chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3FEB97 brief episode, 2-3 min wared arm beside head, had glazed appearance in eyes & failed to respond to mom;there wasn't any isolated, unilateral or even gen convuls activity;mom stated pt had fever,97.7 in office 1hr following incident;
No issues/No Adverse event on Patient; Temperature Excursion; This spontaneous report was received from an office manager and refers to a 11-year-old male patient. No information on patient medical history, current conditions and concomitant medications was provided.  On 31-OCT-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis (product storage error and no adverse event).  Temperature excursion total time was 25 minutes. There were 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
5 inches x 5 inches erythema, warmth, firmness left deltoid MCV, Tdap.
First COVID-19 Vaccine given was Pfizer and the Second COVID-19 vaccine given was Moderna- no signs or symptoms reported via patient
Two days after receiving the 1st booster dose I tested positive for COVID-19. I have had extreme aches and pains, the headache is so severe that nothing is alleviating it. My lungs sound good but the cough keeps me up at night. I cannot taste or smell anything, I have no appetite at all. I have diarrhea.
Patient states he noticed "faded red spots" around the Smallpox vaccination site which were hot to the touch when he changed his bandaid at 0700 hours on Wednesday, 14 Dec 2005.  Patient states "spots were more solid and zit-like", dark red, and hot to his touch when he checked the same site on Thursday, 15 Dec 2005, at 0700 hours.  Patient presented to this Immunization Clinic at 0940 hours on Friday, 16 Dec 2005 requesting to have his Smallpox sited checked.  After viewing the site we asked the PAC to also view the site.  The PAC viewed the site and had the patient return with her to the clinic where the patient underwent an office visit with the PAC.  See diagnosis and prescription information in box 12.
I started experiencing vertigo which gradually got worse and worse to the point where I can't drive and need a cane to walk. My PCP did some physical therapy which didn't help and I was referred to a specialist.
After the vaccine, I was told I was good to go. 10 minutes later, I started profusely bleeding from my nose. I was able to stop the bleed without medication but it continued into the night. I woke up choking on blood. Went to the ER, they could not find the source of the bleed. There was a total of 7 nosebleeds within approximately a 10-hour window. I do not have any history, or suffer from nosebleeds, high blood pressure, etc. At the ER, I ended-up with a rocket pack in the left nostril, which stopped the bleeding. I was referred to a specialist. Upon seeing a specialist the following day (or day after receiving the vaccine), the specialist was also unable to find the bleed and cauterized a small bleed they believe was due to the trauma of the rocket pack. I was given medical nasal spray. I was told to see what happened and respond as necessary.
Vaccine given 11/30/2005 between 2-4pm.  On 12/02/2005. patient noted right facial weakness and mouth drooping.  He denied any numbness or tingling, slurred speech, weakness of arms or legs, difficulty swallowing.  He stated that symptoms appeared to be resolving, but he wondered if this had anything to do with recent vaccine.  Referred to MD for evaluation. 01/04/2006 per telephone f/u with reporter diagnosis was Bells Palsy and sinsus infection. Sinusitis was treated with Zithromax.
About a week after the shot,  and three weeks after an ATV accident, I began to experience tingling and numbness in my extremities. The doctor suggested I see an Orthopedic specialist because he suspected my ATV accident caused a back injury that gave me the symptoms. They did xrays on my back and said I may have fractured a disc, but the Ortho doctor didn't think it could cause the issues I was having. Since then I have also had numbness in my face. I never lost functionality but have suffered from discomfort and stress. I feel like my symptoms are slowly but surely improving, having peaked about a month after onset.
Chills, body aches, fever, swollen supraclavical lymph nodes on L side
Sore arm with all 3 doses; This is a spontaneous report from a contactable consumer, the patient from a Pfizer sponsored program Support.   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. Medical history included autoimmune disorder and cancer. The patient concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. On an unknown date, the patient experienced sore arm with all 3 doses. The outcome of the event was unknown.  The lot number for the vaccine BNT162B2 was not provided and would be requested during follow up.  Follow-up attempts are completed. No further information is expected.
