chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore throat; Swollen lymph nodes; injection site hurt so much I couldn't lift arm; Extreme chills; 104.5F fever; headache; Sore joints; malaise; Cough; out of breath after walking around; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 37-years-old male patient received bnt162b2 (BNT162B2), (Formulation: Solution for injection, Batch/Lot Number was Unknown, Expiration Date: Unknown) as dose 2, single via an unspecified route of administration, administered in Arm Left on 10May2021 09:00 (at the age of 37-years-old) for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine received was bnt162b2 (BNT162B2), (Formulation: Solution for injection, Batch/Lot Number was Unknown, Expiration Date: Unknown) as dose 1, single via an unspecified route of administration, administered in Arm Left on 14Apr2021 09:00 for covid-19 immunisation and no reaction reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 10May2021 16:00, the patient experienced sore throat, swollen lymph nodes, injection site hurt so much i couldn't lift arm, extreme chills, 104.5f fever, headache, sore joints, malaise, cough, out of breath after walking around. All events reported as non serious. The patient did not receive treatment for events. The clinical course reported as follows, my symptoms continued for 5 days. I had a sore throat and swollen lymph nodes for days 3-5. On day 1, injection site hurt so much I couldn't lift arm. Extreme chills on days 1, 3, 4 and 5. A 104.5F fever on day 4. A headache for most days. Sore joints and general malaise the entire time. Cough starting day 5, out of breath. The patient underwent lab tests and procedures which included body temperature: 104.5 fahrenheit on an unspecified date. The outcomes of events were recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dizziness, lightheaded.  Worsening over the past 48 hours. No fever or chills.
Heart rate 170, mottled legs and feet (purple), tingling in face, metabolic acidosis with serum PH of 7.02
Client called us 6/23/04 reporting that the injection site where Yellow Fever was given is red, hot to touch, and has been getting larger each day. Says the area is about 2" by 3". Reports feeling allitle tired. No other complaints. Referred client to her doctor for evaluation. Emphasized the importance of having it evaluated.
Approximately 14 minutes post-vaccination patient stood up from chair in waiting area complaining of nausea and GI complaints. Patient was instructed by pharmacist on duty giving vaccinations to immediately sit down. Patient described nausea and feeling a little cold. Patient's smart watch reported a heart rate of 56 bpm at around 1:18pm.  Pharmacist assessment showed that patient was cold to the touch, not dizzy, slightly uncomfortable, and after a few minutes was visibly perspiring. Patient took 1/3 of a bottle of water provided to him while waiting for Emergency Responders were contacted. Patient then noted that they had some tongue swelling and upon observation by Pharmacist on duty patient's tongue was inflammed and lightly swollen. Emergency Responders advised against further fluids or food intake so patient was denied further fluids until Emergency Responders arrived. Patient was layed flat on the floor as a precaution until Emergency Responders arrived. Patient was assessed at around 1:20pm by Firefighters who arrived on the scene first and vitals were taken. Upon instruction by Firefighters patient stood up straight and noted no signs of dizziness. Firefighters did note some swelling of the tongue and patient insisted on being evaluated at the Hospital.
Pt was on 4J as inpatient for rehab post stroke when he contracted COVID due to outbreak on the unit. He was transferred to 3E for isolation. Ver had mild nasal congestion the day he was diagnosed, but was otherwise asymptomatic throughout his COVID course. He did receive Cas/Imde mabs, and was later transferred back to 4J reinstate rehabilitated.
This spontaneous report was received from a Registered Nurse refers to a 5 month old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. On 08-MAR-2018, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB, lot # N012921 (expiry date: 28-FEB-2020) for prophylaxis (incorrect product storage) (dose not reported). The vaccine was concomitantly reconstituted with properly stored sterile diluent (MERCK). The vaccine underwent a temperature excursion of 34.70 F for 0.25 hours. No adverse effects were reported. The call was because of a data logger. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1804USA000815: US-009507513-1809USA002916: US-009507513-1809USA002917: US-009507513-1809USA002918: US-009507513-1809USA002919: US-009507513-1809USA002920: US-009507513-1809USA002921: US-009507513-1809USA002923.
