chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: Patient is a 62 yo male with HTN, T2DM, and diabetic peripheral neuropathy presenting to ED 10/17/18 with two months of progressive weakness and muscle pain resulting in falls. Two months ago, pt reports muscle soreness began the day after he received the Shingrix vaccination (8/27/18). 2-3 weeks later, pt reports fairly rapid progressing weakness, initially developing in his legs and spreading to his arms. Patient reported feeling ?sore and weak all over?. Additionally, patient reports having approximately 5 falls, with 2 occurring prior to the Shingrix administration. Patient denies feeling weak or sore before the vaccination and attributes the falls to feeling off balanced.  After the Shingrix vaccination, patient wrote into his PCP on 9/10/18 complaining of soreness in every joint, muscle, tendon, and bone in his body. Patient also reported losing almost all of his muscle strength and unable to lift 15 pounds. Though the symptoms subsided, patient reported he still felt very weak and tired. PCP attributed the symptoms to the vaccination. Meloxicam was later prescribed for pain.  Patient's weakness had progressed to the point that he couldn't lift his legs and needed assistance out of chairs and cars. He was also unable to lift a glass or bottle, using a straw to drink. Though pt is now discharged, he remains very weak.  PMH includes diabetic neuropathy resulting in baseline numbness in his feet and ankles that has remained unchanged. Patient's statin on admission has varied over the past 4 years, but he is currently on Atorvastatin 40mg and has been for the last 8-9 months. He was on simvastatin prior (switched b/c of policy, not b/c of any sx's). Denies any problems with statins prior to this or any history of reactions to vaccination. Pt reports being ?on and off? statins for years, possibly starting in 2002.  Symptoms: Symptoms: 1. ElevatedLiverEnzymes, 2. statin-induced immune-mediated necrotizing myopathy 1 - GLOBULIN, IMMUNE Dose: 10 Units: MG Freq: QID Route: IV 2 - METHYLPREDNISOLONE Dose: 1000 Units: MG Freq: EVERY DAY Route: IV
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 75-year-old male patient who received SHINGRIX. Concurrent medical conditions included shingles and cataract extraction. Concomitant products included cholesterol. On 18th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 18th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site swelling, injection site pain, injection site erythema, injection site warmth and injection site rash. The patient was treated with TYLENOL. On an unknown date, the outcome of the injection site swelling, injection site pain, injection site erythema, injection site warmth and injection site rash were recovering/resolving. The reporter considered the injection site swelling, injection site pain, injection site erythema and injection site warmth to be related to SHINGRIX. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional information was received as follows: The patient took blood pressure medication as a concomitant drug. The reporter did not provide the lot number or expiration date for SHINGRIX. The patient reported that after receiving SHINGRIX he experienced injection site reactions. The patient experienced pain, swelling, redness and warmth to the touch just below his injection site by about 3 inches on his left arm. Caller states that it appears almost like a rash and is about 3.5 inch circumference around his arm. The reporter states that on the day of injection the reactions were at a 10 and at the time of reporting they were about a 5 on a 10-point scale. The patient was began to take TYLENOL yesterday and on the day of reporting to help with the symptoms.
pt recv vax 9JUN98 & 9JUL98 pt devel a pruritic rash;pt seen by MD & is currently being treated w/med;
pt recvd flu vax & was 1 of 15 who devel influenza & was hospitalized;
pt recvd vax 25FEB93 & w/in 1/2 hr devel severe weakness, diaphoresis, anxiety, nausea, pallor, vomiting & severe pain in all joints & muscles; pt hands also became red from fingers to wrist; however did not exp itching;
patient said she had worsening of  ringing in her ears.  As of 11/18/19 the ringing is still happening
Swollen deltoid muscle with extreme pain to point of immobility lasting almost 2 days. Some nausea.
No adverse event; Bivalent doses administered after the BUD to patient 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patient 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 29-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 15-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patient 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patient 12 and up.) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patient 12 and up.).    Patient ID was reported.  No concomitant medication was reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Reportedly, in this report the patient was not Eligible. Breakdown of doses were reported as 51 doses from batch numberAS7140C and 60 doses from Batch number AS7148B.  No treatment medication was reported.
Red splotchy area on upper left arm around the area of injection. It's not itchy or painful, raised, bumpy, or warm to the touch. It's just red.  First noticed in the evening of the following day after the injection. The red area grew throughout the day of the 2nd day following injection.  This occurred after the second dose of the moderna vaccine. I had no adverse effects after the first dose.
