chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe migraines severe pain in arm numbness in arm where shot was given irritability loss of sleep loss of appetite weight loss emotional stress anxiety
This spontaneous report was received from a nurse (L.P.N.) refers to unspecified patients. The patients were vaccinated with improperly stored GARDASIL. It was reported that the first excursion occurred in May, 2011 were GARDASIL were exposed to 31 F for 4 hours and the second excursion occurred on 29-MAY-2012, where GARDASIL were exposed to 30F for 12 hours. No adverse effects reported. This is one of several reports received from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Severe flare ups in joints are 24 hours of second dose causing me to not be able to work
When the covid liquid went in it hurt very bad; took the needle out there was blood coming out of the needle site; urse gave him the shot she put the needle half way in then stopped and repositioned her hand to then put the needle in the rest of the way but angled it upwards.; This is a spontaneous report from a contactable consumer (patient, reported for self).  A 64-year-old (non pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number and Expiration date: UNKNOWN), via an unspecified route of administration on 05Mar2021 at 13:00 as a single dose for COVID-19 immunisation. Lot unknown rea-son: Unable to locate or read the details. Patient did not receive other vaccine in four weeks. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post  vaccination was none. The patient's medical history and concomitant medications were not reported. No COVID prior vaccination.   On 05Mar2021 at 13:00, the patient reported to have received the vaccine while sitting in the car. Patient pulled his left shirt sleeve high but it made his upper arm tight and bunched up. When the nurse gave him the shot she put the needle half way in then stopped and repositioned her hand to then put the needle in the rest of the way but angled it upwards. Patient reported that when the COVID liquid went in it hurt very bad. The shot was given in his left arm about 4 fingers from the boney part of the patient shoulder. When she (nurse) took the needle out there was blood coming out of the needle site. Patient was wondering if the shot went into his deltoid muscle or into the subcutaneous part of the arm. Enquired whether the vaccine was still effective if it had not gone into the muscle.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Could not feel her arm and leg; Not able to walk; This is a spontaneous report from a contactable consumer (patient). A 27-years-old female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. A couple hours after taking the Pfizer COVID-19 vaccine, the patient could not feel her arm and leg and was not able to walk. After an hour, she felt better and did not experience that feeling in her leg anymore. Outcome of both the events was recovered on an unknown date.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Temperature of 100.2; Legs hurting; Chills; Legs were little swollen; Legs hurting; Legs felt funny; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Legs were little swollen), PAIN IN EXTREMITY (Legs hurting), LIMB DISCOMFORT (Legs felt funny), PYREXIA (Temperature of 100.2) and MYALGIA (Legs hurting) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]), AMLODIPINE, CARVEDILOL, CETIRIZINE HYDROCHLORIDE, SIMVASTATIN, MONTELUKAST SODIUM (SINGULAIR), SOLIFENACIN SUCCINATE (VESICARE), CALCIUM, VITAMIN D3, ESTRADIOL, LANSOPRAZOLE (PREVACID), VITAMIN C [ASCORBIC ACID] and ZINC for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced PERIPHERAL SWELLING (Legs were little swollen), PAIN IN EXTREMITY (Legs hurting), LIMB DISCOMFORT (Legs felt funny), MYALGIA (Legs hurting) and CHILLS (Chills). On an unknown date, the patient experienced PYREXIA (Temperature of 100.2). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 28-Apr-2021, PERIPHERAL SWELLING (Legs were little swollen), PAIN IN EXTREMITY (Legs hurting), MYALGIA (Legs hurting) and CHILLS (Chills) had resolved. At the time of the report, LIMB DISCOMFORT (Legs felt funny) and PYREXIA (Temperature of 100.2) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Body temperature: 101.2 (High) 101.2.         This case was linked to MOD-2021-091976 (Patient Link).
Received DTAP and Prevnar in left thigh. About 24 hours later, developed redness and swelling. No fever. On exam, pt afebrile. There is a 5cm X 9cm area of induration and erythema. No pain, tenderness, drainage or fluctuance. Treat symptomatically with cool compresses and Tylenol prn.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 2nd March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported case for herself. The patient received SHINGRIX in an unknown arm. The patient experienced pain in her arm at site of injection. For tolerance after 2nd dose refer US2018110582.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6202), on 01Apr2021 as dose 2, single (Lot number: Ep6955) and on 18Nov2021 as dose 3 (booster), single (Lot number: Ff2506) at the age of 62 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SYNTHROID. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 08Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Unknown Result. Therapeutic measures were taken as a result of vaccination failure, suspected covid-19.  Clinical Course: The patient had no known allergies, had a treatment with Paxlovid from 01Jun2022 to 05Jun2022.  No follow-up attempts are possible. No further information expected.
