chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 27Mar2021 at 13:00 as dose 2, single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CAD" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "drink alcoholic beverage" (unspecified if ongoing), notes: only drink alcoholic beverage very occasionally and did not have alcohol since 01Jun. Concomitant medication(s) included: ATORVASTATIN, stop date: 04Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Diabetic Ketoacidosis (nausea, heavy breath, could not form words, PH dropping); Increase of resting heart rate 114 to 120 to 130 and max 150; Terrible Migraine; Extreme nausea; A spontaneous report  was received from a consumer, concerning her son, who is 27-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced diabetic ketoacidosis (DKA), terrible migraine, nausea, heavy breathing and increased heart rate.  The patient's medical history, as provided by the reporter, included Asperger syndrome and Diabetes. No concomitant products were reported.  On 14 Jan 2021, one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for the prophylaxis of COVID-19 infection.  On 15 Jan 2021, at 10:30 AM, the patient had terrible migraine and extreme nausea. He experienced DKA as he could hardly breath and breathing was heavy. At 6 PM, as stated by the reporter, the patient went to the emergency room and tests were done which confirmed DKA. The patient stayed there for 2 hours but his PH level was decreasing, couldn't form words and heart rate was 150 beats per minute(bpm) and was transferred to bigger hospital where he stayed in ICU. He was discharged in the afternoon on 17 Jan 2021.  On 20 Jan 2021, the reporter stated that the patient again went back into DKA and was sent to hospital.  On 23 Jan 2021, all symptoms were resolved, and the patient was discharged.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events, diabetic ketoacidosis (DKA), terrible migraine, nausea, heavy breathing and increased heart rate, were considered resolved on 23 Jan 2021.; Reporter's Comments: Based on the 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.
Swelling in the armpit noticed after 36 hours. It was very flabby, not stiff. It increased over the next 24-48 hours. By  Monday it had dispersed over the left side of my rib cage down to my belt and across my peck and abs to my sternum and navel. It has not increased in the last 3 days but it has not gone away either. I still have flabby swelling from my armpit my waist, even some between my belt buckle and privates but only on the left side. Besides this, I had some stiff swelling where I received the injection and some fatigue in the 36-60 hours following the injection. These have subsided
Patient reported limb swelling (left arm-fingers) two days after vaccination 1st dose.
Patient called me on 11/24/21 and informed me that she got the shot on 11/22/21 at 1 pm and she started having reaction on 11/23/21 at 9 pm. She had pain in left arm, left armpits and chest pain and pain was radiating to left arm and left side of breast, also soreness on left arm.
On 7/8, client noted "rash at base of neck increasing in intensity on left shoulder" with small 1/4" diameter raised areas. Denies rapid heartbeat or respiratory symptoms, itching.  On 7/11 rash less intense, client has been "very tired, sleeping an extra 2-3 hours per day.  Mother reported event to Health Dept and physician's office.
After getting home I noticed that my face felt numb and was swollen.  I did not seek medical attention. It wore off after a couple hours.
Swollen Arm, Fever, Aches & Pains, Headache.
Narrative: 75 year old male admitted on September 11 2022 with fatigue, body ache, night sweats and hypoxia.. He had received Moderna vaccine x 2 on February 10 2021, March 11 2021. He was treated with he received dexamethasone 6 mg orally x 4 days. Remdesivir was stopped after 2 doses due to bradycardia. He clinically improved and was discharged home on 9/14.
Pt notice her arm was red, warm, and swollen the evening after receiving her FLUZONE HD vaccine. She came to the pharmacy 2 days later and showed the pharmacist her symptoms and stated that she felt it was improving. The pharmacist did notice swelling and redness, but also noticed the location was much lower than where pt would have received her vaccine (deltoid). The reaction appeared to be more in the middle of the upper arm. I told the pt I would call her MD to explain to him the situation and that if it didn't continue to improve she should seek medical advice, At this time, I have been unable to contact the pt's doctor, but will continue to try and also told the pt to follow-up with him Friday if there was no improvement.
Tongue swelling, throat itching, slight shortness of breath, headache, joint pain, fatigue, sore throat
This spontaneous report was received from a physician refers to a male patient of unknown age. On an unknown date, the patient received ZOSTAVAX (dose, route and lot not reported) and developed shingles. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was unknown. This is one report of several reports from the same source. Additional information has been requested.
Joint pain at approx 36 hours after injection, hands wrists, elbows, hips, feet, ankles.
