chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed rosacea after receiving the first dose of the Moderna COVID-19 vaccine; Patient did not receive second dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ROSACEA (Patient developed rosacea after receiving the first dose of the Moderna COVID-19 vaccine) and INTENTIONAL PRODUCT USE ISSUE (Patient did not receive second dose of the Moderna COVID-19 vaccine) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included METOPROLOL, LISINOPRIL, ATORVASTATIN, TRAZODONE and HYDROXYZINE for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ROSACEA (Patient developed rosacea after receiving the first dose of the Moderna COVID-19 vaccine) and INTENTIONAL PRODUCT USE ISSUE (Patient did not receive second dose of the Moderna COVID-19 vaccine). At the time of the report, ROSACEA (Patient developed rosacea after receiving the first dose of the Moderna COVID-19 vaccine) and INTENTIONAL PRODUCT USE ISSUE (Patient did not receive second dose of the Moderna COVID-19 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.   No treatment medications were reported.   Reporter did not allow further contact
Pain for 3 weeks reported on October 22, 2009. Pain is radiating muscle tenderness in the forearm, lump under the derma, Dr. told patient "you received an injection in the bursa area which caused the inflammation. She is getting physical therapy, antinflammatories, heat, exercises and light weight lifting.
Left Leg soreness.  Woke up today,  04/15/2021 with Charley Horse in Left calf.
sore upper right arm which is where the injection took place; This is a spontaneous report from a contactable consumer (patient). A 28-year-old-male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number and expiry dates were UNKNOWN), via an unspecified route of administration in the right arm on 28Jan2021 at 13:30 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. On 28Jan2021 at 18:15, the patient experienced sore upper right arm which was where the injection took place. The patient did not receive any treatment for the event. The outcome of event the sore upper right arm which is where the injection took place was unknown.  Follow-up attempts have been completed and no further information is expected.
Started feeling congested and coughing (strange cough). As evening progressed, by 8pm bones in mouth and teeth hurt. Then eyes were blood shot and swollen upper lids on face. Took aspirin which helped. Congestion pressure started. Sinus hurting really bad. Had headache but took aspirin even sinuses feel better. Called because it was scary when face started to get swollen.
This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "PT caught COVID after vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Dull pain in left arm running from back of shoulder to elbow.  Two Advil do little to numb the pain.
pediatric dose of Havrix to an adult; pediatric dose of Havrix to an adult; first dose in 2019, second in 2022; This case was reported by a nurse via call center representative and described the occurrence of underdose in a adult patient who received HAV (Havrix pediatric) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix pediatric (received 1st dose in November 2019).   In January 2022, the patient received the 2nd dose of Havrix pediatric and Havrix Pre-Filled Syringe Device. In January 2022, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced underdose, adult use of a child product and drug dose administration interval too long. On an unknown date, the outcome of the underdose, adult use of a child product and drug dose administration interval too long 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: The age at vaccination was not reported. The nurses from one of reporter's institution´s ambulatory clinic administered a pediatric dose of Havrix to an adult, which led to underdose, adult use of a child product. The patient received 2nd dose late than the recommended time interval, which led to lengthening of vaccination schedule. The reporter said that patient information was not available to her and that the ambulatory clinic staff had submitted a VAERS report for this incident. The reporter consented to follow up.
Left eye lost the ability to focus. I wear contact lenses and initially thought it was due to tired eyes. I took out the contacts and noticed that my regular glasses had no noticable ability to correct the vision in my left eye. The right eye had no problems and the problem disappeared by the time I got up the following morning.
