chrisvoncsefalvay/vaers-outcomes huggingface dataset:
"Needle hit my bone". Pain 5 on 1-10 scale and 3 after taking ibuprofen. Limited ROM Oct. 18, 2014 spoke with 2 doctors who work with her in ER. States one doctor said it tendon injury, it will take a long time to heal. They recommended MOTRIN and warm compresses. Unable to lift heavy objects. Unable to sleep on left side.
arm hurt; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 85 or 86 years. After receiving Shingrix, the patient's arm hurt for about an hour before resolving. The reporter consented to follow up. For the tolerance of 2nd dose, refer linked case US2021AMR028492.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR028492:same patient
Monovalent vaccine given after deauthorization of booster dose on 08/31/2022.
This spontaneous report was received from nurse practitioner regarding 2 unspecified patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On an unknown date in 2016 (also reported as unspecified dates since 27-JAN-2016) 2 unspecified patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # L013827, expiry date 21-APR-2017) dosage regimen and route unknown. The nurse reported that the doses were exposed to several defrost cycles. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
2 HOURS AFTER RECEIVING THE FLU VACCINE ON 11/19/03, CLIENT EXPERIENCED ITCHING AND SORENESS AT THE SITE.  ON 11/20 CLIENT NOTICED REDNESS AND SWELLING AND PAIN IN RIGHT ARM.  CLIENT SEEN IN CLINIC 11/20.  INJECTION SITE SWOLLEN, RED AND WARM TO TOUCH.  AREA APPROXIMATELY 2 INCHES WIDE.  MD WROTE PRESCRIPTION FOR KEFLEX 500MG PO TID X 10 DAYS AND BENADRYL 50 MG TID X 5 DAYS.  CLIENT WAS CALLED ON 12/1 AND REPORTS SWELLING AND REDNESS WERE COMPLETELY GONE BY 11/29.
Child started to develop flu like symptoms (headache, excessive throw up, runny nose, seemed overly tired and upset, stomach ache including diarrhea. Temperature maintained 97.8 degrees so no fever. Two days post vaccine, symptoms have relieved and child is back to normal self.
can't sleep; she is angry, been crying, is depressed and is taking an antidepressant; headache; couldn't hear anything out of one of her ears temporarily; brain is ringing/debilitating/ringing in head; received vaccine and has been sick; stuttering words; body shaking; trouble walking; This spontaneous case was reported by a consumer and describes the occurrence of SUDDEN HEARING LOSS (couldn't hear anything out of one of her ears temporarily) in a 77-year-old female patient 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 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced SUDDEN HEARING LOSS (couldn't hear anything out of one of her ears temporarily) (seriousness criterion medically significant), TINNITUS (brain is ringing/debilitating/ringing in head), MALAISE (received vaccine and has been sick), DYSPHEMIA (stuttering words), TREMOR (body shaking) and GAIT DISTURBANCE (trouble walking). On an unknown date, the patient experienced SLEEP DISORDER (can't sleep), DEPRESSED MOOD (she is angry, been crying, is depressed and is taking an antidepressant) and HEADACHE (headache). At the time of the report, SUDDEN HEARING LOSS (couldn't hear anything out of one of her ears temporarily), MALAISE (received vaccine and has been sick), DYSPHEMIA (stuttering words), TREMOR (body shaking) and GAIT DISTURBANCE (trouble walking) outcome was unknown and TINNITUS (brain is ringing/debilitating/ringing in head), SLEEP DISORDER (can't sleep), DEPRESSED MOOD (she is angry, been crying, is depressed and is taking an antidepressant) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that, the patient was taking antidepressants for being angry, been crying, was depressed . The patient also stated that she bought silencil an over the counter medication that she bought on the internet but it didn't help. She wanted to know if she could get a tetanus shot.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The patient's age and concomitant use of antidepressants are confounding factors that may play possible contributory roles. No further information is expected at this time.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Added 1 new serious and 3 non-serious events. This case is upgraded per addition of serious event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The patient's age and concomitant use of antidepressants are confounding factors that may play possible contributory roles. No further information is expected at this time.
