chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she couldn't walk and had to stay in bed all day; Weakness; feeling tired/So tired; ear ache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08May2021 (Batch/Lot number: unknown) at the age of 63 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, Anatomical Location: upper right arm), administration date: 17Apr2021, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 08May2021, outcome "recovering", described as "feeling tired/So tired"; EAR PAIN (non-serious) with onset 08May2021, outcome "not recovered", described as "ear ache"; GAIT DISTURBANCE (non-serious) with onset 09May2021, outcome "recovered" (09May2021), described as "she couldn't walk and had to stay in bed all day"; ASTHENIA (non-serious) with onset 08May2021, outcome "recovering", described as "Weakness".  Additional information: Vaccine was not administered at Military Facility. No additional vaccines administered on same date of the Pfizer suspect. Adverse event did not require a visit to Emergency Room/Physician Office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Family Medical History Relevant to adverse event Patient's Medical History (including any illness at time of vaccination) and Relevant Tests were reported as none.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
2-16 - twelve days post vaccine I started with small itchy patch of raised red bumps on my lower back and 1 larger one in my forehead. Every day the rash multiplied and is now covering my entire upper body as well as scalp and upper thighs. Red large spots- similar to welts, with small red spots in between large ones. Have seen pcp who said it appears to be pityriosis rosea. Using steroid cream, Solumedrol injection, vistaril at night and antil bacterial soaps all with no relief.
Patient reports a very large red rash, spanning most of her upper arm that persisted for over 1 week. She also states that about 1 or 2 weeks after the vaccination that she is having difficulty twisting her wrist and some arm movements.
9/17/20 Arm was warm and swollen from the injection sight to my elbow. With a red line around the swollen area. It was painful when moving my left arm. Today  9/20/20I have a sore throat My right arm with the flu shot no problem.
No adverse event; Expired vaccine administered administered to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered administered to a patient) and NO ADVERSE EVENT (No adverse event) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered administered to a patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered administered to a patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered administered to a patient).    No concomitant medication information was provided. It was reported that there was an instance where an expiration date was incorrectly documented for lot number 043h22a. it expired 8Jun23 but was administered to a patient 17Jun23 . Reporter was looking for guidance if the patient needs another dose or not. The vial size was reported as 2.5ml. It was unknown when the vial was initially stored in the refrigerator. It was confirmed that the vial had not undergone temperature excursion issue.  Patient had had reported any adverse event at the time of report. No treatment medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2023: Follow-up received contains no new information.
One day post vax, this pt developed an injection site reaction  with redness and a "black and blue" bruise. He recovered.
Urticaria treated with Benadryl and observed over 30 minutes. Prednisone 20mg q 12 hours X 4 days.
Patient experienced chills headache and arm soreness that evening after the vaccine was given. Patient experienced redness and swelling at the site of injection 2 days after receiving the vaccine. Patient experienced swollen & tender lymph nodes 2 days after receiving immunization. The effected lymph nodes are on the same side as the site of injection.
It was reported that a 25 year old male pt received a Menomune vaccination in the right arm on 09/19/2000 at 12:35pm. Approx 20mins later, the pt felt drowsy and his left eye was "twitching," blinking a lot and his neck became stiff. When asked if the stiffness in his neck zero = no stiffness at five= total rigidity, the pt stated the stiffness he was experiencing rated about a one. Two hours later, the neck stiffness was rated as less than one and rare twitching was noted. The neck stiffness was gone for the most part. Reportedly the pt recovered from this experience. Pt is to be followed up by student health.
she was supposed to get her second dose on the 12Jan2021 but she was still not feeling very well so now they are telling her to go this weekend; she was supposed to get her second dose on the 12Jan2021 but she was still not feeling very well so now they are telling her to go this weekend; tested positive for COVID; tested positive for COVID; not feeling very well; feeling dizzy and weak; feeling dizzy and weak; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899 and expiration date not provided), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. Medical history included Diabetes which was diagnosed in Apr2020. There were no concomitant medications. The patient received the first dose of the vaccine on 22Dec2020. She tested positive for COVID19 on 08Jan2021. The second dose of vaccine on 12Jan2021 was deferred as the patient was not feeling well on an unspecified date in Jan2021. She asked for guidance/information about receiving the second dose after testing positive. She stated that she was still feeling dizzy and weak on an unspecified date in Jan2021. She said that she heard the people were not feeling too well after the second dose and she will get it as long as it will not kill her. She asked what will happen if she does not take the second dose and will she need to get the series again. She wanted to know if she can take the second dose of vaccine. She clarified that she was supposed to get her second dose on 12Jan2021 but she was not feeling very well so now they were telling her to go on the weekend. She does not feel fine. She asked if it was safe for her to take the second dose or should she wait. She wanted to know if the effect of the first dose is null since she has now delayed it so long. She is the supervisor of ultrasound department. She started having COVID symptoms of 04Jan2021, she was tested on 05Jan2021 and got a positive result on 08Jan2021. The outcome of the events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported tested positive for COVID19 based on the known safety profile. However the short duration since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
Localized reaction, erythema and warm to touch. Supportive care, cool pack and prelone syrup x 3 days. 48 hrs later symptoms 100% resolved.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Lot number: EN6199), in left arm, in Mar2021 as dose 2, single (Lot number: ER2613), in left arm, in Oct2021 as dose 3 (booster), single (Lot number: EC3184), in left arm and on 13May2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "COVID-19". 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.  Clinical course: Other medication in 2 weeks: Yes. Patient received Paxlovid from 23May2022 to 28May2022 for treatment of COVID-19. Rebound COVID 6 days following last Paxlovid dose was on 03Jun2022. Patient not had any known allergies.
