chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Only had one Moderna vaccine back in January; Myositis; Arm was swollen, hot, rash; Terrible pain up shoulder and down back; Arm was swollen, hot, rash; arm was swollen; Shoulder and back are weak; Strange horizontal dark colored bump on left arm by injection site; Asthma attack, lungs started to tighten and wheezing; This spontaneous case was reported by a nurse and describes the occurrence of ASTHMA (Asthma attack, lungs started to tighten and wheezing), MUSCULOSKELETAL DISCOMFORT (Shoulder and back are weak), VACCINATION SITE MASS (Strange horizontal dark colored bump on left arm by injection site), PRODUCT DOSE OMISSION ISSUE (Only had one Moderna vaccine back in January) and MYOSITIS (Myositis) in a 72-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.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced ASTHMA (Asthma attack, lungs started to tighten and wheezing). On 13-Jan-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Shoulder and back are weak), VACCINATION SITE MASS (Strange horizontal dark colored bump on left arm by injection site), ARTHRALGIA (Terrible pain up shoulder and down back), VACCINATION SITE RASH (Arm was swollen, hot, rash) and VACCINATION SITE SWELLING (arm was swollen). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Only had one Moderna vaccine back in January), MYOSITIS (Myositis) and VACCINATION SITE WARMTH (Arm was swollen, hot, rash). At the time of the report, ASTHMA (Asthma attack, lungs started to tighten and wheezing), MUSCULOSKELETAL DISCOMFORT (Shoulder and back are weak), PRODUCT DOSE OMISSION ISSUE (Only had one Moderna vaccine back in January), MYOSITIS (Myositis), ARTHRALGIA (Terrible pain up shoulder and down back) and VACCINATION SITE SWELLING (arm was swollen) outcome was unknown and VACCINATION SITE MASS (Strange horizontal dark colored bump on left arm by injection site), VACCINATION SITE WARMTH (Arm was swollen, hot, rash) and VACCINATION SITE RASH (Arm was swollen, hot, rash) had not resolved.        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.   Concomitant medication details were not reported.  Treatment included antibiotics and inhaler.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Updated Events and outcome of events. On 13-Jul-2021: Follow up received included no new information; 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.
By the morning of Thursday March 25 I had a fever of 103.8.  I was bedridden the entire day,  had a headache.  My fever started going down on Friday however I was barely able to get out of bed Friday but forced myself to a few times. I was dizzy or light neaded all of these days including now which is Sunday.  I am still tired/depressed and not back to normal even now.
Diabetic; Neck pain; Back pain; Difficulty breathing; This is a solicited report from contactable consumer (patient) via non Pfizer sponsored program FACILITATED COLLECT based on information received by Pfizer from AbbVie, manufacturer control number: 21K-163-4079276-00.   Solicited report by a consumer of a 78 year old male with events of non-serious neck pain, diabetic, back pain and difficulty breathing with adalimumab (HUMIRA). There was no reported medical history. On an unknown date, the patient experienced diabetic. In 2021, the patient experienced neck pain, back pain and difficulty breathing. Pfizer Biontech covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 12Mar2021 (at 78 year old), patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported) intramuscular as single dose for covid-19 immunisation. Suspect Drugs (include generic name): adalimumab (HUMIRA; Solution for injection in pre-filled pen), subcutaneous for moderate to severe chronic plaque psoriasis and psoriatic arthritis and 1st dose Pfizer Biontech Covid-19  Vaccine(Tozinamera, Injection) intramuscular as covid-19 vaccination given on 12Mar2021.Causality for adalimumab (HUMIRA) :The reporter's causality for the events of neck pain, diabetic, back pain and difficulty breathing with adalimumab (HUMIRA) was no reasonable possibility. Concomitant drugs and dates of administration: Concomitant Drug Not reported. Other Relevant history: Not reported. Outcome of Diabetic was not recovered; outcome of the other events was recovering. Action taken for HUMIRA was unknown. Causality for adalimumab (HUMIRA; Solution for injection in pre-filled pen) and Neck pain, Diabetic, Back pain and Back pain was reported as No reasonable possibility. Causality for Pfizer Biontech Covid-19 Vaccine(Tozinameran, Injection) and Neck pain, Back pain and Back pain was possible and was not reported for Diabetic. The reporter's assessment of the causal relationship of the event Diabetic with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, the causal relationship between the events Diabetic, Neck pain, Back pain, Difficulty breathing and suspect drug BNT162B2 cannot be excluded.