Vertebral artery dissection on V3 resulting in stroke; Vertebral artery dissection on V3 resulting in stroke; Booster; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 44-year-old male patient received BNT162B2 (COMIRNATY), administered in arm left, administration date 08Nov2021 (Lot number: FG3527) at the age of 44 years as dose 3 (booster), single for COVID-19 immunization. The patient's relevant medical history was not reported. Concomitant medication included: FLU taken for immunisation, administration date 23Oct2021. Vaccination history included: Comirnaty (DOSE 1; Lot Number: ER8734; left arm), administration date: 10Apr2021; Comirnaty (DOSE 2; Lot Number: EW0167; left arm), administration date: 02May2021; both when the patient was 43 years old for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior vaccination. The patient was administered with another vaccine in four weeks. The Pfizer vaccine was administered in a hospital facility. The following information was reported: IMMUNISATION (hospitalization) with onset 08Nov2021, outcome "unknown", described as "Booster"; VERTEBRAL ARTERY DISSECTION (hospitalization), CEREBROVASCULAR ACCIDENT (hospitalization) all with onset 11Nov2021, outcome "recovering" and all described as "Vertebral artery dissection on V3 resulting in stroke". The patient was hospitalized for all events (hospitalization duration: 4 days). The event "Vertebral artery dissection on v3 resulting in stroke" was evaluated at the physician office visit and emergency room visit. The patient has been tested for COVID-19 post vaccination. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Nov2021) negative. Therapeutic measures were taken as a result of vertebral artery dissection and cerebrovascular accident which included acetylsalicylic acid (ASPIRIN) and atorvastatin medications.  No follow-up attempts are possible. No further information is expected.  Follow-up (10Jan2022): Follow-up attempts are completed. No further information is expected.
Fever/ chills, headache, muscle aches, fatigue, nonproductive cough.
Swelling, redness heat around injection site, swelling of upper arm 2x size, hives on back, nausea, diarrhea, airway swelling.  Went to ER, Benadryl taken after shot. Upon arrival at ER, Pepcid, Decadron, Benadryl, Epi, Albuterol, repeat Benadryl, etc. 6-8 hour tx. Went home on high dose steroid pack 15 days.   9/11/19 trouble breathing, hives, upset stomach, albuterol and Benadryl worked, no hospital visit.   9/12/19, wheezing, tongue swelling, hives. Self medicated, Epi, albuterol, Benadryl. Ambulance transport to MedCenter. Pepcid, Decadron, repeat, etc. 6-8 stay?    9/29 facial, neck swelling with rash. GI upset, ER visit, Epi, Pepcid, Benadryl, Solumedrol. 4-5 hour hospital stay, placed on high dose steroid pack for 12 days.   10/7/19. Stopped antihistamine 10/5/19 to prepare for allergy testing. Swollen face, lips, hives, diarrhea. Took Zyrtec and Benadryl, so far, no ER visit.
Nearing the end of 15 minute observation period, patient began to experience palpitations, sweating and felt faint.  We moved patient to a private area and RN checked BP, (144/98) and reviewed issues with patient.  Patient then shared that she felt tingling in hands and arms.  She then recalled that she may have experienced this before but continued to feel unwell.  Two RN's continued monitoring of patient until EMS arrival in  <3 minutes and they proceeded to check BP again, (slightly higher) and blood sugar which was normal. They were on site for approximately 10 minutes evaluating and both EMS and patient confirmed that she was able to leave and did not need to visit hospital.
Swelling of injection site with expanding deep red hive-like rash; deep red hive-like rash; fever; Chills; Slight headache; Swollen lymph glands in armpit; Fatigue; General malaise; Arm rash is troublesome; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route on 20Mar2021 at 1330 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patient medical history included irritant induced asthma, latex allergy, myalgic encephalomyelitis (chronic fatigue syndrome), hypothyroidism and alpha gal allergy. Concomitant medications included ambien (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), liothyronine (MANUFACTURER UNKNOWN) and b12 tablets (MANUFACTURER UNKNOWN), all taken for unknown indications from unknown dates. The patient was allergic to latex, sulfa medicines and beef. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route on 27Feb2021 at 1730 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Mar2021, the patient experienced swelling of injection site with expanding deep red hive-like rash hot to touch, grew 2 inches in size in 24 hours and getting bigger, fever of 101, chills, slight headache, swollen lymph glands in armpit, fatigue, general malaise and arm rash. It was reported that the patient took tylenol (MANUFACTURER UNKNOWN) for fever. No other treatment was taken for the events experienced. The clinical outcome of the events swelling of injection site, expanding deep red hive-like rash hot to touch, fever of 101, chills, slight headache, swollen lymph glands in armpit, fatigue, general malaise and arm rash was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Red rash at injection site, appeared 8 days after shot.  Very mild itchiness.   Typical "COVID arm" with Moderna vaccine, as far as I can tell.
Received flu vaccine in left deltoid & has persistent dull aching pain down to Lt elbow with limited ROM for over 2 wks. Has applied heat packs & is taking ADVIL. Rx for NAPROSYN given.
I started feeling fatigue about 2-3 hours after the shot. Body aches started about 5-6 hours after the shot. I feel feverish and have chills, but thermometer registers normal temperature. I am still experiencing all symptoms 8 hours after injection.
