chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No protective antibodies against hep b; This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a adult female patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received the 3rd dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 1st dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   Additional Information: GSK Receipt Date: 18-MAY-2022 Reporter's Comment: Nurse practitioner reported that a patient received three doses of hepatitis B vaccine (manufacturer unknown) and now patient had no protective antibodies against hepatitis B. Did not consent to follow-up. Additional Supportive Information: The patient received 3 doses of Hepatitis B and had no protective antibodies against hepatitis B, which led to therapy non-responder.
Case number PHEH2014US020798 is an initial spontaneous report received from a health care professional on 13 OCT 2014. This report refers to a patient of unknown identifiers. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411501) intramuscularly at a dose of 0.5 ml on unspecified date. It was reported that the patient experienced intestinal issues lasting for 2 days. The final outcome of the event was reported as unknown. The seriousness and causality of the event were not reported. No additional details available.
Redness, warmth, and pain to the left upper arm (outer). Numbness kicked in on 08/30/2013 in the morning hours. Redness and bump noted. Induration and redness was 3 centimeters in diameter.
Client reports that after the last Typhoid (Vivotif) tablet and after an extraordinarily long exhausting day at work he felt exhausted the next day evolving into a migraine headache and feeling like his eyes felt swollen, abdominal cramping with abdominal pain with nausea. 2 hours later he reports chills with a low grade fever which broke overnight. He denies diarrhea or vomiting but admits to dysphagia lasting the weekend d/t on going nausea. He reports Monday he continued to feel achy but admits the episode has now resolved without seeking medical attention.
Muscles kept cramping; Severe stomach cramping; I felt loopy and had trouble driving myself home; I felt loopy and had trouble driving myself home; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old, non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Apr2021 at 11:30 in the left arm (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. On an unknown date in Apr2021, at 19:00, immediately after second vaccination the patient felt loopy and had trouble driving home. The patient slept fine that night but the second night muscles kept cramping. The patient was awakened from sleep by severe stomach cramping that was not felt in years. The patient took an Advil and finally after an hour the terrible pain subsided. The next day the patient seemed fine but noticed since then, random muscle cramping. It's been about a week since the patient last had the cramping. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events muscles cramping and stomach cramping which included ibuprofen (ADVIL). Therapeutic measures were not taken as a result of the events felt loopy and had trouble driving home. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of stomach kept cramping and severe stomach cramping were recovered on an unknown date in Apr2021; while that of the events felt loopy and had trouble driving home were unknown at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Blood in her lung, (she's not sure which); Pneumonia; Bronchitis; 1st dose on 11Jan2021; 2nd dose on 2Feb2021; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY HAEMORRHAGE (Blood in her lung, (she's not sure which)), PNEUMONIA (Pneumonia) and BRONCHITIS (Bronchitis) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-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 PULMONARY HAEMORRHAGE (Blood in her lung, (she's not sure which)) (seriousness criteria hospitalization and medically significant), PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant), BRONCHITIS (Bronchitis) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 11Jan2021; 2nd dose on 2Feb2021). The patient was hospitalized for 2 days due to BRONCHITIS, PNEUMONIA and PULMONARY HAEMORRHAGE. The patient was treated with APIXABAN (ELIQUIS) ongoing since an unknown date for Adverse event, at a dose of 5 mg twice daily. At the time of the report, PULMONARY HAEMORRHAGE (Blood in her lung, (she's not sure which)), PNEUMONIA (Pneumonia) and BRONCHITIS (Bronchitis) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 11Jan2021; 2nd dose on 2Feb2021) had resolved.            No Treatment medications were reported.  Patient stated that she was in the hospital for 2 days two and a half to three weeks ago due to blood in her lung, (she's not sure which), pneumonia, and bronchitis.  Patient asked if patient can get the 3rd shot now since she got the flu shot a week ago.  Company comment: This is a spontaneous case concerning a 83-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Pulmonary haemorrhage, Pneumonia, Bronchitis. The events occurred approximately on an unknown day after the unknown dose of mRNA 1273 Covid-19 Vaccine. The rechallenge was not applicable, as the event happened after the unknown dose. The benefit-risk relationship of mRNA 1273 Covid-19 Vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 83-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Pulmonary haemorrhage, Pneumonia, Bronchitis. The events occurred approximately on an unknown day after the unknown dose of mRNA 1273 Covid-19 Vaccine. The rechallenge was not applicable, as the event happened after the unknown dose. The benefit-risk relationship of mRNA 1273 Covid-19 Vaccine, is not affected by this report.
