chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lung disease; General body pain/body was always in pain in mornings could hardly close hands with Humira; COVID  vaccine caused fatigue; COVID  vaccine caused sore muscles; This spontaneous case was reported by a consumer and describes the occurrence of LUNG DISORDER (Lung disease), PAIN (General body pain/body was always in pain in mornings could hardly close hands with Humira), FATIGUE (COVID  vaccine caused fatigue) and MYALGIA (COVID  vaccine caused sore muscles) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced LUNG DISORDER (Lung disease), PAIN (General body pain/body was always in pain in mornings could hardly close hands with Humira), FATIGUE (COVID  vaccine caused fatigue) and MYALGIA (COVID  vaccine caused sore muscles). At the time of the report, LUNG DISORDER (Lung disease) and PAIN (General body pain/body was always in pain in mornings could hardly close hands with Humira) had not resolved and FATIGUE (COVID  vaccine caused fatigue) and MYALGIA (COVID  vaccine caused sore muscles) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality of HUMIRA for the event(s) of COVID vaccine caused fatigue and sore muscles unknown onset, lunge disease, body was always in pain in mornings could hardly close hands and COVID vaccine caused fatigue  and sore muscles unknown onset was not provided Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Attendee received second dose Pfizer vaccine at 12:34 pm in the right arm.  Lot# ER8729. Attendee was directed to observation area. At 13:00 voiced complaints of Nausea. 85 degrees at the site today. Attendee's respirations were not tachyphemia or dyspnea. Attendee assisted to the cot, but refused to lie down. 13:05  Dry heaving. Stated that the nausea started immediately after the vaccination, but didn't let the staff know until she was really feeling bad. HR:  88   BP:  122/84   RR:   Not recorded   O2Sat%:  96. 13:15 No longer dry heaving  HR:  93   BP:  128/85   RR:   16   O2Sat%:  97   Temp:  98.1
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 11:54 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 11:54 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The patient age was reported as 57.46 years.  It was reported that unknown number of patients were 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 time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  On 03-Apr-2021, At excursion time 09:00 AM temperature was 34, total doses given for the day was 210, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were moved to clinic. Vaccine BUD date was 29-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The temperature recordings were taken by using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
This spontaneous report was received from a physician concerning an unspecified number of patients (demographics unknown). On an unspecified date, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (Lot # K021444; expiration date: 17-SEP-2016) (route not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
pain at injection site, limited movement of left arm.  body aches, fatigue, difficulty breathing, sharp pains in pelvic area.
Patient presented to ED with complaints of substernal chest pain with associated shortness of breath, nausea, and diaphoresis. Patient states symptoms have been intermittent over the past 2 weeks. Patient has irregular heart rhythm, atrial fibrillation identified on ECG. The patient was started on a diltiazem drip and a heparin drip. No PE identified and troponin WNL. The patient was planned to be admitted and seen by cardiology, however patient eloped from emergency department before full admission.
Doses were administered after 30 day beyond use date.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after 30 day beyond use date.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after 30 day beyond use date.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after 30 day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Doses were administered after 30 day beyond use date.).    No concomitant medications were reported. Vaccine was stored in refrigerator up to published expiration date without any indication of storage considerations outlined in standard information. No treatment information was provided.   Reporter did not allow further contact
Awakened by rapid pulse and heart rate. Moved to severe shaking in all extremities, felt cold. Managed through self administered techniques. Resolved in an hour and a half.
1st dose Recombivax HB dev bronchitis, unspecified resp sxs, lethargy, achiness, & fever. Tx Ansaid, unspecifed antibiotics & muscle relaxants. Home for 2.5 wks; arthritis suspected. 2nd dose-sev aching & "ongoing" temp. Dx = fibromyalgia.
Developed hives on back, rear thighs and buttox.  They recur intermittently.  I've never had skin issues before.
Starting withing 2 minutes of injections itching at injection site, then within 1 minute generalized itching with hives, facial swelling, sweaty face and palms, throat tightness.
Shingles on my face; This is a spontaneous report from a 48-year-old female contactable consumer. This consumer (patient) reported.  A 48-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0170), via an unspecified route of administration in left arm on 26Apr2021 at 16:00 (at the age of 48-year-old) as a 1st dose, single dose for COVID-19 immunization. The patient's medical history included rheumatoid arthritis. The patient had no known allergies. The patient experienced COVID prior to the vaccination. The patient's concomitant medications included abatacept (ORENCIA) injection, methotrexate (METHOTREXATE). The patient did not receive any other vaccine in four weeks of COVID vaccine. The patient was not tested for COVID post vaccination. The patient did not receive any other vaccines 4 weeks prior to the COVID vaccine. On 28Apr2021, after 2 days of vaccination, the patient experienced shingles on my face. The patient received antiviral pills which were prescribed as treatment medication for the event. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event was resolving.  Follow up attempts are needed. Further information has been requested.
