chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Low grade fever; chills; body aches; fatigue; This is a spontaneous report from a contactable other health professional reporting for herself. A 59-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number: EK4176, expiry date: not reported), via an unspecified route of administration, on 11Jan2021 10:45 AM, at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. Medical history included COVID. The patient was diagnosed with COVID prior to vaccination. Concomitant medications included unspecified medications; the patient received other medications in two weeks. The patient previously took aspirin and experienced allergies. On 12Jan2021 06:30 PM, the patient experienced low grade fever, chills, body aches and fatigue. The patient was not tested for COVID post vaccination. The patient did not receive any treatment for the reported adverse events. Outcome of the events was recovered on an unspecified date.
Fever, Headache, Chills, Fatigue, Lymphadenopathy Pain in the area of the vaccine.
1300 Pt with head pressure and chest squeezing. 1333 Pt HR-64,o2 sat 93%RA, B/P 122/70. Pt reports 15-20 min after the vaccine he started in with head pressure, chest squeezing gone and weakness. Pt states he took hit am long and short acting insulins and did not eat anything because it takes him quite some time to fix his meal.  Pt A&Ox3, 1400 reports less pressure in head and palpitations gone. 116/66 b/p, hr-72, 94&ra, 1410 O2 sat 94% hr-72 , pt reports head pressure is gone, no chest discomfort, no palpitations, no longer feels weak. Pt reports this is not his usual reaction to low blood sugar. 1415- o2 sat 92% ra, hr-75, pt reports he feels much better and would like to go home. Escorted to his car with staff. Instructed to follow-up with  MD if any further issues are noted. Pt verbalized understanding of these instructions.
Severe vomiting  Headache  Dizziness  Sore muscles  Tired Body hurts all over
COVID ARM -- slightly raised rash below injection site about 4 inches long by 3 inches wide
Administered with vaccine which underwent temperature excursion; Administered with vaccine which underwent temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered with vaccine which underwent temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Administered with vaccine which underwent temperature excursion) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 065f21A, 018B21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered with vaccine which underwent temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Administered with vaccine which underwent temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered with vaccine which underwent temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Administered with vaccine which underwent 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 by the reporter  It was reported that there was a temperature excursion involving 14 Moderna Covid-19 vials. Reporter mentioned that they have 4 thermometers but only the data logger recorded a temperature excursion on 02-May-2022, plus 5.11F which occurred for 7 minutes; thermometer in the freezer and the other 2 data loggers did not record any.  It was reported that vials were stored in freezer and after temperature excursion the vials were quarantined in the freezer.  No treatment medication was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2022: Updated reporter's name and patient's information. Suspect dosage information was added.
Rash and redness around injection site noticed several hours after injection.  Diphenhydramine given to patient and continued to be monitoried.
Swelling, redness, pain, and itching from approximately 1 inch below the injection site (upper deltoid) to  just above the elbow,  distal and proximal of bicep and swollen lymph nodes under the arm.  INTERMITTENT Numbness also noted in the wrist and fingers.  Swelling, redness, and pain did not abate with administration of 600mg every 6 hours x 2 days. Symptoms still persisting. Managing with ice to take heat out of swelling, which has maintained a localized temperature between 101-102 degrees F.
I have no way to know if it's from the vaccine, but it seems like it started shortly after receiving the second booster.  My heart constantly feels like it is fluttering. It's probably not 24/7, but for instance, this morning I noticed it before I even got out of bed. I felt like this was worth reporting since I didn't have it following the first two shots. I would really like to know if it is a common side effect and if it should eventually subside. I've had a pretty consistent headache, but I'm pretty sure that is common with the booster.
had h/a on 25OCt like migraine; mild h/a all wk; 27OCT severe h/a again, had vomiting in evening & all day; 28OCT by 29OCT recovering;
Left arm (tricep region) intense pain, redness, swelling, decreased use, diffuse myalgias, fatigue, suppressed appetite.
Covid Arm-lasted about one to two days. Itchy and rash at injectio site.
Swelling and discoloration with welt.  Swelling, etc. continued to worsen up to day 3.  Swelling increased with welt to 6 inches.  Went to Pharmacy on 11/13/16 for follow-up.  Pharmacy said to take Benadryl and watch to make sure it did not continue and log a reaction.
Patient came to clinic today, left arm red, about size of half dollar.  Has taken Benadryl.  Flu shot in past no trouble.  Family had flu shots, shes the only one with redness - no fever, no swelling.  Is broken out with bites from camping - will see the doctor on Tuesday 12/06/2005.
received dose 1 18 months ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on an unknown date 18 months ago).   On an unknown date, the patient received 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: 25th March 2022 Reporter's Comments: The health care professional reported that patient received dose 1 of Shingrix 18 months ago. No reactions reported. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting patient did not received 2nd dose which led to incomplete course of vaccination. Case kept conservatively valid for incomplete course of vaccination since the details regarding 2nd dose was not provided.
