chrisvoncsefalvay/vaers-outcomes huggingface dataset:
after 15 minutes patient stated she began to feel like her heart was racing and she went to stand up and stated she almost fainted. She stated she was experiencing tingling in hands and feeling of heaviness all over. BP 133/92 HR 94 O2saturation 100 resp 20. Patient placed on stretcher,no altered loc, patient alert oriented x 3 skin warm and dry,coloring remained unchanged. Patient given cheese and crackers,water and soda. Patient stated she had eaten that morning. patient kept and monitored x 1 hour. Bp retaken multiple times. Bp at D/C was 111/74 hr 86 resp 18. this was at 1330p. patient stated no complaints. Instructed to follow up with her PCP and was escorted to cafeteria to get lunch. Reported incident to Supervisor of hospital  and also  Health Dept.
Patient was here for her 11 yr check, she was due for her Tdap, Hpv9 and MCV4, the patient was given Men-B.  This was found upon doing the transfer report.  I notified our Nurse Manager as well as the  provider who Pt saw on 09/02, NP.  NP contacted mom around 2:17pm on 09/03 to let her know she was given the wrong vaccine. Mom reported soreness of the injection site.  Around 4pm on 09/03 the Health Department contacted our office to let us know mom called to report Pt wasn't feeling well, no specific symptoms were reported.  I spoke with mother today, she states Pt was feeling a little more tired than normal, had a headache, and redness and swelling at the injection site. Pt is feeling better now.
24 hours in, high fever, nausea and vomiting- resolved in 48 hours..  2 weeks in  unexpected period (2 weeks early), bleeding /spotting again after another 2 weeks- not a full period.. previous hx of regular periods for 5 years.   Ill  health since vaccine-  fatigue,  dx with 2 different Uris (covid negative on both).  Still appears to be in ?recovery mode?
Patient who received 3 doses; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 89-year-old female patient who received Herpes zoster (Shingrix) (batch number C43KM, expiry date 10th April 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 3rd January 2022 with batch number C43KM and expiry date 10th April 2023) and Shingrix (received 2nd dose on an unknown date ).   On 13th May 2022, the patient received the 3rd dose of Shingrix. On 13th May 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 16-May-2022 Reporter's comment: Registered pharmacist requesting information for a patient who received 3 doses of Shingrix. The 1st dose was administered by the reporter (as well as the 3th dose) but the 2nd dose in another facility (health care professional was not aware). The reporter consented to follow-up. Additional Supportive Information: The patient received 3 doses of Shingrix, which led to extra dose administered. Note: No assumption were applied for 2nd dose as no information was reported.
No additional AE reported; HCP called to report a patient today on (7/25/2023) received expired MMR II Vaccine. HCP provided lot#U022174 and exp 7/14/2023 date. HCP did confirm there was no T/E for this product.  Permission was granted to contact HCP. No additional AE reported; This spontaneous report was received from a nurse referring to a patient of unknown age and unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not reported.   On 25-JUL-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection (lot #U022174, expiration date: 14-JUL-2023; strength was not provided) administered subcutaneously as prophylaxis (expired product administered). It was confirmed there was no temperature excursions (T/E) for the vaccine. There was no additional adverse event (AE) reported.
Two inches around injection site is itchy, red, hot and hard to the touch.  It is painful to the touch and causes numbness in the fingers.
After being vaccinated patient complained of nausea, he was given emesis bag.  Patient vomited 90cc of food, and complained of a stomach ache.  Vitals were taken:  BP 86/62, Pulse 66, O2 98%,  temp 97.2, respiration 14, patient advised to hydrate.  Monitored for additional 15 minutes.  Patient advised to see PCP and if symptoms persist call EMS.
Tetanus (tdaP) -- none. No complaints.  Shingrix -- tired, muscle pain, chills/fever, inability to sleep, itching/pain at shoulder site in right arm. Swelling, headache, right ear pain, rapid heartbeat, lymph node swelling on right side of neck, nerve pain/itching throughout right arm, loss of balance periodically, ordinary objects difficult to hold with right hand, right shoulder/right elbow/right hand/right index finger nerve pain -- arm is useless. Difficulty opening or holding anything with right arm. Random spasms in right arm. Sleeping more.
