chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TOOK TWO UNREFRIGERATED DOSES; A spontaneous case report was received from a pharmacist on 06-Sep-2019 for two consumers.  Based on the information obtained from the pharmacist, two individual case safety reports PVX201909-000723 (PVX2019-2277; husband) and PVX201909-000724 (PVX2019-2278; wife) were created and cross-linked in the database.  This spontaneous case (PVX2019-2277) described a male consumer who "took two unrefrigerated doses" (PT: Product storage error), while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took two doses of Vivotif, which were unrefrigerated for 2 weeks.   Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable. US-PaxVax Berna GmbH-PVX201909-000724:
No Adverse reactions at this time.  Patient is a 7 week old given the flu vaccine by mistake.
6x8cm in diameter, red and warm to touch on the right thigh. Appropriate injection site. No treatment. PT was in office 10/21/2016 @ 2pm.
erythema, pain @ site, low grade temp (100 max), irritability; 2 brief episodes "eyes went white & pt jumped (shook?);
Vaccine was given on 9/23/2021 and had expiration date of 9/21/2021.  This was confirmed on 9/23/21. Health officer notified immediately, medical director notified immediately. Contacted Department of Health and was told to report to vaccine manufacturer.  Those steps were completed by 8pm on 9/23/2021.
Headache; body ache; nauseous; This is a spontaneous report from a contactable consumer, the patient. A 63-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Er8733) via an unspecified route of administration in the left arm on 31Mar2021 at 14:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had a history of allergy to sulphate. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 08:00, the patient experienced headache, body ache, nauseous and also in bed for entire day after the second dose of vaccination. The adverse event did not result in doctor or other healthcare professional office/ clinic visit/ emergency room/ department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events headache, body ache and nauseous were resolved with sequelae on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Left arm pain from shoulder to hand. From 11/9 -> present 11/30/12.
Headache lasted 4-5 hrs. Next night same event, headache lasting 4-5 hrs. Next day dizzy spells short lived next AM total vertigo sudden attack followed by severe nausea and uncontrolled vomiting. I called ambulance, went to ER, treated to control vomiting, Test done showed no physical problems, was released after vomiting under control. Dizziness remained two more days and then began to relent. This Am 10/08/2013 feeling more like normal.
Developed severe chest past 10/10. Has history of sickle cell disease and went to the ER. Treated as sickle cell pain with IVF, ketolorac, dilaudid. Chest x-ray was normal. Labs baseline for patient. Had abnormal EKG (Sinus rhythm -normal P axis, V-rate 50-99 -Abnormal Q suggests anterior infarct -Q >30mS in V2-V4).   Discharged home, but pain took 3-4 days to recover.  Follow up EKG on 7/9/21 showed sinus brady and marked sinus arrhythmia, but otherwise normal. Echo was also normal.
Pt developed a pimple on the back of his Rt upper arm he "mashed it" it became black and blue and red all around it. He believes it is due to flu shot.
Patient stated that he suffers from diarrhea, and had to use the bathroom twice in a row as soon as he went home from the pharmacy. Fellow pharmacist recommended OTC medication for treatment.
09/06 took Tylenol after the vaccine  09/07  Am. Increased temp.,  99.9 I took Tylenol again. By  about 12:00 the cough started I started to feel achy  in my arms and legs. By  about 6:00 Pm the chills started but went away after I went to bed. Slept through the night when I woke up my temp was 100.2 my usual temperature is 97.4 ish.  The aches started non stop I slept all day 3:37 and I took Tylenol half hour ago still high temp.  I take GALYNIA  for my MS .
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 25th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 26th February 2019, 1 days after receiving SHINGRIX, the patient experienced tiredness and sluggishness. On an unknown date, the outcome of the tiredness and sluggishness were not recovered/not resolved. It was unknown if the reporter considered the tiredness and sluggishness to be related to SHINGRIX. Additional details were provided as follows: The anatomical location was right arm. On the day of reporting the patient woke up feeling very tired and sluggish. The reporter gave consent to follow up. The reporter gave permission for his physician to be contacted.