This spontaneous report was received from a medical assistant, concerning 10 to 15 patients of an unknown age and gender. The patients' medical history, concurrent conditions, drug reactions or allergies were not reported. Concomitant medications included a properly store sterile diluent (manufacturer unknown). On an unspecified day in August 2017, the patients were vaccinated with improperly stored doses of ROTATEQ from lot numbers M031804 and M044397; with expiration dates on 02-MAR-2018 and 20-JUN-2018, respectively. The storage temperature was 47 to 77 degrees Fahrenheit (°F) for a time frame of 30 minutes. There was also a previous temperature excursion of 47 to 77 degrees Fahrenheit (°F) for 15 minutes. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Sender's Comments: US-009507513-1708USA011949: US-009507513-1708USA012974: US-009507513-1708USA012975: US-009507513-1708USA012972: US-009507513-1708USA012973.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 28Sep2021 at 10:00 as dose 3 (booster), single (Lot number: EW0187) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05May2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypercholesterolemia" (unspecified if ongoing); "Pollen allergies" (unspecified if ongoing), notes: Pollen allergies; "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: The patient had other medication in 2 weeks since vaccination. Paxlovid was given as treatment from 21Jun2022 to 25Jun2022, lot number GC2897. Return of COVID symptoms after completing treatment with Paxlovid prescribed 5 days treatment was insufficient, resulted in rebound infection, illness.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events drug ineffective, COVID-19 and the suspect drug cannot be excluded.
Fever, chills  and nausea within 5 hours of injection.  The symptoms about 24 hours.  Fatigue followed for another 24 hours.
Arm pain that spread to complete arm, neck, shoulder.  Chills and fever of 101.8 degree. Arm pain and whole body pain next day.
1) Persistent arm pain at injection site 2) Flu like symptoms   a) Sore neck   b) Jaw Pain - similar to TMJ (clicking)   c) Swollen Sinus' - Stuffed/Runny Nose   d) Joint Pain     i) Knees     ii) Back     iii) Fingers     iv) Elbow - particularly on the one with a torn tendon   e) Swollen/Hot Ears   f)  Chills - teeth chattering   g)  Unable to focus - feeling in a fog
had a body ache different than the usual he gets from his arthritis, he had pain in his knee joint; He also had a headache, that was sharp and it came and subsided, came and subsided; sore arm; had a body ache different than the usual he gets from his arthritis, he had pain in his knee joint; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (had a body ache different than the usual he gets from his arthritis, he had pain in his knee joint), HEADACHE (He also had a headache, that was sharp and it came and subsided, came and subsided), PAIN IN EXTREMITY (sore arm) and ARTHRALGIA (had a body ache different than the usual he gets from his arthritis, he had pain in his knee joint) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], LOSARTAN POTASSIUM (LOSARTAN POTASIUM FFP), METOPROLOL and APIXABAN (ELIQUIS) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced MYALGIA (had a body ache different than the usual he gets from his arthritis, he had pain in his knee joint), HEADACHE (He also had a headache, that was sharp and it came and subsided, came and subsided), PAIN IN EXTREMITY (sore arm) and ARTHRALGIA (had a body ache different than the usual he gets from his arthritis, he had pain in his knee joint). On 21-Jan-2021, MYALGIA (had a body ache different than the usual he gets from his arthritis, he had pain in his knee joint) had resolved. On 22-Jan-2021, HEADACHE (He also had a headache, that was sharp and it came and subsided, came and subsided) and PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, ARTHRALGIA (had a body ache different than the usual he gets from his arthritis, he had pain in his knee joint) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications:two medications for anxiety, hydrocholon and albuterol sulphate inhaler.  reatment medication were not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Patient reported about Dose-1 event outcome. Patient said he recovered from the events and there were no events after second dose
Fever; Chills; Bad migraine; Body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Apr2021 at 14:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included overweight. The patient was not allergic to medications, food, or other products. The patient did not receive any medications within two weeks of vaccination.  The patient previously 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 24Mar2021 at 14:30 (at the age of 37-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 vaccination. On 15Apr2021 at 12:00, day after the vaccination, the patient experienced, fever, chills, bad migraine and body aches. Only lasted on 16Apr2021, that next day, and was fine thereafter. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, chills, bad migraine and body aches was resolved on 16Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt felt like her face was swelling, no swelling was appreciated by MD, PA-C or nurse, no other reactions
Left arm with red, circular area approximately 15cm x 13.5cm, warm to touch and tender after receiving Varivax.
