chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pulmonary fibrosis; We still got Covid; This spontaneous case was reported by a nurse and describes the occurrence of PULMONARY FIBROSIS (Pulmonary fibrosis) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna (First dose and Lot no: 012M20A.) on 02-Feb-2021. Past adverse reactions to the above products included No adverse event with Moderna.    On 08-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criterion medically significant) and COVID-19 (We still got Covid). At the time of the report, PULMONARY FIBROSIS (Pulmonary fibrosis) and COVID-19 (We still got Covid) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Patient received all the doses of Moderna vaccines until now. Patient had less severe Pulmonary fibrosis.  Treatment information was not reported.  Company Comment: This is a Spontaneous case reported by a nurse, concerning a female patient of unknown age, with no relevant medical history, who experienced the unexpected and serious (due to medically significant) event of Pulmonary fibrosis, and the unexpected and non-serious event of COVID-19, which occurred on an unknown date after an unspecified dose of mRNA-1273.222 vaccine. Previous doses were administered with mRNA-1273 vaccine. No information disclosed about diagnostic tests performed, clinical course or treatments received. COVID-19 could be a confounding factor for Pulmonary fibrosis. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-747938 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747938:Case for Husband
At checkout reported generalized itching itching only no other sx. Benadryl 50 given
The COVID-19 booster caused substantial pain at injection site for 48 hours.  Then, on December 1st, the finger joints on my left hand became so swollen and painful that my wedding rings (six) got stuck on my hand.  I had to literally rip them off my fingers because leaving them on overnight would have worsened the condition.  Since then, I cannot wear these rings at all.  I was married in 1985, and my rings have never been sized since I first received them.  I also am unable to get an appointment with a primary care physician in my area to look at my joints and suggest a course of treatment.
No adverse effects reported.; an unspecified number of patients received improperly stored dose of RECOMBIVAX, GARDASIL 9, MMRII, or PROQUAD; The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify.  Follow-up information has been received from the practice manager on 18-SEP-2018.  This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided.       On 19-JUN-2018, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin) (strength and route were unknown) (lot# N024562 and expiration date 06-MAR-2019) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK STERILE DILUENT) was properly stored. No adverse event was reported.  The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959:
extreme body pain all over and in particular she is having trouble with her legs; extreme body pain all over and in particular she is having trouble with her legs; Her muscles are rigid and she can't even stretch them; Trouble walking; Her muscles are rigid and she can't even stretch them/leg stiffness; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- UNKNOWN) via an unspecified route of administration on 15Feb2021 as dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included first dose of 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. She had side effects after second dose on 22Feb2021, 1 week (7 days) after the vaccine. Her muscles became rigid, had trouble walking, started sore all over and then legs got stiff and trouble walking, and she walked every day, all day everywhere normally on 22Feb2021. She was wondering, she had her second shot on the 15Feb2021 and she was fine with both shots but then 3 days ago she woke up with just extreme body pain all over and in particular she was having trouble with her legs and it was getting worse every day. It was like her muscles were so rigid and she could not even stretch them. She was wondering was this from the COVID vaccine or was there something else bizarre going on. She walked all day everywhere normally. She said she had somewhere to be if it only takes a minute or 2 she can do a report but if it is longer she would have to do it later. She had been holding several hours to get someone and now she has run out of time. She asked will she be talking to someone now about this. She asked was all of that going to take more than 4 to 5 minutes because she had to get where she was going. She said she will just call them back later. Her muscles became rid get, trouble walking, 22Feb2021 (also reported as 22Jan2021) started sore all over and then legs stiff and trouble walking and she walks everyday. She had not talked to her doctor. The outcome of all event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Patient states she started developing a rash around the sides of her neck that looked like a sunburn that starting the following day and was the worst on following night (9-29-22) but is now clearing up.
7/14/2021 Newly diagnosed systolic heart murmur discovered during regularly scheduled annual exam.  Further testing scheduled but no specific treatment.
Patient received Pfizer Covid-19 (5-11yo) dose instead of >12yo dose.
