chrisvoncsefalvay/vaers-outcomes huggingface dataset:
16 year old was inadvertently vaccinated with the Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old was inadvertently vaccinated with the Moderna vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old was inadvertently vaccinated with the Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old was inadvertently vaccinated with the Moderna vaccine) 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.
Sore arm; mild chills; fatigue; mild headache/medium headache; This is a spontaneous report from a non-contactable consumer. An adult (18-64) female patient started to received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 22Feb2021 (Batch/Lot Number: EL3247) as single dose for covid-19 immunisation .The patient medical history and concomitant medications were not reported. On 22Feb2021 within 12 hours of injection the patient experienced sore arm, mild chills, fatigue and mild headache between 24-36 hours; medium headache between 36-48 hours (both resolved with oral Advil, 3x 200mg total). The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
The evening of my second dose, I felt feverish but when I took my temperature it was 98.3. At 4:30am (approximately 13 hours post vaccination), I had gotten out of bed for a glass of water and an ice pack. Other than a little arm soreness, I felt fine. While in route for said items, I started to have "fuzzy black spots" in my vision and decided to sit down immediately. I suddenly felt very nauseous and remember being confused trying to figure out if I was going to faint or throw up. I put my head down between my knees but the next thing I remember is being on the floor. I sat up, re-oriented myself with my surroundings (it was still dark), and stood up (in retrospect, possibly too quickly). Trying to walk back to my bed, I fainted again. I laid on the floor longer the second time, not in a rush to get back up. I asked my fiance to get me a glass of water and took small sips. I felt very hot (although did not take my temperature in the moment) and was in a full-body sweat. I eventually made my way back to bed. Approximately three hours later, I got up for the day. I walked from my bedroom to the kitchen and started to have the "fuzzy" vision again. That time, I was able to lay down on the couch and put my feet up before I actually fainted. After recovering and sitting up slowly, I took my temperature. It was 97.6. Around mid-day I felt feverish again and took my temperature. That time is was 99.9 and I took some Tylenol. I have had no more fever or fainting (or near-fainting) episodes since. Two days (approximately 45 hours) after the vaccine, I did have a red patch on my arm over the injection site; however, it was nowhere near as burning or itchy as the rash I developed 8 days after the first dose in the opposite arm (previously reported).
Red swollen area - hot, tender, itchy (10.5 cm x 8 cm) at site of Varicella vaccine.
pt recvd vax & 14 days following the vax devel a rash; No further details were provided;
PT DEVELOPED A 3 INCH  ACROSS WELT REDDNESS WITH 2 BLISTERS. ON LEFT OUTER ASPECT OF ARM WHERE CHICKEN POX WAS GIVEN ICE PACK RECOMMEND AND HYDORCORTISONE.
This case describes the occurrence of Addison's disease in a 31 year old female who received Lyme disease vaccine recombinant for prophylaxis. This report was received from the pt, who is a nurse practitioner. The pt received a series of three injections of LYMErix. The third dose (144B9) was administered on 5/15/00. On3/3/02, approximately 22 months after the third dose of LYMErix, the tp began to experience "some" vertigo. The most recent info was received from the reporter on 10/9/03. She reported that a diagnosis of Addison's disease, which she reported to be life-threatening, had been made on 7/30/03. The events improved. The nurse practitioner considered the vertigo to be related to Addison's disease, which she considered to be unrelated to vaccination with LYMErix. As a result of the follow-up info, this report has been reclassified as serious. Information from Annual Follow-up report states reporters no longer available at contact number or address.
'Light-headed' ...'heavy' arm (cannot lift to the side at all); 'warm to the touch;' achiness; general malaise.
p/ pt recv vax approx 1mo later pt devel a rash & was seen by MD
Achiness into knees, shoulders and elbows; upper lip swelling, heaviness in tongue; hot and sweaty. Next am - puffy eyelids, lips remained swollen 1/11/2005, complete resouloution of symptoms by Wed AM 01/12/2005/
After receiving varicella vaccine pt noticed a rash at the site of injection - Pt returned to clinic 1 week later to report that she still had the rash at the site.
