chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash; headache; felt sore; my arm was tender; spacey; dizzy; I had to be thoughtful on how I was walking; slight headache; The injection site was sore; muscle aches; joint pain; nausea; vomiting (4 times); fever; chills; took temperature with peak 100.6 F; neck pain; She felt she was going to die; headache; fatigued; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm), the first episode of HEADACHE (headache), FATIGUE (fatigued), NECK PAIN (neck pain) and MYALGIA (muscle aches) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 062G20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AZELASTINE for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced MYALGIA (sore arm). On 17-Jan-2021, the patient experienced the first episode of HEADACHE (headache) and FATIGUE (fatigued). On 14-Feb-2021, the patient experienced NECK PAIN (neck pain), MYALGIA (muscle aches), ARTHRALGIA (joint pain), NAUSEA (nausea), VOMITING (vomiting (4 times)), PYREXIA (fever), CHILLS (chills), PYREXIA (took temperature with peak 100.6 F), FEELING ABNORMAL (She felt she was going to die) and MYALGIA (The injection site was sore). On 15-Feb-2021, the patient experienced HEADACHE (slight headache). On 16-Feb-2021, the patient experienced DIZZINESS (dizzy) and ARTHRALGIA (I had to be thoughtful on how I was walking). On 17-Feb-2021, the patient experienced FEELING ABNORMAL (spacey). On 18-Feb-2021, the patient experienced TENDERNESS (my arm was tender) and MYALGIA (felt sore). On an unknown date, the patient experienced RASH (rash) and the second episode of HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and MECLIZINE [MECLOZINE] at an unspecified dose and frequency. At the time of the report, MYALGIA (sore arm), FATIGUE (fatigued), NECK PAIN (neck pain), MYALGIA (muscle aches), ARTHRALGIA (joint pain), NAUSEA (nausea), VOMITING (vomiting (4 times)), PYREXIA (fever), CHILLS (chills), DIZZINESS (dizzy), PYREXIA (took temperature with peak 100.6 F), FEELING ABNORMAL (She felt she was going to die), HEADACHE (slight headache), ARTHRALGIA (I had to be thoughtful on how I was walking), FEELING ABNORMAL (spacey), TENDERNESS (my arm was tender), RASH (rash), MYALGIA (The injection site was sore), MYALGIA (felt sore) and the last episode of HEADACHE (headache) outcome was unknown.
This spontaneous report was received from a 70 year old female patient with cardiomyopathy, who was reporting on herself. The patient did not have any known drug reactions or allergies.  On 29-SEP-2016, the patient was vaccinated with a dose of ZOSTAVAX injection, one time via subcutaneous route (reported as under the skin) (exact dose, lot number and expiration date were not reported). On the same day, the patient was vaccinated with pneumococcal a dose of an unspecified "pneumonia shot" (manufacturer unknown) injection (dose, route of administration, lot number and expiration date were not reported). Concomitant therapies included Asian ginseng (+) acetylcarnitine (+) ascorbic acid (+) bacopa (+) biotin (+) choline (+) cyanocobalamin (+) docosahexaenoic acid (+) folic acid (+) ginkgo (+) glutamine (+) phosphatidyl choline (+) phosphatidyl serine (+) resveratrol (+) tyrosine (COGNETIX LABS PROVASIL) and quinapril hydrochloride.  On an unknown date in 2016, reported as a day and a half after receiving ZOSTAVAX and the unspecified pneumonia shot, the patient experienced redness that was 3 and 1/2 inches in size. The patient did not seek medical attention and did not receive treatment for the adverse event. There were no laboratory diagnostic studies performed. There was no product quality complaint involved. The outcome of the event was not reported. The relatedness between the event and the suspect vaccines was not provided. Additional information is not expected as no consent to contact the physician was granted.
