chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to an 84 year old female patient with asthma, hypertension and allergy to Biaxin. On 08-DEC-2008 the patient was vaccinated with ZOSTAVAX (lot # not reported) (total daily dose not reported). Concomitant therapies included Serevent, albuterol (manufacturer unknown), albuterol sulfate, Combivent, Flonase, Lipitor, hydrochlorothiazide, Dyazide and Altace. On 13-SEP-2013, the patient developed the shingles. The patient sought for medical attention via an office visit. Medrol was given as treatment. No lab diagnostics studies were performed. The outcome of shingles was reported as recovering. Additional information has been requested.
Patient received the second monkey pox vaccine before 28 day waiting period. He received the first monkey pox vaccine 09/22/22 and the second dose on 10/13/22.
MMRV and Varicella were given on the same day 1/26/23. No adverse reactions have been reported by parent.
Skin infection and severe acne lesions. Beginning one to two days post first vaccination. One lesion is so severe and and inflamed it is requiring oral antibiotic treatment.
pt recvd vax & exp pain at inject site;neuropathy (hypoesthesia & paresthesia) & tired muscle;events have lasted 4 wks,still not resolved;tx:physical therapy;anti-inflam drug for pain & stiffness;myalgia & arthralgia under care of MD;recove
Patient received the COVID-19 vaccine #1 (Moderna; Lot: 016J212A) on 5 February 2022 on her R upper arm a medical facility.  She received the vaccine around 0930. She noted in 10 minutes feeling lightheaded. She was monitored by medical staff at the facility with reported systolic BP of 92. She remained in the clinic for one hour and was discharged. She reported no loss of consciousness or immediate rash or swelling. She went home and to bed at noon and awoke at 1400 and noticed rash on both upper arms and on the R side of her neck. The rash was itching and persisted on her arms and gradually resolved by 7 Feb 2022 without treatment given.  She also noted after awakening at noon on 5 February 2022, persistent feeling of lightheadedness, fatigue and headache. She noted the evening of 5 February a low grade fever of 99.8.  These symptoms persisted through 8 February 2022 with all symptoms resolved by 9 February 2022.
Information has been received from a physician concerning a Caucasian female patient (previously reported as 4 month old) with an unknown medical history and no known allergies who on 17 Apr 2007 was vaccinated with second oral dose (previously reported as first dose) of Rotateq (Lot # 656195/0025D). There was no illness at the time of vaccination. Concomitant vaccinations on that day included the second dose of PedvaxHIB (lot # 655079/1435F), the second dose of Pediarix (lot # AC1B092AA), and the second dose of Prevnar (lot # B08670E). Within twenty four hours of receiving Rotateq (also reported on 17 Apr 2007), the patient experienced fever of 102, loose stools, bad abdominal cramping. No blood was detected in stool. The patient was also very fussy and decreased appetite. Unspecified medical attention was sought. At the time of the report the patient was recovering. In follow up on 18 Apr 2007, in the early am (9:00am was when the physician was called), the patient had a fever up to 103.5, was fussy, has loose stool, crying unconsolable, poor appetite and everytime she eats a few sips she will start screaming pulling her legs up to her stomach. The patient did not have blood or mucous in her stool and no vomiting. The patient's white blood cell count (WBC) at the patient's mother's family doctor was 3.5. On 19 Apr 2007, the patient was recovering and he patient's temperature was down to 100.5. No further information is expected.
Information has been received from a physician concerning an adult pt who was vaccinated with varicella vaccine. Three days post vax, the pt developed a "mild form of chicken pox." Unspecified medical attention was sought. Additional information has been requested.
seasonal allergy; This is a spontaneous report from a  sponsored program. A contactable consumer reported that a female patient of an unspecified age received first dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medication were not reported. The reporter stated that got the first dose 2 weeks ago, in between doses she got seasonal allergy on 2021. She was asking if it is okay to get her injection for her allergies and if it will weaken her immune system. Due dose of second shot is on the 23Feb2021. The outcome of the event was reported as unknown.   information about lot/batch number requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 54 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 07Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 29Mar2021 as dose 2, single (Lot number: ER8732), in left arm, on 13Dec2021 as dose 3 (booster), single (Lot number: F5870T), in left arm and on 17May2022 as dose 4 (booster), single (Lot number: FH9992), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Shellfish allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient was on treatment with Paxlovid from 21Aug2023 to 24Aug2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300288070 same patient, different drug, different event (Paxlovid case);
purpura on forearms; This case was reported by a consumer via other manufacturer and described the occurrence of purpura in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced purpura. On an unknown date, the outcome of the purpura was unknown.   It was unknown if the reporter considered the purpura to be related to Shingrix.  Additional details were provided as follows: The patient reportedly experienced purpura on forearms.
