chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Additional Details: After administration, patient approached counter so I could print out a copy of her vaccination record. She said she felt nauseas, and started to feel dizzy. As I opened my mouth to tell her to maybe sit down for a little, she fell over and loss consciousness for about 15 seconds. After she came back, I gave her an ice pack as my technician called EMS. The paramedics came and spoke to her, but she refused transport and waited for her husband to pick her up.
3 hours post vax pt developed marked swelling to left deltoid size 15 X 15 cm.
Rapid or fluttery heart beat beginning 1 day after vaccine. Randomly throughout day. Somewhat milder yesterday and today. Vaccine was Pfizer-BioNTech COVID-19 Vaccine EUE
EXPIRED VACCINE USED; MILD FLU LIKE SYMPTOMS; HEART PALPITATIONS; NUMBNESS AND TINGLING IN LEGS; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 28-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-SEP-2021, the patient experienced expired vaccine used, mild flu like symptoms, heart palpitations, and numbness and tingling in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild flu like symptoms on 01-OCT-2021, had not recovered from heart palpitations, and numbness and tingling in legs, and the outcome of expired vaccine used was not reported. This report was non-serious.
Five minutes after receiving shot, patient felt dizzy and anxious. Pharmacist checked blood pressure twice 20 minutes apart and was around 145-150/100 mmHg. Patient remained slightly dizzy and EMT was called. EMT verified blood pressure was still high was pulse was going down slowly (around 113 BPM). They discussed with patient and determined admission was not needed and patient may leave on her own when she desires as she was able to stand and walk on her own. Patient remained at pharmacy for another 15 minutes before leaving.
Patient became lightheaded soon afterwards. Experienced large red lump with itchiness. Saw MD at urgent care the following day.
Shingles on the left side of the body, same side as vaccine injection. Numbness, systemic rash following C8 and T1 dermatome. pain and burning, require emergency care and medications. Rash lasting for over three weeks and nerve damage and numbness in the carpal tunnel of left hand requiring further medical appointments and further medical attention. Apart from this most serious side effect, also experienced fainting and headaches as well as a discontinuance of my menstrual cycle during the initial injection. Subsequently a much shorter cycle the second one after injection of said vaccine.
Information has been received from a registered nurse concerning a 12 month old male patient with no known drug allergies and no pertinent medical history who on 09-SEP-2009 was vaccinated with MMR II (Lot #664607/0609Y) in the right thigh. On the same day the patient was vaccinated with VARIVAX (MSD) (WAES #0910USA01603) and influenza virus vaccine (unspecified) which according to the reporter were administered during the same visit. It was also reported that  the patient developed a wheal at injection site immediately after administration of MMR II. The nurse stated that erythema and induration were developed after ten minutes. The patient was treated with BENADRYL. The patient recovered on the same day. No lab diagnostic tests were performed. Follow up information has been received from the registered nurse who indicated that on 09-SEP-2009 the patient was vaccinated subcutaneously with his first dose of MMR II (Lot #664607/0609Y) in the right thigh. Concomitant vaccination included the first dose of VARIVAX (MSD) (Lot#664905/0865Y) (WAES # 0910USA01603) administered subcutaneously in the left thigh and the first dose of FLUZONE administered intramuscularly in the left thigh. According to the nurse, immediately post injection of MMR II (Lot #664607/0609Y) there was a wheal, erythema and induration around the injection site. No other symptoms were reported. The patient recovered 30 minutes later. This is one of several reports received from the same source. No further information is available.
Patient developed hives at the time of the vaccine that progressed to tightness in her throat. This lasted several hours. She also had facial numbness over the right-side of her face from her nose to her ear. She simply drank a lot of water and over time symptoms regressed.
