chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse practitioner referring to a 82 year old female patient. Concurrent conditions included coronary artery disease, hypertension and osteoporosis. . She did not have known drug allergies. The patient's pertinent medical history and concomitant therapies were not reported. On 04-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, intramuscular (product use issue), lot # M033335 and expiration date 11-OCT-2017 (strength was not reported) for prophylaxis. On 04-DEC-2016, the patient experienced a localized rash at injection site, which spread to arms, upper back, bilateral lower extremities and a scant amount on her upper back and face (rash generalized and rash at the injection site). The reporter stated that patient  was given prednisone (manufacturer unknown) and it seemed to be responding, but rash had not completely resolved. The outcome of rash generalised and injection site rash was reported as recovering. The relationship between the aforementioned events and ZOSTAVAX was not established by the reporter. Additional information has been requested.
Patient called and reported on 3/8/22 that she had been diagnosed with frozen shoulder on the right side.  She says pain started about five days after the Flublok vaccine administration (estimated around 10/21/21) but that she did not seek professional medical help until January or February.  Between October and January she self treated with over the counter medications.  She says she has taken muscle relaxers, had a full cardiac workup (just to exclude cardiac issues causing pain in arm), has been referred to physical therapy and may go to an orthopedic doctor to get a steroid injection.
reddened skin on vaccination arm about 4" x 4". Off and on slight itch but not severe. Slightly warm feeling. Noticed Friday night and by Monday the reddened patch has doubled in size. not a raised rash and color has not changed.
Not being able to smell; Not being able to taste; Chest hurt when she breathed in deep; Felt horrible; Body aches; The injection site was very swollen; The injection site was red; Vomiting; Headache in her eyes; Ran a fever of 103.5 F/ Now fever is about 100 F; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Not being able to smell), AGEUSIA (Not being able to taste), CHEST PAIN (Chest hurt when she breathed in deep), FEELING ABNORMAL (Felt horrible) and PAIN (Body aches) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in February 2021.    On 04-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced ANOSMIA (Not being able to smell), AGEUSIA (Not being able to taste), CHEST PAIN (Chest hurt when she breathed in deep), FEELING ABNORMAL (Felt horrible), PAIN (Body aches), VACCINATION SITE SWELLING (The injection site was very swollen), VACCINATION SITE ERYTHEMA (The injection site was red), VOMITING (Vomiting), HEADACHE (Headache in her eyes) and PYREXIA (Ran a fever of 103.5 F/ Now fever is about 100 F). The patient was treated with IBUPROFEN for Adverse event, at a dose of UNK UNK, q4h and PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK, q4h. At the time of the report, ANOSMIA (Not being able to smell), AGEUSIA (Not being able to taste), CHEST PAIN (Chest hurt when she breathed in deep), FEELING ABNORMAL (Felt horrible), PAIN (Body aches), VACCINATION SITE SWELLING (The injection site was very swollen), VACCINATION SITE ERYTHEMA (The injection site was red), VOMITING (Vomiting) and HEADACHE (Headache in her eyes) outcome was unknown and PYREXIA (Ran a fever of 103.5 F/ Now fever is about 100 F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.5 (High) Fever at 103.5 F and 100 (High) Fever at 100 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication was not reported.  The patient's boss was positive for COVID and the patient wanted to know if loss of taste or smell is a side effect of the vaccine. The patient experienced same event when had COVID in February and the patient was planning for test.
I experienced ringing in my ears started one week after my vaccine.  At time it created a whole lot of pressure to the point it is painful, loud ring. Past couple of weeks have started to subside but the ringing is still present.  I believe I had a sinus infection before I went to get the second dose, but I had attributed to a migraine headache. I still have the sinus infection, it is continuing and I will be seeking treating with another ENT. I've had hearing tests and a sleep test performed.
9/16/21 RECEIVED FLUZONE HIGH DOSE AT 1PM ARM BECAME TINGLY FOR 1 HOUR, AT 2PM PATIENT DEVELOPED A RED PUFFY RASH BELOW INJECTION ON UPPER LEFT ARM LASTING UNTIL MORNING SUNDAY 9/19/21. PATIENT DID NOT TREAT, SHE LET THE REACTION RUN ITS COURSE. DID NOT SEEM LIFE THREATENING. DID NOT REPORT TO DOCTOR OR PHARMACY UNTIL 9/22/21. NEVER HAD REACTION TO ANY OTHER VACCINE BEFORE THIS.