Information has been received from a 58 year old male consumer with type 2 diabetes mellitus who on 04-NOV-2009 was vaccinated with a dose of PNEUMOVAX 23 (lot# 664654/0823Y) on his left arm at the place of his employment since it was covered by their company. Concomitant vaccination administered on the same day included a dose of influenza virus vaccine (unspecified) (Manufactured by Sanofi Pasteur) on his right arm. Other concomitant therapy included metformin. "4 hours" after receiving the vaccine, the patient developed pain on his left arm specifically "above the injection site" where he received the PNEUMOVAX 23. It was noted that his right arm was fine. It was reported that on 05-NOV-2009, the patient could not move his left arm and he had the pain for "16 hours" at the time of the report. The patient reported that he had been having muscle pain, ringing in his ear and headache but he didn't have fever. The patient called the nurse for medical attention. There were no laboratory diagnostic studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
The patients did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 13 months old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 24-JAN-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, dose, route of administration and anatomical location were not reported) of lot # S006647 is an invalid lot number, expiry date reported as 05-MAR-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
On 4-13-11 pt got rash on stomach & upper thighs, reddish pinhead raised, on 4-17 had spread to entire body and was very itchy, esp around diaper area.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 21-MAR-2016 the patient was vaccinated with an improperly stored dose of M-M-R II single 0.5ml dose (rHA, lot # L007577, expiration date 05-MAR-2017, route unknown). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 16 hours with the highest recorded temperature of 49 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown age and gender. No medical history and concurrent conditions of the patients were reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored does of GARDASIL 9 lot # L007560, expiration date 15-JUN-2017 (dose and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter.  Additional information has been requested.
Patient states that since receiving flu shot, he has had chest congestion/pain and has not been able to lift his arm much.  He is seeing his doctor next week.
01/18/2022 Blood coughing - hemoptysis - sclerose of the wound in the lung 01/20/2022 Back to residential care home for the elderly  01/20/2022 Evening: emergency forwarding to nearby stroke unit  stroke detected (right side), left body side coordination not possible heart problem detected (intermittent cardiac fibrillation ED) - cardiac pacemaker implanted 02/01/2022 Back to residential care home for the elderly  Left body side almost no movement, permanent wheelchair usage, voice not understandable due to almost no mouth/tongue movement sorry for bad translation --- if needed I can provide original medical letter in Native language
Patient felt very dizzy within a few minutes of vaccination.  We had patient lie on floor for 15 or so minutes until he was feeling better.  He drank a sunny d and ate ritz peanut butter crackers.
12/9 - Developed dermatographic urticaria - whole body. Benadryl every four hours - no relief. 12/11 - Urgent care visit due to continued presence of urticaria and severe pruritus. Prescribed cyproheptadine 4mg/3x daily.  12/11-12/14 - Sore throat began,  urticaria persisted (slight relief), mild chest discomfort. Very drowsy/dizzy from medication.  12/14 - Appointment with primary care physician. Stopped cyproheptadine. Started prednisone 40 mg/1x daily, Zyrtec 20 mg/1x daily (morning),  Fomatidine 1x daily, Benadryl 1x daily (night). 12/15 - Dermatographic urticaria persists, however pruritus has somewhat  lessened. No sore throat or chest pain.
Given Tdap injection on 1/21/11 and several days later noticed redness and swelling.  Swelling, warmth, and redness measuring 50mm X 80mm has increased over the past 6 days since injection.
On the day I received the second dose of the vaccine (2-12-2021), my arm began hurting and burning later in the day.  I checked my arm and I   developed a rash that spanned the length of my upper arm.  By 2/15/2021, the pain and burning got more intense.  I contacted my doctor via an e-visit.  I took a picture of my arm and submitted to Hospital.  They advised me to use OTC antihistamines and use steroid cream for itching.  I was prescribed triamcinolone.  The rash lasted for 3 weeks and 2 days.
Patient complained of nausea and dizziness. BP checked after patient transferred to wheelchair and lost consciousness, found hypotensive at 69/34. Physician notified, recommended patient be observed in ED. Patient transferred to ED per physician recommendation.
Local reaction within 24 hours of Varivax #2 administered on 12/7/07.  Redness/swelling/tenderness at site, 1" x 1" within 24 hours then increased sxs locally at 48 hours, on 12/10/07 site measured 4 3/4" long x 3" wide: erythema, edema, pallor with c/o pruritus, tenderness improving; no vesicles; no fever; pt. not ill.
Patient started to notice hives on the back of her neck, between legs and on wrist about 5 hours after administration of the vaccine.  Patient has been taking diphenhydramine which is controlling symptoms and was notified to seek immediate medical attention if she had any trouble breathing.
Pt had previously received Pfizer Young Pedi dose x2 and then turned 5.  Pt would need to complete the primary series preferably with Pfizer Pedi (5-11) monovalent dose (or alternatively w/ the 6mo-4yr dose).  However, pt was administered the bivalent booster dose for Pfizer Pedi 5-11yrs.
Red rash on upper chest.   It may not be related to the vaccine...I have had various skin reactions over the past year.  It is still red and inflamed five days after it appeared
Had to travel overseas so I got the second dose of Moderna covid-19 vaccine.  Since that evening I have problems  on and of with tingling/ numbness in both feet?s and both hands. Left side are worse and it also get worse when sleeping. Sometimes it feels like I stepped in something wet with my left foot but I have not., the foot are dry.  The last year I have red dots and bumps all over my body beside my face.
