chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; chills; began vomiting what meal eaten that evening; diarrhea; very, very tired; GI distress; no urge to eat; This is a spontaneous report from  contactable consumer (patient) and Health Professional Registered Nurse reported via Pfizer Sponsored Program COVAX US Support. A 62-years-old female patient received of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch no: ER8734, Expiration date: 31 Jul 2021) via an unspecified route of administration on 05 Apr 2021 as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the Patient is a Registered Nurse reporting the Pfizer Covid Vaccine was administered to her yesterday, 05APR2021 and is reporting side effects. Caller had the Pfizer Covid Vaccine at 13:00 yesterday and by 21:00 last night had a headache, chills and began vomiting what meal she had eaten that evening, then diarrhea began. The diarrhea has continued through today 06Apr2021, Headache has also continued through today 06Apr2021. Patient is very, very tired. Treatment received as has been drinking fluids and took Tylenol for headache and says it helped began Vomiting what meal eaten that evening, vomiting stopped last night but patient is still nauseous.  Reports a wave of nausea on and off. Chills:Reports the chills went away this morning, but patient had them on and off throughout last night. Onset of symptoms: Symptoms began last night about 9 o'clock, that's what started it all. GI distress: GI distress throughout the night and this morning. Its not as severe as it was overnight. No urge to eat: patient still hasn't really eaten anything today. Says she nibbled an English muffin to get something down. Reports no urge to eat but is drinking water. Outcome of the events was recovering.  No Follow-up attempts are required. No further information is expected.
Day one, diarrhea, sore arm, headache, fatigue . Day 2 sore arm, fatigue  day 3 fatigue day 4 headache day 5 headache day 6 swollen neck lymph nodes as well as armpits and body aches
I noticed a red patch on my arm around the injection site. It was a rather large patch that seemed to indicate where the medication was in my arm. It was warm, not hot, to the touch. My arm felt a little heavy and I felt a tingling sensation in my fingers. I first noticed the redness at around 9:00 PM. The tingling sensation began around 9:45 PM.
Vaccinated at 345 w/ DTaP, IPV, MMR, et VZV. 400 Swelling around eyes, red flat rash blanching with pressure. Mostly upper chest. 410 BENADRYL 12.5 mg given moist cough at that time. 440 Swelling upper lip, epinephrine given by paramedic et. transported to ER. Released from ER after observation that evening.
Extremely heavy menstrual bleeding for 5 days - extreme bleeding that would soak through both super plus tampons (used in tandem with) and high absorbency pads every hour.  Accompanied by significant cramping.
Dose Number:3; Persistent nonthrobbing headaches.; intense scalp itching 1 hour after vaccination x 15 minutes,; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Nov2021 (Lot number: 301558A) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hyperlipidemia" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: if Covid prior vaccination: Yes. Concomitant medication(s) included: ATORVASTATIN. Vaccination history included: Bnt162b2 (Dose 2, Lot No: EL3248, Location of injection: Arm Left), administration date: 15Jan2021, when the patient was 66 years old, for COVID-19 Immunization; Bnt162b2 (Dose 1, Lot No: EK9231, Location of injection: Arm Left), administration date: 24Dec2020, when the patient was 66 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021, outcome "unknown", described as "Dose Number:3"; HEADACHE (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Persistent nonthrobbing headaches."; PRURITUS (non-serious) with onset 30Nov2021, outcome "recovering", described as "intense scalp itching 1 hour after vaccination x 15 minutes,". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache and included treatment with ibuprofen. Additional information: Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. There were no known allergies. Facility where the most recent COVID-19 vaccine was administered was at the Hospital. The patient received atorvastatin within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced intense scalp itching 1 hour after vaccination x 15 minutes, recurred after another hour x 10 minutes.
Within 5 minutes, I became hot and flushed face, red arms below the vaccination site, red legs.  Treated immediately with benadyl and extra water, followed by benadryl  and tylenol 6 hours later and again 6 hours later.  After approx 18 hours, my skin looked and acted like a sunburn reaction. After 24 hours I had chills. After 36 hours all symptoms were gone.
