chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe pain in left arm; congestion; severe migraine; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Apr2021 at 10:00 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient had unspecified medical history. The patient had no allergies to medications, food, or other products. The patient received unspecified medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Mar2021 at 09:15 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 17:00, the patient experienced severe pain in left arm, congestion and severe migraine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events severe pain in left arm, congestion and severe migraine were resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Redness at injection site with ecchymosis. Greater than 120mm following the right deltoid throughout. Neg lymphadenopathy or seq.
Information was received on 09-JUL-2018 from a lawyer regarding a case in litigation. A female patient, age unspecified, was inoculated with ZOSTAVAX on 11-MAR-2008 at a pharmacy as recommended for routine adult health maintenance for prevention of shingles. It did not prevent shingles as intended and subsequently the patient contracted a persistent strain of herpes zoster. In 2010 the patient was treated at a hospital for a blistering vesicular outbreak which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, 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, pain, suffering and other damages. Additional information has been requested.
The today (day 3) my lymph nodes, under arms, are swollen.; The next day (day 2) I experienced chills and body aches throughout the day; The next day (day 2) I experienced chills and body aches throughout the day; became suddenly tired in the afternoon; first dose was on 22Dec2020 while second dose on 22Jan2021; sore arm within a few hours of getting the shot; This is a spontaneous report from a non-contactable healthcare professional (patient). A 41-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as Covid-19 vaccine; lot number: EL 3249; expiration date: unknown), intramuscular left arm on 22Jan2021 15:30 at a single dose for covid-19 immunization. Medical history included allergy to mango and passion fruit and covid prior vaccination. The patient's concomitant medications were not reported. The patient did not have other vaccine in four weeks. The patient received her first dose of bnt162b2 (BNT162B2 reported as Covid-19 vaccine; lot number: EH 9899) at the age of 41-year-old intramuscular right arm on 22Dec2020 15:30 at a single dose for covid-19 immunization. The patient reported that on her second dose, she had sore arm within a few hours (22Jan2021) of getting the shot. The next day (day 2 [23Jan2021 11:45 AM]), she experienced chills and body aches throughout the day and became suddenly tired in the afternoon. The today [25Jan2021] (also reported as day 3 [24Jan2021]) her lymph nodes under her arms are swollen. As of now (Jan2021), she has no chills, body aches are not as bad, and her left arm isn't as sore, but her lymph nodes are still swollen. It was reported that the treatment was unknown. The patient has not been covid tested post vaccination. The outcome of the event shills was recovered in Jan2021, for the event swollen lymph nodes was not recovered, as for the events pain in arm and ache were recovering, while the outcome of the other events was unknown.
Pt had abdominal cramping, diarrhea, and vomiting following vaccination. Responded appropriately to questions throughout episode, no difficulty breathing reported , and pulse regular, Pt refused ambulance, called pt mother to take to ER. ER MD prescribed Bentyl & Ondansetron with rest and hydration.
Sever ringing in the ears. The ringing remains severe and at this point I feel that I have hearing loss. I cannot hear conversations in noisy     environments.
Received Tdap (R) deltoid right after shot felt tingling down area. 1-2 hrs later started to c/o pain (R) palm & numbness let forearm & 5th finger. Ultimately had some weakness. Improving when examined on 11/12/12.