Pt recieved her vaccine and within a couple of minutes became unresponsive, full body rigidity, followed by tonic clonic movenents involving her body lasting for over a minute.  BP was 70/ unable to determine. O2 sat was 97%, Pulse was 67. Transported to ER via ambulance. Recieved her first meningococcal vaccine 05/23/2017
Parent contacted HD stated "daughter complaining of itching, hives, and throat swelling". Mother gave her Benadryl and call her MD who "thought she might have reacted to the Meningococcal vaccine." Symptoms subsided after Benadryl taken according to mother.
Arm pain; Fever; Body aches; This case was reported by a physician via sales rep and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, fever and general body pain. On an unknown date, the outcome of the pain in arm, fever and general body pain were recovered/resolved.   It was unknown if the reporter considered the pain in arm, fever and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had arm pain, fever and body aches that lasted several days. The reporter did not agree to follow up from GSK.
Receiver of vaccine was reported dead on 04-22-2021 TOD 0809 to Medical Examiner's Office Report # 052-EMF-79-21
Bell's Palsy; This is a spontaneous report from a contactable consumer (husband) via Pfizer sponsored program Pfizer regulatory authority.   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VAC-CINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date in May2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 30May2021, the patient was affected by Bell's Palsy. This was exactly after 2 weeks after her 2nd Pfizer COVID shot. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation and no reaction were reported. The reporter wrote to you previously as well, but reporter did not receive any reply from your side. Yesterday, reporter contacted the Neurologist and he suggested reporter to write to you again informing about the situation. It seems to be an acute Bell's Palsy and reporter requested to take this matter on an urgent basis. The outcome of the event was unknown at the time of reporting.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100953159 Same reporter/ drug/ event for different patients
Patient reported fainting 3 to 4 times approximately 12 hours after vaccination and severe sharp leg pain. She received IV fluids in the ER and was discharged.
This spontaneous report as received from medical assistant refers to unspecified number of patients of unknown age and gender. No current condition, drug allergic reactions and medical history were reported. On an unspecified dates, unspecified number of patients were vaccinated with VARIVAX (Merck) (strength, dose number, route, lot number and expiry date were unknown) that underwent a supported temperature excursion. No concomitant therapy was reported. No adverse experiences were reported. The outcome of event was unknown. No further information was provided. This is one of several reports received from the same source. Additional information has been requested.
Extreme arm soreness/pressure the evening of 04/13/21. I felt like a boa constrictor was squeezing my arm. My arm was hot and sore. Fever; chills; muscle aches; 4-13-21 through 4-15-21. All the symptoms of my previous Covid-19 returned. These included elevated heart rate; dry eyes; difficulty with bowel movements. I continued to have daily pain in my left arm. This pain was elevated evenings. This pain finally subsided in June 2021. I had soreness under my right arm which continued from my first Covid-19 vaccine from March 16, 2021. I still experience pain under my right arm. On May 3, 2021 at 10:45 am I experienced an episode of heartburn unlike any previously experienced. I am not prone to heartburn continued: This episode was so extreme that I had to stop at a pharmacy and purchase rolaids. My elevated heart rate continued and became quite alarming. On June 1, 2021 my heart rate was 143 just driving my car. I was seen by Dr. June 2, 2021. My blood pressure was high (without hypertension). The procedures I received included: A) Primary Procedure:Health Panel (Multiple Blood Tests) (General health panel This panel must include the following: Comprehensive metabolic panel Blood count, complete (CBC), automated and automated differential WBC count B) Primary Procedure:Fibrin D-dimer Test (Fibrin degradation products, D-dimer; quantitative). I also received an ECG. I was referred for a 24 heart monitor. This did not show any heart rhythm irregularities; however, my heart rate was a still a bit high. I have been monitoring my blood pressure since and it has steadily decreased to normal. On September 10, 2021 my blood pressure was 107/71. My heart rate has also improved steadily. Now when I am sitting it is in the 70's to 80's range. After the vaccines it was 105 to 112 just sitting.
