chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician, via company representatives and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On 18-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016, (dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported and no product quality complaint was involved. On unspecified date, the vaccine experienced a temperature excursion of 47 F (8.333333333 Celsius) for 40 hours (highest recorded temperature). The vaccine status was reported and "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)".  This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a vaccine coordinator via a company representative concerning a 1 year old patient of unknown gender. The patient's concurrent conditions, medical history, historical drugs and concomitant medication were not reported. On an unspecified date in June 2016 (reported as "four months ago"), the patient was vaccinated with ZOSTAVAX (lot number, expiration date, dose, strength and route of administration were not reported) instead VARIVAX (lot number, expiration date, dose, strength and route of administration were not reported) (wrong drug administered). It was reported that the patient seemed fine. A product quality complaint was not involved. Additional information has been requested.
This spontaneous report was received from a physician assistant refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients received doses of ROTATEQ orally, that were improperly stored (strength, lot number, expiration date and dose # were not reported). There was no concomitant medication reported. No adverse experiences were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Tingling throughout body but mostly in my head, sharp shooting pains in the back of my head, ears and abdomen, general full body aches, headache - all began within hours of the vaccine and are continuing more than 24 hours later
pain at site of injection; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) (batch number Y7JL5, expiry date unknown) for prophylaxis.   On 1st October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 2nd October 2020, 1 days after receiving Shingrix, the patient experienced injection site pain. On 9th November 2020, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix in the left deltoid. The reporter stated that, a day after vaccination, the patient had pain at site of injection. The pain was described as significant but not high by reporter. The reporter consented to follow up.
As per mother's history, patient had 102.1 temperature at home on 12/20/2004, not relieved by Tylenol.  Seen at the ER with temperature of 103.4, was diagnosed as viral infection not related to vaccines.  Fever decreased with Motrin.
Pt. has pain on her left arm (injection site). It is most likely mild pain but worse upon waking up and has a hard time moving it up. It is improving slowly since it started. Pt. is doing hot compress few times a day and taking TYLENOL if needed.
The vaccine was expired when given.  The vaccine expired on 4/15/22, and was given on 4/21/22. The patient did not have any symptoms or side effects from the vaccine and parent was notified that the vaccine was past expiration when given.
nausea; headache; fever; chills; injection site pain; This is a spontaneous report from a non-contactable male consumer (patient) reported for himself that male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller had the dose 1 of the Pfizer covid vaccine on an unspecified date, quite a few symptoms, what he heard that they normally didn't get them until after the second dose. He had nausea, headache, fever, chills, injection site pain. The patient asked what it would be like, the second dose for him. The side effects were gone at the time of report. Everybody he talk to the first shot was not bad, the second shot was supposed to be worse, he thought wow, what was the second one going to be like, or what. He had that nausea which was bad, he tried to figure it out, he never threw up, felt like it but didn't. Might be he would have felt better if he did threw up. He did not report to safety department. If he had more time, he had been on hold for 45 minutes, and he did not have any more time. Caller also refused to provide any more demographic information for this agent to report on his behalf. Caller stated that might be he should just wait to report after the second dose and see what happens. The outcome of events was unknown.   No follow-up attempts are needed. No further information is expected.
I?m not sure of exact date but shortly after last booster . I wasn?t feeling right and my handwriting was bad .I kept thinking it would get better. I lived with it for awhile until my family noticed I wasn?t getting better . I didn?t want to deal with it during the holidays so waited until Jan 2023. My life has completely changed . I was going to be a traveling surgical tech in July and now I?m not even going to be a tech any more I?m moving near family as soon. I need help  with life things .I was so independent and now I?m not
dizziness, started a few hours after the injection. lasted 5 days (6/5/2023). able to walk, but feels wabbly. no n/v.
Pt stopped by the pharmacy on 10/26 to complain about his right arm hurting and saying that he couldn't lift his arm.  However, when he was telling me that, he was raising his arm up and down.  He never notified us (the pharmacy) that his arm was hurting.  I had counseled him that his arm would may feel sore or hurt for a few days.  His shot was given per protocol mid deltoid region at a 90 degree angle.
