chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a comprehensive neurological evaluation for a very pleasant right handed 32 year old gentleman who denies any past medical history who presents to the hospital with several day progressive visual changes and facial weakness. Patient reports he noted on Saturday that he had somewhat of a headache, he does get headaches from time to time in particular while looking at screens the television, he did have some associated blurring of his vision as well. This was not the worst headache of his life. He had no other associated symptoms. He went to bed on Saturday, he awoke on Sunday and went out to eat and noted that he couldn't form his mouth around the utensil, his face and lips and mouth felt weak. He still did have an intermittent headache and perhaps some neck pain as well at this point. His vision was still blurry. He denies any recent trauma, no car accident no whiplash no falls. He did go to an outside facility where a CT brain was performed and was normal he was told. He has noted yesterday that he could not close his eyes unless he did it manually, also he notes the way his voice sounds is different to him. He has not appreciated any weakness of his arms or legs. He is able to lift up his head off the bed without trouble. He does not think he has a hard time swallowing or breathing per se however he does describe that he is more "aware" of his breathing. He describes paresthesias of his face and around his mouth. No recent URI or diarrheal/GI illness, he did receive the Johnson & Johnson COVID -19 vaccine March 31st. Seen and evaluated in the ED with ed staff. He does report he recently ran a virtual type marathon over the course of 16 days. Clinical context and exam most consistent with that of GBS type variant (?Miller Fisher).  Treated with IVIG.  Symptoms improved after 1 dose.  4 more doses pending.
Coughing after 2nd booster/He was coughing as he was speaking; He states that his shoulder collar bone towards the neck has a knot, Inflamed, and it is hurting; He states that his shoulder collar bone towards the neck has a knot, Inflamed, and it is hurting; He states that his shoulder collar bone towards the neck has a knot, Inflamed, and it is hurting; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing after 2nd booster/He was coughing as he was speaking), OSTEITIS (He states that his shoulder collar bone towards the neck has a knot, Inflamed, and it is hurting), NECK MASS (He states that his shoulder collar bone towards the neck has a knot, Inflamed, and it is hurting) and ARTHRALGIA (He states that his shoulder collar bone towards the neck has a knot, Inflamed, and it is hurting) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2022, the patient experienced COUGH (Coughing after 2nd booster/He was coughing as he was speaking), OSTEITIS (He states that his shoulder collar bone towards the neck has a knot, Inflamed, and it is hurting), NECK MASS (He states that his shoulder collar bone towards the neck has a knot, Inflamed, and it is hurting) and ARTHRALGIA (He states that his shoulder collar bone towards the neck has a knot, Inflamed, and it is hurting). At the time of the report, COUGH (Coughing after 2nd booster/He was coughing as he was speaking) had not resolved and OSTEITIS (He states that his shoulder collar bone towards the neck has a knot, Inflamed, and it is hurting), NECK MASS (He states that his shoulder collar bone towards the neck has a knot, Inflamed, and it is hurting) and ARTHRALGIA (He states that his shoulder collar bone towards the neck has a knot, Inflamed, and it is hurting) outcome was unknown.            No concomitant medications were reported. The patient was reluctant to provide information and was irritated with the questions. No treatment medications were reported.   This case was linked to MOD-2022-556083 (Patient Link).
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) 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 No adverse reaction (No medical history).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Next day, she had fever; Chills; She had body ache; Swollen at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (She had body ache), INJECTION SITE SWELLING (Swollen at injection site), PYREXIA (Next day, she had fever) and CHILLS (Chills) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 immunisation.     No medical history was provided by the reporter.  Concomitant products included DOXEPIN for an unknown indication.   On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PAIN (She had body ache) and INJECTION SITE SWELLING (Swollen at injection site). On 06-Apr-2021, the patient experienced PYREXIA (Next day, she had fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form once a day. In April 2021, PAIN (She had body ache), INJECTION SITE SWELLING (Swollen at injection site), PYREXIA (Next day, she had fever) and CHILLS (Chills) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: A follow up report received on 26-JUN-2021 included information about the outcome of the events and was updated along with stop date.
Numbness in throat, mouth, lips immediately after both first and second vaccines on Feb 9, 2021 and March 09, 2021. After second vaccine I had chills, fever and headache for 36 hours.  My husband called the hospital but they said there was not necessary to report it so I am reporting it here as a concerned patient.
tinnitus - very minor prior to vaccine; appears to be getting progressively worse. made an appt w/ Dr. 4/14 - vaccine did not come up in conversation. he recommended a 6 week treatment to clear up nasal passage ...follow up appt may 26. i will be calling him but read about many people experiencing similar side effect allegedly from the vaccine and felt compelled to file this report
Weakness, sore throat, muscle pain and cramps, fatigue, headaches, dizziness, foggy brain.
