chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from nurse via a sales representative referring to a 11 year old female patient. The patient's medical history and drug reactions and allergies were not provided. On 16-OCT-2017, the patient was vaccinated with the second dose of GARDASIL 9 for Human Papilloma Virus (HPV) prevention (route, lot# and expiry date were unknown). On the same date, after the second dose vaccination, the patient immediately "fainted and hit her head". The patient did not seek medical attention. The outcome of syncope and head injury was reported as recovering. The causality assessment between GARDASIL 9 and the aforementioned events was unknown.
2 days later was told I had swollen lymph nodes in left breast noted to probably be vaccine. 5 days later I had a sudden event of being unable to breathe and feeling as though I was going to pass out. Called EMS and was found to be in severe atrial fib and extremely elevated BP. Transported to ER, Given Cardiaziem IV during transport, and more Metoporol in ER as well as fluids. Have continued to have increasing bouts of AF, with sudden spikes at any time of day in BP not during AF, Weird H/As that come and go and seem to "move around" spot to spot in my head. Extreme fatigue and in general not myself. Started on Eliquis in ER and now on increased dose of Metoporol and last week started on Losartan 25 mg q HS for continuing BP spikes.
Got my first Pfizer shot on March 24 at 2 pm. The first day I felt way off like I was drunk or on some kind of drug that gets you high with bouts of dizziness and some major hypertension. My back and chest were very tight the whole time. The tension finally subsided around 11 pm that night but I was still uneasy. The 2nd day I felt ok in the morning and throughout the day until about 3 or 4 pm I started getting really nauseated and tired. I went to lay down to sleep and felt a little better when I woke an hour later. Day 3 I started feeling extremely tired and fatigued with some major chills. Basically slept most of that evening and throughout the night. Woke that next day and couldn't get that dizzy foggy feeling out of my head the whole day. Day 4-5 still bouts of dizziness, chills and fatigue with some nausea also I noticed I developed a wheezing dry cough which points towards respiratory distress. Day 6 still feeling yucky, tired, fatigued, some nausea and that dam cough. Today  03-31-21, still feeling weak and tired with some episodes of dizzy spells, nausea and respiratory distress cough.   Also forgot to mention on day 2 and 3 I had some major tingling on the right side of my head for most of the day. Felt like spiders crawling on my head and face. The last time I felt tingling like that I got shingles which also got me very sick and put me in the ER and ICU years ago. So there is also some post traumatic stress from that as well.  Made an appointment to see a Doctor on 03-30-21 to have my blood pressure checked and get an overall check up.  My blood pressure is elevated and stress levels are high with anxiety.  Dr prescribed me some anxiety medication. No other recommendations from the Doctor.
Pt brought back by mother to immunization clinic at 10:58 and site had redness that mesaured 8cm x9cm. Noted a small brusing on area as well. Area marked, pt given cold pack and benadryl and remained in the clinic for approximately 50 minutes to monitor. Redness at site decrease to 4cm x5.5 at the time of discharge. Pt had no respiratory symptoms at discharge.
Developed chills, fevers, and all over body aches 25 hours after receiving the booster. Soreness at the injection site began a few hours after receiving the injection and has progressively became worse. Unbearable pain.
administered vaccine that was in fridge for too long; called Pfizer and they said revaccinate patient
Dose received: 3; Flu like symptoms for 18 hours following booster shot; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).   An 88-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date an unknown date in Dec2021 (Lot number: unknown) at the age of 88 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Heart disorder" (unspecified if ongoing), notes: heart disease. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN), and Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset an unknown date in Dec2021, outcome "unknown", described as "Dose received: 3"; INFLUENZA LIKE ILLNESS (non-serious) with onset an unknown date in Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Flu like symptoms for 18 hours following booster shot". Therapeutic measures were not taken as a result of influenza like illness.  Additional information: The event INFLUENZA LIKE ILLNESS was resolved after the duration of 18 hours. It was not known whether the patient had known allergies. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Very sore arm, red rash 7 days AFTER vaccine injection. It appears to be settling down and subsiding therefor I haven?t contacted my DR. I felt the reaction should only last a few days.
Ringing in left ear; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 11Jun2021 at 15:45 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), amitriptyline (MANUFACTURER UNKNOWN) and ibuprofen (MANUFACTURER UNKNOWN); all for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received morphine (MANUFACTURER UNKNOWN) for unspecified indication from unknown date and experienced drug allergy. On 12Jun2021 at 15:45, after 24 hours of vaccination, the patient experienced ringing in left ear which had not stopped. Since the vaccination, the patient had not been tested for COVID-19. The events 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 event. The clinical outcome of the event ringing in left ear was not recovered at the time of this report.
