chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 18 days after the vaccine I noted a  15mm oblong redness and swelling on my left deltoid as well as a flat area or erythema just below that. My vaccine injection site was approximately in the middle of the oblong reddened area. I noticed it while going to take a shower.  No pain, tenderness or urticaria. 48 hrs later, it was no longer visible.
Pain in right arm after 4 days. Pain in both arms above elbow and in shoulders - some muscular discomfort in right leg - pain intense at times.
had two diapers with frank blood specks 4 days after rotavirus vaccine on teh 3rd of september.   mom states he was gassy, more fussy after the vaccines.  drinking well, no fever.  she had also started sweet potatoes and wondered if they were the cause.  stopped the sweet potato   no blood for a week, had a small speck of blood on the 14th in a stool  mom had corn the night before, he was again pretty gassy and passed a large stool and lots of "explosive gas"  small noticable speck of blood   mom eats yoghurt, not much milk  says patient has always been a little sensitive to spicey foods, things she eats.   otherwise acting well, normal.  little cold and stuffiness  eating well, happy,  no rash no fever  no change in spit ups   2-3 diapers with blood. initial two temporally related to rotavirus vaccine.  no significant blood or symptoms to suggest intussuception  doubt sweet potatoes as cause  continuing "speck" noted recently--still from the vaccine, ? from small fissure, ? maternal dietary source (most likely is generally dairy)  guaic today is NEGATIVE
Information regarding a case in litigation has been received from a lawyer and the spouse of a deceased male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. The patient subsequently contracted a persistent strain condition of herpes zoster. On or about 15-AUG-2016, the patient was treated at a clinic for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the vaccination failure and herpes zoster/shingles was unknown. As a direct and proximate result of using the ZOSTAVAX vaccine, and/or despite using ZOSTAVAX for the sole purpose of preventing shingles of preventing shingles, the patient suffered from shingles and/or other painful herpes zoster-related injuries and required extensive medical and treatment. As a further proximate result, the patient had suffered significant medical expenses, and pain and suffering, and other damages. On 29-APR-2018, the patient passed away. The cause of the patient's death was not reported. It is unknown if an autopsy was performed. Upon internal review, death was determined to be medically significant. Additional information has been requested. Reported Cause(s) of Death: Death.
Hypertension, tachycardia, difficulty breathing , bronchitis, shortness of breath, fatigue
Approximate 3 weeks after getting my 2nd Moderna vaccine shot I noticed/came down with Tinnitus.  I have not had this before.
This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 71-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included Baby ASA and citalopram. On 20th May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 9 days after receiving SHINGRIX, the patient experienced shingles, pruritus and rash. The patient was treated with hydrocortisone and Antibacterial Soap. On an unknown date, the outcome of the shingles, pruritus and rash were recovering/resolving. It was unknown if the reporter considered the shingles, pruritus and rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a medical assistant. The patient was experienced itching, rash and spots on his left hip and buttocks. On 14th June 2018, the patient had an already scheduled physician appointment and was diagnosed that day as mild case of shingles.
On May 13, 2022 I tested positive for COVID-19. On May 12, 2022 I started having a sore throat, by the next day on Friday May 13, 2022 my throat was extremely sore and my husband had started coughing. We both went to Urgent Care and had a PCR test that came back positive.
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 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 at 15:45 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METOPROLOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies. Anti-viral details: COVID 19 Treatment; Paxlovid  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This spontaneous report was received from a health professional refers to multiple unspecified patients of unknown gender and age. Information regarding the patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were inadvertently vaccinated with improperly stored M-M-R II (unspecified lots/expirations (incorrect product storage). This is one of the four reports received from the same reporter. Additional information has been requested.
Information regarding PREVNAR 13 was received from a healthcare professional regarding a 15-month-old male patient who experienced vaccination site cellulitis, vomiting and fever. At 15 months of age, the patient received the second dose on an unspecified date. Additional suspect medication included Varicella Virus Vaccine, Live administered in the same leg as PREVNAR 13. The patient experienced vaccination site cellulitis, vomiting and fever. The patient recovered. See related case(s): US-WYE-H16922210 (adverse event, expedited). No additional information was available at the time of this report.
