chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The morning after the RSV vaccine my mother had a syncopal episode while she was cooking in the kitchen which resulted in her having multiple subarachnoid hemorrhages and a closed frontal bone fracture.  She has no recollection of this event or day even. My father who was at home, noticed her making 3 trips to the bathroom within in the 30 minutes prior to finding her passed out.  Upon EMS arrival, she vomited when she sat up. Prior to EMS transport to the hospital she had one very loose stool. She did not loose bowel or bladder function during the syncopal event and EMS did not report low blood pressure or heart rate abnormality. She was hospitalized for 3 days, during which time she had continued trouble with nausea and vomiting and her strength and balance were significantly reduced. No cardiac abnormalities were found on telemetry, EKG, or Echo. EEG was negative for seizure activity. Orthostatic vitals were normal. No infectious process found.
Patient was directed by vaccintor to wait 30 min for observation due to history of Guillain-Barre. While patient was steated she began to have a syncopal episode, observation team member assisted patient to floor, where she was observed to have regular/non-labored breathing, and a heart rate in the 120's, EMS response was activated. Patient had no hives, no redness, no swelling. Patient denied having any pain, was alert to location and event of receiving vaccine. Patient reported lat oral intake of breakfat between 7-9am this morning, EMS arrived on scene, assuming care, and tranported patient to emergency department for further evaluation.
Shortness of breath, severe; heart palpitations; uncontrollable dry cough, gagging; hot flashes, chills, slight fever, sore throat, fatigue.
Patient said that her arm and armpit was sore and that she couldn't reach out with the arm that the vaccine was administered in.
the DTAP/IPV portion of the Pentacel injection was already injected because it is missing and the ActHIB powder portion remains; Initial information received on 05-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown demographic patient who was vaccinated with a dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot UJ073AAA and Exp. Date 13-Jun-2020) via unknown route in unknown administration site on an unknown date.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate reconstitution technique as it was reported that the DTAP/IPV portion of the Pentacel injection was already injected because it is missing and the ActHIB powder portion remains.  It was unknown whether the patient experienced any adverse event post vaccination.  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.  List of documents held by sender: none.
7/23/21: came to the ED with generalized weakness and cough with low oxygen levels with hx of COPD. admitted with COVID-19 pneumonia, acute renal failure, hypoxemia Note: patient previously vaccinated with Pfizer COVID-19 vaccine on:  1/26/2021 and 2/23/2021.  Lot numbers EL1283 and EL9269 7/27/21: patient still admitted at the time of this report submission.
On 9/29/17 the patient came to see N.P for a check up and flu shot. She received the flu shot and on 9/30/17 her arm began to swell in the spot were she received the injection. The patient came in today complaining of pain and swelling over the weekend. She also stated that the swelling had gone down but she's still in pain.
minor aches; sugar spike; minor tiredness; two days after the shot I was able to walk with ease; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (minor aches), BLOOD GLUCOSE INCREASED (sugar spike), FATIGUE (minor tiredness) and THERAPEUTIC RESPONSE UNEXPECTED (two days after the shot I was able to walk with ease) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 vaccination.     The patient's past medical history included Lyme disease in 2006. Concurrent medical conditions included Drug allergy (Metoprolol ER Succinate 100 mg), Drug allergy (Zyrtex), Drug allergy (Macrobid), Drug allergy (Nifedical XL), Drug allergy (Lisinopril), Lactose intolerance, Supraventricular tachycardia since 2006, AFib since 2006, Vertigo since 2006, Blood pressure, Cholesterol, Osteopenia since 2009, Pre-diabetic since 2009, Supraventricular tachycardia since 2006, Premature ventricular contractions since 2006 and Premature beat atrial since 2006. Concomitant products included LOSARTAN, DILTIAZEM, APIXABAN (ELIQUIS), ROSUVASTATIN, VITAMIN D [VITAMIN D NOS] and CORTISONE for an unknown indication.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (two days after the shot I was able to walk with ease). On an unknown date, the patient experienced PAIN (minor aches), BLOOD GLUCOSE INCREASED (sugar spike) and FATIGUE (minor tiredness). On 04-Nov-2021, THERAPEUTIC RESPONSE UNEXPECTED (two days after the shot I was able to walk with ease) had resolved. At the time of the report, PAIN (minor aches), BLOOD GLUCOSE INCREASED (sugar spike) and FATIGUE (minor tiredness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: increased (High) increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications was not reported. Patient had experienced soreness , minor aches , minor tiredness and sugar spike on 24-NOV-2021. Patient was waiting to schedule two hip replacements when COVID gets under control. On 04-NOV-2021 patient was able to walk with ease at a good clip for a 1 1/2 walk. The cortisone shot had worn out by September 2021. After all 3 vaccines patient's sugar count spiked 15-30 points. Patient experienced soreness , swelling and slight tiredness in the past and described as other vaccines had soreness , swelling and slight tiredness.   This case was linked to MOD-2021-029925, MOD-2021-380489 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up received and events , event outcomes added
There were no adverse events, treatments or outcomes. Her parents thought she was eligible to receive the Moderna booster and we did not realize on our consent form that she was only 15. We have since changed our consent form so the age is right next to where the vaccinating pharmacist initials the form.
