chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Interchange of vaccine products; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Lot number: 32030BD) at the age of 66 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Mar2021 as dose 1, single (Lot number: 006B21A), in left arm and on 15Apr2021 as dose 2, single (Lot number: 040B21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic Lymphocytic Luekemia" (unspecified if ongoing), notes: Other medical history: Chronic Lymphocytic Luekemia; "Known allergies: sulpha drugs" (unspecified if ongoing), notes: Known allergies: sulpha drugs. There were no concomitant medications.The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Treatment of COVID-19; Positive, notes: tested positive with a strongly marked line. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 22Sep2022 to 27Sep2022.  No follow-up attempts are possible. No further information is expected.
I received Shingrix on 8/13/19. Approximately 8/15 in the evening I observed a rash on my Upper Left Arm , Left shoulder and Left Upper back. It did not particularly itch as I didn't notice it until I rubbed lotion on my arm and felt small bumps. It slowly began to resolve on its own. I took a photo of the resolving rash on the early evening of 8/17/19. the rash seems to have resolved now.
12-18 hours after vaccine had feeling of hot/cold/shivering/myalgia.  Few days later started to have chest pain, shortness of breath that progressed and eventually was severe.  seen at ER 2/22/21 and found to have large pericardial effusion on bedside u/s and acute ST changes on EKG. transferred to second hospital and admitted 2/22/21-2/25/21. He was treated with pericardial windows to remove fluid and discharged on ibuprofen and colchicine for presumed viral pericarditis.
Occurrence Date: 03/19/2021.  Patient c/o feeling hot, and sweaty during the observation around 10:15 after receiving his Covid-19 vaccine. V/S taken, and first reading: BP: 179/103, HR: 100, and Spo2: 96% . Hydration provided. Patient was asked about medications. Patient stated that he had taken his meds @ 06:00. Patient did not remember his baseline. Patient was taken to the ED.
The recipient of this vaccine is 12 years old.; Inflamed lymph nodes under his arm; Chills; This spontaneous case was reported by a pharmacist and describes the occurrence of LYMPHADENITIS (Inflamed lymph nodes under his arm), CHILLS (Chills) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (The recipient of this vaccine is 12 years old.) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccine (Patient received 2 primary doses of the Pfizer COVID-19 vaccine.). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine.    On 29-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. In January 2022, the patient experienced LYMPHADENITIS (Inflamed lymph nodes under his arm) and CHILLS (Chills). On 29-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (The recipient of this vaccine is 12 years old.). The patient was treated with IBUPROFEN in January 2022 for Chills and Lymph node inflammation, at an unspecified dose and frequency. On 29-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (The recipient of this vaccine is 12 years old.) had resolved. At the time of the report, LYMPHADENITIS (Inflamed lymph nodes under his arm) and CHILLS (Chills) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants were provided. It was reported that since receiving the booster dose of the vaccine the patient experienced the event and was ongoing at the time of report.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 38-year-old female patient (gravida 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 21-Jun-2021. On 05-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On 05-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No concomitant medication was provided.   Reporter did not allow further contact
This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On unknown dates, the patients were vaccinated orally with an improperly stored doses of oral ROTATEQ lot # L023866, expiry date 24-MAR-2017 (dose was not specified). Administered doses of oral ROTATEQ underwent temperature excursion at 48.6 Fahrenheit degrees for 1 hour and 45 minutes. It was reported that the vaccine underwent previous temperature excursion at 48.9 Fahrenheit degrees for 1 hour and 15 minutes. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Received the first dose of the vaccine; Have now tested positive; Received the first dose of the vaccine; Have now tested positive; This is a spontaneous report from a  pharmacist. It was reported that a patient of unspecified age and gender received bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation .  The patient medical history  and concomitant medications were not reported.  The patient  received the first dose of the vaccine; and have now tested positive.  The patient underwent lab tests and procedures which included sars-cov-2 test: positive  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the limited available information, the company considers that a causal relationship between the reported events and vaccination with BNT162B2 cannot be excluded.
