chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic Arthritis" (unspecified if ongoing); "Seasonal Allergies" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Metronidazole, reaction(s): "Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
From follow up information received on 1/14/05 the seriousness of this case was upgraded from non-serious to serious, as based upon medical judgement. From initial information received on 11/1/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 51 year old male patient received a dose of FLUZONE vaccine, lot number U106888, administered in the right deltoid on 10/17/03. Four days later, on 10/21/04, the patient developed lingering shoulder pain at the right deltoid site. The patient has seen an orthopedic shoulder specialist and has been through physical therapy. He also used non-steroidal anti-inflammatories with no beneficial effect. The orthopedic shoulder specialist thought that the patient may have developed some sort of myositis. Patient's pre-existing medical conditions include high cholesterol. He has no known allergies. He did not have any illnesses at the time of vaccination. Concomitant medications at the time of vaccination included ASA and Zocor. The patient previously received four doses of influenza vaccine with no reactions reported. Reportedly, the discomfort, although it has waxed and waned somewhat, has not diminished significantly over the last several months. The patient has not recovered from these events. From additional information received on 1/14/05, from a physician, it was reported that the patient received a 0.5ml dose of FLUZONE, administered IM in the right deltoid. Reportedly, the patient had no illnesses at the time of vaccination. An MRI of the patient's right shoulder was completed on 10/22/04 due to right shoulder pain. The MRI showed marked AC joint hypertrophy, labrum intact and minor glenoid changes. Per the reporter, the patient's shoulder pain was somewhat improved as of the patient's office visit on 12/23/04. The physician stated that he does not consider the adverse events to be a significant or permanent disability, but it was a cause of significant pain. Reportedly, the patient retained strength, range of motion and function of his shoulder. Contact information for the patient's orthopedic specialist was provided. The adverse event coding for injection site pain was upgraded to shoulder pain.
felt sweaty, however denied CP or SOB, no lightheadedness or dizziness, no nausea or vomiting vitals take were stable, observed in car for 40 minutes and then sent home
Persistent deep sharp pain at vaccination site occurring episodically increased with exercise overhead reaching initially accompanied by left axillary LAD Sxs x 18 mo.
Pt recvd series of 3 hep B vax 11DEC89,16JAN90 & 21JUN90. titer indicated pt nonresponder. Recvd booster vax from same lot #;
began with irregular heart beats that progressed over several months to the point he needed a pacemaker placed 4 months later because of complete heart block
Pain in the arm, swollen, I was unable to raise my arm. Severe symptoms occured on 5th day after vaccination.
Client expressed that on 4/19/2021 at 1:50 pm, received the Pfizer COVID 19 vaccine in left arm. Per Client has soreness at injection site and in Deltoid muscle area on going. On 4/21/2021 Client reports, on the left arm and hip developed a red, itchy, patchy, raised rash and applied Benadryl Gel to sites, with some improvement. Per Client, that evening on 4/21/2021, developed a new rash on right arm and right neck, so Client took antihistamine and applied Benadryl Gel to both sites. Per Client, took Ibuprofen and Tylenol for soreness in arms. Per Client no follow up with PCP for symptoms and still having mild symptoms. PHN suggested that Client follow up with PCP, continue to monitor symtoms and go to Urgent Care,
POSSIBLY GIVEN 1.5ML OF VACCINE; OVERDOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A expiry: 23/JUN/2021) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced possibly given 1.5ml of vaccine. On 27-MAY-2021, the subject experienced overdose. On 27-MAY-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from possibly given 1.5ml of vaccine, and the outcome of overdose and off label use was not reported. This report was non-serious.
19MAY92 pt was seen in hosp & mom reported high-ptiched cry p/last vax 17MAR92; cried a long time very irritable, inconsolable crying; mom stated no fever; Ped DT ordered per NP;
14 year old received Moderna Booster in error, administered by RN.  Patient mother notified, offered counseling by medical director.  Mother denied any adverse reaction.
Initial and follow up information has been received from a physician concerning a 16 year old female who on approximately 07-AUG-2007 was vaccinated with the first dose of Gardasil (Lot# not provided). The physician reported that 10 minutes post vaccination the patient developed a severe headache. The physician reported that when the patient arrived at the office she had not eaten that day and they gave her something to eat (not specified) prior to giving her the vaccination. Subsequently, on an unspecified date the patient recovered from the severe headache. Additional information has been requested.
