chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse via a company representative referring to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. The patient was vaccinated with a third dose of GARDASIL (dose, strength, route of administration, lot# and expiry date were not reported) on an unknown date, 30 days too early. It was not known if the patient received GARDASIL or GARDASIL 9. No adverse effects were reported. Additional information has been requested.
Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case involves a 68 years old female patient who was vaccinated with a 0.5 ml dose of expired vaccine TENIVAC](lot U5411CA and Exp. Date 30 Jun 2018) via intramuscular route in the left deltoid on 12 November 2018. It was reported that, no other vaccines were given on 12 November 2018 (today). The patients past medication history, concomitant medication was not reported. It was an actual medication error case due to Expired product administered. It was reported that, there were no side effects. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Mother called our clinic 7/25/23 and reported that her daughter received Immunizations at her check up 7/11/23 and the injection she received in left arm caused her to have limited range of motion in shoulder joint. Could not lift left arm up high making combing her hair and other activities difficult, couldn't lay flat on back without putting something under left shoulder. Tenderness to left shoulder joint. Mother says in last few days has had some pain up into left side of neck. Mother took her to a urgent care 7/15/23 was prescribed Tizanidine 2mg po q8hr prn. Mother was told it was a sore muscle and inflammation. Mother took patient to Chiropractor 7/25/23. Mother called our clinic for first time to inform us of the issue her daughter was having 7/25/23 and requested a referral be done. Patient set up for follow-up and referral 7/26/23.
I went to my physical and all the sudden had a blockage in my heart in my lower aortic artery. I had a lot of pain in my shoulder and left bicep. I am still going through this at this at this time.
Patient developed erythematous rash on left deltoid after receiving pneumovax.  She also reported subjection fever last evening.
Information has been received from a physician concerning a 26 year old female who on 31-JUL-2008 was vaccinated with a dose of GARDASIL vaccine (yeast) via intramuscular route. Within 2 days after the vaccine, the patient developed swelling of the neck and oedema. Her outcome was not reported. Additional information has been requested.
after administration pt felt light headed. sat pt down, pt requested to lay down.  had pt sit on floor and emt was called. pt conplained of stomach pain and "a little nausea." emt responded within 15 minutes.
Vaccine received 2/5/21. At about 12:30 AM on 2/8/21 she had diarrhea for about 6 hours, severe headache at back of head above occiput and all over body ache for about 48 hours.
There are no known adverse events relating to the vaccination. The issue is that the patient was administered Moderna vaccine and she is under the age of 18 years old. The only vaccine approved for patients under the age of 18 is Pfizer.
something in her throat; high pulse; heartbeat raised very fast; high blood pressure; panicking; lightheaded; very dizzy; felt like she was gonna faint; very nauseous; very bad headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (something in her throat), HEART RATE INCREASED (high pulse), HEART RATE INCREASED (heartbeat raised very fast), HYPERTENSION (high blood pressure) and PANIC REACTION (panicking) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder NOS.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (something in her throat), HEART RATE INCREASED (high pulse), HEART RATE INCREASED (heartbeat raised very fast), HYPERTENSION (high blood pressure), PANIC REACTION (panicking), DIZZINESS (lightheaded), DIZZINESS (very dizzy), DIZZINESS (felt like she was gonna faint), NAUSEA (very nauseous) and HEADACHE (very bad headache). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL DISCOMFORT (something in her throat), HEART RATE INCREASED (high pulse), HEART RATE INCREASED (heartbeat raised very fast), HYPERTENSION (high blood pressure), PANIC REACTION (panicking), DIZZINESS (lightheaded), DIZZINESS (very dizzy), DIZZINESS (felt like she was gonna faint), NAUSEA (very nauseous) and HEADACHE (very bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: increased (High) High. On an unknown date, Heart rate: increased (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitants include Supplements, medicine for her thyroid. Just finished a breast cancer treatment.
Approximately 48 hours after my second Pfizer Covid-19 vaccine, I experienced partial Facial paralysis on right side of face (primarily upper lip).  Symptoms progressively worsened over the next 72 hours. After approximately 6 days post vaccine, facial paralysis began to slightly improve. On Thursday, May 27, 2021 I visited my primary care physician, who suggested I report my adverse reaction to the CDC. I continue to experience slight drooping on the right side of my mouth (upper lip).
Patient was seen at clinic on 10/30/13 for left deltoid pain and inflammation secondary to a reaction to the flu vaccine.
On 10/06/2022  in the morning I woke up with congestion. The next few days I  had fatigue, fever,  and muscle aches. On 10/08/2022  I did a telehealth  with my doctor who prescribed me Paxlovid for 5 days  and Tylenol as needed.