Patient came to pharmacy with well defined, large, red rash on her upper arm. Went from her shoulder to her elbow, non-scaly. mildly painful but mainly itchy. not warm to touch or raised. roughly 7 inches long
injection site reaction; This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was recovered/resolved.   It was unknown if the reporter considered the injection site reaction to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's husband. The age at vaccination was not reported. The patient experienced injection site reaction for 2 to 3 days after receiving a dose of Shingrix vaccine.
Caller got her 1st Covid dose on Wednesday and now her granddaughter who lives with her, tested positive/Exposed to COVID after receiving the first dose of the vaccine; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer. A contactable female consumer (patient) reported that a patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on Jan2021 (Batch/Lot Number: EL8982) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller got her 1st Covid dose on Wednesday and now her granddaughter who lives with her, tested positive for Covid. She wants to know what that means for her. Provided Number and cold transferred  for AE due to wait times, since caller may have been exposed to Covid prior to the Vaccine. Fax to  AE Pfizer  Caller says she has a question. She received the COVID vaccination on Wednesday. Her 6-year-old granddaughter tested positive for COVID. She probably could have been exposed. Will the vaccine still work. Caller confirms she only had the first dose of the vaccine. Before she can return to work, she will have to take a COVID test as she was exposed. The vaccine, because it does not carry a live virus, she will not test positive for the test, right? It will not give a positive result. The outcome of the event was unknown.
Rt thigh w/15 cm warm & w/rash around the rim which is a SC area; Pt has no pain or discomfort but there is warmth in the region; In the middle is a puncture wound; Pt also has to a lesser amt mild SC macular rash on the lt leg;
11/18/02 gave alternating motrin and tylenol, temp normal to 99F, 11/19/02 temp 101F to 103F (axilla) broke out in rash - tiny red raised dots started on torso (not itchy). 11/20/02 rash worse - evening most of body - fever 100F called ER & states nurse said to give benadryl. 11/21/02 rash improving, fever 100F - saw Dr on 11/21/02 (can't remember name of MD and was told to continue benadryl, tylenol & motrin 11/24/02 rash and fever resolved.
After 2 hours swelling around entire left eye.  Called doctor who said to go to ER.  At ER continued to swell.  Gave Benadryl which helped.  Took Benadryl for 2 days.
Right sided Bells' palsy - eye lid weakness, right eyebrow/forehead weakness, right cheek weakness.  Tx: acyclovir, prednisone, lacrilube.  Follow up 5-7 days.
first, 2 days arm soreness, the 4th 5th 6th continued, nausea throwing up, chills, chest and body pain when coughing, headache, light shortness of breath.
No adverse reaction from vaccine, however there was an error with the timing of the 2nd dose. Patient received 2nd vaccine, 14 days after received 1st vaccine. 1st dose date 2/11/22, 2nd dose date 2/25/22. Patient stayed in observation for 20 minutes and did not have any adverse reactions.
Fever (100.8 F)  days, Malaise  days, joint pain  2 days, tiredness, migraine intense  persistent.
Pain in jaw, head, neck, shoulders, and lower back. Started May 30. Not an injury from trauma. Not from overexertion. Back and shoulder pain subsided about about 5 days, but neck pain and headache continued through Tuesday, June 8. Treated with Ibuprofen and Tylenol with little effect. Went to the emergency room on June 2 at the advice of a physician. No apparent cause. I was given a strong anti-inflammatory that eased the pain slightly. The pain was about 5-6/10 for the duration of the event. Relief only came with a full-body massage from a licensed massage therapist. Still suffering from some jaw pain and minor headache.
Pt recv vax on 2/5/99; on 2/6/99 pt exp vax site red, swollen, pain; then redness spread w/ center gray color & pt refusing to walk
Day 8 had very itchy rash just below injection site. Very warm, red, swollen and tender when touched. Around 5 inches long and 3 inches wide
his daughter receiving her 2nd dose of BEXSERO only 20 days after the first dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a adolescent female patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO).   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: his daughter receiving her 2nd dose of BEXSERO only 20 days after the first dose).The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-AUG-2023 and 31-AUG-2023 The patient's father was the caller asking if there would be a negative outcome due to his daughter receiving her 2nd dose of Bexsero only 20 days after the first dose. The reporter referred him to his healthcare professional and provided the telephone number for medical Information department for his doctor.  The patient received 2nd dose of Bexsero earlier than the recommend schedule, which led to shortening of vaccination schedule.