Had redness at site of injection. Had soreness 4 1/2" X 2 3/4" left biceps.
thigh where DTP injected was extremely red & swollen (approx 3x nl size) from near hip into knee;p/swelling & redness gone 4-5 days,  limp remained for 6-8wk @ inj site;
Varicella Disease diagnosed on 4/29/08. Presented with no fevers.
woke up with fever and sore throat on 22nd; went to job and got tested and tested positive; on the 23rd developed right upper lobe pneumonia; on 27th was hospitalized with three lobe pneumonia; On 22nd received got zpack - azithromycin and sudafed; received at hospital doxicycleln IV ; ivermectin and went home with them, as well. Hospital
Couldn't turn his neck back because it hurt so bad; Pain continued to get worse, and affected entire side of his body (left side, same side he got his; Pain in his neck; Pain in his back; swelling of lymph nodes in his neck and under his arm; Fatigue; arm was hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was hurting), MOBILITY DECREASED (Couldn't turn his neck back because it hurt so bad), PAIN (Pain continued to get worse, and affected entire side of his body (left side, same side he got his), NECK PAIN (Pain in his neck) and BACK PAIN (Pain in his back) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, Thyroiditis and High cholesterol.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was hurting) and FATIGUE (Fatigue). On 01-Apr-2021, the patient experienced MOBILITY DECREASED (Couldn't turn his neck back because it hurt so bad), PAIN (Pain continued to get worse, and affected entire side of his body (left side, same side he got his), NECK PAIN (Pain in his neck), BACK PAIN (Pain in his back) and LYMPHADENOPATHY (swelling of lymph nodes in his neck and under his arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of Two or three. On 02-Apr-2021, PAIN IN EXTREMITY (arm was hurting) and FATIGUE (Fatigue) had resolved. On 03-Apr-2021, MOBILITY DECREASED (Couldn't turn his neck back because it hurt so bad), PAIN (Pain continued to get worse, and affected entire side of his body (left side, same side he got his), NECK PAIN (Pain in his neck) and BACK PAIN (Pain in his back) had resolved. On 04-Apr-2021, LYMPHADENOPATHY (swelling of lymph nodes in his neck and under his arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient is on concomitant medicines like Blood pressure medication, Thyroid medication and Cholesterol medication. Advil two or three as treatment medication. Not sure if the patient also took Tylenol.
2 consecutive miscarriages after covid vaccine. 2nd miscarriage requiring D&C
8:10pm tongue swelling noted. 6:00am woke up with head to toe hives and migraine.
This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB 10/1.0 microgram/ml injection, lot # L038018 with expiration date 13-SEP-2017 or lot # L048236 with expiration date 31-MAR-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced a temperature excursion of 31 degrees Fahrenheit for 6 minutes. This is one of two reports received from the same reporter. Additional information is not expected as there was no consent for follow up.
Fever 101, headache, malaise during night time fever prolonged dream state grogginess. Resolved by next morning 4/15/2009.
10/18/2008 presented to ED with cellulitis arm, put on followed up in ED 10/19 and 10/20/08.
Approx 2 inches below where my flu vaccine was administered, I got a 2X3 inch area on my lower deltoid that was red, hot, swollen and painful.  At the office, we drew a line around the edge of the redness to watch to see if the redness would get bigger.  On Thursday, 10/30/14, the area spread outside the margins that were drawn.  It increased in size on the bottom side increasing by an inch or so.  The redness had completely faded on Saturday, November 1, but left a bruised looking area for the last two days. It is no longer painful, just irritated and itchy.  I work in the clinic where the injection was administered, and one of the doctors watched the area through the day on Thursday.
Patient presented with fever of 101, redness on left arm, nausea, vomiting and dizziness. Patient states feeling better today a little better than in the weekend. Patient doesn't have medical insurance. Advised patient to look for a community clinic and see a physician. Patient states unable to stand up for long periods because of the dizziness. Patient reported event on 1/23/2012.
The patient called and came in with complaints of redness, swelling and pain in the bicep. This began around noon Friday. Symptoms were pretty much resolved by 11/05/2001. The patient treated with Benadryl and Ibuprofen to help resolve the pain and swelling.
Headache, neck soreness, Itchy all over, fever, and dizziness.  Patient stated the headache started around 1:00pm on 4/12/21 and the itchy all over started about 4:00pm.  All other symptoms started later that afternoon. Patient called to report this issue and stated he fever is now gone and so is it itchy all over feeling but the sore neck and dizziness are still present.