Approximately 1 hour after 1st dose of vaccine given, I became very sleepy, had chills and started to feel achy.  I woke up 4 hours later feeling achy all over body, with headache and lethargic with chills.  No fever but this felt like a bad case of the flu and only lasted 24 hours.
Left arm is swollen 2 inches below injection site. Patient states that it is red, warm to the touch, itchy and pain when touched.
Fever 105F after VAXELIS vaccine and vomiting; Fever 105F after VAXELIS vaccine + vomiting; This non-serious spontaneous Safety Report, with reference numbers 02208144/02208142, was received on 19-JUL-2022 and forwarded on 20-JUL-2022 from a physician.  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event "fever".  No further information is expected.  FOLLOW-UP INFORMATION was received by a partner on 07-SEP-2022 and forwarded on 09-SEP-202. Additional information was received on 12-SEP-2022.  The case is maintained as non-serious.   The reporter assessed the causal relationship between Vaxelis and the reported events "Fever 105F after Vaxelis vaccine and vomiting" as related.  Further information is expected to clarify patient's duration of hospitalization.
Soreness in arm near injection site. Chills and muscular aches all over. Joint soreness in knees, back, wrists
Had usual flu like symptoms, and sore arm. Now the inner arm is sore, red and warm to the touch. Similar to the injection site, but on the opposite side of the arm
About 2 weeks after the vaccine, a knot lymph node appear on the right side of my neck. I also had swelling lymph nodes under my arm with the first dose. It was about the size of a large grape and felt painful, no fever. I went to the doctor to get it check out. I was advise to wait and see. I was not prescribed any medication. It did take 3 weeks for it to go away. It has not reappeared.
No adverse event noted. Improperly stored vaccine given to patient. Patient called back to receive repeated dose per CDC interim clinical considerations.
his arm was red, swollen, hard and painful at the injection site and down his arm; his arm was red, swollen, hard and painful at the injection site and down his arm; his arm was red, swollen, hard and painful at the injection site and down his arm; generalized acheness; his arm was red, swollen, hard and painful at the injection site and down his arm; his arm was red, swollen, hard and painful at the injection site; his arm was red, swollen, hard and painful at the injection site; his arm was red, swollen, hard and painful at the injection site; his arm was red, swollen, hard and painful at the injection site; nausea, chills; nausea, chills; This spontaneous report was received from a nurse practitioner and refers to a 68 years old male patient. The patient's medical history was overweight. The patient's current condition was hypertension and iodine allergy.   On 11-JUN-2019, the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S009945, expiration date: 10-AUG-2020 intramuscularly in arm (dose not reported) for routine vaccination. Concomitant therapies included calcium (unspecified) (manufacturer unknown), calcium carbonate (TUMS), hydrochlorothiazide, lisinopril (ZESTORETIC), hydrochlorothiazide, lisinoprill (PRINZIDE), vitamins (unspecified) (manufacturer unknown)), sildenafil citrate (REVATIO), timolol maleate (TIMOPTIC), sildenafil citrate (VIAGRA) and vitamin e (manufacturer unknown).    It was reported that, the patient mentioned his arm was red, swollen, hard and painful at the injection site (injection site erythema, injection site swelling, injection site induration and injection site pain) and down his arm (injection site reaction, erythema, peripheral swelling, pain in extremity), after receiving a first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The patient reported that he also had nausea, chills and generalized achiness(pain) after vaccination. The patient had office visit and received treatment for the events.  The outcome of pain in extremity, chills, nausea, injection site induration, injection site pain, injection site swelling, injection site erythema, injection site reaction, pain, peripheral swelling and erythema was reported as recovering. Causality assessment for the events were not reported. No product quality complaint reported.  It was reported that similar events were experienced by other patients (captured in MARRS #1906USA005194 and 1906USA005260) which involved the same pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) with same lot number and expiration date and the reporter requested lot checking.   This is one of the three reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA005194: US-009507513-1906USA005260:
Acute onset headache, significant fatigue, "felt terrible" for 5 days. There was no rash, no injection site pain.
