chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The day after the shot, I had the expected fever. The following day, I began to have hand pain and weakness. This continued and seemed likely to be a flare of Sjogren's, significantly more severe than any symptoms I had previously experienced. After a couple of weeks, my rheumatologist tried me on a pack of methylprednisolone which helped while I was taking them but symptoms rebounded as soon as I finished the pack. This seems like it is not directly related to the vaccine's action, but the timing makes me think it prompted my immune system to get carried away even after it finished the response to the vaccine. We are continuing to investigate treatment, but in the meantime, I am having to get help for things requiring gripping and I am limited in my ability to type and thus work, so I am also having to look at speech-to-text programs.
Fever 100.3, chills, sweats, and joint pain all over. Fever 101.4-101.7. Rash - face, ears, chest, and hips (prickly heat type), red dots rash on legs, arms, back. Rash lasted 4 days.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical histories, drug reactions or allergies and concomitant therapies was provided. On 28-JAN-2017, 29-JAN-2017 and 30-JAN-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M032650 with expiry date of 31-MAR-2019 (dose, route and site of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of below 32 degrees Fahrenheit (with minimum temperature of 25 degrees Fahrenheit) for 14 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA014176:
Shrieked until he fell asleep then would wake up shrieking. He wouldn't eat, just shriek and very high pitched. This continued for hours until I took him to the ER. They immediately brushed off the vaccination but I knew. At first, he broke out from head to toe in eczema right after. Then the reflux started and milk allergy. He now hand claps, PICA and sucks on his shirt until it's drenched, aggressive behavior, must hold and rub a tag, is particular about certain foods and textures, colors and sounds.
Pt stated that a rash started to appear on the forearm of her left arm the evening she received the vaccine.  The rash continued to work up her arm over the next two weeks to almost the shoulder area.  The rash also started to appear on her right arm.
Fever/lack of energy on 4/24 and sore throat. 4/26 - 4/30 cough/low energy/foggy brain/cold like symptoms.
Hives and swollen lips on evening of administration. Mom reports persistent lisp and occasional perioral twitching. PE nonfocal. Mild persistent speech concerns. Question due to residual edema of lips>
Patient stated feeling a little off, redness developed on chest, and some tightness in the throat.
Severe headache; Fever; Chills; Fatigue; This is a spontaneous report from a non-contactable consumer (patient).  A non-pregnant 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 02Feb2021 at 09:15 (Batch/Lot Number: EL3248) as dose 2, single (at the age of 27 years old) for COVID-19 immunization. The patient's medical history included Hashimotos and allergies with sulfa in antibiotics. Concomitant medication included levothyroxine, taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (Lot number: EL3248) on 14Jan2021 at 08:15 AM  in the left arm for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and post vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The facility type vaccine where the patient received the vaccine was in the workplace clinic. On 02Feb2021 at 13:00, the patient experienced severe headache, fever, chills, and fatigue. No therapeutic measures were taken as the result of the events. Outcome of the events was recovered on Feb2021.  No follow-up attempts are possible. No further information is expected.
speech/word  finding difficulty ( dysarthria ), Novocain like feeling left perioral area( perioral anesthesia ) , drooling of food occasionally
Pt. states after receiving the 2nd dose of Moderna 02/14/2021, started experiencing symptoms 02/22/2021 of extreme nerve pain in the legs/hands/feet, fatigue, flu-like symptoms. Primary visit with X-ray (Sprain) 02/28/2021, both feet started experiencing neuropathy throughout the body. Nervousness and anxiety resulting in early retirement. Body aches and nerve pain still continuing. Neurologist seen Perennial+1 diagnosed. No other noted symptoms still continuing Primary visits.
5 hrs. after immunizations. pt was noted to turn pale and became limp. Mom called 911 and was sent to ER and admitted to another hospital. R/O Seizure. Dx: possible GER and Syncope.  11/7/07 Received hospital medical records which reveal patient experienced pale limp episode & then gradually became more responsive.  Had been seen at outlying ER & transferred to higher level of care.  Admitted 10/15-10/16/2007.   FINAL DX: Acute life threatening event; GERD.
8/13 Started with swelling, redness - used cool compresses and Benadryl.  C/O pain.  Examined on 8/15 - pinkish red swelling about 4"x3" - improved since Wed. - still sore.  Also had brief episode of nausea, sweating and clammy skin within 5 minutes of injections - resolved spontaneously.
