chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (lump and hardness to injection site), MASS (bubble next to injection site (Pictures sent to safety)), PALPITATIONS (heart racing), VACCINATION SITE WARMTH (very hot at injection site) and NAUSEA (Nauseous) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE INDURATION (lump and hardness to injection site), MASS (bubble next to injection site (Pictures sent to safety)), PALPITATIONS (heart racing), VACCINATION SITE WARMTH (very hot at injection site), NAUSEA (Nauseous), HEADACHE (headache), CHILLS (chills), VACCINATION SITE SWELLING (lump and hardness to injection site), MYALGIA (body ache) and PYREXIA (mild fever). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) at an unspecified dose and frequency. On 17-Mar-2021, NAUSEA (Nauseous), HEADACHE (headache), MYALGIA (body ache) and PYREXIA (mild fever) had resolved. On 18-Mar-2021, PALPITATIONS (heart racing) had resolved. At the time of the report, VACCINATION SITE INDURATION (lump and hardness to injection site), MASS (bubble next to injection site (Pictures sent to safety)), VACCINATION SITE WARMTH (very hot at injection site), CHILLS (chills) and VACCINATION SITE SWELLING (lump and hardness to injection site) outcome was unknown.            No concomitant medications were reported.
10-7-15 I rash flu shot (inactivated) at Health Dept. 3 days later I developed hives - red itching swelling around my arm, in armpit and up left side of neck pain in arms for 3 weeks afterward.
Large red blotch patch near site of injection approx 3 inches by 2 inches on the left arm, with red 'spot' closest to the site of injections. At time of injection the vaccine had not successfully gone under the skin and liquid had come back out from the injection site and the vaccinating provider chose to attempt a second vaccination which appeared to be successful.  The red blotch patch is extremely itchy and concentrated itch sensation is closest to both injection sites.
Patient felt light headed within 5 minutes of having Modera Covid-19 vaccination.  Consumer then became unresponsive after receiving vaccination.  He was breathing and had a pulse. .  It looked like he was having a seizure; his eyes rolled upward, his left arm shook and he did not respond to touch or voice.  .  911 was immediately called and responded within a couple minutes. After a minute he came to and still felt very lightheaded Upon arrival of 911 his BP and heart rate were extremely low and he was profusely sweating.  He was then taken to the emergency department.
For about 3 days after injection, my left arm was a little sore just at the injection sight.  I had some itching and redness around the site for about 4 days and it subsided.  About January 30th, 10 days after injection, my left arm became red and itching again with a very slight fever of the skin.  The affected area is about the size of a baseball just below the injection site.  I have been using Cortizone 10 to help relieve symptoms.
Diarrhea; Nausea; Vomiting; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), NAUSEA (Nausea), VOMITING (Vomiting) and VACCINATION SITE PAIN (Soreness at the injection site) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetes. Concomitant products included INSULIN for Diabetes, APIXABAN (ELIQUIS) for an unknown indication.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2020, the patient experienced DIARRHOEA (Diarrhea), NAUSEA (Nausea), VOMITING (Vomiting) and VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, DIARRHOEA (Diarrhea), NAUSEA (Nausea) and VACCINATION SITE PAIN (Soreness at the injection site) was resolving and VOMITING (Vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: above 200 mg/dl abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Follow-up received on 07 Apr 2021 included non significant information. Patient email address information was updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient reported experiencing a full-body rash, beginning on the day the vaccine was given (07/30/2018). The rash was still present when she reported it to the pharmacy on 08/01/2018. She declined experiencing any anaphylactic or other life-threatening reactions.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. No information on concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored PEDVAXHIB (unknown strength, route and dose). Concomitant medications were not reported. No adverse effects were reported. The outcome of incorrect product storage was unknown. There was no product complaint involved. This is one of the three reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 05-DEC-2015, the patient was vaccinated with a dose of ZOSTAVAX, (lot #, expiry date, dose, frequency and route of administration not reported). The patient experienced "tinnitus with in 24 hours of getting the dose". The outcome of the event was unknown. Causality assessment was not provided. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
Employee received flu vaccine for the first time around 12pm.  Employee states she started to develop a rash at 10pm.  Employee states rash started on arms first then torso, then legs.  Rash began to itch the next morning.  EE took anti histamine (employee is unsure of name).  Symptoms lasted  3 days then resolved.
Patient complained of headache, metallic taste and numbness on the sides of tongue. She was given 50mg oral benadryl at 11:55am.  No further intervention required. Discharged to home.
I was @ work and my left eye got itchy & started to swell. I couldn't breath very well. My lips swelled up & my eye &l lips were numb. I went to the ER & they gave me Benadryl, epinephrine & another steroid shot to help.
