chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain; whole elbow pain; whole right arm had pain; losing sensation; I have lost use of my right arm where I was injected; This is a spontaneous report from a contactable consumer (patient). This 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204), via an unspecified route of administration in Arm Right on 15Mar2021 (at the age of 64-year-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history and concomitant medications reported as unspecified. The patient stated she was having very difficult time in understanding you, is there somebody that, she can be able to speak with, she didn't need medical guidance, she needed to speak with someone regarding Pfizer vaccine side effect that she had, since she received Pfizer Covid19 vaccine. She had no questions, she needed to report side effect (very bad side effects) that she has already been diagnose by three doctors. Patient added she was not comfortable, it was that they were not able to communicate because she cannot understand what you are saying, so she needed anybody else to speak with. Patient stated she was not at this time although she received a Norfloxacin because of the pain for the side effect that she had, no, she just had whole elbow pain, her whole right arm had pain, she was losing sensation, it was very detailed and very, patient did not know how to describe it to you but basically she had lost use of her right arm (confirmed as anatomical site of administration), where she was injected. Start date of adverse events was 19Mar2021. Patient stated that she did not need for help unless she spoke with someone that can help her with the side effects and help in find that what she was able to deal with her right arm since the vaccine. Outcome of events was unknown.   Follow-up attempts are completed. No further information is expected.
One day post vax pt experienced tenderness in right armpit that resolved within one day. Six days post vax the tenderness returned, the next day right arm very tender, numbness in right arm, thumb and finger tips.
On 2/15/2012, took first vaccine and ther was some pain for cople of days. On 3/8/2021, took second vaccine; there were soreness and pain.  Visit doctor office on 3/24/2021, Doctor stated, arm was swollened, some tenderness and she subjected heating pad.  No medication was prescribed. As of today, my arm still in pain and mobility is weak.  Hurts to rise arm upwards.
felt tired; injection site arm hurt.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tired) and VACCINATION SITE PAIN (injection site arm hurt.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (felt tired) and VACCINATION SITE PAIN (injection site arm hurt.). At the time of the report, FATIGUE (felt tired) and VACCINATION SITE PAIN (injection site arm hurt.) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was unknown.    This case was linked to MOD-2021-339171 (Patient Link).   Reporter did not allow further contact
Ringing in the ears, Tinnitus.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Feb2021 14:45 (Lot number: EN6203) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Inflammatory Bowel Disease" (unspecified if ongoing); "AFIB" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset 08Mar2021 08:30, outcome "not recovered", described as "Ringing in the ears, Tinnitus.". The event "ringing in the ears, tinnitus." was evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus.  No follow-up attempts are needed. No further information is expected.
No additional AE reported; The RECOMBIVAX HB was administered on 03JAN2022 and expired on 04NOV2021; This spontaneous report was received from a medical assistant and refers to an 8-week-old male patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 03-JAN-2022, the patient was vaccinated with an expired hepatitis b vaccine (recombinant) (RECOMBIVAX HB), lot #S002770, expiration date: 04-NOV-2021, administered for prophylaxis (strength, dose, and route of administration were not provided) (expired product administered). No additional adverse event was reported (no adverse event).
states she saw a red ring around the injection site on 4/2/2021 on the LEFT upper arm.  She did not report to a doctor, however she will continue to watch it, she has not used any therapy or medications . 4/3-contacted  the patient , color is fading , pain subsiding , no new symptoms .
This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 23-MAR-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) 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.; Sender's Comments: US-009507513-1802USA001558:
Swelling of Right shoulder to elbow; itching and painful; no rash or blisters; took Benadryl on 11/23/2010 swelling resolved on 11/27.
This spontaneous report was received from a pharmacist concerning him/herself, a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications were not provided. On 02-DEC-2016, the pharmacist was administering a dose of ZOSTAVAX Lot # reported: M020921, expiration date 12-JUL-2016 (strength, dose and route were not reported) to an unspecified patient (case # 1612USA001749). The reporter stated that approximately half of the vaccine leaked out of a faulty syringe onto the pharmacist arm. No adverse effects were reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA001749:
Left upper arm erythematous 4 inch area with 3 inch induration. Warm to touch. No history of fevers. No medication. Pt in office for routine physical. Given DTaP 9/13/04.
No other adverse event reported; HBP calling to report a temperature excursion on PROQUAD, MMR II and VARIVAX; This spontaneous report was received from an other health professional referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 10-SEP-2020, the patient was vaccinated with improperly stored dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 1 dosage form, lot number S027465, expiration date 02-MAR-2021 (route of administration not provided) for prophylaxis. No other adverse event was reported.  This is 1 of 2 cases reported by the same reporter; Sender's Comments:  US-009507513-2012USA001539:
Seen 11/18/01 with progressive lower extremity weakness. By 11/30/01 could not move lower extremities: had loss of reflexes. Sent to ED where diagnostic work up began. Diagnosis of Guillain-Barre Syndrome ultimately made. Per 1 year follow up: Pt recovered. Done well with therapy time.
