chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My menstrual flow began the next morning after the first dose and has continued through today. I have been fatigued and emotional ever since the first dose. The flow ranges from heavier then normal to light. After the 2nd dose, I had a very large lump under my left armpit that lasted about 6 days. It was very painful and visible. Maybe baseball size.
Kinrix (DTAP-IPV)  vaccine is for the ages of 4-6 yrs old and patient received vaccine at 7 months. No adverse reaction was reported.
Severe hives, itching, burning, stinging, and blistering moving to all areas of my body including the scalp
pt felt flushed, slight sob, initial bp at 202/10, gradually decreased, continued to be slightly high, last bp at 177/82, per client, pt due for bp med tonight.  Per MD, ok for pt to go home, pt no longer felt flushed.
Pain and swelling at injection site. Headache, dizziness, mild nausea and chills in exact order. Slight breathing trouble- I couldn't lay on my right side. Went to sleep for a few hours without medicine and woke up alot better.  Have a slight lingering headache but that's it. Injection site still hurts but that's it.
Elevated  Blood pressure, dizziness, fatigue, Headache, Light headed , Nausea .
Vaccine was given and within approx. 5 minutes, a welt developed just below where the vaccine was given, SC. The welt then got bigger and redness developed around the site. The pt was fine and wasn't bothered by it. Benadryl was given and pt was observed for approx. 1/2 hour. Welt appeared smaller with less redness after Benadryl.
Patient experienced chills and fever. Rednees on the same arm but not near the injection site . inflammation almost the size of a baseball.
ADVERSE EVENT NOS; This spontaneous report received from a patient concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested. No concomitant medications were reported. On an unspecified date, the subject experienced adverse event nos. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse event nos was not reported. This report was non-serious. This case, from the same reporter .
Arm redness pain..couldn't lift my arm...in the middle of the night severe hot and cold feelings..drank fluids and vomit stomach muscle cramps..headache with neck pain ...took Tylenol no help..next day couldn't get out of bed...took advice helped with muscle pain in my stomach not my arm..Thursday was able to hold down fluids but headache is not going away and neck pain
This case was reported by a healthcare professional and described the occurrence of hive in a 21-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline).  On 21 October 2008, the subject received 1st dose of ENGERIX B (20 mcg, unknown, left arm).  On 23 October 2008, 2 days  after vaccination with ENGERIX B, the subject experienced hives.  The subject, who is also a hospital employee, was given her first dose  of ENGERIX B and developed hives all over her body 48 hours after.  She was seen back at employee health and advised to take CLARITIN and BENADRYL.  At the time of reporting the outcome of the event was unspecified.
Received FluMist on 1/11/08. Approx 7-10 days later became weak with multiple episodes of falling to ground, difficulty walking, ataxia. Weakness progressive leading to breathing problems. Neurology and genetics diagnosed congenital disease - Leigh's disease which may have been 1st manifested after this vaccine.Swallowing problems, 5/15/08-death certificate received-final cause of death Leigh's syndrome. 5/1/08-records received for DOS 3/15-4/5/08-DX: Leigh's encephalopathy syndrome. Respiratory failure. Sepsis. Presented to ED and subsequently transferred. About 2 months ago received FluMist and since then became weak and wobbly. Weak prior to vaccination but more so after vaccination and was receiving physical and occupational therapy. Starring episodes usually at night. Became more limp. Appears sleepy acts as if drunk. Ataxia. With thes episodes has become unresponsive and starring with them. No clonic seizure acitivity. after surgery remained intubated with mechanical ventilation and required CPAP. Neurologic status became more obtunded and unresponsive. Fever. Fevers secondary to brain inflammation due to Leigh syndrome. Withdrawn from life support and expired.
Redness started 2 days after shot given, by evening the redness had grown to an estimated 4 inch area with heat
15Sep89 pt vax w/ hepta B; devel soreness at inject site + h/a. 18Oct89 vax 2nd hepta B; devel diarrhea, nausea, + adenitis.  22Oct89 devel large lymph gland in right groin + back back + hip pain. Pt seen in  ER.  See worm...
