chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Additional Details: Currently unsure on how many days symptoms will last due to having discovered error on day of reporting the event. Symptoms may last longer than the 1 day reported.
Left thigh injection site with 1.5cm bruise, firm nodule, no significant erythema. Swelling of thigh down to knee with decreased flex/ext 2hrs to swelling.
This spontaneous case report was received from a Licensed practical nurse regarding a patient of unknown age and gender. No concurrent conditions and medical history of the patient was reported. On an unknown date, the patient was vaccinated with dose 1 of GARDASIL 9 (lot number and expiration date unspecified) (strength, dosing regimen, frequency). On an unknown date, approximately 3-4 months after the first dose, the patient was again vaccinated with second dose of GARDASIL 9, (inappropriate schedule of vaccine administered). No adverse event was reported. The outcome of the event was unknown. No product quality complaint was reported. Additional information has been requested.
Child received IPV on 9/14/00 and on 9/15/00 he began having fevers to 104F, which fluctuated for 5 days before resolving. He then developed a diffuse erythematous, maculo-papular rash from head to toe (palms and soles involved). Treated with antipyretics. Seen in ER.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 28 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 23 months old child patient of unknown gender. On 23-JUN-2014 the patient was vaccinated with a dose of PEDVIXHIB (dose and route were not reported, lot# J015437, expiration date 09-OCT-2016) that was improperly stored. No adverse effects were reported. This is the one of several reports received from the same reporter. Additional information is not expected.
This case was reported by a nurse via sales rep and described the occurrence of fever in an unspecified number of adult patients who received 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 fever and injection site pain. On an unknown date, the outcome of the fever was unknown and the outcome of the injection site pain was not reported. It was unknown if the reporter considered the fever and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per product indication. It was stated that, a few patients experienced fever (body temperature: less than 101 degree F) and other patients had pain at injection site. Some patients did not realize how much SHINGRIX would impact them. None of these events deterred receipt of second dose. Lab Comments: On unknown date, the body temperature was less than 101 degree F.
PATIENT GOT LIGHT HEADED AND PASSED OUT AFTER LEAVING THE PHARMACY AREA. PATIENT STATED HE HAD NOT EATEN OR DRANK ANYTHING PRIOR TO COMING IN TO RECEIVE THE VACCINATION. PATIENT WAS ALSO NERVOUS TO START WITH ABOUT RECEIVING THE VACCINE
multiple unspecified patients may have been administered improperly stored VARIVAX that was reconstitiued with properly stored sterile water diluent; no adverse events; This non valid spontaneous report was received from a nurse practitioner referring to multiple patients of unknown age or gender.  The patients' concurrent conditions, medical history or concomitant therapies were not reported.   On unknown dates, the patients were vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # S005079, expiration date on 19-FEB-2021; lot # N030571, expiration date on 31-OC-2019 and lot # R008393, expiration date on 20-MAR-2020 for prophylaxis (doses, routes or frequencies were not provided). The temperature or time frame range from 6°F to 14 °F (12.5 °F) for 21 hours, the nurse stated that other recent temperature excusions occurred as well, but did not have additional information at the reporting time. There was no previous temperature excursions. There was involved a data logger issue. No adverse events were present. The vaccine was reconstituted with properly stored sterile water diluent lo# R003740, expiration date on 23-SEP-2020.
felt like injection was given too high on her arm too close to shoulder joint; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (felt like injection was given too high on her arm too close to shoulder joint) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (felt like injection was given too high on her arm too close to shoulder joint). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (felt like injection was given too high on her arm too close to shoulder joint) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by the reporter. No treatment medication were provided by the reporter.
small hives that are like mosquito bites; Rash; second dose, she developed a rash on site of injection and on her forearm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (small hives that are like mosquito bites), RASH (Rash) and VACCINATION SITE RASH (second dose, she developed a rash on site of injection and on her forearm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (small hives that are like mosquito bites), RASH (Rash) and VACCINATION SITE RASH (second dose, she developed a rash on site of injection and on her forearm). At the time of the report, URTICARIA (small hives that are like mosquito bites), RASH (Rash) and VACCINATION SITE RASH (second dose, she developed a rash on site of injection and on her forearm) outcome was unknown.            No treatment medications provided  No concomitant medications provided
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE STROKE DUE TO OCCLUSION OF LEFT MIDDLE CEREBRAL ARTERY ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
Patient received the vaccine Wednesday June 30th, and woke up Thursday July 1st with a fever. He called to let us know about his fever on Monday July 5th and said it persisted through the weekend.
