chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness in the arm not too bad; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Soreness in the arm not too bad).The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.   It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient experienced a little soreness in the arm but not too bad. The follow up would not possible as no contact details were available.
no adverse effect; patient received improperly stored dose of VARIVAX; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 30-MAR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), 1 dose, lot # S025609, expiration date 18-AUG-2021 (exact dose and route of administration were not reported) for prophylaxis. The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted in a properly stored sterile diluent. The administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) experienced the temperature excursion of 15 Fahrenheit (F) degrees to 46 F degrees for 7 hours. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No additional adverse effects were reported.
Pt recv vax series 11/21/94, 1/9/95 &4/17/95; on 4/26/95 pt exp erythematous of rt arm w/ pain, warmth & induration;dx=bite?; tx=Keflex w/out resolve;5/1/95 pt exp knee pain &LA rx;dx= phlebitis/cellulitis; final dx=erythema induratum
Marked erythema/edema (about 5x/5 cm) starting 24 hrs after injection extending down arm (R). Pt started on po Clindamycin x 10 days. Pt afebrile.
when she tries to bend her right arm, it hurts; joint pain on her right arm; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (when she tries to bend her right arm, it hurts), ARTHRALGIA (joint pain on her right arm) and MYALGIA (muscle pain) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No medical history reported by the reporter.  Concomitant products included LOSARTAN, ATENOLOL, ATORVASTATIN, GLIPIZIDE, LEVOTHYROXINE, METFORMIN and FERROUS SULFATE for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (when she tries to bend her right arm, it hurts), ARTHRALGIA (joint pain on her right arm) and MYALGIA (muscle pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (when she tries to bend her right arm, it hurts), ARTHRALGIA (joint pain on her right arm) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment  included ice pack.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow-up received on 22-Apr-2021 as no new information added email address for the reporter.
A mild constant headache lasted almost a week.  I went to bed last night with it still throbbing but today Mon Sep 14th, it appears to be gone.  I developed a large red area around the injection site, about the diameter of a tennis ball and 4" in length, extremely tender and hot to the touch.  This morning it was finally gone.  I also developed a rash/hive-like appearance on my chest and upper back.  My cheeks were also flushed and red and when I ran my fingers around the top of my forehead and under my eyes at the top of my cheeks, it was tender to the touch.  Once again, all of these symptoms lasted through Sep 13th.  Today, the redness, soreness, and tenderness are gone, and my energy level is returning. I am wondering if it is safe for me to get the second injection, and if so, should I wait the full 6 months?
left shoulder muscle and upper chest swelling; pain on side of injection; left shoulder muscle and upper chest swelling; This is a spontaneous report from a contactable consumer.   A 35-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 17Feb2021 10:15 (Batch/Lot Number: En6201) as single dose at the age of 35-year-old for COVID-19 immunisation, administered at Public Health Clinic.  Medical history included born with Poland syndrome: no left pectoral muscle, known allergies: Pencilin. No COVID prior vaccination. Concomitant medication(s) included verapamil (manufacturer unknown); escitalopram (manufacturer unknown); lamotrigine (manufacturer unknown); calcium (manufacturer unknown), all taken for an unspecified indication, start and stop date were not reported. The patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 27Jan2021 10:30 (Batch/Lot Number: El9262) as single dose at the age of 35-year-old for COVID-19 immunisation. No other vaccine in four weeks. The patient experienced left shoulder muscle and upper chest swelling, and pain on side of injection on 19Feb2021 07:00 am. Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received. The events were considered non serious. COVID was not tested post vaccination. The outcome of events was recovering.    Follow-up attempts are completed. No further information is expected.
Patient called pharmacy to report "extreme numbness" in her hand on the arm that she received vaccine. Numbness started morning of 10-24-19 right hand
Visual disturbance, numbness/tingling of arm, headache, photophobia - symptoms of migraine however no personal or FH of migraines.
Headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st September 2021, the patient received the 1st dose of Shingrix (intramuscular). On 21st September 2021, less than a day after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows:  The case was reported by patient herself. The patient received Shingrix vaccine intramuscularly in left deltoid and experienced a headache. The reporter consented to follow up.
Patient developed itching and rash after vaccination. Presented to ED 4 days later as the symptoms had continued.
approx 130PM 7FEB96 mom called started that pt slept for long time then woke up trembling;no fever;was told to take pt w/immunization record to ER as soon as possible/now;mom agreed to do so
Extreme tinnitus starting about 12 hours after booster shot. I suspect that my manageable preexisting tinnitus was brought on by the initial Moderna shots, and the extreme spike right after receiving the Pfizer booster confirms my suspicion. My tinnitus has gone from 3/10 to 9/10. Very distressing.
