chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received Monovalent for his booster on 09/01/2022 when according to guidelines he should have received Bivalent. Patient called and was not home but left message with wife who also received dose the same day. Informed them that they qualify for the Bivalent 2 months from 09/01/2022. Wife stated will discuss with husband and call to schedule if they decide to do  Bvalent.
Information has been received from a Nurse Practitioner concerning an unspecified number of patients below the age of 50 years old. The gender of these patients were unknown. On unknown dates the patients received a dose of ZOSTAVAX (dosage, route and frequency were unknown) (Lot Number and expired date were known). No adverse effects reported. Additional information has been requested.
Ran a fever with a peak of 101.7. Started around 5:00 pm and was gone this morning ( 5/7/2021) when I woke up.
I had a super sore arm the first day. On Day 2 I developed a rash on my right arm at the injection site. Over the course of a week or so it grew and was large. About 5 inches in diameter. In about a week the rash had completely disappeared. The rash was not itchy and it did not hurt. I didn't even notice it until I saw it on my arm in the mirror.
No adverse event after administration of vaccine.   Pediatric Pfizer vaccine was administered without reconstituting.
This spontaneous case was initially received on 02-Dec-2015. The case report was received from a Health Professional and concerns a 60 year old female patient. On 02-Oct-2014, the patient received FLUZONE (batch number: UI89AD, expiry date, 30-Jun-2015). Weight: not provided, Height: not provided. The patient has a medical history of Penicllin and some opiods allergy. Penicillin (Indication:-; Reaction: Allergy). The patient received flu vaccine on 04-Nov-2015 - unknown stop date, Batch no: not provided, Route od administration: not provided, Dose: no information provided. ZOSTAVAX, batch number L012476, Indication: Prevention of shingles and Unspecified pneumococcal vaccine, Indication not provided. On an unknown date, after vaccination, the patient experienced a rash at the injection site which was "a little bigger than the size of a quarter" and she also described it as being flat, warm and a little painful. The outcome was not yet recovered. Unspecified dose of diphenhydramine. For relevant test results see appropriate report section.
got the flu; Initial information was received on 17-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional (Patient).  This case involves an unknown age/gender patient who experienced got the flu after being vaccinated with 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, route, administration site, expiry date: Unknown) for flu vaccination (Influenza immunization).  On an unknown date the patient developed a non-serious got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  No lab data reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (got the flu).  Outcome: Unknown for the event got the flu.
Pt stated day after vaccinations she developed the flu stated temp of 103 degrees, headache, body aches lasting 2 days. Stated she was having the same symptoms her friend was having after receiving flu shot. Stated red swollen arm. When called if she could come in, stated no all better now. Pt displayed notable cognitive improvement.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 04-AUG-2015, the patient was vaccinated with a dose of GARDASIL for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The patient later received a dose of GARDASIL 9 lot number M013636, expiration date of 15-FEB-2018 ("unknown by reporter") for prophylaxis (dose and route of administration were not reported) on 05-AUG-2016. No adverse effects were reported. No additional information was provided. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In approximately March 2014, the patient was inoculated with the ZOSTAVAX vaccine by a pharmacist or physician at a pharmacy as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about October 2014, the patient was treated by at the emergency room for the onset herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term 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, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Tooth infection; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH INFECTION (Tooth infection) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa and Crohn's disease.    No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced TOOTH INFECTION (Tooth infection). The patient was treated with CLINDAMYCIN for Adverse event, at a dose of Unknown. At the time of the report, TOOTH INFECTION (Tooth infection) had not resolved. Not Provided          No concomitant medications were reported It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporters causality for the event(s) of BAD TOOTH/TOOTH 29 INFECTED with HUMIRA(ADALIMUMAB) was a  reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Bad Headache on 10/23/21 fatigue , left swollen arm, hot to touch, pain.  Started going  down 10/ 25 and started itching.
outside 42 day window for second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (outside 42 day window for second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (outside 42 day window for second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (outside 42 day window for second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received on 26-May-2021 contain no new information
RECEIVED 1ST DOSE OF PFIZER COVID VACCINE ON 02/14/21. ON 02/20/21 REPORTED ED FOR GENERALIZED WEAKNESS, FATIGUE. , AND  NAUSEA/VOMITING/DIARRHEA AND BEING UNABLE TO EAT SINCE YESTERDAY. ON 02/20/21 ADMITTED INPATIENT TO HOSPITAL WITH DIAGNOSIS OF ELEVATED TROPONIN AND GENERALIZED WEAKNESS.
