chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HIVES ALL OVER BODY; ITCHY RASHES IN FACE AND NECK AREA; This spontaneous report received from a patient concerned a 30 year old female. 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, route of admin not reported, batch number: 203A21A expiry: 23/JUN/2021) .5 ml, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-MAY-2021, the subject experienced hives all over body. On 26-MAY-2021, the subject experienced itchy rashes in face and neck area. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, loratadine, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itchy rashes in face and neck area, and had not recovered from hives all over body. This report was non-serious.
Patient received Fluvirin at the pharmacy on 10/1/15 and waited approximately 10 minutes in the waiting room before going home. The pharmacists recommend all patients to stay in the pharmacy for 10 to 15 minutes after receiving any vaccines to ensure that patients don't experience any immediate reaction after vaccination. After going home, he claims there was a bulge at the injection site. He called the pharmacy approximately an hour later and pharmacist informed him that injection site reactions are reported side effects of the vaccine and that he can try to use a cold compress to see if it provides any relief. Pharmacist informed patient to monitor the situation and to contact a medical professional if the condition worsens or does not improve. Patient did not contact the pharmacy after at this time. On 10/30/15, the patient comes back to the pharmacy to inform pharmacist that he has been hospitalized in the ICU for 20 days and was in physical therapy for 10 days due to an unexplained severe reaction to the flu vaccine. According to the patient, he began bleeding within hours of the vaccine and was brought to the hospital by a friend after consulting with a physician. He stated that his platelet levels were very low and that the hospital had to provide intensive care. He stated that none of the physicians treating him could explain why his body had this trigger reaction since he has previously received flu vaccines year after year in the past with no adverse reaction. He has recovered as of 10/30/15.
Information has been received from an approximately 69 year old female with no concomitant medication or drug allergies who, in approximately 2009, about two years ago, was vaccinated with a dose of ZOSTAVAX (Merck). There was not concomitant therapy. The patient reported that "well over a year ago", in approximately 2010, she had weird, tingly feeling and pain. The pain began on the right side and then travelled over the middle near the belly button and it seemed like shingles was trying to come out. The pain came and went. The patient sought unspecified medical attention. The patient was treated with acyclovir 400 mg, 5 tablets a day for 10 days, and tramadol. The patient stated that she was no longer taking tramadol but she was still taking acyclovir. None of lab diagnostics studies performed. Upon the time of the report, the patient's present status was unknown. Additional information has been requested.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 21-MAY-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0975AA expiry date 17-JUN-2013) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
09/20/10- inj. -  Pneu. immunization redness, pain swelling at injection site treatment antihistamines, ice.
Fatigue 2/18 5-8:30pm - went to sleep at 8:30pm Chills 2/18 8:00-8:30pm - went to sleep at 8:30pm Headache 2/18 4:00pm-3:00pm on 2/19 Neck joint soreness upon waking on 2/19 - 2/21 (ending around mid morning)
29APR97 small red bumps appeared on both arms, face, abd;also has loose stools Tuesday until present;parent states doesn't appear to bother client, doesn't scratch @ bumps;no fever accompanying rash;
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: patient experienced lightheadeness and flushing. was given benadryl. after approx 10 minutes was sweating but all other symptoms resolved. after 20 minutes all symptoms resolved
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE ST ELEVATION MI, UNSPECIFIED PERICARDITIS POST ACUTE MI HYPOTENSION 8/15/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Red blood in stool after 2nd dose of vaccine; This is a spontaneous report from a contactable consumer (patient himself). A 51-year-old male gender patient started to receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number: ER8732) via an unspecified route of administration in the left arm on 27Mar2021 at 15:00 (at the age of 51-years-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took BNT162B2(lot number: EN6955) via an unspecified route of administration in the left arm on 06Mar2021 15:00 at single dose for COVID-19 immunization. The patient experienced Red blood in stool after 2nd dose of vaccine on 27Mar2021. Patient did not receive any treatment. The outcome of event was recovering.
Fever, chills, pain at the injection site, my whole body aches, especially my lower back, neck and shoulders.  For treatment, I took Tylenol 500mg.  The adverse event has been ongoing for 6 hours.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 55 year old female. Initial information was processed along with additional information on 29-DEC-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number:1808978 expiry: UNKNOWN) dose was not reported,1 total, administered on 10-APR-2021 on left arm for prophylactic vaccination. No adverse events reported post vaccination (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number:1822811 expiry: UNKNOWN) dose was not reported,1 total, administered on 23-OCT-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 27-DEC-2021, the patient stated that she was tested positive for COVID-19, both by Rapid Antigen test and PCR (polymerase chain reaction) test (confirmed clinical vaccination failure) and received only text that stated she was positive and does not had test results. She also stated she had bad cold and thought that she had breakthrough infection and she thought she got Omicron (subsumed under confirmed Covid-19 infection) (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000209076.; Sender's Comments: V0: 20211261137-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Pt. reported ringing in her ears, dizziness and lightheadedness. Pt. instructed to lie down, given water, crackers, ice pack. Pt. monitored around 20 minutes, stated feeling fine and discharged from office. Instructed to seek medical care if symptoms return.
