chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt was supposed to get a Moderna 12+ Adult dose (private). We are out of private stock and had to borrow from State stock. Pt was given Moderna (state) 6 months - 11 years 0.5ml. I spoke with dr and no treatment or additional vaccines are needed. Pt was notified with no concerns voiced. Advised him of state being notified with no other vaccine or treatment recommended.
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 08/11/2021. PATIENT FULLY VACCINATED ON 02/23/2021.
right hand swelled up; still swollen but not as swollen; at one point twice the size of her left hand; wrist stiff; wrist inflamed; got 3 terrible nosebleeds for over an hour; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (right hand swelled up; still swollen but not as swollen; at one point twice the size of her left hand), JOINT STIFFNESS (wrist stiff), ARTHRITIS (wrist inflamed) and EPISTAXIS (got 3 terrible nosebleeds for over an hour) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06M20A) for COVID-19 immunisation.     The patient's past medical history included Fracture (Fractured right wrist 10 years ago). Concurrent medical conditions included Arthritis (Arthritis in little finger).    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PERIPHERAL SWELLING (right hand swelled up; still swollen but not as swollen; at one point twice the size of her left hand), JOINT STIFFNESS (wrist stiff), ARTHRITIS (wrist inflamed) and EPISTAXIS (got 3 terrible nosebleeds for over an hour). At the time of the report, PERIPHERAL SWELLING (right hand swelled up; still swollen but not as swollen; at one point twice the size of her left hand) had not resolved, JOINT STIFFNESS (wrist stiff) and ARTHRITIS (wrist inflamed) outcome was unknown and EPISTAXIS (got 3 terrible nosebleeds for over an hour) had resolved.            No concomitant medications were reported.  Treatment included heat application, aspirin, and running her hand under hot water.   This case was linked to MOD-2021-056616 (Patient Link).
1st dose 4 years ago, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose 4 years before date of reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 22-Feb-2023 Reporter's Comments:  Reporter was the patient's wife, who states that she and her husband received their first dose of Shingrix 4 years ago and had not yet received their second doses.  Did not consent to follow-up.  Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case was 1 of 2 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023029939:Same reporter
29May90 pt vax; devel half dollar sized redness & swelling at inject site.  w/in 15 min redness was gone.
is pregnant: Yes; severe neutropenia; premature closure of the ductus arteriosus; severe right ventricular hypertrophy and pulmonary arterial pressures; severe right ventricular hypertrophy and pulmonary arterial pressures; This is spontaneous report from a contactable Physician. This Physician reported information for both mother and baby. This report is for baby. The parent received first dose of BNT162B2 (So-lution for injection; Lot number: EL 1283) via Intramuscular in left arm on 29Dec2020 at 08:30 at single dose for COVID-19 immunisation, a baby received second dose of BNT162B2 (Solution for injection; Lot number: EL 1283) on via Transmammary route on 19-JAN-2021 08:45 at single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. On 18-MAR-2021 07:45 the Baby was born at (Withheld) with premature closure of the ductus arteriosus and severe neutropenia. Baby has been in NICU for the last 5 days with severe right ventricular hypertrophy and pulmonary arterial pressures and has been placed on Neupogen, is pregnant: Yes [Hospitalization, Life threatening, Disability, Congenital anomaly), Treatment received for the events. The outcome of the events was unknown.; Sender's Comments: Based on available information a contributory  of BNT162B2 to the reported neutropenia  cannot  be totally excluded.  The reported  premature closure of the ductus arteriosus with severe right ventricular hypertrophy and pulmonary arterial pressures are unrelated to BNT162B2.  The premature closure of the ductus arteriosus is a developmental complication and the  right ventricular hypertrophy and pulmonary arterial pressures are probably due to the premature closure of the ductus arteriosus.  Case will be reassessed if additional information is received.   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.,Linked Report(s) : US-PFIZER INC-2021314932 same drug, different AE and patient, baby and mother
