chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via call center representative and described the occurrence of foot pain in a 43-year-old male patient who received TWINRIX adult (batch number 7C4Z3, expiry date 26th May 2016). Co-suspect products included TWINRIX adult (batch number 797K7, expiry date 26th April 2017). Concurrent medical conditions included sciatica (severe sciatica and other problems). Concomitant products included TWINRIX adult. On 27th June 2015, the patient received the 2nd dose of TWINRIX adult (intramuscular). On 9th March 2016, the patient received the 3rd dose of TWINRIX adult. On 11th December 2015, 167 days after receiving TWINRIX adult and not applicable after receiving TWINRIX adult, the patient experienced foot pain (serious criteria other: Serious as per reporter). On 9th March 2016, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the foot pain was not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown. The reporter considered the foot pain to be unlikely to TWINRIX adult. Additional details were provided as follows: The patient was a firefighter. The injection site reported for 1st and 2 doses of TWINRIX adult was left deltoid. The injection site reported for 3rd dose was right deltoid. After vaccination with 2nd dose of TWINRIX adult, the patient experienced pain in the ball of his right foot. The patient had visited his healthcare provider, but not been to emergency room (ER). On 9th March 2016, the patient received 3rd dose of TWINRIX adult, which led to lengthening of the vaccination schedule. The reported batch number (7C423) for 1st and 2nd doses of TWINRIX adult did not exist and was updated to 7C4Z3 as per sales database.
Slight sore arm for two days, fatigue for 4 days, migraine headache for 5 days, extreme chills for 1.5 days, nausea for 4 days, fever 100.4 for 1 day, vaginal bleeding on day 3 for 1.5 days
Patient can not lift arm vaccine was given in. It is not swollen. she can not lay on arm of lift any weight with arm. It feels like it is bruised. Patient felt this way about 3 hours after vaccine given. The next day, followed up with MD for sinus infection. She will follow up later this week.
That evening when I went to bed my arm was so hot and itching was so bad. I finally fell asleep. I woke up a while later and my scalp was itching. Today is 10/20/17 and rash is finally fading, but arm still itches.
Patient was briefly admitted to undergo a cardiac catheterization. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.
Sore arm on 9/22/13. On 9/29/13 developed GI symptoms diarrhea, cough, cold, fever.
HA, fatigue, local swelling, redness warmth tenderness at site (hive like) irregular border.
Tingly mouth and throat 15 minutes after vaccination. Given 50 mg of Benadryl. Symptoms resolved at 40 minutes post vaccination
This spontaneous report was received from a medical assistant refers to unspecified 13 patients of unknown age and gender. This report pertains to the patient who on 10-DEC-2013 was vaccinated with VARIVAX (Merck), (lot # J003540, expiry date 25-MAR-2015) 0.5 milliliter (ml), subcutaneous. The medical assistant reported that improperly stored VARIVAX (Merck) that was exposed to unsupported temperature conditions was administered to an unspecified patient. No adverse effect reported. No further information was available. This case is linked to 1312USA007815, 1312USA009865, 1312USA009866, 1312USA009867, 1312USA009868, 1312USA009869, 1312USA009870, 1312USA009871, 1312USA009872, 1312USA009873, 1312USA009874 (Same reporter link). Additional information has been requested.
Got really sick after getting vaccine; had diarrhea all day long; exhausted; Fever; This is a spontaneous report from a contactable consumer from a Pfizer sponsored program Pfizer First Connect. A 71-years-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number: Unknown), dose 1 via an unspecified route of administration on 28Jan2021 as 1ST DOSE SINGLE for covid-19 immunisation. The patient's medical history included ongoing 2 arteries that are blocked, has post-traumatic stress syndrome, had stroke, only seemed to affect her emotions and nothing physical, was supposed to get blood work done and had infection. Was placed on anti-biotic. Same time as starting antibiotic she received 1st dose of covid vaccine. The doctor gave her an antibiotic that is the generic, Telocin, 300mg three times. Spelling of generic antibiotic documented as provided by caller. She takes it with food and a lot of water. Caller clarified that she is taking the antibiotic now, but she also got something to help the infection when she was seen at the doctor, ongoing nightmare. The patient's concomitant medications were not reported. On 28Jan2021 caller clarified that when she got home, she had diarrhea all day long, she was exhausted, and she had fever. She is scheduled to go back for her second shot on 18Feb2021. The outcome of the event was unknown.  Information about lot/batch number has been requested.
