chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2012US018687 is an initial spontaneous report received from a health care professional on 05 Sep 2012, and with the follow-up received on 16 Oct 2012: This report refers to an 11-year female child. She was vaccinated with MENVEO (batch number: M11082 and expiry date: 31 May 2014) intramuscularly in the left arm on 31 Aug 2012 at 09:58 am. This vaccine had reached up to 11 degree Celsius for 30 to 60 minutes. No adverse event was reported following this administration error (incorrect storage of drug). Follow-up received on 16 Oct 2012: Updated patient height and weight, vaccine route of vaccination, site of vaccination and time of vaccination.
very sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (very sore right arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Asthma, Dust allergy, Allergy to molds, Grass allergy, Allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy and Drug allergy (very sensitive to Epinephrine.). Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) for Lung disorder NOS, LEVOTHYROXINE for Thyroid disorder NOS, CLOPIDOGREL BISULFATE (PLAVIX), ESCITALOPRAM OXALATE (LEXAPRO), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), FLUTICASONE PROPIONATE and SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for an unknown indication.    On 19-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 MYALGIA (very sore right arm). On 20-Feb-2021, MYALGIA (very sore right arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication include Flonase which was mentioned the indication as Inhaler and for Albuterol the indication was mentioned as Inhaler only for rescue. No Treatment medication was reported.   This case was linked to MOD-2022-474566 (Patient Link).
Pt reported having a firm and warm "knob" on her left upper arm the evening after receiving the vaccine. Had low grade fever 100.3 Tues and Wed evening, which resolved. Redness, swelling, and warmth gradually spreading throughout left upper arm. Here today in clinic and was treated for skin infection.
but then contracted Covid; but then contracted Covid; feels sluggish; ill; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration on an unspecified date as single dose and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient received both shots of the Pfizer COVID vaccine, but then contracted COVID, felt sluggish and ill. The patient underwent lab tests and procedures which included COVID test: contracted COVID. The clinical outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Coughing, shortness of breath, migraine type headache, fever, under arm/armpit pain, swollen lymph nodes under arm, blurred vision, tiredness, dizziness, nausea, chills.   Alternated taking tylenol and Advil for 48 hours.
Left arm numb and tingly. Dec to present needle pricks randomly off and on thru out body.
Achy muscles - lasted about 20 hours; shivering - lasted about 6 hours
Throbbing/pounding pulse, irregular heartbeat/palpitations, chest discomfort.
Pain and skin sensitivity began in right arm on Feb. 1, 2021.  On the evening of  Feb. 8, a rash broke out on the arm.  The next morning  I set up a telemedicine visit  with my doctor for that afternoon (Feb. 9).  In that visit  I described my symptoms and showed him the rash.  He diagnosed shingles. That evening I started a course of the anti-viral drug Valacyclovir. It took approximately two weeks for the pain and rash to disappear.  I got my second Moderna shot on Feb. 26.
Pr received her Moderna covid 19 vaccines on 2/26 and 3/26/21 and per the daughter she went downhill since with progressive fatigue and not acting herself and failure to thrive with poor appetits. she was hospitalized from 6/9-6/19/21 with recurrent urinary tract infection despite appropriate treatment as an out pt, severe sepsis, diffuse pneumonia, acute metabolic encephalopathy, severe, persistent hypokalemia due to poor po intake and a pancreatic mass- possibly malignant with negative ca 19-9 incidentally found on imaging. She was sent home on comfort/hospice care on 6/19/21 as family opted for no further aggressive treatment for the pancreatic mass. she was treated with antibiotics for the sepsis, pneumonia and urinary tract infection during her hospital course.
TESTED POSITIVE FOR COVID-19; This spontaneous report received from a physician concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: feeling ill, felt weak, and tired. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 10-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, Laboratory data included: Fever (NR: not provided) 100.5 degree Fahrenheit, and Vital signs measurement (NR: not provided) stable. On 10-AUG-2021, the patient experienced tested positive for covid-19. On 14-AUG-2021, Laboratory data included: SARS-CoV-2 rapid diagnostic test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid-19 was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as case assessed as non-serious.
12 hours after the second dose of the Moderna vaccine I experienced fever, body aches, and chills
Insomnia,agitation at 11pm 3/4/21 continued until 8am 3/5/21.   Myalgia's and arthralgias began 8am 3/5/21 continued until 10pm 3/5/21.   Temp to 100F 2pm 3/5/21 until 10pm 3/5/21 Upset stomach 4pm until 11pm 3/5/21 Soreness at injection site  Alternated acetaminophen and ibuprofen q8h
I came home and the next day, I felt super weak. I was lethargic, had a headache, chills, body aches. No ever. I laid on the couch all day and the next day I was fine.  By 1/31, my symptoms had resolved.