Moderna Arm.  Swelling , itching and redness at injection site.  I am using Benadryl  which helps.
not feeling good; he fell off a ladder last Friday; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient himself) reported that a 65-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on 12Nov2020 at single dose for immunization; pregabalin (LYRICA, 75 mg Capsule, lot number: CM6411, NDC: 0007110146, expiry date: 31Mar2022), orally from an unspecified date and ongoing at 75 mg, 3x/day for diabetic nerve pain and foot neuropathy. Concomitant drug included flu shot from Nov2020. Patient saw two other doctors a year and a half ago because he could not sleep. Both feet felt like they were getting electric shocks or like they were in a bucket of ice. He had diabetic nerve pain and foot neuropathy. He had a flu shot a week and half ago before he received the pneumonia shot. He did not know the name of it. Caller stated he was not feeling good today. He added that he started not feeling good after he fell off a ladder last Friday (13Nov2020). He also had a pneumonia shot last Thursday. It could have been from that. He started taking pregabalin over a year ago. If he doesn't take it he never sleeps. His legs and feet feel like they are being soaked in ice. Since he has been taking pregabalin he will fall down around 3 to 4 in the evening. The medication relaxes his legs so much. The action taken in response to the events pregabalin was dose not changed. Outcome of not feeling good was recovering, and outcome of other event was unknown.   No follow up attempts are needed. No further information is expected.
Rapid heart beat, fever 102, extreme body aches, heaviness in chest, short breaths with cough.
Outbreak of shingles; This is a spontaneous report from a contactable healthcare professional (patient). A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number was not reported) dose 2 via an unspecified route of administration in the arm left on 30Jan2021 at 16:45 (at the age of 48-year-old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported. The patient had no known allergies. Historical vaccine included the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number was not reported) dose 1 via an unspecified route of administration in the left arm on 09Jan2021 at 16:45 (at the age of 48-year-old) as dose 1, single 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 20Feb2021, the patient experienced outbreak of shingles about 3-4 weeks after second dose of vaccination. The event resulted in physician office visit. Therapeutic measures were taken as the result of adverse event included treatment with FAMVIR 500mg twice a day for seven days. The outcome of the event was recovered on an unspecified date of 2021.  The lot number for the vaccine (PFIZER-BIONTECH COVID-19 mRNA VACCINE) was not provided and will be requested during follow up.
HYPERSENSITIVITY WITH SKIN; SKIN ON FIRE AND BURNING; EXTREMELY COLD; NIGHTTIME CHILLS; MALAISE; FEVER; This spontaneous report received from a patient concerned a 42 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced hypersensitivity with skin. On 14-MAR-2021, the subject experienced skin on fire and burning. On 14-MAR-2021, the subject experienced extremely cold. On 14-MAR-2021, the subject experienced nighttime chills. On 14-MAR-2021, the subject experienced malaise. On 14-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from hypersensitivity with skin, extremely cold, nighttime chills, malaise, fever, and skin on fire and burning. This report was non-serious.; Sender's Comments: V0. medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
reported lt upper arm presented a lump 2 days p/vax which the lump released pus & blood leaving a BB size hole;pt stated area black w/pus & drainage;pt went to ER &  had area assessed & cleaned;
Pt rec'd 2 vaccines in (R) arm. Pt febrile that evening. (R) arm red and swollen at injection site the following day. Pt not using arm. Pt to ER 2 days later and admitted overnight.
Vaccine administered on July 1 may have been opened on Tuesday May 29, which is outside of the 12 hour allotted time window.  Certified Pharmacy Technician administered vaccine assuming another pharmacist had already opened vial that was in refrigerator.  Pharmacist does not recall opening a vial on July1.  It could have been remainder of doses from 6-29-21.  Vial was discarded and new vial was opened for subsequent doses in the day.  Patient waited in the pharmacy for 30 minutes and noted no adverse events.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 11-year-old patient of unknown gender. On 30-MAY-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N020352 (expiration date 10-APR-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
The patient felt lightheaded before the vaccine was administered.  After the vaccine the patient continued to feel light headed and had a racing heart.  The issue resolved after 15 minute observation.
Swelling and redness left lateral thigh first witnessed by parent in morning of 09/20/2014, exacerbating throughout day. Mother took patient to ER 09/20/2014 evening.  Patient was prescribed: Pharmacy: Orapred 15 mg/5 mL oral liquid (Prescribe): 5 mL, Oral, BID, 50 mL hydrOXYzine hydrochloride 10 mg/5 mL oral syrup (Prescribe): 10 mg, 5 mL, Oral, TID, 75 mL, PRN, for itching Septra 200 mg-40 mg/5 mL oral susp (dose on trimethoprim) (Prescribe): 7.5 mL, Oral, BID, 105 mL.
herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 71 year old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 16-JAN-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose and route were not reported) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a healthcare provider for herpes zoster.  The outcome of herpes zoster was unknown.    The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).     Additional information has been requested.
p/vax pt exp pain, redness, swelling, & hot sensation at inj site
heart is beating fast; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart is beating fast) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient is reported to have a  long covid syndrome since he cant breath good for past month.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced HEART RATE INCREASED (heart is beating fast). At the time of the report, HEART RATE INCREASED (heart is beating fast) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications taken by the patient were not provided.   Treatment activities for event was unknown.
