chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness in arm - difficulty moving and sore to touch; Prone to napping; minor dehydration; Constantly thirsty; Soreness in arm - difficulty moving and sore to touch; Fatigue - tired; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0202) in the left arm on 27May2021 at 15:30 (at the age of 27-years-old) as a dose for COVID-19 immunisation. Medical history included anemia and allergic to beef. Concomitant medications were not reported. 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 COVID vaccine. On 28May2021 at 00:30, the patient experienced soreness in arm, difficulty moving and sore to touch, fatigue tired, prone to napping, minor dehydration and was constantly thirsty but nothing extreme. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events soreness in arm, difficulty moving and sore to touch, fatigue tired, prone to napping, minor dehydration and constantly thirsty were unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Info has been received from a CMA concerning a 6 year old male with no allergies or allergies or medical history who on 7/11/06, was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 2/23/06, the pt experienced a rash with a few vesicles around the throat area. The rash was consistent with chickenpox. Unspecified medical attention was sought and he was treated with Tylenol and Benadryl. No diagnostic lab tests were performed. At the time of the report, the pt was improving. A product quality complaint was not involved. Additional info has been requested.
Pt recv vax on 9/21/98; on 9/25/98 pt exp rash on face.
This spontaneous report as received from an approximately 73 years old male consumer concerning on himself with no pertinent medical history and drug reactions or allergies. The patient was vaccinated with a dose of influenza virus vaccine (manufacturer unspecified) (lot #, dose and site of administration were not provided) on approximately 22-AUG-2012. Other suspect therapies included a dose of ZOSTAVAX on approximately 15-SEP-2012 (lot #, dose and site of administration were not provided). Concomitant medications included: RAMIPRIL. The patient reported that he received a dose of ZOSTAVAX about 2 months ago and 3 to 4 days later (On approximately 17-SEP-2012) developed redness and swelling around the injection site. The reaction was a long area on the side of the arm where the injection took place and that was swollen and tender. The patient also explained that he had had a sensation of pins and needles on his back that occurs when he exercises. He explained that the sensation was similar to wearing a wool sweater. The patient had not been able to look at his back to determine if there was rash that was causing this sensation. No treatment was given for the adverse event. No lab diagnostic was performed. The patient did not seek medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Pressure Headache - 101.8 fever chills severe fatigue & flu-like symptoms Loss of appetite for 2 days Redness & swelling in Right Arm
This case was reported by a pharmacist and described the occurrence of arm soreness at injection site in a 75-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). There were no concurrent medications. On 23 October 2010 the subject received unspecified dose of FLULAVAL (.5 ml, unknown, left arm). On 24 October 2010, 1 day after vaccination with FLULAVAL, the subject experienced arm soreness and stiffness at injection site. On 26 October 2010, 3 days after vaccination with FLULAVAL, the subject experienced injection site pain radiating down to hand. The subject required medical attention at an unspecified location. At the time of reporting, the outcome of the arm soreness and stiffness at injection site were unresolved. The outcome of the injection site pain radiating down to hand was unspecified. The pharmacist considered the arm soreness and stiffness at injection site were probably related to vaccination with FLULAVAL. Follow-up information was received on 22 November 2010 via healthcare professional who reported subject has a history of arthritis. On 28 October 2010 the events resolved. At the time of the report, no other information was provided.
side of face were swollen; itching on the neck; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Aug-2021 and was forwarded to Moderna on 15-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (side of face were swollen) and PRURITUS (itching on the neck) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. MLS-319813_r) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced SWELLING FACE (side of face were swollen) and PRURITUS (itching on the neck). At the time of the report, SWELLING FACE (side of face were swollen) and PRURITUS (itching on the neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment medication was provided.
Awoke with hives the day after receiving the vaccines. Symptoms resolved in 3hrs, but awoke with hives again the following day. Treated with Solu Medrol injection-Medrol dose pack and Benadryl.
Member arm was swollen and he went to the emergency room and he was told he had cellulitis. Meds were given.
Around 10 min after injection patient flagged down a technician and said she thought she was going to faint. Fainting has happened to her in the past and she could feel it coming on. The pharmacist moved her closer to the area and gave her water. While pharmacist was standing with her she lost consciousness and control of her bladder. Pharmacist held patient upright as she was still in the chair as to not obstruct breathing. Patient was out for around a min and regained consciousness. Pharmacist in that time had called EMS who arrived later and checked all vitals. Patient drove alone nearly an hour so Pharmacist want to make sure she was ok before driving the long distance home.
