chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm feels worse than any injection she's ever had; enlarged lymph nodes; feels horrible; really bad nausea; pain up through her rib cage; stomach pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Sep2021 15:00 (Lot number: FC3181) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COPD" (ongoing); "Enlarged lymph nodes" (ongoing); "CLL" (unspecified if ongoing); "Enlarged spleen" (unspecified if ongoing); "enlarged brain" (unspecified if ongoing); "Stomach pain" (unspecified if ongoing); "States her brain does not work as it is." (unspecified if ongoing). The patient took concomitant medications. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 08Sep2021 18:00, outcome "unknown", described as "stomach pain"; NAUSEA (non-serious) with onset 09Sep2021 02:30, outcome "unknown", described as "really bad nausea"; MUSCULOSKELETAL CHEST PAIN (non-serious) with onset 09Sep2021, outcome "unknown", described as "pain up through her rib cage"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm feels worse than any injection she's ever had"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "enlarged lymph nodes"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feels horrible". Therapeutic measures were taken as a result of abdominal pain upper, nausea, musculoskeletal chest pain, pain in extremity.  Additional information: Consumer was on chemo and has an enlarged brain and enlarged lymph nodes. She was 70 years old with COPD. She was diagnosed with enlarged lymph nodes about a year ago, states they are getting really big under her arm. She clarified about a week and a half ago she had severe stomach pains and went to the ER and had a cat scan and was told she had an enlarged spleen, not an enlarged brain. This occurred prior to the vaccine. After received the first dose, she started developing severe stomach pain last night on 08Sep2021 at 18:00 and woke up with really bad nausea this morning at 02:30, which included pain up through her rib cage. Stated that her arm feels worse than any injection she's ever had. She called her primary this morning for a prescription for pain meds and nausea medication. She reports that she already had enlarged lymph nodes, and she expected her side effects to be worse. She was wondering if these symptoms are going to go away soon. She feels horrible. She wanted to make sure it was temporary. She was asking if there was information on how long these side effects are expected to last.   Follow-up attempts are completed. No further information is expected.
Symptoms consistent with flare of Ulcerative Colitis: defecation urgency, blood in stool, loose stools.  I notified my GI doctor about symptoms, we agreed to increase my dose of Balsalazide to 3 grams PO BID.   Symptoms had not resolved prior to my receiving second dose of vaccine.  I had not had a flare in 2 years, and had a colonoscopy 6 months prior which showed complete resolution  including normal biopsies.  I continue to have symptoms 2 months later, I'm scheduled for follow up with GI in March. I realize this may just be correlation and not causation but felt it was important to report in case they are related.
My child was complaining of the chest pain two days after the first Pfizer vaccine.  Had vomiting,  diarrhea and slight fever one day after the vaccine. All symptoms resolved after three days.
Patient Flublock Quadrivalent instead of the Fluzone Quadrivalent, no AE; Patient Flublock Quadrivalent instead of the Fluzone Quadrivalent, no AE; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.   This case is linked with case 2019SA309785  This case involves a 16 years old male patient who was vaccinated with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE instead of the INFLUENZA QUADRIVAL A-B VACCINE (wrong product administered), while he received vaccine influenza quadrivalent recombinant vaccine [Flublok QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Oct-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot-QFAA1916 , exp date: 30 June 2020, via unknown route in the right arm.  It was a case of actual medication error due to Inappropriate age at vaccine administration and wrong product administered.  At the time of the report, no adverse event was reported.  Disclaimer: 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.  No further relevant information was reported.
1st shot slight headache took Tylenol slept 2 hours felt better 2nd shot slight headache took Tylenol slept 3 hours, a little better, just tired, next day body aches, joint pain, leg and feet cramps slept on and off all day, three day slightly better still body hurting and feet cramps.
Hardness on the area of the injection; Swelling on the area of injection; Redness (around 2 inches in diameter); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hardness on the area of the injection), VACCINATION SITE SWELLING (Swelling on the area of injection) and VACCINATION SITE ERYTHEMA (Redness (around 2 inches in diameter)) 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 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.   On an unknown date, the patient experienced VACCINATION SITE INDURATION (Hardness on the area of the injection), VACCINATION SITE SWELLING (Swelling on the area of injection) and VACCINATION SITE ERYTHEMA (Redness (around 2 inches in diameter)).   At the time of the report, VACCINATION SITE INDURATION (Hardness on the area of the injection), VACCINATION SITE SWELLING (Swelling on the area of injection) and VACCINATION SITE ERYTHEMA (Redness (around 2 inches in diameter)) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Patient started with spots in school and sent home by school nurse to be evaluated.  Went to hospital and rash continued to develop on belly, back and inner thighs.  Patient took Benadryl to assist with itching.  Scabbing on 12/13/07 per mom.