Right hand has shaky tremor; Feels like he got hit by a semi; 104 Fever; Aching everywhere; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Right hand has shaky tremor), FEELING ABNORMAL (Feels like he got hit by a semi), PYREXIA (104 Fever) and MYALGIA (Aching everywhere) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced TREMOR (Right hand has shaky tremor), FEELING ABNORMAL (Feels like he got hit by a semi), PYREXIA (104 Fever) and MYALGIA (Aching everywhere). At the time of the report, TREMOR (Right hand has shaky tremor), FEELING ABNORMAL (Feels like he got hit by a semi), PYREXIA (104 Fever) and MYALGIA (Aching everywhere) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, Body temperature: 104 (High) 104.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Reportedly, when asked for the expiration date, the only date she had on the card was 28th July, however it was unclear if that was the expiration date or the incorrectly entered date of his 1st dose. She is going to verify with the pharmacy.  Treatment information was not provided.
Yesterday I ended up in Emergency Room with tachycardia, sort of developed over the day and tachycardia as high as 170 beats per minute.; Feel like I have a light flu; Feeling weak; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Yesterday I ended up in Emergency Room with tachycardia, sort of developed over the day and tachycardia as high as 170 beats per minute.), INFLUENZA LIKE ILLNESS (Feel like I have a light flu), ASTHENIA (Feeling weak) and PYREXIA (Fever) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Had chronic COVID in January 2021). Concomitant products included OMEPRAZOLE and SERTRALINE for an unknown indication.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced TACHYCARDIA (Yesterday I ended up in Emergency Room with tachycardia, sort of developed over the day and tachycardia as high as 170 beats per minute.), INFLUENZA LIKE ILLNESS (Feel like I have a light flu), ASTHENIA (Feeling weak) and PYREXIA (Fever). The patient was treated with ACETAMINOPHEN for Flu like symptoms, at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (Yesterday I ended up in Emergency Room with tachycardia, sort of developed over the day and tachycardia as high as 170 beats per minute.), INFLUENZA LIKE ILLNESS (Feel like I have a light flu), ASTHENIA (Feeling weak) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: (Positive) Had chronic COVID. On 03-Jun-2021, Heart rate: 170 beats per minute (High) 170 beats per minute. On 04-Jun-2021, Heart rate: 120 beats per minute.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
No adverse event from the vaccine, but I did end up getting COVID, so I don't know if that's considered an adverse event or not. I received my last dose of the vaccine in August 2021, which was a booster, and then tested positive for COVID on May 31, 2022.
Patient became diaphoretic and slighty lightheaded after administration VS 98/62 p 57 R 22 O2 sat 98%  T 98.6 VS monitored last set 1048 98/62 57 20 O2 sat 98% no dizziness or problems.
Excessive redness, pain after 2 days of injection; Excessive redness, pain after 2 days of injection; This is a spontaneous report from a contactable physician via a sales representative. A female patient of an unspecified age (reported as 65, unit unknown) received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number: W62465, expiry date not reported), via an unspecified route of administration on 15Apr2019 at a single dose for immunization. Medical history and concomitant medications were not reported. On 17Apr2019, the patient experienced excessive redness, pain after 2 days of injection. The patient had to come to office for acute visit on 19Apr2019. It was reported that the patient was prescribed with cefalexin (KEFLEX). No other vaccines were given on the day of shot. Clinical outcome of the events was unknown.
Information has been received from an office worker concerning a 65 year old female patient with no known allergies and a past medical history of allergic rhinitis and abdominal disorder who on 11/12/02 at 10:30 was vaccinated with a fifth dose of pneumococcal vaccine 23 polyvalent (lot # 641532/1353L) in the right deltoid. It was noted that the patient was well at the time of vaccination. Concomitant therapy included fexofenadine, estrogens, medroyprogesterone acetate and calcium. On 11/12/02 one hour after the vaccination the patient developed redness and swelling in the arm the vaccine was administered and the arm was painful and warm to the touch. The patient sought unspecified medical attention. Follow up information received from the office worker indicated that this was the first dose of pneumococcal vaccine 23 polyvalent that the patient received in this office. The reporter also indicated that the patient developed a local reaction within a few hours after the injection consisting of a large area of swelling and induration. The patient was admitted to the hospital for 4 days (also reported as 1 day) from 11/12/02 until 11/16/02. The patient was discharged on 11/16/02 with a diagnosis of soft tissue swelling of the right arm. While hospitalized it was reported that the patient had consults with an ID specialist and an allergist. Laboratory tests included a white blood cell count of 12.7 and a x-ray of the right arm that showed no SC air. The patient followed up in the office on 11/18/02 and that time the patient's tenderness was better but some induration was still present. IT was reported that the patient was still being followed. Additional information has been requested.  A 15-day follow up report received 03/20/2003 adds: Additional info received from the office worker indicates as of 12/18/2002, at the time of an office visit, the pt had complete resolution of the local reactin to the right arm. Additional info is not expected.
