chrisvoncsefalvay/vaers-outcomes huggingface dataset:
stiff neck/he can hardly move his neck; woke up with a stiff neck and it has gotten worst; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EM9810, Expiration date: unknown), dose 2 via an unspecified route of administration, administered in Deltoid Right (injection to his right shoulder once) on 08Feb2021 (at the age of 66-year-old) as dose 2, single for COVID-19 immunization. Medical history included issues with his neck (stated that he had issues with his neck before but it has gotten worst) from an unknown date and unknown if ongoing. There were none concomitant medications. The patient previously received first dose of BNT162B2 on 15Jan2021 for COVID-19 immunization. Patient stated that he had the second Covid vaccine on 08Feb on Monday. Stated that he woke up with a stiff neck and it has gotten worst (2021). Stated that he can hardly move his neck (2021). Patient wanted to know if this was a side effect. Stated that this happened two mornings ago. Stated that he had issues with his neck before but it had gotten worst. Stated that it was bone on bone. Stated that it was so bad that it almost brings him to his knees. Stated that he does not know if vaccine has anything to do with vaccine or not. Stated that it was so bad it brings him to his knees. Stated that he puts ice and icy hot on it. Stated that he had taken Ibuprofen. Therapeutic measures were taken as a result of stiff neck/he can hardly move his neck, woke up with a stiff neck and it has gotten worst. There was no investigation assessment. The clinical outcome of event stiff neck/he can hardly move his neck was not recovered and another event outcome was unknown.  Follow-up attempts completed. No further information expected.
no adverse effects for patient; administration of expired VAQTA; This spontaneous report has been received from a medical assistant, regarding to 73-year-old male patient. The patient's pertinent medical history included: hypertension, hyperlipidemia, hyperthyroidism, anemia, benign prostatic hyperplasia, hepatic steatosis, gout, melanoma, hepatic cyst, prostatic nodule and tortuous aorta. His drug reactions included lisinopril cough (capture in MARRS number: 2009USA002555). Concomitant therapies included atorvastatin, calcium (unspecified), fish oil, febuxostat, levothyroxine sodium, vitamins (unspecified), ascorbic acid and vitamin D (unspecified).  On 04-SEP-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection of 1 milliliter (mL), administered intramuscularly (IM) (vaccination scheme and anatomical location were not provided; lot number S021449 has been verified to be a valid lot number, expiration was on 23-AUG-2020), as prophylaxis. Additionally, no adverse effects were reported for the patient and the vaccine had no excursions. The patient did not sought medical attention.; Sender's Comments:  US-009507513-2009USA002555:
Patient experienced severe leg and arm pain (bilaterally) as well as some subjective shortness of breath approximately 12 hours after the second dose.  Nurse advisor recommended patient be acutely evaluated.  Patient presented to ER for evaluation and was discharged without further consequence.
info recvd from MD concerning a 72 yr old woman who devel herpes on thigh & buttocks approx 2-3 wks p/ exposure to grandchild who devel rash; no cultures of herpes obtained;tx zovirax & had some neuritis residual;
HCP diagnosed shingles; rash was itchy; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th March 2022, the patient received the 1st dose of Shingrix. On 12th March 2022, 7 days after receiving Shingrix, the patient experienced shingles and itchy rash. On an unknown date, the outcome of the shingles and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles and itchy rash to be related to Shingrix.  Additional details were provided as follows: The patient reported case for herself. The patient noticed a rash which was itchy begin to form.  The patient went to the doctor on 14th Mar 2022 and her health care professional diagnosed shingles. The patient was started on treatment for it but it was not resolved. Provided patient with requested data per content and package insert. Provided medical advise disclaimer and referred to health care professional. The reporter consented to follow up and permission to contact health care professional.
