chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had a break through period 15 days into my cycle which is not normal, I saw my obgyn because I was concerned. My cycle was abnormally heavy and long.
covid-19; covid-19; Vaccine Brand: Pfizer / BioNTech, Vaccine Administration date: 09Oct2022, Vaccine Dose number: 5, Vaccine Brand: Moderna,Vaccine Administration date: 19May2023; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Oct2022 as dose 5 (booster), single (Lot number: GJ6739), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19May2023 as dose 6 (booster), single (Lot number: AS718QB), 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 had no relevant medical history. The patient has no known allergies. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19May2023, outcome "recovered", described as "Vaccine Brand: Pfizer / BioNTech, Vaccine Administration date: 09Oct2022, Vaccine Dose number: 5, Vaccine Brand: Moderna,Vaccine Administration date: 19May2023"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (16Oct2023) and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Oct2023) Negative; (21Oct2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient took Paxlovid as treatment from 09Oct2023 to 14Oct2023.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy under interchange of vaccine products with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Fever, fatigue, nausea, sore arm, going between chills and clammy/sweating, dizzy
flu-like symptoms: large swelling at injection site, pain at injection site, muscle pain, whole body soreness/ache, headache, extreme fatigue, rash left thigh and buttock,  inflamed lumps left thigh and buttock
Dizziness  Bad Head ache Body pain Inability to lift my arm  to his full extension without pain   Injection Site swelling
Eyes Watered; Nose was Running; Lymph Nodes Puffed Up; Hard to Swallow; Spitting up Phlegm; Got Sick; he was clogged up / Everything was clogged; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Aug2021 10:00 (Lot number: EWO185) at the age of 79 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabeteic" (ongoing). There were no concomitant medications. The following information was reported: LACRIMATION INCREASED (non-serious) with onset 17Aug2021, outcome "not recovered", described as "Eyes Watered"; RHINORRHOEA (non-serious) with onset 17Aug2021, outcome "not recovered", described as "Nose was Running"; LYMPHADENOPATHY (non-serious) with onset 17Aug2021, outcome "not recovered", described as "Lymph Nodes Puffed Up"; DYSPHAGIA (non-serious) with onset 17Aug2021, outcome "not recovered", described as "Hard to Swallow"; PRODUCTIVE COUGH (non-serious) with onset 17Aug2021, outcome "not recovered", described as "Spitting up Phlegm"; ILLNESS (non-serious) with onset 17Aug2021, outcome "not recovered", described as "Got Sick"; DISCOMFORT (non-serious) with onset 17Aug2021, outcome "not recovered", described as "he was clogged up / Everything was clogged". Therapeutic measures were not taken as a result of lacrimation increased, rhinorrhoea, lymphadenopathy, dysphagia, productive cough, illness, discomfort. No follow-up attempts are possible. No further information is expected.
Pfizer / BioNTech/ tested positive for COVID; Pfizer / BioNTech/ tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Apr2022 as dose 3 (boster), single (Lot number: FK9894) at the age of 52 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's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing); "Chronic back pain" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "Kidney stones" (unspecified if ongoing); "Hemorrhoids" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing), notes: Known allergies: Yes. Concomitant medication(s) included: ESTRACE vaginal; BUSPAR oral; FIORICET oral; SPIRONOLACTONE oral. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Jul2022, outcome "not recovered" and all described as "Pfizer / BioNTech/ tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jul2022) Negative, notes: Testing negative on 05Jul2022; (13Jul2022) Positive, notes: tested positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Return of nasal congestion, cough and decreased taste/smell on 13Jul2022 and tested positive for COVID after previously testing negative on 05Jul2022.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of covid-19 and drug ineffective.
Began 30 minutes after receiving vaccines with weakness and headache.  Than approximately one hour later passed out for around 5 minutes followed by frequent vomiting.