Shingles on his right hip; pain on his right hip; A spontaneous report was received from a male patient of unspecified age concerning himself who received Modern's COVID-19 vaccine (mRNA-1273) and experienced pain and shingles on his right hip.  The patient's medical history provided was not provided. No relevant concomitant medications reported.  On 4 Feb 2021, prior to the onset of the events, the patient received the first dose of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in an unknown anatomical location for prophylaxis of COVID-19 infection.    On 7 Feb 2021, the patient experienced pain on his right hip. On 8 Feb 2021, the patient experienced shingles on  his right hip. No treatment information provided.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of the report, the outcome of event pain and shingles on his right hip was unknown.
Arms, legs, hands, feet, face and neck all became red; Capillaries became inflamed and expanded; A spontaneous report was received from a consumer, concerning a 57-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced erythema and vasculitis.    The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.       On 28 Jan 2021, approximately 8 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 029L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 04 Feb 2021, after receiving vaccine patient experienced systemic inflammatory response where her "arms, legs, hands, feet, face and neck all became red, the capillaries became inflamed and expanded". Treatment for the event included Zyrtec, but it has not helped.     Action taken with mRNA-1273 in response to the events were not provided.  The outcome of the events were not resolved at the time of this report.; Reporter's Comments: This case concerns a 57 year old, female patient, who experienced a non-serious unexpected event of Erythema and vasculitis after receiving mRNA-1273 (Lot# 029L20A). Very limited information regarding this event has been provided at this time. Further information has been requested
Patient called 2 days after vaccination to report that he had developed a rash on both his arms, arm pits, and bilateral upper legs. The patient was instructed to take benedryl and if signs of troubled breathing were suspected to go to the ER. Patient was asked if they had changed use in laundry detergent as he did describe changing his detergent recently, but did not have issue before.
Left eye cataract; Right eye cataract; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old male patient received BNT162b2 (BNT162B2), on 05Feb2021 at 09:00 as dose 1, single (Lot number: EL3248), in left arm and on 26Feb2021 at 13:00 as dose 2, single (Lot number: EL9262), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). There were no concomitant medications. The following information was reported: CATARACT (medically significant) with onset 15Apr2021, outcome "unknown", described as "Right eye cataract"; CATARACT (medically significant) with onset 13May2021, outcome "unknown", described as "Left eye cataract". Therapeutic measures were taken as a result of cataract, cataract. (cataract surgery).
Pain at site injection, vomitting, diarrhea, sore throat, body pain, fever, fatigue, and NOSE BLEED with no nose bleed history.
FLU Like Symptoms after Second Shot; Fever after Second Shot; Chills after Second Shot; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (FLU Like Symptoms after Second Shot), PYREXIA (Fever after Second Shot) and CHILLS (Chills after Second Shot) in a male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (FLU Like Symptoms after Second Shot), PYREXIA (Fever after Second Shot) and CHILLS (Chills after Second Shot). At the time of the report, INFLUENZA LIKE ILLNESS (FLU Like Symptoms after Second Shot), PYREXIA (Fever after Second Shot) and CHILLS (Chills after Second Shot) had resolved.            No concomitant medications reported. No treatment information was provided.
pt recv vax 6NOV95 830-93AM & 10AM threw up;no fever;became very limp/pale, screaming & crying;
Anxious feeling, shakiness, headache, fatigue, nausea and fever of 103 F.
20 minutes after receiving the vaccine I had the sensation of airway constriction which lasted for 15 minutes and then faded.
Staff member came to clinic and received her flu vaccine, left the clinic with no reports immediate reactions. went back to work place. A bit later a coworker came to clinic to inform us she had a reaction and was in the ED. Coworker stated she was pale, the red cheeks, and her tongue was starting to feel funny and they brought her to ED.
I woke up in the morning about 22 hours after my second dose of Moderna vaccine with moderate swelling and puffiness around my eyes  including eyelids, around my brow and upper cheekbones.  (I did not have swelling of other parts of my face as I had about 36 hours after my 2nd dose of Shingrix back in 2018, at which time I had been diagnosed with angioedema by an urgent care physician who advised not to take any further doses of Shingrix if ever recommended.)  I visited an urgent care clinic for examination.  The nurse practitioner who performed the evaluation thought that the swelling could be due to seasonal allergies, though I had not had any similar swelling before or since.  The swelling receded throughout the day and was not noticeable by 24 hours later.
