chrisvoncsefalvay/vaers-outcomes huggingface dataset:
joint pain in both hands; tingling and numbness in the right hand; tingling and numbness in the right hand; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), first dose via an unspecified route of administration, administered in Arm Left on an unspecified date(at the age of 62 years)single for covid-19 immunization. Medical history included thyroid (Verbatim: thyroid), migraine, cholesterol from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine (112 MG), topiramate (TOPAMAX, 100 MG) taken for migraine, atorvastatin (40 MG) taken for cholesterol, start and stop date were not reported. Patient was not involved in Prior Vaccinations (within 4 weeks). On an unspecified date the patient experienced the joint pain in both hands happened 6 hours of the first dose. The tingling and numbness in the right hand it started the next day after the first dose. The pain in the right hand was so severe sometimes it wakes her up in the middle of the night and she has to apply an ice pack. The patient feels tingling all the time and then her right hand goes numb randomly. Time the Vaccination Was Given: 3:00 or 4:00 pm. Adverse events required no visit to Emergency Room, Physician Office. The outcome of the event joint pain in both hands was outcome. While the outcome of the rest of the events was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. On or about 24-DEC-2007 the patient was inoculated with ZOSTAVAX vaccine for routine adult health maintenance and the prevention of shingles at a hospital. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 01-MAR-2013 the patient was treated at a hospital for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
This spontaneous report was received from a nurse referring to an 11 year old female patient.  Information regarding the patient's medical history, drug reactions or allergies and concurrent was not reported. Concomitant therapies included MENVEO. On 29-DEC-2017, the patient was vaccinated with the first dose of improperly stored GARDASIL 9 lot # N020353, expiration date dose 28-APR-2020, by intramuscular route in the left deltoid, for prophylaxis. The vaccine was exposed to a temperature range of 0.4°C, during a time frame of 14 hours, which was called by a data logger. No previous temperature excursions were reported. No adverse effects were reported.
39 years old female with history of breast cancer complaints of feeling "shaky and lightheaded post J&J vaccine in the right deltoid. Patient vs 135/78, normal sinus rhythm . Water provides to patient. She states that she feels better. Patient monitored 15 minutes more and was discharged home. No sign of acute distress noted.
Pt states raised red rash w/ itching for several weeks. Today SC site appears black & blue bruised.
On the morning of Jan 26, 2022, my entire body was covered in rashes. It was very itchy. I took Claritin thinking it was just allergies. During the day, the rash got bigger. I felt it was creeping over my face. My ears felt hot and my eyes felt swollen. I went to urgent care, where I was prescribed 3 tabs of prednisone 20mg for 5 days. It was also advised to take Benadryl before I slept that night. As of date, I am on my third day of prednisone. There are a few rashes left, especially on my lower body. But, the swelling and redness are gone.
High fever for 3 days, headache, fatigue and vomiting ongoing after 7 days
Myalgia, Fever, NauseaVomiting, Chills, body aches Narrative:
Patient received an undiluted dose (0.2ml) of the Pfizer children's 5-11.  Patient stayed with guardian in the pharmacy for 15-20 minutes with parent and no reactions were noted; patient left. manager stated she will follow up with parent.
Pt received PREVNAR 13 IM to right deltoid 07/09/15. Returned to clinic 07-13-15 with c/o localized induration, pain at injection site. Hives extending to tricep area.
Sensitivity of the lower GI tract. I can't eat any tomatoes or tomato sauce, just like the last time I had the 2nd Pfizer shot. I have Lower GI cramps and also my eyelids turned really red & itchy. I got an eye infection after that.
No adverse Event; patient got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient got vaccinated after BUD).    No relevant concomitant medications were reported.  No treatment information was provided.
