chrisvoncsefalvay/vaers-outcomes huggingface dataset:
There are 5 published case reports on patients developing sarcoidosis in close time proximity to COVID-19 mRNA vaccination; This is a literature report.  A patient (no qualifiers provided) received bnt162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SARCOIDOSIS (medically significant), outcome "unknown", described as "There are 5 published case reports on patients developing sarcoidosis in close time proximity to COVID-19 mRNA vaccination".; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event Sarcoidosis and the use of suspect product bnt162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN),  cannot be fully excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.,Linked Report(s) : US-PFIZER INC-202300319518 Same Article/drug/event and different patient;US-PFIZER INC-PV202300165539 same article/drug/event and different patient;
So he got his shot we came home he was just a little irritated. Then 24 hours later he's randomly throwing up and is still at random throwing up. When he throws up he's  just pukes and acts like nothing happened and continue playing. It's  very strange  he doesn't act like his stomach hurts and has No, no other sick symptoms. He's just tired, cranky and puking. He still has previous cough but has not gotten worse with this round of shots.
On the night of the 26th of August my son broke out in a rash on his legs and arms. As the days progressed the rash spread to his face and lower abdomen and also got progressively worse. I took pictures as the rash went from pimple like places to blister like places all over his arms, legs, face, ears, and lower abdomen. It was very enflamed and he stayed itchy and uncomfortable with a good number of the blisters popping open on their own or from scratching leaving scars on his legs and arms. I had to keep him slathered in Caladryl lotion and change his clothes twice a day and wash his sheets daily. He was given Benadryl to help with the itching and to keep him comfortable. He also took an oatmeal bath every night before bed. He had the rash from August 26th and still to this day, September 18th, has a few places left on his arms and legs. It peaked for two weeks but started to go away/lessen around the 8th of September.
Patient complained of increased heart rate, was hot and sweating.  BP 132/78, O2 99%, Pulse 90.  Patient was monitored additional 15 minutes, she felt back to normal and was cleared.
extreme headache; chills; body ache; fever; swelling at the armpit; lumps; itchy; redness; tenderness on the right arm (site where the vaccine was injected); Injection site was swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling at the armpit), MASS (lumps), PRURITUS (itchy), ERYTHEMA (redness) and VACCINATION SITE PAIN (tenderness on the right arm (site where the vaccine was injected)) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 009CZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: SHINGRIX since an unknown date. Concurrent medical conditions included Drug allergy (allergic to biaxin). Concomitant products included IBUPROFEN from 29-Mar-2021 to 29-Mar-2021 for Back pain, DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) from 01-Jan-2021 to 27-Apr-2021 for Headache and Myalgia, PROBIOTICS NOS from 01-Jan-2021 to an unknown date and VITAMIN E NOS for an unknown indication.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced PERIPHERAL SWELLING (swelling at the armpit), MASS (lumps), PRURITUS (itchy), ERYTHEMA (redness), VACCINATION SITE PAIN (tenderness on the right arm (site where the vaccine was injected)) and VACCINATION SITE SWELLING (Injection site was swollen). On 26-Apr-2021, the patient experienced HEADACHE (extreme headache), CHILLS (chills), MYALGIA (body ache) and PYREXIA (fever). On 10-Apr-2021, PERIPHERAL SWELLING (swelling at the armpit), PRURITUS (itchy), ERYTHEMA (redness), VACCINATION SITE PAIN (tenderness on the right arm (site where the vaccine was injected)) and VACCINATION SITE SWELLING (Injection site was swollen) had resolved. At the time of the report, MASS (lumps) outcome was unknown and HEADACHE (extreme headache), CHILLS (chills), MYALGIA (body ache) and PYREXIA (fever) had resolved.            other meds: concomitant medications include vitamin d 4000 iu , osteo bi-flex   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: information was provided, added events, concomitant medications and vaccine details.
Pt reports developing fever of 102 deg F, night sweats, body aches and cough starting on the day after vaccine was given. reports that cough has worsened over the past week.
