chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effect reported; The patient was vaccinated with improperly stored doses of GARDASIL 9; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. No information was provided regarding the patient's concomitant medications, pertinent medical history, drug reactions or allergies.  On 30-JUL-2019, the patient was vaccinated with improperly stored doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot number R029117, with expiration date: 10-JUL-2021 for prophylaxis. No adverse effects were reported.  The doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) underwent temperature excursions of 47.5 degrees Fahrenheit (°F) for a time frame of 2 hours and 45 minutes, which was called by the digital data. There were no previous temperature excursions reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA000459:
Patient developed rash on abdomen, as noted by mother, on the morning of 1/12/01. She also noted a fever of 103 degrees and gave Advil which reduced the temperature to 99 degrees. No other symptoms reported by mother. Rash on abdomen noted by mother in AM of 01/12/2001. Also noted fever of 103 degrees and gave Advil which reduced temperature to 99 degrees. No other symptoms reported by mother.
Possible pregnant patient, is mordena safe for pregnant ladies; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Possible pregnant patient, is mordena safe for pregnant ladies) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Possible pregnant patient, is mordena safe for pregnant ladies). At the time of the report, EXPOSURE DURING PREGNANCY (Possible pregnant patient, is mordena safe for pregnant ladies) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) was unknown.       No concomitant medications were reported No treatment medications were reported.
Initial reaction - sore arm, headache, fatigue  3 days after vaccination (morning of April 2nd) - Loud high pitched ringing in ears and nausea.  Ringing is constant, very loud, and has not subsided as of the time of this report
Moderna 3/3/21, 4/2/21, 11/11/21, 5/12/22. Positive on 1/5/23
A HARSH PAIN IN SHOULDER A DAY AFTER VACCINE SHOT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced a harsh pain in shoulder a day after vaccine shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a harsh pain in shoulder a day after vaccine shot was not reported. This report was non-serious.
No adverse reaction reported. Mom and patient was in the office on 02/23/22 and explained to the mother of the situation, mom stated patient did not complain and she did not notice any reaction. He is okay.
Intermittent fever starting 5 March, lasting for 3 days, highest was 100F tympanic. Red dots started on chest on Saturday March 6th, and now on whole body  - legs and face; not bothered by rash. As of now (11 March 2021, pt still has the rash, MOP states they're slowly going away.  Intially was fussy and forehead was warm so mom checked temperature and was 100.1F tympanic. used Tylenol and fussiness improved.   no sick contacts. continues to eat, drinking, sleeping well. still playful. urinating and stooling as usual.
Pink patch on the injection site; Nasty itch on the left arm/ itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Nasty itch on the left arm/ itching) and VACCINATION SITE DISCOLOURATION (Pink patch on the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Nasty itch on the left arm/ itching). On 10-Apr-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Pink patch on the injection site). At the time of the report, VACCINATION SITE PRURITUS (Nasty itch on the left arm/ itching) and VACCINATION SITE DISCOLOURATION (Pink patch on the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up received on 12-05-2021:Outcome of the events updated.
prolonged menstrual cycle; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 47 year-old female patient received bnt162b2 (COMIRNATY), administration date 26Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series Manufacturer unknown), for COVID-19 Immunization. The following information was reported: OLIGOMENORRHOEA (non-serious) with onset 2021, outcome "unknown", described as "prolonged menstrual cycle".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Loss of taste sensation; Loss of smell sensation; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste sensation) and ANOSMIA (Loss of smell sensation) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Loss of taste sensation) and ANOSMIA (Loss of smell sensation). At the time of the report, AGEUSIA (Loss of taste sensation) and ANOSMIA (Loss of smell sensation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive COVID test after getting both doses of vaccine..         Additional information includes for lab data where patient had reported that he got tested positive for COVID test after getting both doses of vaccine.  Concomitant product use was not provided. Treatment information was not provided.
never ending headache on the right side of my head, temple to jaw, ear, since about four days after receiving the vaccine on 3/27/21. The first three days were weakness and flu like symptoms
Symptoms reported: headache grand mal seizure. Was transferred to ER on 2/10/21. Per staff report ? I was sitting on the couch, and my partner noticed I have having a seizure, he lowered to me to the ground and called the ambulance. My seizure lasted for 1 minute.  When I was in the ER, they gave me 2 bags of fluids, they did an X-ray, CT scan, blood work, and UA, they reported to me that all the result were normal. They did not send me home with any medications. However, they did not clear me to drive. They said that I need to get cleared by a neurologist before I can drive, so that?s why I have not been back to work?
