chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt says she has felt a lot pain in her arm so much that she can barely move it. She cannot lift or turn her arm. She also cannot pick up heavy items. She spoke with PCP and she was taken to the ER where x-rays were done. The pt said the ER gave her medication for the pain but she is still feeling the pain now. The member also said her PCP recommended medications she could take for pain.
This spontaneous report as received from a medical assistant via a company representative, referred to a currently 69 year old female patient. On an unknown date, the patient was vaccinated with one injection of PNEUMOVAX 23 (lot # K004930 with expiry date: 16-MAR-2015; dose and route of administration unspecified). On an unknown date, after receiving PNEUMOVAX 23, the patient called into he office and stated that she developed severe injection site reactions including redness and hardness at the injection site. The patient sought medical attention via calling the office. The outcome of the events was unknown. The relatedness between the event and PNEUNOVAX 23 was not reported. This is one of several reports received from the same source. Additional information is not expected as the reporter did not grant permission to be contacted.
Mother booked appointment online, filled out form with patient. When she showed up for appt she did not have social security number, passport for daughter and no insurance.  She said she just moved here from and needed to find the SSN.  She promised she would call us back once she found.  We waited 3 days with no response and no pick up of phone line. We did a "search" for insurance and found patient had insurance.  We billed it and the insurance told us we had incorrect DOB, she was actually 4 years old.  The mother had lied on the consent and release forms about her daughters age.
Sore arm, just like when I got the flu shot. It never got any better. It hurts when I raise my arm over my head, and I sleep on my left side. I had the shot in my left arm. The pain wakes me up at night.
Adverse reaction after receiving covid-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Adverse reaction after receiving covid-19 vaccine) in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Adverse reaction after receiving covid-19 vaccine). At the time of the report, ADVERSE REACTION (Adverse reaction after receiving covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The reporter called to inquire about the adverse side effects after receiving a Moderna COVID-19 vaccine.  No Concomitant product use was reported. No treatment information was provided.
Information has been received from a Doctor of Pharmacy concerning a male child with celiac sprue who was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccinel ive (+) rubella virus vaccine live (second generation).  One week after vaccination, the patient developed diarrhea.  Unspecified medical attention was sought by the patient.  Additional information has been requested.
A non-serious, spontaneous report of partial dose of FLUMIST given in a four-year old male patient was received from a pharmacist.  There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Patient also received Hep A, varicella, and the flu shot on the same day. Unknown of the exact brand, lot, or manufacturer of any of these vaccines as the patient is reporting this as they present to the ED without any paperwork. Symptoms include possible seizure activity, fever, and rash.
Pt vaccinated with DT experienced rt upper arm erythematous, warm to touch edematous into elbow area. DT given 8OCT90. Pt admitted 12OCT90 with dx of cellulitis rt arm.
CHILLS, NAUSEA, HEADACHE, ANXIETY, LEFT FOOT SWELLING
WITHIN SECONDS OF RECEIVING VACCINE- A PLIABLE LUMP SIZE OF A QUARTER FORMED AROUND INJECTION SITE.
8/18/21 PMH of dementia AOx2 at baseline, HTN, recent admission for treatment of pneumonia who presents from nursing facility for respiratory distress and unresponsiveness
I got chilly; mild headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (I got chilly) and HEADACHE (mild headache) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 039F21A, 024821A and 031L20A) for COVID-19 vaccination.     The patient allergies were unknown.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2022, the patient experienced CHILLS (I got chilly) and HEADACHE (mild headache). At the time of the report, CHILLS (I got chilly) and HEADACHE (mild headache) had resolved.            No concomitant medication was reported. The treatment information was not reported.   This case was linked to MOD-2022-542607, MOD-2022-542609, MOD-2022-542613 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2022: Follow up received contains no new information.
This spontaneous report as received from medical assistant refers to a patient of unknown demographics. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent(MERCK STERILE DILUENT). On 28-OCT-2016 the patient was vaccinated with unspecified doses of expired VARIVAX (lot # K018960, expiry date: 15-OCT-2016) and/or M-M-R II injection (lot # K020188, expiry date: 22-OCT-2016) (dose, frequency and route were not reported) for prophylaxis (expired product administered). It was not reported that, sterile diluent(MERCK STERILE DILUENT) used to reconstitute vaccines was expired. The reporter also stated that, it was unknown whether the patient received MMR II or VARIVAX separately or MMR II concomitant with VARIVAX. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Albumin status for M-M-R II is recombinant human albumin (rHA).
