chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose 1 given on 5/28/21 and dose 2 given on 6/22/2021. By report the patient developed weakness which progressed to ataxia over the ensuing 3 months. This was also associated with tinnitus. He was noted about 2 months after his second dose to have progression of symptoms with abnormal neurologic exam which prompted inpatient admission. MRI brain showed multifocal hemorrhagic lesions in the cerebral white matter, brainstem and cerebellum with greatest involvement in the left pons.  Multifocal short segment enhancing lesions throughout the spinal cord. Patient was admitted for diagnostic work up and initiated on steroids with some symptomatic improvement when on hospital day 10  he had an acute event thought to be a stroke. CTA showed new areas of brainstem intraparenchymal hemorrhage including the dorsal right pons and right-sided cerebellar peduncles.
Information has been received from a registered pharmacist concerning a patient who on 23-MAY-2008 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot# not reported). On 24-MAY-2008, the patient developed a rash and was taken to the emergency room. It was not known if the patient was admitted. The pharmacist reported that the patient may have had an allergic reaction to something that was eaten on leave from the facility. Additional information has been requested.
The patient came for a COVID vaccine on 11-18-22.   She had only received her first Moderna vaccine dose and had not returned for her second dose.  She was erroneously given the Pfizer bivalent booster instead of a second dose of Moderna to complete her primary series due to poor communication.  She has reported no adverse events since receiving the incorrect series of shots.
Patient reports that she experienced redness, burning and strain  in her both eyes beginning 24 hours after vaccination.  She reports that symptoms lasted for 3 days after onset.
A consumer report has been received. The report concerns a 4 year old, male patient. The patient relevant history and concurrent disease was not reported. Patient had been receiving FLUMIST (intranasal), started during Sep-2011. The patient experienced tested positive for flu A and flu B which started during Nov-2011. The outcome of the event of tested positive for flu A and flu B was unknown. The reporter considered the event tested positive for flu A and flu B to be non-serious.
Experienced shortness of breath and dizziness. Use of  Albutero.l inhaler and still using . Still have bouts of dizziness and shortness of breath.
COVID 19 Treatment; COVID 19 Treatment; Dose Number: 4:Moderna / Dose Number: 3:Pfizer / Dose Number: 2:Pfizer / Dose Number 1:Pfizer; 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 78-year-old male patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EL9262), in left arm, on 25Feb2021 as dose 2, single (Lot number: EN6203) and on 20Nov2021 as dose 3 (booster), single (Lot number: FF2588) at the age of 78 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03May2022 as dose 4 (booster), single (Lot number: 056A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Lipotor, reaction(s): "Known allergies: Lipotor". It was reported that paxlovid was received as COVID 19 Treatment from 15Oct2022 to 19Oct2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Positive, notes: Post Paxlovid re-occurance of Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Outcome of COVID 19 was not recovered, outcome of other event was unknown.
Cellulitis at the injection site 9 days after first shot; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Cellulitis at the injection site 9 days after first shot) in a female 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 event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INJECTION SITE RASH (Cellulitis at the injection site 9 days after first shot). The patient was treated with DOXYCYCLINE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, INJECTION SITE RASH (Cellulitis at the injection site 9 days after first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment details were provided.; Sender's Comments: Based on determined causality, the event is assessed as unlikely related to mRNA-1273.
Student went back to class after vaccination.  Student was in Gym Class, when he started complaining of cough, and stated "his throat felt tight" to the teacher.  Teacher took him to the Health Room.  At 10:45, school nurse, and clinic nurse evaluated student who was clearing his throat and complained of tight feeling, color - pale, lips - pale.  BP:102/64, pulse 100, pulse ox 97%.  At 10:45, 2tsp Benadryl given, pulse ox down to 88% (pulse ox questionable due to equipment).  At 10:50 Epi Pen Jr administered, 911 called, parent called, noted relief within seconds.  Breathing normal, student reported "feeling good".  Pulse ox improved. Paramedics arrived by 11:00 - 11:05 am.  Student alert, cooperative.  Student transported to Hospital for evaluation. A school teacher accompanied student.  Parents met student there.  Child evaluated and kept at the ER for 2 hours.  No other complications noted at the time.  Discharged home with parents.  Parents reported that ER stated "allergic reaction".  However, did not state related to flu vaccine.  Child has had flu vaccine in the past.