I started to have slight numbness in my left arm and hand.  It persisted the entire evening.  It was very slight, almost as if my arm had fallen asleep.  Driving home (at about 1:25pm) my face felt slightly numb for bout 1-2 minutes.
pain throughout the body; chattering chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 10:15 (Lot number: ep6955) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: COPAXONE. Vaccination history included: Bnt162b2 (Product: COVID 19, Lot number: en6199, Administration date: 04Mar2021, Administration time: 11:15AM, Vaccine location: Left arm, Dose number: 1), administration date: 04Mar2021, when the patient was 52 years old, for Covid-19 immunisation, reaction(s): "My face got tight", "Got very hot", "Sharp pain down spine", "Hard to breath", "Racing heart lasting about 3-4 minutes", "Pain throughout the body", "Teeth chattering chills (over 2 hours)". The following information was reported: PAIN (non-serious), outcome "unknown", described as "pain throughout the body"; CHILLS (non-serious), outcome "unknown", described as "chattering chills". Additional information: No treatment given for AE. Covid prior vaccination was no. Covid tested post vaccination was no. Known allergies was no. No follow-up attempts are possible. No further information is expected.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Patient Received vaccine past 30-days Expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient Received vaccine past 30-days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2022 at 2:27 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Feb-2022 at 2:27 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient Received vaccine past 30-days Expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient Received vaccine past 30-days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Vaccine administration time 14:27:05
This study case was received from the investigator on 15 January 2013. A 19-year-old male subject, with a past medical history of high blood pressure, received ACAM2000 (lot number not reported) on an unreported date in 2012. On 26 November 2012, within 30 days post small pox vaccination, the subject had abnormal Troponin I result, with highest value of 0.03 ng/mL. On 26 November 2012, the subject had an electrocardiogram (ECG) with abnormal results, and on same day, was diagnosed with an acute myocardial infarction, unspecified site. An echocardiogram was performed with abnormal results on 27 November 2012. MRI of brain, spinal cord, heart and lumbar puncture studies were not performed. On 29 November 2012, the subject was also diagnosed with other primary cardiomyopathies. The subject's outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Peri injection erythema/edema itching left arm at site of varicella injection.
Child had multiple vomiting 12/20/09 and developed grand mal seizure 12/21/09. She was hospitalized 12/21 - 12/24/09. She had 2 more seizures in the hospital.
Tonic clonic convulsion lasting 30 seconds within 24 mins of administration of MENACTRA vaccination. No previous hx convulsions or any neurologic problems
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   No concomitant product was reported.
Initial misuse report received from a healthcare professional on 06 May 2013. It was reported that MENACTRA was administered to a 04-month-old patient instead of "PREVNAR". No adverse event was reported. Documents held by sender: none.
rash, chronic rash; chronic welts; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash, chronic rash) and URTICARIA (chronic welts) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash, chronic rash) and URTICARIA (chronic welts). At the time of the report, RASH (rash, chronic rash) and URTICARIA (chronic welts) had not resolved.            No concomitant medications were reported.  Treatment information was not provided.  Patient received second dose of the Moderna COVID-19 vaccine and reported that she had a rash that turned to chronic rash and got chronic welts. Patient reported that it has been 4.5 months since the start of the events.   Reporter did not allow further contact
she took the booster and die; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (she took the booster and die) in a 98-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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant product was provided. No treatment information was provided. Patient was very healthy, days before vaccination, in TV she said she was very well.  Company Comment: This is a spontaneous case concerning a 98-year-old, female patient with no  medical history reported, who experienced the unexpected serious event of death. The event occurred at an unknown date after the booster dose of mRNA-1273 vaccine. Cause of death was not reported, it is unknown if an autopsy was performed. Patient´s age remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious due to death and important medical event.    Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a 98-year-old, female patient with no  medical history reported, who experienced the unexpected serious event of death. The event occurred at an unknown date after the booster dose of mRNA-1273 vaccine. Cause of death was not reported, it is unknown if an autopsy was performed. Patient´s age remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious due to death and important medical event.; Reported Cause(s) of Death: unknown cause of death
Pain, mild fever (<101 degrees), Weakness for 24 hours, tiredness for 72 hours.
Pt exp pain @ inject site p/flu vax; this pain persisted & was present 1 mo p/vax;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with ZOSTAVAX at the health department as recommended for routine adult health maintenance for the prevention of shingles (route, dose, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster.  In 2016, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the 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.
Information has been received from a nurse practitioner concerning a male consumer with diabetes and a history of eczema who"recently" (date unspecified) was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, the patient "recently" experienced eczema in several places. The nurse practitioner was not sure this was caused by the vaccine because the patient has a history of eczema. The nurse practitioner also reported she did not administer the vaccine, it was administered at a pharmacy. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information has been received from a nurse practitioner concerning this 71 year old male consumer with diabetes, hypertension, hyperlipidemia and a history of eczema as a child who on 19-DEC-2007 was vaccinated SQ in the left arm with zoster vaccine live (Oka/Merck) (lot # 654604/1406F) at 2:50 pm. Subsequently, 1 week after vaccination on 26-DEC-2007 the patient reported a rash. It was reported that the rash itched, but there was no pain. It was also reported that there were no changes in his skin products: lotions, soaps, etc. The rash was located on the left antecubital and bilateral forearms. The rash was described as dry and slightly scaly patches. The patient was treated with triamcinolone cream 0.1%. The medicine helped, but the rash progressed to his arms, his back, upper leg and bilateral popliteals. The rashes were circular patches with red raised borders. The patient was also given prednisone dose pack. It was reported that the rash resolved probably on 22-MAR-2008. Additional information is not expected.
