chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very tired; achy; somewhat nauseated; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of tiredness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th May 2021, the patient received the 2nd dose of Shingrix. On 25th May 2021, 1 days after receiving Shingrix, the patient experienced tiredness, pain and nausea. On an unknown date, the outcome of the tiredness, pain and nausea were not recovered/not resolved.   It was unknown if the reporter considered the tiredness, pain and nausea to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received 2nd dose of Shingrix one day prior to the report and on the day of reporting, the patient was very tired, achy and somewhat nauseated. The patient was resting now and inquired that besides rest what was best for the pain. The follow up would not be possible as no contact details were available.
cramping; bloating; some diarrhea; GI symptoms; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (cramping), ABDOMINAL DISTENSION (bloating), DIARRHOEA (some diarrhea), ABDOMINAL DISCOMFORT (GI symptoms) and FATIGUE (fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN (cramping), ABDOMINAL DISTENSION (bloating), DIARRHOEA (some diarrhea), ABDOMINAL DISCOMFORT (GI symptoms) and FATIGUE (fatigue). At the time of the report, ABDOMINAL PAIN (cramping), ABDOMINAL DISTENSION (bloating), DIARRHOEA (some diarrhea), ABDOMINAL DISCOMFORT (GI symptoms) and FATIGUE (fatigue) had not resolved.            No concomitant and treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact
This spontaneous report as received from a company representative refers to a female healthcare worker (who is also the patient), age unspecified. On an unknown date, the patient was vaccinated with ZOSTAVAX. On an unknown date, the patient experienced a large lump and swelling at the injection site. She sought medical attention via a medical office visit on an unspecified date and was treated with BENADRYL. The outcome of the large lump and swelling at the injection site was reported as recovered/resolved. The healthcare worker considered the large lump and swelling at the injection site to be related to ZOSTAVAX. No information regarding medical history, concomitant medications, or drug allergies was provided. Additional information has been requested.
Information has been received for the pregnancy registry for GARDASIL from an 18 year old female patient, with no pertinent medical history and no drug reactions/allergies, who on 07-MAY-2008, was vaccinated with GARDASIL. Concomitant therapy included RECOMBIVAX HB the same day of the GARDASIL. The patient conceived on 03-MAY-2008. The mother reported that her daughter received GARDASIL and had a miscarriage two weeks ago. The mother reported that her daughter went to the hospital to have dilatation and curettage; however she did not stay in the hospital overnight. The patient sought unspecified medical attention. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
Rash over head and neck, chest, arms, legs  from Day 1- through 5 after vaccine, went to ER on day after vaccine, gave prednisone- took one dose, then benedryl daily
Pt reports lightheadedness following vaccination, Pt sates he wants  his vitals checked.  Took vitals to find them stable.  Pt states his symptoms feel better after sitting for several minutes.  Pt refused transport to ED
Symptoms: severe (high fever (101.6F), body ache,  headache, shivering, lymphadenopathy)  Treatment: Tylenol 325mg (650mg Q4hrs) followed by Naproxen 250mg (Q12hrs), lots of fluids and rest Time Course: 2 days
Pt. came into office on 9-9-15 for second dose of HPV. At that time he informed the Dr. that his arm was numb and he had "pins and needles" since the time of the first. HPV given on 7-8-15. Pt is not having any difficulty using the arm - no limitations.
C/O head ache and nose burning, dizziness and stomach cramping. Had child rest. Gave juice and crackers and monitored VS parent contacted to pick up per child's request.
Information has been received from a physician concerning a female who was vaccinated with a 0.5 ml dose of Gardasil. Subsequently the patient became extremely tired. Unspecified medical attention was sought. There were no laboratory or diagnostic tests performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Fever of 103 on 12/11/04 Rash began on 12/23/04...still has rash
Generalized, intermittent itching with redness. Itching began on 11/21/21 on the mid-upper back. Redness due to scratching. Itching locations change; can be arm, then leg, then back, then trunk, etc.  Treated with Allegra 180mg daily, Triamcinolone PRN on 12/02/21, and permethrin cream prophylactically for mites one treatment 12/02/21. Local pest control ruled out bed bugs on 12/02/21 via canine unit.
Patient came in for 2nd dose of shingrix vaccine. After the patient received the vaccine, he stated that he did not get a reminder message from the pharmacy about getting the second dose. Patient thought he was to receive the 2nd dose 2 weeks after the 1st dose instead of 2 months. According to the CDC, minimum interval is 4 weeks for the second dose to be considered valid. Patient will need to return in 2 months for valid 2nd dose.