This spontaneous report was received from a Medical Assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant medications were not reported. On 26-JAN-2017, the patient was vaccinated with a properly-stored but expired dose of VAQTA injection 25/0.5 (dose, frequency and route were not reported) (Lot number: K004856; expiration date: 07-DEC-2016) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information is not expected as reporter refused additional contact.
Upset stomach; Neck muscles stiff; Sore throat; Tingly lips and throat; Stuffy nose; Tingly lips and throat; Muscle pain more than 5 days; Shortness of breath; Nausea; Diarrhea; Fatigue; Rash; Hives; Itching skin; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30135B2) via an unspecified route of administration on 13Oct2021 at 15:15 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included complicated health profile and many unspecified allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 13Oct2021, the patient experienced upset stomach, nausea, diarrhoea, sore throat, stuffy nose, fatigue, neck muscles stiff, muscle pain more than 5 days, rash, hives, tingly lips and throat, itching skin and shortness of breath. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were 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 upset stomach, nausea, diarrhea, sore throat, stuffy nose, fatigue, neck muscles stiff, muscle pain more than 5 days, rash, hives, tingly lips and throat, itching skin and shortness of breath was recovering at the time of this report.  Amendment: This follow-up report is being submitted to amend previously reported information: added the pregnance information and updated concomitant therapy field.
1.  extremely sore left arm 2.  chilling, cannot get warm 3.  muscle aches
Red bumpy rash around my neck.  Treatment to Benedryl and applied Benedryl cream.
An MA at our clinic gave pt an injection with an undiluted 1ml vial of the above COVID vaccine. Usually the vial is drawn up with 2.2ml of normal saline and each pt is given 0.2ml of the solution. The MA reported the mistake immediately. The pt was monitored for any site reaction or other adverse events. Pt was unaffected. The injection site was not erythematous, tender or warm to the touch. No vital sign abnormalities noted. Pt initially cried after the injection, then breastfed for a few minutes and was alert, calm and happy afterwards.
PNEUMONIA; BRONCHITIS; SUSPECTED COVID-19 INFECTION; DIZZY; BRAIN FOG; HEART PUMPING FAST; This spontaneous report received from a patient concerned a 6 decade old female of an unspecified ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: septic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 01-APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 55 years old. No concomitant medications were reported.  On an unspecified date, the patient experienced symptoms of pneumonia, bronchitis, Covid-19 and was septic before she took the J&J vaccine. She went to the emergency room and they gave the shot and then sent home because they were full. After she was vaccinated, she reported that she was sicker than a dog for 1 whole month. She could not eat nor sleep. She got sicker and sicker and sicker, had loss of taste and smell, got brain fog, could not breathe and walk to her car without shortness of breath, sweating like she had menopause and she was 67. Every once in while, it was like her heart was having a heart attack and it was pumping fast and got dizzy, as she had to stop what she was doing and sit down. She experienced joints ache. She was starving to death on the reported day, but she could not taste anything. Sometimes she did not have an appetite at all. She reported that taking a shower wears her out and she was exhausted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and had not recovered from pneumonia, dizzy, bronchitis, brain fog, and heart pumping fast. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230134478- Pneumonia-  The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
This spontaneous report was received from a physician concerning a patient of unknown gender and age. On 10-JUL-2013 the patient was vaccinated with a second dose of VARIVAX (Merck) (Lot # unknown) 1350 U vial, 0.5 ml, subcutaneous. On approximately 11-JUL-2013, the patient experienced fever (102 degrees F), achiness and sore throat. It was reported that the patient's first dose of VARICELLA (Merck) was given unspecified number of years ago. The patient's outcome was reported as not recovered/not resolved. The relationship between therapy with VARIVAX (Merck) and the event was unknown. The patient sought medical attention by an office visit. Additional information has been requested.
Complaints of nausea generalized. Then had head trauma and feels that evolution of injury was influenced by smallpox vaccine. Delayed wound healing; 2 hours of swelling. Feels smallpox altered how his body responds to injury/trauma.
As per patient spouse, He was admitted in hospital on 10/04/2015 due to pnuemonia and died on 10/12/2015. We don't have hospital report.
