chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8733) via an unspecified route of administration in the left arm in Mar2021 at 13:30 (at the age of 51-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 6206) via an unspecified route of administration in the left arm on 29Mar2021 (at the age of 51-years-old) as single doses for COVID-19 immunisation. Medical history included asthma. The patient did not have any allergies to food, medications, or other products. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021 at 09:00, about week after the first dose, the patient had cramping and a lot pain up and down the legs. For example, when the patient sat, it was hard to stand and legs were almost petrified. When the patient walked it was sore and painful. This lasted for about 4 to 5 days. After the second dose, the morning after it started again and was actually worst than previous time. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events cramp legs, leg pain, difficulty in standing and difficulty in walking. The clinical outcomes of the events cramp legs, leg pain, difficulty in standing and difficulty in walking were unknown at the time of the report.   No follow-up attempts are needed. No further information is expected.
Joint pain and body aches that lasted approximately 3-4 months.  Yellowed/jaundiced appearance, swelling/puffiness of face, decreased capacity for aerobic exertion - all of which endured 4-5 months.  Lab work completed in August 2021 (08/05/2021) that indicated chronic kidney disease range for eGFR (46).  eGFR was tested previously in December 2020 and tested in normal range (63).
Approximately 3 hrs after receiving the flu vaccine, pt experienced flushing, elevated BP, chest & throat congestion & pleuritic chest pain. All responded to Benadryl 50mg/Im.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Dec2021 as dose number unknown, single (Lot number: FJ1620) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history included: "Seafood allergies" (unspecified if ongoing), notes: Known allergies: seafood allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.
ACUTE PULMONARY EMBOLISM 4/30/2023 PAIN ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 4/30/2023 PAIN
Large red area where shot was given, had heat in the area for 2 - 3 days, went away in about 5-6 days.
I started having fevers 100.2, for several days. Extreme fatigue joint swelling and pain. My kidneys hurt. My feet/ankles are constantly swollen.  I had blood work done 5/5/21, my inflammation markers are high. My C3&C4 are higher than any other results I had before.   So I?m in a flare. The lupus website stated we wouldn?t but I did! I?m still in a flare and idk when it will stop.
Patient reported symptoms of fatigue, headache, muscle/body aches, and runny nose that lasted longer than 72 hours.
Entire right leg swelled. Iced and elevated. Next day she was diagnosed with a DVT from abdomen to ankle. 6 surgeries within 7 days, including fasciotomies for compartment syndrome of the calf and eventually AK amputation of right leg.
Felt like my entire skin especially head, face, neck, upper body is burning like a rash but didn't look red. I felt actually cold, but hot to touch. My blood pressure would be very low about to passout to very high. I had to stay laying down to keep blood pressure normal. For my skin burning I started taking benadryl right away, since this didn't help I was prescribed Clobetasol Propionate external steroid, to add zyrtec and continue benadryl as needed. My blood pressure normalized from rest and my skin is no longer burning, it went back down to an itch, and is gone now, unless I introduce cold or heat  to my skin I then start burning itching all over and have to take benadryl. Before this delayed long lasting allergic reaction, immediately after the vaccine I had these symptoms; Back of Head buzz, Headache, Hot Flashes, Chills, Mental confusion , Rage/crying/tight chest(panic attack), went away with fresh air, Fever, Joint pain, Itchy face. The symptoms that lasted the full 72 hrs were on and off fever, elevated blood pressure, chills, and my burning/skin.
Approximately 16 hours after my Shingrix vaccine was administered, I began feeling nauseous and had an elevated temperature. 24 hours post vaccine, my fever registered at 101.7, orally.
R arm swollen and tender. Increase pain with movement. TX RLT: Ret Aralgran, Antihistamine
Reddened area measuring approx 5 by 3 inches with reddened warm area in center that is slightly raised measuring approximately 1 1/2 by 1 1/2 inches.
After receiving vaccination, patient sat down in waiting area to be observed for 15 minutes. She stated on consent form that she has not had any reactions to vaccines previously or any allergies. While in the waiting area, the patient collapsed and slid down onto the floor. She did not hit her head on the way down. I attended to her immediately and had the pharmacy technician call 911. The patient came back to right away. She felt lightheaded and clamy but was not having any difficulty breathing. I had her lie down and gave her water. She began to feel better fairly quickly. After her reaction the patient stated that she has anxiety and has experienced a reaction like this previously to vaccinations in the past. I recommended that if she receives her second dose she does so in a more controlled setting such as the state run clinics with emergency medical care on sight. The rescue arrived and the patient was taken into the ambulence to have her vitals checked. She walked out of the store okay with no issue and was not taken to the hospital.