Site: Pain at Injection Site-Medium, Additional Details: needle detached from barrel and stayed in pt arm. nurse removed needle tip from pt arm
Patient states on day of injection the site got sore and red and then warm. Since then she noticed redness, heat and swelling which traveled down that arm and beyond her elbow.
Moderna COVID-19 Vaccine EUA: adverse event 65 y/o female PMHx morbid obesity, HTN, and Covid+ in 01/2021. Rec'd Moderna vaccines 4/23/21, 5/21/21 and booster approximately 2 weeks. Per patient, she has had SOB x5 days was diagnosed with pulmonary embolism at emergency department on 12/15/21 and sent to the hospital for evaluation due to significant clot burden PTE. Admitted for pulmonary embolism, tx'd w/enoxaparin d/c'd home 12/17/21.
Pt received covid shot and after 10 minutes became dizzy. Recovered well after laying on the floor and resting at the pharmacy an additional 15 minutes
On May 12th I started menstrual bleeding that lasted for about a week that was quite heavy for a couple of days and was similar to a regular period except that I am in menopause and have not had a period for about 3 years
As warned, arm pain, which was more severe around site of injection. Also, not explained, was extreme fatigue and chills on evening of injection. Achy, mild fever and slight headache the following two days. Site of injections continues to be sore, but other symptoms have since subsided as of this afternoon, 01/27/2021. Took Tylenol in evening and morning to counter symptoms, which provided relief.
Date of shot-May 20, 2021 (Thurs) injection site right arm slightly sore. Had chemical taste in mouth within 30 minutes after shot; urine had chemical odor after shot. May 21, 2021 (Fri) injection site right arm more sore and could not turn my head to the right as my right neck (lymph nodes) were all swollen. Had chills, headache, fatigued and threw up after eating light breakfast. I iced and took Advil. PM/Bedtime-could not get deep breaths through nose breathing/had to mouth breath-hardly slept. May 22, 2021 (Sat) called emergency room and Pharmacist (primary Pharmacist still on vacation) was told to switch to HEAT pad on my neck, take Advil. Right arm injection site, up the arm, across collar bone, up the right neck to ear lobe all swollen and painful since Friday-hardly any change.  May 23, 2021 (Sun) so tired from not sleeping well (could not lay on right side since the shot) and slept mostly all day.  May 24, 2021 (Mon) feel a little better but neck is still swollen and sore. 50% motion back to turn my head to the right. Breathing better when laying down through my nose as well.  I would like to talk with a Doctor at the CDC as I do not have a Primary Doctor, and was just referred to one, but cannot schedule to see him until mid June. I am nervous if the 1st Moderna shot is causing internal swelling, bleeding, etc. ? And I am not planning on getting a 2nd Moderna shot after this severe reaction caused by the 1st shot.   I am healthy, never take drugs, get flu shots, etc. and my body felt like it was fighting a battle...and I am not 100% myself. I want to know WHEN my neck will heal, WHEN my motion will be back to 100%  as it is making driving challenging, and what next steps you recommend.  Please advise.
headache and left sided jaw / neck pain with swelling.  There is a rash on the left side of his scalp.  Patient is diagnosed with shingles. Patient starts Valtrex and pain is treated with hydromorphone, diazepam and Percocet..
My arm keeps jump; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (My arm keeps jump) 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 MUSCLE TWITCHING (My arm keeps jump). At the time of the report, MUSCLE TWITCHING (My arm keeps jump) outcome was unknown.            No relevant Concomitant Medications were reported. No Treatment Information Provided.
4hr p/inj fever x 3 days to 103;appetite dec, sleeping more than usual;cries while awake;pink around eyes w/sl swelling;
Rash started on left ankle, then back side of knees, lower back, inner forearms, thighs front and back and buttocks.
The patient received a 3rd dose of Moderna by mistake.  No adverse advents were reported
Information has been received on 04-JAN-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 01-JAN-2015, a healthcare provider at a community health center administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 02-AUG-2016, the patient was treated by a healthcare provider at a community health center for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
Swollen lymph nodes around neck, under and behind jaw, and minor inflammation of tonsils.
Developed symptoms of COVID  3 1/2 days after receiving 1st Vaccine and tested positive the following morning
Client reports that 4 days after receiving vaccines, May 23, 2013, he noticed small red bumps across forehead (he thought it could be a heat rash). He did not go to a doctor. He also thought rash could be related to vaccines being given the same day. He received antibiotics for two different sexually transmitted infections.