Patient called this afternoon, 12/14, reporting a sore arm and fever ill feeling. She took Tylenol and drank water. I advised her to continue to do so and monitor symptoms over the next 24-48 hours and if she worsened to contact the doctor or seek medical attention.
Patient and legal guardian stated they were of age to receive the vaccine. After further investigation the patient was in fact 11 and not 12.
Swollen from shot area to elbow, hard and tender to touch. No redness or warmth.
Pt had increased temp x 1 d 101-102 and uncontrollable shaking with eyes rolling back lasting 3-5 seconds. Pt had these episodes a total of 6-7x. Referred to hospital for full w/u including spinal tap. Dx with complex febrile sz. CSF lab work all negative.  04/23/2008 MR received for DOS 2/27-28/2008 with D/C DX: Complex Febrile Seizures. Pt transported to ER from PMD's office following multiple episodes of tonic-clonic seizure with fever with post-ictal limpness. Pt had several episodes of vomiting and diarrhea recently. Fever continued. Neuro consult with Impression: Complex Febrile Seizures, Mild pharyngitis, no evidence of meningitis, normal neuro exam. D/c with Diastat for further episodes.
6 days after administration I have a large area of redness at the area of injection (15x10cm) that is also slightly raised
Redness at site.  On  April 5, I had severe stomach pains and then a head ache started.  They did a CT Scan and found a Portal Deep Vein Thrombosis. I had to be rushed by ambulance to a bigger hospital and was in the hospital for 2 days.
Client received vaccines a-c listed in #13 on 5-21-14. Client started oral typhoid pills, d on #13, 5-23-14. Client experienced extreme vertigo beginning 5-25-14. Still has mild vertigo. Seeing MD for it.
Injection site soreness; Injection site redness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number C5E43, expiry date 10th August 2021) for prophylaxis.   On 1st May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were unknown.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient received Shingrix on left arm. The patient experienced soreness and redness at the injection site. The healthcare professional would like recommendations he can share with the patient. The reporter consented to follow up. For tolerance to the 2nd dose of Shingrix, refer case US2019131740.
vaccine.  later that day headache and sore arm.  2am next day throat itchy and painful, later extreme headache and chest pain.
She started having chills and her arm is very stiff and hurts alot. Having slight headaches.
Upon administration of HPV, pt had immediate loss of muscle tone and then had tremors on (L) side & LOC x 10-15 sec. Pt could respond to verbal instruction to squeeze hand but unable to verbalize. After resting 2-3 min moved pt from chair to reclining bed and pt fainted. Pt was carried to bed sitting upright and felt better. Paramedics arrived on scene at 3:48pm.
Tested positive for Covid (using a home test) 24 hours after having symptoms. Currently is sick with congestion, cough, and fatigue. No fever yet.; Tested positive for Covid (using a home test) 24 hours after having symptoms. Currently is sick with congestion, cough, and fatigue. No fever yet.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 59-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 19Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 09Apr2021 as dose 2, single (Lot number: EP6955), in left arm and on 14Dec2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 58 years, in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jun2022 at 17:00, outcome "not recovered" and all described as "Tested positive for Covid (using a home test) 24 hours after having symptoms. Currently is sick with congestion, cough, and fatigue. No fever yet.". No known allergies. No covid prior vaccination. No other vaccine in four weeks and no other medications in two weeks. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jun2022) Negative, notes: Nasal Swab; (20Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Pain during injection/soreness at injection site/burning feeling while vaccine injected; This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a male patient who received HAV (Havrix adult) for prophylaxis.   On an unknown date, the patient received Havrix adult at an unknown dose. On an unknown date, immediately after receiving Havrix adult, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Havrix adult.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had pain during injection, burning feeling while vaccine was injected and soreness at injection site.
This spontaneous report as received from a registered nurse via a company representative refers to a patient of unknown age and gender. No patient's concurrent conditions, medical history or concomitant medications were reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (strength, dose, route of administration, lot#, expiry date were not provided), a first dose in the series. On an unknown date, reported as "three months later", patient received second dose in the series of GARDASIL 9. No adverse effects were reported. Additional information has been requested.