pt recv vax 1130AM & mom called 1:30 stating pt devel an itchy pinpoint rash on arms & legs & it was now spreading to trunk;mom had notified family MD;
Muscle and joint pain, muscle weakness, urticaria, swollen joints and legs, difficulty walking. Treatment: taking pain killers, rest.
This medically confirmed spontaneous report (initial receipt 27-Sep-2011) concerns a 64-year old female patient, who had a medical history of diabetes, hypertension, diverticulosis, hemorrhoid, colon polyps and stroke. She had drug reactions/allergies to sulfa drugs and penicillin. Concomitant medications included glimepiride, alprazolam, atorvastatin, amlodipine, lisinopril, sitagliptin; metformin combination and dipyridamole. On 19-Sep-2011 the patient received AFLURIA in left arm. On the same day she also received PNEUMOVAX 23 (batch number: 1157Z) subcutaneous injection on back of the right arm for indication 'to be vaccinated'. After one day the patient started to swell and it (injected arm) was red and hot. Each day it kept getting bigger and then covered entire back side of her arm from elbow to shoulder. The healthcare profession told her to take diphenhydramine and put ice on it. The physician said it was the dorsal surface of upper right arm, 10 cm red, warm 'succular' and processing from injection site. There were no lab diagnostics studies performed. The event outcome was recovering, but it increased her anxiety. The reporter considered events to be serious as it required intervention to prevent serious criteria.
SUPER VENTRICULAR TACHYCARDIA (47 EVENTS IN 2 WEEKS DETECTED BY WEARBLE MONITOR) TREATMENT: PRESCRIPTION MEDS, SURGERY RECCOMMENDED
This spontaneous report as received from a pharmacy technician refers to a 54 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 08-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1802USA001558:
Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.
Patient presented to pharmacy on 11/3/17 with a bruise approximately 1-2 inches in diameter that occurred at the injection site within approximately 24 hours after vaccination and was still present 10 days later. Bruising was initially dark blue/black, but was resolving into brown/green/yellow at time of presentation. Accompanied by mild pain on contact. Patient was told to return to pharmacy/contact physician if bruising failed to resolve.
Difficulty with balance within an hour of vaccine. Fever 103 began that night, lasted several days. Child had episodes of twitching during fever. Child was difficult to keep awake for 2 days. Significantly decreased appetite for 1 month.
Patient had fever, chills, shaking, slight chest pain. Also experienced numbness, redness & pain at injection site. Currently there is a little bit of redness and pain in the morning.
pt states that she developed chills and fever.  She called her PCP and was recommended to get the Covid test which was negative.  Pt states she had a sore lump on her throat and her PCP swabbed her but did not have any infection.  She had lab work.  On 4/29/21 she developed jaundice.  She went to her PCP the next day and they reviewed her lab work.  Her liver enzymes were in the 1700's and other lab numbers were off.  She had a liver scan which showed she did not have hepatitis.  She was then referred to a gastro doctor.  She was not able to get in until June.  On 5/14/21 she was continuing to decline due to her symptoms so was taken to the Medical Center.  She was admitted and stayed until 5/21/21.  She was studied and had multiple test and then had biopsy of the liver through her jugular vein.  Diagnosed w/ autoimmune hepatitis.  She was treated in the ER on 5/28 /21 because she was having confusion which was from the high liver enzymes and still having nausea and vomiting.  They were able to stabilize her.  She was told that her condition was from taking the J&J vaccine.  She is still being treated and may possibly need a liver transplant. She has been taking prednisone and now has diabetes from this treatment.  She is presently seeing a Dr at the Medical Center for the liver transplant and a hepatologist. She wants to contribute to research.