eyes were burning while she was watching TV; Fever; throwed up a lot; she didn't sleep much; couldn't calm herself down.; probably had all the general symptoms of the flue; arthritis acted up; headache; fatigued; This spontaneous case was reported by a patient and describes the occurrence of ARTHRITIS (arthritis acted up), ABNORMAL SENSATION IN EYE (eyes were burning while she was watching TV), INFLUENZA LIKE ILLNESS (probably had all the general symptoms of the flue), INSOMNIA (she didn't sleep much) and ANXIETY (couldn't calm herself down.) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Depression, Anxiety and Knee replacement. Concomitant products included ALPRAZOLAM (XANAX), VENLAFAXINE HYDROCHLORIDE (EFFEXOR), ATORVASTATIN CALCIUM (LIPITOR) and VITAMINS NOS for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced ARTHRITIS (arthritis acted up), INFLUENZA LIKE ILLNESS (probably had all the general symptoms of the flue), HEADACHE (headache) and FATIGUE (fatigued). On 03-Apr-2021, the patient experienced INSOMNIA (she didn't sleep much) and ANXIETY (couldn't calm herself down.). On 05-Apr-2021, the patient experienced VOMITING (throwed up a lot). On 10-Apr-2021, the patient experienced ABNORMAL SENSATION IN EYE (eyes were burning while she was watching TV) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency; IBUPROFEN for Headache, at an unspecified dose and frequency and CANNABIDIOL at an unspecified dose and frequency. On 04-Apr-2021, INSOMNIA (she didn't sleep much) and ANXIETY (couldn't calm herself down.) had resolved. On 05-Apr-2021, VOMITING (throwed up a lot) had resolved. At the time of the report, ARTHRITIS (arthritis acted up), ABNORMAL SENSATION IN EYE (eyes were burning while she was watching TV), INFLUENZA LIKE ILLNESS (probably had all the general symptoms of the flue), PYREXIA (Fever), HEADACHE (headache) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment: The patient stated she had Ibuprofen and acetaminophen (Tylenol) but they do not help. Now the patient is using cannabidiol (CBD) tablets that help a little - it has cannabigerol (CBG).
like floating in water.; feeling dizzy; constant pain behind the eyes.; bad headache; little soreness in the arm; hardly any pain at the moment; feeling fatigued; nauseous.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (like floating in water.), DIZZINESS (feeling dizzy), EYE PAIN (constant pain behind the eyes.), HEADACHE (bad headache) and MYALGIA (little soreness in the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21D1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced FEELING ABNORMAL (like floating in water.), DIZZINESS (feeling dizzy), EYE PAIN (constant pain behind the eyes.), HEADACHE (bad headache), MYALGIA (little soreness in the arm), VACCINATION SITE PAIN (hardly any pain at the moment), FATIGUE (feeling fatigued) and NAUSEA (nauseous.). At the time of the report, FEELING ABNORMAL (like floating in water.), DIZZINESS (feeling dizzy), EYE PAIN (constant pain behind the eyes.), HEADACHE (bad headache), VACCINATION SITE PAIN (hardly any pain at the moment), FATIGUE (feeling fatigued) and NAUSEA (nauseous.) outcome was unknown and MYALGIA (little soreness in the arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medicines were not provided  Action taken with mRNA-1273 in response to the event was unknown
4X5 cm erythematous raised lesion at injection site, 1 day, post vax, for 11 days. Treated with Atarax 10 mg po TID as needed.
She got her vaccine, had mild soreness of the arm, and just felt tiredness.  She felt more tired with this one, but it wasn't an achy or sick tired, which she just rested and didn't think anything about it.  Then about a week to 2 weeks she started not feeling well, she had a trip coming up.  It was a strange not feeling well (not usual coming down with something ).  She had pain in her legs to touch.  She thought it was due to change of temp as she has  bad right hip and it hurts when weather changes occur.  She had never had a pain in her leg like that, and also around to her back which was so painful and also painful to the touch.  She is a retired nurse.  She flew on 4/19/22 and the leg was flush on the inner thigh, and then flew and had redness and pain and realized it was shingles.  It was on the leg, inner thigh and groin area, and also some on her back, all on the right side.  She then went to the UC the next day, and acknowledged it was shingles and prescribed Acyclovir 5 pills a day until gone, and eventually got a prescription for Lyrica, (Pregabalin) a couple of days later as they would not prescribe it and had to get her doctor to order it.  She got in the salt water which she felt was good for it.  She is still having effects and suffering from the pain of it in her legs.  She is not as tired as she was and is able to sleep.    Feels that there needs to be a study that this is a possible reaction to the vaccine.  Seniors need to know that shingles can happen with the vaccine.