Dizziness, headache, on 6/29/2023-lips numb, high glucose, high blood pressure, diarrhea, light headed, tired,
Chief Complaint  Covid + on 8/25, sent here by PCP for CXR. Not really worse, buy has HX of Pneumonia.Not able to drink due to nausea, did start on Zofran yesterday which has helped some. Pt states O2 sat at home after nap was 83%  History of Present Illness  61yo woman with h/o severe obesity, LE edema, hypothyroidism, gout, who was vaccinated for COVID-19 in March 2021 and presents with progressive weakness, nausea, headache and chills.  Tested COVID positive on 8/25/2021 and has developed DOE.  SpO2 83% on ED arrival with scant nonproductive cough.  No chest pain or other pain.  No diarrhea.  No syncope.
She reported her left arm started hurting about an hour after injection.  Started having a mild to moderate headache around 5:30 pm on 02/23/21.  She reported that she was able to sleep that night.  Woke up around 4:30 am with a severe migraine, swelling in her left arm and fingers which continued to get worse throughout the day.  She took Tylenol, Ibuprofen, Benadryl, Maxalt before contacting the health department and physician.  She was seen by her primary care physician on the 02/24.  She received a Toradol shot, and was prescribed Flexeril. She reported that her headache started to lessen around 9:00 pm on 02/25/21.  She reports a mild head ache the morning of 02/26/21 and by 11:00 am her headache has resolved.  She is still having chills, and nausea.
Pt recv vax on 9/28/98; within 2 to 3 hr post vax pt exp inconsolable crying & vax site rx of erythema, swelling & warmth
pt recvd vax in AM fever 103.2 in afternoon per parent called MD APAP @ 1230 & 430PM; fever 105-ER blood drawn; 8SEP93 mom states pt cont to be fine;
Passed away; A spontaneous report was received from a Healthcare Professional concerning a 57-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and passed away/death.  The patient's medical history was not provided. However, the patient had some serious chronic health condition. No relevant concomitant medications were reported.  On 21 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: LOT: 011L20A Exp: 03July2021) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. He did not experience any symptoms right away and nothing within the next 15 mins under observation.  On 22 Jan 2021, the patient passed away.   Treatment details was not reported.  Action taken with mRNA-1273 in response to the event passed away, was not applicable.   On 22 Jan 2021, the patient died. It was unknown if an autopsy was performed.; Reporter's Comments: Very limited information regarding the event of death has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Passed away
Patient was given PROQUAD and KINRIX on 7-7-14 by mistake. He had already been given these vaccinations on 11-6-12. There were no adverse symptoms.
Received expired doses of the Moderna COVID vaccine; Vaccines placed in refrigerator on 13-Jan-2022 and dose administered to patient on 17-Feb-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 13-Jan-2022 and dose administered to patient on 17-Feb-2022) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 13-Jan-2022 and dose administered to patient on 17-Feb-2022). On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 13-Jan-2022 and dose administered to patient on 17-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the vaccines were placed in refrigerator on 13-Jan-2022. Expiration date placed on vial was 12-Feb-2022.  No treatment medications were reported.
she was diagnosed with Shingles; 3 little flat red spots; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (she was diagnosed with Shingles) and RASH MACULAR (3 little flat red spots) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced RASH MACULAR (3 little flat red spots). On 17-Feb-2021, the patient experienced HERPES ZOSTER (she was diagnosed with Shingles). At the time of the report, HERPES ZOSTER (she was diagnosed with Shingles) and RASH MACULAR (3 little flat red spots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment details were provided.