pneumonia; This spontaneous report was received from a lawyer referring to a 66-year-old female patient. Drug reactions/allergies and concomitant medication were not reported.  In June 2011, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported).        On an unknown date, 3 days after vaccination, the patient experienced pneumonia.    The outcome of pneumonia was unknown.   The reporter considered pneumonia to be a side effect of vaccination.  Upon internal review, pneumonia was considered a medically significant event.   Subsequently the patient was vaccinated with zoster vaccine live(ZOSTAVAX) and experienced shingles, ophthalmic herpes zoster, hearing loss, severe ringing in ears, right hand tremors, panic attacks, bad eyesight, severe loss of vision, anxiety, depression and adjustment disorder (captured in MARRS 2003USA007338).; Sender's Comments:  US-009507513-2003USA007338:
about 3 days after receiving the vaccination for covid, I developed a rash under my right arm pit  I bought Lotrimin lotion and spray and treated myself for 10 days. I also have swollen Lymph nodes under left chin between my jaw and my ear.
A couple of weeks after the vaccine I found a lump in my neck.  It was near my collar bone in the pocket. The lump was the size  of my finger tip. It was not very painful but it made me nervous.  I went to the doctor and he told me it was a swollen Lymph node. It went down after two or three days. I got the second dose of the vaccine and my arm became a little irritated a few days after the shot.
5 month old presented to urgent visit center with mass in left anterior thigh. Received Pediarix, Pedvax, Prevnar on 4/22/04.
-FEVER 101, BODY ACHE, HEADACH, FATIGUE, RUNNY NOSE , - Began within 6 hours Naprosyn helped, Tylenol did not. TXT symptomatically with Pepcid, Claritin, tylenol, Naprosyn
Slight swelling and intense itching.  Arm warm to the touch.  It happened after the first dose one week after receiving vaccine.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 40-year-old male. Neither medical history nor concomitant medications were reported. On 05-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there were no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers no discarding product from previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.
Metal taste in mouth, severely swollen lymph nodes in L armpit, nausea,  and severe testicular pain/sensitivity. Unable to walk or sit without discomfort. Events lasted 2 days.
DEATH Narrative:  Patient died after COVID vaccine dose #1. 01/14 COVID vaccine dose #1 04/13 pt died Patient with advanced ALS, progressive respiratory difficulty and passed away while on hospice. Vaccine did not likely contribute to the patient's death, but was due to advanced ALS. Patient was not hospitalized prior to vaccine or immediately after vaccine. No adverse event following vaccine. No previous COVID diagnosis known.
Case number PHEH2014US023269, is an initial spontaneous report from a physician received on 18 Nov 2014 with a follow up information received from a physician on 13 Jan 2015. This report refers to an 11-year-old male patient. His current conditions included morbid obesity, allergic rhinitis and multiple food allergies. His concomitant medications were not reported. His vaccination status was up to date. The patient received an initial 0.5 ml intramuscular dose of MENVEO (batch number: A13012/X13012) on 03 Nov 2014 at 9:53 am. His concomitant vaccination included a booster dose of BOOSTRIX (other manufacturer, batch number: N4277) at a dose of 0.5 ml intramuscularly on the same date. It was reported that the patient received Men A lyophilized powder component which was expired in Sep 2014. No adverse event was reported following this medication error. Follow up information received from a physician on 13 Jan 2015: Updated patient demographics (height and weight), vaccination status, current conditions and concomitant vaccination.
tested positive for Covid Illness; This is a spontaneous report received from a contactable consumer (on behalf of her boss) via a Pfizer sponsored program and also via Medical Information Team. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Lot number and expiration date was not reported), via an unspecified route of administration on 26Mar2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that, the patient did not feel well on 28Mar2021, and then tested positive for Covid Illness on 31Mar2021. The reporter also stated that the patient was still feeling tired, not 100%. The outcome of the event was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Headachy. Feel very soundly asleep for 3 hrs on day of shot. Same thing next day. Woozy head most of the day. Considered not drivinv.