Beginning day after vaccine, she noticed itching at the site. She mentioned an adhesive allergy on 3/28/17, and did not remove bandage for several hours. On 3/28/17, area became blotchy and red. She came in to show me. Her MD on 3/27/17 told her to try using Hydrocortisone cream. No other symptoms.
client reported, "tingling in arm that goes all the way to his fingers and has been occuring since he received the shot."  it was recommended to contact his primary care phusician in regards to his symptoms and was reassured that a report would be filed to the CDC and FDA in  a confidential mannor.
racing heart/heart palpitations; Other symptoms are elbow joint pain on injection arm; patient was pregnant at the time of vaccination, gestation period was 17 (unspecified); This is a spontaneous report from a contactable consumer (patient). This 35-Year-old female consumer reported for herself.  A 35-years-old female pregnant patient (pregnant at the time of vaccination) received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 Vaccine, Solution for injection, Batch/Lot Number and expiration date: Unknown), via an unspecified route of administration, administered in right arm on 11May2021 at 02:00 PM (Age at vaccination was 35 years) as dose 2, single for COVID-19 immunization. Medical history included Sulfa allergy and COVID (prior to vaccination). Concomitant medication included prenatal vitamins. Patient had COVID prior to vaccination and not COVID tested post vaccination. The patient previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 Vaccine, Solution for injection, Batch/Lot Number and expiration date: Unknown), via an unspecified route of administration, administered in right arm on 20Apr2021 at 03:00 PM (Age at vaccination was 35 years) as dose 1, single for COVID-19 immunization and experienced severe headache, fatigue and rash on feet. On 11May2021, at 05:00 PM, 3 hrs after vaccination, the patient experienced racing heart/heart palpitations, Other symptoms are elbow joint pain on injection arm. On 11May2021, the patient was pregnant at the time of vaccination, gestation period was 17 (unspecified). The patient reported that, After both injections I had reactions similar to my symptoms while I had Covid. My most severe symptoms are racing heart, heart palpitations. Other symptoms are elbow joint pain on injection arm. The patient not received treatment for events racing heart/heart palpitations, other symptoms are elbow joint pain on injection arm. The outcome of the events was not resolved.  Follow-up (24Feb2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
On Jan 6 at 05:30 a.m. while I'm applying lotion on my arms I noticed the redness on  my left upper arm,  the site is tender, swollen with redness, shoulder pain, itchiness and warm to touch. Today, Jan. 7 I went to my Dr's appointment I was seen by ARNP and she  said she will prescribe Lotrisone cream.
Covid; Covid; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of COVID-19 (Covid) and the second episode of COVID-19 (Covid) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In August 2021, the patient experienced the first episode of COVID-19 (Covid). In October 2021, the patient experienced the second episode of COVID-19 (Covid). In 2021, last episode of COVID-19 (Covid) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.   Treatment information was not provided. 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.  Company comment: This is a spontaneous case concerning a 42-year-old female patient with Hidradenitis supurativa on treatment with Adalimumab, who experienced the non-serious unexpected event of COVID-19 (AESI), on the same month after the first dose of mRNA-1273 vaccine and a second episode of COVID-19 two months later. Clinical course, diagnostic tests and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: Company comment: This is a spontaneous case concerning a 42-year-old female patient with Hidradenitis supurativa on treatment with Adalimumab, who experienced the non-serious unexpected event of COVID-19 (AESI), on the same month after the first dose of mRNA-1273 vaccine and a second episode of COVID-19 two months later. Clinical course, diagnostic tests and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Left thigh swollen day after immunization for DTP+Hib. Noted erythema, surrounding vaccination site, non-tender, 4x8cm area.
Shingles; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 04Feb2021 13:00 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on an unknown date for COVID-19 immunisation. On 10Feb2021 the patient experienced shingles. The event resulted in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included medication (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Patient reported tongue numbness, "lump in throat" and left arm weakness. 0.3 mg epi IM given (L) gluteal
Expired vaccine stored in refrigerator; Expired vaccine administered to the patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient) and PRODUCT STORAGE ERROR (Expired vaccine stored in refrigerator) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine stored in refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient) and PRODUCT STORAGE ERROR (Expired vaccine stored in refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   The pharmacy received vaccine on 23-Feb-2022 that a pharmacy staff member looked up the expiration date and came up with an expiration date of Jun-2022 however the correct expiration date confirmed was 01-Apr-2022.  The vial was initially stored in refrigerator on 04-Apr-2022. The vial did not undergo any temperature excursion.  No treatment details were reported.
feeling like he had the flu; arm hurting; body ache; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (feeling like he had the flu), PAIN IN EXTREMITY (arm hurting) and MYALGIA (body ache) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21-B, 939906-B, 025B21A and 044A21A) for COVID-19 prophylaxis.     Patient had no allergy or history of Covid-19.  The patient's past medical history included Palpitation (his father and sister). Concurrent medical conditions included Diabetes, Blood pressure high, Cholesterol blood excessive and Palpitation.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (feeling like he had the flu), PAIN IN EXTREMITY (arm hurting) and MYALGIA (body ache). At the time of the report, INFLUENZA LIKE ILLNESS (feeling like he had the flu), PAIN IN EXTREMITY (arm hurting) and MYALGIA (body ache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included medicines for diabetes, high blood pressure and cholesterol. Patient received dose 5 on 23-Sep-2023 (batch no: AS7147B) and dose 6 on 06-Oct-2023 (batch no: unknown).1 month prior to dose 6 patient had received Flu shot and Shingles vaccine.  Patient had usual symptoms like body ache, arm hurting, and feeling like he had the flu. He still went to work with all the vaccinations and did his normal activities. Treatment medication was not reported.   This case was linked to MOD-2023-744827, MOD-2023-746198.
a lot of itchiness all over body; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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; Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "a lot of itchiness all over body".  Additional information: The patient got the Pfizer Booster vaccine and had a reaction, she had lot of itchiness all over her body and she did not know what to do. The patient was referred to HCP for medical recommendations, but caller disconnected abruptly and was unable to collect further information. This report was not serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 9/29/00, the pt presented to clinic with 12 hour history of rash starting near injection site and continued to spread over legs, groin, trunk, arms, and face. Rash consisted of hives. Treated with Benadryl.