It was reported that about half of 11,000 doses of influenza vaccine administered have resulted in a tiny black dot "tattoo" at injection site. Outcomes were not reported. Follow up information received on 03/Feb/2006 from a health care professional. Per the reporter, about half of more of 20,000 doses of the vaccine resulted in a tiny black dot "tattoo" at the injection site, not half of 11,000 doses as previously reported. None of the recipients had problems from this injections. It was not reported if the recipients had recovered from this event at the time of this report. Follow up information received on 08/Jun/2006 from a health care professional. As per the reporter, the case has been reviewed and there is no additional information. Further information is not anticipated. Follow up information received on 16/Jun/2006. Per the reporter, it was suspected that the needles were causing the previously reported event of black dot "tattoo", but they can not rule out the possibility of a relationship with the vaccine since they have no further information.
Initial information received on 21-Dec-2018 regarding an unsolicited valid non-serious case received from a physician via phone. This case involves an adult patient who was administered only the liquid portion of the vaccine of PENTACEL (lot number and expiry date was not reported) on an unknown date. The patients' past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of an actual medication error due to inappropriate reconstitution technique. Since the patients were administered only the liquid portion of the vaccine and not the powder. It was not reported whether the patients experienced any adverse events or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with PROQUAD (Merck) lot number L007228 and L016395 with expiration date 03-SEP-2016 and 08-OCT-2016, respectively (route was not provided). On an unknown date, there was an incorrect product storage as the unspecified number of patients received the improperly stored PROQUAD (Merck). No adverse event was reported. It was unknown if the patients sought medical attention. At the time of the report, the patients' status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Getting two shingle shot hurted like hell / pain for 4 days from it; This case was reported by a consumer and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain (1st dose received on an unknown date and experienced body pain, for tolerance of 1st dose refer case US2021AMR175894).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced general body pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the general body pain was recovered/resolved.   It was unknown if the reporter considered the general body pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient reported that, he/she received shingle shot, hurt like hell and his/her body was in pain for 4 days from it.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR175894:same patient, same reporter, same suspect
This case involves a 27 years old male patient who had clinic accidentally gave him the high dose of flu shot and it was unintended with no reported adverse event 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 in unknown administration site for unknown indication. On an unknown date the patient developed a non-serious clinic accidentally gave him the high dose of flu shot and it was unintended with no reported adverse event (incorrect dose administered) (unknown latency) following the administration of INFLUENZA VACCINE. Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the event (clinic accidentally gave him the high dose of flu shot and it was unintended with no reported adverse event). At time of reporting, the outcome was Unknown for the event clinic accidentally gave him the high dose of flu shot and it was unintended with no reported adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  SAD20211214001805.
5mo child rec'd shot's 26MAR91; child died on 1APR91; Coroner's report was SIDS; child had tracheal malacia & had been sick so this was first DTP; Second OPV;
Graves Disease; This literature-non-study case was reported in a literature article and describes the occurrence of BASEDOW'S DISEASE (Graves Disease) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.      No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BASEDOW'S DISEASE (Graves Disease) (seriousness criterion medically significant). At the time of the report, BASEDOW'S DISEASE (Graves Disease) outcome was unknown. Related      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered BASEDOW'S DISEASE (Graves Disease) to be related.    Case series of Graves disease following mRNA SARS-CoV-2 vaccination, with symptoms and altered thyroid function tests developing within 7 days of the first dose. Based on the timing of signs and symptoms relative to administration of the vaccine and the absence of other probable causes, we consider the vaccine as a potential contributor to the diagnosis. The viral spike protein, delivered indirectly through an encoded mRNA vaccine, may be capable of triggering an inflammatory cascade and immune response triggering thyroid dysfunction  Company comment: This literature study case concerns a 63-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) event of Graves disease after mRNA- 1273 Moderna vaccine. The event occurred approximately 7 days after the first dose of mRNA- 1273 vaccine. Very limited information is available regarding clinical course, severity of the disease and treatment received. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This literature study case concerns a 63-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) event of Graves disease after mRNA- 1273 Moderna vaccine. The event occurred approximately 7 days after the first dose of mRNA- 1273 vaccine. Very limited information is available regarding clinical course, severity of the disease and treatment received. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Knot on injection site, red and swollen ...was told to give Benadryl every 4 hours.