Information has been received from a physician concerning a patient who was vaccinated subcutaneously with a first dose of ZOSTAVAX (Oka/Merck).  On an unspecified date the patient developed shingles.  At the time of the report, it was unknown if the patient had recovered from the event.  Unspecified medical attention was sought.  Additional information has been requested.
Pt states that for the past 5-6 days she has had a HA in mid forehead.  HA always present to some degree but does vary considerably in intensity.  Pt also c/o anterior neck discomfort earlier in day (not necessarily worse w/ swallowing) that has improved on its own.  She denies stiff neck or posterior neck pain.  She also c/o generalized fatigue, numbness and tingling in both her legs, "hot flashes", and sore muscles throughout her body.  She states her skin feels very sensitive to touch.  She states she has had increased anxiety in recent days (unsure why) and has been very irritable.  She adamantly denies any suicidal or homicidal thoughts/plans.  LMP 1 1/2 weeks ago > normal.  This 18-year-old has been in a couple of times now for this complaint.  She has seen Dr.  All of these symptoms started directly after her HPV vaccination.  This is discussed  in detail in Dr's notes.  The patient's current symptoms include numbness, malaise, swollen glands, joint pain, muscle pain, fatigue, increase in her headache frequency and hot flashes.  She even noticed that her right ear clicks after the injection.  In general, she does not feel well.  The respite from school has helped somewhat.  She is less stressful, but still, according to her and her mother, continues to be very anxious with lots of mood irritability.  She still does go to the gym daily and run.  She enjoys visiting with her friends.  Her sleep is still quite poor.  The AMBIEN has helped.  This recent episode was overlaid with a viral illness.  I reviewed her blood work from a couple of weeks ago with them again and that all looked normal.  This 18-year-old was seen by me last week in the same-day clinic.  I felt she might be depressed.  She was reacting to sore throat, fatigue, and insomnia.  Her lab studies are all perfectly normal.  Her strep screen was negative.  Her monotest was negative as well as a CBC and thyroid testing.  Today, she presents with her mother and history is more complete in that she had GARDASIL vaccine in October and then in December.  Her symptoms started in October, shortly after the first injection and got worse after the second injection.  Her symptoms, though somewhat vague, seem to be pretty consistent in that they include nausea, fatigue, difficulty sleeping, and now she is having some numbness in her calves when she crosses her legs.  Her mother did take her away for a week to get away from all the stress of home life and school, but her symptoms did not improve.  She was given some AMBIEN and did take that once during this last week.  Overall, her appetite has been okay.  While she has some teenage worries, she denies depression.
Altered mental status within 5min. Constricting of the airway. Complete lost of consciousness within 15 min.
Lymph node swelling behind left ear and left posterior neck area developed 7/19; developed fever 101.5 on 7/21. CBC done on 7/21 - sl. low wbc ct, possible viral suppression. Watch for S/Sxs viral illness, also discussed S/Sxs of adenitis,
pt recvd vax; day after vax, pt exp nausea; flushing of her face; a persistent headache & fatigue;
Possibly/suspected bell's pulsy; inability to make full smile on the right side; Numbness in on right side of tongue; loss of grip strength in right hand; unable to fully close right eye; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: zho179), the first dose via unspecified route of administration in left arm on 08May2021 at 13:00 as single dose for COVID-19 immunisation. The relevant medical history was not reported. Concomitant medications were reported as none. On 11May2021, the patient experienced numbness in on right side of tongue, inability to make full smile on the right side, loss of grip strength in right hand. No other symptoms presented. Possibly/suspected bell's pulsy unable to fully close right eye. No treatment received for the events. No Covid prior vaccination. No Covid tested post vaccination. The outcome of the events was not recovered.