Pt complained of back aches/ stiffness, swelling, redness the size of a nickel and pain in right arm/ occurring the evening of receiving the tetanus vaccination.
This spontaneous report was received from a registered nurse and refers to a 4-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-DEC-2018, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB, lot # R014261, expiration date 25-MAR-2021 or lot # R005118, expiration date 28-NOV-2020 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Sore arm; Headaches off and on; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2022, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, 1 day after receiving Shingrix, the patient experienced pain in arm and headache. On an unknown date, the outcome of the pain in arm and headache were recovered/resolved.   It was unknown if the reporter considered the pain in arm and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-JUN-2022 Reporter's Comments:  The patient reported case for himself. The patient had a sore arm the next day that lasted for a couple of days and getting headaches off and on that started on the third day after his vaccine and last for a few weeks. The patient did not have any further information about the vaccine. The reporter did not consent to follow-up. No HCP for follow up.
Five days days after the vaccine I pain in my chest and all the way around my back on left side.  The pain was intermittent and it seemed to move. I went to the the emergency room and they did some tests and the results were normal. I have been taking some Tylenol and it helped a little. It has been four weeks and I still get the pain intermittently for a couple of hours every day and it is mostly in my back. It is a little less frequent but not much better.
Tightness, and some pain in chest; shortness of breath; numbness in left arm
Pt described having headache & nausea after getting flu shot. Called the pharmacy 5 days after having had flu shot. Not sure if it's from flu shot or other underlying condition.
PRESUMED DIAGNOSIS, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) (COUGH/WHEEZE/COULDN'T BREATHE); This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the patient experienced presumed diagnosis, chronic obstructive pulmonary disease (copd) (cough/wheeze/couldn't breathe). On 12-APR-2021, Laboratory data included: Oxygen saturation (NR: not provided) low. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of presumed diagnosis, chronic obstructive pulmonary disease (copd) (cough/wheeze/couldn't breathe) was not reported. This report was non-serious.
Suspected vaccination failure/Patients have shingles despite being fully vaccinated; Shingles; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included covid-19.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     Additional Information: GSK receipt date: 07-Apr-2022 Reporter's comment: The physician at her speaking event reported that as a physician she had seen many more patients had breakthrough shingles cases despite being fully vaccinated with Shingrix after having covid infection (unspecified number of patients, unknown date of birth of patients, and unknown gender).  The reporter did not provide any additional demographical information or contact information.  The health care professional was not currently practicing. Consent was not obtained, lot/expiry date not available. No further information was provided. Did not consent to follow-up. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
I'm not sure it's related and it's embarrassing. Day one I had a sore arm and joint pain. Day 2 I had a low grade fever Day 3- multiple spontaneous orgasms ( well over 30) I have never experienced anything like this before. It is uncomfortable and embarrassing
Red rash around injection sites on both legs. Erythema started 12-16 hours post vaccination. No treatment other than close observation.
9/12/15-c/o dizziness. 9/14/15-hard to swallow. 9/15/15-hives (R) and (L) leg, rapid heart rate, trouble swallowing.
Intense arm pain in left arm, swollen supraclavicular lymph nodes on left side, strong fatigue within 24 hours, intermittent fatigue daily for six days after, 48 hours headache not responding to acetaminophen
reaction in the arm / pain/ soreness; reaction in the arm / inflammation; reaction in the arm / pink colored skin; This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th July 2021, the patient received the 1st dose of Shingrix. In July 2021, less than a week after receiving Shingrix, the patient experienced inflammation localized and skin discoloration. On 24th July 2021, the patient experienced pain in arm. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain in arm, inflammation localized and skin discoloration were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, inflammation localized and skin discoloration to be related to Shingrix.  Additional details were provided are as follows: The age at vaccination was not reported. The patient was taking anticoagulants. The patient received 1st dose of Shingrix on an unknown arm and less than a day after receiving Shingrix, developed reaction in the arm which included pain, soreness and less than a week after receiving Shingrix, had inflammation and pink colored skin. The reaction was not located in the exact injection site but a few centimeters down. The patient did not presented fever, chills or swelling of the lymph nodes. The patient had been taking Ibuprofen since then. The pain started after the injection, but the rest of the symptoms developed through time and remained till the time of reporting.  Lot number and expiration date of the vaccine were not obtained since the administration of Shingrix was done in an unknown facility. The reporter consented to follow-up.
Systemic: Fainting / Unresponsive-Medium, Additional Details: PT had a syncopal episode 2 minutes post vaccination, fell with questionable head strike. PT was unconscious for less than 10 seconds and was easily arousable afterwards. EMS activated and PT continues to feel dizzy and somewhat nauseous. Transported to hospital for further evaluation.