7 days after 2nd booster.  I went out to dinner with friends I started to have palpitations in my chest. Which was unusual for me. My blood pressure went up to 150. I noticed that the palpitations were getting bad, so I called 911. By that time, it went up to 218. While in route to the hospital It was 175. I started feeling pain in mid back area, so they gave me aspirin.  I had alcohol and coffee on one evening and the palpitations were really bad. I am on a beta blocker. The straps used to restrain me, felt tight so I was given aspirin. They drew some blood, and a physician came and said and told me that I did not have a heart attack. I was there until 1 am hooked to a machine to monitor my blood pressure. I had a strange cough that would influence the palpitations. I was placed on a halter monitor from May 31, 2022. Halter study demonstrated that there were no pauses seen. Occasional blocked PAC were observed after 3 days of wearing. Yesterday I went a friend's house and had tea and last night I could not sleep. It was not the regular palpitations, but it was disturbing. The cardiologist placed me on a beta blocker called Metoprolol Tartrate. After the ER visit, the palpitations were horrible. I have to lie down on the couch when attempting to cook a meal. That is slowly improving but the palpitations are still there. I advised the cardiologist that the pills were not making a difference.
This case was reported by a consumer via call center representative and described the occurrence of pain in a 85-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included acetylsalicylic acid (Aspirin), diltiazem hydrochloride (Diltiazem), pravastatin sodium (Pravachol), ascorbic acid (Vitamin C), cinnamomum cassia extract (Cinnamon Capsules), alendronate sodium (Fosamax) and omeprazole (Prilosec). On 14th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a month after receiving SHINGRIX, the patient experienced pain, injection site erythema and rash. On 21st May 2018, the patient experienced skin peeling. The patient was treated with diphenhydramine hydrochloride (Benadryl (Usa)). On 19th May 2018, the outcome of the rash was recovered/resolved. On an unknown date, the outcome of the pain and injection site erythema were recovered/resolved and the outcome of the skin peeling was not recovered/not resolved. The reporter considered the pain, skin peeling, injection site erythema and rash to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient's concomitant medication included Immune booster medication and Centrum Silver for women. The patient's medical history diagnoses prior to receiving vaccine were unknown. The patient received SHINGRIX vaccine in the left deltoid. The patient stated that she received the SHINGRIX vaccine and it hurt like the dickens. Two days after receiving the vaccine around 9 a.m. the patient noticed that her left shoulder was very red. On the inner aspect of her upper arm, abdomen, and chest, there were also rashes. The patient was informed by her pharmacist to take Benadryl that she did take. Two days after that on Friday, the rashes were fading and by Saturday, they were completely gone. The patient stated that by that following Monday, she had a lot of skin peeling on her hands and feet but it was not itchy or sore. The patient was informed by the physician at the pharmacist not to get the 2nd dose of the SHINGRIX vaccine. The permission to contact MD was obtained.
1 week after injection, February 10th, 2 itchy red spots appeared on back of left thigh. Thought they were bites, as I had no other symptoms. The itching and size of spots increased over a week, but did not find blisters until February 17th. Saw Nurse Practitioner on Feb. 18th, who sent swab to lab for verification of Shingles and started me on antiviral, valACYclovir (Valtrex), for 7 days. By Feb. 21. no new outbreaks, and 2 of 4 areas of outbreak were drying.
The flu vaccine was given at about 3pm 11-14-06. The following morning complained about his arm hurting.  The arm was itchy, hard, hot, and red about 3 inches around the site of the injection.  This lasted for about 48 hours, during which time the parent took the child to the doctor and the doctor asked for a report to be filed.
Information has been received from a registered pharmacist referring to a 54 year old female patient with none pertinent medical history and none drug reactions/allergies. On 25-JUL-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot#, strength, route and dose were unknown). Concomitant medication included thyroid medication. On an unspecified date in 2015, the patient then developed a rash that was itchy and red at injection site. The patient returned to the pharmacy on 06-AUG-2015. She showed the pharmacist the rash that was fading and was no longer itchy. There was redness around the injection site of the ZOSTAVAX. The patient also reported that she had a cold sore (in 2015) and did not specify where the cold sore was located on her body. The patient visited an unspecified physician on an unspecified date in 2015 for the cold sore and was prescribed FAMVIR. The patient declined the varicella zoster virus (VZV) analysis. The outcome of injection site rash was reported as recovering/resolving. The outcome of cold sore was unknown. The causality was not reported. Additional information has been requested.