STABLE ANGINA 12/27/2022,  12/1/2022, 12/6/2022,  11/30/2022, 2/14/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Given Enoxaparin &  Pepcid; no other covid studied medications at this time
feeling exhausted the day after the shivering stopped; the shivering lasted for about 4 hours; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 73-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th October 2020, the patient received FluLaval Tetra 2020-2021 season (intramuscular) and Flulaval Tetra Pre-Filled Syringe Device. In October 2020, 48 hrs after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced shivering and exhaustion. On an unknown date, the outcome of the shivering and exhaustion were recovered/resolved.   It was unknown if the reporter considered the shivering and exhaustion to be related to FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient had reported the case for himself. The patient had a reaction 48 hours after receiving vaccine on 9th October 2020, shivering lasted for about 4 hours and felt exhausted was stopped the day after the shivering stopped. The reporter did not consent to follow-up.
He took the first Pfizer Covid-19 Shot and he developed blood clots from those shots; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: Unknown, Expiration date: Unknown), via an unspecified route of administration in Mar2021 as dose 1, single for COVID-19 immunization. It was not known that how many doses of BNT162B2 was administered to the patient. The patient's medical history and concomitant medications were not reported. The patient took the first pfizer COVID-19 shot and developed blood clots from those shots in 2021. The outcome of the event was unknown at the time of report.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Pain and area of redness over the skin at the site of injection 7 1/2 x 4 cm. No further reported problems as of 5/26/09.
noticed tenderness in armpit area when laying down in early morning of 10/31/21 and noted swelling and tenderness in armpit in comparison to other armpit.  Symptom is ongoing at present.
Severe pain and swell in left calf muscle one day after second Pfizer vaccine. Had extensive ultasound and CAT scan tests
At site of injection: redness of skin about 2 inches in diameter lasting 4 days, swelling, soreness decreasing in severity over the days until 6 days after injection. Fever 99.5 degrees and fatigue for 24 hours after injection.
Patient developed signs of syncope about 5 minutes after vaccine given - 7:50 dose and 7:55am she felt warm, dizzy and had blurry vision and a dry throat.  We supplied ice packs and she felt symptoms subside by 8:11am.  At 8:18am she felt a wave of symptoms back and had an itchy throat - she was given 50mg of oral benadryl and felt better - leaving the pharmacy with her husband at 835am.  I called patient at 1:18pm 3/14/21 and she had just gotten home from the ER where she was treated with iv fluids, benadyrl and steroids per husband
Patient states severe pain at injection site and excessive swelling throughout upper left arm within 24 hours of vaccination.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 25-FEB-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Adverse event: Experienced Bell's Palsy on right side of face starting on 9/28 after taking 2nd shot of Pfizer on 9/21/21.  Previous to 9/28 woke up during the night (1 night) with severe cold sweats thru body Blood work and CAT Scan done on head on 10/4 Adverse event lasted 3 weeks PCP doctor did not prescribe any treatment except to do blood work and have a CAT scan done which did not show any signs of stroke After 3 weeks symptoms of Bell's palsy started to clear and have since gone away
Woke up the following morning with a headache, fever, body aches, stomach ache
Patient Received Moderna Bivalent Booster dose given as vaccine #1 in Primary Series Rather than the Bivalent dose designated For Primary Series
PATIENT REPORTED HIVES OVER BODY STARTING SECOND DAY AFTER VACCINATION, WAS TREATED BY PRIMARY CARE AND PROVIDED A STEROID REGIMEN. REDNESS REDUCED/GONE BY 2ND DAY OF STEROID TREATMENT, BUMPS REMAINED FOR AN ADDITIONAL 5 DAYS
Information has been received from a registered pharmacist concerning an 80 year old female who was vaccinated with pneuomococcal 23v polysaccharide vaccine.  On 10/26/2004 the patient came into the pharmacy complaining of swelling at the injection site.  Unspecified medical attention was sought.  No product quality complaint involved.  Additional information has been requested.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 injection, lot# L014420, expiry date 23-FEB-2017 (dose, route of administration and anatomical location were not specified). On an unknown date, the administered doses of PNEUMOVAX 23 underwent temperature excursion at 32.4 Fahrenheit degrees for 1 hour. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PCQ) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Noted redness and swelling on left ventro gluteus area day after immunization was given. Keflex 250/g 3/4 tsp x Qua x 7 days.  Benadryl 17.5/5 1 1/4 T po Q6 degree PRN itching. Last seen by MD 2-2-06 reaction better.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 1:28 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 1:28 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's age was reported as 75.47 years.  No concomitant medications were reported.  Batch number 022M20A administered on 17-Feb-2021 underwent temperature excursion with temperature of 20 degrees Fahrenheit at 08: 00 am and 22 degrees Fahrenheit at 09:00 am.  Number of vials sent to clinic were 6. Out of which 1 vial was moved to fridge on 09-Feb-2021 and beyond use date for these vials was reported as 10-Mar-2021. Remaining 5 vials were moved to fridge on 11-Feb-2021 and beyond use date for these vials was reported as 13-Mar-2021. Products were moved to clinic on 17-Feb-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
not feeling well; This is a spontaneous report from a contactable consumer. An unknown gender patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on 13Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On 14Apr2021, well within 24 hours of the vaccination, the patient was not feeling well. It was unknown whether therapeutic measures were taken as a result of the event. The clinical outcome of the event not feeling well was unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
lt MLT is hot to touch w/red, splotchy area on inner thigh about 2 inches from inject site; thigh appears to have local edema; mom says temp @ day care was almost 101; advised APAP & cool compresses-see MD if no improvement;
The patient was diagnosed with a rotator cuff injury after receiving the flu shot. He noticed pain immediately after receiving the shot.