Case number PHHY2012US051207, is an initial literature report received on 14 Jun 2012. The authors discussed about a case of "Vogt-Koyanagi-Harada Syndrome Associated with Bilateral Serous Macular Detachments Responsive to Immunomodulatory Therapy". This report refers to a 44-years-old female patient. The patient was vaccinated with INFLUENZA (manufacturer and batch number unknown) on an unspecified date (one-month previously). After vaccination on an unspecified date, she experienced bilateral red and painful eyes and an associated decrease in vision. There was no significant ocular or medical history. There was no history of trauma and the presence of tinnitus was noted on review of the systems. On ocular examination, her best-corrected visual acuities were counting fingers at two-meters in both eyes, with the presence of intraocular inflammation 2+ cells in both anterior chambers and 1+ vitritis bilaterally. The fundus appearances demonstrated serous macular detachments, which were further confirmed with both fundus photography and optical coherence tomography. The immunomodulatory therapy was initiated promptly with intravenous methylprednisone followed by systemic oral corticosteroids (1 mg/kg), with azathioprine 50 mg daily and cyclosporine 100 mg daily as steroid-sparing and long-term immunomodulation. She responded well to treatment. At the ninth-day of follow-up examination, serous macular detachments in both eyes resolved with resolution of the serous macular detachments and visual acuity improved to 20/25 in the right eye and 20/30 in the left eye. There was an overall decrease in intraocular cellular activity and her general overall visual acuity improvement, which reflected on fundus photography. The optical coherence tomography of the (A) right and (B) left eyes revealed relatively normal retinal architecture. The authors concluded that this case was unusual in its etiology and presentation with the development of Vogt-Koyanagi-Harada syndrome in a patient who received INFLUENZA vaccination one month previously and the presentation of the syndrome with bilateral serous macular detachments. The patient responded well to therapy, with resolution of her serous exudates and inflammation and restoration of visual function. More recent studies suggest that first-line immunomodulatory therapy can achieve superior visual outcomes when compared to corticosteroids as mono-therapy or with delayed addition of immunomodulatory therapy for the treatment of inflammatory disease with Vogt-Koyanagi-Harada syndrome.
Injection site erythema starting was noticed the day after vaccination and is painful to the touch. It still hasn't gone away.
This spontaneous report as received from nurse via company representative refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On unknown dates, the patient was vaccinated with four doses of GARDASIL 9 (dosing details were not reported), intramuscularly for prophylaxis. No known adverse effects reported. No product quality complaint involved.
On the second day of vaccination, I felt minor dizzy on the morning with a little bit headache, but the symptom disappeared in the afternoon.  On the third and forth days after vaccination, I felt sore on both of my shoulders, especially on the right side, I can feel a nerve pulling from my shoulder to my rare side of my head causing headache occasionally, but the symptom disappeared after two and three days.
terrible itching; swelling to a kind of hard knot; swelling to a kind of hard knot; kind of a rash; redness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (terrible itching), SWELLING (swelling to a kind of hard knot), INDURATION (swelling to a kind of hard knot), ERYTHEMA (redness) and RASH (kind of a rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced ERYTHEMA (redness). On 27-Feb-2021, the patient experienced PRURITUS (terrible itching), SWELLING (swelling to a kind of hard knot), INDURATION (swelling to a kind of hard knot) and RASH (kind of a rash). On 03-Mar-2021, PRURITUS (terrible itching), SWELLING (swelling to a kind of hard knot), INDURATION (swelling to a kind of hard knot), ERYTHEMA (redness) and RASH (kind of a rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2021: Followup received on 16-MAR-2021 and contain no new information. On 23-Jul-2021: Patient withdrew consent for follow up.
herpes zoster; Information has been received regarding a case in litigation from a lawyer, and a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On and unknown date in 2014, at age 67, the patient was administered the zoster vaccine live (ZOSTAVAX) by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider for the following injury resulting from his zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the herpes zoster is unknown.  Additional information has been requested.
Noticed rash  and swelling on left thigh on 3-2-23 in the evening.  Seemed to be spreading.  Office visit on 3-3-23. Dr. noted an approximate 12x8 cm lesion on anterior left thigh with erythema and induration, mildly tender.   Cellulitis vs large localized allergic reaction. Plan:  Cool compresses, ibuprofen, antibiotic.  Marked erythema with permanent marker to make sure was not expanding.
I had a sore throat, dry cough that lasted for a couple weeks, and a stuffy nose. I tested positive for COVID-19 at home. I called my PCP and she said just to drink plenty of fluids. I tested negative on 12/23/2022.