chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client  Received the 2nd dose of Pfizer COVID vaccine lot #ER8735 and expiration date 07/04/21 at 1:34pm.  At 1:34pm, client reports to vaccinator that she feels dizzy. Vaccinator offer client water and client starts drinking it.  PHN 1 & PHN 2 arrive client reports she "feels weird" PHN asks client to explain and client is unable to describe. Client is alert and oriented X 4 and is already seated in zero gravity chair due to reporting history of syncope.  Vaccinator offered client water and client starts drinking it.  Client reports no headache, no shortness of breath, no blurred vision, no chest pain, just dizziness.  At 1:34PM vitals heart rate taken manually by PHN :72 and blood pressure: 128/74, unable to get oxygenation due to long acrylic nails.  PHN gets report from mother that client reports with the first dose something similar happened that she experienced dizziness after vaccine. Client was kept in observation and symptoms resolved prior to client going home. Clients mother reports no medical history, no medications and no history of allergies. At 1:36PM PHN gets called away for another adverse reaction and PHN  stays with client.  At 1:39pm client reports dizziness is resolving but still "feels weird", PHN asks client to clarify what weird means and she says "it feels like my heart is slower." At 1:40pm client reports she is feeling sleepy,  PHN attempts to call 911 and gets disconnected.  At 1:41pm vitals: blood pressure: 130/82 and pulse:134.  At 1:42pm PHN calls 911 again to reconnect and observes clients lips look purple, closed eyes but able to answer questions and speak in complete sentences. Ask RN to get AED as instructed by 911 dispatcher.  At 1:45pm, client reports having trouble breathing and RN placed zero gravity chair to laying position and assist client with coaching her to take slow deep breaths.  Fire department paramedics arrived at 1:47pm and assumed care. Client was wheeled out on a gurney at 1:50pm.
ovarian cysts; This is a spontaneous report from a contactable consumer, the patient. A 31-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 06May2021 as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose on 06May2021, a week after the patient had ovarian cysts. She indicated the only thing that was changed, she has been working from home.  The outcome of the event was unknown  Information on the lot/batch number has been requested.
tired, fatigue and temperature of 101.4 at 2:15pm on Jan 14, 2021
diagnosed with symmetric high-frequency sensorineural hearing loss; tinnitus in both ears; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 27-JUL-2016, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route, lot # and expiration date not provided) by a pharmacist, at a pharmacy, as recommended for long-term prevention of shingles and zoster-related conditions. O an unspecified date, the patient suffered the following injuries and was diagnosed as a result of the zoster vaccine live (ZOSTAVAX) vaccine with: tinnitus in both ears and was diagnosed with symmetric high-frequency sensorineural hearing loss. The outcome of the events was unknown. Causality assessment between the events and the suspect vaccine was related.  Upon internal review symmetric high-frequency sensorineural hearing loss was considered to be medically significant event.
Information has been received from a 37 year old female consumer with no medical history and an allergy to penicillin who in October 2007, was vaccinated with the first dose of GARDASIL vaccine (yeast) in her left arm "in the muscle". In December 2007 the patient was vaccinated with the second dose of GARDASIL vaccine (yeast) given in the same spot on her left arm. In April 2008, the patient was vaccinated with the third dose of GARDASIL vaccine (yeast) on the back side of her right arm. There was no concomitant medication. A few days after (also reported as a few weeks after) the first dose a red mark appeared that looked like a pimple at first. The red mark was still there when she went back for her second dose. After the second dose the red spot became worse. The patient did not have any red marks after the third dose. At time of reporting, the mark on the patient's left arm was still there, looks like a scar, but has gotten fainter. Unspecified medical attention was sought. Patient outcome was recovering. No further information was available.
PATIENT STARTED TO EXPERIENCE WARMTH AT THE SITE, TINGLING ALONG THE INJECTED ARM, AND DIZZINESS. STAFF NURSES APPLIED COLD PACK TO INJECTION SITE, TOOK VITALS, GAVE PATIENT WATER, MONITORED FOR WORSENING SYMPTOMS. KEPT PATIENT AT SITE FOR OBSERVATION FOR 30 MINUTES.
Neuropathy. At it's worst - it felt like my body was getting shocked.  Today, my feet, shins and hands have tingling. I was diagnosed with Small Fiber Neuropathy today.