Client was given MCV 4 1-17-07 and was given a dose 6-6-07 of MCV4
This case was reported by a physician via a sales representative and described the occurrence of cellulitis in a 8 year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included unspecified vaccines (multiple other childhood vaccines - manufacturer unspecified) given on the same date as INFANRIX. On an unspecified date the subject received unspecified dose of INFANRIX at 0.5 ml in an unknown thigh. Within a couple of days of vaccination with INFANRIX, the subject experienced cellulitis. Signs included injection site redness, hot (injection site hot to touch) and swelling. The physician considered the events were clinically significant (or requiring intervention). The subject was treated with KEFLEX. The subject resolved on therapy. Product complaint was noted. The site claimed good aseptic technique was followed and there was no change in the appearance of the vaccine administered. It was reported that cellulitis was probably related to treatment with INFANRIX. A note was made that other childhood vaccines were given at the same time, but infections have occurred only at either INFANRIX or KINRIX injection sites or that leg affected. Four subjects received INFANRIX from lot number AC14B126AA with expiration date 03 March 2013 and one subject each received KINDRIX from lot number AC20B168AA with expiration date 02 December 2012 and lot number AC20B164BA with expiration 13 October 2012 (six subjects affected in total ranging in age from 15 months to 8 years). Additionally, no other subjects have received these vaccines from these lots and "not" had cellulitis with the exception of three subjects the site is still trying to locate.
Pfizer 11/2/21, 11/29/21. Positive on 1/27/23
There are no adverse events, no treatment or outcome to report. It was an expired vaccine, and the Health Dept was contacted for guidance, as well as the company - Pfizer. Both recommending re vaccination.
left arm was sore/throbbing pain in her left arm; left arm was sore/throbbing pain in her left arm; tendinitis/tendonitis/it was in the shoulder area around the injection site and she has been scratching and then it went down her whole arm to her finger and it felt weird; shoulder area around the injection site and she has been scratching and then it went down her whole arm to her finger and it felt weird; tendinitis/tendonitis/it was in the shoulder area around the injection site and she has been scratching and then it went down her whole arm to her finger and it felt weird; shoulder area around the injection site and she has been scratching and then it went down her whole arm to her finger and it felt weird; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EW0202), via an unspecified route of administration administered in left arm on 09Aug2021 (21-year-old at the time of vaccination) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced her left arm was sore, throbbing pain in her left arm, tendinitis. The patient reported that she had her first dose of the Pfizer-BioNtech Covid-19 vaccine on 09Aug2021 in her left arm and her left arm was sore and that went away. Now the patient has throbbing pain in her left arm and her coach said it is tendinitis but she said she has not been in the weight room for a minute. The patient stated it was in the shoulder area around the injection site and she has been scratching and then it went down her whole arm to her finger and it felt weird. The patient stated now it is not hurting but yesterday it was going strong. The reporter stated she just had a question, she got the vaccine, the first dose, then her arm was sore, it went away, but now its like a throbbing pain in her arm, her coach said its just tendonitis but she doesn't really know. The patient wanted to know if this was normal and if it will go away and if it is safe to get the second dose after this. The patient stated that she got the first dose, she has not gotten the second one yet because she is scared to get it. The patient thinks she is 8 days past, something like that. The patient confirmed the throbbing pain is in her left arm, stated that is the arm she got the vaccine in. The reporter stated on social media it is going around that after the vaccine people are forming blood clots and it is compromising immune systems so there is information stating that everyone is going to die in two years. The reporter stated that she heard on social media that everyone who gets the vaccine is going to die in two years and she did not know if this was true. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
After dinner time, about 6pm signs started showing: shallow breathing; Fast heartbeat; Weakness; Strong pain in arm; Strong pain in wrist; Strong pain in neck; Face and neck felt puffy; Feeling unwell; Tired; Joint pain; Awoke a few times at night with strong nausea; This is a spontaneous report received from a contactable consumer, the patient. A 40-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 21Apr2021 at 10:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included herpes (herpes virus infection) for which patient took valtrex occasionally. The patient had no known allergies to medications, food or other products.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included valaciclovir hydrochloride (VALTREX) for herpes from unknown date and unknown if ongoing. On 21Apr2021 at 18:00, after dinner time, the patient experienced shallow breathing, fast heartbeat, weakness, strong pain in arm, wrist and neck, face and neck felt puffy, feeling unwell, tired, joint pain and awoke a few times at night with strong nausea. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were taken as a result of events strong pain in arm, wrist and neck, face and neck and joint pain which included treatment with paracetamol (TYLENOL) which helped with the pain. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events shallow breathing, fast heartbeat, weakness, strong pain in arm, wrist and neck, face and neck felt puffy, feeling unwell, tired, joint pain and awoke a few times at night with strong nausea was resolved on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.
