chrisvoncsefalvay/vaers-outcomes huggingface dataset:
painful muscle; muscle is tight and being pulled and its hasn't gone away; This is a spontaneous report from contactable consumer. A 72-year-old female patient received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 27Apr2021 as dose 1, single dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced painful muscle on his left arm after a couple of days. She experienced muscle pain whenever she is reaching above or behind. On her second shot, she reported the side effect with the pharmacist and was told the pharmacist is not aware or known to this side effect. The muscle in her upper arm on the inside was painful when she would reach behind her or up above, left arm. Pfizer shot on 27Apr2021 and a couple days after that she noticed the muscle in her upper arm on the inside was painful when she would reach behind her or up above and she mentioned it to the pharmacy when she got her second shot, and (name withheld) the pharmacist hadn't heard about that kind of reaction before. Caller states she got her second shot and she's still having that muscle pain when she reaches behind her with that arm or when she reaches up. Caller states its almost like the muscle is tight and being pulled and its hasn't gone away.  That information on the Lot/batch number has been requested
No adverse event; A nurse reports that they inadvertently administered the pediatric bivalent (pink cap) as the initial dose to a 6 month old patient on 01-May-2023.; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (A nurse reports that they inadvertently administered the pediatric bivalent (pink cap) as the initial dose to a 6 month old patient on 01-May-2023.) and NO ADVERSE EVENT (No adverse event) in a 6-month-old female 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.     Patient had no relevant medical history, allergy, concomitant diseases and risk factor. It was reported that patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant products included PENTACEL, ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX), HEPATITIS B VACCINE (HEP B VAX) and PNEUMOCOCCAL VACCINE (PNEUMOCIN [PNEUMOCOCCAL VACCINE]) for an unknown indication.    On 01-May-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .2 milliliter. On 01-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (A nurse reports that they inadvertently administered the pediatric bivalent (pink cap) as the initial dose to a 6 month old patient on 01-May-2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (A nurse reports that they inadvertently administered the pediatric bivalent (pink cap) as the initial dose to a 6 month old patient on 01-May-2023.) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (A nurse reports that they inadvertently administered the pediatric bivalent (pink cap) as the initial dose to a 6 month old patient on 01-May-2023.).    No medical history was reported by reporter. No treatment information was provided.
The same day as vax, the pt woke up around 7:30 PM and was crying non-stop. She was taken to the local ER and then transferred to another facility ER. Exam was normal except for gassiness. The pt has calmed down after being swaddled and given Mylicon drops.
All hours post shot: -8 hrs: uncontrollable chills  -10 hrs: fever set in for the next 24 hrs at 102 my normal temp is 97. -13 hrs: body aches like you couldn?t imagine-I could not move my arm. Could not lift it, nothing.  -13-24 hrs: loss of appetite/nausea wicked body aches took an aspirin, lowered the fever to 100 but it came back in the middle of the night. -extreme thirst and feeling dehydrated even though I was drinking massive amounts of water  -24-30 hrs: lethargic and I basically went from my couch to my bed and slept but not a deep sleep more like a pass out from the pain sleep. Didn?t eat all day.  ??Massive headache and pressure that lasted for 48 hrs.  -32hrs: Finally got the energy for a bath that helped with the pain in my lymph nodes and joints. Took two Asprin. Fever came down at around 34/35 hrs post shot -36hrs: Started to feel better and ate something. Body aches and pains subsided.  -Fever came back in the middle of the night (101) on the second day took aspirin and it went away  -48 hrs: Feel really weak like I just had the flu. Headache.
Abd flat red rash onset 10/13/13 AM spreading to entire lower torso chest down, face around eyes and mouth and neck, no lessening with OTC BENADRYL.
Patient falsified DOB when registering for vaccination, stating the minor was 05/28/2004. Guardian consented to the vaccination. Department of Health verified with statistical records that the patients actual DOB is 05/28/2005 which made the vaccine a contraindication. No known adverse reactions noted.
6-23-14 received a ZOSTAVAX vaccine at MD office. Area was clean and prepped with alcohol. Shot was not given in deltoid region and skin was not pinched, so I am not sure if it was administered sub q as manufacturer directed. Subsequently developed large, cellulitis spreading from area of administration over entire arm and axilla. Two additional office visits. Prescribed course of prednisone, cephalosporin, and probiotics. I am not sure if the skin is highly irritated from wrong administration technique of it med was contaminated. No known allergies to ingredients.
myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (myocarditis) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.  Company Comment: This is a Spontaneous case concerning a male patient of unknown age, with no medical history reported, who experienced the expected and serious (due to medically significant) ADR of Myocarditis, on an unknown date after a dose of mRNA-1273 vaccine. This case is reported by a consumer during a call to medical information, who stated that her next door neighbor has myocarditis after a dose of mRNA-1273 vaccine. No information disclosed about diagnostic tests performed, clinical course or treatments received for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-577107 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a male patient of unknown age, with no medical history reported, who experienced the expected and serious (due to medically significant) ADR of Myocarditis, on an unknown date after a dose of mRNA-1273 vaccine. This case is reported by a consumer during a call to medical information, who stated that her next door neighbor has myocarditis after a dose of mRNA-1273 vaccine. No information disclosed about diagnostic tests performed, clinical course or treatments received for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Shingles on right side head, back, and neck 1 week following second dose. Painful lesions and neurological discomfort as well as muscle pain occured.
