chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested because of exposure to friend and co-worker who tested positive two days after having coffee and visit at her home. refused to have 2nd sample obtained for a send out to
Shakiness, feeling of wanting to faint, headache, fatigue, exhaustion , nauseous So far I have taken Excedrin
7/23/21 First Dose:  3 hrs after injection developed raised red spotted rash under left armpit and chest with fever & extreme malaise that lasted 3-7 days.  Rash resolved after 7days.  8/9/21 Second Dose:  "Reports being extremely sick!" Fever, severe malaise, full body raised red dotted rash, body pain, rash very itchy and painful.  Headache, diarrhea, N/V x 3-5 days.  Doctor prescribed Benadryl.  Rash  resolved in 9-10 days post vaccine.
The vial was initially stored in the refrigerator on 02-Mar-2023 and administered after manufacturer expery(11-Feb-2023); No adverse event; Patient received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Mar-2023 and administered after manufacturer expery(11-Feb-2023)) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Mar-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Mar-2023 and administered after manufacturer expery(11-Feb-2023)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Mar-2023 and administered after manufacturer expery(11-Feb-2023)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Mar-2023 and administered after manufacturer expery(11-Feb-2023)).    Concomitant medication was not provided.  Nurse reported that the vial was intact carton and size was unknown. The vial was initially stored in refrigerator on 02-Mar-2023 and was administered to patient on 02-Mar-2023. The vial did not undergo any temperature excursion. Treatment information was not provided. This case contains information for the 3rd patient out of 6 child patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-715544, US-MODERNATX, INC.-MOD-2023-715545, US-MODERNATX, INC.-MOD-2023-715548, US-MODERNATX, INC.-MOD-2023-715549, US-MODERNATX, INC.-MOD-2023-715551 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715544:Patient 1(Master case) US-MODERNATX, INC.-MOD-2023-715545:Patient 2 US-MODERNATX, INC.-MOD-2023-715548:Patient 6 US-MODERNATX, INC.-MOD-2023-715549:Patient 4 US-MODERNATX, INC.-MOD-2023-715551:Patient 5
This case was reported by a physician via sales rep and described the occurrence of painful rash in a 55-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, unknown after receiving SHINGRIX, the patient experienced painful rash and influenza-like symptoms. On an unknown date, the outcome of the painful rash was unknown and the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the painful rash and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient developed painful rash on side of body after administration of SHINGRIX. Rash duration was 2 to 3 days. The patient had mild flu like symptoms for several days.
Acute Lacunar Stroke....Events that led up to the stroke....High Fever, 102.6, chills and aches that began five and half hours after the vaccine (4pm on Sunday 5/16)- on and off till Tuesday morning (5/18).  From 3am to 11am on Monday the 17th intense, unbearable and unrelenting heartburn.  Tuesday 5/18 menstrual cycle started 6 days early.  Wednesday night in the middle of the night woke up feeling like I was having a seizure but I was not sure at the time what was happening.  Thursday night odd headaches.  Friday morning awoke with a stroke.  Vision was distorted.  Unable to see or balance.
pain at the injection site; swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) outcome was unknown.            No relevant concomitant medications were provided. No treatment information was provided. The action taken for mRNA-1273 was not applicable.    This case was linked to MOD21-021778, MOD21-025386, MOD21-029062, MOD21-034087, INC.-MOD-2021-030778 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-021778: MOD21-025386: MOD21-029062: MOD21-034087: INC.-MOD-2021-030778:1st dose
HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on MAR-2021. This report was non-serious.
None- vaccine given 13 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for an unknown indication.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were provided.   This case was linked to MOD-2021-395985 (Patient Link).
Fatigue, body aches, chills, inability to sleep due to discomfort  Took ibuprofen and tried to rest, lessened symptoms about 30%
SEVERE AND PAINFUL BILATERIAL AXIAL AND GROIN LYMPHADENOPATHY.