This spontaneous case reported by a consumer, describes the occurrence of  vaccination site pain (pain at the injection site) and lymphadenopathy (tenderness in lymph nodes in neck and under armpit) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Mar 9, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 9, 2021, patient experienced vaccination site pain (pain at the injection site). On an unknown date, patient experienced lymphadenopathy (tenderness in lymph nodes in neck and under armpit). At the time of the report, vaccination site pain (pain at the injection site) and lymphadenopathy (tenderness in lymph nodes in neck and under armpit) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant product use and treatment information not provided.
pt recvd vax & devel immediate redness & wheal above inject site of MMR; no c/o discomfort; ice pack to inject site; MD notified & DPH given; slight swelling inject site;
patient requesting a moderna vaccine and looked at the paper and miscalculated her date of birth. She is 17 yo as of date of vaccine
Information has been received from a medical assistant concerning a 11 year old male who "about one month ago", in April 2008, was vaccinated with the second dose of VARIVAX (Merck) (lot # 660057/1806U) in the office from a state varicella catch up registry. Subsequently the patient developed redness, swelling, erythema, and hardness at the injection site. The reaction site was about the size of a baseball. The patient recovered. This is one of several reports from the same source. Additional information has been requested.
Anthrax was given intra-dermal, this resulted in a 7 1/2cm X 4 1/2CM reaction with smaller central area of early necrosis (1/2cm X 2cm). Pt was given Atarax and prednisone. Pt followed up on 11/6/00. Her arm was almost all healed.
Headache and nausea which has lasted over 1 week and has not changed. Mild hives on hands and feet, which persisted about 6 days.
Received flu shot at 0900 am September 15, 2009. At 8 pm that night started getting a bad headache. At 9 pm felt as if I had fever and chills. Severe muscle aches in legs, arms, and lower back pain. Generalized fatigue, sore throat, nausea. Called in to be off work at 12 am 9-16-09. Unable to sleep due to severe muscle aches. Temp. was only 98.9F but I had chills and felt feverish. Awoke 9-16-09 and did not have any more muscle aches. I have a slight headache and a sore throat. I considered going to the hospital last night because my muscle aches were so severe but did not go because I did not have fever.Feel better this morning but am wary of getting the flu shot again.
patient started to have trouble swallowing and scratchiness in her throat. This worsened so she received benadryl 50 mg po.  Pt was feeling hot and was diaphoretic.  Pt monitored. Started c/o chest tightness. Was transported to the emergency room.
pt recvd vax 3MAR93 & 15 mins following vax pt became very hot & sweaty allover especially in upper body, face & arms; sx resolved p/appprox 30 mins; No further details were provided;
Shingles pain under my left arm.  Then had a second bout with shingles on 3/11/2012, and a third bout on 6/28/2013.  Now I have chronic nerve pain on the bottoms of both feet and down my left leg.
This spontaneous report was received from a pharmacist, as part of a marketing research program, refers to a 60 year old female patient. Information about patient's concomitant medications, concurrent conditions and medical history reported was unknown. In March 2015, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous (lot, expiry date, dose, site and route were not reported). In March 2015, the patient experienced redness, itchiness at the injection site. The outcome of the events was reported as recovered in March 2015 (it was reported that AE dismissed after stopping suspect drug therapy). The reporter considered the events to be related to ZOSTAVAX. Additional information is not expected as the reporter did not give a consent to disclose personal details.
pt recvd vax;flu like sx,aches & pains in joints,sore throat,nasal congestion,soreness under chin;rash 4feb on abd then entire body;glands behind rt ear enlarged;
Hand numbness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Hand numbness) 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 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 (Hand numbness). At the time of the report, HYPOAESTHESIA (Hand numbness) outcome was unknown.            No concomitant information was reported. Treatment information was not reported.   Reporter did not allow further contact
This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 11th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th October 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and muscle atrophy. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the muscle atrophy was not recovered/not resolved. It was unknown if the reporter considered the injection site pain and muscle atrophy to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. The patient experienced soreness and muscle atrophy at injection site. Limited information was provided by the physician. The physician wanted to speak to GlaxoSmithKline Medical Information (MI).
Patient was given the vaccine on Monday 1/21/07.  Her twin brother was given the same and had a more severe adverse reaction.  Unlike her twin brother, patient's reaction did not surface until Monday evening, Jan. 28, 2008.  There was a red welt at the sight of the shot.  Some discomfort and swelling.  I took her to Dr. and she gave us a prescription for Cephalexin, like her twin brother.
