chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Irregular unscheduled heavy and prolonged menstrual cycle lasting about 5-6 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 35-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Sep2021 (Lot number: fa7484) at the age of 35 years as DOSE 2, SINGLE for covid-19 immunization. Relevant medical history included: "Covid-19" (unspecified if ongoing). Concomitant medication(s) included: LO LOESTRIN FE. Vaccination history included: Bnt162b2 (First dose, Anatomical Location: Arm left, Batch/lot number: fc3138), administration date: 13Aug2021, when the patient was 35 years old, for Covid-19 Immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 05Sep2021, outcome "recovered" (Sep2021), described as "Irregular unscheduled heavy and prolonged menstrual cycle lasting about 5-6 days". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstrual disorder.  Additional Information: The patient had Irregular unscheduled heavy and prolonged menstrual cycle lasting about 5-6 days. Her normal menstrual cycles were 2 days, not heavy and align with LO-LOESTRIN FE cycle. She did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Other medications she received within 2 weeks of vaccination: LO-LOESTRIN Fe. No treatment was received for adverse event. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 16-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) GARDASIL injection (lot # L014415, exp. date: 25-JUL-2017) (route, dose and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
received the first dose of the Pfizer covid vaccine on 08 MAR 2021/positive test on Thursday on 18 MAR 2021; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 08Mar2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer covid vaccine on 08Mar2021, stated, "on the last week, I get the positive covid test, symptoms began, and Tuesday last week Mar 16th, positive test on Thursday on 18Mar2021. The patient wanted to know if she should get the second one, it should be next Monday 29Mar2021. Can I get it, or shouldn't take it I have it right now?" Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Site red tender; approx 5 cm in diameter. Also fluid filled "blister" approx 1 cm in size noted above and to right of inj. site.
Injection site to left deltoid noted to have moderate edema, erythema to a 3in by 5in area. Site hot and extremely tender to touch. Weakness noted to left arm. Unable to elevate arm passed a ninety degree angle. Pulse, motor, sensory intact distal to site. Cap refill < 3 sec. C/O severe weakness and fatigue. Site is local only. Denies any shortness of breath, difficulty breathing, nausea, vomiting, or diarrhea.
broke out in severe rash face, back, neck, behind ears, t101 x 5 days, sore throat
24 hrs after administration of vax - raised, red welt dime - silver dollar size at admin site (left deltoid), warmth. No induration. On 4/4 - non-raised, same size T 24 hrs post admin. 100.4. C/o tired, slight dizziness. On 4/4 redness at site continues - not raised, erythema present.
Patient was admitted from ED due to feeling week for approximately 1 week prior. Has passed out 2-3 times a day over past week.  Patient tested on admission for Covid with a positive diagnosis via POC Rapid SARS-COV-2 Antigen.  Patient was treated with remdesivir, albuterol, ceftriaxone, dexamethasone.  Patient discharged after 5 days with dexmethasone as new med.
This case was reported by a physician via a sales representative and described the occurrence of adverse event in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of FLUARIX (unknown).  At an unspecified time after vaccination with FLUARIX, the subject experienced an unspecified adverse event described as a sensitivity reaction.  At the time of reporting the outcome of the event was unspecified.  The sales representative stated that she was at a large convention on 30 September 2008 and was approached by a physician that reported his hospital had suspended administration of FLUARIX due to 6 subjects developing adverse events after receiving the FLUARIX vaccination.  No details of the report are available and the sales representative heard the report third hand.  Linked cases include:  A0753365A, A0753367A, A0753369A, A0753370A and A0753371A.
Pt. felt light headed at first after immunization. Monitored pt. for approximately 15 minutes. Patient insisted he was fine and left on his own volition. Called pharmacy 2 days later reporting rash on forehead, arms, and swollen eyes. Pt told to go to ER.
Shingles appeared 1 weak ago; This case was reported by a pharmacist and described the occurrence of shingles in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number B4527, expiry date 2nd May 2021) for prophylaxis.   On 28th August 2020, the patient received the 1st dose of Shingrix. On 18th February 2021, 174 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. 1 week ago from the date of reporting, the patient appeared shingles. The reporter consented to follow up.
Short of Breath and lightheaded at 4:47 pm, was given 50 mg oral Benadryl tablets with apple juice, Vitals were as follows: BP: 110/46, P: 99 and SpO2: 99%. 911 was called. She was placed in recumbent position with head and feet elevated and Vitals continued to be monitored until paramedics arrived. Paramedics arrived about 5:10 - 5:15 pm. They assessed her and stated BP was in normal range and her breath sounds were clear bilaterally. She refused to go with paramedics and they left the clinic.
