chrisvoncsefalvay/vaers-outcomes huggingface dataset:
8 to 9 days post vax pt devel serum sickness characterized by fever up to 101, migratory polyarthritis & tendonitis;joints primarily affected were both shoulders, both elbows, both knees, second lt metacarpal joint & epicondyles;
No additional AE reported; Customer called for a temperature excursion and reported PROQUAD that had undergone temperature excursion was administered to patients before calling. No additional AE reported. No PQC reported. No patient demographics was provided. No further i; This spontaneous report was received from a medical assistant referring to a unknown number of patients of unknown age and gender. The patients' medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On an unknown date, the patients were vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number W019628, expiration date 19-DEC-2023 (dose and route of administration) for prophylaxis (product storage error). No adverse event was reported.  No information about the temperature excursion was provided.  Follow up information has been received on 10-MAR-2023.  varicella virus vaccine live (Oka/Merck) (VARIVAX) (Lot numberW018828 expiration date 14-JUN-2024), and  Lot number W006412 expiration date 23-FEB-2024) (dose and route of administration) for prophylaxis (product storage error), and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number W019627, expiration date 19-DEC-2023)  (product storage error).    This is a non-valid case due to the lack of patient identifiers.  Follow up information has been received from an other healthcare professional on 18-APR-2023. The reporter specified the patient's information. Therefore, a valid case was split from original case 2303USA002114. This spontaneous report was regarding a 4-year-old male patient. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported. On 20-JAN-2023. the vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) (lot number W019627, expiration date 19-DEC-2023) underwent temperature excursion for 1 hour. The digital data logger was involved in recording excursion details. On 25-JAN-2023, the patient was vaccinated with the improperly stored vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) (lot number W019627, expiration date 19-DEC-2023, strength and dose were not reported) intramuscularly (IM) at right thigh for prophylaxis at private doctor's office/hospital.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2303USA002114: US-009507513-2304USA007837: US-009507513-2304USA007931:
interval between the 1st and 2nd dose, was over 1 year; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's Comment: The pharmacist reported that the interval between the first and second dose of Shingrix, was over one year. The pharmacist had limited information on the patient and vaccine details. Additional Supportive Information: The patient received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule.
Initial misuse report received from Healthcare professional on 31 October 2014. A patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE HD (Batch number, expiry date, site of vaccination and dose number was not reported) on 30 September 2014. The patient had experienced yellow discoloration at vaccination site on an unspecified date. Lab investigations and corrective treatment were not reported. At the time of this report the outcome of the event was unknown. List of documents held by sender: none.
Patient has rash at injection site. 9 in by 6 in. Marked erythema and tenderness to palpation.
patients who received expired doses of the Moderna COVID vaccine; Vaccines placed in refrigerator on 1/13/22 and dose admistered to patient on 2/17/22; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients who received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 1/13/22 and dose admistered to patient on 2/17/22) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2022, the patient experienced PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 1/13/22 and dose admistered to patient on 2/17/22). On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients who received expired doses of the Moderna COVID vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients who received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 1/13/22 and dose admistered to patient on 2/17/22) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
This spontaneous report has been received from a licensed practitioner nurse (L.P.N.) and refers to an unspecified number of patients of unknown ages and genders. The patients' medical histories, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. The nurse reported that on unspecified dates since 15-FEB-2017, an unspecified number of patients were vaccinated with improperly stored doses of VARIVAX (lot # M033214, expiration date 13-JUL-2018; lot # M031970, expiration date 30-JUN-2018; lot # M027343, expiration date 01-JUN-2018) (doses, routes of administration, and frequencies were not reported) for prophylaxis which were reconstituted with an sterile diluent(DILUENT MRK) injection (lot numbers and expiration dates were not reported). The vaccine data logger measured a temperature range from 15°F to 46°F for a total time frame of 10 hours and 4 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA009968:
From initial information received on 29Sep04 and additional information received on 05Oct04 from a RN regarding an adverse event occurring, it was reported that a 42 year old female pt received a dose of Tetanus toxoid, lot U1048CA, admin ID instead of Tuberculin PPD on 15Sep04. The site of admin was not reported. On 17Sep04, the pt developed papular lesions at the injection site and a 0.5mm red area with induration. She was treated with antibiotics and topical cream and was seen by her family physician. The pt recovered from these events. The reporter of this case is the same reporter as cases 200403093, 200403240, 200403241, 200403242, and 200403243.
couldn't stand to be touched or diaper changed was placed on pillow; pt crying 4 hrs, cont crying for 4-5 hrs;
Body aches, pains, general malaise, gradually increasing over the day and into the next day. Felt like the flu without sinus congestion.