Begin with headache and nausea and progressed to very swollen arm, (Pic after 5 days available) fever ranging to 101.5 (I never went about 100 with Covid) chills, aches, fever, severe headache, nausea some vomiting and symptoms that I would equate to a really severe flu.  Lasted 7 days.    It is unclear if because I had Covid antibodies still within month of vaccine and also took the immunoglobulin therapy night before shot if that impacted on the reaction.
Right after receiving the 1st moderna shot I got dizzy,heart racing that lasted over 6 hours,jittery when I reach my Car at 15 minutes after shot I noticed under my left eye was all swollen and puffy.My upper left arm was warm and numb feeling all around the injection site and lasted 15 minutes then my arm started hurting and turned hard and swollen around injection area.I didn't say anything to professionals about my symptoms because I didn't think they were bad enough.after 5 hours I decided to check my heart rate and it was 122 at resting heart rate.my face continued swelling under both eyes and stayed puffy for a few days.After 2 weeks I developed a big bright red raised itchy rash all around shot area.
The vaccine area became significantly swollen, very red, not to the touch, and extremely painful in that area. It's been a week since I received the first of two Shingrex shots and the swelling has gone down, but the skin is still red, the area is still much warmer than the rest of my arm. Initially, the swelling and redness covered an area of about three inches. Now, the swelling is reduced, but covers an area of about six inches long by three inches wide. and the area has started to itch.
Fever, chills, nausea, headache, pain swelling  itchiness and redness at inection site 2/14/2020-2/16/2020.  Itchiness, swelling, pain, redness still present on 2/16/2020. Fever, chills, nausea and headache subsided by 2/15/2020.
Fever; I feel very bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient received BNT162b2 (COMIRNATY), on 14Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 15Apr2022 at 03:00, outcome "unknown", described as "Fever"; FEELING ABNORMAL (non-serious) with onset 15Apr2022 at 03:00, outcome "unknown", described as "I feel very bad".  Additional information: Consumer stated she got Comirnaty vaccine yesterday and at 3 AM she woke up with a fever and felt very bad so she just wanted to report it in 24 hours.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fever, chills, rigors, malaise, diarrhea nausea night sweats weakness
Pt recv vax on 9/25/98; approx 3 hr post vax pt exp headache, fever (102-103), malaise, myalgia, swelling/ erythema at vax site x 24 hr
Left jaw joint swollen, general enlarged lymph nodes...prescribed  medrol 4mg   6 day pak (methylprednisolone) to decrease swelling, which it did within one day.
I started with a sore throat. Then I just had a stuffy head, a headache and just felt really achy and foggy.
Pt had red, pain, swelling at inj site meas. 12cm x 20cm 2d after inj.