started feeling pain in chest/ my husband starts to feel the same thing; pressure in my chest/ my husband starts to feel the same thing; my heart was racing/ my husband starts to feel the same thing; shortness of breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 31 year-old male patient received bnt162b2 (BNT162B2), administration date 06Jan2022 (Batch/Lot number: unknown) at the age of 31 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number Unknown, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: CHEST PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "started feeling pain in chest/ my husband starts to feel the same thing"; CHEST DISCOMFORT (non-serious) with onset Jan2022, outcome "unknown", described as "pressure in my chest/ my husband starts to feel the same thing"; PALPITATIONS (non-serious) with onset Jan2022, outcome "unknown", described as "my heart was racing/ my husband starts to feel the same thing"; DYSPNOEA (non-serious) with onset 2022, outcome "unknown", described as "shortness of breath". The events "started feeling pain in chest/ my husband starts to feel the same thing", "pressure in my chest/ my husband starts to feel the same thing" and "my heart was racing/ my husband starts to feel the same thing" were evaluated at the physician office visit and emergency room visit. The event "shortness of breath" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter reported that she and her husband received their booster shot on 06Jan2022. She reported that 2 days later she started feeling pain/pressure in my chest, my heart was racing. After 1 month I went to emergency room, the doctors said everything was fine, but last Friday my husband starts to feel the same thing, he went to the hospital today everything looks good. this was heart pain. We want to know because the doctors say everything was okay. We had never had this before. Reporter again stated his heart was rolling too right now sometimes it was racing. Sometimes you know it was more 'a lot real' like that and he was feeling the same thing in the chest like the pain like the pressure and he went to the room, emergency room where they say that everything looks okay (Further not clarified) but we started feeling these after the booster you know what I mean. I just wanna know was this something like a reaction by the vaccine you know or something because we are confused because the doctor said that everything was ok but we do not feel.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
upper respiratory  infection; was so sick; This case was reported by a consumer via interactive digital media and described the occurrence of upper respiratory tract infection in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received the 1st dose of Influenza vaccine Quadrivalent unspecified season. On an unknown date, several days after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced upper respiratory tract infection and sickness. The patient was treated with antibiotics nos. On an unknown date, the outcome of the upper respiratory tract infection was unknown and the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the upper respiratory tract infection and sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Flu shot once in life.  The patnt had always been healthy.  A few days later the patient got the worst upper respirator infection in life.  The patient was so sick for 12 long weeks.  The patient made 4 trips to the doctor and they had to keep switching the antibiotics and finally patient was on complete bed rest because it would not go away The patient thought wasn't going to make it.  The patient would never take another vaccine.  The patient had not been sick sense that was almost 10 years ago. It was reported They were poison.
The day after my second Moderna Vaccine shot, my ear (r) starting ringing and has not abated.
red arm with red mark at injection site.; headaches; interrupted sleep; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number L7SY9, expiry date 4th July 2021) for prophylaxis.   On 26th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 26th April 2019, immediately after receiving Shingrix, the patient experienced erythema of extremities, headache and sleep disturbance. On an unknown date, the outcome of the erythema of extremities was recovering/resolving and the outcome of the headache and sleep disturbance were not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities, headache and sleep disturbance to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on right arm, intramuscularly and experienced a red arm with a big red mark at the injection site. The patient was experiencing headaches that were waking her up at night.  These side effects occurred immediately, however, the redness was less till the time of reporting, but still evident. The patients headaches are still unresolved. the discrepancy between the outcome reported in the structured field (recovering/resolving) and the outcome reported in the narrative (not recovered/resolved).
Fever and myalgia that started 24 hours later.  As a physician, I assumed these to be normal and expected side effects. However, I had progressive worsening of muscle pain and stiffness that limited my ability to function.  Ten days after the vaccination,  I developed tetany of my elbows and could not straighten them at all for about 10 minutes and it took about 6 hours for that to completely resolve.  I was severely affected for 6-8 weeks with horrible muscle pain and stiffness.  The latter was so bad that I had trouble standing from a seated position and exercise performance deteriorated.  My energy level declined.  My hair started falling out.  It took a full 3 months for me to return to my level of functioning and relative pain free state that I was enjoying in the 2 weeks prior to my Shingrix shot.   I had difficulties with muscle pain and stiffness for about 7 years prior to the vaccination, however, my symptoms had improved tremendously over the last several years and I was nearly asymptomatic at the time of the injection.  I do not know if this was a true adverse reaction to the Shingrix shot or if the Shingrix vaccination really exacerbated my underlying condition.
Nausea; shakes; chills; joint ache; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes), CHILLS (chills), ARTHRALGIA (joint ache) and NAUSEA (Nausea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A, 012L20A and 939906) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included L-THYROXINE [LEVOTHYROXINE] and ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 16-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021 at 8:00 PM, the patient experienced TREMOR (shakes), CHILLS (chills) and ARTHRALGIA (joint ache). On 16-Sep-2021, the patient experienced NAUSEA (Nausea). On 08-Feb-2021, TREMOR (shakes), CHILLS (chills) and ARTHRALGIA (joint ache) had resolved. On 17-Sep-2021, NAUSEA (Nausea) had resolved.            No treatment medications reported. Patient took Shingles vaccine in 8/20 and experienced same events.  This case involves a 73-year-old female subject with unknown medical history who experienced the unlisted non-serious adverse event of tremor and the listed non-serious adverse events of chills, arthralgia and nausea over her three vaccination doses. No re-challenge information was provided or is applicable.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-339520, MOD-2021-322828 (Patient Link).; Sender's Comments: This case involves a 73-year-old female subject with unknown medical history who experienced the unlisted non-serious adverse event of tremor and the listed non-serious adverse events of chills, arthralgia and nausea over her three vaccination doses. No re-challenge information was provided or is applicable.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient was standing and felt dizzy. He felt as if he was going to pass out. He was taken to an exam room, layed flat on a exam table, he was given Orange Juice. His b/p was 110/62. After 10 minutes he was sitting up and felt better. He slowly stood up and remained in the same standing position for 2 minutes where he felt good enough to leave the clinic.