Was not feeling well enough to go; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date, 1st dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient missed her second dose of the COVID-19 vaccine, which was due on 10May2021, because she woke up in the morning and was not feeling well enough to go. The patient did not specify symptoms but stated that she felt it was not related to the vaccine. The patient asked if the second dose of the vaccine has to be given at the same vaccination site as the first dose. The outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information in the case report, A causal relationship between reported event and suspect drug BNT162B2 cannot be excluded.
After the first shot, diarrhea became an issue. It was controlled with Imodium prior to the second shot. After the second shot, diarrhea and abdominal cramps became debilitating. I eventually had to have a colonoscopy with showed inflammation and ulcers, and the biopsies came back positive for Crohn's Disease. I have never had a digestive system issue in my life prior to this.
A few chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (A few chills) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced CHILLS (A few chills). At the time of the report, CHILLS (A few chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use included arthritis medication and high blood pressure medication. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up received on 12-May-2021 and does not contain any new information.
She drops things; Kind of a headache; Felt tired for the first couple of days; Got tinnitus, can only hear whistles and noise; Shaking, hands are shaking / hand shaking; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Got tinnitus, can only hear whistles and noise), TREMOR (Shaking, hands are shaking / hand shaking), GRIP STRENGTH DECREASED (She drops things), HEADACHE (Kind of a headache) and FATIGUE (Felt tired for the first couple of days) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic.    On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, the patient experienced TREMOR (Shaking, hands are shaking / hand shaking). On 27-Aug-2021, the patient experienced TINNITUS (Got tinnitus, can only hear whistles and noise). On an unknown date, the patient experienced GRIP STRENGTH DECREASED (She drops things), HEADACHE (Kind of a headache) and FATIGUE (Felt tired for the first couple of days). At the time of the report, TINNITUS (Got tinnitus, can only hear whistles and noise), TREMOR (Shaking, hands are shaking / hand shaking), GRIP STRENGTH DECREASED (She drops things), HEADACHE (Kind of a headache) and FATIGUE (Felt tired for the first couple of days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Aug-2021, Blood pressure measurement: increased (High) Blood pressure increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not take any medication for the adverse events and does not take any concomitant medications.   Most recent FOLLOW-UP information incorporated above includes: On 05-Sep-2021: Patient medical history and lab data were added. Event verbatim was changed and hand shaking event date was added.
Infected with COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Infected with COVID) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Infected with COVID). At the time of the report, COVID-19 (Infected with COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) Infected with COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.  No Treatment information was reported.
I developed shingles on my left side of lower belly. I went to urgent care on 7/16/2021. The doctor gave me the following medication: HYDROcodone-acetaminophen, predniSONE, valACYclovir. I recovered after 10 days.
1 week following vaccination, vaccine site in right deltoid bright red, hot to touch, swollen, firm to touch; red spot appeared lower on same arm to left, then red line connected the spots.   Redness continued down arm as time went on .  Line drawn around redness ended up shaped like state of Florida, next morning redness and swelling went over right bicep, past line drawn.  Today, Sunday, 2/ 7, redness is fading and swelling/firmness is reducing.  Looks like "COVID ARM" as described on news.