Pt. c/o swelling, itching and blisters at site of injection on 7/25/12. By early AM 7/26/12 the upper (R) arm is red, swollen, warm to touch. Skin was excoriated with open areas very painful. Size of area was approx. 5" X 4". Pt. admits to scratching area. Dx with cellulitis at hospital. Given IV antibiotics - also given ointment and oral antibiotics.
Patient presented to nurse at vaccination clinic with rash on abdomen, rash with hives on both arms, neck and face. Patient complained of tingling in her arms and hands.  No complaints of respiratory distress or symptoms. Epinephrine and Benadryl given IM. EMS transported to hospital.
Pfizer-BioNtech COVID 19 Vaccine EUA 2nd COVID vaccine 1/16/21 Within 24 hours headache, nausea, vomiting, & hot flashes without fever. Sx resolved and headache returned 1/23/21.  Headache has been constant since 1/23/21 (No relief despite OTC, px, consults, chiropractic care, etc)
The patient felt light headed and appeared pale in color after receiving the vaccine.  We gave him a bottle of water and allowed him to sit in the immunization booth until he felt better.  After about 15 minutes he looked better and he said he felt better and that he was no longer light headed.
Swelling, redness, itching, and pain at injection site.  Diameter of area affected - approximately 4".
patient received expired dose of ACTHIB/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a other healthcare professional.  This case involves a 16-months-old female patient who received expired 0.5 mL fourth dose of HIB (PRP/T) VACCINE [ACT-HIB] (frequency: once, strength: standard, lot number: UJ063AA and expiry date: 31-Oct-2020 via an intramuscular route in the right thigh) (expired product administered) on 02-Dec-2020 for prophylactic vaccination.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP).  The patient's medical history, past medical treatment, vaccination and family history were not provided.  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.  Reporter stated that the product was not used for first time in the patient.  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 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.
Patient came in to fill RXs for Acyclovir 800 mg three times daily x 7 days and MEDROL dose pak. She stated she had a Flu shot 3 days prior, and MD diagnosed her with "viral Bell's Palsy." Her right side of face was droopy, (R) eyelid did not close when she blinked, stated loss of feeling in (R) side of face.
feeling like she thought she was going to die; sick for 6 days, it was awful; she couldn't come to herself; producing so much phlegm she choked when speaking; body aches; running nose; did not feel well; trouble lifting her arm from so much pain; producing so much phlegm she choked when speaking; itching; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 14Oct2021 (at 79-year-old) as dose 3 (booster), single for COVID-19 immunisation. Medical history included allergic to a lot of things and patient didn't take medications because she was allergic to it. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose1 and dose 2, both via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient reported feeling like she thought she was going to die on an unspecified date and several adverse events after the dose on 14Oct2021 including: running nose, body aches, trouble lifting her arm from so much pain, producing so much phlegm she choked when speaking, and itching. She did not feel well for six days and has taken cold/flu medications to help. She was not too thrilled about it. She asked if these symptoms have been reported before. She took the Pfizer 1 and 2 shot no problem and took the booster and she thought she was going to die. 3 hours later her nose was running, her body was aching, when she tried to speak she was choking on so much phlegm. She was sick for 6 days, it was awful. She knew people that have taken it without any effects but for some reason she did. She wound up having itching since she took the shot and went to her dermatologist. She was allergic to a lot of things and they didn't ask questions or say they need to know anything about anything. She didn't know if she would take another one, it was like 6 days like that and she couldn't come to herself. She couldn't lift her arm to put on clothes she was in so much pain, it was weird. Patient thought it must be something in the shot. She said this was 6 days. She took some medication to try to ward it off and that took time and she was getting better and better. She was fine before the vaccine and was sick as a dog after. Her neighbor has been checking on her and she talked to her doctor and he told her to take cold and flu medication and that helped. Other than for itching her doctor gave her some allergy pills, she tooke allergy pills every day but he gave her something else for morning and evening. She didn't like to take medications, vitamins were ok. The outcome of the events was recovering.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Information has been received from a consumer concerning her 18 year old daughter with a fruit allergy who on approximately 30-NOV-2007 was vaccinated with her first dose of Gardasil (lot# not reported). There was no concomitant medication. On approximately 01-JAN-2008 the patient experienced a soy allergy (can be anaphylactic and the patient has an epi pen). The patient's soy allergy persisted. The patient sought unspecified medical attention. Additional information has been requested.