COMPLAINED OF A SORNESS TO SCAPULAR AREA ON LEFT SIDE OF BACK AND SHOULDER WITHIN 8 HOURS OF VACCINE, LASTING ABOUT 2 DAYS
Redness, swelling for 1-2 hours after vaccination. Swelling 8 inches x 4 inches 24 hours later. Flu-like symptoms, chills, tired, no fever.
Chills; Muscle aches; Fever; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received second dose on bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration, administered in the left arm on an unspecified date at 10:00 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 on an unspecified date at 14:05, via unspecified route of administration in the left arm and experienced soreness at injection (Left arm) for covid-19 immunisation, and tested positive for covid-19 three days after receiving the vaccine. On an unspecified date about 12 hours after the second dose, the patient developed chills, muscle aches, and fever of 101.30 F. The events did not require emergency room visit or physician office visit. The patient recovered from  all the events on an unspecified date about 5hrs after they developed.      No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a Registered Nurse and refers to a multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, multiple unspecified patients received doses of improperly stored VAQTA (dose, route of administration , injection site, lot# and expiration date were not reported). Administered doses of VAQTA underwent temperature excursions at 47 Fahrenheit degrees, for unknown time frames. Information about the previous temperature excursions was not 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 has been requested.
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Patient came with her mother to get first shot of COVID vaccine. Mother recieved vaccine,  followed by daughter. Shortly after receiving vaccine, pt started becoming lightheaded, wanted to sit down. Pt sat in chair, mother gave her water to drink. Within a minute or less, patient started to become unresponsive/stop breathing and went to the floor. I ran, grabbed, and immediatiely administered an Epipen dose x1. Patient immediately became responsive and started to breathe again. 911 called.
She got her vaccine, had a little pain at the injection site  but nothing unusual.  Then a couple of days later has had multiple joint pains, and has had osteoarthritis for years, but has never had this much pain in this many joints at the same time.  The worst is shoulder, wrist, thumbs and some fingers, as well as hips and knees.  Called her Dr. on Monday who prescribed Meloxicam for this, and has not alleviated the symptoms.
6"x4" red rash on left arm started tracing on day day after vaccine and still on day 5 spreading daily.  Rash is not raised but warm to the touch and red, very tender to the touch
Information has been received from a physician concerning a 13 year old female who at time of vaccination with unspecified sickness was vaccinated with a dose of GARDASIL (LOT# not reported, duration and dose not reported). Secondary suspect vaccination included PNEUMOVAX 23 (duration and dose not reported) and another unspecified vaccine. It was reported that the patient was "already sick" at the time of vaccination and went to the office for a check up and was administered the vaccinations. After receiving vaccinations, the patient experienced muscle achiness and soreness. At the time of the report it was reported that the patient was recovering. No further adverse event information provided at this time of report. No further information is available.
17NOV92 pt had sweats, woke up w/sore neck & 1/2" nodule present near clavicle; sharp pain in lt neck area, numbness lt neck face & lt arm; went to ER for help; 20NOV nodules appeared on lt lymph area @ neck; inc weakness & h/a;
Very bad Chills ans shaking first night. Nausea day 2 and 3. Normal on day 4. Severe diarhhea days 5 and 6 along with all over body aches.  Unable to eat due to nausea days 6-8,  Day 7 severe nausea, body aches with uncontrollable shaking all night,  Entire body of nerve  in excruciating pain.  Day 8 (today) Felt like I needed to go to the ER last night.  Can't go to work.  In bed all day with continued bouts of chills and shaking.  Fever has been low grade or none during all this.