chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a elderly female patient who received SHINGRIX for prophylaxis. The patient's past medical history included rotator cuff injury. Previously administered products included SHINGRIX (1st dose vaccinated on an unknown date at the pharmacy). On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm, fluid retention and shoulder pain. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the fluid retention and shoulder pain were unknown. It was unknown if the reporter considered the pain in arm and fluid retention to be related to SHINGRIX. The reporter considered the shoulder pain to be unrelated to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The exact age of the patient was unknown but reported to be 65 years or older. The patient experienced pain in the injected arm after vaccination with SHINGRIX. The pain had not resolved, till it had been two or three weeks after vaccination with the second dose of SHINGRIX. The patient carried out a Magnetic resonance imaging (MRI), which showed fluid in her arm. It was unknown if the fluid was causing the pain. The patient was also experiencing shoulder pain at the time of reporting but this could be due to the previous injury to her rotary cup as per the reporter.
Severe pain , redness and swelling left arm and armpit-significant pain at rest- unable to get comfortable/sleep  Chills, fatigue, myalgia all over  Unable to work
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 lot # M040412 for prophylaxis. On an unknown date the patient experienced incorrect product storage. No adverse event was reported. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. Sender's Comments: US-009507513-1708USA013405.
Breathing difficulties, swollen lymph nodes for a week, heavy menstruated  cycle, headache, lower back pain.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19. Clinical course: Treatment start date=19May2023; Treatment stop date=23May2023  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300203787 Same reporter/patient, different drug, different AE.;
Headache, throat pain, Jaw Pain, Chest Congestion, Trouble breathing.
Pt mentioned (about two weeks after the vaccine was administered) that her arm was itchy and warm.  She stated that she had a bruise and her arm was sore for the first week after administration but did not inform anyone. Now the pain/soreness is gone but her arm is itchy and warm.  I examined her arm there appeared to be no swelling or bruising today.  I advised her to contact her MD she said she was feeling fine and will mention it to her doctor before second dose.  I still advised her to consult her MD and to inform her MD and I if it worsens.
Shoulder pain, limited movement.  Pain increased every day for 7 days until ER visit.  Follow up determined by doctor that vaccine was injected into bursa area which caused severe pain and limited movement.
Patient complained of pain in multiple joint areas including wrist, hips, back & neck plus generalized "lethargy" - all for 5 days.
10/25/09 headache late PM 10/26/09 fever,large whelps, face and lips swollen, sorethroat, stuffy nose. rapid heart rate, rash on scalp, back of neck and from right hip up through to rib cage. late AM early PM  Motrin by mom. ER late PM on 10/26/09  tylenol, benedryl. symptoms subsided after 4 hours.
Janssen COVID-19 Vaccine EUA Headache, nausea, extreme exhaustion, muscle/body aches, fever, dizziness, sensitivity to light and sound (headache), skin sensitive to touch, loss of appetite. Vaccine was administered at 10:38 AM. Symptoms began 10:00 PM 3/10/21. The worst of it was 8 AM to 6 PM 3/11/21. Some lingering mild headaches until 3/13/21.
A physician reported that two days subsequent to receiving vax, the pt developed an injection site reaction characterized by a 15 cm area of redness and swelling. The pt was treated with Tylenol and recovered. No further information was available at the date of the report.
After receiving the second dose of COVID on April 10th,  my husband experienced chills, muscle pain, fatigue and a low-grade fever. On the 4th day after vaccination, he started having a temporal headache that first was throbbing in the temple on left side of his head and tender to the touch. the headache was persistent for several days, and then, started coming and going until was gone. Overall, he had those headaches for about 10 days. I did report about this side effect to his PCP.
