chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine was administer after the 30 day refrigerator beyond use date; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine was administer after the 30 day refrigerator beyond use date) and NO ADVERSE EVENT (no adverse event) in a 15-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine was administer after the 30 day refrigerator beyond use date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine was administer after the 30 day refrigerator beyond use date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (vaccine was administer after the 30 day refrigerator beyond use date).    No concomitant medications were reported. No treatment medications were reported.
mom reports pt had temp 103.5 & arms & legs were trembling for approx 10min;mom phoned ER pt did not lose consciousness nor did eyes roll;ER advised mom to phone pediatrician in MA;pt is much later today;
Patient began to have hives, redness and coughing. Was given 25 mg of Benadryl which initially began to help. Patient then began with more coughing and stated she felt razor blades in her throat. Was given another 25 mg of Benadryl and then evaluated in the ER, treated and released.
Diagnosed with COVID 4 days after receiving first dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID 4 days after receiving first dose of vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced COVID-19 (Diagnosed with COVID 4 days after receiving first dose of vaccine). At the time of the report, COVID-19 (Diagnosed with COVID 4 days after receiving first dose of vaccine) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 antibody test: positive positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant drugs were not reported.  It was reported that, 4 days after the vaccination, patient was diagnosed with COVID. Received monoclonal antibodies as treatment for COVID-19.
Hot flashes; Headache; pain and swelling in injection site; swelling in injection site; chills; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flashes), HEADACHE (Headache), VACCINATION SITE PAIN (pain and swelling in injection site), VACCINATION SITE SWELLING (swelling in injection site) and CHILLS (chills) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced HOT FLUSH (Hot flashes), HEADACHE (Headache), VACCINATION SITE PAIN (pain and swelling in injection site), VACCINATION SITE SWELLING (swelling in injection site) and CHILLS (chills). On 16-Apr-2021, HOT FLUSH (Hot flashes), HEADACHE (Headache), VACCINATION SITE PAIN (pain and swelling in injection site), VACCINATION SITE SWELLING (swelling in injection site) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment information not provided.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of PROQUAD (Merck) (dose, route, lot # and expiration date were not provided) which were exposed to temperatures outside of the recommended range. No adverse effects had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Rash on arms (multiple wheals, erythema on the extensor surface of the upper arms, few scattered wheals on the back and chest. Cheeks flushed, slight erythematous
The fist symptom to appear was a fever ranging from 101 to 102 degrees F.  On 10/1/2016 the fever rose to 103.8 degrees F and the child was taken to the emergency room where pneumonia was diagnosed.
Shingles shot was a little rough; Pain; Nerve pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of malaise in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included knee replacement (had 2 knee replacements).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced malaise (Verbatim: Shingles shot was a little rough), pain (Verbatim: Pain) and nerve pain (Verbatim: Nerve pain). The patient was treated with ambiguous medication nos (Oxy (Nos)). The outcome of the malaise, pain and nerve pain were resolved.   It was unknown if the reporter considered the malaise, pain and nerve pain to be related to Shingles vaccine.     It was unknown if the company considered the malaise, pain and nerve pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR051740   Additional Information: GSK Receipt Date: 16-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that the Shingles vaccine was a little rough. The patient stated that he or she had a lot of nerve pain and it was worse than the other pain. The patient received Oxy as a treatment and it really did not touch it. The patient stated that the shingles is nerve pain and it can go on for weeks and in some instances, be permanent. The patient was not willing to roll that dice, please everyone get vaccinated. This case had been linked with US2023AMR051740 by same reporter for same patient.  This case had been linked with US2023AMR051750 by same reporter for different patient. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR051750:Same reporter US-GSK-US2023AMR051740:Same reporter
No Adverse Event; vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients; vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients), PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients) and NO ADVERSE EVENT (No Adverse Event) in a 46-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022 at 6:13 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 dosage form. In 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients). On 22-Sep-2022 at 6:13 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients), PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients).    Concomitant medication information was not provided.  The nurse reported about Moderna monovalent and bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to Aug-2022 that were administered to patients.  The patient received first, second and third doses of Moderna COVID-19 vaccine via intramuscular route and site of administration was reported as deltoid muscle.  The patient received the fourth dose of Moderna COVID-19 bivalent vaccine on deltoid muscle.  No treatment information was provided.   This case was linked to MOD22-025077 (Linked Report).; Sender's Comments:  MOD22-025077:
Approx 5 minutes post injection, the pt had a near syncopal episode, felt clammy, dizzy and nauseated.  He was dry heaving upon arrival to med obs area.  BP 120/74, HR 62, O2 100%.  Pt laid down on stretcher for several minutes until his symptoms started to subside.  He was able to tolerate water and sit on side of stretcher while chatting with clinician.  At 11:54 his BP was 120/74, HR 77 and O2 100%.  He denied all symptoms and was discharged via wheelchair to father at 12:09
Fever for 3 days. 101.2-101.6, chills, body aches, sore arm at injection Severe migraine type headache lasted for 4 days Severe exhaustion 4 days No appetite 4 days Day 5 just wiped out!