Patient experienced shoulder pan; decreased rang of motion.  Sometimes persistent pain that is like shooting pain on left arm. To him, it feels as if its a recurring pain.  Has regained back some range of motion and decrease in pain.
This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 08-JAN-2015, the patient was vaccinated with improperly stored PROQUAD (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, PROQUAD was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PROQUAD was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Ascending paralysis, numbness, tingling within 14 days of taking vaccine, completely paralyzed by Oct 22nd. Ongoing treatment with IVIG - Ongoing numbness.
Extreme pain in left injection site, around to left upper chest and left upper back area.  Continued after fever, chills, headache and body aches subsided and after 24 hours after injection.  Still continue.
2 days after second Covid Vaccine dose, developed a "softball" sized swollen lymph node in the armpit of the left arm, same arm that vaccine was administered.  Was severe for 3 days, can patient could not even put his arm down to the side all the way.  Resolved by 1/27/21
Client observed vomiting and sweating. Client able to verbalize need and stated that he was/felt extremely nauseous after receiving second dose of vaccine.  Client seen and assessed by EMT and V/S are: b/p 115/70, HR 65, O2 98.  Client decline transfer to ER and voiced that he will go himself if symptoms worsen and cleared to go by EMT.
Rash on left leg at injection site and right foot. Loss of appetite. Dr. informed to take Benadryl for the next few days until rash is gone.
adverse event; This case was reported by a pharmacist via call center representative and described the occurrence of adverse event in a unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication.  The patient reportedly spoke with other women who received Shingrix and patients who received the second dose closer to the two month mark rather than six months experienced a higher rate of symptoms. The reporter did not have information for the other patients mentioned. The reporter consented to follow up.
3RD DOSE OF MODERNA COVID VACCINE GIVEN 11/29/21, #069F21A;  due to decline in functioning mobility and cognitive decline; pt had a positive COVID test on 10/31/22 and passed away in the facility on 11/4/22.
Axillary nerve palsy x 2 weeks. Supraspinatus able to abduct arm 15 degrees and then no further abduction. Positive drop arm test. Treatment - observation, improved day 11 from vaccination, resolved after day 14 from vaccination.
day after (Sunday) had fever, chills, sweating, headache, tiredness, and body aches. Fever broke Sunday night. Monday still had slight aches and chill. Tues, Wed  & Thurs, still having extreme fatigue and slight chills/sweating.
Seven days after injection developed area of pain, itching, redness, swelling and erythema at injection site, 6 inch diameter.  Lasted 48 hours, then started to gradually resolve.  Completely gone after another 72 hours.
Onset 1/27/2000, temp of 102-103, then down to 101 x 2 days. Onset 1/30/2000, small red welts on face and neck traveling to chest by the following day. Slight SOB, fatigue and intermittent nausea.
GI uncomfortable; Diarrhea; This is a spontaneous report from a non-contactable Other HCP (Patient). A 47-year-old non-pregnant female patient received first dose BNT162B2 (COMIRNATY, Solution for injection, lot number: Unknown, Expiration date: Unknown), via unknown route of administration in the right arm on 15Jan2021 at 12:00 as single dose for COVID-19 immunization in hospital. The patient's medical history and concomitant medications were not reported. Other medications taken within two weeks before the event onset reported as None. The patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 19Jan2021 the patient experienced Diarrhea and GI uncomfortable. No treatment was taken regarding the events. Patient was not affected prior to vaccination and no covid test was taken post vaccination. The outcome of the events was recovered.  No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
This is a spontaneous report from a contactable consumer. A 69-year-old female patient received PREVNAR 13, via an unspecified route of administration, on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced breaking out in rashes all over her back, arms, legs and stomach on an unspecified date. Therapeutic measures were taken as a result of itching which included an unspecified cream but reported that it keeps coming back and the doctors can't seem to regulate it. Outcome of the events was unknown.