Pain, swelling, warm to touch, redenss, hard then next day s/s were worse generalized malise, and respiratory symtoms began on Saturday AM. Respiratory s/s were cough, hoarseness, low grade fever s/s to arm area where vacinated remained red, tender warm and swollen.
intense itching/ itching on his hips and on his back; gets red whenever he scratches it; after the injection his arm got a little sore; Feels like it is hot; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3246, expiry: 30Apr2021) intramuscularly into the left arm on 06Jan2021 at a single dose for covid-19 immunisation. Medical history included nerve damage, brain damage, disability from 1997, anxiety, major severe depression, occupational exposure to heavy metal uranium, chronic obstructive pulmonary disease (COPD), early stage emphysema and diabetes. Concomitant medication includes unspecified medications for brain damage, anxiety and major severe depression. It was reported that after the injection, his arm got a little sore on 06Jan2021. On 13Jan2021, patient experienced intense itching; further reported as itching on his hips and on his back which gets red whenever he scratches it. It was also reported that the more he would scratch it, the more intense the itching would get. On an unspecified date in Jan2021, the patient also feels like it is hot. The patient applied EUCERIN cream and CORTISONE 10 for the events "intense itching/ itching on his hips and on his back" and "gets red whenever he scratches it". The patient was scheduled for his second dose on 27Jan2021. Outcome of event "intense itching/ itching on his hips and on his back" was not recovered while for the events "after the injection, his arm got a little sore", "gets red whenever he scratches it" and "feels like it is hot" was unknown.
Onset of redness and swelling around injection site < 24 hrs after vaccine. No fever treated with Benadryl, ice pack.
1st Pfizer Covid vaccination on April 1, 2021 Morning of April 2 she woke up with severe lower extremity spasticity and the inability to mobilize.   Presented to hospital April 3rd. Started high-dose intravenous Solu-Medrol on hospital day 3 and it was not until hospital day 4 that we begin to see improvement of her spasticity and ability to move her legs Felt to be acute myositis,  most likely an immune mediated post vaccination event Received 1000 mg IV Solu-Medrol x5 days Course complicated by bilateral pulmonary embolisms in setting of severe spasticity and immobility Hospitalized 4/3/21-4/13/21 Discharged to rehab, on day of discharge requiring maximal assist to stand and for transfers
Left arm with redness and induration from DTaP injection site from prox deltoid towards elbow 3 cm x 4 cm. Other injection site is not red or involved in area erythema, moderate itching, mild pain.
This report describes the occurrence of autism in an approximately 2 year old male who was vaccinated with hep B vaccine (manuf unk) for prophylaxis. This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional. The subject's medical history, concurrent conditions, and concurrent medications were not reported. He was allegedly "born healthy" and "was developing normally. He sat up, walked, and babbled at the appropriate ages. He interacted with his parents like a normal infant." The subject received injections of hep B vaccine on 1/30/95, 4/3/95 and 12/1/95. He also received diphtheria and tetanus toxoids and pertussis vaccine (manuf unk) on 4/3/95, 5/31/95, 8/9/95 and 10/15/97; haemophilus influenzae type B conjugate vaccine (manuf unk) on 4/3/95, 5/31/95, 8/9/95 and 5/8/96; oral poliomyelitis virus vaccine (Orimune) on 4/3/95, 5/1/95 and 10/15/97; and MMR II on 2/2/96. The subject's attorney alleged that "By the end of his second year, the subject avoided eye contact with his parents, indicated a strong preference for being left alone, would "bounce." He had stopped talking and playing. In or around October of 1998, he was diagnosed with autism." The attorney alleged that the autism was a result of mercury present in thimerosal-containing vaccines. The autism and mercury toxicity in this report was considered medically serious (OMIC).