Local reaction (edema, erythema, papular rash) at vaccine site starting 8 hrs after vaccination then over 10 days developed an exanthematous body wide reaction - Treated with prednisone burst on 11/21/13.
Patient was receiving her first Covid-19 vaccination. Nurse intended to give monovalent, but instead used a vial of bivalent vaccine for 1st. dose.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 25-NOV-2013 at 07:45, ZOSTAVAX lot # J008434 was exposed to -12C for an estimated total time out of range of 42.75 hours. On 27-NOV-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J008434, Exp. Date: 11-OCT-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
TIAStroke headache with partial visual loss and expressive aphasia dx stroke 2/11/21 by MRI Narrative: no residual from stroke, also found to have small patent foramen ovale
patient only had the expected side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (patient only had the expected side effects) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (patient only had the expected side effects). At the time of the report, VACCINATION COMPLICATION (patient only had the expected side effects) outcome was unknown.            Concomitant drugs were not reported.  Treatment details were not given.  Patient reported he only had the expected side effects, which were mild he didnot  have anything too severe.
This spontaneous report as received from a pharmacist refers to a 90 year old male patient with no pertinent medical history or known drug reactions or allergies. No information regarding the patient's concurrent conditions was provided. On an unknown date, reported as years ago, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route of administration, lot# and expiry date were not reported). The patient had no concomitant therapies. On an unknown date, reported as a few months ago, the patient developed shingles. He sought unspecified medical attention. The event was treated with unspecified antiviral medications. The outcome of the event was reported as recovering (it was also reported that the shingles had not yet resolved at the time of this report). The relatedness between ZOSTAVAX and the event was not provided. Additional information is not expected as the reporter declined any further contact.
Joint, bone aching (head, neck, back). Gastric distress. Some chills. Lasted 24-30 hours, reducing over time period.
Headache, Myalgia, Arthralgia, Tachycardia, 1/27: tingling/cooling sensation started 30 mins post vax admin. 1/28: injection site pain. Tingling in hands/forearms and feet/lower legs with cooling sensation. Tachycardia, fatigue/tiredness. Narrative:  Other Relevant History:
Booster dose was given too soon after second dose of pfizer. Patient had second dose on 07/19/2021 and the booster should not have been given on this date because it had not been 6 months since second dose.
right eye was extremely dry behind eye and behind upper lid; twitching happens to right eye; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 19Apr2021 (Batch/Lot number: unknown) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Hashimotos" (unspecified if ongoing); "Autoimmune reactions affect my eyes" (ongoing), notes: I have had autoimmune reactions affect my eyes for the past few years. Concomitant medication(s) included: SYNTHROID. Past drug history included: Augmenting, reaction(s): "Allergies", notes: Known allergies: Augmenting, Percaset, Zyrtec; Percaset, reaction(s): "Allergies", notes: Known allergies: Augmenting, Percaset, Zyrtec; Zyrtec, reaction(s): "Allergies", notes: Known allergies: Augmenting, Percaset, Zyrtec. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Lot number: EN6208, Administration time: 09:00 AM, dose number: 1, Vaccine location: Left arm), administration date: 29Mar2021, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: DRY EYE (non-serious) with onset 2021, outcome "recovering", described as "right eye was extremely dry behind eye and behind upper lid"; BLEPHAROSPASM (non-serious) with onset 2021, outcome "not recovered", described as "twitching happens to right eye". Therapeutic measures were not taken as a result of dry eye, blepharospasm.  Additional Information: After 2nd dose right eye was extremely dry behind eye and behind upper lid. Where I have to add rewettimg gel drops 4 times a day. More symptoms happened to left eye, but twitching happens to right eye. The dryness is improving now (2nd dose was 19Apr2021. Twitching is not as often but still comes and goes. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Could barely stand up; so tired; Had chills; Her whole body hurt for days; Diraheaa; This case was reported by a consumer via interactive digital media and described the occurrence of difficulty in standing in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced difficulty in standing, tiredness, chills, generalized aching and diarrhea. On an unknown date, the outcome of the difficulty in standing, tiredness, chills, generalized aching and diarrhea were unknown.   It was unknown if the reporter considered the difficulty in standing, tiredness, chills, generalized aching and diarrhea to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient could barely stand up and was so tired, chills and her whole body hurt for days after taking this shot.  No further information was provided.