extremely tired/fatigue was the worst; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extremely tired/fatigue was the worst) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced FATIGUE (extremely tired/fatigue was the worst). On 12-Mar-2021, FATIGUE (extremely tired/fatigue was the worst) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Around Aug 1, I was looking at my tattoo on my shoulder and I noticed a pimple and then I saw a lump. I know it was where the injection site. I was very cautious when I was feeling my shoulder, I noticed it was the size of a dime in diameter. Over the next 3-4 months, I noticed it started growing. I started getting concerned because it was getting bigger than a quarter in size. I just saw that it was getting bigger and bigger. I saw my PCP on Jan. 18 she palpated and told me to get it checked out. They did an ultrasound and they found it wasn't fluid filled. It caused coolness lower in my arm and it radiated from that lump. They removed it based off the irritation on March 11. They sent it out to get tested for pathology it seems consistent injection in the fat. The dr. findings were dysplastic lipoma and then sent to Pathologist, sent the lump to another doctor to rule out a ALT.
A couple of weeks after receiving my bivalent dose, I started experiencing vertigo; it started off pretty mild and has gotten progressively worse. The dizziness is beyond controllable. I contacted my doctor and told her about the dizziness, so she prescribed me meclizine 25mg twice daily; I started it taking immediately. It's helped reduce and calm down the dizziness when it was at its worst and has now made it tolerable when I'm having an episode.
color was going down arms; hurts to the bone; hurts really deep; localized swelling; Redness; A spontaneous report was received from a consumer who was a 44-year old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced localized swelling, redness, huge lump underneath, color is going down my arms, hurts really deep, hurts to the bone which was getting worse and not better.   The patient's medical history was not provided. Concomitant medications reported included diphenhydramine citrate, ibuprofen and melatonin.  On 29 Dec 2020, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 in the left upper arm for prophylaxis of COVID-19 infection.  On 29 Dec 2020, the patient experienced localized swelling and redness.   On 07 Jan 2021, she reported that the redness was much worse, she developed a huge lump underneath, the color was going down her arms and it hurt really deep and to the bone. The condition was worsening and not getting better. Treatment for the events included Advil and Benadryl.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, localized swelling, redness, huge lump underneath, color is going down my arms, hurts really deep and hurts to the bone which was getting worse and not better were not reported.; Reporter's Comments: This case concerns a 44-year old, female patient. The patient's medical history was not provided. The patient experienced NS, expected event of injection site swelling, erythema, injection site pain and unexpected event of Pain NOS, skin coloration. The events of injection site swelling , erythema occurred on the same day, events of Injection site pain, Pain NOS, skin discoloration occurred 10 days after the first dose of mRNA-1273. Treatment for the events included Advil and Benadryl.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Redness, swelling, itching, warm to touch, left deltoid.  Temperature 99.4 F.  Swelling of face noted next day after shot given.
had Moderna for 1st and 2nd doses; given Pfizer as booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (had Moderna for 1st and 2nd doses; given Pfizer as booster dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (had Moderna for 1st and 2nd doses; given Pfizer as booster dose). On 07-Oct-2021, INTERCHANGE OF VACCINE PRODUCTS (had Moderna for 1st and 2nd doses; given Pfizer as booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had third dose on 7-OCT-2021 with lot number FF8839, expiration date was 01-FEB-2022 at 0.3 ml intramuscularly.   No concomitant medication was reported. No treatment drug details was reported.   This case was linked to MOD-2021-345540 (Patient Link).
Erythematous, swelling at site of injection no fever no systemic symptoms. No other sign.
01/29/2022 2 days post booster vaccination, I had a fever, chills and body aches all over the body. I went to the physician's office and had developed a cough, I was told I had the flu and bronchitis. I was treated with an antibiotic and after a week I was feeling better. I could not get out of bed. After the bronchitis, I got conjunctivitis in my right eye I then received more antibiotics to treat my eye. I still have lingering symptoms being a problem with both eyes, which is having crusting build up.
Location of vaccine presented with a red, raised, hot to touch bump larger than a half dollar. Pt reported that it was painful to the touch. Pt also stated he was unable to lift his arm the night after obtaining the vaccine
2 days post vax pt broke out in rash on abdomen & back, rash spread to extremities, low grade fever t100-101, very irritable; MD told mom felt was vax related sx, recommend Ped DT for future doses;