diagnosed with COVID-19 disease/testing positive/sick/all the nightmares of COVID /felt very ill/COVID took the 3 pounds off/fevers my eyes/body temperature kept dropping; diagnosed with COVID-19 disease/testing positive/sick/all the nightmares of COVID /felt very ill/COVID took the 3 pounds off/fevers my eyes/body temperature kept dropping; some fatigue/tired; stomach upset/stomach was really feeling weak; not feeling real well; nauseous; This is a spontaneous report from a contactable consumer reporting for self. This 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 23Jan2021 at single dose for COVID-19 immunisation.  Medical history included menopause hormone replacement therapy.  Concomitant medication included progesterone (PROGESTERONE), estradiol (MINIVELLE) for menopause hormone replacement therapy.  The patient received her first injection of the Pfizer-BioNTech vaccine on 23Jan2021. She reported experiencing symptoms of COVID-19 on 09Feb2021 and was diagnosed with COVID-19 disease on 11Feb2021 after testing positive. After the first injection, and prior to getting COVID-19 disease, she did experience some fatigue, stomach upset, and not feeling real well.  It was reported that when she had the first dose the only symptoms was stomach was really feeling weak, just felt extremely tired and nauseous so that was the first and then fine, by the third day she was feeling okay but then unfortunately, on 09Feb2021 and she began getting sick and went for a COVID test and tested positive on 11Feb2021.  She had experienced multiple symptoms due to her COVID-19 disease and had to go to the ER for treatment after they appeared (she went to the emergency room so they didn't keep her there, she was there for maybe 6 hours).  She felt very ill with this COVID, she had been in the hospital twice, she did not, she was not left in ICU that was good for her, but reported that "between the fevers my eyes, I don't know what happened to my eyes but ophthalmologist will be checking it seems to be same and it's been everything that you can ever think as 'hard' and I just want to know if tomorrow I can have the second boost." It was reported that when she was in the hospital because of the, body temperature kept dropping so the doctor send her to the hospital and they did blood test. Patient weight was 135 at that time, now she was 131. She thought COVID took the 3 pounds off. Her second dose of the Pfizer-BioNTech vaccine was cancelled due to her illness and now her second dose is scheduled for tomorrow (25Feb2021). The patient reported she is only now starting to feel a lot better, that she was really sick for 15 days. Today (24Feb2021) was the first day that she was feeling a little bit better from all the symptoms and all the nightmares of the COVID illness.  The outcome of events was recovering.
Vaccinated with an expired dose of Bexsero; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB28AA, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th July 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 4th July 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:13-JUL-2022 Reporter's Comments:  The reporter stated that, the patient administered expired dose Bexsero. The reporter consent to follow up. Additional Supportive Information: The patient received expired dose of Bexsero, which led to expired vaccine used. The case had been linked with US2022106152 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022106152:Same case/same reporter
After approximately 15 minutes of receiving the vaccine, patient experienced dizziness and hypotension. He appeared pale, sweating and cold. At 10:21AM, patient's blood pressure was 85/44. We called paramedics and they arrived at 10:29AM. Patient refused to go to the hospital. At 10:41AM, patient's blood pressure was at 119/66. He was stable and left our clinic.
Weakness for two (2) days sick to my stomach. The site where vaccine admin. turned red, itch, hives, wept, dizziness, swelling at site of vaccine.
DOSING ERROR (VACCINATION ADMINISTERED TOO CLOSE TOGETHER) Narrative: Patient received first COVID vaccine 2/27/21. Herpes zoster recombinant vaccine was administered only a couple days later on 3/1/21. Order for Herpes zoster had activated 12/17/20. Vaccine given 3/1 per active order and pursuant to clinical reminder. No noted adverse reaction related to this administration error.
pt recv vax & devel inj site rxn;no further details were available at the time of this report;
1 week after dose 1 of Pfizer Covid-1 vaccine, I developed a case of shingles.  I had chicken pox when I was young, but had not experienced any symptoms of it as an adult until after the Pfizer shot.