Evening after vaccination developed redness and swelling spreading from proximal to distal arm - area 8 x 16cm - No drainage warm to touch - area mid anterior tender to (R) medial area. Pt applied ice and given MDP.
Patient received vaccine at 615am, around 7am pt started to have itching and had hives/welts develop on her face-lips, eyelid, arms and legs. Took Benadryl and it went away. Came back the next day in the afternoon so patient went to ER. Was given oral prednisone and advised to take Benadryl as well and follow up if symptoms come back.
Information has been received from an agency concerning a 20 year old female with a tetracycline allergy and a history of dry skin who on 07-MAR-2007 was vaccinated intramuscular into the left arm with a dose of Gardasil (Lot # 656049/0187U). Concomitant therapy included ethinyl estradiol/ethynodiol diacetate (DEMULEN), telithromycin (KETEK) and dextromethorphan hydrobromide (+) guaifenesin (+) phenylpropanolamine hydrochloride (AQUATAB C). on 07-MAR-2007, within 1 hour of receiving the vaccination, the patient developed whole body hives, diffuse urticaria, itching and her chest felt heavy. A physical exam was performed and was within normal limits with the exception of confluent hives on arms. No laboratory diagnostic studies were performed. The patient responded to injected diphenhydramine hydrochloride (BENADRYL) and methylprednisolone acetate (DEPONMEDROL). At the time of this report, the outcome was unknown. Whole body hives, diffuse urticaria and chest felt heavy were considered to be immediately life-threatening. The original reporting source was not indicated.   A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigations was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Patient's father gave the date of birth which made her 12 years old and eligible to get the vaccine.  When processing the vaccine to the insurance it was discovered that the patient is only 11 years old.  Patient's father stills confirms that she is 12 years old but has yet to bring us her birth certificate so we can confirm.
4" x 2" red rash. 4" x 7" swollen area. Both around shot location.
This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Patient had fever) and FATIGUE (Patient was tired for about two or three days) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy. On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Patient had fever) and FATIGUE (Patient was tired for about two or three days). At the time of the report, PYREXIA (Patient had fever) and FATIGUE (Patient was tired for about two or three days) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported. Treatment included Painkillers, physical therapy and acupuncture. Patient didn't had any other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient tested positive on 24-Dec-21 and tested positive some more times but doesn´t remember the dates. This case was linked to MOD-2022-511845, MOD-2022-511849 (Patient Link).
c/o nausea, sore throat, t99.2 po 12 hrs p/vax; states had same sx w/1st vax but occurred 24 hrs p/vax;
On Monday: The first thing, I was dizzy and was unable to stay standing. I felt like I had intense vertigo and I was wobbling and difficult to stay up straight it lasted about 48 hours where it was intense. I felt like I was on a boat still after that. I could stand but it still wasn't normal; still felt disorientated and that lasted the rest of the week. by Wednesday, I had extreme fatigue and no energy to get up or do anything. Saturday, I felt like I had flu, nausea, dizziness and extreme fatigue and I went to Urgent Care (10/2) they took vitals. When I told them about the dizziness, they had me look to the corner of the room and they said my eyes weren't focusing. It was like I was drunk, and my pupils moved back and forth fast. They said it was clear I was having balance issues. they said they couldn't do much for me. They said to take Meclizine three times a day and Sudafed every 4 -6 hours and I did that for the next week. The dizziness is much less right now. There is still moment when I feel really disoriented but not as bad as that first week. I was probably in bed for three weeks with that fatigue and as of yesterday just starting to feel like I can sit up to my desk for a few hours at a time. My energy is still not back to normal yet.