6 hours  post vax, the pt broke out in a rash. Father states rash was pink and papular to trunk lasting 3 days. No itching. No welts. No fever. Never evaluated at the time.
Couldn't lift her right arm; Had a flare up on my right arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Jul2021 (Formulation: solution for injection, Batch/Lot number: unknown) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Scoliosis" (unspecified if ongoing), notes: scoliosis which is, curvature of the spine and had surgery for that at 17.; "Arthritis" (unspecified if ongoing), notes: she was 17; "Musculoskeletal conditions" (unspecified if ongoing), notes: She says after having that when she was 55 she had, musculoskeletal issues that she takes medication for.; "Rheumatoid arthritis" (unspecified if ongoing); "surgery" (unspecified if ongoing), notes: Scoliosis (From:, Unknown To: Unspecified) Additional Information for, Other Conditions: Caller says she was diagnosed wit hthis when she was 17 and had surgery for it when she, was 17; "shrinking" (unspecified if ongoing), notes: every year she is shrinking, but recently she was five feet, four and a half inches, tall. The patient took concomitant medications. The following information was reported: ARTHRITIS (non-serious) with onset 2021, outcome "unknown", described as "Had a flare up on my right arm"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset Jul2021, outcome "unknown", described as "Couldn't lift her right arm". The event "had a flare up on my right arm" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of arthritis. Additional information: The lot number for bnt162b2 was not provided and will be requested during follow up.
Swelling and redness below right eye, dermatology consult suspected cellulitis and sent me to ER, ER doctor entertained cellulitis or shingles and prescribed antibiotics and antivirals, following day I saw Ophthalmologist, who concluded it was an allergic reaction from Moderna vaccine to leftover from injectable filler (Juvaderm/volume) from august 2015. Doctor who performed the filler injection in 2015 also said she had a reaction from first Moderna vaccine in the lip area. Treatment consisted from antihistamine, cold compresses and finishing antibiotics (just in case). Lasted about 4 days.
Patient was mistakenly given 3 doses of Fluzone (0.5ml) in 3 injections; 2 in left thigh and 1 in right thigh.  Vaccinator realized mistake immediately after administering Fluzone.  Father and neighbor given all instructions of normal side effects of Fluzone, if needed to call on-call provider/911.  F/U over the phone was done; child had only low-grade fevers for 3 days after vaccination, no other sx reported.
Initial report received on 02 August 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 13-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3879AA received on 26 July 2011, lot number C3913AB received on 11 October 2011 and lot number C4045AA received on 06 January 2012 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 01 July 2012, approximately five months after the last dose. On 12 July 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting, apnea and sleep disturbance. Laboratory testing included positive PCR on 16 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 16 July 2012 for five days. The subjects was not hospitalized. At the time of final contact on 18 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 17 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Patient fully vaccinated against COVID-19 on 2/22/21 and received a Booster dose on 8/25/21. Patient was admitted to reporting hospital due to shortness of breath, weakness, cough and hypoxia. He went on vacation with his wife prior to illness. Patient was admitted with COVID-19 pneumonia. Admission test was positive for COVID-19 by PCR NP swab on 9/14/21. Patient was admitted on 9/24/21 and remains admitted at this time. Patient's booster shot was on 8/25/21 Pfizer IM Left Arm, lot# PAA165969.
This case was reported by a other health professional via call center representative and described the occurrence of myelitis transverse in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced myelitis transverse (serious criteria GSK medically significant). On an unknown date, the outcome of the myelitis transverse was unknown. It was unknown if the reporter considered the myelitis transverse to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter did not has any information about said patient or the event. This patient was not the patient of reporter. Her patient inquired about transverse myelitis because they heard of someone that developed it after receiving SHINGRIX.