She got her vaccine, was fine, just the sore arm.  Then on the 5th day later in the afternoon she started just feeling achy, mostly her legs, feets, arms and hands.  She tried to ignore it, and later that night her back was involved.  She went to bed, and was really painful.  She took 2 Ibuprofen and tossed and turned all night.  The next day it should of lingered through the night.  It came on again last night and then she took Tylenol, and it didn't really  help all that much either.  She tossed and turned and feels sluggish today, called the pharmacy and they me to report it to you.  She just feels low energy, just not right.
Fever of 104.5; Chills; Nausea; Joint pain; She really is very miserable; She is ill; This is a spontaneous report from a contactable consumer or other non hcp.   A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown), via an unspecified route of administration on 01Apr2021 (at the age of 60-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  Medical history was none. The patient's concomitant medications were not reported. The patient experienced fever of 104.5, chills, nausea, joint pain, she really is very miserable, she is ill on 02Apr2021 and I don't know what to do. Reporter stated, "I really do not know, I am just reading from the paper that she was given at the time of the vaccine. So I do not know the LOT#. I do not have her vaccination card .  The patient underwent lab tests and procedures which included body temperature: 104.5 on 02Apr2021. The outcome of all event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Headache, Bell's Palsy right, decreased taste, decreased corneal reflex, increased tearing.  RX: Prednisone 60 qd x 7d, Valtrex 1000 qd x 5d.  (Mother also had Bell's Palsy after Flu shot in past).
COVID vaccine given to patient under 18 years old.  Unknown adverse effects, was unable to contact parent to discuss.
Two hours and 15 minutes later pt experienced loss of balance. If she closed her eyes she would fall. This was a 2nd time after vaccination with Ataxia last year it occurred too according to pt. Recovered after 9 days. 12/4/09 Medical records received for date 11/2/09. DX: COPD, HTN, Depression, central pontine myelinolysis, allergic reaction bee sting. OV pt states received flu shot 10/5/09, couple hrs later lost balance and fell. Pt has h/o w/ prev. flu vax. MD states reaction is flu vax related.  Neuro consult  5/4/09. DX: acute progressive gait difficulty w/ abn MRI brain showing white matter lesion in the pons. Pt has had complete resolution of sx, w/ tx. Etiology of sx likely to be demyelinating.
Symptoms: Copious, voluminous watery diarrhea. Cramping, churning abdominal pain. Gastroparesis. Vomiting. Muscular soreness involving arms, legs, back, neck. Fatigue, malaise, chills, hot flashes (but no fever, temperature never went above 99.0 F). Treatment: 1 L PLASMA-LYTE, TYLENOL, Gatorade, ZOFRAN, IMODIUM, fluid rehydration and supportive care. Time Course: Symptoms began the afternoon of 1/24 with diarrhea, progressing into abdominal pain and vomiting. By midday 1/25, the diarrhea, vomiting, and abdominal pain had subsided but muscular soreness and fatigue were still present. Now on 1/26, I still feel exhausted but am able to eat and drink and no longer have pain or diarrhea.
90 days after vaccination I started to have feelings of shortness of breath that I?ve not had before.  I started to have chest pains and was told by an ent doctor I had acid reflux.  I?ve never had an issue with acid reflux I believe the vaccine had caused me to develop this.  Now almost 10 months later I now have a swollen arm swelling in my neck .  Since having the vaccine I have been to so many doctors more than I?ve ever had before.  I believe the vaccine has been causing me to have problems that I?ve never had before.  I am a healthy individual with normally no major issues.
Patient was here for a nurse care visit for their COVID (Moderna) vaccine. They had received a Moderna Monovalent vaccine in March of 2023. At their May appointment they were given 0.2ml from the pink cap Moderna vial which was incorrect. They should have received a 0.25 ml dose from the blue cap Moderna vial.
On 3/12 my arm in the area of the injection began feeling like it was burning and itching. Looking at it showed some small red bumps in a zigzag line. Over night it increased to a semi round area about the size of a tennis ball. It is swollen and red. Does not hurt but is uncomfortable like a cross between an itch and a burn. Was given a prescription for loratadine(1xday). Also told to apply ice and watch for about 3 days. If no better or spreads then go to the emergency department.