1st shot hot spot red swelling at injection area.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 13:15 (Lot number: ER5732) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asma high blood pressure" (unspecified if ongoing), notes: Asma high blood pressure; "Asma high blood pressure" (unspecified if ongoing), notes: Asma high blood pressure; "Known allergies: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "1st shot hot spot red swelling at injection area.".  No follow-up attempts are possible. No further information is expected.
a 12 year old patient received fourth dose of IPOL vaccine, No AE; IPOL vaccine was exposed to a temperature excursion, had stability issue for open Ipol but given the product already by the time they found out they should not have given it to patient, No AE; Initial information was received on 23-Jul-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional (office staff).  This case involves a 12-year-old female patient who was vaccinated with the fourth dose of vaccine IPV (VERO) [IPOL] (lot number R1B252M and expiration date 13-Mar-2021) via an intramuscular route in the left arm for prophylactic vaccination on an unknown date. However, this vaccine was exposed to a temperature excursion.   The patient's medical history, medical treatment, vaccination and family history were not provided.  The patient received concomitant VACCINE VLP RL1 4V (YEAST) (GARDASIL) for prophylactic vaccination.  It was an actual medication error case due to inappropriate age at vaccine administration and incorrect product storage as fourth dose of Ipol should be administer in 4 to 6 year of age  and it was reported that, There was stability issue for open Ipol but had given the product already by the time they found out they should not have given it.  The patient had no adverse event at the time of reporting.  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 and Module VI of the 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.
High fever 101.9 tested after the first round of medication. 200 mg Advil and two White willow bark.
Information has been received from a health professional and a pharmacist concerning a 20 year old patient who on an unspecified date was vaccinated with a dose of Zostavax vaccine instead Gardasil vaccine (yeast). Unspecified medical attention attention was sought. The patient was not experienced any known symptoms. It was reported that the error was not a result of product confusion. There was no record of the patient ever receiving Varicella virus vaccine live. There was no product quality complaint involved. No further information was available. Additional information has been requested. 6/17/10 It was reported that the administering employee did not follow the 5 R's, did not ask for assistance from another health care professional and "did not know what she was doing." It was confirmed that this was not a case of product confusion. No further information was available.
Patient felt faint after receiving the vaccine. Patient did faint lost her color and was very sweaty
I have been having bad headaches off and on since I received the second vaccine. It feels like pressure inside my head. My blood pressure has been increasing and at times it has reached Hypertensive Crisis readings. My doctor has started me on medication Metoprolol to help decrease my blood pressure.
Moderate rash just below injection site appeared approximately 10 days after vaccine. Itching but no inflammation or soreness. At onset, was approximately 3 inches in diameter and very red. Spread larger but got lighter in color each day. Dissipated after approximately 4 days after first appearance.
Myalgia, Fever,  HEADACHE, CALF PAIN  Narrative:  Employee went to the ER and had the Calfpain evaluated. ER stated that it was only calf pain/myalgia related to the vaccine reaction.
The patient presents following fall xPTA with associated right hip pain. Pt states that he was ambulating with his walker at the nursing home when his walker slipped from him, causing him to fall on his hip. Denies fever, chills, sore throat, cough, SOB, CP, abdominal pain, N/V/D, dizziness, HA, neck pain, back pain, and LOC.  The onset was just prior to arrival.  The occurrence was single episode.  The fall was described as lost balance. (Covid 19 Incidental finding)
PATIENT CAME IN ON 3/8/16 AND COMPLAINED OF A RED WELT (HIVE) ON HER LEFT ARM AFTER GETTING ZOSTAVAX SHOT. THIS WAS ALMOST UNDERNEATH HER ARMPIT AND WAS NOT WHERE THE SHOT WAS GIVEN. PATIENT HAD DR APPT FOR THE NEXT DAY FOR A REGULAR CHECKUP AND WOULD CHECK WITH THE DOCTOR ABOUT IT. I TOLD HER TO TAKE SOME BENADRYL AND APPLY ICE PACKS TO THE SITE FOR COMFORT/RELIEF.
Pt c/o itching @ site of DT inject area 36mm circumference; round indurated, hard, reddened area warm to touch; pt denies pain; MD notified & saw area; instructed to apply ice & return to office in 2 days to recheck;
breathing was labored; minor sore arm; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 27Jan2021 13:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included asthma, hypertension, Immature White Blood Cells (monitored for years), heart Premature ventricular contractions, anxiety, gastrooesophageal reflux disease, drug hypersensitivity. The patient had not taken any other vaccine in four weeks, he took other medication within two weeks. The patient did not had covid-19 prior to vaccination and not tested for covid-19 post vaccination. On 27Jan2021, patient had no side effects at time of vaccination but at night of vaccination date, patient experienced minor sore arm and on the next day on 28Jan2021 at 07: 00AM breathing was labored. The patient visited to doctor or other healthcare professional office or clinic visit. The doctor put patient on Zpac and Oral Steroids as therapy for events. Outcome of events was recovering. Lot/batch number was not available despite the follow-up attempts made.  Follow-up attempts have been completed and no further information is expected.