Following 1st Covid shot on 12/31; about 2 hours afterward experienced extreme fatigue, nausea, and dull headache.  All mild and expected as possible side effects.  No concerns.  Symptoms continued and by 1/5; all symptoms had move to severe level and are still occurring today 1/8.  Temperature spikes to 102.8; chills, severe headache especially in eye sockets, body aches, and heaviness in chest.  Could not work on 1/7 and only for a bit on 1/8 (working from home).  Became concerned and was flu and covid tested on 1/7;  both negative.  I was retested for Covid on 1/8 and still negative.  I am not sure if maybe I am sick with something else and this is coincidence or if I am just experiencing issues from the vaccine that are a little different from others?
some mild congestion and flu like symptoms; sick as having Covid; bone burning uncontrollable; Immediately felt a strange taste; This spontaneous case was reported by a pharmacist and describes the occurrence of SUSPECTED COVID-19 (sick as having Covid), TASTE DISORDER (Immediately felt a strange taste), BONE PAIN (bone burning uncontrollable) and INFLUENZA LIKE ILLNESS (some mild congestion and flu like symptoms) 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 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, the patient experienced TASTE DISORDER (Immediately felt a strange taste). On 16-Sep-2021, the patient experienced BONE PAIN (bone burning uncontrollable). On 17-Sep-2021, the patient experienced SUSPECTED COVID-19 (sick as having Covid). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (some mild congestion and flu like symptoms). At the time of the report, SUSPECTED COVID-19 (sick as having Covid), TASTE DISORDER (Immediately felt a strange taste), BONE PAIN (bone burning uncontrollable) and INFLUENZA LIKE ILLNESS (some mild congestion and flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter. Company Comment:  This case concerns patient of unknown age and gender with no medical history reported, who experienced the unexpected non-serious AESI of suspected COVID-19 (sick as having Covid), with concurrent taste disorder and influenza like illness. The event occurred approximately 3 days after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns patient of unknown age and gender with no medical history reported, who experienced the unexpected non-serious AESI of suspected COVID-19 (sick as having Covid), with concurrent taste disorder and influenza like illness. The event occurred approximately 3 days after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
fluttering in my chest; Debilitating headache; fatigue; stomach pains; diarrhea; eyes burning; rash; brain fog worsened; dizziness; nausea; This is a spontaneous report from a contactable consumer, the patient. This 51-year-old non-pregnant female patient reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot: Unknown) via unspecified route in the left arm on 20Apr2021 at 12:00 (at the age of 51-years-old) as a single dose for COVID-19 immunization. Medical history included lower back injury, 2 times surgeries, on disability and worker's compensation, gastritis, COVID-19 and long COVID (1 year, 6 days). The patient's known allergies included moxifloxacin (AVELOX) and ciprofloxacin (CIPRO). Concomitant medications received within 2 weeks of vaccination included metoprolol succinate (TOPROL), escitalopram oxalate (LEXAPRO), famotidine (PEPCID), carisoprodol (SOMA), butalbital, caffeine, paracetamol (FIORCET), colestipol hcl (COLESTID 'MEL'). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Apr2021 at 01:00 AM, the patient experienced debilitating headache, fatigue, stomach pains, diarrhea, fluttering in chest, eyes burning, rash, brain fog worsened, dizziness, nausea. There was no treatment received. The outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
This is in follow-up to report(s) previously submitted on 10/12/2007. Initial and follow up information has been received from physician's assistant, and a consumer concerning her 16 year old daughter with an allergy to CECLOR, who on 24-FEB-2007 was vaccinated with her first dose of GARDASIL. After the first dose the patient experienced nausea. On 28-APR-2007 the patient received her second dose of GARDASIL and on 28-AUG-2007 received her third dose (lot # 658558/1061U); she did not experience nausea after these doses. On 17-SEP-2007 (previously reported as 15-SEP-2007) the patient developed hives. She was brought to the ER three times because the hives kept coming back. The patient received an IV in the ER. Unspecified blood work was performed. At the time of the report, the patient was recovering from hives. Follow up information received from a physician's assistant indicated that the outcome of hives was unknown, and was possibly attributed to tanning lotion and situational stress. Additional information is not expected.
I had the normal adverse symptoms that many have had including aches, chills, lethargy, and headache but wanted to report a somewhat strange and probably not very common condition relating to the rash that some have had on the injection site. I have no rash on my injection spot of the vaccine. Rather, I have extreme itching and a small rash on the vein where I had previously donated blood the week before (the previous Wednesday so a week and a day). I read on the symptom sheet about the arm being prone to rashes so I am not at all worried. I really just thought it was interesting...and super itchy but that's why they have creams!
This case was reported by a pharmacist via call center representative and described the occurrence of bell's palsy in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 30th October 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown. It was unknown if the reporter considered the bell's palsy to be related to SHINGRIX. Additional details were provided as follows: The reporting pharmacist did not have SHINGRIX batch number and expiry date available.