Pt came to office and had a local reaction on the right deltoid it was a spot 4 1/2 x 3 1/2 cm in width/length red, warm to touch. HCTZ cream recommended.
Vaccinated 9/2/15. Site warm, red, swelling 9/2/15, 9/3/15 itching 9/2.
PATIENT DESCRIBES ITCHING ON ELBOWS, THEN ARMS AND LEGS.  ITCHING GOT WORSE OVERNIGHT, THEN PATIENT NOTICE HIVES.
Days have passed and I?m still very tired and weak. Head feeling pressure. No fever but temperature is rising.
This case was reported by a pharmacist via call center representative and described the occurrence of feeling hot in a 75-year-old male patient who received SHINGRIX (batch number 49R72, expiry date 13th February 2021) for prophylaxis. This case was associated with a product complaint. Concomitant products included SHINGRIX. On 16th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In January 2019, less than a day after receiving SHINGRIX, the patient experienced feeling hot, lethargy and feeling unwell. On an unknown date, the patient experienced feels awful and pharmaceutical product complaint. On an unknown date, the outcome of the feeling hot, lethargy, feels awful and feeling unwell were not recovered/not resolved and the outcome of the pharmaceutical product complaint was unknown. It was unknown if the reporter considered the feeling hot, lethargy, feels awful and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. On 12th November 2018, the patient received the 1st dose of 0.5ml SHINGRIX (batch number 49R72, expiry date 13th February 2021) intramuscularly. The patient received the dose of the SHINGRIX vaccine in the left deltoid. The morning after receiving the SHINGRIX vaccine, the patient did not feel good, he felt like he had a fever, he was lethargic and had been in been all day. The patient in the background during the phone call said that he felt horrible. The reporter did not consent to follow-up. This case was 1 of 5 cases, reported by the same reporter.
feeling sick; diarrhea; hot flash; itchy arm; nausea; vomiting; chills; red arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (feeling sick), DIARRHOEA (diarrhea), HOT FLUSH (hot flash), VACCINATION SITE PRURITUS (itchy arm) and NAUSEA (nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018BZ1A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included DILTIAZEM, METOPROLOL, METFORMIN, SIMVASTATIN, DIGOXIN, FUROSEMIDE (LASIX [FUROSEMIDE]), MAGNESIUM and SITAGLIPTIN (JANUVIA [SITAGLIPTIN]) for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION COMPLICATION (feeling sick), DIARRHOEA (diarrhea), HOT FLUSH (hot flash), VACCINATION SITE PRURITUS (itchy arm), NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills) and VACCINATION SITE ERYTHEMA (red arm). At the time of the report, VACCINATION COMPLICATION (feeling sick), DIARRHOEA (diarrhea), HOT FLUSH (hot flash), VACCINATION SITE PRURITUS (itchy arm), NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills) and VACCINATION SITE ERYTHEMA (red arm) was resolving. Not Provided          Treatment medication included Tylenol. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to US-MODERNATX, INC.-MOD-2021-073639 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073639:
I thought I was having a stroke. My head felt very heavy. I had a staggering gait. I had a high fever that felt like it was cooking my brain. It was progressing and I got weak in my ankles and my knees. I went to sleep and woke up confused. I had joint pain, and a horrible lingering headache. I had a coated tongue. still have headaches and my voice is hoarse and I have a cough.
Within 12 hours, had a bad headache, progressed to migrane. Had neuro changes 23 hours after receiving the vaccine, including hemaniopia of right side, numbness/tingling in right arm, slow mental processing, delayed speech, visual aura. Headache continued but other neuro symptoms resolved within 6 hours.  21 weeks pregnant at the time. EDD 2/25/2024. Tolerated flu shots in the past for many years.
"More reactions" than usual / reported a rash; This case was reported by a physician and described the occurrence of rash 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 rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash 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 was captured as adult as per vaccine indication. The reporter stated that, the patient received the dose of Shingrix and experienced Rash.as opposed to the usual muscle pain and fever The reporter asked information about Shingrix recall and mentioned that they had none to return and was not sure if she had any from the lots that were affected, she also asked what was the risk to the patient. The reporter was not certain though if the reaction was from the Shingrix nor if they were of the same batch of recalled Shingrix. The reporter did not consented to follow up. The reporter did not have any additional information regarding the events or the patients (demographics). This case was linked with US2021AMR057595 and US2021AMR057596 reported by the same reporter. Note- Since the reporter was just inquiring about recall of Shingrix and Hub also added comment about the same, no event about product recall has been coded.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR057595:Same reporter. Patient #2. US-GLAXOSMITHKLINE-US2021AMR057596:Master case. Several pts.
The pt experienced an improperly placed Anthrax injection. The vax was injected into the ulnar nerve and the subcutaneous nerve. The event triggered immune response in/on both nerves. At the time extreme neuropathic pain which subsided to moderate, loss of strength, and motion. Treated with steroids with little improvement. Symptoms still persist. On 60 Day FU: same symptoms as previously reported are still relevant and related to this adverse event, there has been no change.