I found out I had COVID-19 because my husband tested positive. I proactively took a COVID-19 test as well. The test was a Flowflex COVID-19 antigen home test. The result was positive. I called my doctor. I was prescribed PAXLOVID and picked it up the same day. I began taking it that day and took it for the duration of the prescription. My symptoms at the time were fatigue and loss of appetite. On the 5th day of PAXLOVID, I repeated the COVID-19 test. The result was negative. I isolated myself from my husband for two weeks to give us each time. I was still tired and had no desire to go out and be among people. That lasted about two weeks. I continued to wear a mask out for the next two or three weeks.
Heart palpitations, pounding heart that feels irregular, at times. Felt nausea a couple of morning along with heart symptoms and a sensation of difficulty breathing. However, I am able to take a deep breath when feeling this way and am able to work out with no difficulty. The symptoms continue intermittently, but do not happen constantly. A Kardia Mobile device purchased and I was unable to detect irregular heart rhythms with it. I considered going to the doctor and possibly the emergency room to get it checked out, but decided against as the symptoms would stop. They still continue off and on to this day.
inability to stand or walk; slurred speech; inability to stand or walk; left sided pain in chest; left sided pain in chest, neck & scapular area; left sided pain in chest, neck & scapular area; elevated BP; lightheadedness; left hand started become cold & felt heavy; left hand started become cold & felt heavy; This is a spontaneous report from a contactable other health professional reporting for herself. A 48-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: unknown), intramuscular (arm left) on 06Jan2021 17:45 (05:45 PM) at SINGLE DOSE for covid-19 immunisation. Medical history included endometriosis from an unknown date. The patient's concomitant medications were not reported. The patient did not take other vaccines in four weeks and no other medications were taken in two weeks. Patient did not have COVID prior vaccination. The patient was tested for COVID post vaccination (Unknown results in 2021). On 07Jan2021 11:30 (also reported as less than 24 hours post vaccination), the patient experienced left hand started becoming cold and felt heavy. On 08Jan2021 12:00 (reported as around noon), the patient experienced inability to stand or walk, elevated BP, slurred speech, lightheadedness; and left sided pain in chest, neck and scapular area. The patient was taken to urgent care and emergency room due to events left sided pain in chest, neck and scapular area, inability to stand or walk, elevated BP, slurred speech and lightheadedness. BP came to baseline by 1am (unspecified date in 2021). Treatment was given for the events. Outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Dysstasia, Dysarthria, and Gait inability cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Pt. rec'd flu vaccine (2011-2012) x 2. Rec'd 1st vaccine 10/13/11 & 2nd vaccine 11/30/11. Pt did not remember getting 1st vaccine & req'd another. No known injury.
It was hard to distinguish if the symptoms were because of Covid or because of my pregnancy, but I became more congested, I had a headache and sore throat, I was very very fatigued, basically I spent 10 days in my bed, I never had a fever, I had a minor cough and a little bit of dizziness. I took Tylenol and Aspirin and Benadryl.  I got the Covid test trough Keiser on 07/30/2021 and on 08/02/2021 they contacted me because I had an OBGYN appointment and I told them to switch them because I did not want to infect anybody else.  I still feel very tired and pretty congested but it is definitely getting better at this point, Pregnancy history: first time being pregnant, healthy for the most part, I am due on 08/15/2021
Shortness of breath, dizziness, numbness of face, hands, legs, feet, shaking, elevated blood pressure, itching, dry mouth and throat, difficulty swallowing. Symptoms began within two hours of receiving flu shot.