This 44-day-old female received vaxs on 04/26/1999. Within 2 hours post vax, the infant developed a red rash that looked like a 'rough rash' which worsened, and extended to her chest, back, arms and legs. She also developed vomiting and 'explosive green loose stools' which started one day post vax and lasted for 2 days. The pt was presented to the physician and was diagnosed with acute gastroenteritis. Subsequently, the pt recovered form acute gastroenteritis. No further information is available.
After waking in the AM of the following morning after vaccination,  felt total exhaustion and weakness, unable to function with morning duties, left arm sore with a notable lump approximately 2 inches wide.   Able to lie down and sleep for about an hour; awoke and felt better.  Took two 200mg ibuprofen and laid down again.  Within an hour of rest, felt awake with no weakness or exhaustion.  Arm was less sore; however placed a warm heating pad on arm throughout the day which improved the lump and soreness.
57 yo Hispanic female  c/o dizziness and heart palpitation 15 minutes after receiving her 1st dose of Pfizer vaccine.  Patient husband  stated when he attempted to lift her from her seat she got light headed. Staff member notified EMS and NP of the incident. Patient  was evaluated by on-site EMS and NP.  VS and EKG initiated. All WNL.  Patient has no PMH. NKA . After about 15 minutes patient was reevaluated by NP and EMS. Patient stated she was feeling better and agreed to allow family member to drive her home.
fever, crabbiness; temp max 102; crabbiness intermittent resolved in 48 hr;
Initial misuse report received from a healthcare professional (nurse) on 30 December 2013 and the case was received on 21 March 2014 at GPV. A 68-year-old patient (gender was not reported) had received a dose of FLUZONE ID vaccine (batch number, route and site of administration was not reported) on an unspecified date. No adverse event was reported. List of documents held by sender: none.
a female patient received Adacel when she was 63 years of age, and again in 6 months at the age of 64, no AE; Initial information received on 14-Feb-2020 regarding an unsolicited valid non-serious case from a other health care professional (medical assistant).  This case involves a 64 years old female patient who received a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (ADACEL) when she was 63 years of age, and again after 6 months at the age of 64 (lot number and expiry date not reported)  via unknown route and in an unknown administration site for prophylactic vaccination on an unknown date.  Medical history, medical treatment, vaccination and family history were not provided.   It was an actual medication error due to extra dose administered.  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.  Information on batch number was requested.
Presented with syncope at home; +covid in ED; mild hypoxia; VSS; also dx with UTI; Labs: D-dimer <0.27; WBC 5.1; TX: steroids, supplemental O2 (2 LPM NC), antibiotics (doxycycline), zinc; Rocephin for UTI; back to room air at D/C
Improperly stored dose of GARDASIL 9 was administered to the patient on an unknown date; no adverse effects; This spontaneous report was received from a medical assistant regarding a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # N022952, expiration date: 14-JUN-2020 (exact dose, strength and route of administration were unknown) for prophylaxis (product storage error). The vaccine underwent temperature excursion below 36 degree Fahrenheit: 32.1 Fahrenheit for a duration of 8 hours. There was no previous temperature excursion. There was an involvement of data logger. No product quality complaints were involved.
100 x 80 cm circular, raised, warm to touch, red swelling, on right thigh.
Next day about 11 am, began fatigue, chills, low grade fever. 99.8 to 100.3 slept most of the day. Vaccine sight was sore but no more than expected. All side effects have subside by this morning as I got up. Still tired but had a poor nights sleep with an episode of heavy sweating. Feeling fine now..
My symphons were lightly sore arm and took the two Tylenol on the same day and the pain went away 2 -3days. The other was extra fatigue for about one off and on.
Mom called office 1 hour after child received vaccine states she felt dizzy and nearly fainted. Also reported increased irritability.
Myalgia; Slight fever; Joint pain; Fatigue; Chills; Worsening of tinnitus; Headache; Gastrointestinal distress; Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 50-years-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6199, expiration date: unknown) via an unspecified route of administration, administered in Arm Right on 25Mar2021 11:15 (at the age of 50-years) as dose2, single for covid-19 immunization at workplace clinic. Historical vaccine included received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration. administered in Arm Right on 04Mar2021 11:00 (Batch/Lot Number: EN5318) (at the age of 50-years-old) as SINGLE for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient medical history included hypertension and had covid-19 from an unknown date and unknown if ongoing. Patient concomitant medications included Losartan, Lexapro and Eliquis all were taken for an unspecified indication, start and stop date were not reported for any. The patient previously took avelox and experienced drug allergy. On 26Mar2021, the patient experienced myalgia, slight fever, joint pain, fatigue, chills, worsening of tinnitus, headache, gastrointestinal distress and had swollen lymph nodes. The patient did not received any treatment for the events. The outcome of all the events was not recovered.  No follow-up attempts were needed. No further information was expected.