Received shingle shot. Asked nurse if it would hurt, no just like flu shot. It did hurt and burned. 03-19-09 4 AM Difficulties Breathing for 1 Hr. Noticed itching all over body. Later swelling of LT arm- Got worse- Called nurse. From Scan 03-20-09, suggested urgent care, Called Dr, got cephalexin 500 mg capsules for 10 days 4times Daily and Cream. Swelling and dark red part is gone. Still itch. (See Attached)
On 10/05/2022, first thing in the morning, I had palpitations, felt lightheaded and faint.  Over the next several months, I had cardiology appointments and wore a halter monitor in December for 21 days.  I just had a loop recorder implanted.
had Td & MMR 6JUN94 early AM on 7JUN94 noticed fatigue that has inc since then-no fever or other sx; still w/intense fatigue; advised if no improvement x 24 hrs to call MD
My arm is in excuriating pain, raiding from shot area to elbow, and up to neck, its painful beyond anything else.
My son had very bad dizziness starting about 5 minutes after flu shot on the left arm, almost passing out while walking to the water fountain. He complained headache, not able to see the road clearly and ear popping, very bad headache, and stiff neck. We were about to call ambulance, but decided to watch him getting better. Staff also provided water and pharmacy staff measured heart rate and pressure. He rested on a chair for about 30 minutes, and we gave him water and lemonade. He felt better after resting about half hour. This could be life-threatening, if he did pass out.
Tachycardia cooling sensation, burning throat Received Moderna vaccine and was in the observation room when she noticed at 1:29 feeling symptoms of: -cooling sensation -burning throat -rapid heart rate. MSA notified patient calling 911 No medications needed for treatment. By time EMT's arrived, the symptoms resolved, pt thinks related to anxiety. Declined EMT treatment. After EMTs left, obtained set of VS HR 69, Bp 108/73, she went back to work after leaving vaccine clinic.
Patient got a sinus infection; Patient got COVID-19; This spontaneous case was reported by a patient and describes the occurrence of SINUSITIS (Patient got a sinus infection) and COVID-19 (Patient got COVID-19) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy and Blood pressure high (No Recent change in status such as improvement or worsening).   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Aug-2022, the patient experienced SINUSITIS (Patient got a sinus infection) and COVID-19 (Patient got COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. On 27-Aug-2022, SINUSITIS (Patient got a sinus infection) and COVID-19 (Patient got COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2022, SARS-CoV-2 test: (Positive) Positive.         Concomitant medication was reported as unspecified blood pressure medication.  It was reported that patient had 4 doses of Moderna COVID-19 Vaccine but did not remember dates. Patient did not experienced any adverse events after any of the vaccines.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-269961, US-MODERNATX, INC.-MOD-2022-651195 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-269961:second dose US-MODERNATX, INC.-MOD-2022-651195:
infection in the surgical incision site; inflammation in the surgical incision site; Pain; This spontaneous case was reported by a consumer and describes the occurrence of POSTOPERATIVE WOUND INFECTION (infection in the surgical incision site) in a 59-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.     The patient's past medical history included Surgery. Concurrent medical conditions included Immunocompromised.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POSTOPERATIVE WOUND INFECTION (infection in the surgical incision site) (seriousness criterion medically significant), INCISION SITE INFLAMMATION (inflammation in the surgical incision site) and PAIN (Pain). At the time of the report, POSTOPERATIVE WOUND INFECTION (infection in the surgical incision site), INCISION SITE INFLAMMATION (inflammation in the surgical incision site) and PAIN (Pain) outcome was unknown.            No concomitant medication was reported. The Patient was immunocompromised, in turn, Patient told the caller that patient had surgery three weeks ago. After receiving the vaccine (on 17DEC2021, LOT NUMBER: Not Provided), Patient began to experience severe inflammation and infection in the surgical incision site.  The patient has a lot of pain. Consent given to follow up with safety. Treatment medication was not provided by the reporter.; Sender's Comments: This case concerns a 59-year-old, female patient with relevant medical history of immunodeficiency and recent surgery, who experienced the unexpected events of Postoperative Wound Infection and Incision Site Inflammation. The events occurred approximately 1 day after the third dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as events occurred after the third dose. However, the recent surgical history in this immunocompromised patient remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
Redness, warm, swelling, hardness to L arm, overall fatigue, and pain settling into joints.  Symptoms lasting over 1 week and was seen by emergency room physician in Auburn and prescribed antibiotic for 7 days.  symptoms resolved.
Extreme nausea, vomiting. Went to ER to see if he had a virus infection. No definite answer from MD ER.
