chrisvoncsefalvay/vaers-outcomes huggingface dataset:
high bp; weakness; fatigue; tiredness; legs cramps in both legs below knee; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Mar-2021 and was forwarded to Moderna on 08-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (legs cramps in both legs below knee), BLOOD PRESSURE INCREASED (high bp), ASTHENIA (weakness), FATIGUE (fatigue) and FATIGUE (tiredness) 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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced MUSCLE SPASMS (legs cramps in both legs below knee). On 03-Mar-2021, the patient experienced BLOOD PRESSURE INCREASED (high bp), ASTHENIA (weakness), FATIGUE (fatigue) and FATIGUE (tiredness). At the time of the report, MUSCLE SPASMS (legs cramps in both legs below knee), BLOOD PRESSURE INCREASED (high bp), ASTHENIA (weakness), FATIGUE (fatigue) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report was received from a physician via company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 03-AUG-2015, the patient was vaccinated with an improperly stored PEDVAXHIB Single Dose Vaccine, 10-pack, lot number K004541, expiration date 04-DEC-2016, (dose, route and anatomical location were not reported). The improperly stored PEDVAXHIB was in a Refrigerator, and, the highest temperature of excursion was 47 Fahrenheit degrees (8.33 Celsius degrees) with a sum of 24 hours of excursion. No adverse effects were reported and no product quality complain was involved. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning an 86 year old female, with an allergy to codeine and history of a recent hip fracture who on 25-AUG-2006 was vaccinated, most likely via intradermal route, in the right forearm with a 0.5 mL dose of Pneumovax 23 (Lot # 651356/0089F). Concomitant therapy included several unspecified medications (therapy unspecified). On 25-AUG-2006 the patient developed a red raised area around the site. The physician has ordered the patient cephalexin (KEFLEX). No product quality complaint was involved. The patient's experience, red raised area around the site, was considered to be an other important medical event by the reporter. Additional information has been requested.
This is a spontaneous report from a contactable nurse through a company representative. This nurse reported similar events for two patients. This is the first of two reports. A patient of unspecified age, gender and ethnicity received PREVNAR13 on unknown date at 0.5 ml single. Exact dates of vaccination was not known, but the reporter stated it was over a three year period. Patient medical history and concomitant medication were unknown. On unknown date the patient had chronic respiratory symptoms. The patient was referred to an allergist and immunologist, who told that pneumococcal protection was low and required follow up with PNEUMOVAX23. After that this pneumococcal vaccine was given the patient had less chronic respiratory symptoms. Outcome of events was reported as unknown. Follow-up (13MAR2015): Follow-up attempts completed. No further information expected.
Derma filler swell on top lip  that went away about a week later. But also had filler that bubbled up onthe water line of lip. It almost looks like blisters but  can visual tell it was derma filler.; Have these 3 lumps inside my lips that now need to dissolve; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 29Mar2021 at 18:00 as DOSE 1, SINGLE for covid-19 immunization. Medical history included very sensitive skin to products and the patient had reactions to products so it might have something to do with skin sensitivity. The patient had been getting fillers for over 18 years though and never had this happen until the day after the first vaccine. The patient had skin allergies to fake jewelry, allergy to metals, and allergic to nickel, sensitive skin from an unknown date and unknown if ongoing, but patient had no medications of any kind. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included buprenorphine (BUPRENORPHINE) and alprazolam (XANAX) taken for an unspecified indication, start and stop date were not reported. On 30Mar2021 the patient experienced derma filler swell on top lip that went away about a week later. but also had filler that bubbled up on the water line of lip. it almost looks like blisters but can visually tell it was derma filler and have these 3 lumps inside my lips that now need to dissolve. It was not that big of a deal and if the patient had to go back in time to get the vaccine again knowing this would happen, she would still get the vaccine. she just thought it should be reported for educational purposes. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events derma filler swell on top lip and had three lumps inside her lips that now needed to be dissolved was recovering at the time of this report.  The lot number for the vaccine, PFIZER-BIONTECH COVID-19 mRNA VACCINE, was not provided and will be requested during follow up.
Two weeks after went for prescheduled mammogram. When the results came, hospital called and needed follow up due to right breast area. Ultrasound of right breast. Did not find anything but cyst. Still having discomfort and soreness on same side, lateral side of right breast and under arm. Already had pain before vaccine. Due for follow up.