After vaccine patient is crying all the time.  Patient went to school and complained stomach hurt, crying and vomiting.  Patient did not have fever so parent's have not called the doctor yet or provide any medication/treatment. Today, patient has chills and is throwing up severely--might take her to the ER
a female patient received the FLUZONE QUADRIVALENT at their office on 28Oct2020 and another dose of the flu vaccine yesterday with no AE; Initial information received on 24-Nov-2020 regarding an unsolicited valid non-serious case received from a nurse via The Agency (Reference number- 00370464).  This case involves a 67 years old female patient who received a dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] at their office on 28-Oct-2020 and another dose of the INFLUENZA VACCINE on 23-Nov-2020 [batch number and expiration date not reported] via an unknown route and site for prophylactic vaccination (extra dose administered).  The patient's medical history, medical treatments, vaccinations, family history and concomitant medication were not provided.  It was a case of an actual medication error due to extra dose administered (latency unknown).  Upon transfer, nurse was not aware of any adverse effects patient is experiencing at this point. Nurse stated that the patient received the second flu vaccine at an outside pharmacy, so she does not know that brand of flu vaccine it was, or whether it was a Sanofi product or not.   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 holders 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.  There will be no information available on the batch number for this case.
pt slept all day; very hard to arouse; seemed limp, sx lasted about 8 hrs;
Initial misuse report received from a healthcare professional on 21-AUG-2013 and at GPV on 21-MAR-2014. An 18-months-old patient had received the dose of TENIVAC instead of DTAP, i.e. wrong vaccine administered. The patient re immunized with DTAP. Infant not adequately protected against Diptheria and Pertussis. No adverse event was reported. List of documents held by sender: none
Patient was given MMRV Proquad, which is not indicated for under 4 years old.
redness at injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, after vaccination with dose of shingrix, experienced injection site redness, which lasted for few days and then resolved. The reporter consented to follow up. This case has been linked with case US2019229382, reported by same reporter.
Pressure and pain in my chest.  Did not appear until 3/21/21, along with headache.  Only issue since 3/18/21 shot, until then, was sore arm where shot was given.  Chest discomfort not quite as bad today, but still lingers some.
pt recvd vax & 36hrs later devel severe back pain, severe muscle pain in the lower extremities w/T105;pt hospitalized & treated w/IV Toradol & APAP;pt recovered;
R thalamic stroke 2 days after 2nd dose of Moderna vaccine with L sided numbness acute in onset
Initial misuse report received from a healthcare professional on 24 October 2013. The cases were received on 21 March 2014. It was reported 3 year-old patient had received 0.25 ml dose of FLUZONE. No adverse event was reported. List of documents held by sender: none.
Immediate pain at site. Within 12 hours swelling, redness and pain at site with numbness and tingling down left arm/hand and that evening, wheezing and SOB. Within 24 hours of injection, wheezing and SOB better but left arm with numbness,and underarm pain and SEVERE swelling of lymph nodes affecting whole underarm, breast area. Now Monday, 10/17 not quite 36 hours with decreased swelling but still underarm sensitivity, pain and swelling.
COVID Breakthrough Case  Pfizer Dose 1 9/10/21 ew0177  CV+ 9/21/21  9/21/21 The patient presents with altered speech and Patient is 81-year-old male who presents today from home with confusion.  This was 1st found today.  The time family is not present, and EMS report is very limited.  Patient is able to provide a very limited history.  He did have difficulties with speech on arrival, with unknown history and a concern for aphasia, stroke alert was called and patient was sent to CT scanner.  On arrival back, patient does seem to be slightly improved and is now able to tell me he is in the hospital, but cannot provide further information.  He declines all symptoms at this time. Unknown medical history..  The onset was unknown.  The course/duration of symptoms is unknown.  The degree at onset was unknown.  The degree at maximum was unknown.  The degree at present is unknown.  The patient's dominant hand is unknown.  Prior episodes: Unknown.  Therapy today: emergency medical services.  Associated symptoms: none.  Non-hemorrhagic cerebral vascular accident, hemorrhagic cerebral vascular accident, transient ischemic attack, Sepsis, pneumonia, COVID, UTI. Rationale:  Patient is an 81-year-old male who presents today with confusion, initially suspected this may be related to CVA, sent for stroke alert head CT, this was negative.  On further assessment, patient is febrile, slightly hypoxic at 89% on room air.  He has crackles on exam.  He has no evidence of stroke for me, and actually did not appear that confused.  Blood work was overall unremarkable, chest x-ray does show bilateral infiltrates concerning for a viral pneumonia.  COVID rapid was negative.  This does with patient's clinical syndrome.  2-4 L of oxygen therapy.  He will require admission due to this.  Discussed with granddaughter who provided some additional history here.  Patient admitted Family Medical Clinic service..