This case is part of 2 cluster cases and is linked to case number 2013-09274 (same reporter, events after receiving ADACEL (lot number: C4432AB) and MENATRCA (lot number: U4648AA). Initial report received from a healthcare professional on 16 AUGUST 2013. A patient whose gender, and age at the time of event was not reported, had received intramuscular first dose of ADACEL (batch number: C4432AB) in the left deltoid and intramuscular first dose of MENTACTRA (batch number: U4648AA, side: right, anatomical site of vaccination was not reported) on 13 AUGUST 2013. The patient had no known drug allergies or illness at the time of vaccination. The patient's concomitant medications were not reported. On 13 AUGUST 2013, the patient developed redness and swelling on left deltoid at vaccination site. The corrective treatments and laboratory investigations were not reported. On an unspecified date, the patient had recovered from the events. Documents held by sender: none. Follow up information received on 11 NOVEMBER 2013. A 11 year old female patient (birth date 28 FEBRUARY 2002), had received a intramuscular dose of ADACEL on left arm deltoid region and a intramuscular dose of MENACTRA on right arm. It was reported that on 13 AUGUST 2013 the patient experienced right and left upper arm pale pink, warm and slight tender. The patient had the vital signs included temperature 97.6 degree Fahrenheit and weight 104 lbs, physical examinations included right upper extremity; upper out arm pale pink, warm and slight tender and left upper extremity; upper out arm pale pink, warm and slight tender. The patient had the corrective treatments included Ibuprofen PRN for pain, cool compression PRN for pain, warm compress PRN for muscle spasm, monitored for increased redness, tenderness or streaking. After the discussion the event was not an allergic reaction, but the body's response to the vaccination, as it was starting to build immunity and the swelling which was already improved within 24 hours, it should resolve over the  next 7-10 days. The event cessation date was 15 AUGUST 2013.
Two days after receiving vaccine in left deltoid, my left ear became bright red and registered 100*F on multiple thermometers. The area around my ear remained 98.7*F. As it progressed I developed minor amounts of blotchy red areas along the hairline on the left side of my face only. Nothing occured on the right side of my body. Diarrhea developed with multiple episodes. All of this lasted approx. 3 hours before subsiding without treatment. I have had significant amount of vaccines and immunizations from the civilian and military sectors and never suffered this before.
This case was reported by a healthcare professional and described the occurrence of vomiting in an adult (possibly elderly) subject of unspecified gender who was vaccinated with FLULAVAL, (GlaxoSmithKline).  On 05 or 21 November 2008 the subject received a dose of FLULAVAL at 0.5 ml.  On 26 November 2008, the subject developed severe nausea, vomiting, diarrhea and body pain.  Dehydration was also reported.  The nursing supervisor of the facility was concerned that the outbreak was related to vaccination with FLULAVAL.  This was considered to be a product complaint.  The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention).  The subject was hospitalized.  At the time of reporting the events were unresolved, but the outcome of nausea and dehydration was not specifically reported. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL.  A health educator requested information for a specific lot of FLULAVAL.  A retirement home vaccinated a number of adults and elderly subjects on two different dates.  On 26 November 2008, approximately 40 of these individuals (staff and residents) developed severe nausea, vomiting and diarrhea.  Body aches were also documented.  The nursing supervisor of the facility was concerned that these outbreaks were related to vaccination with FLULAVAL.  Three of the subjects developed dehydration and were also hospitalized.  The facility was ruling out viral causes also. Linked cases numbers include:  A0758812A, A0758823A, A0758823A and A0758825A.
Vaccination failure; 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 male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: ERB737), in left arm, on 22Apr2021 as dose 2, single (Lot number: EWO170), in left arm and on 27Oct2021 as dose 3 (booster), single (Lot number: 301558A) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOVASTATIN, start date: 01Sep2015, stop date: 12Jul2022; LOSARTAN, start date: 01Sep2015; HYDROCHLOROTHIAZIDE, start date: 01Sep2015. The following information was reported: COVID-19 (medically significant) with onset 12Jul2022, outcome "not recovered"; VACCINATION FAILURE (medically significant) with onset 12Jul2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jul2022) Positive; (25Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Chills for about 10 hours, all her joints and muscles ache, and a very bad headache.
Disruption to hormones and menstrual cycle, leading to change in bleeding, disruption to otherwise normal cycle, cramping, bloating, eventual missed periods, patient accrued additional medical costs for diagnosis and lab work.