Nurse calling for TE evaluation on frozen products states products have been administered.; No additional AE details.; This spontaneous report has been received from a nurse, concerning an unknown age and gender patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On an unknown date, the patient was administered vaccine measles, mumps, rubella, and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHa) (PROQUAD) subcutaneous injection (valid lot number W004029 [expiration date 02-AUG-2023]) (dose, vaccination scheme, and frequency were not provided) for prophylaxis, and sterile diluent (dose, vaccination scheme, frequency, lot number, expiration date were not provided), after a temperature excursion of 6 degrees Fahrenheit (F) up to 14 degrees F (8F) for 0 hours (h), 18 minutes (min) and 0 seconds (sec), 14 F up to 46 F (18.40F) for 0 h, 45 min, 0 sec (product storage error). No previous temperature excursion was reported.   No additional adverse event (AE) details.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA002231: US-009507513-2206USA002184: US-009507513-2206USA002208: US-009507513-2206USA002264: US-009507513-2206USA002249: US-009507513-2206USA002383: US-009507513-2206USA002264:
Initial report received on 6/6/06 from a health care professional. An 18 year old female pt, with no past medical history, had received an injection of Menactra, lot number unknown, on 2/15/06. Route and site of administration were not reported. It was determined that the pt was pregnant at the time of vaccination. The pts last menstrual period was 12/25/05, and her estimated date of delivery is 10/01/06. The pt had no prior pregnancies. The pt had two ultrasounds in order to determine gestational age that showed normal 20 weeks. Per the reporter, there was no adverse event. Follow up information received on 6/30/06. Per the reporter, the lot number for Menactra was 61656AC and it was given IM on 2/15/06. This was the first dose of Menactra the pt had received. It was not known that the pt was pregnant at the time of the vaccination with Menactra. The pregnancy was confirmed at the later date. The pt was originally evaluated in the physicians office on 2/15/06 for breast tenderness after cheerleader cheerleader practice. The date of the pts last menstrual period was reported as 12/05. The expected date of delivery was not reported. An ultrasound was completed on 6/27/06 at 20 weeks gestation revealing that the fetus had a mild ventriculomegaly versus hydrocephalus. Per the reporter, the pt (the mother) has not experienced any adverse events. Follow up information received on 8/4/06. Per the reporter, the mother , who is the pt, was hospitalized for an episode of pyelonephritis. The date of hospitalization was not reported. The pt was treated in the hospital with IV antibiotics and placed on Macrodantin by mouth on 6/26/06. The Macrodantin will be continued throughout the remainder of the pregnancy. The pt was also started on Wellbutrin XL for depression on 6/26/06. The pt was treated with IV Fe Iron for severe chronic anemia. The date the pt was treated with tin IV iron was not reported. An alpha feto protein test was normal on 5/5/06. Per the reporter, the pt also had an ultrasound done on 6/1/06, but the result were not reported. Another ultrasound was completed on 7/5/06 that showed the fetus to have hydrocephalus. The patient had an amniocentesis on 7/25/06, and the result was pending at the time of this report. The pts expected date of delivery was reported as 10/21/06. After medical review of this new information, and the pts hospitalization, this case has been upgraded to serious (OMIC). The information regarding the fetus is reported in case 200601628 (Serious case).
"70 yo wo/man presents for COVID vaccination reaction Began with rash at injection site and on front anterior neckline on 2/18/21. Patient reports tenderness at L upper arm (site of injection)."
This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Concurrent medical conditions included cancer (terminal cancer). On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced shingles and product supply issue. On an unknown date, the outcome of the shingles and product supply issue were unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The patient had two children and a wife. The patient was due for booster dose of SHINGRIX which was suddenly stopped supplying 3 months ago. The patient had a rare terminal cancer and one side effect of the experimental treatments was to contract and spread shingles to other people. The reporter said that since SHINGRIX had been approved, there were an extraordinary amount of demand from patients and healthcare professionals. Due to the remarkably high demand. Hence this vaccine would be temporarily out of stock. If the patient didn't received 2nd dose of SHINGRIX vaccine, this could probably cause a shingles epidemic. The patient reported to representative, this would become dangerous and anyone he come into contact with. The representative suggested to the patient to take suggestion from healthcare physician on how to continue the SHINGRIX series. Individual medical guidance should be provided by medical professionals. The representative provided FDA approval schedule to the patient. 1st dose of SHINGRIX should be at month 0, followed by a second dose 2 to 6 months after the first dose. If the patient was more than 6 months since the first dose, he or she should get the second dose a soon as possible and the patient did not need to restart the vaccine series. The patient suggested to the representative action on it as soon as possible. The experimental treatments the patient had been getting had decimated his immune system and while reporting the patient was already started getting outbreaks of shingles which the vaccine supposed to control. Without the second and final shot the patient might infect anyone who came into contact with him.
Developed adverse symptoms including chills, aching muscles, nausea, listlessness and fatigue within eight hours, and these lasted approximately 36 hours.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of an unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored of RECOMBIVAX HB (dose, lot #, expiration date and route of administration were not reported). There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
got my first shingle shot on the 24th of June and now I have shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 24th June 2021, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a month after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for himself or herself. The age at vaccination was not reported. The patient reported that, he or she received the Shingles vaccine on 24th June and now had a shingles. No further information was reported.
Fast heart rate; body aches; couldn't sleep; chills; Nausea; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heart rate), PAIN (body aches), INSOMNIA (couldn't sleep), CHILLS (chills) and NAUSEA (Nausea) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K202A KJ) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Had it bad).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced HEART RATE INCREASED (Fast heart rate), PAIN (body aches), INSOMNIA (couldn't sleep), CHILLS (chills), NAUSEA (Nausea) and HEADACHE (bad headache). On 06-Jan-2021, HEART RATE INCREASED (Fast heart rate), PAIN (body aches), INSOMNIA (couldn't sleep), CHILLS (chills), NAUSEA (Nausea) and HEADACHE (bad headache) 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.   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.; 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.