Patient felt nauseous within 5 minutes of receiving the Moderna COVID vaccine. Patient had no anaphylaxis reaction- we made sure. Patient vomited right before the paramedics had arrived. Paramedics stated her vitals were all normal. Patient was suffering from anxiety. Patient stated she felt better after vomiting. Paramedics did take her with them. No further information was given by the paramedics.
Case number PHEH2013US014700 is an initial spontaneous report from the health care professional (practice manager) received on 08 Jul 2013. This report refers to a 12-year-old female patient. On 05 Jul 2013, the patient was vaccinated with Men A lyophilized conjugate of MENVEO (batch number: A12120) mixed with a sterile diluent, instead of MenCYW-135 liquid component. No adverse event reported following the mal-administration. No other information was available. Following an internal review on 16 Jul 2013 a non-significant correction done for the information received on 08 Jul 2013: The LLT of the event inappropriate preparation of medication, changed to wrong solution used in the drug reconstitution as per non serious line listings.
Burning headaches, haven?t had a period in 15 years and have been bleeding up to 20 days at times every month, brain fog, night sweats, very tired, no energy, a lot of bruising, cough that won?t go away, rapid heart rate
Patient also was diagnosed with COVID-19 infection with a positive test.  Patient did have elevated inflammatory markers and D-dimer.  Therefore, he was placed on Solu-Medrol steroids and Zithromax antibiotic. Presented with abdominal pain, fevers, chills, constipation. Found to have SBO and ileus post hip replacement along with Covid.
12/23 @ 5pm - arm felt numb and some pain 12/23 @ 6:15pm - chest tightness  12/23 @ 7pm - space between shoulder blades tight and painful, pain up and down arm 12/24 @ 4am - skin hurts, feel cold, shaking and shivering 12/24 @ 6am - muscles hurt, joints feel like they want to explode, legs numb 12/24 @ 7am - able to move legs again, still tingling like asleep, nerve pain running down my mid back, around my thighs down my legs to the tops of my feet, unable to stand 12/24 @ 8:45am - chest tightness became pain 12/24 @ 9am - can't catch my breath 12/24 @ 11am - so much pain I can't stand or lay down or sit unassisted  12/24 tried getting to urgent cares in area but all were closed, got to ER and waited in lobby over 40 minutes. Chest pain and breathing got worse, was seeing black. Ekg was taken, hard to get due to the breathing and shaking  12/25 - still unable to walk without assistance. Chest pain is not as bad, able to breathe better 12/26 - still unable to walk without assistance, chest pain is gone, still difficult to breathe 12/27 - still unable to walk without assistance
Hospitalization for shortness of breath due to COVID-19  on dates 6/15/2022- 6/19/2022.  Treated with prednisone, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.?
(L) deltoid - pain, redness and large swelling, throbbing headaches, fatigue, pain in legs
At 1300 on March 26 I received the shot in my left arm. I went back to work after receiving the vaccine I returned to work. At 1720 I was at home and started itch all over my, arms legs, and stomach. Broke out in a rash on my stomach and chest. At 1830 my tongue was swelling and had a hard time speaking. I call a friend and told her. She told me to take some Benadryl. I did. I then went to bed. My friend came over at about 2100 because she was worried and found me in bed. My breathing was off and she tried to wake me. She called 911 and I was transported to the hospital.  I am now in rehab with undetermined results as to what happened.