Persistent and chronic cough , shortness of breath, wheezing, severe fatigue and worsening shortness of breath with any exertion.  Chronic and worsening  rash, dermatitis on face and hands, joint stiffness and pain. Symptoms have all slowly worsened since 9/22/2021. Several courses of antimicrobial medications and inhaled steroids.  No improvement so far.
Pt started to have facial and neck swelling, pain and tightness in throat and difficulty with breathing x12 hours before coming into ED.
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) was resolving. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications were reported.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included CLONAZEPAM for Anxiety, PARACETAMOL (TYLENOL) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced TINNITUS (Tinnitus). On 16-Apr-2021, TINNITUS (Tinnitus) had resolved.            No treatment information was received.   This case was linked to MOD-2021-275381 (Patient Link).
VACCINE WAS GIVEN AT APPROXIMATELY 10:35AM ON 7/16/19.  AFTER AROUND 10 MINUTES SHE STARTED TO COMPLAIN THAT SHE WAS FEELING DIZZY.  SHE RECIEVED A 50MG DOSE OF BENADRYL AS A PRECAUTION.  AFTER ROUGHLY 1 MINUTE SHE SAID THAT IT WAS GETTING WORSE AND WE LAID HER DOWN.  THE DIZZINESS KEPT GETTING WOSE AND AFTER ABOUT ANOTHER MINUTE, SHE SAID THAT SHE WAS HAVING DIFFICULTY BREATHING AND HER CHEST WAS STARTING TO TIGHTEN UP.  AT THIS POINT EMS WAS CALLED AND A DOSE OF EPINEPHRINE 0.3MG WAS GIVEN IM AT APPROXIMATELY 10:47.  SHE BEGAN TO CATCH HER BREATH AFTER DOSE 1 OF EPINEPHRINE.  EMS ARRIVED AFTER ABOUT 5 MINUTES.  THEY ADMINISTERED A SECOND DOSE OF EPINEPHRINE IN THE AMBULANCE.
Received Tdap to right deltoid 5/22; developed chills and fever and headache that evening. Seen in UC 5/24; right UE was not red, warm or tender. On 5/26, right UE was slightly red; treated with KEFLEX.
felt badly; tired; malaise; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced felt badly, tired, malaise after second vaccine of COVID-19. Outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
redness, hardness, hives @ inject site; hives alos on lt leg; referred to family MD who ordered antihistamines;
I got it on left arm and it is little swollen under the armpit; I knew it was not before; Body ache; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: FK9729) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psychosis" (unspecified if ongoing); "Hodgkin's lymphoma", start date: 2015 (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE. Vaccination history included: Covid-19 vaccine (Dose: 1, Unknown Manufacturer, Prior vaccinations (within 4 weeks): Consumer stated, "No, nothing. My last vaccine was first dose was 202 days."), for COVID-19 immunization, reaction(s): "first shot do not have reaction"; Covid-19 vaccine (Dose :2 , Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose: 3, First booster), for Covid-19 Immunization. The following information was reported: SWELLING (non-serious), outcome "unknown", described as "I got it on left arm and it is little swollen under the armpit; I knew it was not before"; PAIN (non-serious), outcome "unknown", described as "Body ache"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient got his second booster on Thursday in now the first shot do not have reaction it was not anything like swelling. Now second one patient get this Thursday patient noticed today, patient got it on left arm and it is little swollen under the armpit. patient knew it was not before. That reaction to the shot?" Product Pfizer, Covid-19 Vaccine. When paraphrased the concern patient stated, Yes. It was fine before, it was okay on Thursday and nothing yesterday but today but it looks like little swollen under the armpit but patient feel nothing has swollen ever.Prior vaccinations within 4 weeks: Patient stated, No, nothing. Patient last vaccine was first dose was 202 days.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
difficult to lift arm; cloudy brain; soreness at the injection site; body aches; fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (difficult to lift arm), FEELING ABNORMAL (cloudy brain), VACCINATION SITE PAIN (soreness at the injection site), MYALGIA (body aches) and PYREXIA (fever) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included CITALOPRAM for Anxiety, CETIRIZINE for Seasonal allergy, CELECOXIB (CELEXA [CELECOXIB]) and ROFLUMILAST (ADAIR) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced HYPOKINESIA (difficult to lift arm), FEELING ABNORMAL (cloudy brain), VACCINATION SITE PAIN (soreness at the injection site), MYALGIA (body aches), PYREXIA (fever) and HEADACHE (Headache). On 27-Feb-2021, VACCINATION SITE PAIN (soreness at the injection site), MYALGIA (body aches), PYREXIA (fever) and HEADACHE (Headache) had resolved. On 28-Feb-2021, HYPOKINESIA (difficult to lift arm) and FEELING ABNORMAL (cloudy brain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Additional info received,event added, concomitant medications added
One day post vax, the pt developed localized redness and swelling which progressively worsened. By two days post vax the pt had experienced a huge amount of swelling and redness extending to posterior aspect of leg. Pt seen by physician but no treatment given other than cool compress to site. Swelling and redness gradually subsided and completed resolved within 7 - 10 days.