broken femur; early morning fall (maybe related); lethargy; memory issues (beyond normal for her); low grade fever; This is a spontaneous report from a contactable consumer. An 88-years-old (non-pregnant) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD). Concomitant medications included atorvastatin (ATORVASTATIN), gabapentin (GABAPENTIN), lorazepam (LORAZEPAM), losartan (LOSARTAN), metoprolol succinate (METOPROLOL SUCCINATE), pantoprazole (PANTOPRAZOLE), paroxetine (PAROXETINE), and zolpidem (ZOLPIDEM). The patient had no other vaccines in four weeks. The patient had no COVID prior vaccination. On 20Feb2021 at 12:00, the patient had a low-grade fever for 2 days, followed by lethargy and memory issues (beyond normal for her) on the 3rd day (23Feb2021). Finally, on the 4th day (24Feb2021), by early morning, the patient had a fall (maybe related) and a broken femur. The events resulted in emergency room/department or urgent care, hospitalization as the patient was hospitalized for two days due to the events. Treatment for the events was unknown. The patient underwent lab tests and procedures which included Blood test/viral RNA: Negative on 26Feb2021. The events had not resolved.   Information on the batch/lot number has been requested.
After receiving PREVNAR 13 and ACTHIB, pt began to cry and held his breath longer than average patients, within seconds, pt became cyanotic and red, lasted for 45 secs - 1 minute. Pt took a short gasp and began to breathe slowly. Rashes in the chest and left thigh developed within seconds. 3 minutes after event, pt displayed s/x of pallor and malaise.
hands started to itch;moved up arms, down side, down back, legs, feet; hives; fast heart beat;abnormal feeling in throat;30min resolved;
Vaccinations were recieved on June 21st. On the 27th of June I noticed a slight fever, and irrability. Fever continued on the evening of June 29th my son woke in the night with a very high fever, in which I stripped his clothes, gave him tylenol and cool wash cloth. June 30th woke with slight fever in morning so I continued with tylenol. The docter said a slight fever could occur 7-10 days after shots so I thought nothing of it. By the afternoon when he woke from his nap he was very warm and acting out of sorts, he just wanted to be held and was staring off into distance mumbling and laughing to himself. I started to worry, and took his temp it was 103.7, I called the (800)-ask a nurse helpline and within a 1/2 hour he's temp was 104.4. We immediatley decided to bring him to the E.R.(which is a 45min. drive). The whole time he's mumbling, and giggling to himself not giving us any eye contact. I sat in back with him trying to give him water because he's little body was so hot to the touch. After giving him Motrin and Tylenol at the hospital to bring fever down they did x-rays, and discovered that he had pnemounia. It was a shock to us my son had no cold or flu symptons to bring on pnemounia, he has never even been in a smoking enviroment and he's been so healthy he hasn't even had an ear infection. Dr. put him on 400 ml of Amoxicillan 2ce a day for 9 days. He also got quite a few "chicken poxs" randomly showing up around the same time ranging from his head to toes. Also swollen glands on the back of neck.