After 16 hours, onset of nausea; Chill; Muscle aches; Tired; Very swollen lymph node under left arm; Day 1 - headache for first 16 hours; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 07Mar2021 at 10:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously took fluconazole (DIFLUCAN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamin D (MANUFACTURER UNKNOWN) and daily iron supplement (MANUFACTURER UNKNOWN); both for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration in the left arm on 14Feb2021 at 11:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 07Mar2021, the patient experienced headache for first 16 hours and sore arm. On 08Mar2021 at 02:00,after 16 hours, the patient experienced nausea, chill, muscle aches, tired and very swollen lymph node under left arm. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache was recovered on 08Mar2021; while that of event sore arm, nausea, chill, muscle aches, tired and very swollen lymph node under left arm were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Pt received Prevnar #4 in right deltoid on 11/16. Returned today with cellulitis at same area.
pt had a circular area of redness and mild inflammation that was warm to the touch around the injection site.  the area was described by pt to be the size of a plum and itchy.  she used benadryl otc and applied cold pack.  area was much better the next day according to phone conversation with patient.
Narrative:  Patient received her Pfizer booster today. While patient was waiting during her 15mins monitoring, she complained of pounding heart beat, chest pressure and tingling sensation to her tongue. Patient expressed she didn't have this type of reaction to the Dose #1 and 2 of the Pfizer vaccine. Patient v/s 98.2, 126, 18, 142/104, 98%. Resp. even and unlabored. Patient was escorted to the ED for further evaluation by staff.
Tested positive; This spontaneous case was reported by a patient and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In June 2022, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2022, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  The patient had appointment for tryout on 16-Jun-2022 but unfortunately he could not be present as tested positive during that week.   Company comment: This spontaneous case reported by a patient concerns a male patient of unknown age with no reported medical history who experienced the unexpected non-serious AESI of SARS-CoV-2 test positive. The event occurred unknown days after the mRNA-1273 Vaccine. Other details are not available. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case reported by a patient concerns a male patient of unknown age with no reported medical history who experienced the unexpected non-serious AESI of SARS-CoV-2 test positive. The event occurred unknown days after the mRNA-1273 Vaccine. Other details are not available. The benefit-risk relationship of mRNA-1273 is not affected by this report.
swollen in the center, exactly where the shot went in; noticed a red area that towards the night was a 3-inch oval mark at the site of injection; It was red and itchy; arm soreness, a lot of uncomfort, closer to the elbow; arm soreness, a lot of uncomfort, closer to the elbow; arm soreness, a lot of uncomfort, closer to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness, a lot of uncomfort, closer to the elbow), DISCOMFORT (arm soreness, a lot of uncomfort, closer to the elbow), VACCINATION SITE PRURITUS (It was red and itchy), ARTHRALGIA (arm soreness, a lot of uncomfort, closer to the elbow) and VACCINATION SITE ERYTHEMA (noticed a red area that towards the night was a 3-inch oval mark at the site of injection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and Cholesterol. Concomitant products included VITAMIN D NOS for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness, a lot of uncomfort, closer to the elbow), DISCOMFORT (arm soreness, a lot of uncomfort, closer to the elbow) and ARTHRALGIA (arm soreness, a lot of uncomfort, closer to the elbow). On 14-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (It was red and itchy) and VACCINATION SITE ERYTHEMA (noticed a red area that towards the night was a 3-inch oval mark at the site of injection). On 15-Mar-2021, the patient experienced VACCINATION SITE SWELLING (swollen in the center, exactly where the shot went in). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) 03-Mar-2021 for Pain in arm, at a dose of 1 dosage form and HYDROCORTISONE (ABIX [HYDROCORTISONE]) from 14-Mar-2021 to 15-Mar-2021 for Vaccination site pruritus, at an unspecified dose and frequency. On 05-Mar-2021, PAIN IN EXTREMITY (arm soreness, a lot of uncomfort, closer to the elbow), DISCOMFORT (arm soreness, a lot of uncomfort, closer to the elbow) and ARTHRALGIA (arm soreness, a lot of uncomfort, closer to the elbow) had resolved. On 15-Mar-2021, VACCINATION SITE PRURITUS (It was red and itchy) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (noticed a red area that towards the night was a 3-inch oval mark at the site of injection) and VACCINATION SITE SWELLING (swollen in the center, exactly where the shot went in) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products included cholesterol medication and  high blood pressure medication.