I am actually not the recipient of the Moderna vaccination. However, my husband was vaccinated and I feel that I have had adverse affects since. Shortly after him being vaccinated, my menstruations have been much longer than they were previously. My normal cycles are between 4-5 days. One month in particular my cycle lasted 9 days. I believe that was the longest one, but all the others since his vaccination have been longer than my normal. In addition, I have had spotting between my cycles and have had bleeding occur during sexual intercourse, which is not typical or normal for me.
throat closure; her face very puffy/she had a lot of swelling to where she doesn't look like herself anymore; swelling on lymph nodes around arms; brain fog; her right arm where she got her injection had more swelling than anything on her left side; This is a spontaneous report from a contactable consumer (patient). A Female patient of 58-years  age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), first dose on right arm via an unspecified route of administration on 29Mar2021 (Batch/Lot number was ER 2613), (Expiration date- 31Jul2021)at dose 1, single for COVID-19 immunisation. Medical history include Hypertension, Hypothyroidism, Prediabetes, Asthma. No concomitant medications reported. She says she had her first dose of the shingles vaccine over 6 months ago, that was a long time ago, which she had that early, that's about it. She says the last vaccine before this one was the flu vaccine, in September 2019. she has COVID brain that she had when she had the shot, it felt like she was drugged for two days, the fog that comes with COVID when you get COVID, like that. Caller clarifies that she has not had COVID. she called to report side effects and to hopefully get information about whether or not to get second dose. She says she wanted to report adverse side effect to the COVID-19 vaccine, she got the first dose on 29Mar and she had throat closure. She says she got assistance by paramedics, and she took her Albuterol, which helped. She says two days later, her face very puffy, she had a lot of swelling to where she doesn't look like herself anymore. She says she also had swelling on lymph nodes around arms. She says for her throat closure she did not go to the hospital, they put her in a wheelchair and wheeled her to a private cooler location with a lot of air conditioning and she was fine, they checked her out and she was ok, her Albuterol worked for her throat. Albuterol inhaler: 66993-019-68, LOT/EXP She says this information is covered by part of her inhaler and she doesn't have the box the cartridge came in, and doesn't want to remove it. She says her swelling is a bit better, her face is just a little swollen, her face and neck and all. She says her lymph node swelling is a little down, her right arm where she got her injection had more swelling than anything on her left side, and it is a little bit better. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Left there after 15 minutes and started driving.  About 5 minutes down the road started having stabbing back pain shooting from the middle of the back up and down the spine.  Chest feels like someone bear hugging hard from the back.  Chest tingle and neck pain.  This has been for the day.  I turned around and went home crying because I was and am scared.  Still hurts now and it's 9pm.  No insurance and the hospital already has me in collections so I can't go.
Have this rash / on my leg; Have this / scratch on my leg; This case was reported by a consumer via media and described the occurrence of rash on leg in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced rash on leg and scratch. On an unknown date, the outcome of the rash on leg and scratch were unknown.   It was unknown if the reporter considered the rash on leg and scratch to be related to Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The patient received Shingles vaccine and experienced rash or a scratch on leg. The patient did not known what it was from and patient took the shingles shot maybe a week ago of reporting.
Pt's arm (upper) and shoulder swollen and painful. Pain is keeping her up at night. Pt contacted PCP, and is waiting to hear back. Treating pain w/Ibuprofen currently, but pain is still severe.
24 hours after vaccine my husband went from stable-good health to: alternating fever & cold/chills -- sweats (4 t-shirts in one night due to sweats), groggy & spacey mentation, body aches (muscles, bones & joints). His heart rate fell to 33 (he has a meter at home). We took him to ER and they admitted him to ICU for monitoring. The first 48 hours were the worst of the symptoms (which were at home), the next 24 hours he became stable. Now he is about 60% better. He was discharged from the hospital after 28 hours. They dosed him pretty heavily with antibiotics and anti-vitals. Now he is taking a powerful antibiotic by mouth. He is still sweating, but his energy is returning and his mentation coming back to more clarity.