fast heartbeat; This is a spontaneous report from a contactable consumer reporting for self. This 82-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021 at left upper arm at single dose for COVID-19 immunisation.  Medical history included blood pressure abnormal and blood cholesterol abnormal. Concomitant medications included lisopnphill (as reported, spelling as provided by caller- as close as he can get) started it 3 years ago (in 2018) for blood pressure; pravastatin started about 3 years ago (in 2018) for cholesterol. On 07Jan2021, patient experienced a fast heartbeat for about a minute when was going to lay down to go to sleep. He had not had the other symptoms like dizziness or chills, and did not experience a rash, dizziness, or swelling all over face, that had not happened.  He saw his primary guy 3 days after and all his counts were good, his blood pressure and everything, etc. so they didn't suspect anything at this time. He will go ahead with the second shot. He had an exam with his private doctor on 12Jan2021, and everything was fine. The outcome of event was recovered on 07Jan2021.   Information on the lot/batch number has been requested.
Sweating, chills, aches, high fever (102 F), headache, pain and soreness at injection site, flashing pain in back of head, on 08/27/13 pat developed baseball size rash.
Pt vaccinated with MMR c/o headache continued 13SEP90 became worse called local medical doctor possibly flu - 14SEP90 vomiting called MD - Hosp- WBC 19,000 - hospitalized spinal tap done- started IV fluids & antibiotics. DC hosp 20SEP90.
Symptoms later during day 7/28/21-Body aches; Symptoms next day 7/29/21: Chills, low grade fever, headache, body aches, nausea which continued into 7/30/21; 7/31/21 had chest pain right when woke up in the morning.
cold; Deep cough; This is a spontaneous report from a contactable consumer or other non hcp.Pfizer Sponsored Program.   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced cold, deep cough on unknown date. The seriousness of the events was reported as non-serious. The outcome of all events on an unspecified date were unknown.  Follow-up attempts completed. No further information expected.
started with a mild headache before bedtime. woke up in middle of night with arm/shoulder pain in left arm (injection arm) also was feeling fever-ish (although no fever indicated by thermometer). Woke up several other times throughout the night with sweats and chills. Headache and body fatigue lasted for about 36 hours.  Arm/should pain lasted for about 72 hours post injection.  Occasional shooting arm pain all the way down to hand, especially during movements. Was painful to raise arm above head and outwards (away from shoulder). Ice was applied several times and did help in the short term. After about 72 hours arm/should pain subsided.   Overall I have fully recovered and those adverse effects are no longer present.
Initial unsolicited report received from a non-healthcare professional on 28 April 2015. A female patient, whose age, medical history and concomitant medications were not reported, had received a dose of INFLUENZA VACCINE (batch number, dose, route of administration, site of administration were reported) on an unspecified date. On an unspecified date after vaccination, the patient experienced flu. Laboratory investigations and corrective treatments were not reported. At the time of this report, patient had not recovered from the event. Documents held by sender: none.
3 days of : Fever over 102, aches, chills, elevated blood pressure and heart rate.  Decrease in hearing .  Tinnitus, fatigue are some dizziness started  within 5-7 days  It has been almost 2 months since shot and tinnitus is still significant, disrupting  daily life.
Began as sore arm, redness and heat began then patient started having trouble breathing. Went to walk in Er and received meds to help and given a script of a medrol dose pack.