chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Autoimmune disorder; Drug allergy; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4216087-00 (Abbvie).  A 38 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 30Mar2021 (Batch/Lot number: unknown) at the age of 37 years as dose 2, single and intramuscular, administration date 25Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "Autoimmune disorder"; DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Drug allergy". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unspecified date, the patient experienced non-serious severe allergic reaction to the medication and thought humira gave another auto immune disease with humira (adalimumab). Pfizer Biontech COVID-19 vaccine (tozinameran) was also considered suspect.   The reporter's causality for the event(s) of severe allergic reaction to the medication and thought humira gave another auto immune disease with humira (adalimumab) was a reasonable possibility.  Causality for Humira (Adalimumab):  Drug allergy (Drug hypersensitivity) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Reasonable possibility Dechallenge: N/A  Autoimmune disorder (Autoimmune disorder) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Probable Dechallenge: N/A  Causality for Pfizer BioNTech COVID-19 Vaccine (Tozinameran):  Drug allergy (Drug hypersensitivity) Causality as per reporter (Drug/Vaccine): Possible  Autoimmune disorder (Autoimmune disorder) Causality as per reporter (Drug/Vaccine): Possible  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event Drug hypersensitivity, Autoimmune disorder  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Information has been received from a registered nurse concerning a 12 month old white female patient with no known drug allergies and no past medical history who on 6/16/03 was vaccinated SC in the left leg with a first dose of varicella virus vaccine live (lot # 644247/0019N). Concomitant therapy included Streptococcus pneumoniae vaccine and HIB conjugate hepatitis B vaccine. Illness at the time of vaccination included fever and fussiness for 24 hours. On 6/28/03 the patient developed 15 varicella lesions and had a temperature of 101.4 F on 6/29/03. There was no treatment given. Follow up information indicated that the patient developed a rash for four days, of a red round area with blister in the center, which scabbed over. There were about 15-20. Additional follow up information indicated that the patient recovered on 7/1/03. No further information is expected.
I have not yet been able to contact the patient. I am not aware of any symptoms, just that the vaccine was accidently given early (46 days from last dose instead of 2 months).
feeling like disoriented; aches and pains; Affecting vision; the aches and pains have gotten worse It's weird because I have like pinching needles on my left arm and leg and it kind of hurts; Dizzy; This spontaneous case was reported by a patient and describes the occurrence of DISORIENTATION (feeling like disoriented), PAIN (aches and pains), VISUAL IMPAIRMENT (Affecting vision), PAIN IN EXTREMITY (the aches and pains have gotten worse It's weird because I have like pinching needles on my left arm and leg and it kind of hurts) and DIZZINESS (Dizzy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced DISORIENTATION (feeling like disoriented), PAIN (aches and pains), VISUAL IMPAIRMENT (Affecting vision), PAIN IN EXTREMITY (the aches and pains have gotten worse It's weird because I have like pinching needles on my left arm and leg and it kind of hurts) and DIZZINESS (Dizzy). At the time of the report, DISORIENTATION (feeling like disoriented), VISUAL IMPAIRMENT (Affecting vision), PAIN IN EXTREMITY (the aches and pains have gotten worse It's weird because I have like pinching needles on my left arm and leg and it kind of hurts) and DIZZINESS (Dizzy) outcome was unknown and PAIN (aches and pains) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. 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.
Client called complaining of severe muscular pain in left deltoid every night in middle of night without any relief from pain medication. He ices and gets relief from that.
after received the shot, he was sitting in the designated area with his brother, then he told his brother that he was going to faint.  Then he hit the floor. 911 was called.   We put the yoga mat under head and put his feet up while waiting for the paramedics.  He was conscious the whole time. the paramedics came and checked on his vitals and all hos vitals were in normal limits. He declined the transport and signed the waivers for the fire department. then his brother took him home.
I been having Migraines and joint and muscle pains throughout my body.  I now have Dyslexia.   I have impaired vision now.  I also have Depression.  I lost my taste and smell (Parosmia).  I went to my doctor about this.  I have been referred to 6 specialists and no one can do anything about this.
Shortness of breath, nauseated, 103 degrees temp, dizzy, looked like: "posturing of all joints", severe headache. DK reddened face, hurt all over. Some confusion, hot/cold started about 1 hr after vaccination & increased until severe by AM.
Averse event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION COMPLICATION (Averse event) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Averse event). At the time of the report, VACCINATION COMPLICATION (Averse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Refridgeration excursions identified; No adverse event; Poor quality vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Sep-2022 at 5:36 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 16-Sep-2022 at 5:36 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    No concomitant medications were reported.  Anatomical location for vaccine administration was reported as deltoid. It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation.The Nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. Date vial moved from freezer to refrigerator was 07 Sep 2022. The vial underwent temperature excursion. No adverse reactions reported for the patient.  No treatment products were reported.