Information has been received from a pharmacist concerning a 43 year old female patient who on an unspecified date in May 2009, was vaccinated with the first dose of VARIVAX (Merck) (lot#, route and site of administration not reported). On an unspecified date the patient developed "varicella-like rash" after vaccination. At the time of this report, the patient had recovered. Additional information has been requested.
Chills, fever 101-103 which began Friday evening. Noted rash on hands on 1/8/00 and hives on legs and buttocks. Hands swollen, dizzy, weak and increased heart rate. Saw family MD who did lab work, no infection but questionable viral. Pt was taking Tylenol and ASA every 4 hours, for fever.
Began clearing throat, then wheezing, followed by coughing and extreme hoarseness.
Left lat deltoid muscle 1 in a 1 inch area of redness, swelling and puffiness, non tender. Slightly warm at injection site.
Post vax on 12/05/2000 the patient developed chicken pox that started off as pustules on his left cheek. Subsequently, the patient had three pustules appear on this right axilla, one on his abdomen. The child was acting well. Upon physical examination the patient had a lesion on his left cheek that was erythematous and appears to have begun to scab. A similar lesion on the inner aspect of the right upper arm was noted. Near that lesion there was a pustule on the lateral trunk wall, on right, there was another pustule lesion that has the appearance of varicella. There was also another lesion at the base of the neck on the left that was erythematous. No actual fluid filled blisters were noted. The patient was treated with Tylenol as needed. Additional information is not expected.
(L) arm where shot given got red/swollen/tender/erythematous progressively over a 3-day window.
Patient was given Moderna Covid-19 vaccine at age 17 on 9/10/21, not approved for under 18. Decision made by clinical team to complete the moderna series rather than switching in the middle of the initial series of immunizations. This represents that chose dose. Patient had NO adverse outcome, this is a report of a medication variance.
Severe chills; Joint pain; Severe Headache; Stomach Ache; Cold feet/ Cold hands; Forgetfulness; Mumbled speech; Numbness; Tingling all over; Difficulty focusing; Body Aches; Fatigue, Tiredness; Foggy head; This is a spontaneous report from a contactable other hcp (Nurse). A 40-years-old female non pregnant patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number was EL0142), intramuscular, administered in Arm Left on 28Jan2021 at 08:00 as 2nd dose, single for COVID-19 immunization. Historical vaccine of bnt162b2 as first dose (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm right on 08Jan2021 at 03:00 PM (Batch/Lot Number was EL0140) as first dose single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No allergies were found. Patient was not pregnant at the time of vaccination. Patient had not known allergies. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. On 28Jan2021 at 17:00 patient experienced severe chills, joint pain, severe headache, stomachache, cold feet/ cold hands, forgetfulness, mumbled speech, numbness, tingling all over of, difficulty focusing, body aches, fatigue, tiredness and foggy head. No treatment was received. The outcome of the events was recovering.  Follow-Up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.
He received the shot around noon then later on around 11:30pm that same evening  he started experiencing flu like symptoms including mild fever chills body aches that lasted about 5 or 6 hours then resolved.
Pt. states that after receiving the 1st dose of Phizer 08/13/2021, immediately after symptoms of sharp chest pain throughout the right then left rib cage, numbness through the right arm and left thigh continuing down to the feet with tingling in the left foot. Nausea associated with mild confusion, with pain in the lower left side of the head. No noted Primary visit but planned appt. shortly after.
Client's wife (employee) reported today over 6 weeks after flu vaccine given, that he had developed local reaction of redness, swelling and tenderness - she reports that his arm was hot to touch. He had no fever or other systemic symptoms, fluid accumulated at the site even totally absorbed he had no treatment and did not see the dr about it - today he still has some redness and discomfort at the site.