Muscle pain, joint pain, redness & swelling @ injection site, "overwhelmed by pain", unable to sleep.
Inappropriate age at vaccine administration; fever at 100.2F; Pain in arm; headache; nausea; This is a spontaneous report from a contactable consumer or other non HCP.  A 13-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0167) intramuscular, administered in Arm Left on 15May2021 17:00 (at the age of 13-years-old) as 1st dose, single dose for covid-19 immunisation at store. The patient had no other medical history and no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On an unspecified date of May2021, the patient experienced pain in arm, headache, nausea, fever at 100.2F. The patient did not received treatment for the adverse event. The outcome of the events was unknown.
At injection site - started itchy and red then progressed to swelling and increased redness, this spread down pt's arm. Pt was seen at walk in on May 6th and prescribed prednisone. As of 5/8/17 condition has not resolved. Pain has subsided though.
Donor states symptoms initially began with a headache, then about 5 minutes after than began feeling weak, dizziness and fatigued. Donor was brought to office. Sat down in chair and was given an ice pack to put behind the neck. V/S at 10:56 P-62, BP-118/66, Temp 99.2. States she now feels a headache 5/10. Was initially an 8/10.
pt recvd vax 10FEB95 & w/in 24hrs pt's foot appeared pink/purple for approx 2hrs; the color change resolved when extremity was moved;no other sxs;no sequelae;pt had similar event following 3rd vax-resolved w/o sequelae
Call 4/18/2019, pt came by office to look @ site 4/18/19 449pm 7x 7.5 cm area of localized redness (Left Det) warmth (only localized to inj. site), firmness/induration No streaking, no Fever/chills, "itches", not painful No decreased ROM, no shoulder/joint involved 4/19/19 Reported ER visit, treated for cellulitis (cephalexin) 4/22/19 F/U ER visits @ our clinic - improved
only wants to stay in bed and sleep; headache; vomited; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (only wants to stay in bed and sleep), HEADACHE (headache) and VOMITING (vomited) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced LETHARGY (only wants to stay in bed and sleep), HEADACHE (headache) and VOMITING (vomited). At the time of the report, LETHARGY (only wants to stay in bed and sleep), HEADACHE (headache) and VOMITING (vomited) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported. No treatment information was reported.
Prior to vaccine, patient was very anxious about receiving vaccine.  Vaccine administered 1:30. Patient displayed signs of anxiety until 1:35 Patient was monitored via PulseOx at 1:36 BP:190/105. Decision was made by pharmacist to administer Epipen and Benadryl 50mg at 1:36. The patient was advised to use deep and controlled breathing exercises. Vitals returned to more normal values (150/100) at 1:40 Patient remained seated for another 30 minutes as vitals continued to normalize (BP 140/100 HR 79) Patient felt better and remined on property for another hour and was advised by the staff to go home for the day. We followed up with the patient 2 hours after the incedent and she reported that her blood pressure returned to normal and she felt better. Patient was advised to follow up with health care provider and report the incedent
Aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches) and CHILLS (Chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     Concomitant products included EMPAGLIFLOZIN (JARDIANCE), LISINOPRIL, HYDROCHLOROTHIAZIDE, MONTELUKAST, SIMVASTATIN, GLIMEPIRIDE, LEVOTHYROXINE, METOPROLOL, DILTIAZEM, GABAPENTIN and CYANOCOBALAMIN (VITAMIN B-12) for an unknown indication.    On 03-Apr-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 PAIN (Aches) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Aches) and CHILLS (Chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medical history was provided by the reporter   This case was linked to MOD-2021-425598, MOD-2021-425592 (Patient Link).
Right thigh swollen tender to the touch. Father states that child complained of pain occasionally and limps occasionally. Around injection site slight hardness localized erythema (inner) swelling extends from groin to knee (3 cm > Lt)
felt "weird" the evening of the shot The next morning reported he couldn't "maneuver" had HA No appetite for several days, mind was "foggy" No fever, arm was sore...Went to see his provider on 3/29 and had lost 12 pounds due to "dehydration" and poor appetite Was given RX for Mertazapine He is now 3/12/21 back to pre-immunization weight and feels mostly recovered