Chills; muscular pain; tiredness; This is a spontaneous report from a contactable consumer. This 40-year-old female consumer reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL3247) via an unspecified route of administration from 12Feb2021 at 01:15 pm to 12Feb2021 at 01:15 pm at single dose (dose number; 2) on left arm for covid-19 immunisation. Patient was 40 years old and not pregnant at the time of vaccination. Patient's medical history was not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL3247) via an unspecified route of administration from 22Jan2021 at 12:00 pm to 22Jan2021 at 12:00 pm at single dose (dose number; 1) on left arm for covid-19 immunisation. Facility type vaccine was reported as workplace clinic. Patient's concomitant medications were not reported. If other vaccine in four weeks was reported as no facility type vaccine was administered. Patient experienced chills, muscular pain, tiredness on 12Feb2021 at 06:00 pm. Treatment for adverse event was reported as no. If COVID prior vaccination; no, If COVID tested post vaccination; no. The outcome of events was recovered on an unknown date.
Lethargy, crying, fussiness, fever (100), pain at injection site, sleeping more than usual
Day of vaccine (1/11/2021: ~5:00 pm - mild right sided facial numbness, mild right ear ache, mild sore throat, runny nose right nare,  ~2:00 am on 1/12/2021 - right leg swelling and pain ~11:00 pm on 1/12/2021 - significant whole body pain, significant headache
This patient circled Pfizer for vaccine choice. She did not bring her vaccine card with her, nor did I look it up on her report. After questioning post Pfizer administration, I learned that she never received her 2nd dose of Moderna in September 2021, when it was due.  This dose of Pfizer was her 2nd dose, her 1st dose was Moderna. There were no adverse outcomes. No medical treatment was needed.
Patient received Moderna vaccine for 1st dose, accidentally given Pfizer for his second dose. Patient has reported no adverse events at this time.
2 weeks later on 12/16/21 I started itching really bad all over. A few hours later a rash developed and it come and go along with being be a mixture of bumps and hives.  The rash sometimes appears as skin writing. I am able to take Zyrtec to help minimize the symptoms, but it does not ever go away completely. It is now 1/19/2022 and still continuing.
Mother reports within a few hours after injection, child developed redness and swelling from her elbow to the top of her shoulder. the area was hot to touch, "hard as a rock", and extremely painful requiring pain relievers. She reports child also had extreme lethargy/tiredness for the first 24 hours after the vaccine. Child also developed hives for 5 days. Mother treated at home with Benadryl.
The area became swollen and very red. It felt hot and hard and hurt. The glands under the arm became sensitive and also hurt.
i feel sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (i feel sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (i feel sick). At the time of the report, MALAISE (i feel sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. List of concomitant medication were not given.
Hormonal change; Swellness in the breast; Lost of hair; This is a spontaneous report from a non-contactable consumer, the patient. A non-pregnant female patient of unknown age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not reported. On an unknown date, the patient had hormonal change, swellness in the breast and lost of hair. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hormonal change, swellness in the breast and lost of hair was not resolved at the time of the report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt has weakness. Trouble swallowing. Body stiffness. Flu Like symptoms. admitted to hospital a week for 2 days . Head shakes and gets very weak.
Headache, dizziness, given PO fluids. BPs 120/83 (pulse 86), 128/85 (final, pulse 77).
serious danage to my body; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (serious danage to my body) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (serious danage to my body) (seriousness criterion hospitalization). At the time of the report, VACCINATION COMPLICATION (serious danage to my body) outcome was unknown.            No concomitant medications are reported.  No treatment medications are reported.  Patient hospitalized from 40 days after vaccination due to serious danage to body.  Very limited information regarding this event has been provided at this time. Further information regarding temporal association (vaccination and event dates) is necessary. Translation of non-english text in narrative is pending.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information regarding temporal association (vaccination and event dates) is necessary. Translation of non-english text in narrative is pending.
10/16/12 Tuesday pt given ZOSTAVAX inj. SQ (L) upper arm. 4" diam. whelp is evident with heat and redness. Rec: ibuprofen & BENADRYL x 3-4 days.