Following my second dose of the Pfizer vaccine , the next day (4/8/21) I've experienced greatly increased mouth and eye dryness.  I do have Sjogren's disease and my eye and mouth dryness have been very consistant over the past 3-4 years but after my second Pfizer dose  eye and mouth dryness has significantly increased.  Now, roughly 6-weeks post second dose and my increased dryness symptoms don't seem to be abating.
Information has been received from a registered nurse concerning a female patient who in 1998 was vaccinated with one dose of Hepatitis B vaccine recombinant. In 1998 the patient experienced flu-like symptoms for 24 hours post vaccination. Unspecified medical attention was sought. Additional information has been requested.
This spontaneous report as received from a 29 year old female patient refers to herself with no allergies or medical history. The patient did not have measles immunity. On 04-AUG-2008, the patient was vaccinated with a dose of unspecified rubella containing vaccine (dose and route unknown). There were no concomitant medication. The patient explained that she developed a "massive reaction" after receiving an unspecified Rubella containing vaccine. The patient stated that the reaction included development of hives over her entire body which lasted for about 5 days and began about 1 day after receipt of vaccine ( on 05-AUG-2008). There were no lab diagnostics studies performed. The patient sought medical attention via calling the physician. The patient was unsure if the vaccine she received was the M-M-R II or the now discontinued MERUVAX II. The patient provided the following lot identification information for the vaccine: Lot# 659371/1815U, which was valid for MERUVAX II, and not valid for M-M-R II; Expiration Date : 11-AUG-2009. The outcome of the event was reported as recovered on 09-AUG-2008 last for about 5 days (also reported as "within 1 week following vaccination") Additional information has been requested.
Pt recv vax on 2/25/99; on 2/26/99 pt exp swelling/ red of LA vax site; pt imp 3-4 days
Six (6) vials stored in the refrigerator were exposed to temperatures below 36°F; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Six (6) vials stored in the refrigerator were exposed to temperatures below 36°F) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (Six (6) vials stored in the refrigerator were exposed to temperatures below 36°F). On 23-Sep-2021, PRODUCT STORAGE ERROR (Six (6) vials stored in the refrigerator were exposed to temperatures below 36°F) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  Reporter called to check on a temperature excursion. Refrigerator was cooling a little bit more than normal. Six (6) vials stored in the refrigerator were exposed to temperatures below 36°F. Minimum temperature was 34.7°F. There were 145 incidents in total and each one lasted less than 15 minutes: 142 times fridge temperatures were between 35°F and 36°F; while 3 times temperatures were under 35°F, reaching 34.7°F (minimum).    Patient had experienced a temperature excursion.  No Treatment medications were reported.
I received a flu shot and the next few days my shoulder was sore the pain did not go away with time or rest.  My shoulder would hurt at different times and with different movements never the same movement twice.   I had difficulty dressing and sleeping.  Never had shoulder pain discomfort before flu shot this year.
BODY ACHES; VOMITING; CHILLS; FEVER; FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a 23 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced vomiting. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, fatigue, body aches, nausea, and vomiting. This report was non-serious.
Information has been received from a registered nurse for GARDASIL, a Pregnancy Registry product, concerning a 25 year old female patient with no pertinent medical history and no drug reactions/allergies. The Last Menstrual Period was 19-NOV-2011. On 07-DEC-2011, the patient was vaccinated with her third dose of GARDASIL, injection 120 Y, (dose, route, lot number and expiration date not reported) while pregnant. Concomitant therapy included prenatal vitamins. The patient called the office to report the pregnancy. The office estimates her date of conception about 03-DEC-2011. No adverse effects were reported. The Estimated Date of Delivery would be 25-AUG-2012. There was no laboratory tests performed. The pregnancy outcome was outcome pending. Follow up information has been received from the physician via the Certified Nurse Midwife (CNM) for GARDASIL, a Pregnancy Registry product, concerning the patient who was vaccinated with her third dose of GARDASIL. Concomitant therapy included ONE-A-DAY WOMEN'S PRENATAL. The nurse reported that the pregnancy was confirmed on 16-JAN-2012 by ultrasound, with gestation of 8 weeks and 2 days. Follow-up information has been received for GARDASIL, a Pregnancy Registry product, concerning the patient. All telephone attempts to obtain follow-up information had been unsuccessful. The pregnancy outcome was changed to lost to f/u. The Estimated Date of Delivery was also reported as 28-AUG-2012. Additional information is not expected.