History of Present Illness:  30 year old male who received four anthrax vaccines in his right arm where he subsequently developed osteomyelitis of the proximal humerus.  The pain he experienced after the 3rd dose on 18 Dec 03 did not resolve before he received the 4th dose 18 May 04.  He was deployed at the time he received the 3rd dose and was lifting weights in his spare time.  He thought he had torn a muscle in his right shoulder.  The shoulder intermittently ached and he had some weakness with certain movements.  He returned from deployment in March 2003.  He took leave and for approximately two months he did not do any exercise.  During this time, the pain in his right shoulder was intermittent, usually in the evenings, and would wake him up at night.  He rates the pain as a "5" on a 0-10 pain scale when it bothered him.  It would increase to "6" at times.  Motrin effectively relieved the pain.  He never lost function of the right arm or shoulder. He received anthrax #4 on 18 May 04 in the right deltoid.  On 9 Jun 04 he sought medical attention for the pain in his right shoulder.  A MRI revealed a lesion of the right humerus.  He underwent curettage of the right proximal humerus lesion on 17 Aug 04.  He currently has a constant dull ache at the operative site that he rates as 1-2 on the pain scale and escalates to a 3 or 4 with use.  He is not taking any medications for pain currently.  He is scheduled to follow-up with Orthopedics on 29 Aug 04.    IMMUNIZATION          DATE                                  SYMPTOMS Anthrax #1  Influenza 24 Oct 03 "Golf ball" size knot at anthrax injection site with tenderness and warmth and soreness.  Knot resolved within 2 weeks.  Anthrax #2 Smallpox 12 Nov 03 Immediate burning sensation at anthrax injection site with same size local reaction.  States pain with this injection was more intense and lasted longer than with first dose.  Unsure of exact duration of symptoms, but resolved before 3rd dose. Anthrax #3 18 Dec 03 Same as second dose with pain as described above.  Pain did not resolve before 4th dose. Anthrax #4 18 May 04 As above.
pt recv vax 7APR96 & 11DEC96 pt exp zoster;it was noted by the MD that pt case of zoster was moderate & pt had no known contacts w/chicken pox;
This spontaneous report refers to a 71 year old male patient with diabetes and no drug reactions reporting on himself. On 10-OCT-2013 the patient was vaccinated with ZOSTAVAX VIAL 19400 PFU (dose, concentration and lot number were not reported). Concomitant therapies included LANTUS, metformin, ramipril, amlodipine besylate and ZIAC. On 11-OCT-2013, the patient experienced joint and muscle pain on his upper left leg after receiving ZOSTAVAX. The patient sought medical attention, he spoke with his physician on the phone. No treatment was given for the events. Lab diagnostics studies were not performed. The outcome of the events was reported as improve, on therapy. Additional information has been requested.
Swollen and red - size of a baseball. Hot to touch. State swollen area extended below the inject. site to the inside of her arm. Pt felt feverish (slightly) by 5/10/10. Pt was feeling better swelling had decreased.
Patient received an expired booster dose (more than a month ago, 13SEP2021).; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired booster dose (more than a month ago, 13SEP2021).) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired booster dose (more than a month ago, 13SEP2021).). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired booster dose (more than a month ago, 13SEP2021).) had resolved.            No concomitant or treatment medication provided.  The patient experienced no adverse events after vaccination.
Patient reports the day of and up to 3 days following vaccination pain with urination. On day of report, patient stated painful urination no longer an issue but headache persisted. Patient states in the past they have had kidney stones but the pain was not similar to the pain they experienced with the stones.
C/O R chest tightness/SOB/hyperventilating.  Client was clammy.  Laid down.  Breathing improved.  Vitals stable.  Client drank 1 1/2 bottles of water.  Client then sat for awhile until pain subsided.
3/6/2021- received vaccination. 3/9/2021 didn?t feel good  3/12/2012 went to q clinic and got a Covid-19 test and flue test. Both negative and was sent home. 3/15/2021 Doctor sent me to get a x ray, diagnosis pneumonia. Symptoms: Fever, Headaches, rash under both breast, muscle aches, nausea, fatigue, loss of appetite  As of 4/12 2021 I am still nauseated , and fatigued
Patienyt vaccinated with Janssen product 5/5/2021, admitted to Medical Center on 7/2/2021 with hypoxemia and noted COVID 19 Positive.  Treated with BiPAP, dexamethasone and remdesivir.