had my period 8 days earlier after my first shot; bleeded more than usual; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (had my period 8 days earlier after my first shot) and HEAVY MENSTRUAL BLEEDING (bleeded more than usual) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No Adverse Events.    On 25-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MENSTRUATION IRREGULAR (had my period 8 days earlier after my first shot) and HEAVY MENSTRUAL BLEEDING (bleeded more than usual). At the time of the report, MENSTRUATION IRREGULAR (had my period 8 days earlier after my first shot) and HEAVY MENSTRUAL BLEEDING (bleeded more than usual) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided    This case was linked to MOD-2021-170358 (Patient Link).   Reporter did not allow further contact
Information has been received from a nurse practitioner concerning a 20 year old male with no drug reaction or allergies, who on 11-JUN-2010 was subcutaneously vaccinated with the first 0.5 ml dose of VARIVAX (Merck) (lot #664502/0687Y). There was no concomitant medication. On 24-JUN-2010, about 13 days after the first dose of VARIVAX (Merck) was administered, a rash appeared on the patient's left shoulder, trunk, and back. The nurse practitioner reported the rash was a scattered, maculopapular rash, which went away shortly after it appeared. No lab diagnostics studies were performed. The nurse practitioner stated that "she would not be administering a second dose to the patient." The patient sought unspecified medical attention. Follow-up information has been received from the nurse practitioner concerning the 20 year old male volunteer with no medical history and illness at time of vaccination who on 11-JUN-2010 was subcutaneously vaccinated with the first dose of VARIVAX (Merck) (lot #664502/0687Y) to the left arm. The patient reported rash on left shoulder on 24-JUN-2010. The patient was examined by registered nurse of employee health revealing scattered maculopapular rash among both shoulders. Patient complained of headache without itch and fever. On 10-JUL-2010, the patient recovered from the events. No diagnostic laboratory tests performed. No further information is available.
under 18 years of age; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years of age) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years of age). On 14-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years of age) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Initial additional document contains no new information.
blood in stools; Cough; Body ache; Chills; Fever; tired; Dizziness; A spontaneous report was received by medical information from a nurse concerning a 63 year old, male patient who developed/experienced: cough (cough), body ache (myalgia), fever (pyrexia), chills (chills), dizziness( dizziness), fatigue (fatigue), tired (tiredness) and blood in stools (haematochezia).   The patient's medical history was not provided other than concomitant medications.  Products known to have been used by the patient, within two weeks prior to the events, included: Metformin, Zinc and B12.    The patient received their presumed first dose of the mRNA-1273 vaccine on 27Jan2021 (Batch #: 032L20A) as it was indicated by the reporter that the patient was due for the next dose around the time of the report. The events occurred following the first dose of the vaccine but exact dates of the events were not provided, only duration in days.   The day following the administration of the vaccine, the patient reported cough, body ache, fever, chills, fatigue and feeling tired. These symptoms lasted for 10 days.   Approximately 2 weeks following the administration of the vaccine, the patient reported dizziness which lasted for 5 days.   The patient took Tylenol for treatment and was noted to be feeling better as of 13Feb2021. No further outcome information was provided.   The patient reported having blood in stools and was seen by their doctor, date of onset was not provided. The doctor indicated this was "probably hemmoroids" and that "he (the patient) was fine and drink lots of liquids." No other treatment or outcome information was provided.    It is unknown if the subject received the second dose of mRNA-1273.    No assessment of causality was provided by the reporting nurse or the patient's doctor.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
mild shingles outbreak after her first COVID-19 vaccine shot/has shingles outbreaks now and then and that it was not untypical for the patient to have mild shingle outbreaks; This is a spontaneous report from a contactable physician via a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. Medical history included mild shingles outbreaks. Concomitant medications were not reported. On an unspecified date, after her first COVID-19 vaccine shot, the patient experienced a mild shingles outbreak. The physician reported that the patient has shingles outbreaks now and then and that it was not untypical for the patient to have mild shingle outbreaks. The shingles outbreaks stay mild. The patient's second dose was scheduled on 23Feb2021. The physician asked if the patient would be able to get her second COVID-19 Vaccine while having a mild shingles outbreak. The outcome of the event was not recovered.  Information on lot/batch number has been requested.
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), in Oct2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "liver issue" (unspecified if ongoing); "Known allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid as COVID-19 treatment from 12Apr2023 to 17Apr2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300167548 same patient, different drug/event (Paxlovid);