Fasting blood glucose elevated; This is a spontaneous report from a contactable consumer or other non hcp.     A 67-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that, The patient experienced fasting blood glucose elevated on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included blood glucose: elevated.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
23MAY95 awakened felt like had flu, achy, fever to 101.9(o) 23MAY95; 23MAY95 2" diameter red raised area @ site of inj;
extreme discomfort up left side of neck and face; extreme discomfort up left side of neck and face; extreme aching teeth; Severe headache; red sore throat; extreme discomfort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: ER 8729) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing); "Chronic Inflammation" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN CALCIUM; METFORMIN. Past drug history included: Novocaine, reaction(s): "Allergies: Novocaine". Vaccination history included: Bnt162b2 (Dose 1, single, Lot Number: ER 8737, Administration time: 04:00 PM, Vaccine location: Left arm), administration date: 31Mar2021, when the patient was 55 years old, for COVID-19 immunaisation, reaction(s): "Slight pain", "discomfort up left side of neck and face", "aching teeth". The following information was reported: FACIAL PAIN (non-serious), NECK PAIN (non-serious) all with onset 26Apr2021, outcome "not recovered" and all described as "extreme discomfort up left side of neck and face"; TOOTHACHE (non-serious) with onset 26Apr2021, outcome "not recovered", described as "extreme aching teeth"; HEADACHE (non-serious) with onset 26Apr2021, outcome "not recovered", described as "Severe headache"; OROPHARYNGEAL PAIN (non-serious) with onset 26Apr2021, outcome "not recovered", described as "red sore throat"; DISCOMFORT (non-serious) with onset 26Apr2021, outcome "not recovered", described as "extreme discomfort". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of facial pain, neck pain, toothache, headache, oropharyngeal pain, discomfort.  Additional Information: Facility type vaccine: Pharmacy or Drug Store. No, other vaccine in four weeks. Other medications in two weeks: Atorvastatin, Metformin  No follow-up attempts are possible. No further information is expected.
Experienced lesser side effects; This case was reported by a nurse via call center representative and described the occurrence of adverse event in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of adverse event (recieved 1st dose on unknown date, refer case US2020AMR014607).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the adverse event was recovered/resolved.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. The patient received Shingrix stated that the doctors at her workplace are stating that it was their general finding in their clinical setting that patients who got the 2nd dose further apart from the 1st dose experienced lesser side effects. The reporter consented to follow up. This case linked with US2020AMR014606 and US2020013944, reported by same reporter.
On day of 2nd vaccine, suffered extreme indigestion. Stomach had not been right since. Always very loose stools, often with what appears to be oily droplets floating on top. Frequent digestive cramping.
Injection site is hard & warm to touch. There is slight redness & arm is achy. Symptoms showed up a week after the injection.
July 16, 2021 had a subarachnoid brain aneurysm.  Was sent to Hospital from another Hospital as he was critical care.  Had a craniotomy, in a coma for 30 days, got  pnenuoma, had a triachea put in, feeding tube and 40 days later a shunt put in.  He left the hospital on August 27, 2021 and went to Rehabilition center for 3 weeks until he could walk again.  Returned home from Rehab on 9/21/2021 with feeding tube, catheter, many prescriptions and rehab for months after.  Has much short term memory loss, takes many medications when he never had any, does not drive or work any more and needs me to get thru days.
got Flu now; gone into Bronchitis; Initial information received on 31-Dec-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who got flu now and gone into bronchitis after receiving Influenza Vaccine.  The patient's past medical history included COVID-19 and Pneumonia last year (2021), patient was hospitalized for pneumonia for by days and got COVID when got home The patient's past vaccination(s) included COVID-19 VACCINE. in 2021 The patient's past medical treatment(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route with unknown form, strength, frequency, route, expiry date for Immunisation.  On an unknown date the patient had got flu now (influenza) and gone into bronchitis (bronchitis) (unknown latency) after the administration of Influenza Vaccine.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (gone into Bronchitis, got Flu now).  Outcome: Unknown for the event bronchitis and was Not Recovered / Not Resolved for the event influenza.  Seriousness criteria: medically significant for event influenza.; Sender's Comments: Sanofi company comment dated 04-Jan-2023: This case concerns a patient who has received Influenza Vaccine and experienced influenza and bronchitis. There is no evidence to suggest a causal role of the suspect product hence the event has been assessed as unrelated to the product. There is no pharmacological plausibility of the patient to develop influenza and bronchitis after receiving Influenza Vaccine, hence the benefit risk profile of product is not affected by this report.
Evening of and the next day: Itchy legs, achy legs, fatigue  Two days after: Fever, chills, muscle aches, fatigue, headache
Neck sorenesss and a lump developed on the neck which sounds like a swollen lymph node.  The neck soreness lasted about three days and is now subsiding
sudden onset of symptoms: left side of face drooping. Pain in left ear radiating along jaw line. PCP put me on course of steroids
Initial spontaneous report received on 04-OCT-2013 from a nurse. A 33 years old female patients whose medical history and concomitant medications were not reported, received a dose of FLUZONE ID (lot # UT4719AA, route is intradermal and site of vaccination was not reported) last injection on 10-Mar-2013. Nurse stated that patient was 9 weeks IUP. List of documents held by sender: none.