on left arm, almost immediately after left hand became increasingly cold; This is a spontaneous report from a non-contactable Other-HCP reporting for herself.  A 40-years-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, via an unspecified route of administration on arm left from 14Jan2021 07:00 to 14Jan2021 07:00 at SINGLE DOSE for covid-19 immunisation. Medical history included Prolonged QT syndrome. The patient's concomitant medications were not reported. The patient had her first dose of BNT162B2 on 23Dec2020 to 23Dec2020. On 15Jan2021 at 07:00, on left arm, almost immediately after left had became increasingly cold. Right had was ok and did not change in temperature. Area around the shot was not cold, only hand. Coldness lasted for about 15 minutes before slowly getting back to normal temperature. The patient had not received any treatment for the event. The patient was not pregnant at the time of the report. Outcome of the event was recovered on an unspecified date.   No follow up attempts are possible, information about lot/batch number cannot be obtained.
Booster dose was prepared using pediatric Pfizer formulation inadvertently, diluted as if it were the adult product with 1.8 mL, and 0.3 mL given (approx 10 mcg).  Patient/physician were notified and arranged to have the correct booster dose re-administered.
Fever and chills into the best day.  Severe pain down into the fingers of  the injected arm for 3 days.
arm swollen up; red pinkish all to elbow; she couldn't move, talk, reach her arm AND head, leg and body not working; no control of her body; had no feeling in her body; pee in her pants; mouth was hanging open, couldn't move; horrifying; so ill; "i'm going to hit myself"; not felt good; chills; fever; A spontaneous report was received from a consumer concerning a 64 years old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypotonia, mental distress, hypoesthesia, malaise, dyskinesia, feeling bad, arm swelling, chills, fever and arm erythema.   The patient's medical history was not provided. Concomitant product use was not provided.  On 14-Mar-2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 14-Mar-2021, patients had fever and chills. On 15-MAR-2021, she was so ill, lost all function of her body, she could not move, talk, reach her arm. She thought she was going to die. She did not felt good, went to bed and 5 minutes later she thought she was going to hit herself because she had no control of her body, her head in the bead, she pee in her pants. Her mouth was hanging open, could not move. The patient mentioned her head, leg and body not working, had no control of her body, she described the situation horrifying, so close to death, had no feeling in her body. Se did not want to go to the ER.. Husband stayed with her and she improved 3 hours later without treatment. On the next day, they contacted her physician who prescribed over the counter treatment.   Laboratory test were not reported. Treatment included Benadryl, Advil and Tylenol.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events, hypotonia, mental distress, hypoesthesia, malaise, dyskinesia, feeling bad, arm swelling, chills, fever and arm erythema were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
gait disturbance with visual symptoms for 4 days, numbness of left side of face, flare of cold sore
expired Havrix administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 56-year-old male patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 14-APR-2023, the patient received Havrix. On 14-APR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: expired Havrix administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-APR-2023 The reporter reported that expired Havrix administered. The reporter given consent for safety follow up. The reporter reported that expired Havrix administered, which led to expired vaccine used.
Pt recvd 3 doses of Hep B vax on 20FEB91, 26MAR91, & 6SEP91 & on 7SEP91 pt exp achiness & itching @ inject site; 2 wks later pts sx persisted; subsequently pt recovered;
ON 12/31, DEVELOPED BODY ACHES, NAUSEA, SWOLLEN LYMPH NODES UNDER ARMS AND NECK. INJECTION SITE WAS VERY SORE. RESOLVED AFTER 48 HOURS.
chills, fever 101, sore swollen right arm at injection site, achy flu like symptoms, headache   starting 12/28/20 in the morning until approximately 4:30 pm
Severe stomach cramps, gas, painful burning, slight fever, sleepiness, tired. Symptoms have been ongoing and 2 doses of oral pills have been taken. Issues started a day after taking the pill...fine before that. Very painful and have to stop taking pills to see if this will go away. Will seek medical care if not better in 1-2 more days.