I developed an UTI that lasted three months. It started on 03-29-2021 and it cleared up about the beginning of July. I had MRI of the kidneys as well as an ultrasound of the kidneys were performed at Hospital because they could not explain why this was happening to me. The UTI is now gone and I am left in inflamed urethra that I have to take Myrbetriq 50mg medication for. I also had a cystoscopy performed. I am currently seeing a Doctor, due to my inflamed urethra.
I started itching on my back and then I noticed the rash. It spread down to my chest and arms. I called and visited my doctor and all they told me was to take antihistamines and use a cream. Even when the rash went away. February 19 , I had the second dose (023M20A) and the rash came back. On 3/10, I was supposed to have my Evenity shot (postponed until March), but I couldn't due to the rash. I received a steroid injection. I took Hydro Oxyzine Pam 25mg cap for my itching. I was then told to take it 3 times a day to help with the itching. I still have the itch, but it's no longer unbearable. I am scheduled to see a dermatologist because they are thinking that I've developed an allergy to the preservative in the vaccine and they want to make sure that it isn't the same preservative in the Evenity injection.  My cancer was treated with a chemo drug call 5FU. I wanted to mention it in the event that it is linked to my reaction.
fever, nauseated and headache symptoms about 13 hours after injection, administered Tylenol for fever over last 12 hours at 6 hour intervals. Fever and headache relieved but weakness and nausea persist. drinking crystal lite for hydration.
Right upper arm area immediately became painful turning to pink color on third day. Visited Dr. who diagnosed full-blown Cellulitis. Took Cephalexin 500 3 times a day for 10 days. Recovered.
ITCHY THROAT STATED IT FEELS THE SAME AS WHEN SHE EATS SHRIMP
Tingling on the left side of her face; broke out into blisters/hard for the patient to open her eye, blister under the eye; nerve pain on the left side of her face; left side of her face is also swollen; her left eye is swollen shut; Eye infection; This case was reported by a consumer via call center representative and described the occurrence of tingling in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number MR75G, expiry date 13th July 2023) for prophylaxis.   On 16th June 2022, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced tingling, blisters, facial neuralgia, facial swelling, eye swelling and eye infection. The patient was treated with valaciclovir hydrochloride (Valtrex), ophthalmologicals (nos) (Eye Ointment (Ingredients Or Trade Name Unknown)) and ophthalmologicals (nos) (Eye Drop (Nos)). On an unknown date, the outcome of the tingling, blisters, facial neuralgia, facial swelling and eye infection were unknown and the outcome of the eye swelling was not recovered/not resolved.   It was unknown if the reporter considered the tingling, blisters, facial neuralgia, facial swelling, eye swelling and eye infection to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-JUL-2022 Reporter's comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and experienced tingling and nerve pain on the left side of her face and then broke out into blisters.  The left side of her face was also swollen and her left eye was swollen shut.  The patient went to the walk-in clinic and was prescribed Valtrex. She also went to the eye doctor and was prescribed eye drops and eye ointment just in case of an infection.  The patient had another appointment with the eye doctor.  The outcome of initial visit with the eye doctor was that everything looks okay with her eye, but she needs to went back so the doctor could get a better look.  It was hard for the patient to open her eye as she had a blister under the eye. The reporter consented to follow-up.
1830 severe abd epigastic pain with vomiting requiring IV fluids, anti emetics in ED. 2130 transfer to medical center. DX Acute Pancreatitis 7/18/07-partial med rec received as patient remains in facility. Presented with pancreatitis, hyperbilirubinemia, hematemeses and hematochezia following the treatment for a dog bite. Presented to hospital with abdominal pain and recurrent vomiting with bloody diarrhea approximately 4 hours after vaccine and IVIG as well as Augmentin. No clear etiology. 8/23/07-DC summary received for DOS 7/16-7/20/07-DC DX: Pancreatitis. Seconary diagnosis: Gastrointestingal bleed. Likely immune reaction to rabies immunoglobulin. Transaminitis. Presume esophagitis. PE: Circumferential scleral icterus.