Received shot at 800 pm 12/1/10 -> At 200 am 12/2/10 pt was having problems with shortness of breath. No problems with injection site or nausea.
Client states nauseated for about 1 hr about 4 hrs post IMM but thought is was food related.
Patient became disoriented, light headed, briefly lost consciousness, and fell out of the chair.  He then got up and began sweating profusely and began vomiting.  911 was called and patient was taken to the hospital by EMS.
Rash on her side that showed up a week after; Has a lot of stomach problems; This is a spontaneous report from a contactable other non-healthcare professional or female consumer (patient) reported for herself.  A female patient of an unspecified age received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and Lot number: not reported )via an unspecified route of administration on 19May2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced rash on her side that showed up a week after and has a lot of stomach problems. Investigation Assessment was not Provided. The outcome of the events was unknown. Patient said that her doctor told her that she should contact Pfizer, because she was about basically at wits end.  Follow-up attempts are needed. Additional information been expected.
Pt recvd 3 doses of Hep B vac on 7SEP89, 16OCT89, & 20MAR90 ; 1st dose of vax Recombivax & 2nd & 3rd w/Engerix-B; It was determined that pt did not respond; Booster dose of Engerix-B was administered 18APR91;
Around 10 minutes after the injection patient began having chest pressure, metallic taste in her mouth, and flushed feeling all over her chest. Symptoms did not resolve. RTT called to further evaluate. Patient was sent to ED.
Felt fatigue; Slight headache; Sore arm; could not sleep; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt fatigue), HEADACHE (Slight headache), VACCINATION SITE PAIN (Sore arm) and INITIAL INSOMNIA (could not sleep) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for an unknown indication.     The patient's past medical history included No adverse event.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced FATIGUE (Felt fatigue), HEADACHE (Slight headache), VACCINATION SITE PAIN (Sore arm) and INITIAL INSOMNIA (could not sleep). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FATIGUE (Felt fatigue), HEADACHE (Slight headache), VACCINATION SITE PAIN (Sore arm) and INITIAL INSOMNIA (could not sleep) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Reporter did not allow further contact
64 year old female patient was given Fluzone HD, no AE; 64 year old female patient was given Fluzone HD, no AE; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 64 year old female patient who received 0.7 ml INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  Medical history, medical treatment, vaccination and family history were not provided.   No Concomitant medication administered to the patient.  On 06-Oct-2020, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ482AA and expiry date: 30-Jun-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of overdose and actual medication error due to inappropriate age at vaccine administration and overdose (latency on same day).  At the time of report no adverse event was reported.  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.
pt taken to trauma room, SQ epi, IV access performed;pt given IV tagamet, DPH, solumedrol;sx resolved w/in 1hr;pt observed for addtl 4hr then discharged home;anaphylaxis;
APPROXIMATELY 25- 30 MINUTES AFTER VACCINES WERE GIVEN HE COMPLAINED OF ITCHING ON HIS BACK, ITCHY FEELING THROAT AND HARDER TO BREATHE. PATIENT WAS TAKEN TO TREATMENT ROOM AND VITALS SIGNS WERE MONITORED AND WERE WITHIN NORMAL RANGE. PATIENT SAID HE WAS FEELING BETTER AFTER APPROXIMATELY 45 MINUTES OF CONTINUOUS MONITORING AND PATIENT WAS RELEASED. PATIENT SENT TO PHARMACY TO PICK UP BENADRYL PRESCRIPTION.
Information has been received from a Licensed Practical Nurse (LPN), a 69 year old female concerning herself, she was vaccinated in the arm with one dose of ZOSTAVAX (Merck) (LOT# 663196/1417X) on 28-NOV-2008. Concomitant therapy included an "unspecified blood pressure medication". On 20-APR-2009, the patient developed shingles on the right side of her trunk. The patient was seen by a physician, no laboratory or diagnostic tests were performed. At the time of the report the patient had not recovered. No further information is available.
