chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 07/30/2000, the patient developed breakthrough chicken pox, and broke out with the rash and approximately 150 blisters. As of 08/07/2000 it was reported that she now only has a little over 100 scabs, the others seem to have disappeared without ever having reached a big blister-scabbing stage. Also, she endured quite a lot of pain for about 2 days to the point of screaming at the top of her lungs in agony. No itching was noted. It was reported that the patient recovered from pain. A lot check was done and no problems were found. Additional information has been requested. Follow up information from the physician indicated that on 07/31/2000 at 07:30 am, the patient developed a mild case of chickenpox. It was reported that there were greater than 100 spots, full blisters with no complications and the patient was febrile. Subsequently, the patient recovered. No further information is expected.
Mother of child reported that child had  erythema bilateral arms. Erythem started on 4-17-09 and no longer present on 4-19-09. Mother of child stated that she had put lotion on the childs arms and "Maybe that caused the rash". Child asymptomatic at this time.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CONFUSIONAL STATE (she experienced confusion), FACIAL PAIN (pain and numbness in face), HYPOAESTHESIA (numbness in face), MIGRAINE (She also had pain in her head almost like a migraine) and ILLNESS (just wasn't feeling well) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in March 2021.On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced CONFUSIONAL STATE (she experienced confusion), FACIAL PAIN (pain and numbness in face), HYPOAESTHESIA (numbness in face), MIGRAINE (She also had pain in her head almost like a migraine), FATIGUE (extreme fatigue, couldn't keep her eyes open) and HEADACHE (temples felt sore and stuffy). On 10-May-2021, the patient experienced ILLNESS (just wasn't feeling well). The patient was treated with VITAMINS NOS at an unspecified dose and frequency. At the time of the report, CONFUSIONAL STATE (she experienced confusion), FACIAL PAIN (pain and numbness in face), HYPOAESTHESIA (numbness in face), MIGRAINE (She also had pain in her head almost like a migraine), ILLNESS (just wasn't feeling well), FATIGUE (extreme fatigue, couldn't keep her eyes open) and HEADACHE (temples felt sore and stuffy) outcome was unknown. No concomitant medication not provided. No treatment information provided. Action taken with mRNA-1273 in response to the event/s was not applicable. This case was linked to US-MODERNATX, INC.-MOD-2021-116590 (Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-116590:dose 1
Consumer took Vivotif on days 1, 4, 6, and 8; Spontaneous report received on 22JAN2020.  A pharmacist reported that a consumer (unknown age and gender) who "took the Vivotif on days 1, 4, 6, and 8" (PT: Inappropriate schedule of product administration) for immunization. The action taken with Vivotif with respect to reported event was not applicable. The clinical outcome of the reported event was unknown.  Company Comment: A consumer took Vivotif doses on days 1,4,6, and 8 (Inappropriate schedule of product administration) instead of taking it on alternate days. The causality of the event is assessed as not applicable with Vivotif.; Sender's Comments: A consumer took Vivotif doses on days 1,4,6, and 8 (Inappropriate schedule of product administration) instead of taking it on alternate days. The causality of the event is assessed as not applicable with Vivotif.
fatigue; arm pain; headache; fever; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6205), via an unspecified route of administration in left arm on 06Mar2021 (at the age of 53-years-old) as dose 2, single for COVID-19 immunization. Medical history included endometriosis, depression, anxiety, ovarian cyst, and codeine allergy. Concomitant medications included hydroxyzine and estradiol (ESTRACE) cream. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks and was not pregnant. The patient experienced fatigue, arm pain, headache, and fever on 07Mar2021. Since the vaccination, patient has not been tested for COVID-19. No treatment was received for the event. Outcome of events was resolved on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Vaccines given around 10:00 AM on April 22, 2015.  Parents brought patient to ED at 9:45 PM on April 2, 2015 for unresponsiveness and dusky color.
The pt experienced a 9 1/2 x 6 1/2 cm red, raised warm area on right thigh with itching. Noted on 4/7/00 at 8:00 PM.  The pt also experienced a fever.
Pt complained of dizziness, headache, and nausea. Pt had multiple systolic b/p  readings over 200. Ambulance was called and pt was released home from the ambulance .
Spinal lesion from C4-C6 that has regressed.  It caused numbness of upper & lower extremities and anal spincture 1/8/08-records received-DOS 11/12/01- C/O left hand numbness a month ago, week later developed right lateral elbows and arm numbness and another week later numbness in both legs and buttock and perianal areas. 2/27/02- symptoms improving some sensory symptoms remain in upper extremities. DX: Idiopathic myelitis. 1/15/2010 Residual numbness of 3-5 fingers left hand 4 and 5th fingers right hand, toes bilaterally and some anal spincter numbness.  02/02/2010 Residual numbness of left fingers, toes bilaterally and anal spincture. Servical lesion did not completely resolve.
