chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Numbness in arm and hand of the right side; Experiencing anxiety; Digestion issues; Itching of injection site; Redness of injection site; Swelling of injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in arm and hand of the right side), ANXIETY (Experiencing anxiety), DYSPEPSIA (Digestion issues), VACCINATION SITE PRURITUS (Itching of injection site) and VACCINATION SITE ERYTHEMA (Redness of injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in arm and hand of the right side), ANXIETY (Experiencing anxiety), DYSPEPSIA (Digestion issues), VACCINATION SITE PRURITUS (Itching of injection site), VACCINATION SITE ERYTHEMA (Redness of injection site), VACCINATION SITE SWELLING (Swelling of injection site) and HEADACHE (Headache). At the time of the report, HYPOAESTHESIA (Numbness in arm and hand of the right side), VACCINATION SITE PRURITUS (Itching of injection site), VACCINATION SITE ERYTHEMA (Redness of injection site) and VACCINATION SITE SWELLING (Swelling of injection site) outcome was unknown and ANXIETY (Experiencing anxiety), DYSPEPSIA (Digestion issues) and HEADACHE (Headache) had not resolved. Not Provided          Concomitant medications were not provided by the reporter. Treatment information was not provided.    This case was linked to MOD-2021-260290 (Patient Link).
I received my Pfizer Bivalent booster for COVID-19 and a flu shot on 9/23/2022. On the evening of 10/18/2022, I felt more tired than usual. We were out socializing with friends, and I couldn't wait to get home and rest. I basically felt like I was coming down with a cold. That night, I also developed a headache, a runny nose, a hacking cough, and watery eyes. I also continued to experience the aforementioned fatigue. These symptoms all continued throughout the day of 10/19/2022. On the morning of 10/20/2022, I took my temperature, which was around 100 degrees. I felt pretty sure it was the cause of my headache. I also had the symptoms I had developed on 10/18/2022. At around 11 AM that day, I took a rapid test for COVID-19 and got a positive result. I then contacted my doctor, who prescribed me Paxlovid, which I began taking that evening. I then spent the rest of the day sleeping. On the morning of 10/21/2022, I took my temperature, which was about 99. I had previously alternated Tylenol and ibuprofen to manage my temperature, and it seems that they worked well. I continued to periodically take my temperature for the rest of the day, and it remained in the normal range. When my fever subsided, so did my headache. On 10/22/2022, my other symptoms began to decrease. I coughed less, my nose was less runny, and my eyes were less watery. However, I still had fatigue. On 10/23/2022, I felt like almost all of my symptoms were gone, though my fatigue continued. On 10/24/2022, I stayed at home and rested; I still felt that I was improving, though I still felt fatigued. I also had a little bit of the cough left, but it soon subsided. While I was taking the Paxlovid, I had a metallic taste in my mouth, and I looked forward to finishing taking it, which I did on the morning of 10/25/2022. On the evening of 10/26/2022, I began to have sneezing and a runny nose, so I took Alka-Seltzer to treat the symptoms, and it worked. On the morning of 10/27/2022, I had a little bit of a runny nose, so I took some more Alka-Seltzer, and I haven't had a runny nose since. At the time of this writing, I feel pretty well, but I still feel more fatigued than usual. I work in spurts and then rest. I don't exert myself too much, as my stamina isn't quite what it was before I had COVID-19.
My arm is so sorry can't even hardly use it is this normal; My arm is so sorry can't even hardly use it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm is so sorry can't even hardly use it is this normal) and VACCINATION SITE MOVEMENT IMPAIRMENT (My arm is so sorry can't even hardly use it) 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 01-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (My arm is so sorry can't even hardly use it is this normal) and VACCINATION SITE MOVEMENT IMPAIRMENT (My arm is so sorry can't even hardly use it). At the time of the report, PAIN IN EXTREMITY (My arm is so sorry can't even hardly use it is this normal) and VACCINATION SITE MOVEMENT IMPAIRMENT (My arm is so sorry can't even hardly use it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No Treatment information was provided.