Tingling on Tongue; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Tingling on Tongue) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PARAESTHESIA ORAL (Tingling on Tongue). At the time of the report, PARAESTHESIA ORAL (Tingling on Tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Severe migraine; flu like symptoms; fever; Body aches; could not get comfortable; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 12:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies to medications, food or other products.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 08Apr2021 at 13:00, the patient experienced severe migraine, flu like symptoms, fever, could not get comfortable and body aches. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events migraine, flu like symptoms, fever, could not get comfortable and body aches was not recovered at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
After I received the vaccine, I started with a cold and high fever. I went to the doctor he prescribed Erythromycin for 7 days. It did not helped. I got worse. I went back to the doctor and he prescribed Azithromycin, didn't helped either. I kept getting worse, I had o strength and I felt like if I was going to have a heart attack. I was taken to the emergency room by rescue. I was admitted in the hospital for 3 days, I was first diagnose with pneumonia and after that with asthmatic bronchitis. I've been in my house for about a week now taking the following medications, Iphatropium Bromide Inhalation, Xopenex Inhalation, Levquin, Singular, and Methylpred Nisulonof. I've been out of my job now for about 10 days. I'm schedule to go back to work this Friday, March 7, 2007. I don't know if I can make it, because I still feel very weak. Thank you for your help. 4/23/08-records received for DOS 2/24/-3/25/08-presented with 1 month hitory of congestion and subjective fever soon after receiving vaccine.  DX Bronchitis.
One bump was initially found on chest w/itchiness then increased bumps noted (little red) (L) breast, back chest.
Patient had vaccine on 10/7/15. She woke up at 3 AM on 10/8/15 with pain from top of left shoulder down to the elbow radiating to the mid back below the neck. There is a numbness feeling in the fingers of left hand. She has pain from left shoulder through to axillary region.
Presented at appointment on 02/05/08 with rash on left side of chest. Diagnosed zoster by MD.. Application of emollients recommended for treatment.
pt recvd 3 doses of Engerix-B 19SEP90 & 23OCT90 & 12MAR91 & 2MAY91 lab tests indicated did not convert; recvd booster dose of Engerix-B 9MAY91 & 2JUL91 lab tests indicated pt converted;
Patient received the Pfizer-BioNTech COVID-19 Vaccine at 0804. Reported onset of symptoms at 0808. Patient developed urticaria and hives on RUE. Administered diphenhydramine 25mg po and asked patient to stay additional 15 minutes (20 mins.total).
Received DTaP and Varivax approximately 9:30 am 9/14/04. Mom called office approximately 11AM 9/17/04 with swelling, redness and warmth at injection site. Evaluated here and placed on Augmentin for cellulitis.
This spontaneous report as received from a Licensed Practical Nurse refers to 1 or 2 patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date approximately in March 2014, the patients were vaccinated with a dose of PNEUMOVAX 23 lot H021941 expiration date 11-JUL-2014 (route was not reported). On 26-MAR-2014, the nurse reported that she noticed some odor from opened PNEUMOVAX 23 multi-dose vial. Nurse reported that normally, she would not smell anything from the vial but as she was withdrawing a dose that day (26-MAR-2014), some doses leaked out from the dispensing hole in the rubber stopper, where needle was inserted, and she was able to smell and there was that odor that she never smelled before. Nurse described the odor as "medicine-like" but stated that odor was not foul. Nurse reported that only reason she smelled anything was because some drops leaked out and she mentioned that this odor might be normal for PNEUMOVAC 23, she had never smelled this odor from PNEUMOVAX 23 vial before. No adverse effect reported. Additional information has been requested.
Very sore upper arm and shoulder; Very sore upper arm and shoulder/pain through shoulder and neck throughout the night; pain through shoulder and neck throughout the night; difficulty sleeping; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 14:00 at SINGLE DOSE for COVID-19 immunization.  The patient's medical history was not reported. 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 hasn't been tested for COVID-19. Concomitant medication included birth control (not specified). On 15Jan2021 16:00, the patient experienced a very sore upper arm and shoulder, pain through shoulder and neck throughout the night, caused difficulty sleeping; ibuprofen helped, lasted 1 day.  Therapeutic measures were taken as a result of events. Outcome of events was reported as recovered.  Follow-up attempts are completed. The following information on the batch number has been requested.