Headache, Myalgia, Fever, Confirmed to have Covid 19 on 6/9/21 after fully vaccinated. congestion, fatigue, loss of taste/smell and chills.  Narrative:
Moderna vaccine administered at (privacy) due to previous reaction to first 2 doses of Pfizer vaccine. Client admitted to ER after receiving the Moderna booster and admitted for the night for observation due to reaction.
Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported.  The reporter informed that, the vaccine was used beyond use date of some lot numbers for Moderna that were administered to patients. There was no adverse reaction noted or reported to the reporter ever regarding after administration of vaccine.  It was unknown if the patient was tested positive or diagnosed with COVID-19. It was unknown if acute illnesses at the time of vaccination and up to one month before. And it was unknown if chronic or long-standing health conditions.  No treatment drug details was reported.
Fever, lethargy, chills, elbow pain, N/V; no ill contacts, so suspect vaccine reaction.
Cellulitis of finger of left hand. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Redness and tenderness around site of injection 2cm. Local reaction vs. cellulitis.
Approximately 15 minutes after receiving vaccine patient experienced metallic taste in mouth, felt flushed, heart racing, sweating, and felt clammy. Blood pressure was elevated at 142/102. Patient states he drank a lot of water and after approximately an hour and a half of being at the clinic he felt well enough to go home. In the 24 hours after receiving the vaccine, he felt very achy, specifically in the bottoms of his feet. He felt so achy that he could barely walk. He also experienced a fever and did not take anything to help with these side effects because he reports Tylenol does not work for him very well. All adverse effects were gone by 2-3am on 3/14/2021.
Balance problem; Some foot drop; Brain fog; Neck pains; Extreme weakness; Some dizziness; This is a spontaneous report from a non-contactable consumer, the patient. A 69-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Feb2021 (at the age of 69-years-old), as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received codeine (MANUFACTURER UNKNOWN) and experienced drug allergy on an unknown date. On 26Feb2021, the patient experienced extreme weakness, some dizziness, balance problem, neck pains, brain fog and some foot drop. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events balance problem, some foot drop, brain fog, neck pains, extreme weakness and some dizziness were recovered with sequelae on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administered in arm left, administration date 16Feb2021 (Lot number: EL1283) at the age of 26 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Chronic migraines" (unspecified if ongoing). Concomitant medication(s) included: BOTOX taken for migraine, start date: 11Feb2021, stop date: 11Feb2021.The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "Arm soreness". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
pt recvd vax & exp funny feeling which resolved 1-2 hrs later; immed p/2nd dose was disoriented; event resolved p/ a few hrs;
Uncomfortable; Arm Very Sore; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Uncomfortable) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced LIMB DISCOMFORT (Uncomfortable). At the time of the report, LIMB DISCOMFORT (Uncomfortable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants were reported. No treatment was reported.
Starting the next morning I had Chills, 99 temp,  nausea, arm hurt (from top of shoulder to my fingers) and a general feeling of just not feeling good,  the next day a little better, but a horrible headache, pain in under arm (lymph node I think), and 99 temp
Beginning to have symptoms on 18th of November mental agitation, easily upset at things, suicidal thoughts and outbursts. experiencing schizoaffective disorder, which progressively got worse until  worst episode was the 22nd of November.
Patient complains of upper left arm pain, inability to move arm, and weakness. Its been about 2 weeks since the vaccination took place.
Painful rash in area where vaccine was administered on upper shoulder; Painful rash in area where vaccine was administered on upper shoulder; The rash also spread on torso area and hand; This is a spontaneous report from a non-contactable physician via Pfizer sales representative. A 16-year-old male patient received first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunisation. No underlying conditions or on concomitant medications. The patient experienced painful rash in area where vaccine was administered on upper shoulder, the rash also spread on torso area and hand on an unspecified date 2 1/2 weeks after first dose of meningococcal group b rlp2086 with outcome of unknown. Information about Lot/Batch number cannot be requested.   No follow-up attempts are possible. No further information is expected.
after receiving the vaccine the patient started itching over his body.  it lasted 4 or 5 days
1-2 minutes after administration, patient passed out and fell out of chair, face first, and had a few minor convulsions. Patient was checked out by paramedics but refused transport to hospital.
Swelling and redness to right outer thigh. size is approx 6-7 cm area of erythema right outer thigh with warmth/hyperemia, mild tenderness; indurated in center. itching present.
This case was reported by a nurse via call center representative and described the occurrence of general body pain in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 16th May 2018, the patient received SHINGRIX. On 16th May 2018, immediately after receiving SHINGRIX, the patient experienced general body pain, heart rate increased, chest pain and chills. On 17th May 2018, the outcome of the general body pain, heart rate increased, chest pain and chills were recovered/resolved. It was unknown if the reporter considered the general body pain, heart rate increased, chest pain and chills to be related to SHINGRIX. Additional details reported as follows: The patient reported that almost immediately after receiving a SHINGRIX injection, she experienced body aches, chills, rapid heart rate and chest pain. The events resolved the next morning of vaccination.
large local skin reactions at the vaccine site\. No Fever or other sx. Resolved without TX
Worsening dyspnea and cough since 11/17/21. Tested positive 11/22. Presented with fever of 102.9 and tachycardic to 126 BPM.