muscle aches; a rash appeared on his back; has progressed to almost sores; complained of not being able to sleep for 3 days due to it; body aches in back and sides; fatigue; chills; body aches in back and sides; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (also experienced aches in back and sides, chills and fatigue after receiving 1st dose in November 2020, for tolerance refer case US2021030867).   On 29th January 2021, the patient received the 2nd dose of Shingrix. On 31st January 2021, 2 days after receiving Shingrix, the patient experienced rash and skin ulcer. On an unknown date, the patient experienced general body pain, fatigue, chills, back pain, difficulty sleeping and muscle pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the general body pain, fatigue, chills, back pain, difficulty sleeping and muscle pain were recovered/resolved and the outcome of the rash and skin ulcer were unknown.   It was unknown if the reporter considered the general body pain, fatigue, chills, back pain, rash, skin ulcer, difficulty sleeping and muscle pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient himself. Less than a week after receiving Shingrix, the patient had same symptoms of aches included body aches in back and sides, chills and fatigue presented and were resolved in 2 days. Two days after receiving the vaccine, a rash appeared on his back and it had progressed to almost sores. Less than a week after receiving Shingrix, the patient complained of not being able to sleep for 3 days due to it. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021030867:same reporter
couldn't walk for 3 days; dizziness; loss of balance; I was disoriented; A Spontaneous was received from a Consumer concerning a 68 years old Male patient  who experienced I was disoriented, Couldn't walk for 3 days, Dizziness and Loss of balance.    The patient's medical history was not provided. Concomitant medications was not provided.    On 12 FEB 2021 , prior to the onset of the events, the patient received their First of two planned doses of mRNA-1273 Batch no: 007M20A Intramuscularly in the Left Arm for prophylaxis of COVID-19 infection.  It was reported that the patient experienced I was disoriented, Couldn't walk for 3 days, Dizziness and Loss of balance.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events was included, I was disoriented, Couldn't walk for 3 days, Dizziness and Loss of balance was considered unknown.
administered TENIVAC that expired 3 days ago with no reported adverse event; Initial information was received on 25-Jan-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age/gender patient who was administered DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] that expired 3 days ago with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Jan-2023, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6922AA and expiry 22-Jan-23) (expired product administered, latency same day) (dose formulation and strength: unknown) via unknown route in unknown administration site for prophylactic vaccination.  Action taken with DIPHTHERIA AND TETANUS TOXOIDS (TENIVAC) was not applicable.  At time of reporting, the outcome was Unknown for the event administered tenivac that expired 3 days ago with no reported adverse event.  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 the 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.
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: rash ,swelling,burning,itchy at injection site-Mild, Additional Details: patient believes she may have been allergic to the band aids
Developed itchy painful rash 8 days after vaccination at injection site about 4 inches x 4 inches
FELT LIKE BEING FORCED TO MOVE; FELT SEVERE FATIGUE; SLEPT FOR THE DAY/ SLEEPS FOR 13-15 HOURS.; This spontaneous report received from a patient concerned a 52 year old male. The patient's weight was 265 pounds, and height was 69 inches. The patient's past medical history included: shingles, and concurrent conditions included: sleep apnea, alcohol user, and non smoker, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage. The patient was previously treated with diphtheria vaccine toxoid/pertussis vaccine acellular/tetanus vaccine toxoid; and experienced drug allergy when treated with phenobarbital. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 13-JUN-2021) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021, the patient experienced slept for the day/ sleeps for 13-15 hours. On JUN-2021, Laboratory data included: Blood test (NR: not provided) Normal, and Electrocardiogram (NR: not provided) Normal. On an unspecified date, the patient experienced felt like being forced to move, and felt severe fatigue. Treatment medications (dates unspecified) included: solriamfetol hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt severe fatigue, and slept for the day/ sleeps for 13-15 hours., and the outcome of felt like being forced to move was not reported. This report was non-serious.
Giant red spot covering the entire bicep/tricep area above the elbow with severe itching, burning, and pain. This stayed for 4 days. I had to take Benadryl for all 4 days and it only helped a little bit.
getting worse; painful rash over the neck and shoulders.; his arm started hurting; Rash; left side of his neck is in excruciating pain; Left arm is going numb; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200348601 (Pfizer), US-PFIZER INC-202200354082 (Pfizer).  A 76 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Jan2022 11:00 (Lot number: F0611) at the age of 76 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, date: 27Dec2021, Lot: FJ8957, Expiration: Unknown), administration date: 27Dec2021, when the patient was 76 years old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 20Jan2022, outcome "not recovered", described as "his arm started hurting"; RASH (non-serious) with onset 20Jan2022, outcome "not recovered", described as "Rash"; NECK PAIN (non-serious) with onset 20Jan2022, outcome "not recovered", described as "left side of his neck is in excruciating pain"; HYPOAESTHESIA (non-serious) with onset 20Jan2022, outcome "not recovered", described as "Left arm is going numb"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "getting worse"; ARTHRALGIA (non-serious), outcome "unknown", described as "painful rash over the neck and shoulders.". The events "his arm started hurting", "rash", "left side of his neck is in excruciating pain" and "left arm is going numb" were evaluated at the physician office visit and emergency room visit.  Additional information: Patient got the second dose of the Pfizer Covid-19 vaccine. As soon as he got the second dose, his arm started hurting. He developed a rash on his left side, the left side of his neck was in excruciating pain and it was getting worse. It has been 6 weeks. His left arm was going numb and getting worse. He was on insurance and they only pay for 80%. His second dose was 6 weeks ago on 20Jan2022. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as None. Prior Vaccinations (within 4 weeks), Medical History, Family Medical History Relevant to AE was reported as None.  Follow-up attempts are completed. No further information is expected.