pt recv vax APR & MAY96 & lab eval revealed a lack of seroconversion;SEP96 pt devel neuro problems consisting of dizziness & orthostatic hypotens;it was reported some kind of autonomic neuropathy;
1HR after shot- numbness in mouth and metallic taste.  2HR after shot- eyes blinking at different rates. 12HR after shot- complete Bell's Palsy right side of face.
This case was reported by a pharmacist via call center representative and described the occurrence of lip swelling in a 53-year-old female patient who received FLUARIX QUADRIVALENT (batch number 572KT, expiry date 26th May 2018). Previously administered products included flu vaccine. Concomitant products included Hydrochlorothiazide, Lisinopril, SYNTHROID and vitamin C + D. On 21st November 2017, the patient received the 1st dose of FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 21st November 2017, 15 min after receiving FLUARIX QUADRIVALENT, the patient experienced lip swelling (serious criteria other: as per reporter) and facial swelling (serious criteria other: as per reporter). The patient was treated with BENADRYL, MEDROL and PEPCID. In November 2017, the outcome of the lip swelling and facial swelling were recovered/resolved. The reporter considered the lip swelling and facial swelling to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient had no allergy to medicines. The patient was on her concomitant medicines for years and took her regular medicine earlier on the day of vaccination. On the same day, 15 minutes after receiving FLUARIX QUADRIVALENT, the patient's lips began to swell and her face began to swell about an hour after the vaccination. The patient took BENADRYL 25 mg immediately and the next morning she also took a MEDROL dose pack. The patient continued to take her BENADRYL as well as PEPCID. The patient's condition improved after the 3rd day. The patient required emergency room visit. The patient normally takes a flu vaccine, but this might have been the first time that she took FLUARIX.
Since the day that she received the COVID vaccine, she has been feeling nausea and throwing up every evening. This never happened before the vaccine.
He has pain around injection site; Last night, He noticed swelling around injection site on left arm/This morning it swelled up; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Last night, He noticed swelling around injection site on left arm/This morning it swelled up) and VACCINATION SITE PAIN (He has pain around injection site) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced VACCINATION SITE SWELLING (Last night, He noticed swelling around injection site on left arm/This morning it swelled up). On 07-May-2021, the patient experienced VACCINATION SITE PAIN (He has pain around injection site). At the time of the report, VACCINATION SITE SWELLING (Last night, He noticed swelling around injection site on left arm/This morning it swelled up) and VACCINATION SITE PAIN (He has pain around injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications include BP medicine, heart medicine, Diabetes medicine. The Treatment information was not provided.
fatigue; chills; woesening sinus issues; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), CHILLS (chills) and SINUS PAIN (woesening sinus issues) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for an unknown indication.     No Medical History information was reported.    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 FATIGUE (fatigue), CHILLS (chills) and SINUS PAIN (woesening sinus issues). At the time of the report, FATIGUE (fatigue), CHILLS (chills) and SINUS PAIN (woesening sinus issues) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Increasing swelling, pain and redness at injection site. Currently the size of an egg. Began a few hours after injection and has become more widespread and swollen each day since.  Uncertain if cellulitis, but treating as such.