Hands and feet, knee swelled. Neck joint and jaw joint were stiffen. CPK raised to 400 early August and to 1100 a month later. Did chest CT scan and x-ray. The doctor diagnosed the patient to have polymyositis with Interstitial lung disease. The patient started predniSONE 20 MG tablet on September 14, three times a day.
developed ringing in ears; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2, solution for injection), on 19Jan2021 as dose 1, single (Lot number: EL0142) at the age of 75 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Anal cancer", start date: 2013, stop date: Aug2013, notes: Pertinent Details: Chemo/Radiation Remission; "Heart disease", start date: 16Feb2016 (ongoing), notes: Pertinent Details: 3 stents placed; "Hypothyroid" (unspecified if ongoing); "Lipid high" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism (ongoing); PRAVASTATIN [PRAVASTATIN SODIUM] taken for lipids increased, start date: 2001 (ongoing); ASPIRIN 81 taken for cardiac disorder, start date: 2016 (ongoing); CO Q10, start date: 2001; PLAVIX taken for cardiac disorder, start date: 16Feb2016, stop date: 29Apr2022; VITAMIN C [CALCIUM ASCORBATE], start date: 2000; VITAMIN D [VITAMIN D NOS], start date: 2019; STATIN for 25 years; MULTI VITAMIN, start date: 2019. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "developed ringing in ears".  Additional information: After first vaccination 19Jan2021 developed ringing in ear, Doctors refused to address this cause because I had hearing lost.
Rt arm "feels heavy" , dizzy, head hurts, T 97.4. Rx- hydration. Sent to class 10:14 a.m.
Felt like I had stomach flu- body aches, headache, chills,fever and vomiting
FLUVIRIN multidose vaccine was administered to patient on 2/6/17. Pt developed facial paralysis and symptoms of Bells Palsy on 2/10/17.
On February 13, 2003 he received IPV, MMR, influenza, Hepatitis A #1, and Hep B#1. He felt strange afterwards but did not experience any significant reactions. On March 13, 2003 he received Hepatitis B #2, typhoid, and tetanus. Approximately one week later he noticed a rash on his shoulder that resembled pinpricks and was brownish in color. At this time he also began experiencing short-term memory loss and bouts of confusion. He reports that his left hand occasionally felt as if it were going to sleep and tingle and his right arm felt as if he had hit his funny bone and he was having joint pain.  His left leg occasionally would feel cold and tingly. It was during this time that he began to experience sensations like his heart was skipping beats and felt as though he would black out. He was seen by a psychologist at that time and told that his symptoms were probably related to stress. July 2003 he received Hepatitis A #2 and Hepatitis B#3 as two separate injections. After this he states that the joint pain in his right arm began to migrate. The chest palpitations changed to chest pressure and he began to have kidney pain. He also reports that his visual acuity has changed.
Severe abdominal pain located right hand side below navel toward hip; This is a spontaneous report received from a contactable patient. A 61-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6207) via an unspecified route of administration in the left arm on 18Mar2021 at 12:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. The patient medical history included high blood pressure but under control with medication. The patient was allergic to nuts, some fish, melons. Concomitant medications received (unspecified medication). Prior to the vaccination the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not tested positive for COVID-19 since having the vaccine. On 12Mar2021 at 01: 00, the patient experienced severe abdominal pain located right hand side below navel toward hip. The patient did not receive treatment for the event. Adverse event not resulted in doctor health care visit. The clinical outcome of severe abdominal pain located right hand side below navel toward hip was not recovered.   No follow-up attempts are possible. No further information is expected.
Ironically, my mother who also had Moderna this year is now suffering the same ill fate-Hair loss; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ALOPECIA (Ironically, my mother who also had Moderna this year is now suffering the same ill fate-Hair loss) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Ironically, my mother who also had Moderna this year is now suffering the same ill fate-Hair loss). At the time of the report, ALOPECIA (Ironically, my mother who also had Moderna this year is now suffering the same ill fate-Hair loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2021: Non-Significant follow-up appended to AER
Approximately 7 hours after vaccination on 3/10/09, started feeling febrile (no temperature was taken), chills, sweating, weakness, full body muscle ache, headache, and light-headed.  Sweating and chills resolved by morning, and all other symptoms except for headache resolved by the afternoon of the 11th.
