chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site swelling; Arm was red; Itching in the arm; sore; Discomfort; Arm Discomfort; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Discomfort), LIMB DISCOMFORT (Arm Discomfort), PAIN IN EXTREMITY (Pain in arm), INJECTION SITE PRURITUS (Itching in the arm) and PAIN (sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided by the reporter.  Concomitant products included LISINOPRIL, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and MULTIVITAMIN & MINERAL for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced DISCOMFORT (Discomfort), LIMB DISCOMFORT (Arm Discomfort), PAIN IN EXTREMITY (Pain in arm) and PAIN (sore). On 08-Mar-2021, the patient experienced INJECTION SITE PRURITUS (Itching in the arm). On 09-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (Arm was red). On 10-Mar-2021, the patient experienced INJECTION SITE SWELLING (Injection site swelling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DISCOMFORT (Discomfort), LIMB DISCOMFORT (Arm Discomfort), PAIN IN EXTREMITY (Pain in arm), INJECTION SITE PRURITUS (Itching in the arm), PAIN (sore), INJECTION SITE ERYTHEMA (Arm was red) and INJECTION SITE SWELLING (Injection site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment includes ice.
Patient was meant to receive the Pfizer bivalent vaccine, but in turn received the Pfizer monovalent vaccine. Pfizer drug safety report reference number issued.
Great deal of pain on right neck; Great deal of pain right side behind ear and small area by hairline; Great deal of pain on right eye lid; I have developed a rash; Great deal of pain on right upper arm; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the right arm on 19Jan2021 at 07:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history (The patient never had any issues). The patient had no known allergies to medications, food or other products. The patient did not receive any concomitant medication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284) via an unspecified route of administration in the right arm on 28Dec2020 at 15:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. 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 COVID vaccine. On 08Apr2021 at 06:00 the patient developed a rash and a great deal of pain on right upper arm, neck, behind ear, eye lid and small area by hairline. Everything was on the right side. The patient did see a doctor who said that was not shingles and could not explain what that was. That had been going on for one week. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with antibiotic and steroid (oral both) from an unknown date and unknown if ongoing. The clinical outcome of the events rash, great deal of pain on right upper arm, neck, behind ear, eye lid and small area by hairline were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Symptoms started Wed - swelling, warm, redness in shape of "X" appeared and then redness spread out to top 2/3 of upper arm. Soreness and pink now. No fever.
The patient thinks they got dose SQ vs IM, because the vaccinator pinched her arm while giving the injection.; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (The patient thinks they got dose SQ vs IM, because the vaccinator pinched her arm while giving the injection.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was unknown if the patient had any allergies to medications, food, and other products.  It was unknown if the patient ever had COVID positive test or diagnosis. It was unknown if the patient had a medical history relating to mentioned adverse event and both Acute and Chronic illnesses at the time of vaccination.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (The patient thinks they got dose SQ vs IM, because the vaccinator pinched her arm while giving the injection.). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (The patient thinks they got dose SQ vs IM, because the vaccinator pinched her arm while giving the injection.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was unknown if any other vaccines were given to the patient within 1 month prior to Moderna COVID-19 vaccine.  The reporter stated that the patient think they got dose SQ (subcutaneous) vs IM (intramuscular), because the vaccinator pinched her arm while giving the injection. It was also reported that the patient wanted to be revaccinated. Reportedly, the patient received their second booster dose.  It was unknown if the adverse event caused the patient to seek medical care. It was unknown if the patient experienced a similar event in the past. It was unknown if the symptoms had improved or worsened.  No treatment information was provided by the reporter.
-Reported to mom- 2 records in state. Current record and up to date. Pt has 2 files on program. Gave #4 HPV already had 3. Spoke to program nurse. No effects.
Information has been received from a health professional concerning a male (age unknown), who on 02-NOV-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On 02-NOV-2007, the patient developed a large lump on his arm at the injection site. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. This one of two reports from the same source. Additional information has been requested.