Varicella vaccine #1 given in (R) arm SQ. Now red, warm inflamed area.
Local erythema (6 cm x 5 cm). Induration, pain, itching.
1st dose was on 12/22/2020-day of injection left shoulder pain for 3-4 days then left armpit pain for 3-4 days along with a headache.  2nd dose was on 1/22/2021 at 945am-day of injection right shoulder pain still having , second day after armpit pain and still have, day of injection at approx. 730pm chills, arms and leg muscle so painful you could not touch them for approx. 14-16 hours then was better and came back next night but not as painful and now gone, Headache started approx. 730pm day of injection and has continued and still have, muscles that normal hurt are 10 fold more painful since injection but are finally starting to easy up, fever of 100.9 night of injection only,
Migraines and swollen hands were first experienced in October 2022. By November she was experiencing severe gut and diarrhea; she went to her PCP, who did bloodwork and sent her home. She went back again and then went for more bloodwork. They gave several diagnoses that proved incorrect after two different ER visits. On January 6, she was in the ER for the third time and they transferred her to the hospital and was admitted; they did a colonospy on January 9th and diagnosed 3/4 of her colon was ulcerated. On january 13 she was transferred to a local hospital and they removed her colon.  Dr said that ' the colon disintegrated in his hands like a wet paper towel." She was in ICU for 5 days and did not get released until February 1, 2023. The diagnoses was ulcerative colitis, one of the adverse events listed by Pfizer as an 'adverse event'. The doctor said she would have died if they did n ot remove the colon.
pt recvd vax & devel h/a w/in 24 hrs, 48 hrs later was feeling off color w/low fever; by 72 hrs arm red & swollen & sl itchy, seen by MD was put on Naprosyn did not help was seen again 10APR95 whole upper lt arm swollen, red raised area;
At 1:30 AM the morning after receiving PNEUMOVAX, pt. experienced pain in the entire arm, numbness in fingers and had trouble moving her arm. This was still happening when she came in to the pharmacy the morning of 8/18/17. Still had pain and stiffness in entire arm as of 6 PM when pt. came back in the pharmacy.
The pt experienced difficulty breathing, heart palpitations, lightheadedness, severe pains in rib area, extremely weak and nauseous.
Information has been received from a physician concerning a 79 year old male with a history of chickenpox (when was child) who on 05-May-2009 was vaccinated with one dose of ZOSTAVAX (Merck) (route unspecified, lot number 664028/0137Y) on right arm, also on the same day the patient received a dose of PNEUMOVAX (dose, route and lot number unspecified) in the other arm. Concomitant therapy included Aspirin, Atenolol, Lisinopril, Viagra and generic Synthroid. A diagnosed laboratory (specimen collected for PCR) was performed on 11-May-2009 (results were not reported). The patient reported he had no exposure to chicken pox or herpes zoster recently. The physician stated that on 07-May-2009 the patient went to the physician office because he had a rash, which the physician said was a classical shingle rash type dermatome vesicular with 8 lesions distributed on his right shoulder, up the neck behind his right ear (C-4-5). Other systemic symptoms were reported in the same day: (Maximum temperature: 97.8), fatigue, neuropathy and pruritus. The patient's pain was rated at 8 on a scale from 0 to 10. The physician reported that she diagnosed the patient with the shingles and she did not go back to work until 15-May-2009. At the time of reporting, the outcome of the patient was unknown. The patient was enrolled in the varicella zoster virus identification program to identify if VZV is present and if it is present to identify if it is associated with the wild-type strain or with the Merck vaccine strain. Follow up information has been received from the VZV identification program. It was reported that the PCR results for the specimen from a vesicular lesion identified the presence of Wild Type VZV. Additional information has been requested.
Had DTAP in right arm on 5/24/10, 3 days ago.  Noted some eryth & swelling 2nd day, getting more over last 24 hrs.  No fevers, does c/o some pn, but able to use arm normally.  No prior vaccine RXNS.
Reactivation of herpes virus a week after the second shot. I had not been diagnosed before this, but my Wife has. I remember having an initial outbreak 12 years ago, but hadn?t had an outbreak since until after getting this vaccine.
This case was reported by a consumer via call center representative and described the occurrence of injection site mass in a 63-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received about 3 to 5 years before the reporting date). On 14th August 2018, the patient received the 1st dose of SHINGRIX 50 mcg/mg. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site mass, injection site pain, injection site itching, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site mass, injection site pain, injection site itching, injection site erythema and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site mass, injection site pain, injection site itching, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: This case was not previously reported to anyone. The patient received SHINGRIX on left arm. The patient experienced bumpy, pain, itching, burning, redness and swelling at the injection site with an area of 2 inches by 3 inches. The patient had reported this events to the pharmacy but not to her physician. The health care professional was not asked and not involved at that point of reporting.