Fatigue, by 9:00 PM had fever <100, shaking chills, body aches, exhaustion. Took Ibuprofen 600 mg and hot shower. 3-20-2015 Next day could not get out of bed until 10:30 AM, had to nap from 1:00 to 3:00 PM. Low grade temp, fatigue, shaking chills, body aches (treated with Ibuprofen 600mg), nausea - forced fluids, could not eat.    3-21-2015 Better, but fatigue all day.
Area around where ZOSTAVAX was administered on rt. arm was red, swollen, painful. Patient said started out as large area and got better once ice was applied. Patient stated that it itched, too. She stated today that she is very sensitive to vaccines.
I took my booster shot on 8-24-21 I did very well with my arm only feeling sore and I was tired, but then I thought that was it, but up to now all I do is feel really tired all of the time. I still want to sleep for half the day at least. I was never this tired until the booster shot from Pfizer. I live in a small town so next time I travel 100 miles to my doctor I will have blood work done. I hope other symptoms don't show up. Sincerely.
fast heartbeat; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced fast heartbeat (non-serious) on Mar2021. The patient underwent lab tests and procedures which included heart rate on Mar2021: fast heartbeat (at night, she had a fast heartbeat).  The outcome of the event was unknown.   No follow up attempts are possible; Information about Lot/batch number cannot be obtained.
pt was unresponsive, pulsless, t31C, probable dx SIDS;
At about 12 hours post injection, I developed fever (101.2), chills, fatigue, nausea, headache, muscle and joint pain . The symptoms were present for almost 24 hours. Headache lingered another 6 or so hours . I took Advil liquid gel caps about every 8 hours until resolved. Felt fine within 48 hours
Pt. arrived today for an appt. Pt. explained that her (R) deltoid (upper extremity) had a reaction from vaccine. Area noted to be 50mm x 50mm (round and circular). Pt. denies pain. No fever/chills. Area noted to be pink, no evidence of cellulitis.
My arm muscle was soar after the shot and the muscle continues to be soar four months later.   I heard a news story about this situation this morning  thus I am reporting my experience now.
patient reported waking up in the middle the night feeling mildly short of breath with a sensation of throat tightness.  Did not seek medical attention and symptoms resolved without treatment by morning.
soreness in arm 2 days p//vax;h/a, general malaise, anorexia (loss of appetite);
R Hand numbness and she is not answering questions appropriately. Face numbness instructed parent to take child to see doctor.
annoying; little rash; itchy; (rash) is even in my scalp; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE IRRITATION (annoying), INJECTION SITE RASH (little rash), INJECTION SITE PRURITUS (itchy) and RASH ((rash) is even in my scalp) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 an unknown date, the patient experienced INJECTION SITE IRRITATION (annoying), INJECTION SITE RASH (little rash), INJECTION SITE PRURITUS (itchy) and RASH ((rash) is even in my scalp). At the time of the report, INJECTION SITE IRRITATION (annoying), INJECTION SITE RASH (little rash), INJECTION SITE PRURITUS (itchy) and RASH ((rash) is even in my scalp) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not provided. Treatment details were not provided.
headache; menstrual changes/she still has her period and that is very unusual; . This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 15 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 23Jul2021 19:00 (Formulation: solution for injection, Lot number: FA7485) at the age of 15 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; MENSTRUATION IRREGULAR (non-serious), outcome "not recovered", described as "menstrual changes/she still has her period and that is very unusual". Therapeutic measures were not taken as a result of menstruation irregular.  Additional information: The reporter is the grandmother of a 15-year-old female patient and just got her granddaughter aged 15 vaccinated and the 1st dose of the vaccine was on 23Jul2021 and states the patient's period started on 19Jul2021 and she still has her period and that is very unusual, and she is always regular and wanted to know if this is related to the vaccine. And the patient also stated that she will not be getting the second dose as scheduled on 13Aug2021 if they don't figure out what's going on or her period doesn't stop. And reporter also wants to know where to go and what to do and if this has something to do with the vaccine. And the reporter declined to provide HCP information and states the patient has a pediatrician that will not see the patient for this, and it is (HCP name withheld) and the HCP said she does not know anything about this and there is nobody to call for the HCP, and reporter also states can Pfizer not direct them to where to go. The patient was not administered any additional Vaccines on Same Date of the Pfizer Suspect. Patient was not going any emergency room visit or not went to any Physician office. The patient had not received any other vaccine within 4 weeks prior to the vaccine.  No follow-up attempts are possible. No further information is expected.