Tinnitis- constant high pitched noise in left ear and ear easily clogs. No wax build up and no loss of hearing.
tiredness; hand and foot joints are aching; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st July 2020, the patient received the 2nd dose of Shingrix. In July 2020, less than a day after receiving Shingrix, the patient experienced tiredness and arthralgia multiple. On an unknown date, the outcome of the tiredness and arthralgia multiple were not recovered/not resolved.   It was unknown if the reporter considered the tiredness and arthralgia multiple to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose 24 hours ago and patient's hand and foot joints were aching after receiving 2nd Shingrix shot. The patient asked if this to be expected and how long it would remain and asked if these achy joints (hands especially) and tiredness were normal side effects. The patient wanted to know if most of people felt achiness and if these would remain more than a day.
I experienced soreness in my left arm immediately after each vaccine.  I am now at the 6 months out mark and still have intermittent soreness in my left arm at the site of the vaccine.  It tends to occur when I've been physically active with my left arm.
Local reaction at injection site. Mild symptoms of anxiety angioedema, diaphoretic.
Had vax on 18NOV; on 19NOV started w/a sneezing cold, on 20NOV it went to lungs & 99.9 fever, much coughing, by 22NOV started to get better, by 23NOV was well again;
Unbearable pain in left arm that is not relieved by Tylenol. Pain is still unbearable one week later (5/29/21) Vomiting on night of 5/22-23/21
This case was reported by a lawyer and described the occurrence of injection site pain in a 68-year-old female patient who received FLUARIX (batch number GB749, expiry date 22nd June 2016). Concurrent medical conditions included heart disease, unspecified. Concomitant products included PREVENAR 13. On 23rd November 2015, the patient received FLUARIX (intramuscular) 0.5 ml. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to FLUARIX. Additional details were provided as follows: This case was reported by a pharmacy via a pharmacy claims management company. On 12th January 2016, the patient reported that she continued experiencing pain the right arm (injection site pain). The reported batch number (6B749) of FLUARIX vaccine did not exist and was updated to GB749 as per sales database.
headaches, nausea, body aches, chills,  sore throat, fatigue, light headedness approximately 12 hours after administration which continued for a few days after.  Medicated with Ibuprofen to manage pain.
w/in 3hr p/vax pt arm became edematous, erythemic & painful approx size of a lemon;edema & erythema dec to lower forearm;pt had w bruises w/broken skin;
This is a spontaneous report from a contactable other Healthcare Professional. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318), via intramuscular route of administration on 17Feb2021 (at the age of 53-year-old), as dose 2, single in left arm, and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318), via intramuscular route of administration on 27Jan2021 (at the age of 53-year-old), as dose 1, single in left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported as unknown if the patient had received any other vaccines within 4 weeks prior to the COVID vaccine. It was reported as unknown if the patient had COVID prior vaccination and the patient was tested COVID post vaccination. On 30Jul2021, 5 months and 13 days after second dose of vaccine, the patient was tested positive for COVID and became ill. The patient visited to Doctor or other healthcare professional office/clinic in response to event. It was reported as unknown if the patient received any treatment for event. The patient underwent lab tests and procedures which included SARS-CoV-2 test nasal swab, positive, on 30Jul2021. The clinical outcome of the events was reported as resolving.  Based on the available information ,a possible contributory role of suspect product BNT162B2 to the development of the event covid 19 cannot be excluded.
Wasn't feeling very well; dead arm; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ANAESTHESIA (dead arm), PYREXIA (fever), CHILLS (chills) and MALAISE (Wasn't feeling very well) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE ANAESTHESIA (dead arm), PYREXIA (fever) and CHILLS (chills). On 17-Jan-2021, the patient experienced MALAISE (Wasn't feeling very well). On 18-Jan-2021, VACCINATION SITE ANAESTHESIA (dead arm), PYREXIA (fever), CHILLS (chills) and MALAISE (Wasn't feeling very well) had resolved.            Treatment and concomitant medications were not provided by reporter.
Started with occipital headache 20 minutes post injection.  Arm became red, swollen with "sore joint" 6-9 hours post injection.  TYLENOL for headache-continues-helping.  No fever.  "Redness improving"-getting smaller.  Currently 7/30/08 11AM 25x40 mm.