The vial expired on 02-May-2022, was put in refrigerator on 03-May-2022 until 1:45 PM and administered on 03-May-2022 between 2-3 PM; dose administered past manufactures expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date) and PRODUCT STORAGE ERROR (The vial expired on 02-May-2022, was put in refrigerator on 03-May-2022 until 1:45 PM and administered on 03-May-2022 between 2-3 PM) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     The patient had no known allergies.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 03-May-2022 at 2:50 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 03-May-2022 at 2:50 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 02-May-2022, was put in refrigerator on 03-May-2022 until 1:45 PM and administered on 03-May-2022 between 2-3 PM). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date) and PRODUCT STORAGE ERROR (The vial expired on 02-May-2022, was put in refrigerator on 03-May-2022 until 1:45 PM and administered on 03-May-2022 between 2-3 PM) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date) to be related. No further causality assessment was provided for PRODUCT STORAGE ERROR (The vial expired on 02-May-2022, was put in refrigerator on 03-May-2022 until 1:45 PM and administered on 03-May-2022 between 2-3 PM).    No Concomitant medication was reported  The vaccine vial was initially pulled from freezer at 10 AM on 03-May-2022 and was put in refrigerator until approximately 1:45 PM. All 12 doses were administered between 2-3 PM on 03-May-2022.The vial did not undergo any temperature excursions. No Treatment medication was reported
Urticarial rash beginning 2 days after ADACEL injection, treated with oral PREDNISONE and BENADRYL 8/31/09.
chronic cough; Itchy welt in the lower of my back, its more like swell; whelps; This is a spontaneous report from a contactable nurse reported for herself.  This 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EJ1685, Expiry Date: 31Mar2021) via an unspecified route of administration at single dose in the right deltoid on 22Dec2020 08:00am for Covid-19 immunisation. Medical history included stage 0 breast cancer, she had a lumpectomy and radiation in 2016,  she also just her Zyrtec for her seasonal allergies a few minutes.  Concomitant medications were not reported. The patient experienced whelps on 22Dec2020 02:00pm with outcome of not recovered, chronic cough on an unspecified date with outcome of unknown, itchy welt in the lower of my back, its more like swell on an unspecified date with outcome of unknown.  The events were described as follows: After getting the vaccine she noticed raised whelps on her lower back. They are about 1-2 cm in length and that was the largest and the smaller ones are about 1/2 a centimeter long. There are 4-5 on her lower back and there is one right around her upper scapula area. She describes them as itchy, red, and raised. She has never had this happen to her before and so she immediately took Benadryl. The patient also reported that she has a chronic cough which has been described as a combination of things. It is an asthma variant cough, she has drainage and a hyper-reactive airway but doesn't not have asthma technically.  The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
Large area erythema, warmth, tenderness up into shoulder and almost down to elbow. 1 soft mobile 3/4 inch right left axillary node.
The 23rd within the first hour my arm had gone numb, I do have the similar reaction with the flu vaccine. Within the first hour I felt dizzy and I was going to pass out and nausea. I completed the rest of my shift, not sure how I did it.  I woke up in the middle of the night with a head ache and not feeling well. On the 24th I started sweating and dry heaving very bad and had no temp. I was in and out of the bathroom the entire shift.  The next day  (25th)I woke up and thought I had the flu, my lymph nodes in my throat had swollen and I just felt bad  the entire day.  The fatigue and exhaustion was un believable.  By the 28th I started to feel much better. Then everything returned back to normal.
My right arm muscles are in spasm all the time and I can barely grip my right hand to pick up an object. I had no previous right arm difficulties.
Day 1 and 2 post booster:  101 Fever, fatigue, chills, sore arm, aches, sweating down front of torso, spotting to period cycle starting  Day 3 and 4 post booster:   Fever resolved.  Fatigue, chills, sore arm, aches, sweating down front torso, unusual heavy flow period  Day 5 and 6 post booster:  Nausea, warm and dull headache behind both eyes and top of head.  Sore arm, Fatigue, unusual heavy flow period  Reporting as very concerned of timing of second doses, additional boosters and dosage.  My body cannot handle two shots 10 months apart.  Concerned for any young child, adult, senior, myself in future to have this many symptoms and for this long.  Especially for those who have fully recovered from a Covid Variant infection and have natural viral antibodies already established.  I took round the clock Tylenol and cold washcloths for at home treatment.    Grateful for Vaccine and strongly feel the TIMING of second doses and any additional boosters needs to be closely looked at.   Especially for those who have established natural viral antibodies.  Kind thanks
This case was reported by a healthcare professional (nurse) and described the occurrence of pain during injection in a 49-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 23 July 2013 at 15:15 the subject received 3rd dose of ENGERIX B (1 ml, unknown route, left deltoid). On 23 July 2013, during vaccination with ENGERIX B, the subject experienced pain during injection. On 24 July 2013, the subject experienced injection site tenderness and bump at injection site. On 25 July 2013, the subject experienced injection site redness and low grade fever. The reporter also stated that the subject experienced "swelling, redness, and low grade fever." At the time of reporting the outcome of the events were unspecified. Follow up was received from nurse on 27 August 2013. The nurse stated that some information was unavailable as the subject lived "in another state." The nurse documented that all adverse events had resolved. The nurse did not consider the events to be serious. The nurse documented that she did not consider the events to involve severe or permanent disability. Medical history, alcohol use and tobacco use were all unknown. Per the injury report, the subject reported the events on 25 July 2013. The subject mentioned that "when she received the vaccine it did hurt but did not have any symptoms other than the pain." On the date of the injury report, the subject reported her pain was 7 out of 10. Per the report, the subject was evaluated by a physician for another unknown reason and asked the physician to look at it. The subject was evaluated another doctor on an unknown date. Per the nurses correspondence, the doctor told the subject that "she was having an allergic reaction." The subject was instructed to "treat with BENADRYL and to go to the hospital if it got worse for a BENADRYL IV." Also per the nurse's correspondence, the reaction was "getting much better. The doctor said to expect it to take about a week to clear so she [the subject] is on track with that."