Administered SQ Friday - AM. Dizzy in the afternoon. Has softball - baseball sized red, raised, hot area. Sunday lethargic and tired.
felt sick-chills, lo grade temp;p/morning rash started on arms to body to legs; about 1/4" red bumps w/itching;mom called ER said to give DPH & calamine lotion;back to school next day;
This spontaneous report was received from a licensed visiting nurse, referring to multiple unspecified patients of unknown age and gender. The medical history and concurrent conditions of the patients were not reported. On multiple unspecified dates, the multiple unspecified patients were vaccinated with improperly stored doses of ROTATEQ by oral route (lot # K01022, expiration date 12-MAY-2016 and lot # K023534, expiration date 22-MAY-2016) (dose and frequency were not reported). No concomitant medication were reported. No adverse effect was reported. No product quality complaint was involved. This is one of two cases received from the same reporter (MARRS # 1509USA013325). Additional information has been requested.
Patient developed cellulitis approximately 3-4 inches below where the injection took place. Patient went to an urgent care and received a prescription for cephalexin 500mg, antibiotic and is currently taking it. Patient seems healthy otherwise at sign of contact and presentation of cellulitis. We are following up on Monday.
Had influenza shot on Tuesday Octboter 2 around 1:00pm.  No complications Tuesday night.  On Wednesday, noticed about a baseball size red welt at injection site severe redness, tenderness, and warmth at sight.  Also experienced all over body "burning sensation", like a hot flash.  No visible signs of inflammation or redness on outward skin.  Felt as like internal "cooking".  Felt sunburn like but with no redness.  Was unable to get any sleep due to soreness of arm or hot flash sensations.  Was advised by employee health to take ibuprofen.  I took ibuprofen 800mg x 2 doses and hot flashes resolved but came back after ibuprofen wore off.  Redness and swelling at arm is not resolved at this time
This case was reported by a consumer and described the occurrence of autism in a child female subject who was vaccinated with DTPA, manufacturer unspecified.  A physician or other health care professional has not verified this report.  The subject received concurrent vaccinations that were not specified.  On an unspecified date the subject received unspecified dose of DTPA (unknown).  At an unspecified time after vaccination with DTPA, the subject was diagnosed with autism.  This case was assessed as medically serious by GSK.  At the time of reporting the outcome of the event was unspecified.  It was reported that this event occurred in five of the consumers children, three boys and two girls.  Case A0725679A serves as the master case and the other case numbers are A0725685A, A0725686A, A0725687A and A0725688A.
Tested positive for covid August 28th. Stuffy head and headache and achy body
A non-serious spontaneous report of fever, puffy face and eyes has been received from a health professional concerning a 47-month-old male, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 28-Sep-2010 for an unknown indication. On 02-Nov-2010, the patient developed a fever. On 07-Oct-2010, the patient's face and eyes were puffy. Treatment for the events was not provided. The outcome for the reported adverse events was not reported.
This case was reported by a nurse via call center representative and described the occurrence of injected limb mobility decreased in a 49-year-old female patient who received TWINRIX (batch number 7C4Z3, expiry date 6th May 2018). Concomitant products included CRESTOR. On 26th April 2016, the patient received the 2nd dose of TWINRIX (intramuscular) 1 ml. In May 2016, 14 days after receiving TWINRIX, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the injected limb mobility decreased was not recovered/not resolved. The reporter considered the injected limb mobility decreased to be unrelated to TWINRIX. Additional details were provided as follows: The patient received TWINRIX on the left arm. The patient started experiencing a decreased range of motion in her left arm 2 weeks after receiving a TWINRIX vaccination and the patient cannot lift her arm above her head. At the time of reporting, the patient was seen for an evaluation, and this information was reported.
had the shots, most painful shot I can ever remember having; This case was reported by a consumer and described the occurrence of injection site pain 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 injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were provided as the patient self reported this case. The age at vaccination was not reported. The patient got the 1st shingle shots and for some reason, it was the most painful shot he/she could ever remember.  The patient was glad that he/she did it though. For tolerance to 2nd dose, refer case US2021AMR180458. Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR180458: Same patient, different dose.