Arm has been sore since she received the vaccine; Fever; rash and heat at the injection site; Rash and heat at the injection site; period heavier than normal; Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (period heavier than normal), PAIN IN EXTREMITY (Arm has been sore since she received the vaccine), VACCINATION SITE WARMTH (Rash and heat at the injection site), PAIN IN EXTREMITY (Covid arm) and PYREXIA (Fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021b21a and 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis. Concomitant products included MELOXICAM for Arthritis.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (Covid arm). On 14-Apr-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (period heavier than normal), VACCINATION SITE WARMTH (Rash and heat at the injection site) and VACCINATION SITE RASH (rash and heat at the injection site). On 28-Apr-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm has been sore since she received the vaccine). On 16-Apr-2021, PAIN IN EXTREMITY (Covid arm) had resolved. On 30-Apr-2021, PYREXIA (Fever) had resolved. At the time of the report, HEAVY MENSTRUAL BLEEDING (period heavier than normal), PAIN IN EXTREMITY (Arm has been sore since she received the vaccine), VACCINATION SITE WARMTH (Rash and heat at the injection site) and VACCINATION SITE RASH (rash and heat at the injection site) outcome was unknown.            No treatment medication was reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: The follow up was received: patient demographic details was added
Vaccine was taken out of refrigeration at 9 am by other staff member when 2 doses were administered at that time and vaccine was not returned to fridge after administration.  Additional dose drawn up at 11:20 am by a different staff member, not realizing the vaccine was beyond 2 hours at room temperature and dose was administered.  Called Jansen (6/14/22 at 12:00 pm) manufacturer who stated that vaccine company had conducted studies regarding vaccine stability in vial at room temperature and showed stability for up to 12 hours.  Contacted client (6/14/22 at 12:20 pm) and informed of error and information that manufacturer shared.  Identified that he was ok with dose and declined additional information be sent by email provided by manufacturer.
first shingrix shot almost a year ago/ 10 months between Shingrix shots; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose almost a year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-JUN-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient reported he/she still need to get second dose of Shingrix vaccine, and asked was it too late. The patient reported that ten months between Shingrix shots. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 36-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. It was reported that no adverse reactions were reported by any patients. No treatment medication was provided.
Patient received the TRUMENBA vaccine in LT arm - painful site after without red or swelling - he applied ice at home and his arm went numb - mom call the clinic after hours and Dr. who told him to use heat. It was better. C/O dizzy - light headed.
Irregular heartbeat,chest pain light headed after moderna vaccine. Wasn't warned of possible side effects. No follow up. It should be your job to see this is done You need to have follow up with everyone that had moderna vaccine.
Immediately after immunization given, patient complained of headache. Approximately 30 minutes later patient complained of tongue feeling fat. Benadryl 50mg po administered. Approximately 20 minutes later, patient noted with visual swelling of her face around her mouth. Patient sent to walk in clinic. She was administered IM steroid and given a prescription for PO steroid.
Administered ID dose to patient under 18. Patient had no adverse effects. We just realized we had given ID dose to him & let mom know. She said patient had no problems.
Returned pt's call on 02/16/2022. Reviewed time line of events as noted in her previous notes. Pt stated that all she felt was a sore left arm at the injection site after her first visit on 01/17/ 2022 and that the symptoms of left leg lesion, left shoulder pain, chest discomfort and swollen left ankle and foot began a couple days after after second Ixiaro vaccine on 01/24/2022. The left leg lesion was a singular lesion about 1/2 inch in diameter, red and slightly swollen with no streaking. A scab formed around the edges with a pink center and is just about healed as of toay. Denies any knowledge of having been bitten by an insect or spider. When she was seen by the Podiatrist she was given a steroid injection in her left foot which seemed to help. Pt is unsure of what the Dermatologist thought was the cause and the PCP referred her back. The foot pain and swelling are gone. Pt denies any episodes of fever, SOB, dyspnea, generalized body rash or feeling of malaise. Pt is due to leave on 2/20 x 6 weeks. Discussed studies that I researched regarding side effects of Ixiaro and Ixiaro and Typhoid and that they don't fit the profile of her symptoms. I will submit Vares Form. Pt strongly advised that if symptoms return that they may indicate a health problem and she should return to her PCP for a medical evaluation. She was cleared by her PCP to travel.
MUSCLE SPASMS IN ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced muscle spasms in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of muscle spasms in arm was not reported. This report was non-serious.
dull headache; body aches; This is a spontaneous report from a contactable consumer, the patient received from Pfizer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 vaccination.  Medical history and concomitant medication were not reported. On an unspecified date, the patient experienced dull headache and body aches. The clinical outcome of dull headache and body aches was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.