Patient looked like they were having a seizure and collapsed.  Patient was unconscious for about 3-4 minutes.   Called 911, paramedics arrived in about 5-10 minutes assessed patient and transported patient to the emergency room.
ischemic stroke with diagnoses of antiphospholipid syndrome. Patient is a healthy 20 year old, college student and athlete.  She was having a hard time saying words.  She could see them in her mind but couldn't come up with the word.  She also had an extreme headache at the time as well.  This went on and off for 2 days before we took her in because who would think a 20 year old college athlete would be having a stroke?  After running a CT scan and MRI it showed. She had an ischemic stroke and now has been diagnosed with Antiphospholipid syndrome, hospitalized one day but #21 won't let me mark that. Was in hospital.
Suddent large swelling in ankle joints, pain in joints. Now knees are get swelled up too.  Sensation of burning in the site of swelling.
Significant swelling noted to left arm at injection site. Hot to touch and red. Skin slightly discolored to center of reddened area. Very painful and pruritic. Saw MD no treatment, Benadryl given.
Employee received Moderna fist dose 8/18/21, Moderna second dose 9/25/21 and a Pfizer third dose/booster on 1/11/22. There have been no adverse events or outcomes.
increasing pain at injection site; This is a spontaneous report from a contactable consumer. This consumer (mother) reported for a 16-year-old female patient (daughter) that: A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number and Expiry Date was not reported) via an unspecified route of administration, administered in Arm Left on 07May2021 15:45 (at the age of 16-year-old) as second dose, single dose for covid-19 immunization. The patient Medical history included coeliac disease from 2007 and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number and Expiry Date was not reported) via an unspecified route of administration, administered in Arm Left on 16Apr2021 as single for covid-19 immunisation. On 07May2021 the patient had increasing pain at injection site a month later, started day of vaccine. It was reported that, she put ice on it and she took some Advil. The outcome of the event was not recovered.  Information regarding the lot/batch number has been requested.
This spontaneous report was received from a registered nurse refers to an unknown number of patients with unknown demographics. On unspecified dates, beginning in July 2016, the patients were vaccinated with improperly stored ROTATEQ lot # M039061, expiration date: 28-APR-2018, oral for prophylaxis. No symptoms reported. It was confirmed that no doses were administered past the expiration date. The ROTATEQ was exposed to temperature of 29F for time frame of 5292.5 hours. There was no previous temperature excursion involved. No data logger. No product quality complaint. No further information provided. There was consent to follow up. Sender's Comments: US-009507513-1707USA011869.
Received Menveo rather than Bexsero; Received a third dose of Menveo; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA766A, expiry date 1st December 2023) for prophylaxis.   Previously administered products included Menveo (received 1st dose in 2017) and Menveo (received 2nd dose in August 2022).   On 26th October 2022, the patient received the 3rd dose of Menveo. On 26th October 2022, unknown after receiving Menveo, the patient experienced wrong vaccine administered and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered and extra dose administered were unknown.   Additional Information: GSK receipt date: 27-Oct-2022 Reporter's comment: Nothing else was reported. The vaccine administration was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient mistakenly received third dose of Menveo rather than the intended Boostrix, which led to wrong vaccine administered and extra dose administered.
Redness, swelling and lump at the site of shot on left arm, swelling spreading from shoulder to elbow of left arm a/w pain only
Heart inflammation; Heart swelling; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CARDITIS (Heart inflammation) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CARDITIS (Heart inflammation) (seriousness criterion medically significant) and CARDIOMEGALY (Heart swelling). At the time of the report, CARDITIS (Heart inflammation) and CARDIOMEGALY (Heart swelling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information provided.  Very limited information regarding these events has been provided at this time and a causal relationship cannot be excluded   Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time and a causal relationship cannot be excluded
Patient stated pain started Monday evening, October 5th, and she took Tylenol. Swelling started Tuesday, October 6th, she called pharmacy and was suggested to take Diphenhydramine by R.Ph and see physician if worsens. Patient went to see ARNP on October 7th. She was given a steroid injection and received a prescription for diphenhydramine 25mg po tid for 7 days.
