chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bleeding from the injection site immediately after the administration; This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a 30-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 33AT7, expiry date 7th November 2022) for prophylaxis.   On an unknown date, the patient received Boostrix (intramuscular). On an unknown date, immediately after receiving Boostrix, the patient experienced injection site hemorrhage. On an unknown date, the outcome of the injection site hemorrhage was unknown.   It was unknown if the reporter considered the injection site hemorrhage to be related to Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Boostrix on left deltoid and experienced bleeding from the injection site immediately after the administration. The reporter consented to follow up.
STOMACH CRAMPING; HEADACHE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the patient experienced stomach cramping. On APR-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and stomach cramping was not reported. This report was non-serious.
1.5 days after vaccination I became irritated and on edge. I began to feel a squeezing pain in my ribs and upper abdomen then vomited 3 times over the course of a few hours. The pain in my ribs was increasing so I went to the emergency room. I had ultrasounds and fluid, I showed higher than normal levels that show potential blood clots and the ultrasound came back as having liver damage which I have had no inclination of in the past.  The pain did not subside and I ended up back in the er the following day. Was given pain medication, nausea meds and more tests. Ultimately the ruling was unknown but with 25 years of having fibromyalgia I know my body very well and that was a very abnormal experience. As well, seeing the studies done regarding liver damage and vaccines I am extremely scared to attempt the second out of fear of liver failure. I then began my period over a week early, following a two week break. Another, and then a 6 week span. It was about 3 months before my cycle was normal.
injection site reaction, swelling and knotting even 6 days after injection. Losing feeling in right hand and tingling.
Diagnosed with Shingles; Rash on left buttock; Fatigue; Headache; Nausea; Difficult to walk because of the pain; intense sharp pain (pain scale of 7) on her buttocks that runs all the way down to her left leg, behind her left knee then on her left foot; Problem sitting down because of the pain on her left buttock; Blister on left buttock; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Difficult to walk because of the pain), PAIN IN EXTREMITY (intense sharp pain (pain scale of 7) on her buttocks that runs all the way down to her left leg, behind her left knee then on her left foot), MUSCULOSKELETAL PAIN (Problem sitting down because of the pain on her left buttock), BLISTER (Blister on left buttock) and HERPES ZOSTER (Diagnosed with Shingles) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy, Pollen allergy and Allergy to molds. Concomitant products included METFORMIN, VITAMIN D3, CETIRIZINE HYDROCHLORIDE (ZYRTEC R), FLUOXETINE HYDROCHLORIDE (PROZAC), ATORVASTATIN, LISINOPRIL, FISH OIL, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) and LEVOTHYROXINE for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced GAIT DISTURBANCE (Difficult to walk because of the pain), PAIN IN EXTREMITY (intense sharp pain (pain scale of 7) on her buttocks that runs all the way down to her left leg, behind her left knee then on her left foot), MUSCULOSKELETAL PAIN (Problem sitting down because of the pain on her left buttock), BLISTER (Blister on left buttock), RASH (Rash on left buttock), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea). On 30-Apr-2021, the patient experienced HERPES ZOSTER (Diagnosed with Shingles). At the time of the report, GAIT DISTURBANCE (Difficult to walk because of the pain), PAIN IN EXTREMITY (intense sharp pain (pain scale of 7) on her buttocks that runs all the way down to her left leg, behind her left knee then on her left foot), MUSCULOSKELETAL PAIN (Problem sitting down because of the pain on her left buttock), BLISTER (Blister on left buttock), HERPES ZOSTER (Diagnosed with Shingles), RASH (Rash on left buttock), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided
patient  received  dose of Moderna vaccine beyond  30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient  received  dose of Moderna vaccine beyond  30-day use by date) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient  received  dose of Moderna vaccine beyond  30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient  received  dose of Moderna vaccine beyond  30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  HCP reports vial was brought to clinic and placed in refrigerator of January 05, 2022.  Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 03-Mar-2022: Follow up contains No New Information.
patient received Pfizer vaccine.  At 1110, patient complained of "tingling and numbness" in left arm radiating to fingers. vss. o2 sat's stable. no redness or edema at injection site. at 1118, patient continues to complain of numbness and tingling. no shortness of breath. vss. at 1122, patient offered to go to ER for evaluation and patient refused. patient left and returned to work
You got the vaccine, and had no reactions to the vaccine, and it was close to 3 weeks later that he walked out of the house, went in the garage and all of a sudden his right ear was not working at all, that was 3/7/21.  He still has no hearing from the ear.  He has bad balance and afraid of falling down, dizziness when he tries to get up.  He called his doctor and he prescribed Methyl Prednisolone, and for him to call back today which he is waiting on him to call him back.