No adverse effect; Patient was inadvertently administered Proquad via intramuscular rather than subcutaneous route; This spontaneous report was received from a medical assistant refers to an 12 month old male patient. Patient's medical history, drug allergies/reactions and concurrent conditions were not reported. Concomitant therapies included sterile diluent (DILUENT MERCK Injection) (lot# S000130, expiry date of 23-AUG-2021). On 26-JUN-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, (lot # S002494, expiration date of 23-JUL-2020) via intramuscularly route (incorrect route of product administration) for prophylaxis. The reporter informed that vaccine administered inadvertently via intramuscular route instead of subcutaneous. The vaccine was properly stored and it reconstituted with properly stored sterile diluent. Patient did not experience any adverse effects (no adverse event).  No product quality complaint involved.
pt reports 2nd dose 3/16/2021-apx 2pm chills, headache, woke 7am 3/17/2021- Severe HA, leg pain, joint pain- unable to ambulate, leg pain has improved not resolved
Raised patchy rash near injection site.  Started the size of a quarter, is continuing to double in size.
Patient seen in ED with CC of unilateral leg pain x3 days. Pt attributes the leg pain developed shortly after receiving the J&J COVID Vaccine. Ultrasound demonstrates superficial thrombis of greater saphenous vein. Hemodyanimcally stable. Pt prescribed Eliquis 10mg bid x7 days followed by 5mg po bid.   Cannot confirm pt has been administered J&J vaccine -not documented in medical chart, pt only self-reports. Also with sedintary lifestlye/bed-bound.
Severe headache, nausea, chills, body ache for 6 days and still continuing; Tylenol was not effective. Had to take ibuprofen (400 mg) three times a day.
red puffy hot sore eyelids; red puffy hot sore eyelids; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Mar2021 12:45 (Lot number: EN6204) at the age of 60 years as dose 1,single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 12Mar2021, outcome "recovered" (13Mar2021), described as "sore arm"; ERYTHEMA OF EYELID (non-serious), EYELID PAIN (non-serious) all with onset 15Mar2021, outcome "not recovered" and all described as "red puffy hot sore eyelids".  Additional information: Other Products were reported as, No. Clinical course was reported as, Reporter stated she got the Pfizer Covid vaccine on Friday, 12Mar2021 at 12:45 in the afternoon, states she had sore arm for less than 24 hours. States she had no other symptoms until she woke up this morning and eyelids are puffy, red, hot, and sore. Reporter wanted to know if she needs to be concerned or be seen about this. Reporter was encouraged to reach out to her healthcare provider for medical advice.  No follow-up attempts are possible. No further information is expected.
The morning after H1N1 vaccination, patient complaints of lower back muscle aches on arising in a.m.; difficulty in getting out of bed. Pt has been taking Motrin which has been helping the aches approximately 80%. Symptoms have been occurring daily since vaccination.
The severe pain on the shot location (left shoulder) gradually spread to the middle arm muscle in the evening. The pain locations were hot and lasted more than 3 days.  The first day after the shot was in gloomy mood.
Lump turned to large bump (size of egg), itchy, red, and feverish.
Rushed to hospital by ambulance with severe pain in my liver area (Oblique area), vomiting (no blood) severe pain crying in pain
Started with a fever of 103, kept it for days. Went back to DR. 6/19 he advised she had an ear infection gave amoxicillin. Rash showed up on 6/26 on her trunk, went back to DR. He advised looked like some type of reaction but was not sure it was vaccine. Stopped amoxicillin and advised rash would begin to clear up if it was amoxicillin. Rash has spread is covering her entire body and face.
Sensorineural hearing loss; Initial information received on 05-Sep-2022 regarding an unsolicited valid serious case received from non-healthcare professional via Health Authorities under reference GB-MHRA-ADR 27267693.  This case involves a 14 years old female patient (176 cm and 65 kg) who experienced sensorineural hearing loss after receiving vaccine MENINGOCOCCAL A-C-Y-W135 VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 16-Jul-2022, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 VACCINE (dose, formulation, lot number: unknown) via unknown route in unknown administration site as Routine vaccination (immunization). She also received a dose of the same vaccine (dose, formulation: unknown) (lot: U3G306V; expiry date: not reported).  Patient complained of headaches for weeks after the vaccination. She fainted three weeks after the vaccination. On an unknown date, three weeks and four days after the vaccination she had hearing loss (deafness neurosensory) in her right ear.  She has seen an ENT (ear, nose, and throat) consultant for the event. Adverse reaction did not occur as a result of an exposure during pregnancy. Action taken: not applicable.  Corrective treatment: Two doses of steroid injections and a course of steroid tablets for deafness neurosensory.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event sensorineural hearing loss.  Seriousness criteria: Medically Significant  for the event sensorineural hearing loss.; Sender's Comments: Sanofi Company comment dated 12-Sep-2022: This case involves a 14 years old female patient (176 cm and 65 kg) who experienced sensorineural hearing loss after receiving vaccine MENINGOCOCCAL A-C-Y-W135 VACCINE. However, the patient's past medical treatment, concomitant medication, vaccination, lab data and other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Low-grade fever (100.5), chills, and headache; was managed with ibuprofen and had ceased in 24 hours