I woke up one morning and could not see well at all out of either eye. I went to my computer and could not see the screen, I had pain in both eyes, everything was blurry, shooting stars, I was seeing floaters in the path of my vision. I bent over one day to tie my shoes and saw a big orange blob. I made an appointment to see my eye doctor. Once I got into the eye doctor we discussed my symptoms, he had many tests ran on both eyes. A standard eye exam, OCT test that showed I had macular edema behind the retina, the eye pressure test came back negative for glaucoma; slit lamp test came back normal. I was prescribed medicated eye drops Ketorolac and Prednisolone Acetate. I do have a follow up with my retina specialist in May.
Pt recv vax on 6/11/98; 1 hr post vax pt exp dizzy, no control over body
Raised like bumps in underarms, creases of the arm, along the arms, and legs. Patient came in for treatment 12/10/2009. Patient diagnosed urticaria given Periactin 4mg, Hydrocortisone cream 30 gram, Benadryl 50 mg. Patient recovered fully within a couple of days of treatment.
This spontaneous report as received from a nurse, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 02-JUN-2015, unspecified number of patients were vaccinated with improperly stored VAQTA injection (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Follow up information has been received on 13-JUL-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received on 20-JUN-2015 with additional information on 21-JUN-2015. The patient was approximately 12 months old. The patient demographics were updated. On 03-JUN-2015 the patient was vaccinated with improperly stored VAQTA (lot # K019560, expiration date: 02-JUN-2017) strength, dose and route unspecified). Additional information has been requested. Patient, suspect therapy and narrative were updated.
expired dose of Menactra administered; Initial information received on 22-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 18 years old male patient who was vaccinated with 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5948AB (Expiry date 03-Jul-2019 ) via intramuscular route in the left deltoid, on 22-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant vaccines were given.   It was a case of actual medication error due to expired vaccine used. It was reported that expired dose of Menactra administered.  At a time of reporting no adverse reaction reported  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
strokes; feel sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 54 year-old male patient received bnt162b2 (BNT162B2), administration date 18Jan2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant) with onset 2022, outcome "unknown", described as "strokes"; MALAISE (hospitalization, medically significant) with onset 2022, outcome "unknown", described as "feel sick". The patient was hospitalized for cerebrovascular accident, malaise (start date: 2022).  Clinical course details: The patient is turning 55. Recently, he was admitted to the hospital for two undiagnosed strokes. He began to feel sick a week or two after the third dose with no history in his family, ever, of strokes. He began to feel sick after he got the third dose, which was why he was rushed to the hospital.  The lot number for bnt162b2 was not provided and will be requested during follow up.
I am only reporting this because of an email and phone call from vaers.  The hypertension started with vaccine, and was followed up by visit to another physician on 2/9/21, who started me on valsartan, and then 2/18 added amlodipine.  on 8/14 I developed palpitation episodes with irregular pulse.  So the symptoms developed could be due to meds and not COVID vaccine.    Also long COVID before vaccine could have caused problems as well.
Signs of early anaphylaxis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician assistant and describes the occurrence of ANAPHYLACTIC REACTION (Signs of early anaphylaxis) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Signs of early anaphylaxis) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Signs of early anaphylaxis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported treatment information was not provided by reporter  Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Dr. received a call from her parents on 9/20/14, stating she had a bloody stool and diarrhea. She received ROTAVIRUS vaccine 5 days prior. She was sent to ER; her ultrasound was neg, rota Ag was neg, shign toxin neg, stool cx neg. She was went home. Now passing normal stools w/o blood.
Did not feel good after second shot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Did not feel good after second shot) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced FEELING ABNORMAL (Did not feel good after second shot). On 26-Feb-2021, FEELING ABNORMAL (Did not feel good after second shot) had resolved.            No concomitant medications were reported. No treatment medications were reported.        This case was linked to MOD-2021-406940 (Patient Link).
After administering the vaccines the client stated he was feeling dizzy, he was assisted to lying position on the ground, pillow behind head, bilateral lower extremities elevated,  cold pack to forehead and nape of neck, pulse and blood pressure checked.  After 30 minutes client was assisted to sitting position in a chair and monitored for an additional 20 minutes. Client states he felt better.
Headache, Myalgia, LIGHTHEADEDNESS, CHILLS, INSOMNIA, SORE THROAT, FATIGUE Narrative:
Redness and swelling in the injection site, arm discomfort, headache, general body discomfort, Chills.