Received injection and feels that the injection was given too high on the shoulder. Severe pain on left shoulder so that she could not mover or lift her arm. She conducted a virtual visit but was still having no relief and went to Urgent Care on Monday March, 22nd. They did x-rays and prescribed Naproxen. She can not sleep or find comfort.
COVID-19 INFECTION; This spontaneous report received from a health care professional via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced covid-19 infection. Laboratory data (dates unspecified) included: COVID-19 virus test positive (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Doses given after temperature excursion; Had a 20 min excursion in the freezer; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Doses given after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Had a 20 min excursion in the freezer) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 28-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Had a 20 min excursion in the freezer). On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (Doses given after temperature excursion). On 28-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Had a 20 min excursion in the freezer) had resolved. At the time of the report, PRODUCT ADMINISTRATION ERROR (Doses given after temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not provided.  The dose was administered from 29-Nov-2021 to 01-Dec-2021.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Dec-2021: Follow up received contain patient demographics and dose details.
The patient received the vaccine and was advised to stay around 15 minutes to make sure that medical attention can be provided if they need it. The patient stated that he was not anxious before the vaccine. However, the patient stated that after the incident he felt a bit anxious prior to fainting. The patient said that he was trying his best not to think about his anxiety, but the more he thought about it the more he got anxious and the next thing he knows he passed out.
9/30 Elevated temperature (99), muscle pain, joint pain, increased joint crepitus, fatigue. 10/1 Fever (100), increased muscle pain, extreme stabbing pains in abdomen (both front and back) near bottom of rib cage, muscle spasms, eye pain. 10/2 normal temperature, continued but decreased stabbing pains in abdomen, muscle spasms. 10/3 continued but decreased stabbing pains in abdomen, no other muscle spasms detected.
Lips tingled; Panic attack; Could nt sleep; Hurt in chest; Mouth swollen; Couldn't swallow; Upper part of gums, throat, and tongue felt like razor blades with sores; upper part of gums, throat, and tongue felt like razor blades with sores; upper part of gums, throat, and tongue felt like razor blades with sores; upper part of gums, throat, and tongue felt like razor blades with sores; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ORAL DISCOMFORT (Lips tingled), PANIC ATTACK (Panic attack), SLEEP DISORDER (Could nt sleep), CHEST PAIN (Hurt in chest) and OEDEMA MOUTH (Mouth swollen) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced ORAL DISCOMFORT (Lips tingled), PANIC ATTACK (Panic attack), SLEEP DISORDER (Could nt sleep), CHEST PAIN (Hurt in chest), OEDEMA MOUTH (Mouth swollen), DYSPHAGIA (Couldn't swallow), GINGIVAL PAIN (Upper part of gums, throat, and tongue felt like razor blades with sores), OROPHARYNGEAL PAIN (upper part of gums, throat, and tongue felt like razor blades with sores), GLOSSODYNIA (upper part of gums, throat, and tongue felt like razor blades with sores), MUCOSAL INFLAMMATION (upper part of gums, throat, and tongue felt like razor blades with sores) and NAUSEA (nausea). On 19-Feb-2021, ORAL DISCOMFORT (Lips tingled), PANIC ATTACK (Panic attack), SLEEP DISORDER (Could nt sleep), CHEST PAIN (Hurt in chest), OEDEMA MOUTH (Mouth swollen), DYSPHAGIA (Couldn't swallow), GINGIVAL PAIN (Upper part of gums, throat, and tongue felt like razor blades with sores), OROPHARYNGEAL PAIN (upper part of gums, throat, and tongue felt like razor blades with sores), GLOSSODYNIA (upper part of gums, throat, and tongue felt like razor blades with sores) and MUCOSAL INFLAMMATION (upper part of gums, throat, and tongue felt like razor blades with sores) outcome was unknown. At the time of the report, NAUSEA (nausea) outcome was unknown.            This case was linked to -MODERNATX, INC.-MOD-2021-071324 (E2B Linked Report).; Sender's Comments:  -MODERNATX, INC.-MOD-2021-071324:Linked case for second vaccine dose