chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm soreness,; Weakness throughout entire body; Lethargy; Fever; Migraine; Sweating,; Cold shivers; Upset stomach; Diarrhoea; This is a spontaneous report from a contactable nurse, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 29Mar2021(at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included atopic dermatitis, acne and sciatica. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included multivitamins (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), tretinoin (RETIN A), probiotics (MANUFACTURER UNKNOWN) fenugreek capsules (MANUFACTURER UNKNOWN) and pre workout drinks (MANUFACTURER UNKNOWN) all taken from unknown dates for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an intramuscular route of administration in the left arm on 02Mar2021 at 16:00 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. On 04Dec2020 and 11Mar2021, the patient underwent a nasal swab test (SARS-CoV-2 test) and tested negative. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 30Mar2021 at 07:00, the patient experienced arm soreness, weakness throughout entire body, lethargy, fever, migraine, sweating, cold shivers, upset stomach and diarrhea. The events did not result in a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures included intake of ibuprofen (MANUFACTURER UNKNOWN) for the events arm soreness, fever, migraine and cold shivers. The clinical outcome of the events arm soreness, weakness throughout entire body, lethargy fever, migraine, sweating, cold shivers, upset stomach and diarrhea were resolved on an unspecified date in 2021.   No follow-up attempts are needed; information about lot number cannot be obtained.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Note on 3/2/21 shows concern from patient's family that his health is declining as he was not eating, he was in pain, and short of breath despite being on 2L oxygen. His contributing comorbidities include CHF, CKD, COPD, CAD, anemia, AAA, HTN, HLD. On 3/9/21 he was admitted for a CHF exacerbation. They found a blood clot in his arm during his hospital course and his status never improved. On 3/24/21 they discharged him home on hospice, and he passed away on 3/30/21.
On 11/9/99, the pt developed diffused papular rash with vesicular erythematous on the right thigh. The pt was seen by a pediatrician and was instructed to take Acyclovir every three hours. Also, she was referred to a dermatologist. Subsequently the pt's symptoms resolved. No further information is available.
Red spot about the size of quarter at injection site, itchy,   Appeared about a week after shot.  Lasted a few days, benadryl helped.    Also had soreness under my arm,  felt like a sore muscle or something.    Started same time as red spot did and lasted only about a week.     Not too painful and caused no issues with working or exercising or anything.   Very mild discomfort.     Went away on it own,  only took Benadryl because it was sort of like a reaction I used to get when I took allergy shots so I knew Benadryl would help.
Symptoms: 13x20 cm area of redness, swelling, warmth and pruritis over left arm.  Occurred approximately 24 hours post vaccination.
Severe Rash covering my legs.  Lasted 4-5 days.  Around day 3, I went to patient first.  Was given prednisone.
vision loss in both eyes; severe outbreak of a rash and shingles on her left leg, back and the side of her abdomen/multiple shingles outbreaks; This spontaneous report as received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 04-AUG-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).   Shortly after receiving the Zoster Vaccine Live (ZOSTAVAX), on or about 24-AUG-2015, the patient experienced a severe outbreak of a rash and shingles on her left leg, back and the side of her abdomen, tremendous pain in her ankle as well as a sickness that included headaches, vomiting, and diarrhea. The shingles and associated injuries eventually resulted in vision loss In both eyes resulting in a surgery on her right eye in May 2016. She suffered multiple shingles outbreaks as a result of the Zoster Vaccine Live (ZOSTAVAX). As a direct and proximate result of the defective Zoster Vaccine Live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of Zoster Vaccine Live (ZOSTAVAX), the patient sustained severe and disfiguring personal injuries. Further, as a tragic consequence of Zoster Vaccine Live (ZOSTAVAX), the patient suffered serious, progressive, permanent and incurable injuries, as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient suffered and incurred damages, including medical expenses, loss of accumulations and other economic and non-economic damages. The outcome of the events was considered as not recovered. The events were considered to be related to zoster vaccine live (ZOSTAVAX).    Outbreak of shingles and vision loss were considered to be disabling.  Upon internal review vision loss was considered to be medically significant.
Noticed left upper arm red, hot and hard yesterday AM. Tried MOTRIN & warm compresses but not better.
extreme pain in arm where shot given red, swelling, pain across entire arm-back-other arm;h/a, crawly skin, legs felt semi paralyzed;T102 & fatigue, dizzy, flu sx, congestion, swollen throat, blurred vision;
Reaction started w bumps on the upper part of both arms. By bedtime the bumps were red. By morning the bumps were a solid bright red mass that was extended below the elbow. I took one Benadryl on 10/08/2016 at 8:30 AM and headed to urgent care. I was given a shot of MethylPREDNISolone Sodium Succ 125MG.
This spontaneous report as received from a registered nurse refers to multiple patients (number unspecified) of unknown age. The patients were vaccinated subcutaneously with doses of ZOSTAVAX (lot # and dose not reported) on unspecified dates. No other co-suspects were reported. No concomitant medications were reported. The registered nurse reported that a medical assistant at the physician's office told her that she administers ZOSTAVAX intramuscularly because they get too many reactions when it is administered subcutaneously. No treatment information was provided. It was unknown if the patients sought medical attention. At the time of the report the outcome of the patients was unknown. This is one of several reports received from the same source. Additional information has been requested.