Pt. had a delayed immunization reaction to Kinrix administered 6/10/2020. Pt developed complaint of headache & general malaise, with a large local area of redness & induration measuring 13.5x11cm
Patient stated he has a fever of 99.2 degrees F and arm pain in both arms as of the morning of 10/13/17. Patient has not sought treatment.
Arm locked up. Unable to lift/ move and extremely painful in shoulder joint. Was given steroid dose pak, steroid injection, muscle relaxer snd pain medication. Took 2 days to be able to use.
Patient said that Md said that she got a bone infection from the vaccine. He treated her with Doxycycline Hyclate 100mg 1bid for 7 days. Patient also stated that after second dose she also had a reaction and was treated again .
This spontaneous report was received from a Medical Assistant referring to an unspecified number of patients of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not provided. Staring on 14-JAN-216 and on unspecified dates after, the patients were vaccinated with improperly stored doses of ROTATEQ (administration routes, lot numbers and expiration dates were not provided). The details of the temperature excursion were as follows: Temperature/time frame: 32.9F for 15 hours and 74.6F for 5 hours. There were no previous temperature excursions. No adverse effects were reported. This is one of two reports from the same reporter. additional information has been requested.
After the first vaccination, I had fever, chills, fatigue, etc. About 23 hours after the 2nd vaccination, I had severe vertigo. I woke up that morning feeling fine and was happy to have no adverse effects. At about 10AM, I started feeling a little dizzy. I had had vertigo about 5 years prior so got on the floor to do a maneuver hoping that would help. When I stood up, the room turned black, and my head started spinning fast. I made it to the couch but fell into it facing the back. About 30 minutes later, I started vomiting all over the couch and myself but because of the spinning, I could not move. I called 911. The EMTs took my vitals which were fine and gave me an anti-nausea pill. I dozed off after they left but was still spinning. My son came home at approximately 3PM and helped me from the couch to the bathroom then to the bed. A few hours after that, I could walk to the bathroom on my own but only by staring at the floor. The next day, I could walk into the kitchen staring at the floor. That night I woke up around 2AM spinning, but it went away in an hour or so.  Since then I have not had the severe spinning, but I cannot move my head quickly and have a general feeling of heaviness in my head. I did not drive for several months, and started to get anxiety. I am driving now, but I cannot drive long distances.
Information has been received from a consumer, who was told by a person that their son was vaccinated with a dose of MMR II (lot # not given) "and then became autistic." The child reportedly stopped talking two weeks after receiving the vaccine and family pictures, compared with those taken prior to receiving vaccine, showed that he was withdrawn. The pt, age seven at the time of the report, has "mild to moderate autism," and is starting to talk. The reporter stated that there was a second report from a separate person regarding their son (WAES0208USA01874) who also developed autism after receiving MMR II. It was unknown if medical attention was sought. *F/UP report on 10/21/02: Add'l info indicated that the MD's office did not know the name or age of the PT."* **F/UP report on 10/10/02: F/UP info received from the MD indicated that he does not recall who the PT is.* Upon internal review, the pt's experience was considered to be an important medical event (OMIC). Additional info is not expected.
Coughing; Congestion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2022US006845 (Privacy).  A 50 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (non-serious), outcome "unknown", described as "Coughing"; NASAL CONGESTION (non-serious), outcome "unknown", described as "Congestion".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache Fatigue Inflammation Shortness of Breath Difficulty Swallowing  Chest Pain Myocarditis Bell Palsy - Left Side of Face Neurological issues Numb Left Leg  Abdominal Bloating
pt recv vax 18OCT96 & as the day went on pt got very quiet, tired & would not eat supper;pt took a 1hr nap;when pt woke up was having sz & not responding to mom;911 called;@ hosp pt had t101.5, arm where shot given blew up twice its size;
This spontaneous case reported by a consumer, describes the occurrence of headache, myalgia (body ache), nausea, extreme fatigue and COVID-19 (COVID-19 positive) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 006M20A) for an unknown indication. The patient's past medical history included no adverse event since an unknown date. On Feb 17, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 18, 2021, patient experienced headache, myalgia (body ache), nausea and extreme fatigue. On Feb 19, 2021, patient experienced COVID-19 (COVID-19 positive). At the time of the report, headache, myalgia (body ache), nausea and extreme fatigue outcome: unknown. Diagnostic results: On Mar 19, 2021, SARS-CoV-2 test: positive.