On 10/10/11, vaccine administered. On 10/23/11 AM, patient reported muscle stiffness, stiff neck, head ache, nausea and fever. Symptoms resolved after about 4 to 5 days. Patient reported same symptoms in previous year.
A sales representative reported that a 6 month old female received Acel-Imune, Hib-Titer and IPV (Aventis Pasteur SA) vaccines on 2/22/00. Immediately, post vax of Acel-Imune, she developed swelling at the injection site. She recovered after 5 to 7 minutes. This is 1 of 2 pts from this facility who experienced this event following receipt of Acel-Imune, lot 466023.
Burning back pain starting at mid spine area and radiating to the right side back and right side chest.  Starting Prednisone today.
Wheezing, congestion, fever 101.8 - to ER 1/9/05. Treated for croup, breathing Tx, Albuterol. Also Dx with ear infection; put on ABT's, steroids.
fever, inject site & surrounding tissue very swollen, hard, red & hot to touch; swollen are approx 4 inches in diameter; staff person sent to MD; DPH given & cold packs prescribed for swelling;
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Sep-2021 at 4:43 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 30-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.
Started to feel very tired and never felt better about a week after the moderna booster shot in November. I made an appointment to my PCP and had blood test done in December . I was told I had a deficiency in vitamin D  so was given an rx for vitamin D to take 400-500 units per day for a month.
muscle pain; joint pain; just feeling all over unwell; This is a spontaneous report from a contactable consumer (patient herself). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, on 13Feb2021 as dose 2, single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, on an unspecified date as dose 1, single for covid-19 immunisation. Medical history included sciatica (she takes Tramadol for her sciatica and after experiencing the above symptoms) and heart failure from an unspecified date and unknown if ongoing. Past drug includes Tramadol taken for sciatica. Concomitant medications were unknown. Caller stated that patient received her second dose of the Pfizer BioNTech COVID-19 vaccine on 13Feb2021 and stated "I was ok at first" but then stated that later she experienced muscle pain, joint pain, "just feeling all over unwell" and that it "did seem to go over all my body." on an unspecified date in Feb2021. Caller stated that she had a history of sciatica and thought the joint pain and "just feeling all over unwell" were the same side effects she experienced with her sciatica. Caller stated that she took Tramadol for her sciatica and after experiencing the above symptoms after her second dose of the vaccine, took "three tramadol in 2 days" to help. Caller would like to know if taking the Tramadol has any effect on the vaccine. Caller stated that she did call an after hours doctor and asked about taking Tramadol with the vaccine and was told "it wouldn't matter." Caller also stated she recently received steroid injections on 01Feb2021 and "takes about 12 things" including medication for heart failure. Caller stated that she received both doses of the Pfizer BioNTech COVID-19 vaccine and would like to know how long she needs to "stay in to be perfectly safe" after receiving the vaccines. She has heard from different sources that the recommended time of quarantining is "6 days, 10 days, 2 weeks." Caller also stated that she herself has been quarantined since last March. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Chills; body aches; fever; headache; This is a spontaneous report from a non-contactable nurse.  A 26-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 intramuscular, administered in Arm Left on 13Jan2021 23:00 (Batch/Lot Number: EL3248), age at vaccination of 26-years-old, as single dose, for covid-19 immunisation.  Medical history included coeliac disease from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing (Sulfonamide allergy), drug hypersensitivity from an unknown date and unknown if ongoing (Cephalosporins), gluten sensitivity from an unknown date and unknown if ongoing. The patient was not pregnant and was not pregnant at the time of vaccination. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 23Dec2020 23:00 (Batch/Lot Number: EK9231), age at vaccination of 26-years-old, as single dose, for covid-19 immunisation. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Jan2021 (09:00 am) the patient experienced chills, body aches, fever (101F) and headache for 3 days. Facility type vaccine: Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatments were given for the events. The patient underwent lab tests and procedures which included body temperature: 101 fahrenheit on 14Jan2021. The patient recovered from the events in Jan2021.  No follow-up attempts are possible. No further information is expected.
(R) upper exterior aspect of the arm red and painful (+3 x5). Developed fever (102.0) and chills on evening of 12/17 per mom.
Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment information was reported.
pt exp fever to 101, neck pain & muscle spasms, fatigue, arthralgias, redness & swelling around inject site
A few hours after I returned home my collar bone and neck started hurting.  This lasted for a few weeks. About a month ago it started hurting again.