No Adverse Event; Moderna Bivalent booster administered to 2 patients as their Primary dose on 21Dec2022; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna Bivalent booster administered to 2 patients as their Primary dose on 21Dec2022) and NO ADVERSE EVENT (No Adverse Event) in a 5-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Moderna Bivalent booster administered to 2 patients as their Primary dose on 21Dec2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (Moderna Bivalent booster administered to 2 patients as their Primary dose on 21Dec2022) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Moderna Bivalent booster administered to 2 patients as their Primary dose on 21Dec2022).    No concomitant medication information was provided. It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment medication were provided.
I contracted COVID in July. Congestion in upper respiratory area. Coughing and sneezing. I had a fever and chills for 1 day, the fever going up to 103. I felt detached and sick and fuzzy headed. I felt low energy. It felt like the first 24 hours after being vaccinated. After 2 days the fever and chills and fatigue stopped but the congestion remained. No headaches. I took PAXLOVID for the symptoms.
This spontaneous report was received from a nurse and refers to multiple patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant medications were not reported. On multiple, unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX injection, lot # reported as N012488, expiration date 20-APR-2019; lot # reported as N012132, expiration date 17-APR-2019; lot # N001528, expiration date 13-JAN-2019; lot # reported as N000683, expiration date 06-JAN-2019 (dose, route and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered doses of vaccine were stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions reported. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006208.
Patient reported a very sore arm and injection site swelling. The next day she had a fever of 101. She had overall body aches for several days. She reported adverse events 4 days after injection and said all symptoms have resolved accept injection site and still swollen and itchy
This spontaneous report was received from a father refers to his 16 year old son (who is the patient). The patient had no pertinent medical history, drug reactions or allergies. Approximately on an unknown date in April 2013, the patient was vaccinated with a dose of GARDASIL, (lot number, expiry date and route was not reported). Concomitant medications were not reported. On an unknown date, within a couple of days after the vaccination the patient started feeling extremely disoriented and lethargic to the point he had missed a week of school. There was no laboratory test performed. The patient was prescribed a Z-PAK as a treatment at the doctors office. The outcome of the event was reported as not recovered. The patient sought medical attention (doctor visit). Additional information has been requested.
Fever started on morning of 08/06/2016, then mother noticed red rash/spots that started developing morning of 08/07/2016. Swelling and redness got worse as day went on. Came to physician's office today. Redness, swelling with bullae at the site of injection as well as scattered isolated popular lesions with surrounding erythema.
Patient experienced a golf-ball sized rash at the injection site and itching and also experienced some sinus congestion the night of receiving the vaccine.
pt recvd vax;eve following dose 3, exp fever & ha; no tx given; subsided;
Narrative:  Patient c/o "whoosh" feeling in his head with mild numbness 10 mins post vaccination. Pt reports never having a reaction post vaccnation before but did endorse mild anxiety. Vital signs 135/70, HR 75, Pulse ox 97%. Denies DIB, throat tightness, itching or any other signs of anaphylaxis. Provided patient water. Had patient pull over to side and switch from driver side to passenger side of vehicle. Patient laid back with feet elevated on dashboard. Repeated vital signs x2 and both stable. Last set of vital signs 125/73, HR 60, Pulse ox 100%. Patient staated those vital signs were his baseline. Held patient for total of 30 mins post vaccination. Patient state symptoms improved. Denied dizziness. Wife to drive patient home. Instructed that if symptoms worsen to go to nearest ED. Patient and wife greatful for care and feel safe to leave vaccination area.
Moderna COVID- 19 Vaccine EUA: Six days after receiving vaccine patient reported tongue and lip swelling starting soon after vaccination. Patient did not take diphenhydramine. During clinic visit seven days after vaccination patient reported chest burning, alternating hot/cold sensation, fever, facial erythema, and sensitivity to smell. No swelling or erythema noted on physical exam: findings include malaise/fatigue, tinnitus, constipation, back pain, nervousness, and insomnia. Vital signs all within normal ranges. Patient discharged home from clinic stable with prescription for hydroxyzine.