Rash on Right and left thighs. Treated with BENADRYL 12.5 mg 1 tsp p.o 3 x daily.
Pt received one dose of Flulaval which is indicated for adult use only.  Pt received injection in left deltoid and per Mom had no reaction.
No additional adverse event; VARIAX was inadvertently administered after being improperly stored and expired.; VARIAX was inadvertently administered after being improperly stored and expired.; This spontaneous report has been received from a pharmacist referring a patient of unknown age and gender. The patient's concomitant medications included sterile diluent. Concurrent conditions and medical history and were not reported.  On 19-OCT-2022, the patient was vaccinated with an expired and improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot number T002843 with expiration date 23-JAN-2022, administered for prophylaxis (strength, specific dosage, vaccination scheme, route of administration and anatomical site of application were not provided) (product storage error and expired product administered).   The vaccine administered experienced a temperature excursion of 5 celsius (C), for 336 hours. There was no previous temperature excursion. No additional adverse event reported.
Tinnitus in right ear.  Ringing/buzzing.  Started in middle of the night and hasn?t eased up at all.
Nightmares; Fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "Fever"; NIGHTMARE (non-serious), outcome "not recovered", described as "Nightmares". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Started with a very runny nose. By Thursday evening he was having severe asthma! It was about 24hrs after that of constant treatment. We were using the nebulizer every 2-3 hrs to keep his breathing under control. Plus the albuterol inhaler in between that and I started his Flomax prescription Thursday as well. Never had a fever but struggled with his breathing through Sat morning. Sat through Monday he had some residual stuffiness and congestion but we were able to stop with the treatments. He only gets asthma when he is sick but never near how bad it was after the Flumist. It was horrible! I called the advice nurse during the night Thursday and she said all you could do was treat the symptoms after the flu vaccine. We almost took him to the ER but the advice nurse just told me to treat the symptoms so I didnt. When the doctor's office opened Friday I called and he said he shouldn't have gotten the Flumist with asthma. He admitted fault but everyone has told me to report the incident to you guys so I am.
A report was received from a consumer on 10/03/2002 concerning a 36 year old male vaccinee who experienced raised patches on arm. abdomen, back and leg one day after receiving Fluvirin on 09/25/2002. The vaccinee had no known drug allergies nor egg allergy and was not taking any concomitant medications. The vaccinee had a past history of tinea versicolor, the vaccinee did not experience any reaction at previous flu vaccine(brand unspecified) administrations. On 09/25/2002 the vaccinee received Fluvirin intramuscularly in his upper arm. The following day the vaccinee experienced some small, non itchy "raised patches" on his arm. By the weekend, he had similar "raised patches" on his abdomen, back, and leg/ The vaccinee was not sure if the reaction was secondary to the Fluvirin, or if his past skin condition was flaring up. The rash he experienced was different than he had experienced due to the tinea versicolor. At the time of reporting the patches on his arm had almost all recovered, but the rash on his abdomen, back and leg were still persisting.
My son is currently admitted in hospital with pericarditis.  He has been sick since 10/22/21 With many symptoms.
Seizure, unresponsive, intubation, admission to Neuro ICU, medications for critical care, AND life support
Prolonged post vax pain, swelling & fever; extent of had swelling, redness & pain quite extreme for DTP; same extensive & prolonged local rxn to same vax in several other pts from same vial;
Parent reported that patient woke up Friday (10/14/11) AM and arm where flu shot given was red, swollen, feverish, blisters and split skin at injection site.