Doses administered to patients 18 hours after first vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered to patients 18 hours after first vial puncture) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered to patients 18 hours after first vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered to patients 18 hours after first vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Mild headaches; Joints hurt when lifting the arm; Tightness on the Shoulder; Rash on the Thighs; Rash on the feet; Rash on the stomach; Shoulder Soreness; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (Tightness on the Shoulder), RASH (Rash on the Thighs), RASH (Rash on the feet), RASH (Rash on the stomach) and ARTHRALGIA (Shoulder Soreness) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced JOINT STIFFNESS (Tightness on the Shoulder), RASH (Rash on the Thighs), RASH (Rash on the feet), RASH (Rash on the stomach), ARTHRALGIA (Shoulder Soreness) and ARTHRALGIA (Joints hurt when lifting the arm). On an unknown date, the patient experienced HEADACHE (Mild headaches). On 25-Mar-2021, RASH (Rash on the Thighs), RASH (Rash on the feet) and RASH (Rash on the stomach) had resolved. At the time of the report, JOINT STIFFNESS (Tightness on the Shoulder), ARTHRALGIA (Shoulder Soreness), HEADACHE (Mild headaches) and ARTHRALGIA (Joints hurt when lifting the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
patient had an episode of syncope/seizure, certainly not clear that is related to the vaccine, admitted for further work-up
therapy with Pfizer COVID Booster for Rheumatoid arthritis; Chills; Not feel well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s):  A 57-year-old 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 rheumatoid arthritis. The patient's relevant medical history included: "Aneurysm in heart" (unspecified if ongoing); "Pneumonia" (unspecified if ongoing); "clogged artery" (unspecified if ongoing); "Smoker" (unspecified if ongoing); "Thyroid issues" (ongoing); "Cholesterol issues" (ongoing); "Trouble breathing" (ongoing); "cough" (ongoing); "Rheumatoid arthritis with rheumatoid factor of multiple sites without organ or systems involvement" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR HFA; AMLODIPINE; ATORVASTATIN; CLOPIDOGREL; LEVOTHYROXINE. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), outcome "unknown", described as "therapy with Pfizer COVID Booster for Rheumatoid arthritis"; CHILLS (non-serious), outcome "unknown"; MALAISE (non-serious), outcome "unknown", described as "Not feel well".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Onset of hives within 15 minutes, parents gave antihistamine, which pt. vomited. Family then directed to ED, given epinephrine IM with rapid resolution of symptoms, prescribed 5 day course oral steroids.
Pt received FLUARIX at pharmacy came back next day to receive MENACTRA and complained of pain/soreness to site of injection. States her joints also hurts. Pt. currently taking naproxen and sulfasalazine. Notice slight decrease in pain from yesterday.
Rash: red, warm, tender to right deltoid, redness appeared within minutes of receiving shots. Redness worsened the next day with tenderness and swelling beginning this AM. Showed erythema & swelling approx. 4 x 4 in size. Showed erythema localized to a lesion. Prescribed ZYRTEC 1mg/mL syrup po - 2.5 mL qd for 30 days.
Grandmother took the vaccine and had complications and was on her death bed.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unkown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "Grandmother took the vaccine and had complications and was on her death bed.".  The lot number for bnt162b2 was not provided and will be requested during follow up.
3/18/2021 approximately at 9pm it started with a headache, nausea, fatigue. All symptoms except  the headache resolved. headache continued intermittently until present date.  New symptom occurred (3/20/2021)2 days after vaccine, this menstral cycle was one week early and lasted 2.5 weeks with mild abdominal pain. Mensuration ended  on 4/12/2021 with mild abdominal pain persistent to present date.
has a non-tender dime sized hard nodule; This spontaneous report was received from a pharmacist, regarding a 55 year old female patient. The patient's concurrent conditions, concomitant medications and medical history were not reported. It was reported that the patient had not known allergies.   On 22-MAY-2019, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) intramuscularly, (dose and anatomical location were not reported) (lot # R017624, expiration date 17-MAY-2021) administered for prophylaxis.   On that day, the patient experienced a non-tender dime sized hard nodule at the injection site (injection site nodule) and at the moment of this report the patient still had it. It was unknown if the patient received treatment for this event.   The causality assessment between injection site nodule and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not reported.