Patient with rash, papule.  Non specific rash over head, neck and trunk.  Diagnosis: modified measles vs rubella.
pain at the injection site, left arm; so stressed; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK9231) solution for injection intramuscular in the left arm on 18Jan2021 at 15:00 (at the age of 72-years-old) as a single dose for COVID-19 vaccination. Medical history included allergic to sulfa. Concomitant medications were not reported. Past drug history included drug allergy: ciprofloxacin (CIPRO) and codeine. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 18Jan2021, the patient experienced pain at the injection site, left arm and so stressed. There was no emergency room or physician office visit. No treatment was provided for event pain at the injection site. The outcome of the event pain at the injection site was not recovered. The outcome of the event stressed was unknown.
Shakes, dizziness, hives(mild), itchiness -- took benadryl
Arm sore at injection site; Muscle achiness; Fatigue after shot and next day; Joint achiness the next day; This is a spontaneous report received from a non-contactable other health care professional, the patient. A non-pregnant female patient of unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 01Mar2021 and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 22Mar2021 at 14:30, each as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within two weeks of vaccination. On an unspecified date in Mar2021, the patient experienced fatigue after the vaccination and the next day, the patient also experienced arm sore at injection site, muscle and joint achiness. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the arm sore at injection site, muscle and joint achiness and fatigue were recovered on an unspecified date in Mar2021.  Information about lot number cannot be obtained. No further information is expected.
Arthralgia & purpura of wrists, elbows & to lesser extent to shoulders;
Information has been received from a medical assistant concerning a 65 year old female with a history of arthritis, vitamin B12 deficiency, hyperlipidaemia and hypothyroidism who on 06 Feb 2007 was vaccinated with a dose of Zostavax (lot #656412/1476F). There was no concomitant medication. Subsequently the patient's vaccination arm was hard, swollen and red. The patient also had pain in both hands. She could hardly move one wrist, was achy and felt feverish, but had no fever. Her non vaccination arm and shoulder were painful She was prescribed antihistamines. At the time of the report, the patient had not recovered. There was no product quality compliant involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/14/2007. The patient recovered after two days, on approximately 08-Feb-2007. No further information is expected.
Morning of April 4, pt experienced a full aching in his right side (front, below shoulder, above ribs). This went away after a few hours. Around 1 am EDT on April 7, the pain returned, slowly subsiding over the course of 12 hours. Between 6-7 pm EDT on April 7, a new more intense pain started in his mid-back, right side accompanied by shortness of breathe. We took him to the ER where he was diagnosed with three pulmonary emboli. He was given blood thinner tablets and send home with prescriptions for more thinners and pain medications. 1.5 days later, his pain has not subsided. He is also protein s deficient and has fact v leiden (homozygous).
7 days post injection: swollen lymph nodes under LEFT armpit, very sore-NSAID used x 2 days.   Injection site became red and slightly swollen-previously the injection site was unnoticeable.
TOOK VIVOTIF EVERYDAY; This spontaneous case report (PVX2019-1923) was received from a pharmacist on 25-Jul-2019. It described a male consumer who "took Vivotif everyday" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took a dose of Vivotif on 24-Jul-2019 and 25-Jul-2019, respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took Vivotif everyday" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif everyday" was considered as not applicable.
Neuropathy started july 2021 in both legs, became worse, EEG was done, peroneal nerves damaged, diagnosed in January of 2022 with charcot marie tooth disease.
I received the vaccine at 2:30pm. In the middle of the night after receiving the vaccine, I felt feverish, headachy, cold, and shaking. My temperture (via oral digital thermometer) at 6:40am the following morning was 100.4F. That day I was fatigued, sleeping most of the day. I had a bad headache. My eyes, neck, shoulders, back, hips, and legs hurt. At 2:30pm I took one Advil. Later that afternoon I started to feel better and by 10:00pm my temperture was normal and most of the headache and body pains were gone. The following two days I was tired, but no fever and no pain.