Localized reaction-red, hot, swollen with a quarter sized lump. Generalized-malaise, chills, body aches, headache. Treatment Atarax and Tylenol symptoms lasted for 2 1/2 weeks.
Narrative:  Patient vaccinated against COVID 4/8 with Janssen vaccine at outside facility. Vaccine card not available to provide lot #, etc. Admitted 8/8 with confirmed COVID-19 after being exposed to his unvaccinated roommate on 7/29. He was deemed severe and started immediately on HHFNC at 90% and IV dexamethasone. ID service consulted to assist with management given morbid obesity (150 kg), AKI.
Fever, chills, fatigue, nausea, headache, body aches, sensitive skin
After receiving first dose of covid vaccine and sitting the observation area, patient complained of a tingling sensation around his lips. The observation nurses continued to observe him, and a few minutes later he developed numbness on his nose, followed by a dry cough. Within a few minutes his lower lip started to swell.  Patient showed no signs of respiratory distress, and was alert and oriented. He was then escorted by RN  in a wheelchair to the ED for evaluation
Information has been received from a physician concerning three patients who on unspecified dates was vaccinated with the dose of ZOSTAVAX (Merck) (LOT# not reported). On unspecified dates, the patients experienced shingles. The physician did not report the patients' outcomes at this time. It was unspecified if the patient sought medical attention. Follow-up information has been received from the physician who stated that he did not consider these adverse experiences but considered them part of the 48% of patients who could potentially got shingles after receiving ZOSTAVAX (Merck). He said that no vaccine was 100% and that at least the cases of shingles that patients got after ZOSTAVAX (Merck) were milder. Follow-up information has been received on 14-SEP-2010 from the physician who on 07-SEP-2010 reported that these occurrences were three episodes of shingles occurring 1.5 to 3 years after ZOSTAVAX (Merck) vaccination so the physician did not consider these to be reportable adverse events. Follow-up inconsistently information has been received from the physician who stated that the patient was no adverse reaction. This is one of several reports received from same source. No further information is available.
Was pregnant at time of second vaccine should have been approximately 4 weeks but was not aware I was pregnant. At viability ultrasound there was no heart beat and it did not match with how far along i should have been. Repeat ultrasound a week later showed no growth and was diagnosed with a missed miscarriage.
Injuries; This spontaneous case was reported by a consumer and describes the occurrence of INJURY (Injuries) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJURY (Injuries). At the time of the report, INJURY (Injuries) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication were provided.
Injection site reaction of 6 cm on the right deltoid. Developed 7-8 days after immunization. Subjective swelling in the right axilla, but not noted on exam. No other systemic symptoms.
This spontaneous report was received from a pharmacist, and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was provided. On 26-NOV-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # M024673 with an expiration date in 17-NOV-2017), for prophylaxis (dose, frequency, route and strength were not provided). No adverse effects were reported and no product quality complaint (PQC) was involved.
Administered with vaccine that had undergone temperature excursion; 10 vials were all administered to patients. Does not know the number of patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Administered with vaccine that had undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (10 vials were all administered to patients. Does not know the number of patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered with vaccine that had undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (10 vials were all administered to patients. Does not know the number of patients). At the time of the report, PRODUCT STORAGE ERROR (Administered with vaccine that had undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (10 vials were all administered to patients. Does not know the number of patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The temperature log had a date when the refrigerator reached 34 and 32 degrees F. The storage temperature was too cold. 10 vials were all administered to patients. No concomitant product was reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Added batch/lot number and expiry date
Patient experienced generalized itching in face area 1 hour after injection. Itching spread to neck and chest area soon after. Patient was given benadryl 25 mg at 09:25. Given another benadryl 25 mg and pepcid 20 mg at 10:00 due to start of itching again. Itching has mostly resolved as of 10:15. Patient advised to contact primary physician to notify them of vaccination and to monitor for any more adverse events after leaving hospital.