It was reported that a pt (2 of 3) received a Tripedia vaccination (date not specified). Reportedly, the pt developed a local reaction at the injection site (onset date not specified).
( whole arm) hot to the touch; whole arm was red; red spot near injection site; hypersensitivity reaction; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (( whole arm) hot to the touch), ERYTHEMA (whole arm was red), PAIN IN EXTREMITY (arm soreness), INJECTION SITE ERYTHEMA (red spot near injection site) and HYPERSENSITIVITY (hypersensitivity reaction) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Drug allergy (Demerol- vomit and pass out), Drug allergy (Augmentin- stomach cramps), Environmental allergy (mold- wheezing), Environmental allergy (mildew- wheezing) and Crohn's disease since July 2012. Concomitant products included MESALAZINE (LIALDA) for Crohn's, ESTRADIOL (VAGIFEM) for Dryness vaginal, LANSOPRAZOLE (PREVACID) for Reflux esophagitis, LEVOTHYROXINE, METHOCARBAMOL, CENTRUM SILVER +50, CALCIUM, ASCORBIC ACID, ECHINACEA PURPUREA (ECHINACEA + VITAMINA C VITATECH) and BIOTIN for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On 06-Feb-2021, the patient experienced HYPERSENSITIVITY (hypersensitivity reaction). On 10-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (red spot near injection site). On an unknown date, the patient experienced INJECTION SITE WARMTH (( whole arm) hot to the touch) and ERYTHEMA (whole arm was red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 06-Feb-2021 to 03-Mar-2021 at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTOBISMOL) 28-Feb-2021 at an unspecified dose and frequency. On 01-Feb-2021, PAIN IN EXTREMITY (arm soreness) had resolved. On 11-Feb-2021, HYPERSENSITIVITY (hypersensitivity reaction) had resolved. At the time of the report, INJECTION SITE WARMTH (( whole arm) hot to the touch), ERYTHEMA (whole arm was red) and INJECTION SITE ERYTHEMA (red spot near injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included evening primrose oil, used for unknown indication.   This case was linked to MOD-2021-192267 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow-up was received on 01-JUN-2021 Contains significant information. added patient demographics, current condition and allergy details in medical history tab, updated dose and indication for concomitant medication, New treatment medication and new event were added. On 30-Jun-2021: Follow-up was received on 30-JUN-2021 contains No new information.
Infection; Took 1 dose of Vivotif and had her stop the Vivotif to start the antibiotic; Took 1 dose of Vivotif and had her stop the Vivotif to start the antibiotic; A spontaneous report was received from a pharmacist on 24OCT2023 regarding a female patient of unknown age who "took 1 dose of Vivotif and had her stop the Vivotif to start the antibiotic" (PT: Incomplete course of vaccination and PT: Therapy cessation) for an "infection" (PT: Infection). The patient took Vivotif (typhoid vaccine live oral Ty21A; lot number: unknown) for an immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient took the first dose of Vivotif and needed to take antibiotics for an infection. Thus, the reporter had to stop Vivotif to start the course of antibiotics of the patient. Reportedly, the patient had two months before she would be "exposed to Typhoid".  The outcome for the event "took 1 dose of Vivotif and had her stop the Vivotif to start the antibiotic" was not applicable and for event "infection" it was unknown.  The action taken with Vivotif with respect to the event "infection" was withdrawn and it was not applicable for event "took 1 dose of Vivotif and had her stop the Vivotif to start the antibiotic".  No additional information was reported.  Company comment: This case concerns a female patient who took 1 dose of Vivotif and had her stop the Vivotif to start the antibiotic (incomplete course of vaccination and therapy cessation) for an infection (infection NOS). This case lacks information on the event of infection, start date, and relevant medical history of the patient. Hence, the causality for the event of infection NOS is not assessable until further information is received.  The causality for the events of incomplete course of vaccination and therapy cessation is assessed as not applicable considering the nature of the events.; Sender's Comments: This case concerns a female patient who took 1 dose of Vivotif and had her stop the Vivotif to start the antibiotic (incomplete course of vaccination and therapy cessation) for an infection (infection NOS). This case lacks information on the event of infection, start date, and relevant medical history of the patient. Hence, the causality for the event of infection NOS is not assessable until further information is received.  The causality for the events of incomplete course of vaccination and therapy cessation is assessed as not applicable considering the nature of the events.