Swelling at injection site; Redness at injection site; This case was reported by a physician via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABX749AA, expiry date 29th February 2020) for prophylaxis.   On 21st June 2019, the patient received the 1st dose of Bexsero. On an unknown date, less than 2 months after receiving Bexsero, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to Bexsero.  Additional case details were reported as follows: The patient received vaccine in left arm. The patient had "quite an impressive amount of swelling and redness at the injection site. The patient was unsure how long the symptoms lasted but stated that she was better now. The reporter gave permission to follow up.
Heart attack, myocarditis.  Life flight to hospital, 6 days in hospital, numerous tests and appointments once released.
Developed left eye herpetic keratitis and notes induration and warmth to the left upper arm with erythemic rash starting ~3 days after vaccination.
Severe expected symptom (9h-48h after injection): - swelling of arm - headache - chills/body aches - 102-104 degree fever (treated with Tylenol -- only medicine taken)  Unexpected symptoms - vomiting, diarrhea (6h-18h after shot)  - swollen lymph nodes in armpit of injected arm (12h-72h after shot) - dizziness/disorientation (6h-36h after shot)
Pain, redness and tenderness developed in left deltoid and migrated up and over shoulder into upper left chest area. Everything cleared after 3 days.
Oct. 16,2021 had ruptured brain aneurysm; transfered via ambulance to Healthcare. and then via helicopter to Hospital for treatment: surgery included coiling of aneurysm, placement of shunt, drainage of intra-cranial blood, therapies, medications;  after release from Hospital had two (2) weeks of inpatient therapies at Rehabilitation Hospital.
Collapses on the field; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a 31 years old and unknown gender patient who collapses on the field while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a serious event collapses on the field (Loss of consciousness) (unknown latency) following the administration of Influenza Vaccine.   It was reported that goes on and on, and on. It's happening everywhere, and is not normal. 31 years old collapses on the field.  Action taken : not applicable.  Corrective treatment : No corrective treatment reported for the event.  Event Outcome : Unknown for the event collapses on the field.  Seriousness criteria : This event(Loss of consciousness) was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 06-Feb-2022:This case involves a 31 years old and unknown gender patient who collapses on the field while receiving vaccine Influenza Vaccine. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses, and concomitant medications. The role of the vaccine cannot be assessed this.
Initial report received from a health care professional on 03 November 2010. A 4-year-old child, with no medical history or concomitant medications, received on 29 September 2010 an injection (route and site not reported) of DAPTACEL, lot number C3142AA, an injection (route and site not reported) of TUBERSOL 5 TU, lot number C3586AA, and an injection (route and site not reported) of MMR II, Merck lot number MSD05322. The patient developed behavior changes on an unknown date after the vaccines in 2010. The patient's mother reported that the child became difficult in the morning, clings and cries at school and also now was afraid of the wind. The symptoms were reported first to the health care provider on 01 November 2010. The outcome was reported as not recovered. Follow-up information was received from the health care professional on 10 January 2011. The DAPTACEL was given intramuscularly in the left deltoid, the TUBERSOL 5TU intradermally in the left forearm, and the MMR II subcutaneously in the left upper arm. The patient had not received any other vaccines within 4 weeks of 29 September 2010, and had not previously experienced any adverse events following vaccination. His birth weight was 7 pounds 2 ounces, and he had 2 siblings (1 brother and 1 sister); neither sibling had ever experienced adverse events following vaccination. He was seen by his physician on 05 November 2010, and underwent a strep culture which was normal. On 08 November 2010 the patient underwent the following testing, all of which was within normal limits: Epstein Barr Virus, Lyme serology, complete metabolic panel, CBC with differential, mono serology, and A1C. He had also undergone Thyroid testing (free T4, TSH, and total T4); results were not yet available. The patient had not received any treatment for the event. The reporter noted that, per the patient's mother, the patient was "better re: anxiety", and was "a little less tired". Documents held by sender: None.