Passed out multiple times; Blood clots; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out multiple times) and THROMBOSIS (Blood clots) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out multiple times) (seriousness criterion medically significant) and THROMBOSIS (Blood clots) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out multiple times) and THROMBOSIS (Blood clots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Patient was taken to hospital where it was discovered that he had blood clots that needed to be removed.  Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
administered frozen Shingrix; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number C43KM, expiry date 10th April 2023) for prophylaxis.   In March 2022, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 7-Apr-2022 Reporter's comments: The nurse administered frozen Shingrix vaccine to the patient within 7th March 2022 to 31st March 2022. The healthcare professional provided consent to follow up. Information within adverse event report was all the healthcare professional provided at this time. Additional Supportive Information: The patient received frozen Shingrix vaccine which led incorrect storage of drug. This was 1 of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022061871:Same reporter. US-GLAXOSMITHKLINE-US2022061870:Same reporter. US-GLAXOSMITHKLINE-US2022061873:Same reporter. US-GLAXOSMITHKLINE-US2022061872:Same reporter. US-GLAXOSMITHKLINE-US2022061865:Same reporter. US-GLAXOSMITHKLINE-US2022061866:Same reporter. US-GLAXOSMITHKLINE-US2022061868:Same reporter US-GLAXOSMITHKLINE-US2022061864:Same reporter. US-GLAXOSMITHKLINE-US2022061860:Same reporter. US-GLAXOSMITHKLINE-US2022061875:Same reporter.
patient passed out a few minutes after receiving the shot.  unknown if it was truly caused by vaccine or the anxiety caused by receiving it.  patient said her hands and feet were tingly.  she was flush and hot.  we gave her water. she stayed at the store for around 45 minutes after.  we used a wheelchair to get her to the car because her legs were still wobbly.  contacted patient to check on her but have not heard back.
31 year old man without prior history of smallpox vaccination reported rash (onset date of 11-June-2008 approx). Lab testing performed by CDC showed anti-vaccinia IgM and IgG ELISA positive. Case is linked to 3 other contact transmission cases all of which are members of the same facility.  There has been no identification of further transmission of any of these cases to family members or other close contacts. The source case has not yet been identified but the investigation is ongoing.
Patient received both doses of vaccine. last dose 4/14/21 developed symptoms 8/8/2021 and tested + for COVID  on 8/10/2021
Flu-like symptoms; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The reporter wanted to know was it safe to get a Shingrix shot when it's possible he/she could catch Covid-19 (or already have it). The patient was due for second shot of the shingles vaccine but it gave flu-like symptoms for several days last time. This made the patient worried that if it happen to catch Covid-19 the same week of getting the shot the patient might get sicker than otherwise would if he/she did not get the vaccine, since immune system was already responding to one invader. If the vaccine causes an immune response to create shingles anti-bodies while Covid-19 causes an immune response to create coronavirus antibodies at the same time, was it possible that there would be a cascade effect. Or that might have a greater than normal inflammatory response to one or the other (or both) as a result. Or that response to Covid-19 might be weaker as a result of being exposed to a different invader at the same time.
Fever (up to 101.4) for two days with sore injection site, then 99 for three more days, chills, exhaustion, acid reflux, nausea intermittent for 5 days, day 4 diarrhea, day 6 nausea and dull headache. Visited clinic on day 6 for tests. Given numerous tests and ZOFRAN. Two days later I had severe constipation due to the dehydration I experienced.
Severe Pain in left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Severe Pain in left arm) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Severe Pain in left arm). At the time of the report, PAIN IN EXTREMITY (Severe Pain in left arm) outcome was unknown. Not Provided          Patient is taking concomitant medication (not specified). Treatment information was not provided.
This spontaneous report was received from a pharmacy technician referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 14-JAN-2016, the patient was vaccinated with an expired dose of ZOSTAVAX lot # K016325, expiration date 24-DEC-2015, (route and dose were not provided). There was no concomitant medication described. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Got 2 shingle shots and got shingles a year latter/Suspected vaccination failure; got Shingles a year latter; pain down my arm very annoying; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got 2 shingle shots and got shingles a year latter/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got Shingles a year latter) and pain in arm (Verbatim: pain down my arm very annoying). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain in arm were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain in arm to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain in arm to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 07-JUL-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she had a mild case of shingles and they never got the fluid in them. The patient got pain down his/her arm very annoying. The patient received 2 shingle shots and got shingles a year later. This case was considered as suspected vaccination failure as details regarding laboratory confirmation for shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Pt recv vax on 3/30/99; on 4/7/99 pt exp vomiting x2, fever (101-102); on 4/8/99 pt exp irritability, sluggish, red rash over body, red cheeks, no eating or drinking