Ok well on May 17th 2021 I went in for my regular like pregnancy check up appointment and my BP was high and they sent me over to the hospital and they diagnosed me with Preeclampsia. They induced labor and I had the baby early, I was induced on the 17th of May. They put me on Labetalol and I am still on that for High blood pressure. My Date of Delivery was to be June 6th 2021. The baby's weight was 5lb 9ounces. I do not have any previous pregnancies.
This spontaneous report as received from a registered nurse refers to a 12 month old patient. On 29-OCT-2013 the patient was   vaccinated with PROQUAD (also reported as MMRV) (of lot and expiry date J007862, 28-DEC-2014). Other suspect therapies included VARIVAX (Merck) (of lot and expiry date J003230, 15-MAR-2015) administered on same day. The patient was ordered to receive M-M-R II, but actually received PROQUAD on that day. The reporter stated that the healthcare worker who administered PROQUAD instead of the MMR reported that she confused the two products. The nurse stated that the cartons and the labels did look very similar and it would be helpful if the labels were of a different color. The nurse stated that the patient was brought to the clinic on 07-NOV-2013 with a measles-like rash, and the patient was seen by physician assistant. The physician assistant informed that besides the measles-like rash, the child was playful and a-febrile. The nurse informed that the rash was distributed on her chest, arms, and groin. The patient had not recovered from the event at the time of report. The report also had a comment that Varicella Zoster Virus Identification Program (VZVIP) was not offered because the rash did not resemble varicella, and this scenario did not fit the criteria for VZVIP. Additional information has been requested.
This spontaneous report was received from a Medical Assistant and refers to a patient of unspecified age and gender. The patient's concurrent conditions, medical history or concomitant medications were unknown. On 17-AUG-2016, the patient was inadvertently administered an expired dose of VAQTA (dose, route and anatomical location were not reported) Lot # L018498, expiration date 28-APR-2016. No adverse effect was reported. Additional information has been requested.
Immediately after vaccine, patient complained of scratchy throat and slightly swollen neck lymph nodes.  We had her wait an EXTRA 15 minutes.  Symptoms did not worsen, and she went home.  When she called a nurse call center, they instructed her to go to Urgent Care.
Initial report received from nurse on 25-Nov-2013. A female patient, whose age, medical history and concomitant medications were not reported, had received a dose of ADACEL intramuscularly (lot number and site of vaccination were not reported), on 25 November 2013. On an unspecified date, after receiving vaccine the patient experienced no adverse event occurred but ADACEL given was expired and administered during pregnancy. Corrective treatment was not reported. Documents held by sender: none.
enormous pain; injection site hot; flu symptoms; low energy; skin is hard; injection site is red; headache; really tired; slight soreness; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (enormous pain), VACCINATION SITE WARMTH (injection site hot), INFLUENZA (flu symptoms), ASTHENIA (low energy) and VACCINATION SITE INDURATION (skin is hard) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced MYALGIA (slight soreness). On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (enormous pain), VACCINATION SITE WARMTH (injection site hot), INFLUENZA (flu symptoms), ASTHENIA (low energy), VACCINATION SITE INDURATION (skin is hard), VACCINATION SITE ERYTHEMA (injection site is red), HEADACHE (headache) and FATIGUE (really tired). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (enormous pain), VACCINATION SITE WARMTH (injection site hot), INFLUENZA (flu symptoms), ASTHENIA (low energy), VACCINATION SITE INDURATION (skin is hard), VACCINATION SITE ERYTHEMA (injection site is red), MYALGIA (slight soreness), HEADACHE (headache) and FATIGUE (really tired) outcome was unknown.        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.
Felt very faint, sick and had body aches. Blood pressure dropped to 75\40. Could not stand up for several hours due to light headedness. Lasted for 12 hours. Slowly got better over that time period.