Red, slightly raised area 6x11cm noticed on second day after injection given. Complaints of itchiness.
first night, 104 F fever and chills, complete body pain, weakness, sleepless, headache  next day felt almost normal, maybe just weak and tired  next night, bad sore throat, bad runny nose, slight headache  on going 4/18/21. 6PM
facial numbing; This is a spontaneous report from a contactable healthcare professional (patient). A 36-year-old male patient received his first single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EJ1685) intramuscularly at 10:45 13Jan2021 at left arm for Covid-19 immunization. The patient had no known allergies and had no medical history or concomitant medications. Approximately 20 minutes after administration of the vaccine (13:15PM), the patient began to experience facial numbing, the feeling as similar to the return of sensation after having a numbing agent (at the dentist, for instance). He was more aware than usual of an effort required to move his face. It was not unpleasant, apart from being concerning- He did not know when or if this symptom might pass. Within 90 minutes of onset the sensation was 90% resolved. There was minor sensation with smiling until awakening the next day (approximately 19 hours after administration). No treatment was received for the event. The patient had no Covid-19 before vaccination and had not tested for it. The event resolved at the time of reporting (unspecified date in Jan2021).
Four days after the second dose of Moderna vaccine  began involuntary movement of her mouth, tongue, and toes.  Later diagnosed as Tardive Desconecia (TD).
GARDASIL 9 but is unable to confirm or deny if Patient completed series; no additional adverse events reported; This spontaneous report has been received from a physician assistant, referring to a male patient who was 17 years old at the time of the report. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported.   On an unspecified date, the patient was vaccinated with either HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (route of administration, anatomical site of vaccination and vaccine scheme were not reported; dose, lot number and expiration date were unknown by the reporter) as prophylaxis.   The physician assistant reported that the patient's mother stated that she was unable to confirm or deny if the patient received HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). In addition, it was reported that it was unknown if the patient completed the vaccine series (inappropriate schedule of product administration). No additional adverse events were reported (no adverse event).
""rare" side effects"; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (""rare" side effects") in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (""rare" side effects") (seriousness criterion hospitalization). At the time of the report, ADVERSE EVENT (""rare" side effects") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was admitted I ICU.  No concomitant drugs were reported. No treatment information was reported.  Very limited information regarding this event has been provided at this time. Further information is not expected.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information is not expected.
Started with extreme ache in stomach and head...chills, then aches all over. Fever ran between 101 and 103.3 for close to 12 hours. Had nausea. Had extreme diarrhea starting that morning and last a week which was yellowish in color. Had low grade fever for 3 days following.
Had both shingles and DTaP vaccine on 1-18-13. Got a raised bumpy red rash on face from bottom of nose down neck to thyroid area...prickly, uncomfortable and warm feeling. Taking antihistamine tablets and applying antihistamine ointment helps some. Three days later (today) I still have rash with no improvement in condition. I think this is caused by the shingles vaccine. I have not had shingles before but I had chickenpox at age 6.
diahrea for 5 days; Gastritis; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8733), via an unspecified route of administration, administered in Right arm on 01Apr2021 at 10:00 AM (at the age of 71-year-old) at single dose for COVID-19 immunisation. Medical history included Diabetes, left breast cancer, arthritis. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included rosuvastatin calcium (CRESTOR); pramipexole dihydrochloride (MIRAPEX); levothyroxine; tramadol and celecoxib (CELEBREX). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Gastritis and diahrea for 5 days, both on 02Apr2021 at 08:00 AM. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for events. The outcome of the events was recovering. AE were not resulted in Emergency Room Visit nor Physician Office Visit.  No follow-up attempts are needed. No further information is expected.
Within 10 minutes of receiving the vaccine on 01/22/21, slight tickle in back of throat, wave came over me, heart rate increased to 118, nauseous, chest slightly tight, light headed; heart rate regulated (about 70-72 bpm) and chest felt okay then body went tingly from arms to legs with some light headedness. Oxygen fine the whole time; heart rate regulated after the beginning and no fever - feeling a bit better within 1 hour. Headache started that night and lasted until midnight the next day. Very tired the whole next day until about 5:30pm.
Information regarding PREVNAR 13 was received from a healthcare professional regarding a 19-month-old female patient who experienced developing a red, hot, golf ball sized swelling at the injection site. At 19-months of age, the patient received a dose on 24-May-2010. The patient experienced developing a red, hot, golf ball sized swelling at the injection site on 24-May-2010. The outcome is unresolved. The reporter only suspected PREVNAR 13 for the event. No additional information was available at the time of this report.
