chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A little fatigue; Woke up in the middle of the night with the worse arm pain/Arm pain 10 out of 10; Couldn't raise her arm and "couldn't pick up a feather; Bone aches; Slept for 24 hours; Headache (2 out of 10); Body pain (5 out of 10)/Muscle aches; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Woke up in the middle of the night with the worse arm pain/Arm pain 10 out of 10), VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't raise her arm and "couldn't pick up a feather), BONE PAIN (Bone aches), SOMNOLENCE (Slept for 24 hours) and HEADACHE (Headache (2 out of 10)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (Woke up in the middle of the night with the worse arm pain/Arm pain 10 out of 10), VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't raise her arm and "couldn't pick up a feather), BONE PAIN (Bone aches), SOMNOLENCE (Slept for 24 hours), HEADACHE (Headache (2 out of 10)) and MYALGIA (Body pain (5 out of 10)/Muscle aches). On 17-Jan-2021, the patient experienced FATIGUE (A little fatigue). On 17-Jan-2021, PAIN IN EXTREMITY (Woke up in the middle of the night with the worse arm pain/Arm pain 10 out of 10), VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't raise her arm and "couldn't pick up a feather), BONE PAIN (Bone aches), SOMNOLENCE (Slept for 24 hours) and MYALGIA (Body pain (5 out of 10)/Muscle aches) had resolved. On 19-Jan-2021, FATIGUE (A little fatigue) had resolved. At the time of the report, HEADACHE (Headache (2 out of 10)) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No conmeds were reported.  No lab reports and patient prior medical history were provided.   Reporter did not allow further contact; Sender'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.
headache, body aches, nausea and fever.  These were all symptoms noted on day after vaccine dose given.  Within 48 hours had red spots on body
Partial right facial nerve paralysis ( Bell's Palsy ) At 2 PM, Sunday, looked in mirror, noticed drooping of right angle of mouth and flattening of naso labial fold. Seen MD , had MRI of brain which was normal. Was referred to and evaluated by physical therapist, prescribed daily exercises, massages .
Patient showed me pictures of a large, blistery rash that appeared on her arm. It has now spread to her scalp. She went to the doctor and they diagnosed her with a case of Shingles. She said about 3 days after the vaccine she experienced vomiting as well.
pt recv vax 5NOV96 & mid to late November red knuckles & elbows;pt taken to local MD;thought was eczema;didn't improve took to dermatologist;dx dermatomyositis;19SEP97 EMG muscle biopsy lab tests confirmed;
3" diameter red and raised area at site of injection. Swollen stiff right knee since injection though it has improved somewhat.
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Mild
itchy, swollen soft pallet, need to cough started approx. 15 mins after vaccine given and continued and plateaued for hour and half. Benadryl and prednisone given in ED. Monitored and D/C with no further progression of sx.
Few hours after injection.  Localized welts at injection site.  Cont to slowly spread,  Now this morning with on arms. Legs, ears and trunk.
anaphylactic shock; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "anaphylaxis shock" (unspecified if ongoing), notes: historical risk of anaphylaxis shock after receiving vaccines. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer: Johnson and Johnson, DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 immunization. The following information was reported: ANAPHYLACTIC SHOCK (hospitalization, medically significant), outcome "unknown".  Clinical course of the events: patient was a female medical assistant in a medical group that she call on. She reported time that she took the Johnson and Johnson Covid-19 vaccine due to her historical risk of anaphylaxis shock after receiving vaccines. She took the Pfizer BioNTech Covid 19 vaccine in the hospital and ended up going into anaphylactic shock. She was taken care of in the hospital and this incident has been reported to VAERS. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event anaphylactic shock and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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.
6 year old patient received flu shot on 11/29/2005 in left arm at mass flu clinic.  He was restrained by his father during the injection.  Parents state he had pain in left arm after the injection and has been unable to move left arm or hand since he received the injection.  He was taken to ER on 11/2, 11/6, and 11/7.  Received Tylenol with Codeine and Prelone prescriptions.
-Patient almost threw up, felt nauseated and dizzy and was sweating.  He looked pale and felt like he was going to fall down.   -I (the pharmacist) gave him sports drink and checked his vitals.  BP was 106/70.  He was having a hard time drinking sports drink since he felt like throwing up, but about 5-7 min he started feeling better.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 01-AUG-2014 the patient was vaccinated with PNEUMOVAX 23 injection, lot # J004747, Exp date 20-JUL-2014, (dose and route unspecified). No adverse effect reported. Additional information has been requested.
sick; patient couldn't walk 10 feet without running out of breath; Initial information regarding an unsolicited valid non-serious case was received from a consumer via social media and transmitted to Sanofi on 08-Dec-2020.  This case involves patient with unknown demographics who experienced sick (Illness) and patient couldn't walk 10 feet without running out of breath (Dyspnoea exertional), while patient received vaccine INFLUENZA VACCINE.  Relevant medical history and concomitant medications were unknown.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number: unknown and expiration date: unknown) via unknown route in unknown administration site for prophylactic vaccination.   On an unknown date, the patient developed a non-serious sick (illness) and patient couldn't walk 10 feet without running out of breath (dyspnoea exertional).  Final diagnosis was patient couldn't walk 10 feet without running out of breath and sick.  Action taken with suspect was not applicable.  It was not reported if the patient received a corrective treatment.  At the time of reporting, event outcome was unknown for both the events.  There would be no information available on batch number for this case.
Extreme pain in right  arm going from shoulder to hand. It intensified over several hours until it was almost unbearable. Nausea. Headache. Fatigue.
Pain in top of arm; Pain going up to neck; Pain in shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in top of arm), NECK PAIN (Pain going up to neck) and ARTHRALGIA (Pain in shoulder) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013m20a) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS), LEVOTHYROXINE SODIUM (SYNTHROID) and METOPROLOL TARTRATE (METOPROLOL - 1 A PHARMA) for an unknown indication.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in top of arm), NECK PAIN (Pain going up to neck) and ARTHRALGIA (Pain in shoulder). At the time of the report, PAIN IN EXTREMITY (Pain in top of arm), NECK PAIN (Pain going up to neck) and ARTHRALGIA (Pain in shoulder) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow-up received on 05-05-2021: Resolved all the events.
FEVER AND CHILLS RESULTING IN 24 HOURS OF LOST WORK TIME.
Information has been received from a physician concerning a 19 year old female who on 19-Jan-2007 was vaccinated with the first dose of Gardasil (Lot # not provided). On 26-JAN-2007 it was reported to the office, that on an unspecified date, post vaccination, the patient developed nausea and vomiting. Unspecified medical attention was sought. On an unspecified date, the patient recovered from the nausea and vomiting. The physician does not know if the patient will receive their second dose of the vaccine. Additional information has been requested.
Within 24 hrs post/vax, pt had 2-3 episodes of staring spells with stiffness, eye rolling & hand shaking & a dx of seizure was made. Info from mfr, pt could not bend neck. Pt was admitted to hosp for observation.
Patient reported fever, chills, and diarrhea that started around 24 hours after receiving the Shingrix vaccination.
Narrative: 101 year old male admitted on 3/25/22 with dyspnea on exertion. He had previously tested positive for COVID on 3/11/2022 and received monoclonal antibodies at an outside institution, unclear where. He was found to have NSTEMI on admission. He had been vaccinated x 3, Pfizer in the community (1/7/2021, 1/28/2021, and 10/6/2021). He did receive dexamethasone during admission. Date of death was 4/1 which was attributed to COVID-19, NSTEMI, Lung mass, Heart failure with reduced ejection fraction and Peripheral arterial disease on documentation of death.
Active shingles while Shingrix administration; This case was reported by a nurse via call center representative and described the occurrence of off label use in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (On 11th September 2022 patient had Shingles).   On 12th September 2022, the patient received Shingrix. On 12th September 2022, unknown after receiving Shingrix, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.   Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's Comment: The reporter was a nurse. The reporter reported that the patient received Shingrix vaccine on 12th September 2022 and at that time patient had Shingles on 11th September 2022. The reporter lot number and expiration was not provided. The reporter did consent to follow up. Additional supportive information: The reporter reported that the patient received Shingrix vaccine while having active shingles, which led to off label use.
headache comes instant of cough; feels in back of neck; not getting good blood flow to capillaries; feels in back of neck; constipated; pulse headache/like pulse, or pressure headache/feels like hammer cracking head with it; COVID-19; Drug ineffective; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (headache comes instant of cough), BACK PAIN (feels in back of neck), CARDIOVASCULAR DISORDER (not getting good blood flow to capillaries), NECK PAIN (feels in back of neck) and CONSTIPATION (constipated) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Venous stasis (in Leg). Concomitant products included AMLODIPINE, BENAZEPRIL and HYDROCHLOROTHIAZIDE for Blood pressure, PRAVASTATIN for Cholesterol.    On 07-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (headache comes instant of cough), BACK PAIN (feels in back of neck), CARDIOVASCULAR DISORDER (not getting good blood flow to capillaries), NECK PAIN (feels in back of neck), CONSTIPATION (constipated), HEADACHE (pulse headache/like pulse, or pressure headache/feels like hammer cracking head with it), COVID-19 (COVID-19) and DRUG INEFFECTIVE (Drug ineffective). At the time of the report, COUGH (headache comes instant of cough), BACK PAIN (feels in back of neck), CARDIOVASCULAR DISORDER (not getting good blood flow to capillaries), NECK PAIN (feels in back of neck), CONSTIPATION (constipated), HEADACHE (pulse headache/like pulse, or pressure headache/feels like hammer cracking head with it), COVID-19 (COVID-19) and DRUG INEFFECTIVE (Drug ineffective) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medication was mentioned
4 year old child and 16 year old child in room 4 year old child inadvertently given MCV4 and HPV intended for 16 year old sibling. Guardian present at time of vaccination and notified of med error. Educated r/t common side effects and when to follow up with primary care. Child left clinic happy, playful and appropriate for age. Follow up phone call to guardian, guardian denies any problems or concerns states child doing well. Discussion with supervisor to ensure avoiding future medication error. Will ensure two pt identifiers and label pt vaccines with appropriate pt name.
Case number PHEH2012US023535 is an initial spontaneous report received from a health care professional on 28 Nov 2012. This report refers to a 15-years-old male patient. On 29 Oct 2012 he was vaccinated intramuscularly with 0.5 ml MENVEO (batch number: A11082, expiry date: May 2014) which had multiple temperature excursions above 46 Fahrenheit (F). The vaccine was stored at 55 F for 1.5 hours, 52 F for 3 hours on 27 Jul 2012 and 08 Sep 2012. It also experienced two temperature excursions: 49 F for 1 hour and 50 F for 2 hours on 09 Sep 2012. No adverse events were reported following this administration error (incorrect storage of drug).
Tested positive for COVID-19; Tested positive for COVID-19; Allergy like symptoms; This is a spontaneous report from a contactable nurse (patient's wife). A 29-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 01Apr2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. On 30Apr2021, the patient had tested positive for COVID-19; and had allergy-like symptoms. The patient had received paracetamol (TYLENOL) as treatment for the event, 'tested positive for COVID-19'. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the events drug ineffective with SARS-CoV-2 test positive and hypersensitivity cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.  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.
My lips are a bit swollen especially on the inside.; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6208; Expiration Date: 30Jun2021), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history was not reported and concomitant medications were none. The patient experienced my lips are a bit swollen especially on the inside. on an unspecified date. It was reported that, patient took the vaccine on unspecified date at 4:15 pm and wait on this line for almost 4 hours. After she took the vaccine her lips were a bit swollen especially on the inside and usually did not have any reaction as such. It has been over 6 hours since she took the vaccine so patient thinks nothing serious would happen at this point. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Redness on right arm around the injection site, felt a little warm 10cm x 10cm area of redness and induration around Rt deltoid and 5cm x 3cm pinkness no induration left deltoid.
2 INCH RED PATCH, SWELLING, AND ITCHING AT INJECTION SITE ABOUT A WEEK AFTER SHOT. ONLY SYMPTOMS RIGHT AFTER INJECTION WAS MILD SORENESS IN ARM FOR A FEW DAYS
redness, heat, and pustules developed near the injection site (closer to bicep).  Reaction started the evening the vaccine was given worsened for 1-2 days before getting better about 2 days after the vaccine.
This spontaneous report was received from a pharmacist refers to a 6 month old infant patient of unknown gender. On 12-FEB-2016 the patient was vaccinate in error with GARDASIL 9 injection (lot # L016428; expiry: 30-JUL-2017) dose # 1. No concomitant medications were reported. On 12-FEB-2016, the nurse at the clinic where error occurred stated that, when she reached into the refrigerator to grab the vaccine that was intended for this patient, she saw the "H" of the "HPV" on the label of the GARDASIL 9 vial and grabbed GARDASIL 9 instead of the "Hib" vaccine that the patient was indicated to receive. The nurse stated that the "triple-check" that was usually done prior to administration was not done before this patient received the dose of GARDASIL 9. The nurse states that this patient has not demonstrated any adverse effects. No additional information was provided. Additional information has been requested.
unbearable itching, wheezing, shortness of breath, extremely swollen lymph nodes
I developed a small hydrocele (smaller than a fingernail) on my right testicle following my first dose of the Pfizer COVID-19 vaccine. I experienced no other adverse effects. My symptoms lasted about 4 days and self resolved.
Approx 4:00 PM 5/8/2021  - sore throat and sore arm.   Approx 10 PM 5/8/2021 - fever and lethargic. I normally run 97.4 and my fever was 100 - 101 degrees.  Approx 12 AM  5/9/2021 - I developed chills that lasted for 2-3 hours. I was freezing cold and shaking uncontrollably, despite wearing multiple layers and being under blankets. Chills were following by a feeling like my insides were on fire and melting this also lasted for a few hours. It was not an external sweating feeling. I was unable to sleep and felt very ill, the sickest I have ever felt. I took two Tylenol to try to decrease fever.  From 12 AM 5/9/2021 - 1 AM 5/10/2021 - I was running a fever that ranged from 99 degrees to 101 (my normal is 97.4). I continued to take Tylenol every 6 hours, which did help. I rotated from being cold to sweating, but not as severe as the previous night. I still felt very ill. I also had a headache.   All day 5/10/2021  and 5/11/2021 I had extreme fatigue and was unable to resume normal activities.
Stomach soreness; Leg soreness; Cannot see out of right eye; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Cannot see out of right eye), ABDOMINAL PAIN UPPER (Stomach soreness) and PAIN IN EXTREMITY (Leg soreness) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 040B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced VISUAL IMPAIRMENT (Cannot see out of right eye). On 17-May-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach soreness) and PAIN IN EXTREMITY (Leg soreness). On 19-May-2021, ABDOMINAL PAIN UPPER (Stomach soreness) and PAIN IN EXTREMITY (Leg soreness) had resolved. At the time of the report, VISUAL IMPAIRMENT (Cannot see out of right eye) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications are not provided. Treatment information not provided.
nauseous; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced NAUSEA (nauseous). At the time of the report, NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided.  No treatment drugs were reported.
Minor strider (itchy throat, feeling like I needed to clear my throat) that resolved with use of albuterol inhaler however since vaccination, my asthma has remained acute with around the clock use of my rescue inhaler in addition to daily maintenance inhalers.
1st shot 12/29/2021 Went to Hospital on 12/30/2021 with pneumonia.  2nd shot 1/26/2021 Heart stopped on 1/27/2021. Death occurred.
8NOV approx 330AM started feeling nauseous;late morning diarrhea & upset stomach w/fever;did not take temp;9NOV h/a, body aches & upset stomach;no diarrhea;10NOV still h/a & clammy;
Pt had severe outbreak of herpes zoster. Patient received vaccine 1/0/08 then on 12/29/08 had a severe outbreak of herpes Zoster.
Stomach cramps, vomiting, chills 4 hours Sleep disturbance and fatigue for 6 days Headaches 4 days. Handled by Ibuprofen or aspirin