Information has been received from a registered nurse concerning a currently 6 month old patient who on 27-DEC-2011 was vaccinated with the first dose of ROTATEQ (dose, route and lot # not provided). On 13-JAN-2012, 2 weeks after the first dose, the patient received the second dose of ROTATEQ (dose, route and lot # not provided) and on 24-FEB-2012, the patient received the third dose of ROTATEQ (dose, route and lot # not provided). No adverse effect had been observed. Follow up information has been received from the physician. The male patient was vaccinated with the fourth dose of ROTATEQ (lot# reported as 1672AA) orally on 24-MAY-2012. The patient tolerated well. The lot number of the third dose of ROTATEQ was reported as 1539AA. Additional information is not expected.
swelling, muscle pain, neck pain, raised red bump size of a peach, hot to the touch, muscle weakness. fatigue, itching Used antihistamine cream from hot/itchy bump on arm.  seeked workers comp due to severity of muscle weakness treated with Steriod pak- did not work had to schedule a emg after this electro-magnetic therapy for my arm
Pt vaccinated with DTP/OPV developed fever to 105 (R) & increased irritability. Given Tylenol.
24 hrs after Inj. redness & pain (L) upper extremity, continue to worsen over the week. 2 sites, one inferior to inj site 6cm in diameter & tender. Distally, 10cm area warm, tender, & redder. Treated with KEFLEX 500mg Tid.
Within 15 minutes of vaccine - tightness in chest, difficulty swallowing;  Liquid Benadryl administered a symptoms reversed; April 25, developed severe Dermatographic Urticaria;
Immediately experienced arm pain. As the day went on, the pain escalated substantially. I essentially lost all use of my right arm the pain was so excruciating. My arm also swelled up and turned red and slightly purplish. (Took pictures of it, too.) I would try to move/lift my arm but absolutely could not. By late Sunday/early Monday (Jun 30/Jul1), the pain lessened some. The swelling went down by Wed., 7/3. It is nearly 2 weeks later, and I am still experiencing constant pain with sharp sudden pains when I raise my arm, try to sleep on my side, or use my muscles. I am concerned I may have permanent nerve damage now.
4 year old female patient inadvertently administered expired dose of QUADRACEL, no AE; Initial information received on 01-Dec-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a four year old female patient who was inadvertently vaccinated with an expired dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation.  On 30-Nov-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5532AA and expiry date: 31-Oct-2020) via an intramuscular route for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  Product used: used  At the time of report, 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.
MY LEFT ARM AT THE INJECTION SITE, IS VERY RED, HAS FEVER AND SKIN IS ROUGH, I HAVE ITCHING IN THAT AREA ALSO.  LAST NIGHT I HAD AN EPISODE WHERE I ITCHED ALL OVER MY BODY, BUT TOOK BENEDRYL AND THAT IS BETTER NOW.
PATIENT REPORTS A BURNING SENSATION DURING VACCINATION.  PATIENT FELT VERY SICK WITH FLU LIKE SYMPTOMS FOR TWO DAYS AFTER VACCINATION AND MISSED TWO DAYS OF WORK.
arms didn't get painful or sore. Unless I press really hard on it,; This is a spontaneous report from a contactable consumer(patient). This 77-year female patient BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: EM9809, Expiration date: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter stated she received the first dose of the Pfizer vaccine on Monday morning and had no reactions at all. "My arms didn't get painful or sore. Unless I press really hard on it, I wouldn't know I got an injection" on an unspecified date. Reporter queried that Was it possible that she was given a dose that was not effective and assume there wasn't any issues; with them storing it, diluting it correctly. Outcome of the event was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Once the needle was placed in the patient's arm, when the plunger was pushed the needle hub disconnected from the syringe and the liquid ran out. Readministered a new vaccine prepped syringe/needle into Left Deltoid.
POSITIVE COVID RESULT 9/7/21. KNOWN EXPOSURE ON 9/2/21 FROM FAMILY MEMBER