Sleep apnea; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP APNOEA SYNDROME (Sleep apnea) and COVID-19 (COVID-19) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to Severe).   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. In 2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced SLEEP APNOEA SYNDROME (Sleep apnea). At the time of the report, SLEEP APNOEA SYNDROME (Sleep apnea) had not resolved and COVID-19 (COVID-19) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. It was unknown if patient was enrolled in a covid-19 vaccine trial. No treatment medication was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a 62-year-old male patient with no medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown time after the first dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 62-year-old male patient with no medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown time after the first dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.
PATIENT WAS GIVEN THE IMMUNIZATIONS THEN WE WENT BACK TO THE FRONT OFFICE FOR ME TO PUT THE VACCINES IN AND PRINT OUT A SHOT RECORD FOR SCHOOL. HE CAME IN AND SAT DOWN. THEN HE PUT HIS HEAD DOWN ON THE DESK. I GAVE HIM A CUP OF WATER THEN HE STARTED LEANING OVER DROPPING THE CUP. THEN ME AND HIS GRANDMOTHER STAYED WITH HIM UNTIL HE WAS FELLING BETTER SITTING IN THE CHAIR. B/P WAS 143/64 AT 8:35 AM.
Swelling and erythema that started in the injection site area and spread up to the shoulder; Swelling and erythema that started in the injection site area and spread up to the shoulder; Patient under 65 years of age received Fluad (TIV); This spontaneous case was received on 12-Oct-2020 from other health professional via Health Authority (reference number: SEQW20-03386) and concerned a patient of an unspecified age and gender, who was under the age of 65 at the time of this report.  The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with Fluad (TIV) (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: 0.5 ml; route of administration: intramuscular and anatomical location: not reported) (explicitly coded as 'Inappropriate age at vaccine administration') as influenza prophylaxis. The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving Fluad (TIV) vaccine, the patient experienced severe swelling and erythema that started in the injection site area and spread up to the shoulder.  The outcome of the events was not reported.  The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious.  This case is linked to cases 202005145 and 202005146 (the same reporter).  Company comment: A patient under the age of 65 was administered Fluad (TIV). The patient experienced extensive swelling of vaccinated limb and vaccination site erythema (reported as severe swelling and erythema that started in the injection site area and spread up to the shoulder) an unknown amount of time after receiving vaccine. The patient medical history and concomitant medications were not provided. With information available, causal role of the suspect vaccine is possibly related. Product administered to patient of inappropriate age is assessed as unrelated per company conventions.; Sender's Comments: A patient under the age of 65 was administered Fluad (TIV). The patient experienced extensive swelling of vaccinated limb and vaccination site erythema (reported as severe swelling and erythema that started in the injection site area and spread up to the shoulder) an unknown amount of time after receiving vaccine. The patient medical history and concomitant medications were not provided. With information available, causal role of the suspect vaccine is possibly related. Product administered to patient of inappropriate age is assessed as unrelated per company conventions.
Myalgia sinus congestion Narrative: She experienced body aches and sinus congestion x2 days following vaccination. She went to her doctor for COVID testing. She was given antibodics for the sinus congestion (infection?).
Feeling faint. Felt better after 50 minutes of wait time. Offered water or powerade and she declined. Checked vitals x 1 and she was stable.
Initial report received from health care professional on 23 Dec 2009: This patient received FLUVIRIN on 17 Dec 2009. The patient experienced flu like symptoms, fever, chills and muscle pain with latency of 9/12 hours on the same day after FLUVIRIN was started. The outcome was reported as condition unchanged on an unknown date.
Rash. Triamcinolone 40 mg once, diphenhydramine 50 mg once.
Patient reports blurred vision approximately 20-30 minutes after vaccine given. The visual disturbance progressed to severe headache.  Headache began approximately 40 minutes after injection.