The patient was administered a volume of 0.25mL instead on 9-7-22 of the intended volume of 0.5mL. The error was recognized the next day and action was immediately taken to reach out to Moderna and CDC for clinical recommendations on the appropriate steps forward. On 9-16-22 responses were received, with the direction to have the patient come back as soon as possible to repeat the dose to receive the full dose of 0.5mL.  No adverse effects were reported. The patient returned and received the full dose on 9-16-22.
Extremely heavy onset of (on time) menstrual cycle, with bleeding 5X the volume of typical cycle.
She had "a burning sensation, not quite a headache" in her head; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 28Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing). Concomitant medication(s) included: ACTEMRA, start date: 12Feb2021, stop date: 12Feb2021. The following information was reported: BURNING SENSATION (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "She had "a burning sensation, not quite a headache" in her head". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient was  interested in the data for antibody testing around vaccination, especially because she is on an immunosuppressive agent. She was wondering if the Actemra and vaccine has interaction or the effectiveness will decrease. She was supposed to inject herself with Actemra but she skipped (drug holiday) her dose because this might have an effect on the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Shakiness-Medium, Systemic: Tinnitus-Mild
Pt recvd vax & devel pruritic skin rash following vax; No further details were provided;
Information has been received from a health professional concerning a female who on 22SEP2003 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy the same day included measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live and tuberculin purified protein derivative. On 05NOV2003, the patient developed chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. The reporter indicated that two other patient's had similar experiences following exposure to varicella virus live. Additional information has been requested.
tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old male patient received BNT162b2 ((PFIZER-BIONTECH COVID-19 VACCINE), on 17Apr2021 at 09:00 as dose 2, single (Lot number: EW0151) at the age of 25 years, in left arm for COVID-19 immunisation; COVID-19 vaccine (manufacturer unknown), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Jun2022, outcome "recovering" and all described as "tested positive for COVID". The patient first tested positive for COVID on 18Jun2022 and started Paxlovid the same day. He fully completed 5-day course of Paxlovid and the symptoms had improve greatly on this day. On 25Jun2022, 7 days after testing positive, the patient tested negative. Then on 02Jul2022, 7 days after first testing negative, he tested positive again and had symptoms of fatigue and nasal congestion. The patient was recovering.
This spontaneous report as received from an office manager refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored MMR II injection, lot# K016153, exp. date: 24-SEP-2016; lot# J013431, exp. date: 24-OCT-2017 and lot# K022285, exp. date: 12-NOV-2016 (dose, strength and route unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Arm got very sore the evening after injection.  Developed a headache about 3 hours after the injection.  On 01/16/2021 woke up with cold like symptoms such as stuffed up nose, slight cough that lasted about 2 days.  Body very tired and sluggish for about 2 days as well.
Breast Cancer Scare; This spontaneous case was reported by an other health care professional and describes the occurrence of BREAST CANCER (Breast Cancer Scare) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.     On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BREAST CANCER (Breast Cancer Scare) (seriousness criterion medically significant). At the time of the report, BREAST CANCER (Breast Cancer Scare) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Very limited information regarding this event has been provided at this time.; Sender's Comments: Very limited information regarding this event has been provided at this time.
Patient developed pain, numbess and tingling in left arm from her shoulder to her fingers. Of note, she previously had two doses of Trumemba, this was her first dose of Bexsero
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 11:18 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 11:18 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was reported as 33.55 on 15-Apr-2021.  Concomitant products were not reported.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.   On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
RASH ON ARM AND ACROSS CHEST;  GLANDS SWELLED A LITTLE; BURNING, ITCHING AND STINGING ARMS AND LEGS;  CONTINUED FOR 5 WEEKS  AND STILL CONTINUES ALTHOUGH SUBSIDING.  STOMACH MUSCLES HURT BUT NO NAUSEA.   EXPECTED FATIGUE, DIZZINESS AND WEAKNESS BUT NOT CONCERNED ABOUT THAT.    RAISED BLOOD PRESSURE AND PULSE RATE ON 2/3/2021.  STILL EXPERIENCING VARIATIONS IN HEAT/COLD FEELINGS..MAY OR MAY NOT BE RELATED.