Patient reported arm soreness, few minutes later left leg starting to feel numb, shortness of breath. Then he reported tight throat and tongue swelling. Immediately called 911 and activated ems. Vitals: 0xygen 100%, bp 230/130, HR 80. Symptoms seem progressing so epinephrine 0.3 mg was administered at 11:30 a. EMS arrived 2-3 minutes later after epi was administered . Epi lot: OFM242, exp 11/01/2021. Patient left with EMS on gurney
half dose given instead of full dose,patient never received 2nd full dose; 2nd dose (0.25 ml) given > 35 days from 1st dose; This spontaneous case was reported by a health care professional and describes the occurrence of UNDERDOSE (half dose given instead of full dose,patient never received 2nd full dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose (0.25 ml) given > 35 days from 1st dose) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B and J07BX03) for COVID-19 vaccination.     No Medical History information was reported.   On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On 30-Nov-2021, the patient experienced UNDERDOSE (half dose given instead of full dose,patient never received 2nd full dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose (0.25 ml) given > 35 days from 1st dose). On 30-Nov-2021, UNDERDOSE (half dose given instead of full dose,patient never received 2nd full dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose (0.25 ml) given > 35 days from 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
The patient experienced redness and warmth at injection site; The patient experienced redness and warmth at injection site; This spontaneous report has been received from a pharmacist via a company representative, concerning a 13 year old male patient.      The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 26-JUL-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, anatomical location lot number and expiration date were not reported) for prophylaxis.  On that same day, he was also vaccinated with other suspect therapies included meningococcal vaccine (unspecified) and diphtheria toxoid (+) pertussis acellular 1-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid(DTAP-IPV) (dose, frequency, anatomical location lot number, indication and expiration date were not reported)  Later on 28-JUL-2019,  the patient experienced "redness and warmth" at injection site (injection site erythema and injection site warmth). Therefore, as treatment , he received ibuprofen and fexofenadine hydrochloride (ALLEGRA). In addition, he did not seek for medical attention. At the reporting time, the outcome for both events was unknown.    The causal relationship between injection site erythema, injection site warmth, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and other suspect therapies included meningococcal vaccine (unspecified) and diphtheria toxoid (+) pertussis acellular 1-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid(DTAP-IPV) was not reported.
On 3/19 Dr advised that I should have PCV 13 injection and I said I would get it done at a local pharmacy. I rec'd the shot at the market on 3/22. On 3/23 I started coughing and could hardly speak. On following days my condition was and is worse and as of 3/26, am unable to leave house because of coughing and diarrhea.
Client received vaccine on 3/16/17 around noon and on morning of 3/17/17 on arm that shot was administered on became red and had rash on it. Client also reported arm being very sore and having hard knot on it. Client went to doctor on 3/17/17. Client contacted Health Department 3/21/17.
1 day after vaccines, child's L arm became swollen. Parents took child to JFK ER where pt was dx with cellulitis and prescribed Keflex
Headache, Myalgia, PT REPORTED MUSCLE ACHES , CHILLS, FATIGUE, AND HEADACHE DAY AFTER INJECTION Narrative:  Other Relevant History:
Evening of shot, child experienced severe nausea, no vomiting. Mother took child to ER. Mother reported doctor there said it was a local reaction. Mother.child sent to me with Duricef and directions for mother to put warm compress on swollen area, hot, and itchy also. Additional info child was very fearful of receiving shots.
Occasional rapid heart rate.   My GP prescribed Lopressor (beta blocker) when these happen.  Only 3 events in one year.  Currently on a Holter monitor until Dec. 6 2022 to see if there is an underlying condition.
Employee reports severe redness, swelling and severe pain at site that caused her to seek medical advice.  She reports that her MD feels that the reaction is related to circulating Tetanus antibodies, and that she should avoid future Tetanus shots.  As of 9/29/11 continues to report pain at site.
inadvertently gave expire pentacel to patient with no reported adverse event; Initial information received on 24-Oct-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves Infant patient of unknown gender who was inadvertently given expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Suspension for injection) (strength; lot number; expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation). Information regarding batch number will be requested in this case.  On an unknown date the patient was inadvertently given expired pentacel to patient with no reported adverse event (expired product administered) (latency: same day).   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 the 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.
Severe Back pain started Friday at 330 PM, Heartburn and skin rash/hives