Severe vomiting q1/2hr.Starting 130am on 21Mar91 lasting until 400am.Was seen in ER @ 300am on 21Mar91 wheezing & vomiting.ER MD said wheezing was from vomiting,lung clear.No sx of infection,ears clear,no fever.Started /w diarrhea,T 102 ax
Pt recv vax on 10/9/98; on 1/25/99 pt exp red, bumpy rash on lt leg-scab then purple color; pain; dx=shingles
Pt initially developed redness and swelling at injection site of seasonal flu vaccine in right arm, which worsened 12/30/09. 12/31/09 the redness and swelling began to subside but he became light headed, dizzy, and developed intermittent shortness of breath.
This spontaneous report was received from a nurse regarding multiple unspecified patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, unspecified multiple patients were vaccinated with improperly stored VARIVAX lot# M028551 with expiry date 07-JUN-2018 for prophylaxis (dosing details not reported). No adverse effects were reported. Temperature was 68F, time frame was 1 hour, no previous excursion and no data logger involvement. No product quality complaint was involved. This is one of the three linked reports. 1612USA010738 (Same Reporter Link) and 1612USA010737 (Same Reporter Link). Additional information has been requested.
I just went and got my covid test done with a sore throat; This is a spontaneous report from a Pfizer Sponsored Program. A non-contactable nurse (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/batch number and expiry date unknown), via an unspecified route of administration on 16Dec2020 at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received her first dose of the COVID vaccine on 16Dec2020, stated that her boyfriend just tested positive. She stated, "I just went and got my covid test done with a sore throat".  She wanted to confirm if she can receive the second dose and also asked if there is a problem with delaying the second dose of the vaccine. The patient underwent lab tests and procedures which included Covid test: unknown results on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
On 12/8/01, states: complained of weakness and muscle pain as well as joint pain, immediately upon awakening. Signs and symptoms increased and he was admitted to the hospital ICU. Exhibiting signs and symptoms of cardiac and neurological involvement.
Dizziness, lightheaded, vertigo symptoms mostly when changing between sitting/standing/lying down, but also sometimes happens randomly.  Not associated with dehydration or lack of food.
Tested positive for Covid 19 per antigen on 12/27/2021. Treated with Bamlanivimab and Regeneron infusion 12/29/2021. Presented to ED on 1/13/2022 with respiratory failure, SOB, hypoxia, tachypnea, wheeze, prolonged QTC. Treated with fluids and dexamethasone and admitted. Placed on decadron protocol. Later on high vapotherm and BIPAP support. Pt With further worsening hypoxia on 2/7, started on Zosyn. On 2/11 , pt further worse, tachypneic, desaturating despite being on max vapotherm/BIPAP. transitioned to comfort care. Pt died 2/12/2022.  Submitter does not have access to full medical record. If further details are needed regarding the medical course while inpatient, please contact the healthcare worker at the local hospital.
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), on 24Feb2021 as dose 2, single (Lot number: EN6201) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (ongoing); "hyperthyroid" (ongoing); "Fibromyalgia" (ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose 1, lot EL9262), administration date: 27Jan2021, when the patient was 77-year-old, for Covid-19 immunisation. The following information was reported: DIZZINESS (non-serious) with onset 24Feb2021, outcome "unknown"; PRESYNCOPE (non-serious) with onset 24Feb2021, outcome "unknown", described as "almost passed out".  Additional Information: The patient had high blood pressure diagnosed long time ago; don't know when this was diagnosed but she went to her doctor on Tuesday for a regular check up and it was low and was 112 over 60 something, thyroid condition hyperthyroid; was diagnosed a long time ago and she has been taking thyroid medicine for quite a while. 2nd shot she got, she had almost an immediate reaction to that but did not realize that is what it was until later and the reaction was that she got dizzy, had to be driven home and was in a chair at the store; she had gone to physical therapy and went and almost passed out and someone had to come get her.
Patient was given an extra MMR-V and Dtap-IPV at 5 years old when she had already received both of these vaccines at 4 years old.
Information has been received from a physician concerning a 67 year old female pt with "a touch of insomnia," a history of a "recent cold" and no allergies who in October 2002, was vaccinated IM with a dose of pneumococcal vaccine 23 polyvalent (640744/0994L). Concomitant vaccine therapy included a dose of influenza virus vaccine (Fluzone). There was no illness at the time of vaccination. Concomitant therapy included alendronate sodium, Ceftin and azithromycin. Subsequently, the pt developed nausea that started 7-10 days after the injection and lasted for 30 days (previously reported as being present since right after the pt received the shot). The pt also had difficulty sleeping and had a cold. The physician feels as if the cold was unrelated to the shot but questioned if the injection could possibly cause the nausea. On 12/17/02, no intervention was reported. On 1/10/03, it was reported that the pt had a GI consult, unspecified blood tests and an MRI of the head, all of which were negative. Subsequently, on 12/23/02, the pt recovered. Additional info is not expected.