15 mont child vax dtp/opv. next day had fever 105.8 F.and convulsions
Nausea and tiredness were the strongest. They began the next day in the afternoon. I was so exhausted, although I had gotten a full night?s sleep.
Around 1/5/2021 started feeling slight tingling of R foot which has carried on till present time 1/6/21 0600.  Around 1/5/21 2100 started experiencing frequents stools leading to persistent diarrhea until present time.
PATIENT REFERS THAT TWO WEEKS AFTER RECEIVING HIS SECOND DOSE OF VACCINE STARTED WITH SKIN LESIONS. WAS DIAGNOSED WITH STEVEN JOHNSON
Following smallpox vaccination (2 weeks-fever, diarrhea, nausea).  Also have Anthrax vaccine day this time.  History of experienced seen fatigue.  Work up to date-Normal except low testosterone level.  Anthrax shots started 03/02/03 and as listed below. Pt relates illness to immunizations.  Will send to clinic.
None.  Behind on immunizations.  Tdap given instead of DTAP by error for 5th dose.
had to shock his heart back into rhythm 3 times 3 hours after getting the dose; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer. The consumer reported similar events for three patients. This is the third report. A 23-year-old male patient received bnt162b2 (COMIRNATY Lot number was 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. The patient got his first dose of the Pfizer BioNTech Covid-19 vaccine, and they had to shock his heart back into rhythm 3 times 3 hours after getting the dose. He is a football player, and is now on heart medication. The outcome of the events was unknown.   The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101377481 same reporter and drug, different patient and similar event;US-PFIZER INC-202101375428 same reporter and drug, different patient and similar event
This is an instance of breakthrough COVID-19 after which death occurred.   The individual was vaccinated with the Pfizer product on 02/24/2021 and 03/17/2021. They were brought to emergency department on 09/21/2021 in respiratory distress. They reported about a week of fever, cough, shortness of breath, nausea, vomiting, and diarrhea. Laying down flat made shortness of breath worse. They were admitted to hospital same day and tested positive for COVID-19 upon admission on 09/21/2021. They were diagnosed with  COVID-19 pneumonia and to have a pulmonary embolism. They were in process of being prepped for intubation when pulse was suddenly lost. The family opted to discontinue CPR and death was called on 09/21/2021.
My vaccine card does not have the Lot number for the Moderna dose 3. In January 2022,  I had excruciating joint pain. It started in my eye joint. I got treated with steroids. That went away. It ended up going into my right ankle. that went away. Then it went to my right eyeball. Then it goes away after 3 or 4 days. Then it went to both of my shoulders, and I could not raise my arms then it went to my left wrist. Then it went to my right wrist. All in the course of 4 months. I went into a walk-in clinic.  The doctor told me my  C reactive protein was 166 which is indicative of severe inflammation process going on in my body. He sent me to a rheumatologist.  I was tested for rheumatoid arthritis, Lyme screen, Lupus, nothing came back positive. So, the rheumatologist said it was caused by the COVID-19 vaccine. She put me steroids Prednisone and it resolved within a month. I was not comfortable with her diagnoses of the cause being the Moderna vaccine. I went to get a second opinion with a health and wellness doctor. She diagnosed me a co-infection of Lyme. It's the babesia bacteria.  I am at that 2 week mark now that I have not had any more joint pain. It's better, but not totally resolved.