Had terrible headache in back of head and neck. Also extreme muscle aches. Lasted for 48 hrs.
2 MIN POST VACCINE PT BECAME CLAMMY, LIGHTHEADED AND DEVELOPED TUNNEL VISION. PT ASSISTED TO FLOOR BY STAFF. VISION RETURNED AND SYMPTOMS IMPROVED. PT TRANSPORTED TO MED OBS VIA WC AT 1710. PT PLACED IN REVERSE TRENDELENBURG POSITION. VITALS OBTAINED AND MONITORED. VSS. WATER AND SNACKS GIVEN. PT SLOWLY TRANSITIONED TO SITTING AND THEN STANDING POSITION. SYMPTOMS RESOLVED. PT RELEASED TO HOME WITH WIFE DRIVING AT 1730. PT ESCORTED TO EXIT BY STAFF WITH NO FURTHER ISSUES. VITALS AS FOLLOWS: 1711 BP 153/82 HR 86 SPO2 99 1716 BP 152/84 HR 81 SPO2 100 1721 BP 163/89 HR 71 SPO2 100 1728 SITTING BP 146/88 HR 71 SPO2 100 1729 STANDING BP 137/95 HR 80 SPO2 98
The child was given the Pfizer bivalent 12+ dose (0.3 ml) by mistake. No know symptoms at this time.
Patient presented at the Emergency room on 5/7/2019 at 13:47 for complaints of right shoulder and arm discomfort, Right cheek and right ear warm to touch and red.  Fever of 100.7 at home.  Per mother patient is subdued and more lethargic.   Eating and drinking normally.   Motrin Ranitidine, Benadryl given at 16:19 in the ER.   05/09/2019 Mother took patient back to the ER with concerns of redness on right arm.  Diagnosed with Cellulitis.  Keflex , tylenol, ibuprofen and benadryl give.
1. First incident occurred 3 weeks after initial COVID-19 vaccine-Pt was walking outside and fell down in her driveway. She had a sudden collapse of motor function and felt as if "someone pulled the plug on me and I fell". She saw her PCP who did a complete cardiac evaluation, which was normal.  2. Second incident occurred 3 weeks after second COVID-19 vaccine-Pt had sudden and complete loss of bladder function for several weeks. PCP did a work up, gave her antibiotics but urine culture revealed that she did not have a bladder/kidney infection. Her function did slowly return over the course of several weeks.
9:30 am 9/1/21 started getting headache and dizzy.  school nurse sent him home at noon, and i picked him up from school and took him home to go to bed.   Symptoms were headache, dizzy, walking wobbly, some chills, head feels heavy, visual aura in periphery vision, flashing lights like a laser light show.  Green dot in the center that is spiraling out and spiraling back in.  He went to bed at 12:30pm. I checked on him at 2pm and woke him up accidentally.  He felt hot so i took his temp and  he and now has a 101.3 fever.
Severe body ache; Lack of sleep; Fever of 100.9; Chills; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection;Lot Number: EW0169) via an unspecified route of administration in the arm left on 27Apr2021(at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on 08Apr2021 (2 days after the first dose of vaccine). Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN) from unknown date for unknown indication. Prior to the vaccination, the patient was 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. No known allergies.Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) dose 1 for COVID-19 immunisation and tested positive for COVID-19. On 28Apr2021 at 04:30 (about 12 hours after vaccination), the patient experienced severe body ache, a fever of 100.9, chills, and nausea, which ultimately led to a lack of sleep. All these lasted for 12 hours thereafter (28Apr2021). On 08Apr2021, the patient underwent COVID-19 virus test and the result was positive. On 28Apr2021, the patient got his body temperature checked and the result was fever of 100.9. Therapeutic measures were taken as a result of events and included treatment with tylenol PM and then aleve. The clinical outcome of the event severe body ache, fever of 100.9, chills, nausea and lack of sleep was resolved on 28Apr2021 at 16:30.