Tested positive for COVID after being vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID after being vaccinated) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced COVID-19 (Tested positive for COVID after being vaccinated). At the time of the report, COVID-19 (Tested positive for COVID after being vaccinated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medications were not provided. Treatment information was not provided.  Patient stated that he was tested positive after his daughter was exposed at school.  Company Comment: This is a spontaneous case concerning a male patient of unknown age, with no relevant medical history, who experienced the unexpected, non-serious, AESI event of COVID-19. The event occurred in Jan-22, an unknown duration after the second dose of mRNA-1273 vaccine administered on an unknown date for the indication of COVID-19 vaccination. SARS-CoV-2 test done on an unknown date in Jan-22 was positive. At the time of report outcome of the events was Unknown. Further details about the event are not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a male patient of unknown age, with no relevant medical history, who experienced the unexpected, non-serious, AESI event of COVID-19. The event occurred in Jan-22, an unknown duration after the second dose of mRNA-1273 vaccine administered on an unknown date for the indication of COVID-19 vaccination. SARS-CoV-2 test done on an unknown date in Jan-22 was positive. At the time of report outcome of the events was Unknown. Further details about the event are not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
BODY ACHES; CHILLS; VERY SLIGHT FEVER; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced body aches, chills, and very slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and very slight fever. This report was non-serious. This case, from the same reporter is linked to 20210950782.
Rash spreading on the arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash spreading on the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced RASH (Rash spreading on the arm). At the time of the report, RASH (Rash spreading on the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was provided.
This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (vaccine given 17 days post expiry) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 046C21A and 041L20A) for COVID-19 immunization. No medical history reported. On Jan 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 23, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 23, 2021, patient administered expired product (vaccine given 17 days post expiry). On Nov 23, 2021, administered expired product (vaccine given 17 days post expiry) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Patient did not experience any other adverse reactions. This case linked to MOD-2021-395985 (patient link).
Itching and burning rash that spread across back of neck and both shoulders, down center of back, and then along waistline. Dermatologist was unsure what it was and prescribed clobetasol 0.5% ointment. Has been using for ~6 weeks and rash is starting to get better
SHINGLES; ELEVATED BLOOD PRESSURE; NERVOUSNESS; ANXIOUNESS; INJECTION SITE ITCHINESS; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid disorder, and blood pressure disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029,  expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination to the right arm. No concomitant medications were reported. On 11-MAR-2021, the subject experienced injection site itchiness. On 13-MAR-2021, the subject experienced shingles. On 13-MAR-2021, the subject experienced elevated blood pressure. On 13-MAR-2021, the subject experienced nervousness. On 13-MAR-2021, the subject experienced anxiouness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shingles on 15-MAR-2021, and injection site itchiness, and had not recovered from elevated blood pressure, nervousness, and anxiouness. This report was non-serious.
NAUSEA, VOMITING, WEAKNESS---UNABLE TO ATTEND SCHOOL.
on 2/4/21, patient developed refractory seizures, requiring hospitalization and antiepileptic medications among others. She had no history of seizures, as well as negative LP studies and negative CNS imaging.
No adverse reactions reported. In November 2022 our Immunization  program did our every-other-year audits in Both our offices.  It was discovered at that time, that some Covid Vaccines were administered outside of the 10 week expiration date (which is calculated from the date the vaccines were received from the state.) The program directed us to fill out forms and send them to you. The state also counselled us that it was  our providers + parents joint decision as to whether to re-vaccinate pts or not.  We only use Pfizer vaccines for Covid- and the listed lot #'s given outside the expiration date are listed below.  FM0698 (orange top) FM0698 (purple top) FL8095 (orange top) FL8094 (orange top) FM7553 (purple) FM0698 (purple) FP4554 (purple) FL8094 (orange) FL8095 (orange) FT1551 (orange) Please see the attached forms, and feel free to contact the office for further questions or concerns.
COVID positive; COVID positive; This is a spontaneous report from a contactable nurse (parent). The reporter reported 2 cases. This is the case for the son. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter (nurse) experienced covid positive and mentioned her son also had the same symptoms, a split case is necessary. Outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Within 2 weeks of vaccination noted R shoulder joint pain that has progressively worsened to this day.