Presented to ED s/p syncopal episode & fall w/ injury to lt ankle; reduction performed; COVID+ w/hypoxia; tx w/O2, abx, steroids, Vit-C & zinc; weaned to RA and dc'd to SNF for rehab.
nausea; fever; malaise; headache; abdominal pain; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th March 2022, the patient received the 2nd dose of Shingrix. On 8th March 2022, 1 days after receiving Shingrix, the patient experienced nausea, fever, malaise, headache and abdominal pain. On an unknown date, the outcome of the nausea, fever, malaise, headache and abdominal pain were not recovered/not resolved.   It was unknown if the reporter considered the nausea, fever, malaise, headache and abdominal pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received her second dose of Shingrix on Monday and on Tuesday the patient experienced nausea, fever, malaise, headache, and abdominal pain. All symptoms were unresolved. The reporter did not consent to follow-up
PATIENT RECEIVED 2ND DOSE PFIZER VACCINE AFTER HAVING 1ST DOSE MODERNA VACCINE. NO ADVERSE REACTION TO REPORT JUST WRONG COMBINATION
Nx Vx 1 day, migraine headache, L arm soreness.  Received Twinrix #3 on 2/14/08 LD - IM.  SxS started 2/16/08.  Went to ER 2/23/08 eval for headaches.
She got her vaccine, started becoming short of breath a couple of days after the vaccine, during the night around midnight.  On Sunday it was harder for her to breath, but wasn't like a really tight tight portion, but could still do some deep breaths.  On Monday morning she could not take a deep breath, was short of breath, her heart was racing, chest was tight.  She got up and did things around the house, it eased up some.  She did a COVID test at home and it was negative.  She went on about her business that day.  That night she had to lie on her back to be able to breath.  She was not having chest pains, just tightness on one side or the other.  She managed to sleep that night some, got up to use the restroom often.  On Tuesday morning when she awoke for the morning around 4:00 AM she was really really short of breath, strenuous to sit on the edge of the bed, tight near the center of her chest, and was very very short of breath.  She could not do a deep breath, could not breath through her nose.  She took another COVID test and it was negative.  She went to the ER on 7/19/22.  When she got there she told them that she could not breath, asked her background and her medications, etc.  She handed them her sheet that documents her history and the nurse wanted to know about her documentation when, what and other things.  She had gone to her cardiologist and CV surgeon on June 5th and was doing well.  In the ER they did an EKG, blood work, and the doctor came back in and said that it seemed that she was having fluid build up and give her some Lasix and to check it out.  He diagnosed her with acute combined systolic and diastolic congestive heart failure.  By that time her breathing had eased off due to the Lasix and fluid discharge.   She had been tired on Wednesday, anxious and yesterday she felt like she felt before she had all of this.  She is not short of breath this morning, she has some phlegm production, but she can breath and feels good, and her BP is down as well, and feels almost back to normal.    She went to Hospital, and all of her records from her visit to her cardiologist in July.  She saw Dr.
I (Patient) first noted a rash on on my left arm and shoulder on March 6 (2021), three days after vaccination. As the rash spread across my chest (left side) and blisters appeared, I went to my physician's office on March 9. Dr. diagnosed "shingles" and recommended OTC meds for pain and itching. In following weeks, the rash started healing, but the pain persisted which was not relieved by Tylenol or other OTC drugs. I could not sleep, and with strong pain and upset stomach went to the ER on Sat. March 27, I was seen. I was treated at ER for pain and nausea; Gabapentin was prescribed for nerve pain.
Miscarriage of 6 mo fetus, no HR at 12/10/09 visit. Delivered stillborn 12/11/09.
Information has been received from a nurse, concerning a 12-year-old female patient with no known drug allergies, who on 22-AUG-2008, received the first dose of 0.5 ml, GARDASIL (lot# 659437/1266U, injection site unknown) via intramuscular route. On 23-AUG-2008, after the administration, the patient developed several red areas off to the side of the site of injection. According to the mother of the patient, " the areas initially looked like the skin had been burned, almost blister-like. The areas are extremely pruritic". On 30-OCT-2008, the patient was examined by her physician. It was noted that she now had a half-dollar size circle (34 mm by 30 mm) that was without pigmentation (very white). She also had two small red dots an a red area 5 cm by 4 cm to the left of thee white area. The red areas of skin were flattened. The patient stated that the areas never released fluid or became scabbed. At the time of reporting, the patient was not recovered from the events. Additional information has been requested.