Covid Pfizer  adult vial vaccine was mixed with 1.3 ml of saline and 0.2ml dose was given to patient instead of Pfizer covid ped dose.
COVID vaccine breakthrough case. Moderna  024M20A on 2/26/21 & Moderna 030A21A  on 3/26/21 and boosted with Moderna 051F21A on 12/06/21.
Nausea, diarrhea, pain to left arm, stated had headache. Blood pressure 135/105 at 3:50 PM.
shot given @ clinic on 12OCT94 came into office 16NOV findings: boil noted over right thigh area about 2cm in diameter w/central loosening consistent w/abscess formation (@ site of inject)-referred to MD for excision & drainage;
Patient  came to pharmacy to receive second Moderna covid shot.  Patient received shot and asked to stay for 15 minute for observation. While waiting, patient complaint chest pain when he breathe in deeply.  Patient waited little longer and felt symptom was getting worse so patient wanted pharmacy to call 911.  The paramedics came soon after and patient left with them.
I noticed a bald spot on the top of patient's head.  Within days I noticed more balding spots and thinning.  I took her to her pediatrician who referred me to a dermatologist who referred me to our current Pediatric Dermatologist Specialist.  Patient has used/ is using 2 different medications on her scalp and received injection in her scalp on April 23, 2010.  She has lost about 35% of her hair.  It falls out every day by the handfuls.  She has been diagnosed with alopecia areata.  It was caused by the H1N1 shot.
Large red painful welt at site of injection  Extreme cold chills, to the point of feeling like needles were in my skin  Body aches that confined me to my bed and did not allow me to move
Rectal bleeding on day 2 close to 40 hours after getting 2nd shot of the Moderna series.  pt  had severe fatigue that morning that continued to increase & he left work early.  Once he got home he used the bathroom and had visible blood noted with BM.  Painless rectal bleeding x 1 episode.  was set up with GI for upper & lower scope both scopes were negative
Pt presents with cc of; continued reaction at injection site of Hep A immunization. She c/o that injection was quite painful and for at least 30min after injection. Then she developed swelling, redness and heat in a 5x 7.5 cm diameter area. It was and continues to be very tender to touch. She noted a bruise the next day and yesterday as redness and swelling resolved noted several itchy, minute, raised, red areas around several follicles that were very close to outline of resolving bruise. She tried to tx with ALLEGRA that itch but it didn't seem to have any effect at all. She will keep an eye on it and call with any worsening of sx, or signs of infection. She will try BENADRYL for the itch tonight.
headaches; injection site pain; higher than normal blood pressure; pain in arm; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (headaches), VACCINATION SITE PAIN (injection site pain), HYPERTENSION (higher than normal blood pressure) and PAIN IN EXTREMITY (pain in arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches), VACCINATION SITE PAIN (injection site pain), HYPERTENSION (higher than normal blood pressure) and PAIN IN EXTREMITY (pain in arm). At the time of the report, HEADACHE (headaches), VACCINATION SITE PAIN (injection site pain), HYPERTENSION (higher than normal blood pressure) and PAIN IN EXTREMITY (pain in arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment icepack at night after first vaccine.   This case was linked to MOD-2021-014742 (Patient Link).
Pt loss consciousness for approximately 10 seconds upon administering Tdap and seasonal flu vaccine.