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 POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in an 83-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 POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (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.   Concomitant medication of the patient was not reported.  The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. Reporter stated that no adverse reactions were reported by any patients.  No treatment information was provided by the reporter.
Still has headache 15 days later; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Still has headache 15 days later) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Still has headache 15 days later). At the time of the report, HEADACHE (Still has headache 15 days later) outcome was unknown.            No Concomitant and  treatment medications were provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Actually started after my initial two doses which were given on 12/22/2021 and 01/12/2021.  After these doses I started getting headaches and eventually ringing in my ears (tinnitus). These symptoms lasted for months and I had a doctors visit on July 6, 2021 about the headaches and I mentioned the tinnitus. In about October the headaches seemed to subside and the tinnitus had diminished. Then on November 2, 2021 I received the third shot (booster) and a few days later the headaches came back and the tinnitus came back as well. Today the headaches have subsided but the tinnitus is always present with some days it being more intense than others. The COVID19 (Pfizer-BioNTech) shots I received in December and January of 2021 have the following lot numbers (EK9231) and (EL3246).
Shortness of breath, cough, increased heart rate, decreased oxygen saturation, shaking, full body rash of hives started ~48 hours later. Resolved within 15 minutes of taking oral benadryl 2 tablets.
mom brought pt into room-very pale, nauseated, h/a, sleepy; elevated feet, applied cold compress to head; BP 80/40, P160, perspiring; remained cold & clammy-ketosis noted; MD felt it was an anxiety attack;
Headache, Myalgia, Arthralgia, Fever, ErythemaMultiform, UrticariaPruritus, chills, fatigue, injection site pain/arm pain, swelling  at injection site, rigors Narrative:   Other Relevant History:
Shortness of breath.DVT, Right leg. DVT Showered into lungs, Multiple Bilateral Pulmonary Emboli.
High fever 103.7; Shivering; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (High fever 103.7), CHILLS (Shivering) and FATIGUE (Fatigue) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (High fever 103.7), CHILLS (Shivering) and FATIGUE (Fatigue). At the time of the report, PYREXIA (High fever 103.7), CHILLS (Shivering) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 103.7 high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included paracetamol, ice pack and cold bath as per physician's instructions.   This case was linked to MOD-2021-007917 (Patient Link).
some rash firming on both of her arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH (some rash firming on both of her arms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 26-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, the patient experienced RASH (some rash firming on both of her arms). At the time of the report, RASH (some rash firming on both of her arms) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Myalgia, Fever, chills Narrative: symptoms lasted 48 hours, fever was 99.8F
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On 01-SEP-2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for routine adult health maintenance and the intended purpose for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of her shingles and associated injuries. On or about 01-OCT-2015, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Pt experienced mild tightness of the throat, a metallic taste, and acute onset coughing (he said this was the same rxn he had had to previous doses of iodine and heparin). Coughing continued for about 20 minutes, at first wanted me to use the Epipen, but when I told him I would have to contact 911 once I used it, he declined injection. Waited in the immunization area for 15 minutes, then left the store with his wife once he felt he was ok. I called him at 7:48 pm and he now feels fine.
Redness on face, neck, and arms,  Tachycardia, HTN
Information has been received through the Merck pregnancy registry through a nurse concerning a 26 year old female who on 03-APR-2007 was vaccinated with her first dose of GARDASIL. On 07-JUN-2007, the patient was vaccinated with her second dose of GARDASIL. On 27-SEP-2007 the patient was vaccinated with her third dose of GARDASIL. Subsequently, it was determined that the patient was pregnant (LMP = 23-SEP-2007, also reported as 27-SEP-2007). No adverse reactions were reported. This is a consolidation of two reports. Additional information has been requested.
Increased temp of 103.2 to 100.9 degrees after being vaccinated.
This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 63-year-old male patient who received SHINGRIX (batch number 5MG5E, expiry date 5th May 2021) for prophylaxis. On 9th January 2019, the patient received the 2nd dose of SHINGRIX. On 9th January 2019, 5 hrs after receiving SHINGRIX, the patient experienced headache, fever and chills. On an unknown date, the outcome of the headache, fever and chills were not recovered/not resolved. It was unknown if the reporter considered the headache, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and about 5 hours later, the patient experienced headache, fever and chills. It was not known if events has improved. The reporter gave consent to follow up.