headache; feeling very sleepy; tired; sinus problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 13Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: since she was a child. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; SOMNOLENCE (non-serious) with onset 2021, outcome "unknown", described as "feeling very sleepy"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tired"; SINUS DISORDER (non-serious) with onset 2021, outcome "unknown", described as "sinus problems".  Additional information: The patient received her first dose of the Pfizer vaccine this past Saturday, 13Mar2021 along with her husband. She mentioned that she has been feeling very sleepy, really tired, and sinus problems where she would tend to get a headache. She mentioned that she's had allergies since she was a child and it was no issue for her. She is asking if these side effects may last 5-6 days after receiving the 1st dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Face became red with hives and swollen., sweating and clammy, chest tight and tachycardia. Went to emergency room. Given Benadryl. Occurred about 8 hours after vaccine
Case number PHEH2012US015399 is an initial spontaneous report received from a nurse on 2 Aug 2012. This report refers to a 12-years-old male patient. He was given only the MenA powder component of MENVEO vaccine (batch number: unknown) intramuscularly, which was reconstituted with a wrong diluent that came from MMRV vaccines (manufacturer and batch number: unknown) on 30 Jul 2012. Within 24 hours after vaccination he experienced redness and swelling at injection site. The final outcome of the events was reported as not yet recovered at the time of reporting.
Individual fully vaccinated with COVID19 Pfizer vaccines and tested positive for  SARS-CoV-2 on 04/08/21
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 27-FEB-2019, the patient was vaccinated with M-M-R II lot # N014482 (albumin status: RHa), expiration date 10-MAY-2019 and VARIVAX lot# N026072, expiration date 20-SEP-2019; both vaccines via intramuscular route for prophylaxis. In addition, both vaccines were reconstitute with sterile diluent. No adverse effects were reported.
Information has been received from a licensed practical nurse concerning a 21 year old female with no pertinent medical history or drug reactions/allergies who on 02-NOV-2007 was vaccinated with a first dose of GARDASIL (lot# 659435/1265U) 0.5 mL IM in the left arm.  The patient did not experience any problems after the first dose.  There was no concomitant medication.  On 04-JAN-2008 the patient was vaccinated with a second dose of GARDASIL (lot# 659435/1265U) 0.5 mL IM in the right arm.  On 18-JAN-2008 the patient experienced an outbreak of venereal warts.  Medical attention was sought.  The patient used (imiquimod) ALDARA cream which cleared up the venereal warts.  On 07-FEB-2008 the patient recovered from venereal warts.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/14/2008. Initial and follow-up information has been received from a licensed practical nurse concerning a 21 year old white female with no pertinent medical history or drug reactions/allergies who on 02-NOV-2007 was vaccinated with a first dose of GARDASIL (lot# 659435/1265U) 0.5 mL IM in the left deltoid. The patient did not experience any problems after the first dose. There was no concomitant medication. On 04-JAN-2008 the patient was vaccinated with a second dose of GARDASIL (lot# 659435/1265U) 0.5 mL IM in the right deltoid. On 18-JAN-2008 the patient experienced an outbreak of perinal warts. The patient complained of "bumps" in the vaginal area. The diagnosis was perianal warts by the physician. The patient used ALDARA cream which cleared up the perianal warts. On 07-FEB-2008 the patient recovered from perianal warts. Additional information iss not expected.
Full body-Burning, stinging pain (Small Fiber Neuropathy) Heart palpitations  Auditory hallucinations  Fainting  POTS
Moderna COVID-19 Vaccine EUA: patient hospitalized for recurrent falls and hypoxia. Received oxygen, physical and occupational therapy, medications adjusted,  and patient discharged to home medically stable.
Severe aversion to all foods in terms of taste,  texture, and smells. I would throw up, experience severe nausea, or be unable to taste pretty much any food for about a week.   To combat this,  I drank water and had meal replacement smoothies/ drinks when I could stand them.
pt recv vax 15MAR99 4PM & pt presented 24hr later to ER w/site redness, swelling (12cm), pain, fever 102.5 & cellulitis;sx presented approx 12-18hr post vax;inj site erythema, >5cm or SC nodules or pruritus @ site, fever 101 w/in 24hr;
1st dose of vax 28AUG90 3 days post inject developed arthritic sx; on 8SEP or 9 SEP90 noted a fever 100; describes as "feeling flu-like & achy". Also felt very tired, chest tightness (hard to breathe-recovery 2SEP90); Sinus headache
Post vax, the pt experienced a swollen arm, fever, and was generally ill. The pt sought unspecified medical attention.