I do not know if this is related to the vaccine: CDC called and asked to fill in this, but I am not sure that the vaccine and the event are related. The simple event is stiffness in the calves when waking up in the morning (something that did not happen before). Nothing bad so I basically ignored it until about after one month I suffered a calf strain in the left leg while walking. Once again, nothing bad, but apparently the outcome of waking up with stiff muscles every morning.
sore arm; 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 78 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 78 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: The patient got her first covid vaccine. Everything was great she only had a sore arm. She got the second one. She never perforated her skin. When she was driving she should have turned around and went back. There was a white liquid on her arm. She never perforated her arm.She went and showed them her card and they couldn't give her a shot because it said her shot was completed, but it's not because she never gave her the shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
chills, temp, muscle ache, up all noc, lethargic & drained;
Covid vaccine given on 1/21, the same day I developed a local reaction at the injection site.  The red, raised, painful area around injection site remained for 2 days then resolved.  Approx 8 days later, the red area around the injection site returned.  The area is approx  3" x 2", red, raised and itchy, only mildly painful/tender to touch.  The skin over the area feels bumpy and appears "hive-like".  No fever, chills, aches etc.  Went to PCP today.  MD feels it is likely an on-going hyper immune response.
redness below the injection site/redness became the size of baseball; itchiness; swelling; hardness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (hardness), ERYTHEMA (redness below the injection site/redness became the size of baseball), PRURITUS (itchiness) and VACCINATION SITE SWELLING (swelling) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 04BA21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE MASS (hardness) and VACCINATION SITE SWELLING (swelling). On 10-Apr-2021, the patient experienced ERYTHEMA (redness below the injection site/redness became the size of baseball) and PRURITUS (itchiness). At the time of the report, VACCINATION SITE MASS (hardness), ERYTHEMA (redness below the injection site/redness became the size of baseball), PRURITUS (itchiness) and VACCINATION SITE SWELLING (swelling) outcome was unknown.            No concomitant information was reported. No treatment information was reported.
My father received his vaccines in February, within a month his mobility became difficult and every month since then his ability to use his legs has decreased and as of July he is unable to move his legs on his own.  He is now confined to a wheelchair.  My dad was mobile in April with some difficulty but he has no use of his legs now.  he cannot even pick his foot off the floor, his legs are light dead weight.
No additional adverse events; 1st dose of GARDASIL 9 in 2016, second dose of  GARDASIL 9 in 2017, and 3rd dose of GARDASIL 9 was administered on 10-DEC-2019.; This spontaneous report was received from a pharmacist referring to a approximately 22 -year-old patient of unknown gender. The patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not reported.   On an unspecified date in 2016, 2017 and 10-DIC-2019, the patient was vaccinated with the first, second and third dose respectively with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (concentration, route and anatomical location of vaccination, lot number and expiration date were not reported) as prophylaxis. (inappropriate schedule of product administration). No adverse event was reported on the patient.