Patient call call center. Pt stated feeling very tired in afternoon everyday since got her 1st dose covid vaccine Pfizer on 04/06/2021 and feeling discomfort, not going away these sx. Denies fever or any other emergency sx at this time. Speech clear.  Pt stated very concerned about to get 2nd dose covid vaccine and need to do consult with MD for her ongoing sx after got vaccine. Scheduled telephone consult appt with MD today at 3:45pm as per pt request for consult with provider. Notified pt to go to ED if any emergency sx arises,assure understanding.
Initial consumer report received on 05 Oct 2010: This patient with an unknown medical history had received a dose of Influenza virus vaccine (unknown manufacturer, unknown batch number), 3 to 4 years ago (date not specified). The patient subsequently developed shingles. The outcome was not reported.
12/26/06 immunizations. 12/28/06 pm right arm swollen at Dtap injection site - seen at clinic - called agency. Diagnosis: arthritis reaction - Motrin and hot compresses prescribed. 01/02/07 pm swelling resolved and no further symptoms per facility (aunt and legal guardian).
low back pain, thoracic myositis & pain;myalgia & arthralgia;
Client c/o rash on arm and tongue swelling after taking 3rd dose of oral typhoid. PCP encouraged ER visit where client was monitored and dc'd home with instructions to use oral BENADRYL on 3-6-12. Spoke with client on 3-8-12; symptoms resolving & doing well.
This spontaneous report as received from a medical assistant refers to a patient who was vaccinated IM with the three doses of GARDASIL on 07-JUN-2012, 10-AUG-2012 and 09-OCT-2012, respectively. No adverse effect was reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 92-year-old patient of an unknown 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported.  No treatment medications provided by the reporter.
flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The caller reported that she was aware of a female patient that had the Shingrix and experienced flu like symptoms. At the time of this report, limited information was provided. This is 1 of the 3 cases reported by same reporter.
Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Apr2021 as dose 1, single (Lot number: Ew0161), in right arm, on 11May2021 as dose 2, single (Lot number: Ew0173), in left arm and on 16Nov2021 as dose 3 (booster), single (Lot number: 30155ba) at the age of 29 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: PROZAC, start date: 01Dec2019, stop date: 21Sep2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201201137 same patient, different event, different drug;
about 2 weeks after first dose I woke up with numbness in lower half of my body. both legs and torso. I ended up in emergency room and was looked at over next week in hospital for stroke and different disease including MS, Transverse myelitis, Guillen-Barre.
Child developed chicken pox with classic vesicular lesions #10. Tx: Acyclovir 200/5 8 1/2 PO QIDx5 days
redness, itching, heat Narrative: redness, heat, itching at injection site for 1 week
9 hours after the vaccine, I felt very weak and achy.  I did not sleep very well and the next morning ~24 hours after the vaccine, the aches were worse and I had a lump appear on my left foot. It was painful to walk on and very hard. It was at the joint of my left toe and painful to walk on, similar to a Tailors bunion. The lump remained for a couple of days and then went away.  The next week, there were no problems, however a couple of weeks later the pain in my foot came back. This time, the lump was not as big, but the pain came back. It was painful to walk on my foot.  On November 21st 2021, when I woke up my right arm was painful under the armpit. (The pfizer booster was given on my left arm). The pain under my armpit was a sharp pain but not severe, more like a chronic irritation. It persisted for about 1 week and then went away. The pain was more pronounced at night and I took ibuprofen and naproxen as medication. It came back a couple of weeks later and my left foot started to hurt again. The pain then went away for the second time.   Currently, I am experiencing a dull pain under my right arm and it is January 7th 2022. The pain is not getting any worse and I have no pain in my foot.
dizzy; having a hard time to breathe; hard to control walking; kept going from cold and hot; This is a spontaneous report from a contactable consumer (patient's husband).   A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 18Apr2021 10:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 for Covid-19 immunization. Around 19:00 on 18Apr2021, patient was dizzy, having a hard time to breathe, hard to control walking and kept going from cold and hot. Caller stated they put ice on her head, she took ibuprofen and they put two to three pillows on her head to help her breathe. Outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.