Patient started vomiting every 15 minutes for 24 hours. She lost control of her bowels for a few hours. She became disoriented for three days and was close to having an adrenal crisis and required extra steroids
This initial spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. The reporter stated that on multiple unspecified dates ranging from 30-SEP-2015 through 13-OCT-2015, the patients received improperly stored doses of RECOMBIVAX HB injection (lot # K021444 with expiration date 17-SEP-2016, lot# L004754 with expiration date 10-NOV-2016 and lot# L014418 with expiration date 13-APR-2017; dose, frequency and route were not provided). No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Headache and raised, swollen, itchy red area at injection site about 3.5 by 4 inches.
Chest pain. Began 8 hours after administration of vaccine at 11pm. Next day no issues until I tried to eat around 4:30pm. Chest pain came in waves like something was stuck way down in my throat in my chest. Swallowing while Drinking or eating was difficult because of the pain
my entire body was numb and tingling; my entire body was numb and tingling; legs felt heavy and twice their size; legs felt heavy and twice their size; left side of my face went numb; my arms went numb;   Report about Covid vaccine: Yes Reporting type: AE Reporter type: Patient Patient occupation: None of the above If other vaccine in four weeks: No  Other medications in two weeks: metoprolol tartrate BID  Adverse event: 10 minutes after the shot I got up to leave and my entire body was numb and tingling and continued until the next day. Twice overnight got up and legs felt heavy and twice their size. 2 days later the left side of my face went numb which lasted 7 or 8 days then areas of the left side of face went numb for about 2 more weeks and sometimes my arms went numb. I was the last person to get the shot at name withheld that night and the pharmacy dept. was closed when I felt the numbness and tingling so there was no one to report the side effect to.  If treatment ae: No if Covid prior vaccination: No if Covid tested post vaccination: No
Information has been received from medical assistant concerning a 7 year old patient who "about one month ago" in April 2008, was vaccinated with the second dose of VARIVAX (Merck) (lot #660057/1806U) in the office from a state varicella catch up registry. Subsequently the patient developed injection site reaction. The reaction was charactered by redness, swelling, erythema, and hardness at the injection site. The reaction was the size of a baseball. The patient recovered. This is one of several reports from the same source. Additional information has been requested.
Large local reaction: Erythema and mild induration measuring 10cm x 7cm distal to the injection site. No warmth, tenderness. Moving extremity well. Weight-bearing, walking normally. Was here yesterday for her WCC, had her DTaP vaccine. This morning noticed a pink swollen area around where she had the shot. Seems to be firm and slightly bigger this afternoon. Doesn't seem to bother her otherwise. Was seen 7/8 for 18mo WCC. Received DTaP in (L) thigh. Returned the following day w/ a large erythematous wheal at the injection site. It was not felt to be infected. They have been giving patient BENADRYL q 6 hrs while awake. The area of erythema has gotten larger. It does not seem to bother patient at all. She is still moving the (L) leg without difficulty and walking fine. She has not been grabbing or itching the site. Has not been more irritable, no fever. Perhaps a little sleepy from the BENADRYL.
Patient Fainted 2-3 minutes after receiving vaccine while in observation waiting area. Blood pressure was really low at 84/50. We monitored patient for 20 minutes more, had her put feet up, cool pack on chest, gave a cool water to drink, and checked BP 3 times. Patient was fine after initial fainting. She was walked to her vehicle and did get home safely
The vaccine was injected on my left arm. In the afternoon, I began feeling pain on the left side of my back side of my body from my neck to my lower back. It was painful and uncomfortable to move my arm and move my neck and back.
Subsequently post vax, the pt developed an injection site reaction characterized by redness and swelling. The redness and swelling improved within 4 to 5 days with local treatment.
Pt had throat tightness about 5 mins after administration. She was closely monitored and given water and two tabs 25 mg diphenhydramine HCl. The pt was responsive but her throat was feeling tight. Continued to monitor. After about twenty minutes, patient was having difficulty speaking and was pointing to her throat. 0.30 mg of epinephrine was given to the patient. Pt appeared to do better after this and EMS was called. The pt was assessed by EMS and taken to hospital for further monitoring.