This spontaneous report was received from a certified medical assistant, referring to an unspecified number of patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored PEDVAXHIB (lot # M014926, expiration date 17-FEB-2019; lot # M020102, expiration date 08-MAR-2019); which were exposed to temperature of 49F for 1 hour and 48F for 1 additional hour. There was not previous temperature excursion and the call was because of a data logger. No adverse effects were reported. This is one of the several reports received from the same reporter. As of 13-DEC-2016, all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1610USA015290: US-009507513-1610USA015314: US-009507513-1610USA015316: US-009507513-1610USA015317: MERCK 1610USA015315:Mfr number.
vaccine side effect.  tingling in bil cheeks x 1 day, J&J vaccine received Friday; denies any fevers/chills.
Patient only received half the dose on lot EJ1685. Pfizer was called and advised it was okay to administer a full dose which lot was EL1284 @1821
Red; swollen painful arm. Used ice at injection site 12/01/2009. Visited doctor office. No other treatment.
Patient received Prevnar vaccine on 8/1/08.  Within 24 hours, patient stopped all usual babbling and "talking".  Patient was extremely irritable: no sounds, other than coughing, were made until 8/15/08.  On that day, patient's behavior appeared totally normal and has been since.
Exacerbation of arthritis spread everywhere in body; Hands in so much pain she cannot bend them; inflammatory response; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Exacerbation of arthritis spread everywhere in body), MOBILITY DECREASED (Hands in so much pain she cannot bend them) and INFLAMMATION (inflammatory response) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Osteoarthritis since 2016, Lyme disease and Rheumatoid arthritis since 2016. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Exacerbation of arthritis spread everywhere in body), MOBILITY DECREASED (Hands in so much pain she cannot bend them) and INFLAMMATION (inflammatory response). At the time of the report, ARTHRITIS (Exacerbation of arthritis spread everywhere in body), MOBILITY DECREASED (Hands in so much pain she cannot bend them) and INFLAMMATION (inflammatory response) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient lab data include blood work. Patient second dose on 22-Apr-2021 was provided. No treatment medication were provided.
Fever 101.3, extreme chills, fatigue. Took Tylonol. Fever didn't down. Extreme sweating. Diarreah. Swelling, stiffness, painful, and itching in arm. Arm still sore.
Erythematous flat lesion 3 x 2.5 irregular area (L) lower arm without other symptom. Rash developed 3 days post injection.
arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11May2021 (Lot number: EW0171) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diverticulitis", start date: Jan2021 (ongoing), notes: Verbatim: Diverticulitis; "Retinitis pigmentosa" (ongoing), notes: Verbatim: Retinitis pigmentosa. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: 08Apr2021, when the patient was 55 years old, for COVID-19 Immunization, reaction(s): "arm soreness". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness". Relevant laboratory tests and procedures are available in the appropriate section.   Additional Information: She was first told about her diverticulitis in Jan2021, and she had an issue in her sigmoid area, she had a micro perforation and a small abbess that they had to drain. At that time, Jan2021, she had a fever, a high white blood cell count and pain that was much, much greater. Honestly, if she wouldn't have had the neck and shoulder pain she may have ignored the discomfort in her pelvic area at this time because it felt so minor. But that is what they called it, but she did not have the elevated white blood cells and it didn't seem to be like the infection she had in Jan2021, it was just inflammation that was visible on a CT scan that they did on her pelvis. She says that the only symptoms that she had seemed to be that she was tired for so many hours after the 1st COVID vaccines and then she had a little arm soreness afterwards but nothing else. She confirms these were side effects were felt after her 1st and 2nd dose of the Pfizer COVID vaccine. She got those doses in her right arm and for some reason the pharmacist suggested that she have the booster dose in her left arm, which is a different arm.  Follow-up attempts are completed. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of herpes zoster keratitis in a male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included ophthalmic herpes zoster (had a history of herpes zoster (ocular keratitis)). On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced herpes zoster keratitis (serious criteria GSK medically significant). The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the herpes zoster keratitis was not recovered/not resolved. It was unknown if the reporter considered the herpes zoster keratitis to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and there was a recurrence of herpes zoster (ocular keratitis) that most likely happened after the first dose. The patient was taking Valtrex at the time of reporting. The reporter declined to provide patient information (and follow-up from Safety). The reporter did not consent to follow-up.
Fever, chills, vomiting, eyes feel like they are swimming in lava, ears also feel like they are swimming in lava, upset stomach, burping, severe aches and pains in entire body, dizzy, listless, shortness of breath, itchy skin everywhere, and really red skin.
4.5 inch in diameter, swollen and red area around injection site.. tender, very itchy, and warm to the touch.
Achiness, myalgias, arthralgias, since the MMR and Hep B vaccines.