Chest wall pain (significant) - bilateral anterior and lateral Bilateral axillary lymphadenopathy with discomfort Numbness and tingling - started in the left arm initially but later became diffuse Above symptoms started about 5-6 days post second dose of vaccination and worsened over the next 2-3 months,  have continued to last through most of the year, although improved significantly past 7-8 months
maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in a 42-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use from July 2020 to August 2020. Concomitant products included LEVOTHYROXINE for Hypothyroidism, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 03-Aug-2020 and the estimated date of delivery was 17-May-2021. On 09-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy.  On 09-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Sep-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Blood glucose: normal (normal) Normal. On an unknown date, Ultrasound foetal: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 7-SEP-2020, the patient received a positive pregnancy test. 24-AUG-2020 was reported as estimated date of conception. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: Upon internal review on 19-Jul-2021, patient tab, event- coding, analysis tabs and regulatory reports were updated.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (my arm was bad) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 001A21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (my arm was bad). At the time of the report, PAIN IN EXTREMITY (my arm was bad) had resolved. Concomitant products and treatment information were not provided. Action taken with mRNA-1273 in response to the events was not applicable. This case was linked to MOD21-038530.
Vaccines didn't work for me/ Suspected vaccination failure; Vaccines didn't work for me; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Vaccines didn't work for me/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Vaccines didn't work for me). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-JUN-2023 This case was reported by a patient via interactive digital media. The patient reported that the vaccine did not work for him or her. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
This spontaneous report was received from a registered pharmacist refers to a patient of unknown age (gender unspecified). On 03-AUG-2012, the patient was vaccinated with second dose of GARDASIL, (lot number, expiry date and route was not reported). On 26-FEB-2013, the patient asked about the 3rd dose of GARDASIL which was late. The patient was not experiencing any known symptoms. Additional information is not expected.
Left arm is itching; vaccination site erythema; vaccination adverse reaction; vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Left arm is itching), VACCINATION SITE PAIN (vaccination site pain), VACCINATION SITE ERYTHEMA (vaccination site erythema) and VACCINATION COMPLICATION (vaccination adverse reaction) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol, Cellulitis, Asthma and Breast cancer since 1998. Concomitant products included ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) for High cholesterol.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain). On 15-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Left arm is itching), VACCINATION SITE ERYTHEMA (vaccination site erythema) and VACCINATION COMPLICATION (vaccination adverse reaction). At the time of the report, VACCINATION SITE PRURITUS (Left arm is itching), VACCINATION SITE PAIN (vaccination site pain), VACCINATION SITE ERYTHEMA (vaccination site erythema) and VACCINATION COMPLICATION (vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details was reported.       Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Non-Significant follow up
When I cough it was blood in that cough couple of times; Left leg swell up from my feet to all the way up; When I woke up, I didn't know what time, what date, nothing; I was all confused; Feeling achy/ body ache; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (Pfizer COVID vaccine), lot no. EL347, via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization at a health department because she was at high risk and she was 73. Medical history was not reported. Concomitant medications included unspecified medications. The patient had an injection done 2 weeks, not this last Friday, the Friday before that. They had to make her wait for half an hour before she left and she was okay. Then Saturday (23Jan2021), she started feeling achy but to she was okay. Then Sunday (24Jan2021), she had a very bad experience, she went and start watching TV and she fell asleep. When she woke up, she didn't know what time, what date, nothing. And she looked at the time on her TV and it said 6:45, she didn't know if it was am or pm. And it was dark outside and she didn't know if it was Monday or Sunday. She was all confused, she called someone to make sure what day and time and all and still she was still confused. And then she had to call her aunt and then she told her no it's Sunday and it's night time and so on. Then she got better. Then during the week she didn't have that much body ache, she expected that because that was in that papers. Then today is Sunday, Friday morning (29Jan2021) she got up and she coughed, when she coughed it was blood in that cough couple of times. Then her daughter came over and took her to the hospital (hospitalization details were not clarified). She had lab work the day they took her in the emergency room. At the hospital, they did all kind of tests, on top of that her leg, her left leg swelled up from her feet to all the way up, all the way up. They thought that it could have been some blood clot. And they took test and all and nothing, everything was okay. They couldn't find out why her whole leg was swollen. On top of that, they did chest x-ray and they did something else she can't remember, another test. And they took all kind of blood work and all. And they did to see if she had the virus, the COVID. And yesterday they called her from the hospital and they said that she didn't have the virus. And she asked them about the blood work and they told her if there was anything more than they would call her. So, she thinks all this came from that injection. She called because this was not guaranteed if this was from injection. When confirmed that COVID test was negative and blood work report was not out, she stated they haven't called her that meant her blood work was okay. The swollen leg has been gone down and blood once in a while she sees a little bit. They gave her 2 prescriptions, one was antibiotic and one is steroid. Due date for the next shot is 12Feb2021. The outcome of the events was recovering.
Temp 100.3 F, severe chills, body aches, mild headache, malaise. Minimal response to tylenol. Lasted about 8 hours
p/vax pt presented to MD w/swollen arm that was warm to the touch from elbow to fingers; tx ice & ROM as tolerated;