This case was reported by an other health professional via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were reported as follows: The age at vaccination was not applicable for this report. The reporter said if a patient missed his 2nd dose of Shingrix by 1 year, do they have to restart the 2 dose vaccination. The patient did not received 2nd dose of Shingrix till the time of reporting which led to incomplete course of vaccination. No contact details were available.
April 3, 2022 I broke out in hives and have had severe back pain to the right of my spine just below waist level.  April 9 I went to my rheumatologist and had a blood draw.  My Sjogrens was back and my numbers were 3x worse than when I last tested positive for the disease
Patient returned 6-23-19 and told me she had some swelling and redness.  Sore arm.  Recommended she watch and contact her Dr if worsens.  Returned to pharmacy on 6-26-19 stating unable to move arm , swelling gone. and Dr office gave her a "antiinflammatory " shot. unknown what it was.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 1:36 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 1:36 PM, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 76.07  Concomitant products were not provided.  On 12-Feb-2021 Excursion time was reported at 10 am and 11 am with temperature as 35 and 35 degrees Fahrenheit respectively , total doses given for the day was unknown, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 12-Feb-2021. 3 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Got 2nd SHINGRIX injection after waiting 2 months after first and got similar side effects including body aches, headache, malaise. Lot no 32PE4, exp 1/23/2021.
Initiated vaccine series on 7/25/19, completing on 7/31/19. On 8/5/19 vomited once, felt better afterwards.  On 8/10/19 experienced several hours of stomach ache, nausea and cramps; vomited 8/11/19 at 0200 hrs; followed by several hours of stomach ache. No further symptoms. Denies fever or diarrhea, nor additional possible causative factors. Did not seek medical treatment.
Information has been received from a certified medical assistant concerning a 19 year old female with no pertinent medical history and no known allergies or adverse drug reactions reported. On 9/5/06, the pt was vaccinated IM with one dose of HPV rL1 6 11 16 18 VLP vaccine yeast. Concomitant therapy included Ortho Tri Cyclen. It was reported that the pt woke up the next morning and her skin was pink from head to toe. There was no rash, no pain, no itching, no swelling and no hives. It was reported that her only symptom was a sunburn like appearance to her skin. the pt sought unspecified medical attention. On 9/7/06 in the evening, the color began to subside. As of 9/8/06 her skin was reported as looks better and the pt was noted as recovering. Additional information has been requested.
Severe pain to left deltoid, decreased ROM to ipsilateral shoulder, no swelling, erythema or rash to injection site.
Cluster of 3 patients (individual patient identification provided) experienced injection site reaction with Decavac (lot number U1587BA) received from a nurse in the USA on 16 November 2006. A 37-year-old female patient developed redness, swelling, pain and itchiness at the site, 3 hours after she received an injection of Decavac (lot number U1587BA, routed of administration not reported) in the left arm on 03 November 2006. The symptoms lasted for 1 week. The patient recovered. Follow-up information received on 05 March 2007 from a health care professional. Decavac was administered intramuscularly. Additional medically relevant information was not reported. This case has the same reporter as case 2006-03127, 2006-03128, 2006-031129.
covid arm; red rash; bumps; itchy; A spontaneous report was received from a consumer concerning a 62-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events covid arm, red rash, bumps, itchy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 17 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 045A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 25 Mar 2021, the patient experienced the event(s) covid arm, red rash, bumps, itchy.  Treatment details included none.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), covid arm, red rash, bumps, itchy was unknown.
slight tingling in my left cheek on my face; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN), via an unspecified route of administration in the left arm on 24Feb2021 at 09:30 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history included shellfish allergy and gluten intolerance. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Feb2021 at 10:00 the patient experienced slight tingling in left cheek and on face which was reminiscent of allergic reaction to shellfish. The patient did not receive any treatment for the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of tingling was recovered on an unknown date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
c/o arthralgias in bilat 1st metacarpals, bilat 1st metatarsals & lt hip several hr p/vax;spontaneously resolve p/7-10 days;has occurred p/all 3 vaccinations w/anthrax;negative fever, chills, malaise, N&V; no tx needed;
Pt recv vax in 12/98; immediately post vax pt exp knot at vax site w/ purple color
On approximately 03/20/2001 the patient experienced redness and swelling at the injection site. Subsequently, the patient recovered from redness at the injection site. Subsequently, the patient recovered from redness at the injection site and swelling at the injection site up to the neck. On approximately on 04/02/2001 the patient recovered. Additional information has been requested.
arm pain, fatigue, headache, muscle pain, fever 102.4, severe chills, nausea, dizziness, fast heartbeat