administered FLUBLOK to a 14 year old patient/ no AE; Initial information was received on 13-Oct-2021 regarding an unsolicited valid non-serious case from consumer/non-healthcare professional and physician via call center via Medical Information (Reference number- 00811402).  This case involves a 14-year-old male patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  On 12-Oct-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: UJ724AA and expiry date: 30-Jun-2022) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error case due to inappropriate age at vaccine administration (latency: same day).  It was reported "Clinical supervisor reports that one of their staff administered FLUBLOK to a 14 year old patient."  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt recv vax; subsequently,exp dizziness, nausea & devel dry heaves;on 24mar94, recv 2nd dose of vax & devel a recurrence of her previous sx;
Blood pressure was high today; Arm was hurting more; shoulder blades and back were hurting; shoulder blades and back were hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was hurting more), ARTHRALGIA (shoulder blades and back were hurting), BACK PAIN (shoulder blades and back were hurting) and HYPERTENSION (Blood pressure was high today) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event on 05-Mar-2021. Concurrent medical conditions included Diabetes.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was hurting more), ARTHRALGIA (shoulder blades and back were hurting) and BACK PAIN (shoulder blades and back were hurting). On 05-Mar-2021, the patient experienced HYPERTENSION (Blood pressure was high today). On 05-Mar-2021, PAIN IN EXTREMITY (Arm was hurting more), ARTHRALGIA (shoulder blades and back were hurting) and BACK PAIN (shoulder blades and back were hurting) had resolved. At the time of the report, HYPERTENSION (Blood pressure was high today) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was reported.     This case was linked to MOD21-046711 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: No specific follow-up information recorded.; Sender's Comments:  MOD21-046711:Crosslinked
Our patient received a Moderna booster dose that was in room temperature less than 24 hours, but longer than the recommended time from initial puncture. He was informed of the incident and stated that he feels well, with no rash, fever, SOB, or any unusual symptoms. Reported incident to Moderna , and waiting response on the validity of the booster dose given.
Febrile 101.3 R started 6 hours post vaccines given. Very fussy. Lab work CBC and L/A negative. Admitted R/O sepsis. Discharged, afebrile 8/22/02. The follow up received on 9/9/02 states no Rx.
redness  swollen    hard to touch     bruised    sight began to widen symptom began on the day of the injection which was 01/14/2021 and now just began to look better 01/29/2021
Patient presented with blotchy skin and tightness in the chest. Blood pressure was 190/110. Patient was given some oxygen and blood pressure had decreased. Patient blood pressure was still high and complaining of chest tightness.
pt states his left arm was tender and next day he began to develop soreness in all joints.  He started taking over the counter aleve and tylenol.  The joint pain continued to progress.  He has constant pain.  He contacted Labs to have blood work.  The blood work showed the protein levels at 48% which is why he was having so much inflammation in his joints.  The RA test was normal.  Pt will be going to an Urgent Care since he is still in so much pain and the symptoms are not getting any better.  He was very active and now has trouble moving around.  Mobility is down 25 to 30%  compared to 100%.
Fever (100-102 degrees) for 8 days, treated with acetaminophen.  Diarrhea for 5 days, no treatment.
pt recvd vax & 1 1/4 hr later rt hand jumped, shook, & went numb then slurred speech, rt side face numb; called 911-ER stroke home 21FEB93; pt recovered but rt hand still weak;
pt vax 04Aug1997 w/ varicella live; broke out w/ rash 24Oct1997
arm became bright red; black like a bruise; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm became bright red) and CONTUSION (black like a bruise) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced ERYTHEMA (arm became bright red) and CONTUSION (black like a bruise). At the time of the report, ERYTHEMA (arm became bright red) and CONTUSION (black like a bruise) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported  No treatment information was provided
Patient developed GI bleed few days after vaccination.  Unclear if it is related.  His platelet count is normal.  developed acute anemia due to GI bleed.   Also has remote history of GI bleed 9 years ago with negative workup.  did not have any recurrent bleeding since then until this episode and have been getting routine GI screening.
33 hours after vaccination, about 5 inch area surrounding vaccination site noticed to be significantly erythematous, hard, warm. Has tolerated multiple flu shots in the past, as well as other vaccinations, has no allergies or intolerances. Brother had same reaction but more severe. Vaccinated at same pediatric clinic at the same time as brother. Brother brought in to emergency department, reaction confirmed- did not bring patient in as treatment was minimal.
Headaches, BP rise to 170/100.  Had to start taking blood pressure medication, 50 mg of losartan twice a day now.  Was never on BP medication before or have record of hypertension at regular appointments.
despite the two doses of the COVID-19 vaccine, tested positive for COVID; despite the two doses of the COVID-19 vaccine, tested positive for COVID; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (COMIRNATY; lot number and expiration date were not reported) on an unspecified date, dose 1, single and on an unspecified date, dose 2, single; both via an unspecified route of administration for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, despite the two doses of the COVID-19 vaccine, the patient tested positive for COVID with the following symptoms of sore throat, congestion, chills, headache, tiredness, loss of sense of smell and taste. The patient underwent lab tests and procedures which included COVID test: positive on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Patient came into the store the day after his vaccination stating that he could not move his arm. Upon further evaluation, I could see that the technician that administered the vaccination gave it too high on his shoulder. He said he would follow up with his physician.