Fever, severe body aches, spine pain, convulsions, shaking, difficulty turning torso/spine without pain (still occuring), fatigue
pt recvd vax & cried but mom stated pt settled down shortly thereafter & fell asleep; upon wakening started crying non-stop; mom remained @ clinic awaiting on appt for self; 250PM brought pt to child hlth nurse;
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. The nurse reported that ZOSTAVAX underwent a temperature excursion on 31-JUL-2014, stability was supported. An unspecified number of patients received doses of these vaccines on unspecified dates after 31-JUL-2014 (in August 2014) (dose, frequency, route and lot # unknown). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
I was unable to move neck either way doctor thinks pharmacy person may have nicked the nerve in her arm. I was alright until I went home and went to bed. My neck was making a cracking sound like something was loose. My arm was hurting all the way down to between my thumb and pointer finger. My shoulder blades were throbbing. The arm was in pain for 8 weeks. It still hurts when in a cold environment. The doctor gave me steroids to decrease the pain. Left arm. It became more extreme the next day.
FEVER, NAUSEA, FATIGUE, SORENESS, AT INJECTION SITE Narrative: After initial symptoms subsided (2 days, 9/30/21 & 10/1/21), employee had new onset urticaria, SOB and cough x 2 nights (10/4/21 & 10/5/21. For those nights employee took diphenhydramine, cimetidine and Symbicort inhaler (prescribed for asthma) .No further episodes occurred beyond those 2 nights.
Client's husband telephoned approximately three hours after travel vaccine administration to report his wife telephoned him c/o severe (L) arm pain ("like it's being pulled off") and possibly swelling of the mouth and tongue. Advised to call for immediate transport to nearest E.R. ER report documentation: Chief complaint allergic reaction; pain reaction after shot admin. Admin. Morphine sulfate x2. D/C to home. Addendum: Husband reports (R) arm pain in wife on 10-19-15.
This is a spontaneous report from a contactable nurse through a sales representative. This nurse reported about a female patient of unknown age that received PREVNAR13, 0.5 ml single dose on an unknown date and experienced pain at the injection site. Follow-up (13-FEB-2013): Follow-up attempts completed. No further information expected.
pt recv vax 18JUN98 & JUN98 pt devel vomiting, nausea, joint aches, fever, malaise;an ER or MD visit was required;
Patient is having tendinopathy of the supraspinatus tendon in her left arm.
approx 14mos p/vax pt exp a mild case varicella w/less than 50 lesions.
Patient told her mom she was not feeling well right after the vaccine.  Mom told her she would go buy her an icepack to bring home to help her.  The patient got up to follow her mom and fainted in the aisle.  Her sister came and got the pharmacist and by the time I got to her she was already coming to.  We did call an ambulance but by the time they paramedics arrived the patient was ok to leave on her own with her mom.
This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a adult female patient who received BEXERO. On 16th December 2016, the patient received the 1st dose of BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced injection site erythema, injection site lump and injection site discomfort. On an unknown date, the outcome of the injection site erythema, injection site lump and injection site discomfort were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site lump and injection site discomfort to be related to BEXSERO. Additional details were provided as follows: The patient's mother called to the reporter in concerned about getting the second shot in the serious for BEXSERO. The patient's mother stated to the reporter that, after the first shot the patient experienced a red knot that formed at the injection site and it was sensitive till the time of reporting. The reporter did not know if this was related to BEXSERO but she had doubts (In her own words).
1st shot received at 09am on 07/02, around 0130am on 07/03, I experienced severe sweating, shivering, chills, severe stomach pains, nausea, severe diarrhea, ringing in my ears, extreme weakness, which lasted until around 5am.  Afterward the diarrhea, chills and nausea continued until around 10am.  Currently, a week later, the right side of my face has broken out with some pustules, some are large, some small-however, they are all on the right side of my face. I received the vaccine in my right arm.
It was reported that an adult male PT received a post exposure Rabies Imovax IM after exposure in mid-June 01. PT experienced weakness in his legs and excess salivation started approximately 1 month ago (Sept. 01).