Shortly after, I would get more frequent headaches, and migraines are what caused the loss of work. I have noticed a change in my periods and a change in my vision. Car sickness that I didn't use to have. Treatment is chiropractic care for the migraines that helps both migraines and headaches.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Aug2022 at 17:45 as dose 4 (booster), single (Lot number: FP7131) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast Cancer x2" (unspecified if ongoing); "Arteriosclerosis" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Chronic Pain Syndrome" (unspecified if ongoing); "allergies" (unspecified if ongoing), notes: Known allergies: Yes. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE lot number FF8841, dose administration time 03:00 PM, vaccine location Right arm), administration date: 01Oct2021, when the patient was 65-year-old, for Covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE; Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; Manufacturer unknown), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 13Aug2022 at 06:00, outcome "recovering", described as "Debilitating fatigue"; ARTHRALGIA (non-serious) with onset 13Aug2022 at 06:00, outcome "recovering", described as "extreme joint pain". Therapeutic measures were not taken as a result of fatigue, arthralgia. Additional Information: Patient had known allergies. 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.
Pt brought to clinic 5/5/06 for PPD read. Dad mentioned red area, circled by mom 5/4/06, that was 2 1/2" x 3" area. Checked now 4" x 6" red. Pt afebrile. Pt c/o "itchy" at red area. Pt seen by pediatrician. Benadryl recommended with ibuprofen. (DX: Inflammatory reaction not infectious).
[1] no immediate symptoms until three months AFTER vaccination.   [2] symptoms Started 08 SEP 2021 Red skin rash all over body following food intake. Rash persists for two hours thence subsides.  [3] assumed allergy. Deleted all normal routine foods to eliminate allergy target...negative results. Same rash condition persists. [4] Never had such symptoms in my life.
My mother has never had any heart issues, and suffered a heart attack on Thursday April 15.  She had 2 stints put in late Thur evening. The surgery went well, but there was too much damage to her heart and she passed away on Sat April 17, 2021
sick feeling; sore back; Achy; Fatigue; Nausea; I had fever and fatigue for the first two doses, a sick feeling; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick feeling), BACK PAIN (sore back), PAIN (Achy), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history information was reported.  Concomitant products included CARBAMAZEPINE for an unknown indication.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick feeling), BACK PAIN (sore back), PAIN (Achy), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (I had fever and fatigue for the first two doses, a sick feeling). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, ILLNESS (sick feeling), BACK PAIN (sore back), PAIN (Achy), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (I had fever and fatigue for the first two doses, a sick feeling) outcome was unknown.            Concomitant medications include Carbamazepine XR 100mg. Treatment medications include Aspirin   This case was linked to MOD-2021-345452, MOD-2021-345470 (Patient Link).
flu-like sx noted 8/19/99 6AM upon waking: achy joint, low grade fever;noticed petechiae on bilat legs from rt below knees to ankles on 8/21/99;flu like sx subsided w/in 24hr from onset;petechiae still present on 8/23/99;
diverticulitis, his condition flares up every once in a while; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Feb2021 at a single dose for COVID-19 immunization. Medical history included diverticulitis. Concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on an unspecified date for COVID-19 immunization. The patient was concerned about efficiency of the vaccine. He received a second dose of bnt162b2 yesterday morning and today (09Feb2021) he was experiencing bout of diverticulitis and his doctor has given him couple of antibiotics, one of them being Cipro and the other was Flagyl to treat diverticulitis and he was just concerned given he just received a vaccine if those antibiotics would affect the efficiency of the vaccine. He was concerned because he has been given antibiotics by his doctor for when his condition flares up every once in a while. The doctor gave him Cipro and Flagyl. He was wondering if he takes these, if it will have any impact on the efficacy of the vaccine. He thinks the flare up was coming on before the shot so he didn't want to do a report. The outcome of the event was unknown.  Information on lot/batch number has been requested.
No signs or symptoms reported; VARlVAX was administered to four patient; This spontaneous report was received from a medical assitant refers to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 13-AUG-2021, the patient was vaccinated with an improper stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number T010314, expiration date 24-MAR-2022 (dose and route of administration not provided) for prophylaxis. No adverse event was reported.  The vaccine underwent a temperature excursion of -13 dregrees Celsius for 1 hour and 30 minutes. There were no previous temperature excursions.  This is one of four cases reported by the same reporter.
Patient presented to hospital on 01/14/2022 with rectal and GI bleeding, with abdominal pain, nausea and dizziness.  In the ED tested positive for Covid-19.  CT abdomen/Pelvis impression: abnormal wall thickening, hepatic cirrhosis associated with splenomegaly and small volume ascites, moderate hiatal hernia.  Patient eventually needed intubation and requiring vasopressor support for sepsis.  Patient expired on 01/22/2022 from sepsis d/t Covid-19 as well as colitis with septic shock and multiorgan failure.