Itchy/tingling feeling in mouth 2 hours after shot, feeling of throat closing, nausea.  After nap, purulent discharge from both eyes.  Does not wear glasses/contacts.  In clinic reported tingling and swelling of lower lip.  No past problem with flu shot.    Given 25 mg Benadryl, and Pepto-bismol.  Eye issue related to conjuctivitis acute bilaterally.  Placed as exempt from flu shot.
Patient reports that he noticed today that at the injection from his shingrex (#2)  there is a red circle about 2.5 inches in diameter, warm to touch, painful at  injection, no hives/rash. Patient denies any chest pain, shortness of air, throat  swelling, palpitations. Patient denies arm swelling.
HEADACHE, NAUSEA, VOMITING, PHOTOSENSITVITY AND BILATERAL LEG WEAKNESS, LEFT AXILLARY LYMPHADENOPATHY WITH ASSOCIATED PAIN.
The patient's mother reported the patient experienced headache after the event. She was fine and went to school the next day.
Severe swollen left leg. Leg was extremely hot and reddened. It itched so much that I had to wrap towels around it to keep her from creating sores on her leg from scratching. She broke open her injection and it became infected. Low grade fever (100). She was legargic and felt achy for three days.  Her leg stayed swollen for two and one-half days.
pt recvd vax & 2 wks p/vax exp Bell's Palsy; was seen by MD; event resolved 1MAR94; pt recvd dose 2 14MAR94;
Welts appeared on throat from ear to ear w/in 5 hours after flu shot.  A friend suggested it my be form flu shot.  Called MD the next day- hives fading, no TX prescribed.  No other symptoms beside welts, itching.  No previous RX to flu shot.  Recommended that future shot be done by MD.
Client awakened at 3:00 a.m. with a 102 F, Temperature and generalized dystonia.  Client's mother called Health Center at 9:00 a.m on 10/23/09.  Nurse Manager advised her to take patient to see his physician.  If not available, take him to the Emergency Room.  Mother verbalized understanding.  RN called CDC Vaccine Info hotline and described event.  They advised to have patient seen and followed closely for the next 1 to 3 days.  Called mother again after speaking to CDC info.  She verbalized understanding and stated that she would be taking him to Clinic.  Spoke with mother again this morning 12/24/2009.  She states that the physician swabbed his nasal passages to make sure that he did not have an influenza like illness.  He was not having any congestion.  Only fever and generalized pain and stiffness.  The physician told her to watch him closely over night and to bring him back today if his symptoms had not improved.  Mother states that the stiffness is much improved this morning.  Only pain and stiffness in the jaw remains.  Temperature is down to 99 F.
9JAN97 t100 to 101 x 3 days-rash all over body began Sat evening-called MD to -DPH;13JAN97 rash still present no fever;
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 14-SEP-2014 the patient was vaccinated with ZOSTAVAX (lot # J011338, expiry date: 19-DEC-2014, subcutaneous, dose unknown. Pertinent medical history and concomitant medications were unspecified by reporter. On 14-SEP-2014, the patient developed a "golf ball sized" red bump at the injection site after receiving the ZOSTAVAX. No treatment was provided for the event. The outcome of the events was reported as not recovered/not resolved. The causality was unknown. No further information provided. Additional information has been requested.
ache; rash that looked like chickenpox; This non-serious case was reported by a nurse via sales rep and described the occurrence of pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on an unknown date, refer case US2023AMR083356.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: ache) and varicella-like rash (Verbatim: rash that looked like chickenpox). The patient was treated with acyclovir. Rechallenge with Shingrix was positive. The outcome of the pain and varicella-like rash were not reported.   It was unknown if the reporter considered the pain and varicella-like rash to be related to Shingrix.     It was unknown if the company considered the pain and varicella-like rash to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR083356   Additional Information: GSK Receipt date: 13-JUN-2023 The patient age was mid-70. The reporter did not consent to follow up.; Sender's Comments:  US-GSK-US2023AMR083356:same patient same reporter
This spontaneous report was received from a pharmacist refers to a female patient of unknown age. The medical history included chicken pox. Drug reactions or allergies and concomitant medication were none. On 26-SEP-2016, the patient was vaccinated with ZOSTAVAX lot # M018453 28-JUN-2017. On an unknown date in 2016 the patient experienced injection site reaction a couple of days after vaccination. The injection site reaction was described as redness and pain at the injection site. On 05-OCT-2016 the patient stated that the pain radiated along the side of the same arm of the injection site to the same side of the body. On 06-OCT-2016, the outcome of the events were reported as recovered/resolved. Additional information has been requested.