Pt began feeling sick the day after the shot. became very congested, productive cough, fever. Took a day off of work and weekend to recover. Has since recovered today (10/16/17).
This spontaneous case was reported by a pharmacist and describes the occurrence of NASAL CONGESTION (Stuffy nose) and SNEEZING (Sneezing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (Stuffy nose) and SNEEZING (Sneezing). At the time of the report, NASAL CONGESTION (Stuffy nose) and SNEEZING (Sneezing) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided.
Information received from a physician on 05JUL2018. The physician reported that a patient has not maintained the boosters yearly. No adverse events were noted. No further information is expected.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients might have received improperly stored PROQUAD (Merck) (dose, route, lot# and expiration date were not reported). No adverse effects were reported. No PQC (product quality complaint) was reproted. Additional information has been requested.
Recieved the flu shot (unsure of which one) and within 5 or 6 hours wasn't feeling well. Had a headache, body ached, stomach hurt. By the next morning she had a fever around 101 and started to vomit later in day. Fearing she had been exposed to the flu based on a friend being diagnosed with it and having the same symptoms, she was taken to the doctor. They ruled out flu and strep. Said it may be norovirus. We are now into day 4 and she still has a fluctuating fever. Treating with advil and tylenol. Fever has been as high as 103.5. Vomiting lasted about 24 hours but she still has abdominal pain that comes and goes. No respiratory symptoms. Historically, if one person catches an illness, someone else in the family has caught it. We have a 2yo and 4yo that put everything in their mouths so germs are freely shared. So far no one has caught anything. We aren't positive but are questioning if this could be a reaction to the flu shot.
10 days after the vaccine I started experiencing heart palpitations, elevated pulse, anxiety, trouble falling asleep, some hair loss.  The anxiety was very pronounced from April 22, 2021 to April 27, 2021 but got better subsequently. The palpitations started on April 22, 2021 and continued almost daily through June 2021
a large cohort of staff are overdue for Engerix-B; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The healthcare professional was Pharmacy Procurement Lead, reports large cohort of staff was overdue for Engerix-B, which led to incomplete course of vaccination. No patient demographics, lot numbers or expiration dates provided. No additional information provided. The reporter did not consented to follow up.
I had sever pain and throbbing in my feet, and the pain would move to different places in my legs. Now I have sever chronic pain in both legs that makes it difficult to even walk and very difficult to walk up stairs. And my platelet count has gone very high and my red blood cell count has gone very low. And I have inflammation
Left face swelling along jaw line, exacerbated by chewing, painful when eating, but otherwise just sore. No issues with breathing
Around 6 months of my 2nd dose of the Moderna vaccine.  I started to notice hair loss, large amounts of hair stopping up the shower drain.  Hair falling out all over my home. This has slowed a bit but still losing an unusual amount of hair. Fears of how thin my hair has become.  I am a licensed hair dresser, this is a Real issue!!
headache, sore throat, cough, chills, fever, body aches, nasal congestion .starting  12/29/21
Fast heartbeat (felt like I was having a heart attack), left chest discomfort, bad headache, dizzy, GI issues, body aches, chills, fatigue
Headache, Myalgia, Arthralgia, Fever, congestion, dyspnea, fatigue, injection site pain Narrative:
Patien called today (1/12/2021) and stated that at approximately 3:00pm yesterday, after receiving her COVID vaccine at 12:30pm. She states that she developed a rash that was itchy. She states it was on her sides and abdomen and patchy. She states this morning she woke up and her lips were slightly swollen and she feels like she has pins and needles throughout her body, and that sensation is intermittent. She states her throat is also itchy. She denies any difficulty breathing, throat tightening or shortness of breath.  She is taking Benadryl and has called her PCP and is waiting for a call back from Dr. r
Skin rash noted 6/26/06. PE sparse erythematous, vesiculopapular lesions sparsely scattered on head, trunk and extremities up to 8 lesions.
Right leg heaviness and pressure.  No weakness.  No erythema.  No swelling.
Swelling and pain in lymph glands surrounding shot arm.  Heading is continuing and has affected affect and has extreme lethargy