Client states severe headache began approx 1030 am 1/23/07. Client describes pain in pariental region of head. Client took homeopathic remedies to try to resolve pain. Histaminicum hydrochloricum, arorica Montana and turmeric capsule. Client denies any other S/SX like nausea. Client applied warm compress to back of head and cold compress to top of head and rested in a darkened room. No prior history of headaches. Client felt HA resolve shortly after 430pm and completely resolve after 1045pm. Client also stated BP taken at home by self has elevated at 13/72 at 1/2pm from am reading approx of 102/58.
Swollen glands in neck, rash all over body, fever, tongue burned, swollen. Went to private doctor 10/9/05 put on steroid, received injection - pt not subjection has had flu shots in the past w/out reaction.
Pt. had allergic reaction to right arm-HPV & MCV given on RA. Immediately turned red after they were given 2-3hrs later swollen & hard about 1/2 dollar size, next day red & swollen & hard about 3/4 dollar size.
1/14 vaccination @ 12 By 1:30 I was experiencing light headedness, brain fog. I went to leave work early and experienced a near syncopal episode. Co workers took vitals. O2 was fine, BP was low. Monitored at work for a couple hours and then helped home.  *anemic **heaviest day of period ***was informed by vaccine administer that these factors would not be a barrier to getting the vaccine.
Patient got 2nd shingles shot on 7/18/22 and  said that on and ever since 7/20/22 she was not able to move or rotate her upper right arm. She is having a lot of pain in her right shoulder.  She saw a chiropractor today and symptoms improved very very slightly, but she is still not having range of motion in her upper arm. She has made an appointment with her PCP.
patient came in next morning complaining that she woke up with a sinus like headache,nausea,fatigue,fever and muscle ages. checked on patient twice today she says she seems to be getting better, so it might have been just side effects due to the vaccine however, I wanted to be reported. Advised patient if she got any worse or did not feel better to go to the ER. But check on her around 5 pm and she said she is feeling a little better.
Vaccine received at 2:45 pm on Tuesday 28Dec.  Approx 30 hours post dose, on the Wednesday evening, I began to experience "brain zaps" (difficult to describe - a frizzing sensation inside my head around my brain) accompanied by loud tinnitus (I have it normally but is usually an even tone - during the post dose period it was more like a bee buzz).  These worsened over Thursday, began to improve on Friday, and largely resolved by late Saturday evening 1Jan.  They were accompanied by fatigue and restless legs.  On Friday, I began to experience increased levels of sighing and significantly depressed mood.  These symptoms closely resemble what happens when I miss more than one dose of effexor, but I had taken every dose as prescribed over the prior month.  I also had changed nothing about my diet, behaviour or other events that might affect absorption of the medication.  I also experienced stabbing pains in my left arm and leg - maybe a half dozen, in different spots.