sore arm; warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and VACCINATION SITE WARMTH (warm to touch) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 PAIN IN EXTREMITY (sore arm) and VACCINATION SITE WARMTH (warm to touch). At the time of the report, PAIN IN EXTREMITY (sore arm) and VACCINATION SITE WARMTH (warm to touch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment drugs were reported
It took 5 days to recover. It was like riding a horse through CoVid-19 with each symptom lasting from 12 to 24 ish hours: headache, chills, buzzing snapses type things in my head, freezing and needed heating pad to stop shaking, weakness so bad I could not get off my couch on my own.  I had a fever, 2 degrees above normal.  Then I got severe stomach / intestinal cramps and pain, I had to lay down and hold my stomach for a few hours.  I became inconvenient and it felt like I had a UTI.  Then it rolled into a sore throat, swollen glands on side of my neck with ear pain, and neck pain.  Then it rolled into my chest with bad pain from throat to middle of chest and it was hard to breathe.  By Monday I started to feel better but for the severe pain in the middle of my chest with coughing every time I took a small breath, had to breathe through my mouth.  Tuesday at about 2:30 am I started to breathe again.  I could not sleep for the first 72 hours and had to go to the bathroom every hour to one and a half hours.
same day / administered /Boostrix; 12 year old patient  received Infanrix; received Infanrix when Boostrix was intended; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 12-year-old male patient who received DTPa (Infanrix) (batch number 5RM39, expiry date 25th November 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) (batch number 575hc, expiry date 28th February 2023) for prophylaxis and dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th July 2021, the patient received Infanrix, Infanrix Pre-Filled Syringe Device, Boostrix and Boostrix Pre-Filled Syringe Device. On 28th July 2021, not applicable after receiving Infanrix and Infanrix Pre-Filled Syringe Device and unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced accidental overdose, inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the accidental overdose, inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: A 12 year old patient received Infanrix when Boostrix was intended to be given, which led to inappropriate age at vaccine administration and wrong vaccine administered. The same day patient was administered the correct vaccine, Boostrix in different arm, which led to overdose. The reporter consented to follow up.
No additional AE reported; expired VAQTA was administered to one patient. Product expired 1/14/2023 and was administered today 1/24/2023.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information of the patient's medical history, concurrent condition and concomitant therapy was not reported.  On 24-JAN-2023 (also reported as today), the patient was administrated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection 1 ml (lot #U021561, expiration date: 14-JAN-2023, strength, anatomical location and route of administration were not provided) for prophylaxis (expired product administered). The product was stored according to prescribing information through the date of administration. No additional adverse event (AE) details were available. No additional AE was reported.
The patient administered booster dose of the Moderna vaccination after the expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient administered booster dose of the Moderna vaccination after the expiration date) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A, 077C21B, 001C21A and 003B21A) for COVID-19 vaccination.     The patient had not tested/diagnosed with COVID-19. The patient had no acute illnesses at the time of vaccination and up to one month before. The patient had no chronic or long-standing health conditions and it was unknown if the patient had prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination. The details of allergies to medications, food, and other products were not reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 25-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 25-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administered booster dose of the Moderna vaccination after the expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient administered booster dose of the Moderna vaccination after the expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient had no adverse reaction  after receiving the vaccine and after 15 minutes of standard post-vaccination observation.  The vial was initially stored in refrigerator on 18-Apr-2022. The vial did not undergo any temperature excursion. Number was doses/vials was 2. The frequency was reported as times per.  No treatment medications were reported.   This case was linked to MOD-2022-553183 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2022: Follow-up document received includes significant information; patient's demographics, medical history, dose details of suspect vaccine was added and I-narrative was updated.
This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received SHINGRIX for prophylaxis. On 6th September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash, pruritus, nasal itching, irritability and skin tightness. The patient was treated with prednisone and ATARAX. On an unknown date, the outcome of the rash, pruritus, nasal itching, irritability and skin tightness were unknown. It was unknown if the reporter considered the rash, pruritus, nasal itching, irritability and skin tightness to be related to SHINGRIX. Additional details were provided as follows: The patient stated that she had been experienced skin tightness, rash, irritability, and intense itching of the midriff, scalp and nose. The patient reported that she was taking prednisone and ATARAX to treat at the reporting date. The patient refused to provide physician information and did not wanted to provide any further details.
Severe bilateral hand pain, swelling, right wrist, elbow, foot pain and swelling. Onset 20 hours after 2nd injection in Right elbow. Treated 2-6 hours with MOTRIN x 48 hours.
Tender lymph nodes; Very large, swollen and groin right and left  lymph nodes.; Slight headache; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0172) via an unspecified route of administration in the left arm on 14Jun2021 at 09:00(at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0172) via an unspecified route of administration in the left arm on 21May2021 at 16:00(at the age of 37-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 15Jun2021, the patient experienced slight headache. On 16Jun2021, the patient experienced very large, swollen and tender left arm lymph nodes. On 18Jun2021, the patient experienced swollen and tender right groin lymph nodes. No therapeutic measures were taken as a result of adverse events. The clinical outcome of the event slight headache, very large tender swollen and tender left arm lymph nodes, swollen and tender right groin lymph nodes was not recovered at the time of this report.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Flu Seasonal TIV Dresden (Influenza vaccine unspecified 2009-10 season) for prophylaxis. On an unknown date, the patient received Influenza vaccine unspecified 2009-10 season. On an unknown date, less than a year after receiving Influenza vaccine unspecified 2009-10 season, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine unspecified 2009-10 season. Additional details were provided as follows: The age at the vaccination was not reported. The patient reported that she has gotten the flu vaccine every year for the past nine years and it usually hurts a little at the injection site, but resolved after a couple days. This was 9 of the 9 cases reported by the same reporter for the same patient.