DID NOT TAKE FOURTH DOSE OF VIVOTIF; DECREASED APPETITE; NAUSEA; STOMACH CRAMPS AND PAIN; This spontaneous case report was received from a nurse (PVX2019-419) on 13-Feb-2019. The report describes a 17-year-old female consumer who had nausea, stomach cramps and pain, and decreased appetite following the intake of oral Vivotif (one dose every other day) for typhoid fever prophylaxis. The consumer "did not take fourth dose of Vivotif".  The consumer had a history of epilepsy, asthma, irregular menstrual cycle and had a knee surgery in past. The consumer was allergic to viscous lidocaine.  The consumer's concomitant medication included oral Singulair (montelukast; 10 mg per day) for asthma and oral Lessina (levonorgestrel; 20 mg) for irregular menstrual cycle.  It was reported that the consumer took the three doses of Vivotif on 17-Jan-2019, 19-Jan-2019, and 21-Jan-2019, respectively. On 17-Jan-2019, after the intake of dose the consumer experienced GI (gastrointestinal) side effects including nausea, stomach cramps and pain, and decreased appetite which got worse with each dose. The consumer did not have any atypical exposure to food, medications or environmental exposures. The consumer also stated that she discontinued Vivotif after completing the three doses of Vivotif.  The action taken with Vivotif with respect to the events nausea, stomach cramps and pain, and decreased appetite was dosage maintained while with respect to the event "did not take fourth dose of Vivotif" was not applicable.  The clinical outcome of the events nausea, stomach cramps and pain, and decreased appetite was resolved while with respect to the event "did not take fourth dose of Vivotif" was unknown.  The reporter's causality with respect to the events nausea, stomach cramps and pain, and decreased appetite was related.  Company's Comment: In this case, it was reported that a 17-year-old female consumer had nausea, stomach cramps and pain, and decreased appetite following the intake of oral Vivoti . There seems to be a temporal association between the intake of the vaccine and the events. Also, nausea, stomach cramps and pain, and decreased appetite are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. The causality of the event "did not take fourth dose of Vivotif" was considered as not applicable. ; Sender's Comments: Company's Comment: In this case, it was reported that a 17-year-old female consumer had nausea, stomach cramps and pain, and decreased appetite following the intake of oral Vivotif . There seems to be a temporal association between the intake of the vaccine and the events. Also, nausea, stomach cramps and pain, and decreased appetite are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. The causality of the event "did not take fourth dose of Vivotif" was considered as not applicable.
I GOT THE MODERNA BOOSTER SHOOT AND  I WAS SICK WITH SORE THROAT, COUGH AND RASH.  I STILL THE RASH AND NOT FEELING MY BEST .
Muscle ache; Chills; Fever; was cold; Joint ache; Tired; Sick; could not sleep all night, she was up half the night; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: F19262), via an unspecified route of administration at her arm on 23Jan2021 at 0.3 mg (as reported) single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that that she and her 94 year old mother got the COVID-19 vaccine at a drive thru, and her mother did great. After the vaccine she had muscle aches, chills, fever, and was cold. She had side effects that lasted 30 hours, starting that night. She was chilling so bad, she would like to know if they think it was safe for her to get the second dose of the vaccine, they said it was worse for the second. She said she could not hardly work she was so sick after the first dose. She stated that she was really cold, and really sick, and all day, she just could not sleep all night, she was up half the night because she was so cold and just feeling sick. She had joint pain, she had it all. She started taking Aleve on Sunday and she started to get better. The night after she got the vaccine she got her heater and was sitting beside it. She felt tired the whole next day. Her symptoms came quicker than that, she took the Aleve the next day.  The outcome of events muscle aches, chills, fever, joint ache was recovered. The outcome of other events was unknown.
Myalgia multiple, see below Narrative: On day of vaccination, developed b/1 lower leg pain, started in calf radiating to shin and feet. Pain described as weird but not cramp-like pain. Resolved within 2 days. Developed leg swelling on 4/7/2021 which resolved within 24 hours. Later, about a week post vaccination, developed bruise on right  hip without trauma. CBC drawn, WNL. PLT= 321
incorrect product storage; No additional adverse effect reported; This spontaneous report recibed from a nurse practitioner refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On an unknown date, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1688504 expiration date 19-NOV-2021 for prophylaxis (strength, dose and route were not provided). No additional adverse effect was reported.  Digital Data Logger registered a temperature excursion between 47 to 77 Fahrennheit degrees (47.7) for 20 minutes.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2104USA002701:
Frequent dizziness; nausea; vomiting; falling; This is a spontaneous report from a non-contactable consumer (patient). A 79-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN5318, Expiration date: Unknown), via an unspecified route of administration on 01Feb2021 17:45 as 1st dose, single dose for covid-19 immunisation at other facility. Medical history included mild dementia. The patient was prescribed with medications and dietary supplements within 2 weeks of vaccination. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 05Feb2021, the patient experienced frequent dizziness, nausea, vomiting and falling. The events result in emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the events with IV hydration. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Case number PHEH2014US026183 is an initial spontaneous report received from a medical assistant on 31 Dec 2014. This case refers to a 12 year old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: A13016) intramuscularly on 31 Dec 2014. It was reported that, Men CYW liquid component vial which expires on Dec 2015 and Men A lyophilized component vial which expired on Sep 2014. No adverse event was reported following this administration error.