The pain moved up to the neck; Pain moved up around ear and into ear/pain in ear felt like an ice pick; Pain in the eye; A lot of pain in arm; Pain moved up to the shoulder; Pain in temple; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (The pain moved up to the neck), EAR PAIN (Pain moved up around ear and into ear/pain in ear felt like an ice pick), EYE PAIN (Pain in the eye), PAIN IN EXTREMITY (A lot of pain in arm) and ARTHRALGIA (Pain moved up to the shoulder) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (1st dose) on 16-Mar-2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE. Concurrent medical conditions included Hypothyroidism (Low thyroid that makes her feel tired and weak usually), Tiredness, Weakness and Balance disorder (Balance problem).    On 04-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced NECK PAIN (The pain moved up to the neck), EAR PAIN (Pain moved up around ear and into ear/pain in ear felt like an ice pick), EYE PAIN (Pain in the eye), PAIN IN EXTREMITY (A lot of pain in arm), ARTHRALGIA (Pain moved up to the shoulder) and HEADACHE (Pain in temple). In December 2021, PAIN IN EXTREMITY (A lot of pain in arm) had resolved. At the time of the report, NECK PAIN (The pain moved up to the neck), EAR PAIN (Pain moved up around ear and into ear/pain in ear felt like an ice pick), EYE PAIN (Pain in the eye) and HEADACHE (Pain in temple) had not resolved and ARTHRALGIA (Pain moved up to the shoulder) outcome was unknown.            Concomitant medications included pig thyroid. No treatment medications were taken by the patient.  It happened 1-2 days after the shot that slowly progressed. Patient was  still having pain in eye, ear and temple and was 11 days at the time of reporting.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer 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, and batch number were not reported, expiry date: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported.  The patient was tested positive for Covid-19 via PCR laboratory test (Polymerase chain reaction) on 31-DEC-2021. The patient had a cough, chest congestion (suspected covid-19 infection and suspected clinical vaccination failure) and flu symptoms and that the patient took medications for symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000213265.; Sender's Comments: V0: 20220139637-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
Patient had vomiting once she got home after vaccines given on 10/10 and resolved on the same day; then on 10/15 she began with red rash on legs but none on arms.
A serious spontaneous report of pneumonia and non-serious events of 23 months old when received FLUMIST, ear infection, strep throat infection and cold-like symptoms has been received from a consumer concerning a 23-month-old male, subsequent to FLUMIST. The patient's medical history includes wheezing and planned neurosurgery. The patient's concomitant medications were not reported. The patient received SYNAGIS in Sep-2010. Within a few weeks of receiving FLUMIST, the patient developed cold-like symptoms and was prescribed an inhaler. Shortly after, he was admitted to the hospital with pneumonia and stayed for about five days. After finishing a course of antibiotics at home, he developed pneumonia again for which he was hospitalized and treated with antibiotics. He had attended day care in the interim between pneumonia infections, so after the second infection, he was pulled from daycare because he was schedule to have neuro surgery in December. For six weeks prior to surgery, and about four weeks after, the patient remained healthy. Then he began to develop cold-like symptoms again. He returned to daycare and within a week he was diagnosed with mild strep throat infection. After finishing another course of antibiotics, he was again diagnosed with pneumonia but because it was caught early, he was able to go home and resume antibiotics. Shortly after this course of antibiotics was finished, he was admitted again to the hospital with pneumonia. After just finishing another course of antibiotics, the patient was now been diagnosed with an ear infection and was on antibiotics again. The outcome of 23 months old when received FLUMIST was recovered while that of all other events was unknown.
Severe vertigo with nausea; Severe vertigo with nausea; Brain fog lasting into week two after second shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 12:30 (Lot number: ER8727) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESILATE; LEXAPRO; ROSUVASTATIN. Vaccination history included: Bnt162b2 (dose 1, product: COVID-19 , brand: Pfizer, lot number: EN6203, lot unknown: False, administration time: 12:30 PM, vaccine location: Left arm), administration date: 02Mar2021, for Covid-19 immunization. The following information was reported: VERTIGO (non-serious), NAUSEA (non-serious) all with onset 31Mar2021 20:00, outcome "recovered with sequelae" (2021) and all described as "Severe vertigo with nausea"; FEELING ABNORMAL (non-serious) with onset 31Mar2021 20:00, outcome "recovered with sequelae" (2021), described as "Brain fog lasting into week two after second shot". Therapeutic measures were not taken as a result of vertigo, nausea, feeling abnormal.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 8 days after her second dose she experienced severe vertigo with nausea. Extreme vertigo with nausea one week after second shot. Brain fog lasting into week two after second shot. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No allergies to medications, food, or other products.   No follow-up attempts are possible. No further information is expected.
9/258/09 09:30 Telephone report from school nurse states this student did receive FLUMIST nasal spray yesterday. Today school nurse states that the child is complaining that he is having difficulty in swallowing and that there is some tongue swelling. Speech does not seem to be impaired. No apparent problems breathing. Referred to PMD.
On 4/11/2000, had red and swollen left arm and nausea. Mom reported on 4/12/2000, took to MD office visit. On 4/13/2000, mom reports on antibiotic therapy for 10 days.