Nothing adverse happened to patient. However, registry said patient was due for 2nd polio, 2nd Hep B, so I gave them. Come to find out an email was sent out this morning from contractor and an issue was identified in registry with the assessment of Hep A, Hep B, Polio and HPV. The email was sent to the Imms clerk.
The patient is a 90 y.o. male with PMH of prostate cancer, uterus stricture, COPD/emphysema, open-angle glaucoma, tremor, chronic respiratory failure, CHF who presents with shortness of breath.   Tested positive upon admission from Emergency Services.
has a bad ankle; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 01Mar2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took ibuprofen. Caller asked if she can take ibuprofen after the first dose since she has a bad ankle.  She took ibuprofen before she took the vaccine. The outcome for all events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Burning with injection, red/itch for 2 inches surrounding site 24 hours later. Ice & BENADRYL used for next 24 hrs, redness continued for next 10 days. Finished with dry skin patch at injection site.
Headaches, nasal congestion, fatigue, sore throat, lightheadedness began 1 day after receiving FluMist vaccine, persisting at day 5 post dose.
Suspected vaccination failure; It gave me the damn flu; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. It was reported that the patient received flu shot once. It gave the flu never ever again. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation for influenza was not provided.
problems they have; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (problems they have) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (problems they have). At the time of the report, VACCINATION COMPLICATION (problems they have) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medication were not provided.
Pt recv vax on 10/22/98; on 10/24/98 pt exp sore arm, stomach ache, fever (100.4), rib pain.  DX=Pneumonia
On 08Jun2021 she noticed red stripes on the back of both thighs and buttocks/ It's really, really red; feels warm or gets hot the red stripes will worsen/much worse when her body gets warm, like after exercise; maybe it's a little itchy in that area; Where the stripes are, the skin is rough, rougher than other parts of her skin/ rough skin is maybe like a half inch wide; This is a spontaneous report from a contactable consumer (patient, self-reported). A 64-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EP7534 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 05Jun2021, as a single dose for COVID-19 immunization at clinic. The patient's medical history included hypothyroidism. Concomitant medications included levothyroxine for hypothyroidism. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0186 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 15May2021, as a single dose for COVID-19 immunization at clinic and no reaction on previous exposure to drug. Vaccine was not administered at this facility. The patient took Covid 19 vaccine due to social pressure because all of a sudden there were different rules for vaccinated and nonvaccinated people. She reported she was very healthy and believes she had a good immune system. She never got the flu vaccine and she never got the flu virus. The patient reported that on 08Jun2021, she noticed red stripes on the back of both thighs and buttocks and it's really, really red. She also mentioned that the red stripes on her thighs is "very pronounce". Whenever she exercises, feels warm or gets hot the red stripes will worsen and much worse when her body gets warm, like after exercise. She's asking if this were "burst blood vessels". Now it's starting to fade a little bit. Where the stripes were, the skin is rough, rougher than other parts of her skin. She could feel with her hand the rough skin was maybe like a half inch wide. It didn't hurt, it's just there and maybe it's a little itchy in that area. The adverse events did not require a visit to emergency room or physician office. Outcome of the events was not recovered.
Rash on backs of both hands.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Aug2021 12:00 (Lot number: Fc3183) at the age of 42 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "ME/CFS" (unspecified if ongoing), notes: Other medical history: ME/CFS, Hashimotos, migraines, arthritis; "Hashimoto's" (unspecified if ongoing), notes: Other medical history: ME/CFS, Hashimotos, migraines, arthritis; "migraines" (unspecified if ongoing), notes: Other medical history: ME/CFS, Hashimotos, migraines, arthritis; "arthritis" (unspecified if ongoing), notes: Other medical history: ME/CFS, Hashimotos, migraines, arthritis. The patient's concomitant medications were not reported. Past drug history included: Vancomycin, reaction(s): "Known allergies: Vancomycin", notes: Known allergies: Vancomycin. The following information was reported: RASH (non-serious) with onset 24Aug2021, outcome "not recovered", described as "Rash on backs of both hands.".  Additional information: The patient was not tested COVID prior vaccination. The patient was not tested COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Received doses from vials that had exceeded the 30 day refrigeration limit; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received doses from vials that had exceeded the 30 day refrigeration limit) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received doses from vials that had exceeded the 30 day refrigeration limit). On 25-May-2021, EXPIRED PRODUCT ADMINISTERED (Received doses from vials that had exceeded the 30 day refrigeration limit) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. The reporter states that the vials were placed in the refrigerator on 21 Apr 2021 and stayed in the same location until their administration date on 25 May 2021.