After 5 hours from injection, slight ache in back, after 16 hours from injection: total body ache, fever, headache with little relief from 100mg Tylenol .  Symptoms intense for 48 hours with 100mg Tylenol ever 6 hours.  After 48 hours a intense lower back pain continued.  After 6 days saw nurse at a family Physician clinic who prescribed Methocarbomol,saw little change to back pain, Saw Doctor, order x-ray, all normal. going to PT to relieve back pain.  never had back pain prior to this event.
Initial information has been received from a vaccine nurse and follow-up information was received from the physician, concerning a patient who in 2007, "over a year ago", was vaccinated with RECOMBIVAX HB. Subsequently the patients developed seizure. The patient was not hospitalized. The patient recovered and left the office approximately 30 minutes after the seizure. It was reported that this happened over a year ago. It was not specified if the patient sought medical attention or not. Upon internal review, seizure was considered to be other important medical event. This is one of several reports received from the same source. Additional information has been requested.
pt recvd MMR vax 2JUL91 & 8JUL91 devel t103 & irritableness; 3 days later devel pharyngeal infect & a rash over trunk & upper legs; 13JUL91 devel OM;
This spontaneous report has been received from a Medical Assistant refers to a unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies, drug reactions or allergies and medical history provided. On an unknown dates, the patients were vaccinated with improperly stored PROQUAD (rHA) injection, lot# M032496, expiration date 02-JAN-2018 and lot# M034692, expiration date 24-JAN-2018 (dose, site and route of administration were not reported). No adverse effects were reported. The vaccines experienced a temperature excursion of between -10 and 8 Celsius degrees (C) for 2 hours and 21 minutes, which was detected by a digital data logger. There was no previous temperature excursion. No product quality complaint was involved. This is one of two reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1701USA007743:
swellling; redness; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced injection site swelling and redness after 1st dose of Shingrix. For the tolerence of 2nd dose refer case US2019234359, reported by same reporter for same patient.
headache; fever 101.5°; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PYREXIA (fever 101.5°) and CHILLS (chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A/4 and 003AHA) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic. Concomitant products included INSULIN and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced HEADACHE (headache), PYREXIA (fever 101.5°) and CHILLS (chills). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PREDNISONE at a dose of Heavy dose. At the time of the report, HEADACHE (headache), PYREXIA (fever 101.5°) and CHILLS (chills) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Body temperature: 101.5 (High) fever 101.5°.         The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was Not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-074749 (Patient Link).
really tired; off-the-chart aches and chills; off-the-chart aches and chills; couldn't move or touch his arm it hurt so much; couldn't move or touch his arm it hurt so much; could tell the exact location of every lymph node in his body; This is a spontaneous report received from non-contactable consumer from a sales representative. The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 21Mar2021 (Lot number: EN6203) 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: PAIN (non-serious), CHILLS (non-serious) all with onset Mar2021, outcome "not recovered" and all described as "off-the-chart aches and chills"; PAIN IN EXTREMITY (non-serious), MOBILITY DECREASED (non-serious) all with onset Mar2021, outcome "unknown" and all described as "couldn't move or touch his arm it hurt so much"; LYMPHADENOPATHY (non-serious) with onset Mar2021, outcome "unknown", described as "could tell the exact location of every lymph node in his body"; FATIGUE (non-serious) with onset 22Mar2021, outcome "unknown", described as "really tired".  Additional information: The patient's age was reported as 62 (unit unspecified). The patient stated that he still a little chilled and moderately achy (although, no fever).  No follow-up attempts are possible. No further information is expected.
Patient experiences numbness on the left side of her face and body a few minutes after receiving each dose of the vaccine: 1st, 2nd, and booster. Patient claimed that the symptoms subsided after a day and a half after the vaccine dose, but was admitted to the ED today after experiencing the AE for the third time (post booster).
04/20/2022 My left arm was very sore. It was a little red around injection site and itchy. It was so sore I was really uncomfortable. That afternoon it was much larger, inflamed and hot to touch. The next morning, I had a well visit with my doctor. She was very concerned with the way my arm looked. She felt I had cellulitis. She put me on Keflex 500mg every 12 hours for 7 days. There was great improvement after 3 doses on Keflex. It is back to normal now.