This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a adult female patient who received SHINGRIX for prophylaxis. On 1st August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 2nd August 2018, 1 days after receiving SHINGRIX, the patient experienced injection site rash, injection site warmth and injection site paresthesia. On an unknown date, the outcome of the injection site rash and injection site warmth were recovered/resolved and the outcome of the injection site paresthesia was not recovered/not resolved. It was unknown if the reporter considered the injection site rash, injection site warmth and injection site paresthesia to be related to SHINGRIX. Additional details were reported as follows: The age at the vaccination was not reported. The patient received SHINGRIX on the left arm. The injection site was hot to touch and had pin and needles sensation as well. The patient planned to follow-up with her physician on an unknown date. The reporter had consented to follow up.
48h Significant pain, firm swelling, redness, skin sensitivity at Pneumovax 23 injection site.
On 7/17/99, the pt experienced a rash on his elbows, hands, and back of thighs. The mother described the rash as blisters or pustules. The pt sought unspecified medical treatment. The physician referred the pt to a dermatologist thinking it might be eczema.
This spontaneous report was received from a registered nurse refers to a currently 4 year old patient of unknown gender. On an unknown date, the vaccine PROQUAD was improperly stored. On an unknown date, the patient was vaccinated with PROQUAD (dose, route and lot # were not reported). No adverse effects reported. At the time of the report the action taken was not reported. Additional information has been requested.
Rashes all over both arms (especially on the right arm) and on right knee and thigh
This is a spontaneous report from a contactable other healthcare professional (patient). A 53-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 53, via an unspecified route of administration, right arm, on Apr 10, 2021, at 21:30, single dose, for COVID-19 immunisation. Medical history included hypertension. Concomitant medications included lisinopril from an unknown date. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 52, via an unspecified route of administration, left arm, on Mar 21, 2021, at 13:30, single dose, for COVID-19 immunisation. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 11, 2021, at 13:15, patient experienced chills, fever of 101.9ºF, soreness in right arm, weakness and difficulty of concentrating. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event chills, fever of 101.9ºF, soreness in right arm, weakness and difficulty of concentrating were recovering (at the time of this report). No follow-up attempts required. Information about lot/batch number cannot be obtained. No further information expected.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 03-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX injection, lot # M025865, expiration date 24-MAY-2018 (dose and route of administration were not reported). There was no adverse effect reported. The administered vaccine was exposed to the temperature between 14 and 46 Fahrenheit degrees for an unspecified time. There was also previous temperature excursion with the temperature of 10.4 Fahrenheit degrees for 1 hour. Data logger was involved. No product quality complaint was.  Additional information has been requested.
COVID arm. Exactly 7 days after I received the vaccine my arm became itchy, swollen, red and hot.
21Mar2021, At 1820, 20 min post injection, allergic reaction including throat and chest tightness, wheezing, voice became barely audible. Coughing.   At 1830, 30 min post injection, EMTs administered IM epinepherine, 25 mg IV Benadryl, 1 albuterol neb.  At 1851 on ER arrival, BP 206/87, pulse 95, resp 18, temp 97.5 F, SpO2 99%.   At 1913, attending physician administered solumedrol 125 mg.   At 1755, blood drawn for total complement, CH50, and tryptase   At 2240 improved, stable, discharged from ER with instructions to take 50 mg oral prednisone for next two mornings and follow up with primary care physician as necessary
I had Covid-19 in January of 2021. I had mild symptoms. One week after the second dose of the vaccine I passed out. I was hospitalized for five days.  My heartbeat was very low I had a heart attack. I was also treated by a Pulmonologist. I now have a C-Pap machine and I have a pacemaker. I have not returned to work and it has been 10 weeks.
This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 20-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified)  for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012690 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
Patient received moderna Covid-19 vaccine that had undergone several temperature excursions; No adverse event; Patient received moderna Covid-19 vaccine that had undergone several temperature excursions; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions).    Concomitant drugs were not reported. It was reported that between 24-May-2022 and 03-Oct-2022 several patients received monovalent and bivalent Moderna Covid-19 vaccine that had undergone several temperature excursions. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-673878, US-MODERNATX, INC.-MOD-2022-673836, US-MODERNATX, INC.-MOD-2022-673644, US-MODERNATX, INC.-MOD-2022-673181 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-673836:same reporter US-MODERNATX, INC.-MOD-2022-673878:same reporter US-MODERNATX, INC.-MOD-2022-673644:same reporter US-MODERNATX, INC.-MOD-2022-673181:same reporter
Vomiting 2 days, fever 104 could have been 24 hr bug;
8 patients got expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8 patients got expired vaccine) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 patients got expired vaccine). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (8 patients got expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.
Within days of the second shot, I had a flare of joint swelling. As that subsided, I noticed I now had tinnitus at a loud level.