Bell's Palsy (7th Cranial Nerve Palsy). After my second Moderna shot on 03/25/2021 against Lot # 040A21A I started experiencing double vision ( 4th Cranial Nerve Palsy) on 03/27/2021. Dr is treating me for the double vision and installed a prism film in the left eye of my glasses. I had a #10 prism installed on 04/08/2021 and it was reduced to a #6 prism on 05/21/2021. It is improving.I have another appointment with Dr.  on 07/23/2021.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 57 years, in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Treatment for breast cancer (including chemo) " (unspecified if ongoing), notes: 2013-14. Concomitant medication(s) included: LETROZOLE, start date: Jan2015, stop date: May2023; MIRTAZAPINE, start date: Sep2013, stop date: May2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient was treated with Paxlovid from 29Apr2023 to 04May2023.
6 days later I had breathing problems , I have copd. But I had severe headaches n breathing problems increased.; 6 days later I had breathing problems , I have copd. But I had severe headaches n breathing problems increased.; 6 days later I had breathing problems , I have copd. But I had severe headaches n breathing problems increased.; This is a spontaneous report from a contactable consumer (patient).  A 55 years old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration, administered in Arm Left on 05Apr2021 at 16:00 (Batch/Lot number was not reported) as SINGLE DOSE for Covid19 immunization.  Medical history included diabetes mellitus,  chronic obstructive pulmonary disease,  hypertension. Concomitant medications included high blood pressure medication (details not provided); ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]); elderberry [Sambucus nigra] (ELDERBERRY [SAMBUCUS NIGRA]). The patient previously took hydrocodone and experienced drug hypersensitivity. Historical Vaccine includes Flu Shot on 11Feb2021 at the age of 55 years old (Flu vaccine given within 4weeks, other vaccine 4weeks vaccine location Left arm).  On 11Apr2021 at 12:00,  the patient experience '6 days later I had breathing problems, I have COPD. But I had severe headaches and  breathing problems increased'. The patient was hospitalized for 3 days. Treatment was given included 'High blood pressure meds, rest, stress tests'.   The patient underwent lab tests and procedures which included Sars-cov-2 test Nasal Swab: results negative  on 08Apr2021, stress test results not provided on an unspecified date. The clinical outcome of the events were recovering.     Information about lot/batch number has been requested.
Information has been received from a healthcare worker reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions/allergies, pertinent medical history or concomitant medication. On 30-OCT-2017, the patient received an improperly stored dose of LIQUID PEDVAXHIB lot # N012120, expiration date 30-JAN-2020 or lot # N000235, expiration date 26-OCT-2019 or lot # N007749, expiration date 29-NOV-2019 for prophylaxis (dose, anatomical location and route of administration were not reported). It was reported that on an unspecified date, the vaccine was exposed to a temperature between 9 Celsius degrees and 25 Celsius degrees for 47 hours and 39 minutes. The vaccine did not undergo a previous temperature excursion. The call was placed because of a Digital Data logger report. No adverse effects were reported. This report is one of multiple reports received from the same reporter.; Sender's Comments: US-009507513-1711USA013916: US-009507513-1711USA013917: US-009507513-1711USA013918: US-009507513-1711USA013919: US-009507513-1711USA013920: US-009507513-1711USA013921: US-009507513-1711USA013913: US-009507513-1711USA013914: US-009507513-1711USA013915:
Pt vaccinated with DTP/OPV experienced hypotonia difficult to arouse, limp, pale, fever 102 R, short lasting 3 hrs limp & pale no stiffening no clonic, had strange cry - wailing survival- urgent cry - cry back to normal after 2 days.
Achiness in legs, then chills, and then my legs felt like they were on fire. The next day I had a terrible headache and very tired.
Patient had a "stroke like" reaction; This is a spontaneous report received from contactable reporter(s) (Physician).  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Patient had a "stroke like" reaction". Clinical course: The customer reported that the patient received a dose of Prevnar "any" years ago (date unknown), and the patient had a "stroke like" reaction to Prevnar. The customer said the patient is needing to undergo surgery soon and need a dose of pneumonia vaccine. Type of surgery unknown by reporter.   The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Based on the temporal relationship, the association between the event "stroke like reaction" with PREVNAR 13 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Dizzy, nauseated, fainted, felt cold couldn't concentrate. Effect lasted for 15 mins.
Rcv'd. shot on Wed. & on Fri. had periods of heavy sweating with any activity. Ran a fever of 99.4 to 100.9. Went to Dr on Monday & everything was clear. Tx'd w/Motrin. The hot sweats lasted over 1 week.
She tested positive for Covid after receiving the vaccine; She tested positive for Covid after receiving the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 15Aug2021 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She tested positive for Covid after receiving the vaccine". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient received the Moderna booster without omicron instead of the bivalent moderna with omicorn. No adverse reactions reported.
PT deceased on 1/6/21 from "complications of CHF" Unknow if it is in fact related to the vaccine.
p/ Anthrax shot #2, noted circular erythema @ inj site that extended circumferentially down below elbow;no systemic symptoms;
Swollen lymph node near collarbone on left side of neck. Same arm as injection site.