Heart beat 160.  Chills.  Fever of 102.9. Bad headache.
Headache; Fatigue; Nausea; Metallic taste; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient reporting for himself.  A 17 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30May2021 16:00 (Lot number: EW0177) at the age of 17 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies Tree nuts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 30May2021 20:00, outcome "not recovered", described as "Headache"; FATIGUE (non-serious) with onset 30May2021 20:00, outcome "not recovered", described as "Fatigue"; NAUSEA (non-serious) with onset 30May2021 20:00, outcome "not recovered", described as "Nausea"; DYSGEUSIA (non-serious) with onset 30May2021 20:00, outcome "not recovered", described as "Metallic taste". Therapeutic measures were not taken as a result of headache, fatigue, nausea, dysgeusia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medical history was none. Adverse events resulted in none of the above. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination.  Follow-up attempts are completed. No further information is expected.
2 days post vaccine, had firmness, redness at injection site (R arm), progressed within a day to same only covering area from shoulder to just above elbow. no systemic signs of illness. area is painful and itchy. treating symptomatically with benadryl and motrin. will follow.
Client received the vaccine at 4:30 pm. Client to be observed for 15 mins after. Client stated she felt fine around 5-10 mins after vaccine. At 4:45 pm client was going to be released but stated she felt some vertigo and felt like "the words on the picture are blurry". Client's BP 168/110 and P 112 at that time. Client encouraged to drink some water, take deep slow breaths and talked about. 15 mins later her BP was 140/84 and P 104 and client stated she felt a little better. Client got up to use the restroom at that time. Client denied any history of high blood pressure but did state her "normal resting heart rate" is higher than most people. BP taken again approximately 15 mins later and 156/100 and P 104. Client stated she felt better but "my heart still feels like it is racing" Denied any shortness of breath, feeling of throat swelling, or itching. Client did state her "chest felt a little tight" but stated "I am fine". Advised client to be evaluated at ER. Client went to ER.
Mother of child reports child woke this morning with a few small hives on his chest. At 1301 she called the Health Department stating school called to report child now has hives on his face, arms, back, and chest. Denies any other symptoms. Advised to monitor and have child evaluated with new or worsening symptoms. Mother spoke with primary care team who advised her to monitor and bring child in if symptoms worsened.
It was reported that the guest felt nauseous and lightheaded and lost consciousness. EMS was called. She was responsive to sternal rub. She was laid down and her symptoms improved. She did, however, continue to complain of nausea and some stomach pain.  EMS took vital signs, The BP was unable to be obtained manually. A doppler systolic was obtained. It did slowly improve. She then was able to get up to a sitting position and denied abdominal pain and nausea. BP continued to improve. Able to stand without feeling lightheaded and BP continued to remain stable. Guest was observed for a total of 35 minutes.
45 minutes after injection my forearm of the injection arm became bright red, 5:30 pm: Small hives on my neck line formed and lasted for 3 hours. At roughly 7:30 pm I became itchy all over. Taking an antihistamine solved these problems. I was fine the next day. No irritation or reaction around the injection site.
Patient had generalized weakness event, similar to MS exacerbation.  It lasted approximately 24 hours, rapid recovery after overnight admission to the hospital.
Initial soreness at injection site in right arm, which largely faded within four hours of vaccination;  Ongoing as of this writing since 11:30 a.m. on 03/30/2021: mild stomach nausea (started at 11:30 a.m. and still going at 02:00 p.m.; vague chest pain (feels mild and seems like what I would expect from anxiety or drinking too much caffeine--of which I have not consumed), which started at about 01:15 p.m. and still going at 02:00 p.m.; a brief headache that lasted about 20 minutes from 01:00-01:20 p.m.; and a few times I had trouble mentally and visually focusing on my work (I do not mean my vision was blurry, just that I felt somewhat distracted). No treatment sought at this time.
One day after shot started to experience light cramping. Cramping continued, then had slight break through bleeding start on 5/10 and 5/11. On 5/12 menstrual  cycle began while on birth control-not supposed to have started for another week. Bleeding is intense and cramping pain increased. This also happened after the first dose but I didn't think too much of it at the time. It's happened again after 2nd dose.