No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 27-MAR-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number N034400 with expiration date in 10-MAY-2019) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011434: US-009507513-1907USA001848: US-009507513-1907USA001847: US-009507513-1907USA001849: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA000952: US-009507513-1907USA000953: US-009507513-1907USA000954: US-009507513-1907USA000959: US-009507513-1907USA000962: US-009507513-1907USA000963: US-009507513-1907USA000964: US-009507513-1907USA000965: US-009507513-1907USA000966: US-009507513-1907USA000967: US-009507513-1907USA000968: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000988: US-009507513-1907USA000989:
Irritability, poor sleep at night: No sustained night sleep, abrupt cessation of day naps.
20-25 mins following above 3 vaccines child started breaking out with rash on her forehead that was with the skin. Mother gave 5 l Benadryl. She continued to break out more. Returned to office in about 1 1/2 hours, where she was covered with hives from head to toes - T 98.8 P 100. Child awake, alert, no respiratory distress. Lungs clear, urticarial on face, body extremities. Resolved with 0-15 EPIPEN
Persistent throbbing pain on R arm (where received the shot) radiating to L arm and down to hips.
Systemic: Fainting / Unresponsive-Medium, Additional Details: pt fainted after receiving Pfizer Bivalent + Flucelvax in opposite arms, pt recovered after approx 15 seconds, paramedics brought her to hospital where she fully recovered after about 3 hrs per pt follow-up interview
My right hand, the thumb, it looks distorted, I guess it swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11May2021 (Lot number: EWO172, Expiration Date: 31Aug2021) at the age of 67 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number:1), administration date: 20Apr2021, when the patient was 67 years old, for COVID-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 12May2021, outcome "unknown", described as "My right hand, the thumb, it looks distorted, I guess it swollen". Therapeutic measures were not taken as a result of peripheral swelling.  Additional information: Consumer stated that It looked swollen, when the patient open the hand and had palm facing, it just looked distorted, it looked swollen but it was not discolored or anything. Patient was asking If the patient had a blood clot or something like that it would be discolored would not. The patient stated that right hand, the thumb, it looks distorted, guessed it swollen. But it was not discolored or anything, the skin tone was normal. The patient was concerned whether it was a side effect from the Pfizer shot.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient does not report pain.  I am her sister and Legal Guardian and I believe she had symptoms prior to 5/24/21.  On 5/24/21, she did not report feeling sick or having a headache and threw up around 11 am.  Throwing up was the only way I knew to ask her how she was feeling.  She said, I think I threw up because my head hurt.  I asked her where it hurt and she said, in the back.  I took her to the ED and she had a brain bleed and 5 blood clots in the major veins and sinuses of the left hemisphere of her brain.  Her medical team said this is a very rare part of the brain to have blood clots.  I would like further investigation into whether this was related to the vaccine.
severe allergic reaction; very fast heartbeat", like she was going to have a heart attack; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (very fast heartbeat", like she was going to have a heart attack) and HYPERSENSITIVITY (severe allergic reaction) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced HEART RATE INCREASED (very fast heartbeat", like she was going to have a heart attack). On an unknown date, the patient experienced HYPERSENSITIVITY (severe allergic reaction). At the time of the report, HEART RATE INCREASED (very fast heartbeat", like she was going to have a heart attack) and HYPERSENSITIVITY (severe allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Pt recv vax on 10/24/97; on 10/25/97 pt exp red/ aching upper LA, stiff LA to left upper back & left side neck, unable to lift LA
Patient called our office on 8/23/23 stating she had a raised hot rash at the site where the prevnar shot was given. NP  advised patient to use cold compress on the site and use antihistamine prn. I called patient on 8/24/23 to follow up with her and she stated after doing the recommendations it has almost completely resolved.
This case was reported by a pharmacist and described the occurrence of elevated liver enzymes in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On 31 August 2009 the subject received 3rd dose of ENGERIX B (unknown). On 3 September 2009, 3 days after vaccination with ENGERIX B, the subject presented to the hospital with elevated liver enzymes. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. The reporting pharmacist refused to provide contact information and would not provide further details at the time of reporting. The pharmacist was not exactly sure if it was ENGERIX B or RECOMBIVAX that was administered.