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age. The medical assistant reported that GARDASIL (MARRS# 1312USA002103), PNEUMOVAX 23 (MARRS# 1312USA005447), RECOMBIVAX (MARRS# 1312USA005448) and VAQTA were improperly stored. On unknown date unspecified patients vaccined with improperly stored RECOMBIVAX. No adverse effects reported. It was unknown if the patient had sought medical attention. This is one of four cases from the same reporter. Additional information has been requested. This is correction information. The LLT and PT of the primary event was recorded to Incorrect storage of drug.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 12 hours post puncture and after exposure to room temperature for more than 24 hours) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination. No Medical History information was reported. On 26-Jan-2022 at 12:25 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2022 at 12:25 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 12 hours post puncture and after exposure to room temperature for more than 24 hours). On 26-Jan-2022 at 12:25 PM, EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 12 hours post puncture and after exposure to room temperature for more than 24 hours) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The vial was initially stored in the refrigerator on 31-Dec-2021.The vial was first punctured on 25-Jan-2022 at 11:30 A.M and stored in RT (Refrigeration Tones). The vial was exposed to room temperature range (8 degree Celsius to 25 degree Celsius or 46 degree Fahrenheit to 77 degree Fahrenheit) for 24 hours and 55 minutes. The vial did not undergo any temperature excursions. Concomitant medications were not provided. Treatment information was not provided.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Aug-2021 at 9:38 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 16-Sep-2021 at 9:19 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On 16-Sep-2021 at 9:19 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 16-Sep-2021 at 9:19 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment information were not reported.   This case was linked to MOD-2021-405636 (Patient Link).
shingles-like symptoms, sensitivity left side of face and scalp. weeping eye. pain left orbital. lasting a few days.
one had a pain in the arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "one had a pain in the arm".  Follow-up attempts completed. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 30Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) positive, notes: Symptoms and positive test recurred about 5 days after end of Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Known allergies were reported as No. It was reported that the patient received Paxlovid from 09Jun2022 to 13Jun2022 as COVID-19 treatment. The patient experienced rebound Covid after treatment with Paxlovid. Symptoms and positive test recurred about 5 days after end of Paxlovid treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
given 0.5ml dose as booster - received first 2 doses of 0.5ml appropriately - dose of 0.5ml given 6 months later  (0.25ml indicated) Pt is good. No complaints. Arm just slightly sore as was with first 2 doses.
The day following my second vaccination I developed a twitch that quickly disappeared followed by a feeling of weakness in my left leg. The next day I began to feel weakness in my left arm. This weakness has not disappeared and makes it difficult for me to perform normal tasks. Walking up and down stairs is most difficult as it makes my leg feel extremely weak. Yesterday I began to develop a stiff and sore neck. Last Friday I went to my family physician and she referred me to a neurologist who I will be seeing on Thursday.
Pain in arm; headache; Tiredness; Numbness facial; Heart racing; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness facial), PALPITATIONS (Heart racing), PAIN IN EXTREMITY (Pain in arm ), HEADACHE (headache) and FATIGUE (Tiredness ) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (High Blood Pressure) and Depression. Concomitant products included PROPRANOLOL and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness facial) and PALPITATIONS (Heart racing). On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm ), HEADACHE (headache) and FATIGUE (Tiredness ). On 09-Mar-2021, HYPOAESTHESIA (Numbness facial) and PALPITATIONS (Heart racing) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in arm ), HEADACHE (headache) and FATIGUE (Tiredness ) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Blood pressure measurement: 155/100 (High) BP raised to 155/100.         No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow-up document contains  No New Information
Had severe cramping during menstrual cycle following administration. Menstrual cycle was 2 weeks late, also had large blood clots. Seems that everything did subside. No other changes in Med Hx except vaccination that would have contributed to adverse effects.