[after second dose] a little sore arm; [after second dose] tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY ([after second dose] a little sore arm) and FATIGUE ([after second dose] tired) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, 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 experienced PAIN IN EXTREMITY ([after second dose] a little sore arm) and FATIGUE ([after second dose] tired). At the time of the report, PAIN IN EXTREMITY ([after second dose] a little sore arm) and FATIGUE ([after second dose] tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.   This case was linked to MOD-2021-374290 (Patient Link).
Large (about 3-4 inches) round, swollen, warm area around injection site. Patient states that she noticed symptoms the next morning after vaccination. She denies fever, increased blood pressure, and general malaise. Patient is going to ice area and take BENADRYL to reduce swelling. Patient is not going to taking NSAID due to high blood pressure. No outcome has been reported from patient. We will follow up with patient tomorrow 5/5/18.
Patient received first shot of Moderna on 8/3 and we administered Pfizer as their second shot 10/5.
No adverse event; Patient got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse event) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD).    No concomitant medications were reported.  It was reported that, the patient received vaccine after the beyond use-by date.  No treatment medications were reported.
INCORRECT PRODUCT STORAGE; VACCINE ADMINISTERED AFTER STORAGE OUTSIDE OF RECOMMENDED STORAGE CONDITIONS; This spontaneous report received from a health care professional concerned a 37 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: 04-AUG-2022) dose was not reported, administered on 21-JAN-2022 for prophylactic vaccination. Age at time of vaccination 37 years old. No concomitant medications were reported. On 21-JAN-2022, the patient experienced vaccine administered after storage outside of recommended storage conditions. On an unspecified date, the patient experienced incorrect product storage.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered after storage outside of recommended storage conditions and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220558390, 20220558451, 20220558511, 20220558598 and 20220558439.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021 at 4:28 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Oct-2021 at 4:28 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.  The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial was moved from freezer to refrigerator on 19-Nov-2021, when the Moderna COVID 19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer or refrigerator, otherwise it was maintained at room temperature. The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursions were reported.   This case was linked to MOD-2021-402935 (Patient Link).
The next day after the vaccine, I could not stand, no balance and drooping on right side of face.  My spouse called 911 and thought I was having a stroke.  I was admitted to the hospital. I had numerous blood work done and tests done and was diagnosed with TIA transient ischaemic attack and to follow up with a neurologist.  I was in the hospital 3 days.  I am being followed by the neurologist.  I still have balance issues and the facial drooping is gone.
Extremely painful, feverish rash- resembling shingles, on the left arm  approximately 3 inches below the injection site.  the rash and pain lasted for about 4 days.  It also caused an outbreak of hives under the skin, which on occasion, breakthrough and become itchy. As listed above, I have chronic Hashimoto's thyroidism and one of the symptoms is Urticaria  The hives are still the on the forearms and left wrist.  I contacted the NurseLine.  I was advised that there was no warning about patients with thyroid conditions.   I was also told that if the hives continued, I should take an antihistamine.   Although the hives are visible, the itch isn't constant  and they break through the skin only occasionally.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with VARIVAX (Merck) (dose, lot and route were not reported) which was improperly stored outside the temperature stated in the prescribing information. No adverse reactions reported. This is one of multiple cases from the same reporter. Additional information is not expected.
Admitted on 12/14/2021 with nausea x 5 days, hyponatremia (Na 113 mEq/L), mild cough , requiring high level of oxygen (up to CPAP on 100 fio2) with inhaled nitric oxide 20 ppm.  Admitted with acute hypoxemia respiratory failure secondary to COVID19 pneumonia and hyponatremia, DKA.   Received dexamethasone IV  Completed 5 days of Remdesivir IV  Status post Actemra IV 12/19/2021,   supportive care in the ICU Blood sugars in the 400s, improved with insulin gtt initially switched to insulin detemir, meal coverage and iss expired on 12/27/2021
triggered serious thyroiditis symptoms; painful thyroid, triggered serious thyroiditis symptoms; This is a spontaneous report from a non-contactable consumer or other non HCP (patient). A 44-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown), dose 1 via an unspecified route of administration on 19Apr2021 as dose 1, single for COVID-19 immunization. Medical history included thyroiditis. Concomitant medication was not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, patient has not been tested for COVID-19. On 25Apr2021, the patient experienced painful thyroid and triggered serious thyroiditis symptoms. The outcome of the events was not recovered.   Information of the lot/batch number has been requested.