Patient received first dose of Moderna vaccine. Patient is underage for Moderna vaccine. Patient will not receive second dose at this facility.
Intermittent Chest pain with Profuse sweating for 8-12 hour periods, extreme tremors/convulsing during sleep (without fever) from  8/13/21-8/18/21, nausea and dizziness.
Developed cellulitis on arm. Being treated with 10 days of keflex. Redness and soreness to touch at area of injection site.
patient fainted after receiving vaccine (1st dose of pfizer). arousable, no loss of consciousness, no trauma, able to place in chair, 13:25 111/75, 100, 59, patient states "this is how she reacts to shots, piercings and tatoos.
MISSED THIRD DOSE; This spontaneous case (PVX2019-804) was received from a nurse on 03-Apr-2019. It describes a female consumer who "missed third dose", while being on Vivotif for an unknown indication.   Case report: The consumer forgot to take third dose, which was due on 02-Apr-2019.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "missed third dose" was unknown.  Company's Comment: The causality of the event "missed third dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed third dose" was considered as not applicable.
Drug ineffective; COVID 19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05May2022 as dose 3 (booster), single (Lot number: FJ4989) at the age of 41 years 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 included: "Penicillin allergy" (unspecified if ongoing); "Tree nuts allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Apr2023, outcome "unknown", described as "COVID 19"; DRUG INEFFECTIVE (medically significant) with onset Apr2023, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid (Lot number: GF5571) for treatment of COVID-19 from 20Apr2023 to 21Apr2023.; Sender's Comments: Based on available information, a possible contributory role of the subject product , BNT162B2 vaccine, cannot be excluded for suspected LOE.  There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.,Linked Report(s) : US-PFIZER INC-202300175614 same patient/reporter, different drug/event.;
At around 3:00 am on June 2, 2021, I experienced chills and an extreme headache. I took Tylenol and layed down.
Patient started with a fever up to 102 within 2 hours of getting the vaccines. Then had vomiting within 18 hours of vaccine, and broke out in a rash starting 2/18/17 faint pink blanching small papular rash on upper chest and back and abdomen. Left upper arm with slightly warm and pink raised area, about 3 inches across, surrounding previous injection site.
PT DEVELOPED FEVER AND RASH 6 DAYS AFTER VACCINES WERE ADMINISTERED.  HIGHEST FEVER WAS 101.7 RECTALLY.
This is a spontaneous report received from a contactable consumer (patient). This is the first case out of the two cases. A 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8733), via an unspecified route of administration on 01Apr2021 as a 2nd dose, single for COVID-19 immunisation. The patient's medical history included arthritis, from an unspecified date and unknown if ongoing. Past drug event included prednisone for arthritis, the patient had been taking it for 25 years. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6206), via an unspecified route of administration on 10Mar2021 as a 1st dose, single for COVID-19 immunisation. The patient's age at vaccination was 81 years. The patient's concomitant medications were not reported. It was reported that, the patient and his wife, both had their shots which had been Pfizer. Stated that, the patient don't know the dates of when his wife had her list. Stated that, they have both come down with like Sciatica pain, both in their right knees both of them and they had been trying also pain medication. It seemed really strange of both of them, both of them had the same shots and both of them came down with the same pain. Stated that, he have had sciatica before that only way back when the patient was younger and driving long distances and sometimes after sitting in, the patient was having this problem and he actually have some homeopathic drops and stuff that he got from a natural doctor stuff (unspecified medication). He usually used that but he was feeling the affect in this they doesn't feel the affect in this sciatica. Stated that, he remember a Pfizer community and he told his doctor about that was happening. He was talking to a pharmacist the other day and he told the patient to call you guys and give you the information. He don't know email and stuff at all, he was not on internet and all that, so he don't know his wife's. Stated that, he just changed to a new medication that pharmacist told him about, it's a diclofenac something. Stated that, he had the container, he had been taking several different pain medication such as Lidocaine and this morning at 6 O'clock just a few hours ago, he started with this new medication that the pharmacist recommended that was diclofenac sodium topical gel 1%. It's for sciatica pain and arthritis. Stated that, when probed for any vaccination prior to the first shot was reported as no, nothing recently, he don't know. Stated that, weight, he don't weight himself fair enough, he think he was still pretty close to 155 pounds (further not clarified hence, not captured in tab). Stated that, it would just be a guess but he think it seemed like it was really close to when he had his second shot but he can't tell the exact date and unable to remember his wife's. Stated that, it doesn't show any expiration date. The investigation assessment was reported as no. The outcome of the event was unknown.