Chills, fever, nausea and general weakness, Arm is still quite sore.
On first injection, after about 7 hours I started feeling extremely lethargic, next day was 103 degree fever which lasted around 5 days with chronic diarrhea, and then a futher 7 days with 100+ degree fever that was not reduced further by OTC treatments. Weakness continued for 10 days, followed by insomnia (2 hours of sleep or less per night) with the ability to fall asleep, but no ability to stay asleep. And lack of appitite, eating around 50% less food than was before the vaccine. 3 weeks after initial injection, PCP recommended Trazodone, which improved the sleep function to about 4-6 hours per night, but not the usual 8, has not improved food intake very much.  6 weeks later, ability to eat and sleep normally has not returned. No other symptoms other than lethargia from caloric deficit.
This spontaneous report has been received from a pharmacist and concerns an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were unknown. It was reported that the unspecified number of patients received improperly stored doses of M-M-R II lot number K014832, expiry date 14-SEP-2016; lot number K009957, expiry date 14-JUL-2016; lot K004948, expiry date 04-APR-2016; lot number K014833, expiry date 14-SEP-2016 (dose and route were not reported) after 23-JUN-2015. It was reported that the vaccine was at 48 Fahrenheit of temperature and its time frame was 1 hour and 33 minutes, there was not previous excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested. This is one of several reports received from the same source.
Information regarding influenza virus vaccine was received from a 60 year old male consumer who received a dose in 1993. The patient's concurrent illnesses include syncope vasovagal, anxiety, allergy to animal, hypersensitivity, and food allergy. Indication for Flu Shield was immunization. Product was administered in 1993. Dose regimen was not provided. Concomitant therapy included Clonazepam. The patient reported that he developed an injection site reaction, injection site arm redness, injection site arm hot, and injection site arm itching in 1993. All events resolved within 24 hours, without treatment. No additional information was available at the time of this report.
cold; sweating; migraine with bight flashing; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), HYPERHIDROSIS (sweating), MIGRAINE (migraine with bight flashing) and FATIGUE (extreme fatigue) in a 77-year-old female patient 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) (Intramuscular) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced NASOPHARYNGITIS (cold), HYPERHIDROSIS (sweating), MIGRAINE (migraine with bight flashing) and FATIGUE (extreme fatigue). At the time of the report, NASOPHARYNGITIS (cold), HYPERHIDROSIS (sweating), MIGRAINE (migraine with bight flashing) and FATIGUE (extreme fatigue) outcome was unknown.            concomitant medication was not provided.  Treatment information was not provided.
Swelling/redness at the injection site; Swelling/redness at the injection site.Did not have any redness for the first week. It was about an inch wide and has since gotten to be about twoinches.; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734), via an unspecified route of administration in the right arm on 01Apr2021 at 12:15 (at the age of 24-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food or other products. Concomitant medications included somatropin (NORDITROPINE) from unknown date for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021, a week later, the patient noticed swelling/redness at the injection site. The patient did not have any redness for the first week. It was about an inch wide and has since gotten to be about two inches. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events swelling/redness at the injection site, did not have any redness for the first week, it was about an inch wide and has since gotten to be about two inches were unknown at the time of reporting.   No follow-up attempts are needed. No further information is expected.
I started out real tired, I would be so tired I would go home I would have fever chills this went on a week before I went to hospital they gave me an IV bag and sent me home saying said it was probably a viral illness. Then I started getting a rash all over my body, I took pictures. I went to a doctor on demand and they put me on steroids. The rash went away. Then my foot started swelling so bad I could barely walk on it and then my whole right side of my body swelled up and I had to go I went to orthopedic surgeon they said I had severe carpal tunnel I could not get the surgery because I can't afford it it. Now my hair is falling out in chunks, I have floaters in my eye. I was fine before I had covid I was fine and before the vaccine I was fine. I don't want to get the booster, I'm already scared to death as it is. My vaccine card does not have a lot number for either vaccine.
first vaccination almost 2 months ago; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first vaccination almost 2 months ago) 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 PRODUCT DOSE OMISSION ISSUE (first vaccination almost 2 months ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first vaccination almost 2 months ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.  It was reported that patient had dose 1 two months ago.