This case reported by a health are professional in the United States on 14 April 2008. A 53-year-old female patient received a left upper arm intramuscular injection of ADACEL (lot number C2853AA) on 04 April 2008, after sustaining a scratch to the right hand. Medical history included an iodine allergy, she was not ill at the time of vaccination. On 10 April 2008 the patient presented to her physician with left arm soreness and swelling at the injection site, and was treated with KEFLEX four times daily. On 11 April 2008 she experienced severe chest discomfort, syncope, and shortness of breath, and was airlifted to the hospital. The patient subsequently recovered, no additional information was provided. The reporter considered the events to be life-threatening.
Patient was vaccinated 4/14. Presented for urgent care 4/23 with three patches of vesicles on left back.
ill-defined disorder; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 73-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medication were not provided. On or about 2016, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a healthcare provider for shingles and other zoster-related conditions. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Approximately 24 hours after injection (March 20, 2021)  I became nauseous and started vomiting.  Then chills set.. Felt like I had COVID 19 all over again.   I did not have fever.   Did not start feeling until 12:00 P.M. March 21, 2021.    I did have the Corona virus in December of 2020.  Waited 90 days to get the first vaccine shot on March 18, 2021.
a huge swollen armpit after 12 hrs, that moved down into a large watery lump on side of torso by May 1st; major tonic seizure; fainted; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old male patient received BNT162b2 (BNT162B2), on 28Apr2022 at 17:00 as dose 3 (booster), single (Lot number: FK9893) at the age of 29 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: DULOXETINE; SYNTHROID. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EW0181, Location of injection: Left arm), administration date: 22Jul2021, when the patient was 29-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EW0196, Location of injection: Arm Left), administration date: 28Jun2021, when the patient was 29-year-old, for COVID-19 immunization. The following information was reported: SYNCOPE (medically significant) with onset 30Apr2022 at 09:30, outcome "recovering", described as "fainted"; TONIC CONVULSION (medically significant) with onset 30Apr2022 at 09:30, outcome "recovering", described as "major tonic seizure"; SWELLING (non-serious) with onset 01May2022, outcome "recovering", described as "a huge swollen armpit after 12 hrs, that moved down into a large watery lump on side of torso by May 1st". The events "major tonic seizure", "fainted" and "a huge swollen armpit after 12 hrs, that moved down into a large watery lump on side of torso by may 1st" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: Unknown results; Electrocardiogram: Unknown results; Electroencephalogram: Unknown results; Fluid wave test: Unknown results; Magnetic resonance imaging: Unknown results. Therapeutic measures were taken as a result of tonic convulsion, syncope, swelling.
Severe chills, muscle and joint aches, fever (101.6). Short shallow breathing, 90% blood oxygen. Mild diarrhea. Lasted 24 hours so far. Still feeling symptoms. Taking ibuprofen and acetaminophen.
Patient went to Dr and Dr described the rash as a Psoriasis Type Rash , even though patient has never been diagnosis with psoriasis in the past
Post-Vaccine Screening Observation Time:30 min Any reaction(s): After 15 minutes, pt was checked and he c/o some discomfort in the left arm, from injection site down the arm. He was observed for another 15 minutes, and this was still his sxs, so NP was asked to check pt. Checked pt at 12:25pm, approx 30 minutes after vaccine given. patient had c/o left arm feeling "odd" and endorsed a sense of shooting pain, not numb or painful or sharp, from the site to the fingers. Sxs started about 5 minutes after the vaccine was given. They have since decreased while he's been watiing Additional post-vaccine screening: See ROS for more details; observed pt for another 20 minutes, he had no progression, he stated that the "odd feeling" in the arm was slowly going away. He was d/c home with instructions to go to UC or ER if the sxs worsened or changed to involving the cardiac/respiratory systems. Patient verbalizes understanding and agreement with plan of care.