Information was received from a physician concerning 4 year old male patient. The patient had no pertinent medical history, drug reactions/allergies or concomitant medications. On 29-JUN-2018 the patient was vaccinated with a Oka-Merck PROQUAD (dose unknown, batch/lot # N029879, expiration date 22-APR-2019) subcutaneously as general immunization and KINRIX (unknown dose, lot number and expiration date). The physician reported that "later that day when the patient was home he started to experience edema, and erythema at the injection site where the Oka-Merck PROQUAD was administered". The patient also started to experience "a fever". The physician reported that the "patient's mother took the patient to an unspecified Urgent Care where he was given cephalexin" (unknown lot number and expiration date). No lab diagnostics/studies was performed. The physician stated that the patient came to his office on 02-JUL-2018 for a "follow up" and the physician reported that the "symptoms are recovering but not fully recovered yet". The causal relationship between the vaccines and the events were unknown.
Administered vaccination. Had patient wait with her father in vaccination area. Approximately 1 minute father approached saying daughter did not feel well. I observed patient who appeared white, sweaty and agitated/slight disorientation. I had her put head between legs, as she would not lay down. She sipped Gatorade  but felt nauseated and eventually vomited. I called 911. EMT examined patient who was beginning to feel better. EMT offered to take patient to hospital via ambulance. Patient and family declined saying she felt better. EMT also said parents could follow-up to ER or PMD as needed. Family/patient declined-said she felt better.
Pfizer-BioTech COVID-19 Vaccine EUA.   Swelling at injection location.  Red raised welts at injection location
Patient reports the vaccine site got very red and swollen. Within a day or two later, he developed pustules around the vaccine site that spread to his left chest area. He has had shingles in the past, and reports this 'felt' like shingles. The redness and pustules lasted approx. two weeks.
SUSPECTED CLINICAL VACCINATION FAILURE; COVID 19 TEST POSITIVE; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnic origin 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: UNKNOWN) dose was not reported,1 total, administered on MAR-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. On AUG-2021, the patient had covid 19 test positive and suspected clinical vaccination failure.  Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid 19 test positive and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210702013.; Sender's Comments: V0. 20210817456-covid-19 vaccine ad26.cov2.s -suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS..
Information has been received from a medical assistant reporting on an 18 year old male patient. The patient had not current conditions, medical history or concomitant medication. On 27-JUL-2017, the patient was vaccinated with GARDASIL 9 for prophylaxis lot # reported as N010497 and expiry date 15-JAN-2020 (dose and route of administration were not reported). On 27-JUL-2017, after the vaccine was administered, the patient walked into the waiting room and sat down, then passed out and fell from chair onto the floor. The patient was unconscious and unresponsive for approximately 10 seconds. Then the patient had a mini-seizure and he was very sweaty. The reporter indicated that that patient's vital signs and blood sugar were assessed (conflicting information, also reported as "no lab diagnostics or studies were performed"). The patient declined transport to a hospital.  No treatment was given for the adverse events. On 27-JUL-2017, while the patient was still in the office the patient recovered from the adverse events loss of consciousness, hyperhidrosis and seizure, and was able to leave on his own. The causal relationship between the event and therapy with GARDASIL 9 was not reported. It was reported the case # 00565267 with additional AE regarding to the same product, and the case was created with MARSS#1708USA012553. The medical assistant considered the event loss of consciousness to be serious for the following reason: life threatening. Upon internal review the events loss of consciousness, and seizure were considered to be medically significant. This is one of two case from the same reporter.; Sender's Comments: US-009507513-1708USA012553:
sore shoulder; Shoulder discomfort (Musculoskeletal discomfort); sleepy; This is a spontaneous report from non-contactable consumer via two different programs. A 77-year-old female consumer reported that she received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiry date was not reported) dose 2 via an unspecified route of administration on 08Apr2021 (at the age of 77-year-old) as 2ND DOSE, SINGLE for covid-19 immunisation. On 02Apr2021, female patient initiated Tymlos (abaloparatide) 80mcg daily subcutaneous injection, Lot# unknown, for the treatment of osteoporosis.Medical history included , intervertebral disc protrusion from an unknown date and unknown if ongoing verbatim: 4th disc slipped on 5th disc and pinched a nerve, and surgery (unspecified) , nerve compression from an unknown date and unknown if ongoing verbatim: 4th disc slipped on 5th disc and pinched a nerve, and surgery (unspecified). Surgery from an unknown date and unknown if ongoing verbatim: 4th disc slipped on 5th disc and pinched a nerve, and surgery (unspecified), tooth injury from an unknown date and unknown if ongoing. verbatim: Teeth were clear after one year of therapy.  The patient's concomitant medications were not reported. Historical drugs included Fosamax (alendronate sodium) and Forteo (teriparatide). Relevant surgical, social, or substance-usage history was not provided Relevant concomitant medications were not provided. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration on an unknown date as single dose for covid-19 immunisation. The patient experienced dizziness (start/stop date 02Apr2021, duration just a few minutes also reported as less than an hour), product use omission (did not use Tymlos on 08Apr2021) (start/stop date 08Apr2021), and intentional product misuse (took two doses of Tymlos on the same day) (start/stop date 09Apr2021). No treatment was reported. 09Apr2021, patient experienced sleepy and shoulder discomfort (musculoskeletal discomfort). On an unspecified date, patient had sore shoulder. Diagnostic tests included a bone mineral analysis; per patient, results were 3.6 (units not reported). The action taken with Tymlos was dose not changed. The outcome of events was unknown.  Additional information has been requested.  Information on the lot/batch number has been requested.
blisters; fever; aches; Feels burning; This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 3HX44, expiry date 15th November 2021) for prophylaxis.   On 11th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 13th September 2019, 2 days after receiving Shingrix, the patient experienced blister, fever, pain and burning sensation. On 15th September 2019, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the blister and burning sensation were unknown and the outcome of the pain was recovering/resolving.   It was unknown if the reporter considered the blister, fever, pain and burning sensation to be related to Shingrix.  Additional details were provided as follows: The reporter was reading the information from a note that another pharmacist left. The patient received intramuscular injection of Shingrix and 2 days after she developed blisters which were painful and burning.  The patient also experienced a fever which resolved after 2 days. The patient also experienced aches. The patient was feeling better now and improved but she still feels pain and burning. The reporter did not know if the blisters had resolved or where on the body they were located. The pharmacist stated that the patient has stated she does not want to get the second shot in the series. The pharmacist did not had patient's MD contact information available.
The right side of my face has gone numb as if I had a dentist's injection. Started the same evening as the vaccination. Includes even the ear.
Information has been received from a female patient of unknown age referring to herself. Information about concurrent conditions and medical history were not provided. The patient reported that she received one dose of VARIVAX (Merck) (lot#, dose and route not reported) as a child on an unspecified date and had titers drawn. The results revealed that she was not immune to Varicella (date unspecified). The patient was administered the VARIVAX (Merck) (lot#, dose and route not reported) series, this time completing two doses on 02-SEP-2014 and 16-OCT-2014 respectively. No information regarding concomitant therapy was provided. However, as of 10-MAR-2015 titers were still showing her not being immune to Varicella. The patient sought for medical attention via visiting physician. The outcome of the event was not reported. Additional information has been requested.
Vaccine remained in the freezer past the recommended guidelines (14 days). Once discovered, Pfizer was contacted but did not have stability data to support acceptability of the product greater than 31 days in the freezer. All patients that were administered vaccine past 31 days were contacted and given an option to be re-vaccinated based on their doctor's recommendation or guidance.
24NOV91 devel rash on chest & back, by evening over entire body; Fever of 101; 25NOV91 no fever, rash worsened; Seen @ ER; given DPH; MD not sure whether rash was due to MMR or rx of Amoxicillin;
Severe injection site pain started the evening of 2/4/21 and resolved in 48 hours. Intermittent injection site pain reoccurs daily especially when lifting up arm (getting dressed, reaching for something). Pain resolves when my arm is not lifted up.
Pt received 4 doses of COVID vaccine - 2 doses here and 2 doses elsewhere in about Feb 2021.   not checked. Pt filled on manual forms - 8/11 stating no previous doses, 8/30 as having a previous dose.  Called pt who thought booster was 2 shot series again & if she told us the truth we wouldn't give her the doses.  Pt says no adverse effects with either dose 3 or 4.