Urticaria at injection site within 2-3 days of GARDASIL administration - local care only (right deltoid),
A patient who is outside of 42 hour window for his 2nd dose of Moderna/more than 35 days passed since the first dose and patient did not receive the second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A patient who is outside of 42 hour window for his 2nd dose of Moderna/more than 35 days passed since the first dose and patient did not receive the second dose) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A patient who is outside of 42 hour window for his 2nd dose of Moderna/more than 35 days passed since the first dose and patient did not receive the second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A patient who is outside of 42 hour window for his 2nd dose of Moderna/more than 35 days passed since the first dose and patient did not receive the second dose) 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 concomitant medication information was provided. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow up received and reporter information added, patient demographics added, product start and batch number, vaccine facility updated.
from telephone contact with reporting nurse supervisor, it was reported that a  4 year old male patient received his 5th dose  of Tripedia  Lot # UO532CA on 08/23/01 administered in the gluteus. A large lump developed with warmth to the touch on 04/25/01. This event resolved and the patient fully recovered.
feeling bad & nauseous in morning during physical therapy.  Asthma flared up.  Used rescue inhaler AM, used again in 3 hours, then in two more hours used nebulizer.   Eventually falling asleep for about an hour.  Woke up and still needed rescue inhaler when trying to perform any tasks.
About 3-4 days later developing a rash at the injection site. Otherwise no major initial symptoms after receiving the dose, other than a mildly sore arm for first two days and some fatigue.
Suspected vaccination failure/got both shots and got shingles 4 months later; shingles/got both shots and got shingles 4 months later; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 4 months after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 22-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got both shots and got shingles 4 months later and lasted 8 weeks. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Admitted to Hosptial on 11/9/2021 for fever, weakness, and altered mental status. Put on 2L O2 and IV dexamethasone while in hospital. Discharged on 11/10/2021. Presented for readmission on 11/13/2021 due to continued weakness and unable to be cared for in her home.
After administering Tdap and Hep A, patient complained of headache, hot flashes, dizziness, nausea. Shortly after she complained of her chest feeling weird, numbness in hands. Patient later stated her feet were tingling and legs were heavy. Patient did say her stomach hurt.  Patient was given crackers and juice. Checked vitals, called EMS.
I had a severe headache in the middle of the night and I have had headaches every night since for the last 5 weeks. It is a cluster headache. I used to have cluster headaches years ago.
Passed out next AM; Itching all over about 30 minutes post injection; Booster; Very dizzy; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received BNT162b2 (BNT162B2), administered in arm left, administration date 22Dec2021 12:00 (Lot number: 331308A) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Seizure disorder" (unspecified if ongoing); "known allergies: yes" (unspecified if ongoing). The patient took concomitant medications. The patient did not receive any other vaccine within four weeks. The patient did not have covid before vaccination. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8730, Vaccine Administration Time: 12:00 AM), administration date: 06Apr2021, when the patient was 58 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Vaccine Administration Time: 12:00 AM), administration date: 16Mar2021, when the patient was 58 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant); LOSS OF CONSCIOUSNESS (medically significant) with onset 23Dec2021, outcome "not recovered", described as "Passed out next AM"; PRURITUS (non-serious) with onset 22Dec2021 at 12:30, outcome "not recovered", described as "Itching all over about 30 minutes post injection"; DIZZINESS (non-serious) with onset 22Dec2021, outcome "not recovered", described as "Very dizzy". The patient described the events as itching all over about 30 minutes post injection. Passed out next AM. Very dizzy. Almost passed out again second day post injection. Therapeutic measures were not taken as a result of loss of consciousness, pruritus, dizziness. Patient did not had covid test post vaccination.
cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (cough). At the time of the report, COUGH (cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.