Information has been received from a consumer concerning her 16 year old daughter with a history of "sensitivity to vaccines" who about a month ago on approximately 25-FEB-2008 was vaccinated with her first dose of Gardasil (lot# unspecified, injection site and route not reported).  There was no concomitant medication.  The patient experienced pain at the site of injection and developed arthralgia after receiving her her first dose.  The arthralgia developed about 24 hours after receiving Gardasil and lasted 48 hours.  The patient sought medical attention by speaking with the physician.  The physician's name is "Dr."  No other information about the physician was available.  The patient recovered on an unspecified date.  Additional information is not expected.
Patient received Pfizer booster and Prevnar20 on 6/13 and began having severe nausea and vomiting, unable to keep even liquids down. No fever, just cold sweat. Advised patient to seek medical care due to concerns of dehydration. ER gave IV fluids, prescribed ondansetron. Patient felt better after receiving fluids but is nauseated again at home. ER physician suspects Prevnar.
This spontaneous report as received from a physician assistant refers to a 18 year old non-pregnant female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On unknown dates (also reported as in patient's childhood), the patient received a full vaccination series with RECOMBIVAX HB (route and site of administration, lot # and expiry dates were not provided). On an unknown date (also reported as unspecified recent date), the patient tested negative for titers for Hepatitis B. The reporter was not able at the time of reporting to provide the dates of administration or the lot numbers and expiration dates of the doses. The physician assistant stated that the patient was healthy and she did not experience any medical difficulties. Because the physician assistant was not able to specify the name of the vaccine the patient received, RECOMBIVAX HB was assumed product. The outcome of the event was unknown. The relatedness between the event and suspect therapy was not provided. Additional information has been requested.
Patient developed ipsilateral arm swelling which progressed to polyarthritis on the elbow and wrist. Within a few days, similar symptoms developed on the ipsilateral leg including knee and ankle.  Also with arthralgias and myalgia in this distribution.  No real improvement with ibuprofen.  Was admitted to hospital for these symptoms and arthritis resolved with NSAIDs, but still with significant arthralgias.  No fevers throughout, but on NSAIDs.
Muscle in arm still sore after 4 weeks.  She reported not sore all the time, but more so when she lays on that side or when using it.
Dizziness, headache, nausea, fatigue- 3 days post vaccine, symptoms still present
dizzy; mild rash on her chest and arm; nausea; arm was inflamed; hives; injection site redness; injection site swelling; injection site pain; lymph node swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (arm was inflamed) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced VACCINATION SITE INFLAMMATION (arm was inflamed). At the time of the report, VACCINATION SITE INFLAMMATION (arm was inflamed) had resolved.        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.   Concomitant product use was not provided by the reporter. She took Benadryl 25 mg to help with the hives on day 7.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the se events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the se events, a causal relationship cannot be excluded.
This is a spontaneous report from a contactable pharmacist reporting for herself via a sales representative. This female patient of unknown age received on 02Sep2015 PREVNAR 13 at 0.5 ml single dose intramuscular for immunization. Medical history and concomitant medications were not reported. On 02Sep2015 the patient was painful. The patient got the shot that day and that same night it started getting very painful. The pain lasted for about 3 days. Additionally it was reported that on an unspecified date the patient had redness and swollen at the injection site. Final outcome was unknown.
After receiving the vaccine, patient complained of itching. I examined the site and it had the appearance of a bug bite with a small raised area and redness surrounding the bump. It was difficult to tell if the redness was simply due to the patient scratching the site. The patient called later in the day and said the area was warm to touch, hard and there was redness in an oval shape approximately the size of an egg. I advised her to take a BENADRYL and to consider having her physician take a look at the site. She said she was not overly concerned and would take a BENADRYL. I called today (day after vaccine) to check on the patient and she said there was marked improvement and the site no longer itched and was not hard, but still felt a little warm to the touch.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 58-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that, there was no power outages that would have impacted the Moderna vaccine. However, the healthcare professional reiterates that because her facility was unable to download the digital data logger, they needed to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the state at this time. It was also reported that, no adverse reactions were reported by the patient.  No treatment medication was provided.
robust headache; 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 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 15:30 (Lot number: EW0150) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: Verbatim: high blood pressure, caller has had for about eight years. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 01Apr2021, outcome "not recovered", described as "robust headache". Therapeutic measures were not taken as a result of headache.  Additional Information: The reporter wanted to known that if the event was normal or should visit the ER. The reporter also wanted to know how long was the event supposed to last. The patient said that she has never had a severe headache. The reporter confirmed that no prior vaccination were received within 4 weeks.  No follow-up attempts are possible. No further information is expected.