vaccine expiration date was September 30,2022  and beyond use date was October 18,2022  Vaccine was given after expiration date
chills; Mild body ache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administration date 17Oct2021 (Lot number: FF2590) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; ATORVASTATIN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6203), administration date: 11Mar2021, when the patient was 58 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 18Feb2021, when the patient was 58 years old, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 18Oct2021, outcome "recovering", described as "chills"; PAIN (non-serious) with onset 18Oct2021, outcome "recovering", described as "Mild body ache". Therapeutic measures were not taken as a result of chills, pain. Additional information: No covid vaccination prior vaccination. No covid tested post vaccination No  No follow-up attempts are possible. No further information is expected.  Follow-up (25Oct2021): Follow-up attempts are completed. No further information is expected.
Stomach pain, nausea, dizziness, and numbness in the left arm and face for 2 hours that went away after a nap,  but the stomach pain and numbness returned for another hour.
Vaccine provided to client whom is under the age limit at time of vaccination. Parent of minor child contacted and provided with information of the medical error made at the time of service. Parent concerned of followup action to be taken for the minor to receive correct vaccine. This nurse will followup with parent when further information is available on action to be taken.
Felt off and weak for the first two days after receiving my second shot, and then things began doing down hill with weight loss and body aches, tested positive for mono and have been mostly bed ridden for months and still going and getting tested from my doctor
following day arm hurt, pain went to neck;had h/a & vomiting;arm swollen, warm to touch, fingers also swollen-arm & hand grip weaker than other hand;MD recommended Ibuprofenq 4hr, warm compress;
Hives around mouth within 20 min receiving FLUMIST, gone by time seen by Dr.
Initial unsolicited report received from nurse on 23-Jul-2018. This case involves six-month-old patient (gender not reported) who was vaccinated with expired dose 0.5 ml of PENTACEL (Batch number: C5390AA, expiration date: 17 Jul 2018, dose, route and site of administration was not reported) intramuscular route in right thigh on 23 Jul 2018. The patients medical history was not reported. Concomitant medications include HEPATITIS B VACCINE (HEPATITIS B VACCINE) and PREVENAR 13. It was an actual medication error due to expired vaccine used. It was unknown if patient had adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in DirectivE and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
administered with expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032N20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) had resolved.        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.   Concomitant medication was not provided. Treatment information was not provided.   This case was linked to MOD-2021-314567, MOD-2021-314570, MOD-2021-314573, MOD-2021-314793, MOD-2021-314545, MOD-2021-314555, MOD-2021-314805, MOD-2021-314810, MOD-2021-314805 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Follow-up information included no new information
Patient c/o heart racing and feeling light headed and dizzy. Patient was assisted to lay down. Stated she felt better then 15 minutes later and still laying down symptoms of hear racing and feeling chest tightness started again
15 days of feeling very sick , rapid onset of extremely high blood pressure 230/120, enzymes in cardiac blood work. 2 days hospitalization after ambulance trip
Sore arm; This is a spontaneous report received from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EL3247) via an unspecified route of administration in the left arm on 18Mar2021 at 10:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid, gastrointestinal stromal tumour (GIST) and allergy to penicillin. The patient had taken unspecified concomitant medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EL3247) via an unspecified route of administration in the right arm on 25Feb2021 at 10:30 as a single dose for COVID-19 immunisation. The patient had not received any other vaccines within four weeks prior to the vaccination. On 19Mar2021, at 05:00, the patient experienced sore arm. The patient did not receive any treatment for the event sore arm. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of event sore arm was reported as recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration on an unspecified date in 2018 at single dose for immunization. The patient's medical history and concomitant medications were not reported. Pharmacist reported that a patient experienced severe pain, redness and swelling after receiving the pneumococcal 13-val conj vac (dipht crm197 protein).The events occurred a few months ago in 2018. The outcome of the events was unknown.
3-4 days after vaccination cough, itchy, scaly skin at area of injection. Still present after 2 weeks resolving slowly.