The patient described a red rash that developed on her arm about 2 days after the vaccine.  It has resolved.  The patient also describes joint pain in hands, feet, ankles, and knee.  Only her hands are sill having joint pain.
5 minutes after receiving first dose of vaccine, patient was sitting in observation area and began to complain of dizziness, weakness, fatigue and nausea. Patient had rapid breathing and stated she was scared.  EMS staff addressed patient and began to assess her when she vomited and had a brief syncopal episode. She was taken to a private area and was monitored.  All vital signs repeated, EKG done, Patient was given IV fluids and antiemetic, and the transferred to ED. Patient was alert and oriented with vital normal vital signs upon transfer.
Flushing about 45 minutes after vaccine. Patient took acetaminophen and issue resolved.
Experienced nausea, headache, and terrible shakes 12 hours after vaccination. About 30 hours later patient was having diarrhea
I was fine until July 10 when I developed cold symptoms followed by temp of 101.7. Took at home COVID test before the fever started and it was negative. After fever treated symptoms with ibuprofen and Tylenol. Advised to take COVID test early morning of 7/12 and it was positive. PCP prescribed Paxlovid. Symptoms mild - fever was gone by that time.  Fatigue remained an issue for almost 3 weeks.
Over the course of a few weeks weeks following the first dose of COVID-19 vaccine (the second dose was received on 1/7/21, Pfizer, Lot#; EJ1686) , there was a dramatic  development of erosive arthritis in both hands, accompanied by significant pain and disfigurement of joints. Xrays demonstrated erosive arthritis changes in multiple finger joints.
Information has been received from a 59 year old male health care worker, concerning himself. The patient had no pertinent medical history and no known drug allergies. On 24-SEP-2012, the patient was vaccinated with a dose of PNEUMOVAX23, one vial dose, injection in the left arm (route and not reported) (Lot # and expiration date were not reported). On 24-SEP-2012 "by Monday evening", the patient developed a red tender area at the injection site. Then, on 25-SEP-2012, the patient's red area expanded to about 3 inches in diameter 4-5 inches above the elbow. Patient stated that it was quite painful and that he could not sleep on the left side of his body. Patient reported that in addition he had a fever of 99.7 (units not specified). No lab diagnostic studies were performed. The patient sought medical attention by sending a note to his physician. At the time of the report, the patient's outcome of red and tender area at the injection site, quite painful, the patient could not sleep and he had a fever of 99.7 was reported as not recovered/not resolved. The relatedness for red area at the injection site, he had a fever of 99.7, could not sleep, it was quite painful and tender area at the injection site was unknown for PNEUMOVAX23. Additional information has been requested.
Information has been received from a consumer concerning her 22 year old daughter who had no relevant medical history or drug reactions/allergies, who in September 2007 (exact date not reported), was vaccinated (site and route not reported) with the 3rd dose of the Gardasil vaccine (lot # not reported).  The patient was concomitantly taking fish oil.  The patient's mother reported that her daughter had an abnormal pap smear.  The patient's mother was told that the, "the pap smear showed abnormal cell growth".  The patient was scheduled for cryosurgery for 18-Dec-2007.  At the time of this report the patient had not recovered.  Additional information has been requested. Information has been received from a registered nurse concerning her 22 year old daughter who has no relevant medical history or drug reactions/allergies, who on unspecified date was vaccinated with a first and second dose of HPV vaccine (lot #, route and site not reported) in September 2007 (exact date not reported), was vaccinated (site and route not reported) with the 3trd dose of the HPV vaccine (lot # not reported). The patient was concomitnantly taking fish oil. The patient's mother reported that her daughte had an abnormal pap smear. The patient's mother was told  that the "the pap smear showed abnormal cell growth". The patient was scheduled for cryosurgery for 18-Dec-2007. At the time of this report the patient had not recovered. Follow up information was received on 24-MAR-2008. The registered nurse reported that her daughter's biopsy was negative and the her daughter recovered (date unspecified) from her outpatient procedure. Additional information has been requested.
Appearance of 3 red, scaley blotches, and persistent muscle pain in the are of the injection  in the deltoid muscle.