No AE/PQC reported; temperature excursion; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 10-JUN-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) for prophylaxis (lot # T027112 was verified to be valid, expiration date reported and established as 07-FEB-2022), (dose, frequency, route and site of administration were not provided).  The administered dose of vaccine experienced a temperature excursion of 6 to 14 Fahrenheit degrees (F) (10 F) for 7 hours. There was also a previous temperature excursion of 6 F to 14 F (6.10 F) for 1 hour and 30 minutes. It was reported that the excursion occurred on 01-JUN-2021. The Digital Data Logger was not involved. The outcome, action taken and the causality assessment were not provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA000296: US-009507513-2106USA008058: US-009507513-2106USA008067: US-009507513-2107USA000174:
Report A0370603A describes the occurrence of arm pain and paresthesias in a 22 year old female who received hep A vaccine inactivated. The subject had no relevant history, concurrent medical conditions, or concurrent medications. The vaccinee had no history of relevant allergies. The subject indicated the use of alcohol. On 6/3/02 at 11:00, the vaccinee received her first injection of Havrix into her left deltoid. Within one hour, she experienced "severe" left arm pain accompanied by paresthesia; the pain radiated to the jaw. Her pain worsened with movement and increased progressively during the day of the injection, prompting her to seek medical attention at an urgent care facility that evening. Upon evaluation at the urgent care facility, the vaccinee also reported abdominal pain and nausea. On physical examination, the physician noted, "questionable swelling on the upper arm near the injection site" with one centimeter of induration. In addition, the physician noted decreased two-point discrimination in the left arm and decreased left handgrip strength. The physician also noted right lower quadrant tenderness. The vaccinee was referred to a neurologist.
Itchy rash at time of injection; Small patches of hives all over my body that come and go. Usually on ''my'' neck, face, thighs, and wrist.; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 12Aug2021 at 15:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 12Aug2021 at 17:00, the patient experienced Itchy rash at time of injection and had since gotten small patches of hives all over her body that come and go usually on her neck, face, thighs, and wrist. Usually, the patches occurred 1-3 times a day but changed locations. Nothing else had changed in her daily routine or products that would cause hives. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the event Itchy rash at time of injection, small patches of hives all over her body that come and go usually on her neck, face, thighs, and wrist was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a 36 year old white female who on 3/19/04 was vaccinated with the second dose of varicella virus vaccine live (lot number could not be provided). There was no concomitant medication. It was noted that the patient was receiving fertility treatments at the time of vaccination. The patient's LMP was 3/15/04. The patient became pregnant shortly after vaccination. unspecified medical attention was sought. There was no laboratory diagnostic studies performed. There was no product quality complaint. Follow up information received from the patient indicated that the patient was tested for varicella antibodies before vaccination with varicella virus vaccine live and the results were negative. The patient was not vaccinated for immigration purposes. The patient had no previous pregnancies. There was no local reaction at the vaccination site, no varicella symptoms post vaccination, and no herpes zoster (shingles) symptoms post vaccination. On 5/3/04, the patient had a spontaneous abortion. Additional information has been requested.
Information has been received from a nurse referring to an unspecified number of patients of unknown gender and age. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with doses of RECOMBIVAX HB (strength, dose, route, lot# and expiration date unknown), which were improperly stored. No adverse experiences had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
I had a sinus infection. I had two rounds of antibiotics. I had two virtual visits.
1 of 5 pts who were vaxed from the same lot# & exp an adverse event;pt recvd vax 8JUN & 9JUN c/o inc pain @ normally painful sites (i.e. knee, hip & lower back);pain treated w/APAP;recovered
constipation; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (constipation) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 003B21A) for COVID-19 vaccination.     Concomitant products included ONDANSETRON for Nausea, RIVAROXABAN (XARELTO), ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), DILTIAZEM HYDROCHLORIDE (CARTIA XT), CARVEDILOL, LISINOPRIL, GABAPENTIN and FAMOTIDINE for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 16-Mar-2021, the patient experienced CONSTIPATION (constipation). On 18-Mar-2021, CONSTIPATION (constipation) had resolved.            This case was linked to MOD-2021-085218 (E2B Linked Report).; Sender's Comments:  MOD-2021-085218:Second Dose Case
Chronic fever, heavy draining and chest congestion, skin reaction, persistent cough and fever still.
This spontaneous report was received from a pharmacist, concerning a male patient of an unknown age. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were unknown by the reporter. On an unspecified date, the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot #, expiration date, strength, dose, route of administration, and anatomical location were not provided), for prophylaxis. Then, after 3 weeks of the first dose administration, the patient received a second dose of PNEUMOVAX 23 (lot #, expiration date, strength, dose, route of administration, and anatomical location were not provided) for the same indication; which was considered as an inappropriate schedule of vaccine administration. It was also reported that an unspecified time after receiving PNEUMOVAX 23; the patient experienced arm soreness; so he sought medical attention and was seen by the pharmacist, but it was unknown if any treatment was given for the event. No laboratory diagnostics studies were performed. No product quality complaint (PQC) was involved. The outcome of the arm soreness was unknown. The causal relationship between the arm soreness and the PNEUMOVAX 23 was not provided.