Pfizer-BioNTech COVID-19 Vaccine EUA: Vaccine recipient was vaccinated on 9/28/2021. Around bedtime on 10/1/2021, he noticed symptoms of numbness on the right side of his face. On 10/2/2021., he woke up and was unable brush his teeth. he noticed that his right face was numb and he could not close his right eye. He then went to urgent care and they diagnosed him with Bell's Palsy. He is currently going to physical therapy. He currently cannot close is right eye completely at all. He has to sleep with an eye patch at night, sometimes he eye burns from keeping it open all the time.  He was out of work for 1 week and returned to work on 10/12/2021.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 06-JUL-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 suspension ten 0.5ml Single-Dose Vial (SDV) (lot # L019297, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 1.11 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
pain at the injection site for about 3 days; body aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th November 2019, the patient received the 1st dose of Shingrix .5 ml. In November 2019, 12 hrs after receiving Shingrix, the patient experienced injection site pain and general body pain. On an unknown date, the outcome of the injection site pain and general body pain were recovered/resolved.   The reporter considered the injection site pain and general body pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022006699  Additional details were reported as follows: The reporter was the patient. The patient received a dose of Shingrix and 12 hours later experienced injection site pain and body aches which resolved 3 days later. The patient wanted to know if he should restart the series. Spoke per content and patient was referred to health care professional.  Consent to follow up was denied. For tolerance to 2nd dose of Shingrix, refer case US2022006699. The case was linked to the case US2022006705, reported by the same reporter for her wife.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022006705:Same reporter. US-GLAXOSMITHKLINE-US2022006699:Same Patient
Pt received her first Pfizer COVID-19 vaccine on 4/9/21.  She did well during the immediate post vax period and went home stable.  Over the course of a few days, she developed word-finding problems, forgetfulness, and numbness / heaviness.  On 4/18/21, she called 911 and went to  ED for L sided weakness and vertigo.  An MRI was done and a questionable brain lesion was found.  She was stable and was discharged home with instructions to follow up with her Kaiser PCP.  On 5/17/21, she called me to report her experience and believes it's all due to the vaccine.
Headache, Myalgia, HOT FLASHES Narrative:  Other Relevant History:
Erythema 1.5 in x 3 in at site of injection; warm to the touch. No edema. Started this am (5/7/15) Seen 5/7/15 at 4 pm. Rash did not spread since AM. BENADRYL PO. OTC topical hydrocortisone cream.
Sharp pain in opposite shoulder to one receiving vaccine nearly immediately.  Intermittently off-balance & dizzy within a half-hour & continuing throughout day, cramps in feet for days, very sore throat & body aches for days, felt too hot then too cold for days, headaches for days, legs felt very heavy for days, difficulty focusing, body aches for days, left chest pains one and off that have not completely gone away and have come back weeks and months later.
Fever--about 101 degrees, achy all over, sensitive skin, stomach upset  (not nauseous), chills and sweats, shivering, fatigue, headache. Fever broke during the night, around 3 am (15 hours after injection). 2nd day, still feels achy, but not as bad. Does not usually have reactions to vaccinations. First SHINGRIX injection went very well.
Erythema approximately 8 x 17 cm LUE - KEFLEX, Ibuprofen.
No adverse event; administered an vaccine that was 3 days expired; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered an vaccine that was 3 days expired) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059F221) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: COVID-19 VACCINE on 27-Jan-2021, COVID-19 VACCINE on 24-Feb-2021, COVID-19 VACCINE on 04-Nov-2021, COVID-19 VACCINE on 06-May-2022 and COVID-19 VACCINE on 17-Oct-2022. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, COVID-19 VACCINE, COVID-19 VACCINE, COVID-19 VACCINE and COVID-19 VACCINE.    On 18-May-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 18-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered an vaccine that was 3 days expired). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered an vaccine that was 3 days expired) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered an vaccine that was 3 days expired).    Concomitant medication details not reported by the reporter. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment details was not reported by the reporter.
Covid-19 symptoms were sore throat, headache, body aches and fever. No cough. Took Paxlovid treatment.
2 days after immunizations he experienced significant neuralgia in the area of his old spinal cord injury: mid-trunk, both front and back x 1 1/2 weeks. Has never reacted to a flu shot. We suspect the HPV shot.
1-15-13 Body aches, hot/cold body temp., no appetite, complained of tiredness and weakness, lightheaded, dry cough, could not do daily self-care, personal hygiene got worse 1/23/13, nausea, vomit, fever. 2/25/13 Severe cough, diarrhea, dizziness - physical weakness.
Within 3 hours of vax, the pt developed irritability, low grade fever up to 100.8, rhinorrhea and cough. 2 days later he was diagnosed with otitis media and treated with Amoxicillin.