Generalised numbness; This is a spontaneous report received from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318) via an unspecified route of administration in the right arm on 26Feb2021 at 12:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included vitamins. Prior to 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 COVID-19 vaccination. On 13Mar2021 at 12:00, about 15 days after the vaccine, the patient began to experience numbness in her leg which over the next day travelled to her right side, and eventually to her face and mouth. The sensation increased and decreased in intensity and location but never completely went away. The patient visited a doctor and they thought the vaccine triggered a reaction in her L5 band for which she was prescribed medication. Therapeutic treatment taken for the reported event was celecoxib, tizanidine and gabapentin. The patient underwent lab tests and procedures, which included blood test and an MRI on her head which showed nothing of interest to the doctors. The clinical outcome of the generalised numbness was not resolved at the time of report. No follow-up attempts are needed. No further information is expected.
mom stated pt recv vax 9MAY96 & pt had temp all day even w/APAP;230AM pt had sz;taken to hosp by amb, t103.5;series of tests were done & spinal tap;mom was told all test were OK & hosp ER thought it was from DTP-pt not adm;
Felt achy, chills. Went to bed early. Next day was numb on vaccine site, aches, pain, nausea, fever. Talked to the nurse who recommended Tylenol for pain but because of nausea was unable to keep it down. Nausea and aches are gradually going away, feels better today.
Patient was given injection and mentioned she had a warm feeling and had tingling in her face. Patient stated, "It made me very anxious." Resp therapist checked her breath sounds no stridor or wheezing. B/P was taken- 116/83 Pulse of 73 bpm. Kept for 15 minutes and the symptoms resolved. Patient was offered Benadryl but stated he mother has had a reaction to Benadryl and patient refuse the medication.
Started having severe headaches with coughing. Tested positive for COVID-19 with a home test; Went to an urgent care and was prescribed PAXLOVID.
Vial was initially stored in the refrigerator on 12-Jun-2023 and vaccine was administered on 13-Jul-2023.; no adverse event; 2 Moderna Bivalent vaccine doses were administered 1 day after the Beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 Moderna Bivalent vaccine doses were administered 1 day after the Beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 12-Jun-2023 and vaccine was administered on 13-Jul-2023.) and NO ADVERSE EVENT (no adverse event) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7643E) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jul-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 13-Jul-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 (2 Moderna Bivalent vaccine doses were administered 1 day after the Beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 12-Jun-2023 and vaccine was administered on 13-Jul-2023.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 Moderna Bivalent vaccine doses were administered 1 day after the Beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 12-Jun-2023 and vaccine was administered on 13-Jul-2023.) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (2 Moderna Bivalent vaccine doses were administered 1 day after the Beyond use date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 12-Jun-2023 and vaccine was administered on 13-Jul-2023.).    Concomitant product use was not provided by the reporter.  Individual vial was 2.5 ml. Vial did not undergo any temperature excursions. Dose administered after 30-day use by date or after manufacturer date of expiry.  Treatment information was not provided.  This case contains information about patient 2nd out of 2 elderly patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-733885 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733885:
At injection site -> redness, bruising, warm to touch, muscle soreness -> pt said she tore bicep muscle approx. 3 months ago.
Tdap erroneously administered ID instead of IM. Local reaction on forearm noted on 17 Oct 2014.
Complaints of headache, nausea, body ache, fever of 101, irritability, and mild tenderness at the injection site.
This case was reported by a pharmacist via call center representative and described the occurrence of arthralgia in a 64-year-old female patient who received SHINGRIX (batch number 27J4P, expiry date 12th April 2021) for prophylaxis. Concurrent medical conditions included arthritis. On 15th October 2018, the patient received SHINGRIX. In October 2018, less than a month after receiving SHINGRIX, the patient experienced arthralgia and arthritis aggravated. The patient was treated with MOBIC. On an unknown date, the outcome of the arthralgia and arthritis aggravated were not recovered/not resolved. It was unknown if the reporter considered the arthralgia and arthritis aggravated to be related to SHINGRIX. Additional details were provided as follows: On an unknown date in October 2018, the patient began to experience arthralgia. On the day of reporting, arthralgia remained ongoing and was not improving. The pharmacist additionally described the arthralgia as significant, and stated that the patient was unsure if it was an exacerbation of her preexisting arthritis. As treatment, the patient used MOBIC, which reportedly helped the patient's symptoms.