On 10/03/2019 a few hours after receiving vaccines patient reports that her right arm swollen up, and was extremely painful, to the point she was unable to raise arm to put on steering wheel of car to drive. Did not take any medication, used a heating pad on arm. Started getting relief on the morning of 10/06/2019. On 10/07/2019 very little and no swelling.
COVID 19 Treatment/COVID-19 positive; COVID 19 Treatment/COVID-19 positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 16:00 as dose 4 (booster), single (Lot number: GH9703) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing), notes: other medical history: N/a. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment/COVID-19 positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19; patient was treated with PAXLOVID.  No follow-up attempts are possible. No further information is expected.
sore throat, fluid/congestion in back of throat suddenly filled lungs, pain in chest, dry cough, lost voice, tired.  By day 6 oafter these symptoms were getting worse. I went to urgent care, was given breathing treatment, Z-Pack, Steriods (Prednisone), Cough syrup. I did improve but not completely, I continue to have chest pain, cough and congestion and feel run down and tired.
Flublok was accidentally given to a 2 year old child, no AE;Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via consumer/non-health care professional via Medical Information (Reference number- 00855256) and transmitted to Sanofi on 12-Nov-2021.  This case involves a 2 year old patient (gender unknown) who was accidentally vaccinated with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Product administered to patient of inappropriate age).  The patient's medical history, medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient accidentally received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE produced by Sanofi Pasteur (lot number and expiry date was not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate age at vaccine administration (latency same day).  It was reported "Caller stated Flublok was accidentally given to 2 children and caller is looking for guidance. The caller would like to know what the follow-up and side effects would be from giving two patients under 18 years old the FLUBLOCK vaccine? The only info the caller has is that a Flublock vaccination was given to a 2 year old and 3 year old"  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 the 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.  There will be no information available on the batch number for this case.
37y/o FEMALE doctor was brought to the ER via gurney from the vaccination area after getting Covid 19 vaccination, patient felt SOB, buffy eye and become pale, she took immediately Claritin and Pepcid, patient was brought to the ER. she denied light headedness. Swelling of lips or the tongue. IMPRESSION --------------------Adverse reaction to the Covid 19 Vaccination-Resolved
fussy, irritable, unable to walk, or bear weight on right leg. obvious joint pain.
passed out; convulsions; This is a spontaneous report from a contactable consumer. A 12-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 12Nov2021 (Batch/Lot number was not reported) as dose 2, single (at age of 12-years-old) for covid-19 immunisation. No pregnant. There was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history and concomitant medications were not reported. Relevant past drug history was unknown. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on Oct2021 (at age of 12-years-old) for COVID-19 immunisation. On 12Nov2021, the patient experienced passed out and had convulsions and was taken to the hospital in ambulance. The patient is fine now. The events result in Emergency room/department or urgent care. There was unknown if the patient was diagnosed with COVID-19 prior to vaccination and unknown if the patient had been tested for COVID-19 since the vaccination. Outcome of the events was recovered on Nov2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a certified medical assistant (C.M.A., also reported as nurse) refers to a 70 year old male patient. No pertinent medical history or drug reactions/allergies were provided. On 02-MAY-2014, the patient was vaccinated with VARIVAX (Merck) INJ (dose, route and lot number was not provided). Co-suspect therapies included ZOSTAVAX (dose, route and lot number was not provided). No concomitant therapies were reported. The reporter stated that on 02-MAY-2014, the patient received VARIVAX (Merck) in error rather than ZOSTAVAX. No adverse effect was reported. The reporter also stated that no product confusion was discovered, just medication error. It was reported that the patient was in the office at the time of the report and the office was intending to administer a dose of ZOSTAVAX to the patient that just received the VARIVAX (Merck) in error. Additional information is not expected.
This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified date, the patient was vaccinated with an improperly stored dose of VARIVAX injection (dose, frequency and route were not reported) lot # M046004 with expiration date of 18-NOV-2018 or lot # M028547 with expiration date of 07-JUN-2018, for prophylaxis. The sterile diluent (lot # and expiration date were not reported) used to reconstitute the VARIVAX was properly stored. The temperature excursion of the VARIVAX was between -9 °C and 8 °C for a time frame of 1 hour and 10 minutes. No previous temperature excursion was reported. No adverse effects were reported. Data logger was involved. Additional information has been requested.; Sender's Comments: US-009507513-1706USA005163: US-009507513-1706USA005174: US-009507513-1706USA005175: US-009507513-1706USA005176: US-009507513-1706USA005177: US-009507513-1706USA005178: