chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; headache; fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old non pregnancy female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN6202) dose number unknown via an unspecified route of administration in Leg Left on Feb2021 (age at vaccination 64years old, Pregnant at Time of Vaccination: No) as single dose for covid-19 immunisation. The patient medical history and concomitant medications was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vac-cine. The patient received any other medications within 2 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in Public Health Clinic/Veterans Administration facility. Since the vaccination, the patient had not been tested positive for COVID-19. On Feb2021 the patient experienced sore arm, headache, fatigue. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was recovered.  No follow-up attempts are needed. No further information is expected.
Day 2 and 3 horrible lower back.pain Day 3 swollen lymph node under left arm
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
ended up in the ER with heaviness around his chest; "fluttering chest"; ended up in the ER with heaviness around his chest; "fluttering chest"; This is a spontaneous report from a contactable Other-HCP.  A 72-year-old male patient (Dad) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for covid-19 immunisation. One day after the 1st COVID19 vaccine dose, the patient ended up in the ER with heaviness around his chest; "fluttering chest". Felt fine 2 days later. Outcome of the events were recovered.  Information on the lot/batch number has been requested.; Sender's Comments: A possible contribution role of the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)  to the onset of heaviness chest and futtering chest cannot be excluded due to temporal relationship. However, it is worth nothing that the patient was 72-year-old, and medical history and concomitant drugs not provided.  This case will be reassessed should additional information become 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.
Shortness of breath; Some chest pain; Terrible side effects; 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 DYSPNOEA (Shortness of breath), CHEST PAIN (Some chest pain) and VACCINATION COMPLICATION (Terrible side effects) 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.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 an unknown date, the patient experienced DYSPNOEA (Shortness of breath), CHEST PAIN (Some chest pain) and VACCINATION COMPLICATION (Terrible side effects). At the time of the report, DYSPNOEA (Shortness of breath), CHEST PAIN (Some chest pain) and VACCINATION COMPLICATION (Terrible side effects) outcome was unknown.            No concomitant medications were provided.  No treatment information provided.
Left arm turned red from my shoulder to my elbow.  Like a big bruise ,  Pain in the shoulder and where the shot was given. Still have pain and redness 02/10/21.  Pain keeps me from sleeping at night.
pt recv vax 9AUG94 & exp arm pain; around 2PM pt devel swollen eyes which were noted to be 4+ erythematous & irritability; pt given DPH; w/in 30-45 mins pt exp abated; pt inj site was bright red, puffy & pruritic;
Subsequently post vax, the pt developed shortness of breath, internal tremor, metallic taste, dry mouth, and an unsteady gait. The pt's neurologist indicated that this may be a reaction to her flu shot.
2 weeks after inoculation left thigh patient developed superficial papules nodular induration with superficial soft tissue redness inflamed.
Nausea and vomiting followed by progresive weakness in hands & feet progressed proximally. Unable to walk to hospital 1/26/11 where intubated/ICU. Transferred to another clinic. Diagnosis of GBS. patients husband describes patient as having frequent sinus problems and frequent colds from exposure to children (schoolteacher). Does not recall a specific viral illness or cold prior to vaccination.
4 hours post vax, the pt started running fever of 102. Motrin was given to decrease temperature.
No adverse effects; patient was administered expired VAQTA; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information on patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.      On 08-OCT-2019, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) lot # R021233, expiration date 05-SEP-2019 (dose, route of administration and anatomical location were not provided) for prophylaxis. No adverse effects were reported.
Pt went to ER on 6/26/09. Pt states he woke up and felt like he was drunk. Pt had dizziness, confusion, trouble with gait. Pt c/o muscle spasm on left side of face. Pt admitted to hospital for 5 days. Pt dx with transient ischemic attack and a hole in his heart.  8/25/09  MR received for DOS 6/26-30/09 with d/C DX:  Left thalamic small vessel acute infarct.  Patent Foramen Ovale. Pt presented after onset of headache, feeling abnormal, altered mental status, veering to the right while walking and facial asymmetry.  Anisocoria noted on PE.  Started on ASA tx and d/c for outpt f/u.
Patient received PNEUMOVAX 23 5 minutes later experienced hot feeling and pain in spine and legs - spasms.
Flu vaccine given 11/15/05. Vaccine site had mild soreness, typical following any vaccine. 3-5 days later she hit the arm with force on a door jam. Client does not recall how soon the pain began following the hit on the door jam but she began to have severe pain with left arm motion (9-10 on a scale of 10). She was unable to lift her arm above her head with her elbow bent without severe pain. Pain with that motion has continued, but the pain has decreased to a 5-6. She is awakened at night with pain when sleeping on her left side. She has taken 1 Aleve per day for the last 2 weeks. She reported initial weakness in her left fingers with slight tingling, but that has resolved. She has not seen a doctor due to financial concerns.
Patient received Moderna COVID Booster dose at approximately 12 pm Nov 20, 2021. Patients wife called at 12:21 pm on Nov 21, 2021 to report severe reaction. Patient states that around 3 AM on Nov 21 that they awoke from severe arm pain and then realized that their throat and tongue were very swollen. Patient states they did not seek medical care and instead spent about 30 minutes trying to move their tongue around and the swelling went down on its own. Patient endorses slight difficulty breathing during this time but that resolved as the swelling went down. Patient denies any lingering symptoms or recurrence. Pharmacist advised patient to seek immediate emergency medical evaluation. Patient rejected recommendation against medical advice. PCP was paged and notified of incident and recommendation. PCP reports they called the patient for a phone evaluation and will monitor situation as patient is stable.
The patient received pneumovax23(lot #u034712 exp 30/jul/23) and then right after she got an allergy reaction( lips swelled up and chest pain and then started shaking and feeling cold then left side headache). However she was conscious and was talking normally.  As soon as she had the reaction I gave her 50mg benadryl and then 2 tabs of acetamenophen (325mg) instructed by her doctor. After taking benadryl chest pain got a little better, but her headache and a chill didn't go away. We called 911 and they came and checked her. Since her blood pressure was a little high and had a headache and a chill she was sent to ER. She said that she will follow up with us. She has allergy to aspirin, NSAID and sulfa, but never had any reaction to vaccines.
Injection site soreness lasting about 48 hours Headache lasting about 3.5 days Fever (99.5 - 100.5 F) lasting about 3 days Nausea lasting about 2 days
Patient indicated she had arm pain at the site of injection and a headache that started immediately after the vaccine.  She indicated she felt anxious.  Blood pressure was high this morning according to the patient because she knew she was going in for the vaccine.  Blood pressure was 180/90 right arm.  Patient indicated she had a small amount of fruit and water today.  She was given some juice and we had her wait the full 30 minutes.  Her blood pressure was back to her baseline of 150 /83 after sitting for the 30 minutes.  She still indicated she had a slight headache but it was somewhat better. She was discharged to home with her family member and indicated she would keep an eye on her pressure at home and let someone know if the headache got worse or changed.
2/22 body aches, fever, rigors, fatigue 2/23 R axillary lymphadenopathy, pain in axilla, shoulder and arm, fever, fatigue, myalgias 2/24 low grade fever, otherwise same as 2/23
Information has been received from a nurse concerning a female patient who in April 2009 was vaccinated with a dose of GARDASIL. On the same day, the patient was concomitantly vaccinated with tetanus toxoid. The patient fainted after administration of HPV vaccine and was observed for thirty minutes. Medical attention was sought by an office visit. The patient recovered from syncope. This report is one of two reports received from the same source. Additional information has been requested.
Pt had (L) thigh swelling. No warmth, no redness. Pt unable to walk. Spoke with MOC pt recovered next day.
Moderna Covid-19 monovalent booster administered after 9/2/22.  On 09/20/22 monovalent booster administered, no adverse reactions noted, informed pt and counseled.
About 5 minutes after administration, patient reported feeling hot and  sweaty. She wanted something cold so we put an ice pack on her neck. First she said she felt better then she reported chest pain. She stretched out her arms and clenched her fists. We called 911. Paramedics and Fire department arrived about 10 minutes later. They attached probes on her body and took reading. They said she was having a panic attack. About 5 minutes after she was calm. She told the paramedics that she used to black out from panic attack previously losing consciouness. She never mentioned this at time of interview prior to vaccination: She said she never lost consciousness today. She heard and saw everything. Paramedic said she was having a panic attached. They offered to take her to hospital but she refused and signed a release for them.  About 10 minutes later she was fine and walked away by herself after she was cleared by the paramedics. Her eyes never closed
Pfizer-BioNTech COVID-19 Vaccine EUA: hospitalized with pneumonia acute hypoxic respiratory failure seven months after vaccination. Received steroids, oxygen, and anticoagulation for elevated d-dimer. Discharged medically stable. Improving on outpatient follow-up.
No energy since the 2nd dose, Weak since the 2nd dose; Tired since the 2nd dose; Knot on side of neck after 1st dose; Bigger knot on side of neck after 2nd dose; Pain in right leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in right leg), ASTHENIA (No energy since the 2nd dose, Weak since the 2nd dose), FATIGUE (Tired since the 2nd dose), NECK MASS (Knot on side of neck after 1st dose) and NECK MASS (Bigger knot on side of neck after 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in right leg). On an unknown date, the patient experienced ASTHENIA (No energy since the 2nd dose, Weak since the 2nd dose), FATIGUE (Tired since the 2nd dose), NECK MASS (Knot on side of neck after 1st dose) and NECK MASS (Bigger knot on side of neck after 2nd dose). At the time of the report, PAIN IN EXTREMITY (Pain in right leg), ASTHENIA (No energy since the 2nd dose, Weak since the 2nd dose), FATIGUE (Tired since the 2nd dose), NECK MASS (Knot on side of neck after 1st dose) and NECK MASS (Bigger knot on side of neck after 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medication was reported by reporter. No Treatment Medication was not reported by reporter.   This case was linked to MOD-2021-201718 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Follow-up information received on 06-04-2021 contains non-significant information. On 02-Jun-2021: Reporter's address, New event were added.
He cried after his shots and then got very pale and limp shortly after. He was evaluated by Dr. who when she arived to the room placed him on the exam table from moms arms and he immediately cried and pinked up VS. normal. EKG done in office and was read as normal. He was admitted to local hospital for over night observation. He was sent home the next day.
Approximately 17 hours after the second dose I had flu like symptoms, chills, headache, fatig ue, sleepiness
Enlarged heart from 05-24-21 to 05-25-21. Insomnia from 05-22-21 to the present and continuing. Treatment received - none.
Headache, confusion, hypertension, hospitalization with idiopathic leptomeningitis diagnosis. Continued bilateral upper and lower extremity weakness, pain.
Initially I felt fine and had no pain.  After about 5 minutes I had tachycardia and sweating, which resolved and seemed to be a vaso vagal reaction.  About 30 minutes after the vaccine I developed ipsilateral facial numbness which lasted about 24 hours.  I would like guidance on whether to proceed with the second dose.
Patient came to the clinic for her COVID booster. She had received 2 Moderna doses and one Pfizer booster. The patient decided to have the Pfizer Bivalent booster. The nurse pulled what she thought was the Bivalent Pfizer booster vaccine by the labels made by the clinic nurse for the expiration date. Unfortunately, the wrong vial was labeled as the booster dose, it was in fact the 12 and up Trisucrose Pfizer regular COVID dose which looks exactly like the booster dose vial, both have gray tops and similar labels. When making the expiration labels prior to this incident, the nurse mixed up the vials and the lot numbers of the two Pfizer vials and mislabeled the type of vaccine, booster/non-booster. Since this huge error, all vials have been double verified with any labels placed on the vials by 2 different nurses. Two nurses will also be verifying the original labels to the clinic made expiration labels before being placed on the vials when received. Clinic will continue to try and call patient to notify her of the incident and let her know she can have the Bivalent dose in two months.
