2 wks of vaccines. She started to display bruising and it increased. Was taken to ER and dx ITP. Was prev. vaccinated with DPT/HIB - new vaccine - Varicella.
48 hours after being administered the dtap vaccination, patient began screaming loudly and high-pitched.  Patient screamed for 5 hours straight and was inconsolable even after being administered tylenol.  A rash and low grade fever also was present.  The patient has had a pink spot of eczema over the injection site for the past 10 months.
Lymph nodes inflammation in groin left area; muscle pain in left arm and breast; pelvic pain; joint pain; headache; This is a spontaneous report from a contactable consumer (patient). A 26-years-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 15Apr2021 at 11:15 (at the age of 26-years-old) (Batch/Lot Number: ER8729) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced lymph nodes inflammation in groin left area, muscle pain in left arm and breast, pelvic pain, joint pain and headache on 23Apr2021 12:00. Events resulted in visit to the doctor's office. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Device date was reported as 04May2021. Patient received no treatment for the events. Seriousness of events were reported as non serious by the reporter. Outcome of all events were not recovered.   No follow-up attempts are needed. No further information is expected.
headaches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) 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 complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300034302 Same reporter/ drug/ event for different patients;
On site soreness in arm from shot. Feeling tired and drained.  Back pain and stomach pain. Back spasm. Right side more tender to touch and movement.
Child received immunizations at 9:30AM today 9/21/04. Infant's mom called at 2:50PM state child had been  crying almost 30 min could not do anything to console child. You could hear child crying in background, I instructed mother to stop by clinic. She stated she was close by. She arrived at the clinic about 3PM. Child arrived at clinic crying inconsolably with high pitched cry. APRN summoned to check infant. Temp checked. Temp 98.1 on exam, found lungs clear, heart RRR, fontanels WNL with bulging noted. Child observed to cry more when she moved her legs. There was also over response to stimuli. APRN talked with DR who instructed her to have mom swaddle infant, offer Tylenol 0.4cc ever 4-6 hrs prn, offer fluids/formula ever 1-2 hrs, to decrease stimulation x 6hrs she also instructed mom to take child to hospital if temp increases to more than 104 with Tylenol, if child becomes listless, unresponsive or fontanel begins to bulge.  APRN also conveyed Dr's instructions to mother. Mother voiced understanding of instructions. APRN swaddled child and child calmed down somewhat after pressure taken off legs which occurred if child held against mom. Order for no more pertussis written per APRN. Also mom had administered 0.6cc Genavar gtts before coming to clinic at 2:40PM. Follow up call to mom she states she took child home and applied ice to legs. She states child slept x 1 hr. She said child awoke and cried off and on for a little while but settled down with application of ice to legs. She states child went to sleep again at 8PM and had a good night. Instructed mom to call clinic if she encountered any further problems.
Complaints of nausea, redness to palms of hands, itchy throat, headache, pain at injection site.