Extreme fatigue and body aches with really sore arm. This lasted for two days. Then noticed a huge red welt the size of my hand about 4 inches below the injection site. Then began developing a harsh dry cough and horseness with sore throat. Eventually lost my voice and began developing chest and back pains.  Returned to doctor on Nov 29 concerned I may be having a heart attack because shortness of breath and dizziness had started 2 days before along with severe chest and back pains. EKG was normal.  Back and chest pains along with bouts of dizziness and shortness of breath continued periodically.  Went to emergency room on Dec 17 for all of the above symptoms along with pains down my left arm (where the shot was given) and I couldn't focus and blood pressure was thru the roof.  I was released with a Non--specific chest pain diagnosis.  Returned to my doctor on Dec 19 with same issues.  That flu shot did something to me where I can't function w/out feeling like I am going to jump out of my skin and I continue to get all of these chest and back pains.  I was in good health prior to it.
altered taste; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 19-year-old female patient received BNT162b2 (BNT162B2), in Jun2021 as dose 2, single (Lot number: EW0179) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1, Lot#ER8733), administration date: Apr2021, for COVID-19 Immunization, reaction(s): "COVID". The following information was reported: TASTE DISORDER (non-serious) with onset Jun2021, outcome "unknown", described as "altered taste".  Additional information: Caller was patient who has had 2 doses of Pfizer COVID 19. She stated since the second dose that she had an altered taste and was asking if this was a known side effect. Patient stated that she waited so long to get her 2nd vaccine because she got COVID between the first and second vaccine doses. She asked if maybe having COVID gave her the altered dose and not the vaccine.
Started having a sore throat and was congested. Took a home COVID-19 test and was positive. Had a telehealth doctor appointment and was prescribed PAXLOVID. Started feeling better a few days later. Took another COVID-19 test and was negative.
5-10 minutes after giving injection patient had red splotchy rash around injection site. little itchy. no shortness of breath or other complaints. Ice pack given patient vitals taken lungs clear after about 15 -20 minutes rash subsided
Patient received shot 1.6.11 (L.A.) Pneumococcal & Influenza (L.A.) MMR: Varicella (R.A.) the patient developed a rash all over and was rushed to ER. No med no hosp. recovered & rash disappeared in 2-3 dys.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 62-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX  and not applicable after receiving SHINGRIX, the patient experienced influenza-like symptoms, chills, fever and product supply issue. On an unknown date, the outcome of the influenza-like symptoms, chills and fever were recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the influenza-like symptoms, chills and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 61 or 62 years. After receiving 1st dose of SHINGRIX, the patient experienced flu-like symptoms, chills and fever which lasted for 2 to 3 days. The patient was concerned about not being able to find a second dose of SHINGRIX as he had called numerous pharmacies in his area but SHINGRIX was not available (product supply issue). This was all the information provided as patient wanted to discuss SHINGRIX availability. The patient asked the call center representative if he could help to locate someone with SHINGRIX vaccine available. The call center representative replied that since SHINGRIX has been approved, there has been an extraordinary amount of demand from patients and healthcare professionals. Due to the remarkably high demand, you may find that your healthcare provider or local pharmacy was temporarily out of stock. To address the current high demand, GlaxoSmithKline had significantly increased deliveries and accelerated shipments of doses of vaccine for this year, and SHINGRIX was expected to be available throughout 2018 and shipped on a regular basis. As you may know the FDA approved dosing schedule for SHINGRIX was the first dose at month 0, followed by a second dose 2 to 6 month after the first dose. The centers for disease control and prevention (CDC) has provided guidance that if it's been more than 6 months since you got the first dose, you should get the second dose a soon as possible and you do not need to restart the vaccine series. The patient was advised to talk with his doctor or pharmacist about this guidance and individual situation. We did not have the information as to what pharmacies or locations would be receiving the vaccine.
Patient began being fussy that afternoon after receiving the shot.  She began a fever that night which at times got as high as 103.  Two nights after receiving the shot, her fever reached its highest and she had a seizure that lasted about 1 minute.  Her body became very stiff and lips were turning blue. We called 911.  She became alert again after about 1 minute and went to sleep. Paramedics arrived and checked her over but we did not take her to the emergency room at that time.  We took precautions to cool her body temperature and her fever dropped.  We took her to the doctor's office the next morning where they checked her over and did a CBC.  Her fever finally broke that afternoon - 3 days after receiving the vaccine.
Lymph nodes swelled afterwards, (Under both arms and groin area); This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph nodes swelled afterwards, (Under both arms and groin area)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced LYMPHADENOPATHY (Lymph nodes swelled afterwards, (Under both arms and groin area)). At the time of the report, LYMPHADENOPATHY (Lymph nodes swelled afterwards, (Under both arms and groin area)) had not resolved.            No concomitant medications reported by reporter No treatment medications provided by the reporter.  Patient reported that booster got two months ago and experienced lymph nodes swelled afterwards.(under both arms and groin area). Still having this issue 60 days later.
At approximately 2 PM which was four hours after vaccination patient began to become ill.  He developed headache, fever, chills, nausea and vomiting.  He continued to have persistent vomiting throughout the night. He was seen in ER. He reports that he was given 2, IV's of Ondansetron (4 mg each) at which time it brought his non stop vomiting under control.  He was also given a shot of Toradol for his headache.  He was given a prescription of Ondansetron  and told to take Tylenol or Advil for his headache.  His symptoms required that he take these medications for 3 days.  Patient was home sick for 24 hours after ER visit and then was able to go to work again in the ER using his medications.