Got Booster 9/15/22.  The next day I had a sore throa/22t, swellen glands, headache and muscle aches.  Then I developed Bronchitis and on 9/24/22  in the early PM I  became dizzy and my blood pressure had risen.  Took BP a few times then it got really in the 195/97 and I know something was wrong.  Went to Hospital ER and was dry heaving.  That was on Saturday afternoon and had chest exray and CT scan and still didn't know what was going on with me.  Very sick.  On Monday morning they did another MRI and CT scan and found out I had a Stoke........
Headache, Sedation, NauseaVomiting, LT ARM PAIN Narrative:
Myalgia, Arthralgia, fatigue Narrative: Second vaccine 01/13/2021 Joint pains, muscle ache, fatigue
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 4:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 4:11 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of the patient was 31.81 years.  Concomitant products were not provided.  On 27-Mar-2021, Excursion time was 09 AM, temperature was 35, total doses given for the day was 195, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 20 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.  On 27-Feb-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 33, 10 AM: 36, 11 AM: 35, 12 AM: 35, 1PM: 35, 2 PM: 35, 3 PM: 34, 4 PM: 34 and 5 PM: 35.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
feel like I had the flu; muscle aches; Joint aches; achy all over body; felt like I was 90 years old; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feel like I had the flu), MYALGIA, ARTHRALGIA, PAIN, and FEELING ABNORMAL in a 57-year-old male patient 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 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY. On 10-Apr-2021, the patient experienced MALAISE, MYALGIA, ARTHRALGIA, PAIN, and FEELING ABNORMAL. On 23-Apr-2021, MALAISE, MYALGIA, ARTHRALGIA, PAIN, FEELING ABNORMAL, and PAIN IN EXTREMITY had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC-MOD-2021-090547, US-MODERNATX, INC-MOD-2021-090554. This case was linked to MOD-2021-090569; Sender's Comments:  US-MODERNATX, INC-MOD-2021-090547: dose 1 case US-MODERNATX, INC-MOD-2021-090554: dose 2 case
coming down with the flu; nose swelling (twice the size of it); This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (coming down with the flu) and NASAL OEDEMA (nose swelling (twice the size of it)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced INFLUENZA (coming down with the flu) and NASAL OEDEMA (nose swelling (twice the size of it)). At the time of the report, INFLUENZA (coming down with the flu) and NASAL OEDEMA (nose swelling (twice the size of it)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Symptoms: Patient reported that she felt like her nose was broken. No treatment medications were reported.
I experienced high fever of 101.7, body and muscle pain, headaches, feeling tired for a full day, the day after receiving the vaccine. On the second day after the vaccine I experienced headaches and mild body aches that resolved with over the counter medication.
slightly itchy; still very red and large; injection site was raised; injection site redness; injection site hard and hot to touch; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), INJECTION SITE WARMTH (injection site hard and hot to touch), PRURITUS (slightly itchy), INJECTION SITE SWELLING (injection site was raised) and INJECTION SITE ERYTHEMA (injection site redness) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 29L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On 12-Feb-2021, the patient experienced INJECTION SITE WARMTH (injection site hard and hot to touch), INJECTION SITE SWELLING (injection site was raised) and INJECTION SITE ERYTHEMA (injection site redness). On 13-Feb-2021, the patient experienced PRURITUS (slightly itchy) and INJECTION SITE ERYTHEMA (still very red and large). At the time of the report, PAIN IN EXTREMITY (arm soreness), INJECTION SITE WARMTH (injection site hard and hot to touch), PRURITUS (slightly itchy), INJECTION SITE SWELLING (injection site was raised), INJECTION SITE ERYTHEMA (injection site redness) and INJECTION SITE ERYTHEMA (still very red and large) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.