SSNHL of the left ear  one day after shot, seen today at ov and placed on a steroid taper, mild loss drop of 25 decibels at 3000 and 4000 hz  manufacturer is Sanofi
Paleness, sweating, loss of consciousness. Patient was rested in immunization room, breathing and pulse monitored. Parents deemed unnecessary to call 911 or ambulance. Lasted approximately 5-10 minutes.
This spontaneous case, initially received from other non-health professional on 26-Oct-2018, concerns a female patient of an unspecified age. It was reported that whenever flu vaccine was drawn up, it leaked out from the rubber stopper. One of the nurses noticed when they popped the secured lock off the vial the rubber stopper was dented in and off a little. The nurses advised when they removed the hard cap and stuck the needle in the middle, there was a corner on the top where the rubber stopper was dented in causing a hole where the medication would leak. About 5 doses were drawn out of 10 doses in the vial. The vials leaked and only 4 vials were leaking so far. On 05-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252234 and expiry date: 30-Jun-2019] from the leaking vial. No adverse events were reported after administration of the vaccine. This case 201804831 is cross-linked to the original case: 201804823, reported by the same reporter. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding PTC reference number was 1034101. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding PTC reference number 1034101. Based on the QA investigation report, it was concluded that FLUCELVAX Batch 252234 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process. A known trend was identified for the FLUCELVAX batches from the 2018/2019 FLUCELVAX commercial season for vials leaking at the stopper during dosing. A review revealed that the complainant was adding air to the vial prior to extracting doses and was inverting the vial when withdrawing the needle from the stopper. It is known that the addition of air to the vial can over pressurize the vial and cause leaking. In addition, inverting the vial while trying to extract a dosage can increase the potential for the vial to leak. The root cause for this investigation was found to be user-improper handling. The reporter assessed this case as non-serious. Follow-up report received from QA department on 19-Nov-2018: The QA investigation report stated that, the root cause for the leaking FLUCELVAX MDV of Batch 252234 was due to user or improper handling. Added new event in the event tab. The narrative and case comment were amended accordingly.
not feeling good; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset Apr2021, outcome "unknown", described as "not feeling good".  Additional Information: Caller had her first dose in March but she missed the second dose in April because she is not feeling good. Caller is asking if it is too late to get her second dose. Caller refused to provide her personal information. Provided the phone number and hours of PMI. Caller refused to be connected with agency. Caller said that she will just call the phone number and then she hangs up.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a NP concerning a 90 year old white female pt who, post vax, experienced injection site erythema 4-5 cm in size. Injection site inflammation and injection site tenderness. The pt was afebrile. Additionally, it was reported that the pt is to be seen by a physician as the nursing home staff states "the site looks like cellulitis." Follow-up information from a NP reported that there no systemic reaction. The duration of the symptoms was 3-4 days. It was reported that the pt's primary physician was notified, but no visit was required.
slightly raised rash on back, center of back ,does not itch, not particularly red but odd looking; Had usual side effects; ill for 3 days; Headache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), RASH PAPULAR (slightly raised rash on back, center of back ,does not itch, not particularly red but odd looking), VACCINATION COMPLICATION (Had usual side effects), ILLNESS (ill for 3 days) and HEADACHE (Headache) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.     On 03-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION COMPLICATION (Had usual side effects), ILLNESS (ill for 3 days) and HEADACHE (Headache). On 05-Jun-2021, the patient experienced RASH PAPULAR (slightly raised rash on back, center of back ,does not itch, not particularly red but odd looking). On 07-Jun-2021, ILLNESS (ill for 3 days) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), RASH PAPULAR (slightly raised rash on back, center of back ,does not itch, not particularly red but odd looking), VACCINATION COMPLICATION (Had usual side effects) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jun-2021, Body temperature: 104 (High) Patient had fever of 104 F.         No relevant concomitant medications reported.   No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Significant follow up includes patient age and illness event was added On 30-Jul-2021: Non significant follow up received