She couldn't move her arm; arm was "so painful"; had a fever; This spontaneous report was received from a consumer, referring to a female patient of unknown age. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.     On 05-APR-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, strength, route, lot# and expiration date were not provided) for prophylaxis.   On 05-APR-2022, the patient had a reaction to the vaccine. She couldn't move her arm, it was "so painful" and had a fever. Fortunately, she was feeling better this morning on 06-APR-2022. The outcome of the events was unknown.  The causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was related.
Onset of fever, shaking chills, headache and severe joint pain. Onset apps 9.5 hours after vaccination. Fever persisted for 18 hours, joint pain improved but right knee pain since the vaccination has persisted.  Ice, NSAIDS and knee brace have been used consistently. Pain improves but does not resolve with rest, ice and NSAIDs,  No injury and no history of knee pain
12 x 18 cm erythema and iduration left arm extending below elbow (LR6)
This spontaneous report was received from a Licensed Practice Nurse refers to a 66 year old female patient. No medical history was reported. On 22-MAR-2013, the patient was vaccinated with a dose of 0.5 ml PNEUMOVAX 23 (lot # h015780, expiry: 11-JUN-2014) intramuscularly. No concomitant medications were reported. On 22-MAR-2013, 8 hours after injection the patient developed redness, pain and swelling at injection site, fever of 104F, fatigue, malaise and achiness. Patient was seen at the office and was given SOLUMEDROL and prednisone 20 mg tablets for 7 days and BENADRYL. There is no information as to whether these treatments relieved the symptoms. No laboratory tests were performed. The outcome of redness, pain and swelling at injection site, fever of 104F, fatigue, malaise and achiness was unknown. The relatedness of the events with PNEUMOVAX 23 was unknown. The nurse called because she is requesting to have a lot check done for PNEUMOVAX 23. This is 1 of 3 reports from the same source. Additional information has been requested.
I have learned that it was syncope. I felt like time was moving quickly. I was jittery and felt like my heart was beating quickly. I was taken to a separate area and felt warm and flush in my chest. They laid me down on the cot and said I looked pale. My hands were cold and within minutes I was shaking uncontrollably. I think it was an anxiety related to my research I've done at my job related to COVID. I don't think it was an allergic reaction, but I do have an appt on Thursday. I was monitored for about an hour. Symptoms went away but I wasn't totally ok until the next day besides soreness in next arm.
Cheeks and both sides of face were numb; Lips went numb; Cheeks puffy; Tip of nose will turn ice cold; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Cheeks and both sides of face were numb), HYPOAESTHESIA ORAL (Lips went numb), SWELLING FACE (Cheeks puffy) and FEELING COLD (Tip of nose will turn ice cold) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Drug allergy (Allergic to sulfa.).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Cheeks and both sides of face were numb), HYPOAESTHESIA ORAL (Lips went numb), SWELLING FACE (Cheeks puffy) and FEELING COLD (Tip of nose will turn ice cold). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) at a dose of UNK dosage form. At the time of the report, HYPOAESTHESIA (Cheeks and both sides of face were numb) had not resolved and HYPOAESTHESIA ORAL (Lips went numb), SWELLING FACE (Cheeks puffy) and FEELING COLD (Tip of nose will turn ice cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  The event lips went numb was reported as soon as she got the shot. Patient spoke to HCP who said it sounded like an allergic reaction to an ingredient in the vaccine. Treatment for the events included levocetirizine.
I noticed ringing/buzzing in my ears several days after the shot. I went to ENT, prescribed large dose (60 mg 7 days) of prednisone. I have been off the prednisone for 4 days and no relief.