Patient was seen by his primary care physician (PCP) on 01/02/15 with chief complaint of right arm pain and swelling for the past 2 days. Patient had received his pneumonia vaccine in his right arm on 12/31/14. Patient reported pain on the day he received his vaccination; however, it increased in pain and swelling. Patient also reported his arm was red and felt warm to the touch. Cephalexin 500 mg TID, Naproxen 500 mg BID.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Lot number: EL8982), on 05Feb2021 as dose 2, single (Lot number: EL9261) and on 21Nov2021 as dose 3 (booster), single (Lot number: EW0217) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Congenital Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Addition information: Start date of treatment for COVID-19 was 24May2022. Stop date of treatment for COVID-19 was 29May2022. Known Allergies was none.
NEUROPATHY 3/10/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
syncope, nausea, feeling of going to pass out, sweating hot. sat and drank water. was fine but had her mother come and take her home
Patient was given vaccine 20 minutes outside of the 6 hour window for an open vial. Patient was fine.
allergic reaction; throat felt scratchy; she felt itchy; lips swelled; face swelled; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first COVID 19 vaccine and had an allergic reaction. Her doctor advised her not to receive the second COVID 19 vaccine. She clarified she received her first COVID-19 vaccine and two days later her lips and face swelled. Her throat felt scratchy and she felt itchy. She took Benadryl. A few days later the swelling went down. Her doctor told her not to get the second COVID-19 vaccine. The caller is asking if she only receives one Covid 19 vaccine then she is only 50% protected. She is calling for information only. The patient was recovering from lips swelled and face swelled; while outcome of the remaining events was unknown. Information on the lot/batch number has been requested.
chest pain; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient experienced chest pain on an unspecified date. It was reported that Caller had the first dose of the Pfizer Covid-19 vaccine and experienced chest pain. Caller is afraid to get the second dose and wants to know if she can still get it. The clinical outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
About 15 minutes after the vaccines the patient became drowsy and had a seizure.  Water, bedside blood glucose, comfort and blood draw was initiated.
Incorrect vaccine given. Intended vaccine was Moderna COVID Bivalent Booster ages 6+, vaccine administered was Moderna (monovalent) COVID Vaccine ages 6 Months-5 years.  No adverse reactions reported
Pain in arm; achy body; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), MYALGIA (achy body) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm), MYALGIA (achy body) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (Pain in arm), MYALGIA (achy body) and HEADACHE (headache) outcome was unknown. Not Provided          The concomitant medications were not provided. The treatment provided is unknown.  Action taken with the outcome of event is not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-090511, US-MODERNATX, INC.-MOD-2021-090536 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090536:cross linked case US-MODERNATX, INC.-MOD-2021-090511:cross linked case
Warmth, erythema and swelling to (L) arm at injection site, area measuring 17x16 cm in diameter, 2 days after injection.
he is experiencing soreness in the arm.; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer reported for an 87-years-old male patient (husband) received first dose of BNT162B2 (solution for injection; Lot Number: EL8982) via intramuscular at left arm on 27Jan2021 12:30 PM as single dose for covid-19 immunisation. The patient medical history reported None and concomitant medications were not reported. The reporter stated that her husband received the vaccine as well he is experiencing soreness in the arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Therapeutic measures were taken for this event. The event considered non serious. The outcome of the event was unknown.
burning; itching; rash down his entire body; This spontaneous case was reported by an other health care professional and describes the occurrence of BURNING SENSATION (burning), PRURITUS (itching) and RASH (rash down his entire body) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-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 BURNING SENSATION (burning), PRURITUS (itching) and RASH (rash down his entire body). The patient was treated with DIPHENHYDRAMINE ACEFYLLINATE at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (burning), PRURITUS (itching) and RASH (rash down his entire body) 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.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant follow-up appended to AER
RIGHT LOWER LEG SWELLING; This spontaneous report received from a patient via a company representative concerned a 54 year old male. 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, intramuscular, batch number: 204b21a, and  expiry: UNKNOWN) dose was not reported, administered on 19-AUG-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On 27-AUG-2021, the patient experienced right lower leg swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of right lower leg swelling was not reported. This report was non-serious.
Fatigue, fussy, yelling, crying lasted a week after being vaccinated. Months later he still yells and has some regression in actions.
Patient stated he experienced double vision and dizziness within five minutes of vaccine administration. Patient was informed to continue to wait in pharmacy's patient observation area until these symptoms passed. Patient was given one 500-mL bottled drinking water to maintain hydration and keep patient comfortable. Patient's blood pressure was taken and measured to be 141/95 at about 10:50am. Patient continued to wait in pharmacy's patient observation area for a total of 42 minutes. At 11:15am, patient stated he was feeling much better, that the double vision and dizziness he experienced were gone, and that he was well enough to leave the pharmacy on his own volition.