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A Health Professional (mother, Registered Nurse) report has been received concerning a 14 years 11 months old, Female patient with height: 69.0 Inches, weight: 117.0 Pounds. No information regarding the relevant history, concomitant disease and concomitant drug was provided. The patient was prescribed FLUMIST (intranasal) full dose in each nostril annually, start date 2009 or 2010 as prophylactic immunization. Mother reported that the patient had Type A flu during Nov-2016, went to Urgent care. The patient prescribed TAMIFLU adult dose twice a day and flu resolved. On Jan-2017 the patient contracted Type B flu, she went to Urgent care, patient's HCP aware, but no treatment provided and the patient had recovered. She reported that the patient missed doses of FLUMIST QUADRIVALENT for seasons 2016 to 2017 and 2017 to 2018. She took patient to Urgent Care on 18-Jan-2018 for fever 103.5 and the patient was diagnosed with Type A flu, she also had a cough and aches and pains. The patient was prescribed the following treatments: MOTRIN 400 mg by mouth every 6-8 hours for aches and pains start date 18-Jan-2018, TAMIFLU adult dose twice a day orally taken 19-Jan-2018 to 24-Jan-2018 and Hydrocodone cough syrup orally for cough prescribed twice a day, patient only took at night on 19-Jan-2018 and 20-Jan-2018, no doses provided. The patient was fever free on 21-Jan-2018 and mother reported that she was over the flu. The patient recovered from the events of multiple episodes of type A flu, type B flu and aches and pains on an unspecified date. Company physician assessed the events multiple episodes of type A flu, type B flu and aches and pains to be non-serious. Company physician suggested to delete the events of fever 103.5 and cough as these are symptoms for Influenza.
Gave AFLURIA to a 4 year old [Drug administered to patient of inappropriate age] This spontaneous case initially received on 04-Nov-2016, was reported by a health professional and concerns a 4-year-old patient of unknown gender. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): The patient received AFLURIA from 04-NOV-2016 to 04-NOV-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: 13149212A. No additional suspect drugs. Adverse reactions/events and outcomes: On 04-Nov-20126, the pharmacist gave AFLURIA to a 4 year old (outcome: unknown, special circumstances: drug administered to patient of inappropriate age). Reporter comments: The healthcare professional classified the event as a medication error.
pt recvd vax 28JUN94 & 4hrs later pt devel redness, swelling & soreness;pt eventually recovered;
pt recv vax on 9SEP96 & 19NOV96;pt was due for 3rd dose on 22APR97 & pt died 20MAR97 while playing basketball;initial listed COD is dilated cardiomyopathy;pt collapsed & became rapidly unresponsive;
Left arm started to hurt hours after shot. Within the week, "deep aching" pain to (L) shoulder, upper arm clavicle area. Pain increased with movement. Still has pain on 12-7-11. (L) arm radial pulse present. Sensation intact, no redness noted.
AKI (acute kidney injury); Acute hypoxemic respiratory failure due to COVID-19; Congestive heart failure, unspecified HF chronicity, unspecified heart failure type; SOB (shortness of breath)
Menstrual bleeding that will not stop nor slow down, beginning two days after second dose of COVID-19  Pfizer vaccine, currently on day 17 of bleeding.
chest pain, night sweats, insomnia, brain fog, migraines, ringing ear, no energy, memory loss, balance problems, visual problems. etc.
Patient reports persistent case of hives since having had first dose. States that hives noted the "morning after" having vaccine. Has been advised by primary care physician not to have second dose.
p/ pt recv vax pt exp fever, also devel less than 25 lesions that scabbed over 48-72 hrs. f/u from MD noted pt devel mild to moderate case of chickenpox w/typical lesions scattered over body in various states from papules to ulcers.
sleepless; pain 7 out of 10; fatigue; headache; muscle ache; nausea; fever; Joint Pain; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (sleepless), PAIN (pain 7 out of 10), FATIGUE (fatigue), HEADACHE (headache) and MYALGIA (muscle ache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0Z1R21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL], GUAIFENESIN (MUCINEX), CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) and OMEPRAZOLE for an unknown indication.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (sleepless), PAIN (pain 7 out of 10), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle ache), NAUSEA (nausea), PYREXIA (fever) and ARTHRALGIA (Joint Pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 2 doses 4 to 6 hours. At the time of the report, INSOMNIA (sleepless), PAIN (pain 7 out of 10), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle ache), NAUSEA (nausea), PYREXIA (fever) and ARTHRALGIA (Joint Pain) had not resolved.            Other concomitant medications included advir.
Chills, rigors followed by fever to 101.9 with headache and fatigue.