Left arm, back, shoulder, head and chest became painful and tight. Breathing was labored and throat felt swollen. It was not a migraine and it wasn't asthma. Oxygen levels dropped below normal when relaxing. After receiving BENADRYL, TORADOL and a breathing treatment, symptoms lessened.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 07-NOV-2012 05:30, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Patient verbalized feeling nausea, stated not new occurrence; she takes Synthroid 112 mg before breakfast and feels nausea in afternoon.  Vitals taken at 1:50PM:  O2 99%, RR 17, Pulse 75, BP 118/74  2:10PM vitals retaken:  o2 98%, RP 19, Pulse 71, BP 120/72.  Patient felt better, water was given to her, denies any distress.  Patient educated on self care post vaccine.  Verbalized understanding.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, INTENSE HA, SINUS PRESSURE, STOMACH PAIN, N, MUSCLE AND JOINT PAIN, HOT SWEATY, COLD Narrative:
terrible pain; lymph system overwhelmed; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer.   On 2nd February 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain and lymphatic disorder. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the lymphatic disorder was unknown.   It was unknown if the reporter considered the pain and lymphatic disorder to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient had lymph nodes removed when she had breast cancer. The patient had the 1st dose of Shingrix and her lymph system became overwhelmed. The patient had the shot in her good arm, the patient had terrible pain for several weeks. Patient would like information on whether or not to receive the 2nd dose of Shingrix. No additional information was provided.
So in mid May 2021 you started feel dizzy. I think May 14, 2021 but this is probably not the exact. I got a referral from Dr. to get a CT scan at  Imagining center, I can't remember the date.  The CT scan came back normal. Then I made an appointment with the Ears, Noses, and Throat doctor  mid May first week of June.  The did basic hearing test with the tones. My hearing was normal except for one frequency that was high in both ears.  I don't have the ENT doctor's name. They prescribe me prednisone for 1 week.  I went back two weeks later to check if the prednisone helped and it didn't and after the appointment they said that I didn't need to see me anymore and gave me paper work stating that the visits were for tinnitus .
SkinRash Hydrocortisone 1 gm prn patient instructed to obtain otc, diphenhydramine 25 mg prn patient instructed to obtain otc
2/15 onset of hives; recurred every other day for 2 wks. PT took Benadryl for Tx of Sx's - effective. Experienced some pain w/breathing for some time period.
Vaccine given approx. 4:45 pm on 5/12/2018. It is now 5/14/2018, 8:00 am. Red hive-like rash appeared & started itching approx. 11 pm same day of vaccine administration, only first appeared on left wrist & left calf/ankle, however is now all over his body (everywhere!) as of 11 pm day following vaccine administration (5/13/2018). Running low-grade fever & having chills off/on. Slightly elevated heart rate.
No adverse event; 3 patients were given monovalent vaccine instead of the bivalent booster around 10:00 CST today 3Mar2023; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (3 patients were given monovalent vaccine instead of the bivalent booster around 10:00 today 3Mar2023) and NO ADVERSE EVENT (No adverse event) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 074B22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Moderna COVID-19 Vaccine (First dose 0.5 mL) on 05-Mar-2021, Moderna COVID-19 Vaccine (Second dose 0.5 mL) on 01-Apr-2021, Moderna COVID-19 Vaccine (Monovalent dose 0.25 mL) on 08-Nov-2021 and Moderna COVID-19 Vaccine (Moderna monovalent dose 0.25 mL) on 17-Aug-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 03-Mar-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Mar-2023,  after starting , the patient experienced WRONG PRODUCT ADMINISTERED (3 patients were given monovalent vaccine instead of the bivalent booster around 10:00 CST today 3Mar2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (3 patients were given monovalent vaccine instead of the bivalent booster around 10:00 CST today 3Mar2023) and NO ADVERSE EVENT (No adverse event) 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.   Concomitant medications were provided. Treatment medications were provided.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713899:same reporter US-MODERNATX, INC.-MOD-2023-713958:Patient 3 case
Neck stiffness, myalgia - started 1 hour after receiving flu vaccine on 10/23/18, persists when seen on 10/24/18 at 1440.