Patient felt warm and lightheaded ~5 minutes after receiving her first covid19 vaccination. Started to develop a sore throat, itching (no hives), hoarseness, and a headache within 15 minutes. Given Benadryl 50mg and observed. Hoarseness persisted through an hour of observation but itching and sore throat resolved. No difficulty breathing or shortness of breath. Given no worsening symptoms, patient felt comfortable going home with her daughter who was counseled on signs and symptoms to watch out for. Patient does have an epi pen available due to history of anaphylaxis in the past and is aware of signs/symptoms and when to seek medical attention.
After administering vaccines child became very fussy and over tired, would not wake to eat and passed away a little over a day later. Autopsy could not say that vaccines did not play role in death.
haven't had a menstrual cycle in over 2 years...in menopause, however after send dose of covid vaccine, passed blood clot and experiencing mild to moderate menstruation. received 2nd dose on Jun 1, started bleeding on June 3 and as of today, still bleeding
pain under armpit; hurts a little; pain in breast and nipple area; Axillary node inflamed; This spontaneous case was reported by a health care professional and describes the occurrence of AXILLARY PAIN (pain under armpit), PAIN (hurts a little), BREAST PAIN (pain in breast and nipple area) and VACCINATION SITE LYMPHADENOPATHY (Axillary node inflamed) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included MELATONIN for an unknown indication.    On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced AXILLARY PAIN (pain under armpit), PAIN (hurts a little), BREAST PAIN (pain in breast and nipple area) and VACCINATION SITE LYMPHADENOPATHY (Axillary node inflamed). The patient was treated with IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE (MOTRIN COLD & FLU) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, AXILLARY PAIN (pain under armpit), PAIN (hurts a little), BREAST PAIN (pain in breast and nipple area) and VACCINATION SITE LYMPHADENOPATHY (Axillary node inflamed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment activities for the event included Motrin, Ibuprofen.  Action taken with mRNA-1273 in response to the events was not applicable.    Reporter did not allow further contact
a little of a month later we both got the Covid virus/Drug Ineffective; a little of a month later we both got the Covid virus; My joints are all aching; have no energy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "a little of a month later we both got the Covid virus/Drug Ineffective"; COVID-19 (medically significant), outcome "unknown", described as "a little of a month later we both got the Covid virus"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "My joints are all aching"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "have no energy". As a retired patient and wife took the 2 Pfizer shots thinking they were safe. Unfortunately, a little of a month later they both got the Covid virus. They talked to others who had gotten the Pfizer vaccines and they also got something with the same problems. For over a year now his joints were all aching and he had no energy. He had seen many doctors, but nobody seems to have the answer. What he thought was that Pfizer put something in the vaccines that affects older people. He thought we were working trying to kill seniors, so they have more money, because the pensions are gone, to sponsor insane money give away to other countries. What would happen was people will have another situation and kill every elected person and people that helped them. His life was on the line and it is too bad I did not live near. He almost gave his life and he would love to put bullets into Traitors. By killing people and others we not only save our country, we will protect the World. Maybe our first act was to talk to your creators of the vaccines to find out what they put in the vaccines and what can be done to correct it. If they did it on purpose they will be arrested and tried for Mass Murder World wide.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient states she broke out and her arm got swollen after getting 2 shots in her left arm few inches apart. She has had FLUZONE HD before (year ago).
deemed to have an allergic reaction; localized swelling of the injection site, the swelling was larger; localized swelling of the injection site, the swelling was larger; Initial information received on 12-Sep-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case is linked to cases 2019SA257583 and 2019SA257467 (same reporter).  This case involves patient (with unknown demographics) who was deemed to have an allergic reaction (hypersensitivity) and localized swelling of the injection site, swelling was larger (localized oedema), while he/she received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via intramuscular route in unknown administration site.  On an unknown date, the patient had deemed to have an allergic reaction (hypersensitivity) and localized swelling of the injection site, swelling was larger (localized oedema) following the administration of INFLUENZA VACCINE. The swelling was larger compared to any other reactions the staff member has had in the previous years.  Other relevant tests not reported.   Final diagnosis was hypersensitivity.  Ice pack was applied as corrective treatment.  The patient recovered from the events.  Information on the batch number was requested.  Documents held by sender: none.
Low grade fever 8-24 hours after injection,  Syncope (fainting) and nausea 15 hours after vaccine, resolved within 1 hour.    Fatigue and injecting site pain up to 3 days after vaccine.