Area where shot was given was red and swollen extending down arm (2" long almost to elbow 1" wide)
Patient received Pfizer COVID-19 vaccine 3/12/2021.  Patient tested + for COVID 03/15/2021. Subsequently admitted to the hospital for COVID-19
This spontaneous report as received from a nurse refers to a 28 year old patient. The first two doses of RECOMBIVAX HB were administered several years ago, perhaps in 2007 or 2009, but the third dose in the series had never been administered. There was no adverse effect reported. No further information was available. Additional information has been requested.
Experienced these symptoms within 12-24 hours: Chills, fever, headache, body ache, nausea, vomiting, confusion, memory loss. Went to hospital 22 hours after receiving shot. Blacked out for 7 hours that day at the hospital. Was tested for meningitis and did MRV scan for brain clots but all came back clear / negative. Likely experienced dehydration and drop in sodium levels. Was hospitalized from 4/12-4/16.
Red, swollen, hot, injection site is low on the arm (beneath deltoid above elbow)
Adverse effect of other bacterial vaccines, init encntr on 2018-05-07.
Constant back pain, hip pain, leg pain. Body feels very stiff, like old man. My problem is not a clearly defined event but seems to be a link with either Lymerix or Lipitor.
States in chart PNEUMOVAX (Rt) deltoid given 9/28/11. (Rt) arm very red, swollen, & hot to touch start with chills & fever day of vaccine on 9/28/11 - Pt came in on 9/30/11. Started with redness on lower 1/3 of humerus redness went almost circumference. Pt started on KEFLEX 500mg 1 P tid x 10 days. (Lt) deltoid was given FLUZONE on 9/28/11. Pt seen on 10/7/11 redness resolved (had cellulitis).
Pt came in for catch-up immunizations.  She required a tetanus booster and was inadvertently given DT instead of Td.  She was followed up for 4 days with phone calls.  She did not report any adverse effects of the DT.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A 100 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) at the age of 100 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "gallbladder removed" (unspecified if ongoing), notes: had gallbladder removed; "colon cancer surgery" (unspecified if ongoing), notes: colon cancer surgery; "damage to her legs" (unspecified if ongoing), notes: recovered from an accident where a grave stone fell on her causing damage to her legs while visiting her husband in cemetery. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (got ill from Covid on Feb2022), administration date: Sep2021, when the patient was 100 years old, for Covid-19 immunisation, reaction(s): "Covid-19", "drug ineffective". The following information was reported: PNEUMONIA (death, medically significant) with onset Feb2022, outcome "fatal", described as "Pneumonia"; FUNGAEMIA (death, medically significant) with onset Feb2022, outcome "fatal", described as "Fungaemia"; ACUTE KIDNEY INJURY (death, medically significant) with onset Feb2022, outcome "fatal", described as "Acute Kidney injury"; ANAEMIA (death) with onset Feb2022, outcome "fatal", described as "Anemia"; RENAL FAILURE (medically significant) with onset Feb2022, outcome "unknown", described as "kidneys failed"; CARDIAC DISORDER (medically significant) with onset Feb2022, outcome "unknown", described as "heart became an issue". Therapeutic measures were taken as a result of renal failure, cardiac disorder. The patient date of death was 25Feb2022. The reported cause of death was pneumonia, fungaemia, acute kidney injury, anaemia. No autopsy was performed. The patient date of death was 25Feb2022. The reported cause of death was drug ineffective, Covid-19, pneumonia, fungaemia, acute kidney injury, anaemia. No autopsy was performed. My Patient became ill from COVID-19 in Feb2022. She got weak, had some cough, chest congestion. She was in the emergency room for 2 days before being transferred to Hospital when bed became available. Slowly, her kidneys failed, heart became an issue, dialysis used, tubes inserted, and she became critical and died on 25Feb2022 just one day from her 101st birthday. Pneumonia. Approximate interval Onset to Death: 45 days, Covid Approximate interval Onset to Death: 45 days. (Onset to death interval for clarification). Tobacco use did not contribute to death. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s): US-PFIZER INC-202200389930 Pfizer; Reported Cause(s) of Death: Pneumonia; Fungaemia; Acute Kidney injury; Anemia.