Tachycardia; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (Tachycardia). At the time of the report, TACHYCARDIA (Tachycardia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported , No treatment medication was reported .
1/26 Headache; 1/27 headache, body ache and fatigue; 1/28 fever blister on lip, eye and eyebrow; 2/1 chills, body ache, elevated temperature 102.7 went to the ED
Pain in left arm, some swelling, mild erythema in upper left arm. Myositis in left deltoid from vaccine? No focal abscess found. No surgical intervention needed.
Muscle ache; Joint pain; Arm still hurt/arm was really sore and my neck was sore/ forearms blades; Arm still hurt/arm was really sore and my neck was sore; Her shoulder, knee blades; Her shoulder, knee blades; This is a spontaneous report from a contactable nurse reporting for herself. A 60-year-old female patient received bnt162b2 (BNT162B2) (lot# EL1284), via an unspecified route of administration, in Jan2021, at single dose, for COVID-19 immunisation.  Medical history and concomitant medications were none. The patient experienced muscle ache, joint pain, arm still hurt/arm was really sore and my neck was sore/ forearms blades; her shoulder, knee blades all in Jan2021 with outcome of unknown. Therapeutic measures were taken as a result of the events and included treatment with ibuprofen and Tylenol.
Patient is a 76 year old male with PMH of COPD/emphysema and afib who presents to the ED. As per patient, the staff thought that he was breathing "heavy" so they administered a Covid test and the patient was positive. Patient is chronically on O2 at 3L/min and as per ED record, patient was satting 83% sent to the hospital. Patient states he was feeling congested and was started on Zithromax and Prednisone today. Patient denies feeling short of breath at present. Patient denies chest pain, nausea, vomiting and diarrhea.
DTap RUE 5/25 5/26 erythema, induration RUE.
Information has been received from a physician concerning an 17 year old female who in December 2009 completed her 3 doses of 0.5ml GARDASIL. In February 2010, the patient had symptoms of inguinal lymph nodes. The patient went to the doctor's office. At the time of reporting, the patient's status was unknown. Additional information has been requested.
MILD PAIN IN THE SITE OF INJECTION; This spontaneous report received from a consumer concerned a 38 year old of unspecified sex. 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: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced mild pain in the site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild pain in the site of injection was not reported. This report was non-serious. This case, from the same reporter is linked to 20210559333.
Stiff upper arms, back, thighs & back (Salonpas helped the back). Then developed headache & fever for 4 days after taking Moderna Bivalent Booster for Covid 19.
Weakness with very sore upper arm 5 hours after injection; dizzyness 8 hours after injection. Next day weakness with redness and some swelling on outer upper arm below injection site down to elbow, no dizzyness. Redness and swelling spread to bicep, less muscle soreness. Second day after injection, less sore, still red upper arm, with swelling; swelling and redness spread to elbow and forearm halfway to wrist and later into inside of arm from bend in elbow half way to wrist; in evening redness turned to yellow and swelling subsided.  Today, third day after injection still feeling some weakness, but able to go about normal business; swelling and soreness subsided, still yellow but less pronounced.
Patient received 2nd Pfizer vaccine on 03/11/2021. Then developed symptoms related to COVID-19 on 09/08/2021. Patient was tested on 09/09/2021 and positive results received on 09/09/2021.
Redness and swelling and warmth of left arm appropriately 1/3 of upper arm, injection site slightly swollen and tingling. Itchiness and rash noted on shoulders, trunk and back. Face red and slightly diaphoretic. Developed fever at during night at home.
inability to eat, clarified as feeling queasy.; inability to eat, clarified as feeling queasy.; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (inability to eat, clarified as feeling queasy.) and NAUSEA (inability to eat, clarified as feeling queasy.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Shingles. Concurrent medical conditions included Bell's palsy.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, 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 experienced FEEDING DISORDER (inability to eat, clarified as feeling queasy.) and NAUSEA (inability to eat, clarified as feeling queasy.). At the time of the report, FEEDING DISORDER (inability to eat, clarified as feeling queasy.) and NAUSEA (inability to eat, clarified as feeling queasy.) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-337833 (Patient Link).