Anaphylaxis; Swelling of the face; Facial flushing; Nausea; Facial flushing; Facial swelling; Cough; This spontaneous case was reported by an other health care professional and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis (treated with Ocrevus has polysorbate as an ingredient.). Concomitant products included OCRELIZUMAB (OCREVUS) for Multiple sclerosis, AMITRIPTYLINE and BACLOFEN for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced the first episode of FLUSHING (Facial flushing), SWELLING FACE (Facial swelling), COUGH (Cough) and NAUSEA (Nausea). On 13-Mar-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criterion medically significant), SWELLING FACE (Swelling of the face) and the second episode of FLUSHING (Facial flushing). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Facial flushing, Swelling, Cough and Nausea, at a dose of 1 dosage form and EPINEPHRINE for Anaphylaxis, at a dose of 1 dosage form. On 12-Mar-2021, SWELLING FACE (Facial swelling), COUGH (Cough) and NAUSEA (Nausea) had resolved. At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis), SWELLING FACE (Swelling of the face) and the last episode of FLUSHING (Facial flushing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was treated with for Multiple sclerosis that has polysorbate as an ingredient. She had a theory that there was some sort of cross-reactivity between the polysorbate in the Ocreubus and the PEG in the Moderna COVID-19 vaccine that caused this reaction.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Non-Significant Follow-Up Appended; Sender's Comments: This case concerns a 37-year-old female with a serious expected event of anaphylactic reaction, and nonserious swelling face, cough, nausea, and flushing. Event onset 2 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Red rash and welts appeared after about 6 days itchy and increased in size over 3 days, increased itchiness and pain..  Applied Benadryl cream (over the counter), ice and took Aleve.  In day 4 now, not real change in size, continue ice and Benadryl for itching.  If soreness gets worse, will take more  Aleve.
This spontaneous report as received from a 38 year old male consumer reporting on himself. The consumer was vaccinated with complete 3 dose regimen at the recommended intervals of GARDASIL (Lot # not reported) IM in 2002 when it was not approved in men. No other co-suspects were reported. No concomitant medications were reported. Additional information is not expected.
Patient states that a week after the shot she developed a rash on both arms and had difficulty breathing. She did not seek medical attention and the symptoms did resolve but we advised her to contact the doctor and not to get the second dose at this time.
Post-injection patient reported feeling hot, sweaty, dizzy, and flushed. Blood pressure was low. Patient began vomiting. Patient was transferred to a nearby doctor's office for further observation. Patient's symptoms resolved.
Medical Assistant Administered a lower dosage for the moderna 2nd dose.  He administered .25 ml instead of a 0.5 ml full dose vaccine.
At work...cough/headache/chills/body aches/runny nose/sneezing/low-grade fever. Later, at approx 10:30 PM (at home) severe cramping, whites of eyes extremely red (not bloodshot), pupil dialated, red face/arms/hands, stinging of hands, heart rate elevated to over 100, dizziness, weakness, disoriented, vomiting, diarrhea, more chills, severe headache, etc. until approx 1:00-1:30 AM on 9/10/09.  Was able to get to sleep, but remained ill next day and went to see my doctor.
All muscles and lymph nodes (stabbing pains) in knees, elbows, feet, hands and back. I am still feeling stabbing and tingling in muscles, L foot is partially numb. 2nd day after vaccination I had chest congestion and headache. Still feeling stabbing in knees and hands. Swollen Lt arm at injection. Dr's office told me to take ADVIL and I cannot take it because of sensitivity. The date is now 10/12/09 I can't afford to visit doctors office but still have congestion, cough, sweating sputum in nose and chest.