After receiving shot had a hard, red lump about the size of half dollar and turned itchy.  Lasted for a few weeks.  Now has flare ups of itchy skin and rash at site of injection.
pt recv vax & family member recv vax w/no medical problems 26NOV96;
Same day flu shot administered. Arm became itchy, from fingers to shoulder. This has continued to present day. Ibuprofen has only relieved pain for short periods of time.
3-4cm circular raised area of erythema at the injection site with warmth. Patient reports itching and mild tenderness. Patient noted the area 2-3 days after injection without any current improvement or worsening. Prescribed hydrocortisone cream to use on the area twice a day for one week.
SICK FOR 24 HOURS; UNSPECIFIED SIDE EFFECTS; This spontaneous report received from a patient concerned a male 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 25-MAR-2021 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 MAR-2021, the subject experienced sick for 24 hours. On MAR-2021, the subject experienced unspecified side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick for 24 hours on Mar-2021, and the outcome of unspecified side effects was not reported. This report was non-serious.
pt recvd vax & was wetting pants; legs were sore & refused to try & move or walk; pt cried constantly for approx 1 1/2 hrs; unable to console pt;
My husband fell down outside on out porch; My husbands right side of the body where is ribs are hurt; Patient arm is tinder in the right arm; My husband complained about a slight headache; A spontaneous report was received from a consumer concerning for Husband, a 90-Year-old male patient who received both doses of Moderna's COVID-19 vaccine (mRNA-1273) and fell down on his right side of the body and had his ribs/chest pain and headache along with vaccination site pain.  The patient's medical history included disability and hypoacusis. Concomitant product use was not provided by the reporter.  On 01Feb2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 032L20A) via Intramuscular route on Right Arm for prophylaxis of COVID-19 infection. On 28Feb2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 003A21A) via Intramuscular route on Right Arm for prophylaxis of COVID-19 infection.  On the same day of the second dose, patient fell down on his right side of the body and had ribs/chest pain and headache, he also had  vaccination site pain. Self treated the chest pain with biofreeze.  Action taken with mRNA-1273 in response to the events was Not applicable.   The outcome of events was Unknown, at the time of this report.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Headache, Myalgia, Diarrhea, felt unwell, site redness, swelling,pain, fatigue - symptoms with both sides Narrative:
Intermitten Chest pains, left and right sides, at random times of the day. Goes away on some days, stays on others. Unsure if side effect of the the first or second shot.
Low-grade fever,  chills and hot flashes, joint aches, headache, lethargy,  and pain, redness, and swelling at the injection site
The next morning I woke up with severe BPPV (benign paroxysmal positional vertigo) involving mostly my right ear, but somewhat my left. I also had most likely an inner ear infection as well, which I did not have symptoms of the previous night. I was developed increasingly worse nausea Sunday, March 3 through Monday noon March 4th. It was eased with the PT treatment for the BPPV as described below and with DRAMAMINE.
Metallic taste coating my mouth. I went to urgent care and they said it would last a few days and it?s going on 2 weeks and it hasn?t changed. It sometimes either taste like metal or a battery
Per pt call on 12.29.22. pt started having half body paralyzed on and off about 7-8 days after injection. After discussing with regular MD was rushed to ER. Pt ok know, but per pt a neurologist said that he had many mini strokes. per pt around 21 mini strokes.
Patient was administed expired Covid-19 Moderna Vaccine. Notified Moderna when we were made on 11/17/21 by regulatory authority Patient has been called and informed of incident and advised to come in and be given an additional full dose of Covid-19 Moderna Vaccine per the instructions of both Moderna and regulatory authority.
Her arm hurt that night, it was uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Her arm hurt that night, it was uncomfortable) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Hypertension. Concomitant products included VITAMINS NOS for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PAIN (Her arm hurt that night, it was uncomfortable). At the time of the report, VACCINATION SITE PAIN (Her arm hurt that night, it was uncomfortable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included medicines for diabetes, high blood pressure, cholesterol, vitamins and blood thinners. patient reported that her arm hurt that night, it was uncomfortable.It's gotten better but it was still tender. she also mentioned that for  first 3-4 days it was very sore, now her arm was a little sore. Treatment for the event included one little aspirin and managed with hot shower, ice and heating pad.