This spontaneous report was received form a nurse practitioner regarding multiple unspecified number of patients of unknown gender and age. The nurse reported that on an unknown date the multiple unspecified patients were vaccinated with PROQUAD (dose, frequency, lot number, expiry date not reported) that were improperly stored and no adverse effects were reported. There was no product quality complaint involved. This is one of several reports from the same reporter. Additional information has been requested.
Itchy rash at injection site that spread down my arm. By May 17, 2021, I went to Urgent Care and was treated with Prednisone, and a steroid cream.
FLUMIST administered, approx. 6 hrs later, facial itching/swelling on face. These developed into hives. Administered steroid cream. Reduced the itching and swelling, but still evident. Repeat applications of cream. ZARTAC and CLARITIN also taken.
This spontaneous report as received from a physician refers to a 12 years old male patient with no pertinent medical history and drug reactions or allergies. The patient was vaccinated with a 0.5 ml third dose of GARDASIL (Lot # 0459AE, expiration date 13-DEC-2014) IM and with a dose of HAVRIX (Lot # AHAVB515AA) on an unspecified date. The physician reported that on 28-AUG-2012, the patient experienced blood pressure dropped, his lips turned blue and he vomited. The doctor had him lay down for 15 minutes and he recovered. The physician stated that the patient did not have any adverse event after the first 2 doses. The patient did not receive treatment for the adverse events. There were no lab diagnosis or studies performed. Additional information has been requested.
Swelling of the left arm at injection site the size of an orange less than 12 hours after Booster.  Low grade fever of 100.5 chills, body aches, tiredness and headache.  The symptoms lasted all day.  took Benadryl and Tylenol to relive symptoms.  Had to repeat every 4 hours with Tylenol.  By the next day the swelling was the size of a grapefruit.  The lymph nodes in armpit are sore and swollen. On Monday at 7am went to primary care office to be seen.  I still had a low fever they marked the redness with surgery marker and was told to monitor the swelling.  Take pictures and send in via patient portal.  Tuesday sent pictures of the swelling spreading  was given a script of cephalexin to take for 7 days.
Patient vaccinated Pfizer covid vaccine 02/11/2021 AND 03/04/2021 admitted to floor covid positive 08/29/2021
A little ache in my arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient said that never got sick from shots, may be a little ache in my arm for 2 days.
Sore arm, which I attributed to the usual pain from a vaccine. I have the flu shot every year, so I wasn't concerned. However, pain continued and even increased as time went on. I can't lift my arm without severe pain, and the entire shoulder region is affected. My doctor believes that the shot was incorrectly put into my bursa cavity instead of the muscle. I did think that she administered the shot higher on my arm than usual. I've received physical therapy to try and help the pain, which has greatly affected my quality of life. My 90-year old grandmother also received her shot at the same time, and, fortunately, she is OK.
Patient presented 3 days after injection for shingles concerned about raised and warm to the touch area at injection site; A follow-up phone call 1/19/15 1 pm with patient was done and patient noted area was improved-not as red and warm to touch.
2/3/23 I started experiencing abnormally cold feet and I could not get them to warm up. I tried different layers, wearing 3 pairs of socks to work. It was very uncomfortable. This went on for three weeks. On 2/13/23 I went to the emergency room and was diagnosed with Peripheral Neuropathy. I was prescribed gabapentin. The doctor said there was no reason given to explain why I was having this neuropathy. I went to my regular doctor on 2/17/23 and he said it was not neuropathy. I was diagnosed with Raynaud's Phenomenon. I was taken off gabapentin and was put on nifedipine. I started taking that medication the next day. I began experiencing side effects that were pretty extreme. My feet started burning and I felt very uncomfortable. I went back to my doctor a week later. He cut the dosage of nifedipine down to one a day from two a day and that seemed to help. I still had burning in my feet that felt like I was stepping on shards of glass, and they were still cold. This past week I have noticed some improvement. I had another follow up with my doctor again. He checked my vitals and was pleased with my progress; said I was doing much better. I have another appointment on May 3, 2023 with my PCP.