Tested positive 5 days after testing negative after taking the Paxlovid antiviral for 5 days; Tested positive 5 days after testing negative after taking the Paxlovid antiviral for 5 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: En6199), in left arm, on 24Mar2021 as dose 2, single (Lot number: Er2613), in left arm and on 18Sep2021 as dose 3 (booster), single (Lot number: Ff2589) at the age of 28 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Tested positive 5 days after testing negative after taking the Paxlovid antiviral for 5 days". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive 5 days after testing negative after taking the Paxlovid antiviral for 5 days; Negative, notes: Tested positive 5 days after testing negative after taking the Paxlovid antiviral for 5 days. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Paxlovid treatment received from 31Jul2022 to 04Aug2022 for covid-19. No known allergies were reported.
Nausea (18 hrs), vomiting (7 hours), diarrhea (24 hours), muscle cramps (24 hrs.), fever (24 hrs). Red, swollen injection site (4 days). Large, painful lump at injection site (5 days and counting...
cerebrovascular accident; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (age not provided). Information about the patient's concurrent condition, concomitant medication or medical history was not provided.  Approximately, on 08-JAN-2016, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage, route, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after, the patient suffered a cerebrovascular accident. As a direct and proximate result of her receipt of vaccination, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, and physical impairment and injury. At the time of the report, the patient had not recovered from the event, and the reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX) and disabling.  Upon internal review, the event of cerebrovascular accident was considered medically significant.
arm was sore; minor nasal drip; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore) and RHINORRHOEA (minor nasal drip) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included QUINAPRIL for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was sore) and RHINORRHOEA (minor nasal drip). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm was sore) and RHINORRHOEA (minor nasal drip) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
has received the entire Engerix B series / still tests negative for titer; This case was reported by a physician via call center representative and described the occurrence of therapy non-responder in a 48-year-old female patient who received HBV (Engerix B) (batch number 4EA77, expiry date 11th September 2022) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number 4EA77, expiry date 11th September 2022) for prophylaxis and HBV (Engerix B) (batch number 9X9ZT, expiry date 19th January 2020) for prophylaxis.   On 14th March 2021, the patient received the 3rd dose of Engerix B. On 14th October 2020, the patient received the 2nd dose of Engerix B. On 14th September 2020, the patient received the 1st dose of Engerix B. In May 2021, between 1 and 2 months after receiving Engerix B, between 6 and 7 months after receiving Engerix B and between 7 and 8 months after receiving Engerix B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.  Additional details were provided as follows: The patient received the entire Engerix B series and still tested negative for titer, which led to therapy non-responder. The titer test was done in between 10th May 2021 to 14th May 2021. The reporter did not consent to follow up.  Note: As no further clarification was available, expiration date for 1st dose was kept as reported.
Pt recvd 3 doses of Hep B vax 4JAN91, 10FEB91, & 5AUG91 & following each dose of vax pt had an exacerbation of arthritis; pt was placed on steroids & anti-inflammatory meds; lab eval approx OCT91 revealed a neg titer for  HBSAB;
5 year old boosters of dtap, ipv and mmr were given in the same thigh, 2 days later she has been seen at the urgent care with swelling of the leg (right thigh was measured at 32cm and left at 26cm) and also oozing of clear liquid from the injection site and noticable limp. Sms resolved completely with Ibuprofen and Benadryl.
A non-serious, spontaneous report of FLUMIST vaccine inadvertently administered to a seven-month-old female was received from a nurse.  This case is submitted in accordance with organization's post-marketing commitment on accelerated reporting for the newly indicated population of 7 years to 59 months of age for FLUMIST.  Concomitant medications include Hib vaccination.  The patient had no known allergies.  There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmunes post - marketing comitment on accelerated reporting for the newly indicated population of 2 years to 56 months of age for FLUMIST.