Swollen Lymph Nodes on Left Armpit, Inflammation Costochondritis, Abnormal Period
Fevers too 100.0F, Chills, Myalgias, Nausea, Vomiting x5.
Thrombocytopenia after MMR vaccine, platelet count of 2 (normal 140-385).
Ongoing weakness of left arm, and pain in left arm where TDAP injection happened. Pain shooting from site of injection to elbow. Reports that it started after injection. She is unable to lift newborn infant. Reported this pain at her postpartum checkup. Referred to physical therapy.
it also feels warm; Arm turned really red on the injection site, the size of my hand; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (it also feels warm) and VACCINATION SITE ERYTHEMA (Arm turned really red on the injection site, the size of my hand) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. (1 or 0) 27A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced FEELING HOT (it also feels warm) and VACCINATION SITE ERYTHEMA (Arm turned really red on the injection site, the size of my hand). At the time of the report, FEELING HOT (it also feels warm) and VACCINATION SITE ERYTHEMA (Arm turned really red on the injection site, the size of my hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported  Treatment using  anti itch cream was reported
her shoulder blade hurt/burns in between the shoulder blades; hurts all over; Her feet started to hurt; her feet tingle/face tingles/; sometimes a place in her face will burn; a lot of pain going on; tongue tingles; unable to sleep; dizzy; her whole left arm (which is the injection arm) started killing her; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (her whole left arm (which is the injection arm) started killing her), ARTHRALGIA (her shoulder blade hurt/burns in between the shoulder blades), MYALGIA (hurts all over), PAIN IN EXTREMITY (Her feet started to hurt) and PARAESTHESIA (her feet tingle/face tingles/) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced VACCINATION SITE PAIN (her whole left arm (which is the injection arm) started killing her). On an unknown date, the patient experienced ARTHRALGIA (her shoulder blade hurt/burns in between the shoulder blades), MYALGIA (hurts all over), PAIN IN EXTREMITY (Her feet started to hurt), PARAESTHESIA (her feet tingle/face tingles/), BURNING SENSATION (sometimes a place in her face will burn), PAIN (a lot of pain going on), PARAESTHESIA ORAL (tongue tingles), INSOMNIA (unable to sleep) and DIZZINESS (dizzy). At the time of the report, VACCINATION SITE PAIN (her whole left arm (which is the injection arm) started killing her), ARTHRALGIA (her shoulder blade hurt/burns in between the shoulder blades), MYALGIA (hurts all over), PAIN IN EXTREMITY (Her feet started to hurt), PARAESTHESIA (her feet tingle/face tingles/), BURNING SENSATION (sometimes a place in her face will burn), PAIN (a lot of pain going on), PARAESTHESIA ORAL (tongue tingles), INSOMNIA (unable to sleep) and DIZZINESS (dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.
BACK PAIN; ARM PAIN; FATIGUE; This spontaneous report received from a parent concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced back pain. On APR-2021, the subject experienced arm pain. On APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, arm pain and back pain was not reported. This report was non-serious.
p/vax pt T102-103; red dots 9/5 back; front arms; scalp & cheeks; rash lasted; fading 9/7
Following injection of COVID19  Moderna LOT 043B21A in the left arm, the patient stated tingling of arm and pain in the injection site. The Client stated that the tingling sensation radiated to opposite arms as well.
"Moderna COVID-19 Vaccine  Was relaxing and getting ready to read my book on phone. A few minutes after taking the vaccine, blood pressure fell, dizzy with risk of passing out, weak, very rapid heart beat, nausea. Jumped up and starting moving to create energy to avoid passing out. The dizziness reduced somewhat and did not get worse, but was still present. Heart rate slowed after a significant period of time. Then symptoms resolved. No emotional triggers and no history of any such events at any time in 60 years.
Metallic smell and taste started when eating dairy products , than it expanded to bread and fried foods.  Now I experience a metallic taste and smell with 95% of the food I eat.  I have tried a variety of different foods with no success of normalcy.  This altered sense of smell and taste had caused me to lose over 30 lbs in 5 months due to the lack of nutrition.  Inability to eat fruits and vegetables has weakened my immune system and body.  I have diarrhea and vomiting daily, especially when I force myself to eat foods that smell and taste metallic.  This has spiked my anxiety and I experience daily chest pain and numbness in my right arm.
Approximately 1 month after receiving a high-dose flu shot in my left arm a tremendous pain hit my left am and chest area that nearly took my breath away. The pain continued through the night, and from that time forward I was not able to sleep on my left side, nor use my arm for hardly anything because of pain and weakness for the next 22 months, when it finally abated and gradually became normal.
I believe it?s acute bronchitis. Had a cough since I got the vaccine and a slight sore throat as well as feeling congested.