This is a spontaneous report from a contactable consumer by way of Claim Letter and Medical Records. A patient of an unknown age, gender and ethnicity was injected with PREVNAR 13 vaccine 0.5 ml one dose (single) on 15Dec2015 in the right arm through intramuscular route. The lot number was reported as 406899, expiration date was Mar2017 and NDC number was 00005-1971-01. The frequency was unknown. The relevant medical history, concomitant medication and past drug history were unknown. On 15Dec2015, the patient developed cellulitis in the right arm. On 21Dec2015 it was reported that, at the site of right arm after intramuscular injection the patient developed redness and swelling. On 21Dec2015, the patient underwent unknown lab tests for which results were normal. The action taken with PREVNAR 13 in response to the event was unknown. On 21Dec2015, the patient was prescribed and treated with unknown antibiotics. As of 04Jan2016, the clinical outcome of the event cellulitis in the right arm was unknown.
Tingling under tongue; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Tingling under tongue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Allergy (unspecified) and Osteoarthritis. Concomitant products included NSAIDS for an unknown indication.    On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PARAESTHESIA ORAL (Tingling under tongue). At the time of the report, PARAESTHESIA ORAL (Tingling under tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: Unknown. The reporter is the parent. A 17-year-old female patient received BNT162b2 (BNT162B2), on 16Apr2021 as dose 1, single (Lot number: EW0153) at the age of 17 years for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No additional vaccines administered on same date of the Pfizer Suspect. Prior vaccinations (within 4 weeks), no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). The following information was reported: URINARY RETENTION (medically significant) with onset 18Apr2021, outcome "recovered", described as "my daughter could not urinate and had to be taken to an ER room to have a catheter placed in her bladder to release her urine". The events "my daughter could not urinate and had to be taken to an ER room to have a catheter placed in her bladder to release her urine" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of urinary retention. Clinical course: Consumer's daughter received Pfizer Covid vaccine in Apr2021. Two days after receiving the first dose, Consumer's daughter could not urinate and had to be taken to an ER room to have a catheter placed in her bladder to release her urine. Then she was normal. She developed the same symptom again after 2nd. The symptom of urinary retention has gotten worse ever since. Was Pfizer aware of this issue? Can Pfizer suggest a treatment? This is urgent and I look forward to receiving any information. The consumer was inquiring about his 17 year old daughter, who had the first two shots of the Pfizer Covid vaccine, the first one in Apr2021 and the second one 3 weeks later. The consumer reported his daughter did receive a booster of the Moderna Covid vaccine. Consumer reported that two days after the first vaccine, his daughter experienced urinary retention. Consumer stated that a catheter was placed in the emergency room, and it resolved. Consumer stated that 3 weeks after the second dose this event happened again. Consumer stated that the symptoms of urinary retention has gotten worse, despite going to many doctors, who have no explanation for the event. From 2 days after the first vaccine. Reported his daughter was released from the emergency room. He reported his daughter went to several doctors such as a Urologist and Primary Care doctors and there was no explanation for the event. Vaccination facility type was reported as either clinic or a hospital. No relevant tests. Sender's Comments: Linked Report(s): US-PFIZER INC-202200828704 Same patient, drug, and event separated in time.
Approximately 12 hours after receiving the injection, I became weak and tired within minutes. My heart began to have palpitations and my heart rate which is usually in the 50s or 60s shot up to 84. My blood pressure was good at 109 over 74. The palpitations lasted until approximately 5:00 a.m.  I did not seek medical attention.
Information has been received from a physician concerning a now 29 year old female patient, who in 1980, at age one was vaccinated with the first dose of MMR II with other unspecified vaccines. After receiving the vaccine, the patient experienced fever and had to be hospitalized. With the second dose, the physician separated the vaccines and just gave the MMR II and the patient had a more severe reaction like seizure and had to be hospitalized, after that the patient developed spasms and neurologic problems. Following the vaccination, the patient experienced facial tick for about a year. The patient sought unspecified medical attention. At the time of reporting, the patient's outcome was unknown. Additional information has been requested. This is in follow up to report(s) previously submitted on 5/29/2009. Follow-up information was received from the physician who reported that she had no additional information regarding these events as they occurred over 25 years ago and also indicated that this was all the patient knew as well. Additional information is not expected.