Pt recvd Hep B vax on 5MAY92 had apnea spells on 11MAY92 adm to hosp;
mom called 330PM stating pt would not wake up, had been sleeping since vax;instructed mom to bring pt to ER or clinic;mom brought pt to clinic pt was lethargic but would respond to stimuli;was alert;
concussion; booster; pneumonia; heart surgery; confused; low platelets; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) as dose 3, single, administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cancer" (unspecified if ongoing); "Sepsis" (unspecified if ongoing); "CLL" (unspecified if ongoing); "heart surgery" (unspecified if ongoing), notes: Caller says he has had three heart surgeries over the last 16 months. The patient took concomitant medications. The following information was reported: IMMUNISATION (medically significant) with onset Aug2021, outcome "unknown", described as "booster"; PNEUMONIA (medically significant) with onset 2021, outcome "unknown", described as "pneumonia"; CARDIAC DISORDER (non-serious) with onset 2021, outcome "unknown", described as "heart surgery"; CONCUSSION (non-serious) with onset Nov2021, outcome "unknown", described as "concussion"; CONFUSIONAL STATE (non-serious) with onset 2021, outcome "unknown", described as "confused"; PLATELET COUNT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "low platelets". The event "concussion" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram head: (2021) no bleeding; magnetic resonance imaging: (2021) unknown results; platelet count: (2021) 120, notes: last six months when it hasn't been 140, it has been under, with the highest being 120, and it is 88 now; (2021) 88, notes: last six months when it hasn't been 140, it has been under, with the highest being 120, and it is 88 now. Therapeutic measures were taken as a result of cardiac disorder.  Clinical course: Patient had pending hernia surgery on14Jan, next month. Patient got concussion from 6 weeks ago, got confused and went to get a fourth dose of the Pfizer COVID-19 Vaccine yesterday. Patient walked into the pharmacy and apparently their computer records weren't the best or they didn't check them and patient told them I needed my second shot. And they gave them to the patient, but the patient already had 3 shots. So that total four, but the shot they gave me they thought was shot number two.   The lot number for bnt162b2 was not provided and will be requested during follow up.
A non-serious spontaneous report of administration of H1N1, Intranasal to a 60-year-old female was received from a healthcare professional/medical assistant. Neither relevant medical history nor concomitant medications have been reported for this patient. On 02-Nov-2009, the patient received H1N1 vaccine. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
plaintiffs allege that as a result of immunization a 4 mo of age in 1983 (no reference is made to any prior immunization), infant suffered seizures the following day and suffered permanent brain damage.
In addition to common flu symptoms, I developed a painful large lump about the size of a lemon in my armpit. Also temporary vision improvement in both eyes.
Pt was given a COVID booster by RN at 1539. At 1551 pt reports she feels her face is flushed and she is becoming itchy. I was notified, benadryl 50 mg, was given at 1554. At 1557, pt reports the itching is improving. No SOB, no rash, no redness anywhere. At 1605, pt continues to endorse that the itching is improving and the warm feeling is going away.
Client called to report numbness in left arm, 2 hours after receiving shots on 1/2/08. Arm (Lt) is swollen and red; also she is unable to tolerate any pressure or carry anything heavy.
No adverse effect were reported; the syringe of PROQUAD dose was stored in the freezer for 6 days prior to being administered to the patient; the syringe of PROQUAD dose was stored in the freezer for 6 days; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, current conditions, concomitant medications, drug reactions and allergies.  On 08-OCT-2019, the vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) with lot number S007813 and expiration date on 14-MAR-2021, for prophyaxis (dose, dose number, route of administration and anatomical injection site were not reported) was reconstituted and drawn into a syringe and this was stored on the freezer for 6 days (product storage error) prior to being administered to he patient on 14-OCT-2019 (poor quality product administered). The vaccine was reconstituted with a sterile diluent, with lot number R006344 and expiration date on 13-DEC-2020 (strength, dose, dose number, route of administration, anatomical injection site and indication were not reported). No adverse effects were reported.
Chills, sneezing, runny nose There is no place to enter: PhizerBioNTech COVID-19 Vaccine.
had shingles vacanation and months later shingles/suspected vaccination failure; shingles on mouth; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (the patient had shingles (1st outbreak) after about 18 months of vaccination refer case US2021AMR176031).   On an unknown date, the patient received Shingles vaccine. On an unknown date, between 1 and 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had shingles vaccination and after about 22 or 23 months later had shingles in the roof of mouth. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR176031:same reporter
Nausea, unconsciousness then fell; on the way down hit head and developed a bump on patients left side of head.