Two days post vaccine, the patient developed approximately 10-12 raised, papular, erythematous lesions on back and thighs.
devel rash on body @ least 18 vesicles p/varicella vaccine;no history exposure to chickenpox;
Mixed Menveo with sterile water; Administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA721A, expiry date 20-AUG-2023) for prophylaxis.   On 28-APR-2023, the patient received Menveo. On 28-APR-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Mixed Menveo with sterile water) and inappropriate dose of vaccine administered (Verbatim: Administered to a patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 01-MAY-2023 The medical assistant reported that having mixed Menveo with sterile water and administered to a patient. The vaccine administered facility was same as the primary reporter. No additional adverse event details were available. The patient received wrongly reconstituted Menveo, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The health care professionals consented to follow to the safety team.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lyme's disease" (unspecified if ongoing); "Seafood" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: No other medication taken in 2 weeks. Treated with Paxlovid from 01Mar2023 to 05Mar2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pain in her arms and legs; Numbness in her extremeties; feels shaky; Dizziness; Nausea; This is a spontaneous report from a contactable Nurse. A 19-year-old female patient received meningococcal group b rlp2086 (TRUMENBA), lot AM6864, intramuscular in right deltoid on 16Aug2019 at 12:30 PM at 0.5 ml, single for immunisation. Medical history included ongoing anxiety and ongoing depression, both diagnosed by a historical provider. Concomitant medications included aripiprazole (ABILIFY), venlafaxine (VENLAFAXINE). Prior vaccinations within 4 weeks was none. The patient previously had received meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA) on unspecified date for immunization, however it was unknown if she had a reaction to that vaccine administration. The patient previously took SINGULAIR for unknown indication and experienced drug hypersensitivity.  On 16Aug2019 at 15:12 the patient experienced pain in her arms and legs, numbness in her extremities, feels shaky, dizziness and nausea. The patient was admitted to the Emergency Department and was treated with IV fluids. The events were considered serious as medically significant. The patient recovered from the events on 16Aug2019 and was discharged from the emergency department at 19:28. The events were assessed related to TRUMENBA.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
got vaccinated still got them/ suspected vaccination failure; got them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that he/she got vaccinated and still got shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation for shingles were not provided.
This spontaneous report was received from a certified medical assistant referring to multiple patients of unknown age and gender. The patients concurrent condition and medical histories were unknown. On an unknown date, the patients were vaccinated with an improperly stored dose of oral ROTATEQ, (Lot # and expiration date unspecified) (dose, administration route and anatomical site of administration were unknown). No concomitant therapies or adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
This is a spontaneous report from a contactable Nurse (patient). A 56-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 06Apr2021 (Batch/Lot Number: EW0151) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing. Concomitant medication(s) that patient received within two weeks of vaccination included losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported; dipyridamole (METROPOLYN) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks previous to the COVID vaccine. Prior to vaccination, patient was not tested with COVID-19. Four days after first vaccine, patient had outbreak of hsv1 on 10Apr2021. No treatment received for reported adverse event. Post vaccination, patient was not tested with COVID-19. The outcome of the event was resolving. No follow-up attempts are required, information about lot/batch number cannot be obtained. No further information is expected.
I have constant tinnitus last 6 days and nights, since the April 14th. That is something new for me. I had usual side effects; nothing significant. Arm pain and tiredness were the top two. I didn't pay much attention to tinnitus, but I noticed it the second night after the vaccine when I went to bed, and two more times after that, and it didn't last long.  However, it started again 13 days after the vaccine, and the hissing sound is more lauder and constant. It is in both ears. It bothers me especially at night. It could be a coincidence, but it could be a vaccine side effect as well. I am afraid that the second doze could make this tinnitus worse.
pt recvd vax for prophylaxis;24 hrs p/ dose 2, exp pain,stiffness & myalgia (head,neck,back);
Arm got red hot and hard at injection site, decreased in size by Monday 10/07/19
8th and 9th day after shot patient ran fever during the day and very high fever during the night. 10th day after shot she began to have a rash along with the fever. 11th day after shot she woke up with terrible looking rash covering her face and upper extremities along with the fever during day and high fever during the night. Doctor saw her on the 11th day post shot to rule out bacterial infection and flu (both bacterial infection and flu came back negative) No treatment given said it should run its course.