Information has been received from a medical assistant referring to multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (dose unknown) (lot# M004544, expiration date 18-OCT-2017) orally for prophylaxis. The vaccine was exposed to temperature excursion of 35Fahrenheit degree (F) for 6 hours. There was no previous temperature excursion. No data logger was involved. No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA001893: US-009507513-1701USA001894: US-009507513-1701USA001895:
Patient began showing the below symptoms on 9/20/2021: muscle aches, runny nose and dizziness. Symptoms not improved. Patient hospitalized on 9/22, further details about hospitalization is unknown. Reported medical hx: hypertension, neurological disorder, and CVA. Patient is fully vaccinated.
Retching; loose stools; extreme/screaming back pain; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (Retching), DIARRHOEA (loose stools), BACK PAIN (extreme/screaming back pain), NAUSEA (nausea) and VOMITING (vomiting) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 007M20A) for COVID-19 vaccination.     The patient's past medical history included Surgery (scheduled for another spine surgery and fusion on 07-July-2021). Concurrent medical conditions included Penicillin allergy, Drug allergy (codeine(nausea)), Drug allergy (Albuterol (jittery)) and Back pain (caused by spondylolethesis, stenosis, cysts and herniated discs)). Concomitant products included VITAMIN D3 and CALCIUM for Back surgery, ABALOPARATIDE (TYMLOS) from 01-Sep-2020 to an unknown date for Bone development disorder, IBUPROFEN for Pain, OMEPRAZOLE for Reflux gastritis.   On 03-Feb-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021 at 8:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced RETCHING (Retching), DIARRHOEA (loose stools), NAUSEA (nausea) and VOMITING (vomiting). 04-Mar-2021, the patient experienced BACK PAIN (extreme/screaming back pain). On 08-Mar-2021, RETCHING (Retching), DIARRHOEA (loose stools), BACK PAIN (extreme/screaming back pain), NAUSEA (nausea) and VOMITING (vomiting) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, COVID-19: positive (Positive) Positive.         No treatment products reported   This case was linked to MOD-2021-034411 (Patient Link).
Diagnosed with COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Diagnosed with COVID-19). At the time of the report, COVID-19 (Diagnosed with COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Vaccine on 5-26-11 -> severe dizziness on 5-28-11. Noted - redness, rash, & itching by 5-31-11 -> only on each breast & still has this problem as of 6-28-11 - used OTC DRAMAMINE.
Varivax #2 admin 11/7/06. Onset fever of 102F, myalgia, malaise, non-productive cough on 11/22/06. Recent viral Upper respiratory infection last of week of October.
Patient had Varivax on 06/20/2005 around 07/22/2005 started breaking out with rash on back of neck, head spread to other body parts. To office 08/05/2005 with varicella infection papules, vesicles and scabbed lesions.
2 fever blisters; arm soreness; redness at the injection site; Headache; joint and muscle pain; muscle pain; chills; fever; inability to walk straight; tiredness; This case was reported by a consumer and described the occurrence of pain in arm in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (for further tolerence refer case US2020AMR244333).   On 2nd December 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 2nd December 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, injection site erythema, headache, joint pain, muscle pain, chills, fever, walking difficulty and tiredness. On 6th December 2020, the patient experienced fever blister. Rechallenge with Shingrix was positive. On 5th December 2020, the outcome of the pain in arm, injection site erythema, headache, joint pain, muscle pain, chills, fever, walking difficulty and tiredness were recovered/resolved. On 7th December 2020, the outcome of the fever blister was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, injection site erythema, headache, joint pain, muscle pain, chills, fever, walking difficulty, tiredness and fever blister to be related to Shingrix.  Additional details were provided as follows: Patient reported that she received the 2nd dose of Shingrix on 2nd December 2020 and later that evening she experienced arm soreness, redness at the injection site, headache, joint and muscle pain, chills, fever, inability to walk straight and tiredness. Patient also stated that the dy before reporting she experienced 2 fever blisters which was not resolved. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR244333:same reporter