Patient claimed to have experienced an "ache all over the body" for 2 days after receiving the 2 vaccines. Claimed to have never experienced body aches before when receiving vaccinations.
Patient received full 0.5 mL dose for booster dose, instead of 0.25 mL. Patient does not qualify as moderately to severely immunocompromised, according to CDC. Patient is not currently showing any signs/symptoms of adverse effects, as of 14:50 on 3/18/2022. Mother was notified by phone of dosing. Mother will closely monitor patient for signs/symptoms, and will notify the clinic if anything occurs.
Had flu shot at 10:30AM on Oct 30th 2004 at the above location. Left to go shopping at mall. At 3:00PM notice urgent need to pass urine and when I did there was burning and spasms when urination ended. I'm not a frequent UTI pt and have only had UTI 3-4 in my lifetime. Drug 412105 smz tmp 800 160 20TAB. Recovered after taking antibiotic for 10 days.
Minimal coughing; Dizziness; Immediately after receiving the injection, he had nausea; Soreness on the injection site; Swelling on the injection site; Headache; He was very fatigue throughout the remainder of 15Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Minimal coughing), DIZZINESS (Dizziness), NAUSEA (Immediately after receiving the injection, he had nausea), VACCINATION SITE PAIN (Soreness on the injection site) and VACCINATION SITE SWELLING (Swelling on the injection site) in a 69-year-old male patient 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 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced COUGH (Minimal coughing), DIZZINESS (Dizziness), NAUSEA (Immediately after receiving the injection, he had nausea), VACCINATION SITE PAIN (Soreness on the injection site), VACCINATION SITE SWELLING (Swelling on the injection site), HEADACHE (Headache) and FATIGUE (He was very fatigue throughout the remainder of 15Apr2021). On 16-Apr-2021, COUGH (Minimal coughing), DIZZINESS (Dizziness), NAUSEA (Immediately after receiving the injection, he had nausea), VACCINATION SITE SWELLING (Swelling on the injection site), HEADACHE (Headache) and FATIGUE (He was very fatigue throughout the remainder of 15Apr2021) had resolved. At the time of the report, VACCINATION SITE PAIN (Soreness on the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment information not provided.
Vaccine may have caused flare in Graves Disease symptoms.  4 days after the vaccination, I started having heart palpitations.  6 days after the vaccination, I started having double vision in the morning.  I have never had heart palpitations from Graves before, although it is a common problem with it I have not had double vision since my eye surgery 5 years ago.  Am wondering whether to proceed with second dose of the Moderna vaccine.
I had been shoveling snow for about 5 minutes when suddenly I had an attack of vertigo.  I fell into a snowbank and my husband helped me get up and walk into the house.  I rested for a couple of hours.  The next day i was still unsteady and went to an ENT. I was prescribed meclizine which I took for a couple of days, but it didn't seem to make me feel better.  A month later, about ten days after my second vaccine,  I had another vertigo  attack which was stronger and longer lasting than the first shot. I have been unsteady and dizzy ever since.  I also had two additional bouts of vertigo. In September, I was transported to the hospital after a severe
experienced side effects with the first dose, Pretty much the same; This case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had fever post vaccination.  The patient stated side effects were pretty much the same after both the doses. This case is linked to case US2020AMR023947 reported by the same reporter (2nd dose).
stroke; He's got the shakes a few garbled words; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed ;unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: SPEECH DISORDER (non-serious) with onset 01Oct2022, outcome "unknown", described as "He's got the shakes a few garbled words"; CEREBROVASCULAR ACCIDENT (medically significant) with onset 01Oct2022, outcome "unknown", described as "stroke".  Clinical course: The patient had his 4th booster shot yesterday, Pfizer, and this morning he was having something similar to a stroke.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.