A report was received from a health care professional on 11/11/03 concerning an unspecified number of vaccinees who inadvertently received 1ml of Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees received 1ml of Fluvirin. No adverse symptoms were exhibited at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 12/4/03: An update report was received from a health care professional concerning a 100 year old female vaccinee who inadvertently received 1ml Fluvirin SC on 10/31/03. On 10/31/03 the vaccinee inadvertently received Fluvirin SC. No adverse symptoms were exhibited at the time of reporting. No follow up pending.
patient received o.5 ml's instead of 0.25 ml's for 4th dose
After receiving the first of two shingles vaccine injections. Fever of 99.4  Normal heart rate 52. Heart rate now 64
Patient experienced itching of eyebrows, behind ears and on face and enlargement of genital parts(no itching or soreness in this area).The patient continues to experience itching since incident and has seen primary physician as well as dermatologist. Genital area has returned to normal but even with various treatments face continues to itch and have rash.
BLOODY MUCOUS IN STOOL; HIGH BLOOD PRESSURE; COLITIS; SLEPT MOST OF THE DAY; ABDOMINAL CRAMPS; VOMITING; DIARRHEA; FATIGUE; This spontaneous report received from a patient concerned a 43-year-old white female of not Hispanic or Latino. The patient's weight was not reported and height was 66 inches. The patient's concurrent conditions included: no alcohol use, and non-smoker, and the patient had no drug abuse or illicit drug usage. The patient was not pregnant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown and expiry: unknown) dose was not reported, 01 total dose administered on 30-OCT-2021;12:30 to left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included Zofran (ondansetron).  On the subsequent day of vaccine administration in addition to Flu shot, on 31-OCT-2021 the patient was extremely fatigued and slept most of the day (Sleep excessive). At around 7:40 abdominal cramps began and she had vomiting with diarrhea. She returned to bed until 7:00 AM on 01-NOV-2021, and had multiple events of bloody mucous in stool. She went to emergency room (ER) at 15:00 PM and checked her blood pressure which was over 200/140. (high) and also performed Computerised tomogram (CAT) scan which showed colitis and was discharged with prescriptions and instructions to follow-up with primary care provider (PCP). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and diarrhea on 31-OCT-2021, was recovering from high blood pressure, and fatigue, and the outcome of colitis, bloody mucous in stool, slept most of the day and abdominal cramps was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0: 20211109951-Covid-19 vaccine ad26.cov2.s-Bloody mucous in stool, High blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Flu vaccine given yesterday- experienced left arm pain at injection site, pain radiating up neck- "hot and cold flashed" on hands and feet and fatigue- skin hypersensitive near injection site
Requested second dose by facility who failed to advise vaccination team that the patient had received Moderna as the first dose of the vaccine. This clinic was known to be a Pfizer clinic.
This case was reported by a consumer via call center representative and described the occurrence of headache in an adult female patient who received TWINRIX adult. On an unknown date, the patient received TWINRIX adult. On an unknown date, an unknown time after receiving TWINRIX adult, the patient experienced headache, sore throat, swallowing difficult, injection site pain and difficulty sleeping. On an unknown date, the outcome of the headache, sore throat, swallowing difficult, injection site pain and difficulty sleeping were unknown. It was unknown if the reporter considered the headache, sore throat, swallowing difficult, injection site pain and difficulty sleeping to be related to TWINRIX adult. Additional details were provided as follows: This case was not previously reported to anyone. The age at vaccination was not reported. The patient received a dose of TWINRIX adult and experienced headache, difficulty sleeping, throat soreness with difficulty swallowing and injection site arm soreness. The patient had denied permission to contact their physician and declined to answer questions for safety report.
pt recv vax & devel lymphadenopathy described as golf ball sized lumps in the axilla of the arm into which vax was injected;this is 1 of 5 employees from this facility to exp this event p/vax;