Information has been received from a physician via a company representative referring to a 16 year old female patient. The patient's pertinent medical history and drug reactions/allergies were unknown by reporter. Concomitant medication included TRUMENBA. In approximately September 2018 (reported as 1 month ago), the patient administered the first dose of GARDASIL 9 (dose detail, route, strength, batch/lot # and expiration date were not reported) for prophylaxis. The patient was observed for 30 minutes after the administration of both vaccines. Physician stated the patient left the medical office and drove to an unspecified school. Upon her arrival at the school, the patient developed a headache, heart palpitations and vomited an unspecified number of times. The patient was taken to an unspecified emergency room for unspecified treatment. The outcome of the events of headache, vomiting and heart palpitations was reported as unknown. The causality was not reported.
Patient experienced red, warm, swelling a few hours after vaccination. Parent's gave her ibuprofen which helped with the swelling and redness.  Patient woke up at 2am with fever, visual disturbances and throat tingling. Parents took her to ER and she was believed to have allergic reaction. She will be seeing a an allergist to identify allergic component.
Swollen face with rash on face, necknd arms plus itching; Swollen face with rash on face, necknd arms plus itching; Swollen face with rash on face, necknd arms plus itching; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old elderly non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534), via an unspecified route of administration in the left arm on 23Mar2021 at 09:15 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included levothyroxine (SYNTHROID) from an unknown date and for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: EN6200), via an unspecified route of administration in the left arm on 02Mar2021 at 09:15 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. The patient had known allergies to morphine, codeine, penicillin and shellfish. The patient had not received 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 was not tested for COVID-19. On 23Mar2021 at 11:00, the patient experienced swollen face with rash on face, neck, arms plus itching. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures and treatments were not taken as a result of the reported events. The clinical outcome of swollen face, rash and itching was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Woke up with a fever and was achy, sluggish.  I had until 10:15pm. On 1/20/10 I still felt achy, sluggish until Thurs 1/21/10. Woke up feeling better.  By the end of the day 1/21 I was very ill again.  I developed a low grade fever, chest, nasal and head congestion, with congestion imparing the hearing in my left ear. Treated with Mucinex, Allegra D. This lasted until 1/25/10.  Today 1/26 I woke up feeling better with more energy, but still a little sluggish.  Still have some congestion.
Pediatric dose administered to adult patient; Pediatric dose administered to adult patient; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 60-year-old male patient who received HBV (Engerix B pediatric) (batch number 53YL7, expiry date 22nd December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd November 2021, the patient received Engerix B pediatric 10 mcg and Engerix B Pre-Filled Syringe Device. On 2nd November 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The adult patient received pediatric dose of Engerix-B, which led to underdose and adult use of a child product. The reporter consented to follow up.
She developed pneumonia in left lung; Drug ineffective; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age receive pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration in 2015 at 0.5 ml, single for immunization, and pneumococcal vaccine polysacch 23v (PNEUMOVAX 23), via an unspecified route of administration in 2008 unspecified dose and frequency for immunization. The patient's medical history and concomitant medications were not reported. Patient reported that she developed pneumonia in left lung after receiving Pneumovax 23 in 2008 and Prevnar 13 in 2015. Had pneumonia in Dec2017, patient experienced drug ineffective. Outcome of the event was unknown.   Information on the batch number has been requested.
Vaccine administered to a 16 year old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 16 year old) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030l20a) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 16 year old). On 14-Jan-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 16 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.