booster vaccine; developed COVID infection with mild flu-like symptoms; developed COVID infection with mild flu-like symptoms; developed COVID infection with mild flu-like symptoms; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) 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 1, Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster vaccine"; DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered" (2021) and all described as "developed COVID infection with mild flu-like symptoms". Both kids developed COVID symptoms with mild flu-like symptoms around 1 week ago (early Jan2022) and both are almost completely recovered. Both parents (? 40s) had the booster vaccine (unclear which brand) within the past few months and also developed COVID infection with mild flu-like symptoms within the past week. They are almost fully recovered as well. HCP did not mention the type of primary vaccine series that he and his spouse received, or when they received the primary series.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information and a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective, covid19 cannot be totally excluded.,Linked Report(s) : US-PFIZER INC-202200056534 same vaccine, similar AE, different patient
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.      In 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient experienced shingles (date unspecified), was treated by a physician and was hospitalized due to the event (date unspecified).  As a direct and proximate result of patient use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was considered as not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
sick; stomach problems; fever; This is spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on 23Feb2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that that she missed her second dose appointment because she got the first dose on 23Feb2021 and after that she was not able to get the second dose because she got sick with fever and stomach problems. she got another second dose appointment for 30Mar2021. No unaddressed medical questions referred or forwarded to medical information. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with PROQUAD (Merck) which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a physician and a licensed practical nurse (LPN) regarding a 20 month old (also reported as age 2, units not provided) female patient (child). On 06-JUN-2014 at 11:57 am, the patient might have been immunized with a dose of PROQUAD (Merck) lot number J015596, expiration date 05-JUN-2015, in the left thigh (dose number, route and dose were not reported) which was not stored at the appropriate temperature (not further specified). Concomitant medications were not specified. The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
3 months in the hospital with COVID and 2 more months in a rehab after that facility; 3 months in the hospital with COVID and 2 more months in a rehab after that facility; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: 30145BA, Expiration Date: 15Sep2021) and as dose 2, single (Lot number: 30145BA, Expiration Date: 06Oct2021) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "3 months in the hospital with COVID and 2 more months in a rehab after that facility". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Additional information: I was in a hospital last year since Jul till 03Dec months in the hospital with COVID and 2 more months in a rehab after that facility (further clarifications unknown). So, I had COVID bad case last year. I don't know what to do, do I need to go in emergency or should I wait? Because, I have been (voice not clear) test was, I just checked it right now and it was negative." When confirmed the name of the vaccine as Pfizer COVID Vaccine booster shot, Consumer stated, "Yes, third one, third vaccine after 6 months, after my 2 doses last year in Oct2021 Expiration date: Consumer stated, "So date is 15Sep21, 15Sep2021 the first dose, second one you need second one? It's the same 30145BA Pfizer, 06Oct2021 (further not clarified hence not captured in tab)."   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a physician and refers to a patient of unknown age (also reported as "0") and gender. No information about the patient's pertinent medical history, concomitant medications and concurrent conditions was provided. On 15-MAY-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ oral solution, lot # M044399 (dose, and expiry date were not specified) for prophylaxis. The administered dose of ROTATEQ underwent a temperature excursion of 48 Fahrenheit degrees for 30 minutes. There was no Digital Data Logger involved. No previous temperature excursion was reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all available information has been received.; Sender's Comments: US-009507513-1704USA001661:
Within 24 hrs.- raised, red, warm and tender to touch, slightly itchy at injection site 3"x2". At 48 hrs. grew in diameter 4"x3". Less red, still raised, not warm to touch. Gone within 4 days. Redness slowly deminished.
Rash was initially papular, rapidly evolved into large confluent macules over face, trunk, extremities began day after receiving smallpox vaccine.
Presyncope Vasovagel symptoms; Lightheadedness; Blurred vision; Sweating; This is a spontaneous report from a contactable consumer, the parent. A 16-years-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 05May2021 at 16:45 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergies to Zithromax. Concomitant medications were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 14Apr2021 at 16:45 (at the age of 16-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 medications or vaccines within four weeks prior to the vaccination. On 06May2021 at 08:00, the patient experienced presyncope vasovagal symptoms with dizziness, lightheadedness, blurred vision and sweating. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events presyncope vasovagal symptoms with dizziness, lightheadedness, blurred vision and sweating were recovered on 06May2021.   No follow-up attempts are needed. No further information is expected.