Suspected Narcolepsy. Started to see daytime sleepiness and cataplexy in early May.  After much bloodwork and trying iron supplementation, narcolepsy diagnosis was made in July.  Currently taking intermittent naps and being medically managed on methylphenidate.
Developed diagnosed left-sided Bell's Palsy (see timeline below): 1/21/21 - 1st dose of Moderna COVID-19 vaccine administered 1/22 /21 - Developed tingling of the tongue 1/27/21 - Developed worsening tingling sensation of tongue along with left side of face, facial drooping of the left side, drooling and inability to whistle; patient was seen at the hospital where patient had lab work done along with 2 MRI's; attending clinician determined diagnosis of Bells Palsy and referred patient to neurology 2/4/21 - Pt contacted Center stating no improved symptoms and has not yet seen a neurologist
Information has been received from a registered nurse concerning a 72 year old female with a history of peripheral swelling of the legs and feet, and no known allergies who on 23-Aug-2007 was vaccinated with a single dose of Zostavax.  Concomitant therapy  included celecoxib (Celebrex), montelukast sodium (MSD), levothyroxine Na (Levoxyl), fexofenadine hydrochloride (Allegra), omeprazole (Prilosec), lisinopril (Zestril), lorazepam, hyoscyamine and acetaminophen (+) propoxphene napsylate (Darvocet-N).  On 23-Aug-2007 the patient developed intense redness, swelling, and broken blood vessels on her left foot and right calf.  Unspecified medical attention was sought.  At the time of this report the patient was recovering.  No further information was provided.  There was no product quality complaint involved.  Follow up information from the nurse indicated that the patient had "bad varicose veins".  Additional concomitant therapies included vitamins (unspecified), calcium (unspecified) (+) vitamin D (unspecified), calcium (unspecified) (+) vitamin D (unspecified), dimethyl sulfone (+) glucosamine, omega-3 marine triglycerides, vitamin E, ascorbic acid, magnesium (unspecified) and flaxseed oil, a sleep aid, tylenol (8-hour twice daily) (sometimes), and cephalexin 2 gm 1 hour prior to dental appointments.  The patient noticed left instep of foot looked like it had hemorrhaged and swelled when she was standing.  She stated that also the right leg behind the knee was very sore.  The patient did see the physician for this and was told it was not related to Zostavax.  There were no lab studies performed, no illness at the time of vaccination, and no adverse events following prior vaccinations.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/21/2007. Additional follow-up has been received concerning a retired female with a positive TB skin test but does not have tuberculosis-negative chest x-ray and a "pear sized" mass in right back for 1 1/2 years for which she will be having an MRI. On 23-Aug-2007 she was vaccinated subcutaneously in the left arm with ZOSTAVAX vaccine (Merck) at a pharmacy. On 23-Aug-2007 between 7-8pm (previously reported as between 6-8 pm) the patient started experiencing the adverse events. It was reported that the patient had stopped taking aspirin lately because she felt like she was bruising easily. Additional information is not expected.
Hives; SoB; diarrhea; intense GERD; tachycardia; once better in January and I tapered off Allegra ~ SOB feeling throat was closing; fatigue; exercise intolerance; burning; white tongue; numbness in face~ diagnosed with POTS;  laryngeal  spasm; vocal cord dysfunction~ still not well. Now on prednisone Allegra; Prilosec; omeprazole; some tests still pending
Fever 102 deg for 2 days, left arm red and inflamed from shoulder to elbow after receiving the pneuoccal vaccine occurred within 24 hours of injection on 10-16-06. Treated with moist pack and Advil, Hz blockers.
This spontaneous report was received from a registered nurse refers to 2 patients of unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, 2 patients were vaccinated with improperly stored VARIVAX, (lot# M002064 (expiry date: 12-JAN-2018) (dosage not reported). No adverse symptoms reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Client is only 61 years old but was accidentally given an injection of Fluzone High-Dose flu.  Spoke to client but he reports no side effects or adverse events whatsoever