1st day of vaccine; I felt very tired and fatigued  and my joints started to hurt and I could not walk due to the pain in my joints. 3rd and 4th day of vaccine; I started to experience numbness sensation to my hands. I also had numbness sensation to my face, right side and lips and also to my head. I went to Urgent Care where lab work was performed as well as a CT scan of the head to check for blood clots and results came back normal. Also an U/S of the right leg to check for any blood clots was performed which came back normal. I then went to see my PCP who performed more tests and exams, again did lab work to check for blood coagulation and still continued with the numbness sensation to my hands and all to my body. After about 10 days of my vaccine, I noticed that my oxygen level was 87, 96, 86, 92 and where my oxygen level has always been around 98 or 99.  I will be also having heart studies in a few weeks. I have not recovered from my symptoms and feel very fatigued and tired all the days.
wearing lingeries, wants to have breasts implants; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 36-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ABNORMAL BEHAVIOUR (non-serious), outcome "unknown", described as "wearing lingeries, wants to have breasts implants".  Additional information: It was reported that they have known him for 2 years now. He was a neuroscientist researcher and professor in (name) university. After his 3 pfizer shots he has been sending me pictures wearing lingeries. This he tells he wants to have breast implants. Is 5.8 feet tall 170 pounds with no medical conditions but has sister.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.   This case is linked to cases 2023SA057309(CLUSTER) and 2023SA057733(CLUSTER).   This case involves Adult patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes (product storage error) (latency: unknown) and was administered to patient post temperature excursion with no reported adverse event (poor quality product administered (latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunization).   It is unknown if the patient experienced any additional symptoms/events   It is unknown if there were lab data/results available.   Action taken: not applicable. Outcome:  Unknown for both the reported events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
This spontaneous report as received from a registered nurse refers to a unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored PNEUMOVAX23. No adverse event was reported. The outcome was unknown. This is one of the 4 reports received from the same reporter. Additional information has been requested.
8-10hr p/vax pt reports onset of nausea, aching muscles, chills-t101+, redness & swelling @ inj site (but this was not main concern);approx 24hrs p/vax pt went to ER;MD advised pt had an allerg rxn to inj & body  has toxic rxn;rx DPH;
Pt developed a diffuse erythematous, pruritic and finely papular rash, worse at injection site at right thigh and in stocking-glove distribution approximately 16-20 hours post injection. No respiratory symptoms.
Redness and swelling at injection site, nickle-sized lump under the skin at injection site (upper thigh), fussiness/tiredness, poor appetite, seizure-like episodes - usually multiple episodes in sequence, several times/day, for months following vaccine.
Retinal Vein Occlusion (right eye); This spontaneous case was reported by a consumer and describes the occurrence of RETINAL VEIN OCCLUSION (Retinal Vein Occlusion (right eye)) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (morphine). Concomitant products included METFORMIN, LISINOPRIL and FINASTERIDE for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced RETINAL VEIN OCCLUSION (Retinal Vein Occlusion (right eye)) (seriousness criterion medically significant). At the time of the report, RETINAL VEIN OCCLUSION (Retinal Vein Occlusion (right eye)) outcome was unknown.            Wife was reporting on behalf of her husband. The reporter stated that the patient had no history of retinal problems.  Treatment information was not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Head ache, frontal and back of head, arm pain into hand for 2 days then sore 2 wks. Felt badly bruised. Vertigo, nausea, stomach, chills and low grade fever. Still have vertigo and headache.
Patient had immediate dizziness, nausea and felt tired after getting the vaccine. She had not eaten that morning. She progressed the next day and was seen back in the office due to worsening fatigue, "lethargic" yesterday after vaccine, eating less, nausea, slowed speech, body aches, limp yesterday, fatigue, more emotional, tingling in fingers, feeling weak, one episode of acute onset and acute resolution chest pain, emesis x1 today. She was seen in the ER for these symptoms due to her history of heart condition - no treatment. She continued with muscle aches, pain at the injection site, fatigue and chest pain intermittently for 7 days. On day #8 after vaccination, she was slowly starting to resolve with less fatigue.
This is a spontaneous report from a contactable consumer (patient). A 17-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 20May2021 at 08:30 (Batch/Lot number was not reported), at the age of 17-years-old, as dose 2, single for Covid-19 immunisation. The patient has no medical history, no concomitant medications and no past drug history. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. The patient previously took the first dose of bnt162b2 on an unspecified date for Covid-19 immunisation with no reaction. On 20May2021 at 15:00, the patient experienced heart pain for 17 hrs. She got the injection at 08:30. Heart started hurting around 3pm and hurt for 17 hrs until next evening. Outcome of the event was recovered on 21May2021.  Since the vaccination, the patient has not been tested for COVID-19.  Information on lot number/batch number has been requested.