Seizures; Mini stroke; Tired; A spontaneous report was received from a consumer concerning a 73-year-old male who received Moderna Covid-19 vaccine and experienced seizures, mini stroke, confused, agitated, eyes were abnormal, memory impairment, and tired.   The patient's medical history included heart attack and stent placement in 2011. His relevant concomitant medications include acetylsalicylic acid, candesartan cilexetil, clopidogrel bisulfate, diltiazem hydrochloride, ezetimibe, adenosine, gabapentin, metoprolol tartrate and rosuvastatin calcium.  The patient received their first of two planned doses of mRNA-1273 on 14 Jan 2021. On 10 Feb 2021, 30 minutes prior to the onset of the events, the patient received his second of two planned doses of mRNA-1273 (Lot#010M20A) intramuscularly in left deltoid for the prophylaxis of COVID-19 infection.   On 10 Feb 2021, With in 30 minutes of receiving the vaccination, the patient had a seizure. They took him to the hospital, where he had a computerized tomography (CT) scan, blood work and had a consult. After consult, they said, it's a mini stroke. They released him and told her if it happens again call 911. He felt so tired and went to sleep at home. Around 17:00 dinner time, he woke up looked very blankly, and his wife reported knowing he had another seizure. She reported he ran to his keys saying, "I have to go", seemed confused, agitated and didn't know where he was. She called 911 andhe was transported to the hospital in an ambulance.  Around 19:00 the same day, he was admitted to do scans overnight. Around 21:00, patient's eyes were abnormal, he became agitated again and nurses confirmed he was having another seizure. 30 minutes later, he was talking to his wife and daughter as if he didn't remember anything. He mentioned some metallic taste in his mouth.  On 11 Feb 2021, they did an electroencephalogram (EEG) and confirmed that he was having seizure. He was prescribed seizure medication and released him from hospital. However, the patient and his wife reported not wanting him to take the medication as they believe the events were due to the vaccine. Treatment information was not provided.   Action taken with vaccine is not applicable as the patient received both the doses.  The outcomes of the events, seizures, mini stroke, and tired, were recovered.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  The patient's medical history of heart attack and concomitant medication use can be confounding factor. Further information has been requested.
Patient experienced a fall in the parking lot after receiving her second Moderna booster. Patient had a knee surgery recently and was using shopping cart for stability while walking. Exiting the store after her vaccine she had a fall going over the curb. According to the patient she did not faint or lose consciousness.
About 2 minutes after the shot, tingling from the shot site to the tip of middle finger started tingling. 10 minutes after shot, right side of throat started tingling and hurting then felt like throat was swelling and it was hard to swallow. This lasted for about 15 minutes. 45 minutes after shot the same issue occurred with the left side of the throat
PT HAD RASH REDNESS AND SWELLING ON RT THIGH WHERE KINRIX WAS GIVEN. DR PRESCRIBED BENADRYL AND IBUPROFEN, AND ASKED PARENTS TO  APPLY COLD COMPRESS ON RT THIGH.
chills; fever; sore arm between doses; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 16Mar2021 as single dose for covid-19 immunisation. Historical vaccination as First dose BNT162B2 for Covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, on an unspecified date, the patient experienced chills, fever and sore arm between doses. The outcome of the events was recovered.
rash; blotched skin with round swollen circles; blotched skin with round swollen circles; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 26Mar2021 (at the age of:60-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated that her wife received her first shot of the Pfizer Covid-19 vaccine on 26Mar2021 and 9 days later presented a rash, blotched skin with round swollen circles. She Went to a dermatologist that prescribed an ointment and it took over a week to go away. Caller would like to know if these reactions are related to the Covid shot. Caller would like to know if her wife should get her second dose of the Pfizer Covid-19 vaccine after presenting adverse reactions from the first one. Consumer calling in regards to his wife. She is scheduled to receive her second Pfizer shot today. He has been reading up on the symptoms such as fever, chills, cough, shortness of breath, fatigue, muscle/body aches, headaches, loss of taste and smell. Caller is asking has any one reported having a rash or blotches on their skin. He wanted to know should she get the second shot or not. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained