chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen arms like two times the size. My other arm it is just huge its still looking sore; Swollen arms like two times the size. My other arm it is just huge its still looking sore; This is a spontaneous report from a non-contactable consumer (patient).   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 'Saturday' on an unspecified date (Batch/Lot Number: Unknown) as SINGLE DOSE for covid-19 immunization.  The patient medical history and  concomitant medications were not reported.  The patient experienced swollen arms like two times the size. my other arm it is just huge (medically significant, its still looking sore on an unspecified date. Consumer states ' I have been waiting on line for really long time. I ended up calling the local hospital because I was not sure what to do and they are on the other line. The clinical outcome of the events was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
On Friday morning  at work, I felt a sharp pain around the left side of my chest.   It sharp pain comes and goes very often throughout the morning and day.  I would describe the pain as a mini heart attack even though I never experienced a heart attack.    Today, the sharp pain around my chest area isn?t as strong as before but I do not feel 100 percent.  There is a feeling in my chest area that I can?t shake out.  It could be all psychological but who knows.
Bit sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Bit sore) 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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN (Bit sore). At the time of the report, PAIN (Bit sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact
Ringing in the Ears, a little more noticable in my left ear, but sometimes and more frequently hearing in both ears. My personal Dr is out of office on vacation, Saw Dr on 04/01/2021, he attempted to electronically prescribe Alegra D 12 Hour 60 mg 1 tab every 12 hours.    After 30 hours of effort involving 3 attempted electronic Prescription requests, several calls to Dr office and several calls and personal visits to CVS,  was unsuccessful in obtaining this drug for treatment.  Went to urgent care clinic in on 04/02/2021 saw Dr- , he precribed pseudoephedrime 30 mg 4X daily and cetrizine 5 mg daily, advised to schedule appointment with Dr
fever of 2-3 degrees; slept most of the day; didn't feel well at all; headache; achey; tired/exhausted; sore arm; woke her up briefly; This is a spontaneous report from a contactable healthcare professional (patient). A 49-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration in the right arm on 31Dec2020 10:00 at a single dose for COVID-19 immunization. The patient was vaccinated in a hospital facility. Medical history included spending 4-6 hrs/day face-to-face with Covid patients for months since early Apr2020. The patient has no known allergies. The patient has no covid prior vaccination, and she was not tested for covid post vaccination. The patient's concomitant medication included multivitamin. The patient did not receive other vaccine in last four weeks. The patient was vaccinated on 31Dec2020 at 10am for her 1st Pfizer vaccine. No symptoms for 6-8 hrs. By bedtime at 06:00 PM, she experienced headache, achey, tired, and sleeping on her sore arm woke her up briefly. Next day on 01Jan2021, more achey, exhausted, fever of 2-3 degrees, slept most of the day and didn't feel well at all. She could tell that her body was fighting something, but she is much better 48 hours out. The patient did not receive any treatment for the reported adverse events. She stated she had no regrets. She stated that she loves Pfizer, because it has given hope. She just wasn't expecting any side effects after the 1st vaccine, only for the 2nd. Anecdotally, it seemed her hospital coworkers who have had Covid react more to the 1st vaccine, possibly for them, 1st vaccine is like the 2nd. She doesn't know if she has had Covid, but as an Acute Care PT on Covid units, she spends 4-6 hrs/day face-to-face with Covid patients for months since early Apr2020. She stated that possible her immune system already recognizes Covid. She is curious. No complaints, only curious. Again, she said thank you. She stated that she has seen too many good people die this year, thus, she didn't hesitate on the vaccine. The outcome of the events was recovered in Jan2021. The report was considered non-serious.  Information on the lot/batch number has been requested.
no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-JAN-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R013858, expiry date 12-JUN-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Off-label use; Booster; body stiffness; aches; arm soreness (a few days later); fatigue; This is a spontaneous report from a contactable consumer or other non hcp.   This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer (manufacturer control number: US-AMGEN-USASL2021124016), license party for etanercept (ENBREL).consumer from a commercial program (PSP00086). A 66-years-old female patient received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on 26Aug2021 (Batch/Lot number was not reported) as DOSE 3 , SINGLE for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis from an unknown date and unknown if ongoing Primary Immunization series complete but unknown manufacturer. Concomitant medication(s) included etanercept (ENBREL; 50 milligram, qwk).) taken for rheumatoid arthritis from an unspecified start date to Jul2021; etanercept (ENBREL; 50 milligram, qwk Lot number: 1127966; 1089818) taken for an unspecified indication from Jul2021 and ongoing. The patient experienced does not feel , injections site bruised slightly as well [injection site bruising], became puffy [injection site swelling .She experienced puffiness and swelling at the injection site twice. In 2021, the patient experienced body stiffness (musculoskeletal stiffness), aches (pain) (non-serious), arm soreness (a few days later) (pain in extremity), fatigue (fatigue). On 26Aug2021, the patient experienced off-label use (off label use) and booster (immunization). The clinical outcome for all the events was unknown.  No follow-up attempts possible. No further information expected.
just a little tiredness; left arm soreness  not severe pain in that he could feel stiffness but could still lift his arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (just a little tiredness) and PAIN IN EXTREMITY (left arm soreness  not severe pain in that he could feel stiffness but could still lift his arm) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 046B21A) for COVID-19 vaccination.     The patient's past medical history included Muscle strain and Neck (lot of stress generally in his neck area with his sometimes getting a stress knot and tightness in his neck and shoulder area.). Concurrent medical conditions included Allergy (allergic angioedema to Advil). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC R) for Seasonal allergy.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced FATIGUE (just a little tiredness) and PAIN IN EXTREMITY (left arm soreness  not severe pain in that he could feel stiffness but could still lift his arm). On 02-Apr-2021, FATIGUE (just a little tiredness) and PAIN IN EXTREMITY (left arm soreness  not severe pain in that he could feel stiffness but could still lift his arm) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not reported.   This case was linked to MOD-2021-116574 (Patient Link).
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021 at 3:43 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jun-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 35.96   Concomitant products were not provided.   On 22-Jun-2021, Excursion time was 08 AM,  temperature was 35, total doses given for the day was 36, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 27-May-2021, vial was moved to clinic on 22-Jun-2021. 4 vials were sent to clinic. Vaccine BUD date was 26-Jun-2021  On 22-Jun-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 35, 9 AM: 39, 10 AM: 47, 11 AM: 36, 12 AM: 42, 1PM: 43, 2 PM: 43, 3 PM: 43, 4 PM: 43 and 5 PM: 00.   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported
Patient stated that since her second shot, she has had burning, pain and cramps radiate down her arm. She also says she has had trouble gripping anything with that hand. She is hoping someone from your office will give her a call.
Severe Headache; Dehyrdration; Really dizzy; Could not sit upright; Heat Rush; This spontaneous case was reported by a consumer and describes the occurrence of MILIARIA (Heat Rush), DEHYDRATION (Dehyrdration), DIZZINESS (Really dizzy), POSTURE ABNORMAL (Could not sit upright) and HEADACHE (Severe Headache) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 008B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MILIARIA (Heat Rush). On 07-May-2021, the patient experienced DEHYDRATION (Dehyrdration), DIZZINESS (Really dizzy) and POSTURE ABNORMAL (Could not sit upright). On an unknown date, the patient experienced HEADACHE (Severe Headache). On 06-May-2021, MILIARIA (Heat Rush) had resolved. At the time of the report, DEHYDRATION (Dehyrdration), DIZZINESS (Really dizzy) and POSTURE ABNORMAL (Could not sit upright) outcome was unknown and HEADACHE (Severe Headache) had not resolved. Not Provided          Concomitant product use was not provided. Treatment information included Tylenol for headache. Action taken with mRNA-1273 in response to the events was  not applicable.
I have had trouble with my back and neck from whiplash from car accidents. After my second injection, my back became twisted up with muscle spasms. A friend who is a physical therapist spent about an hour working on loosening up muscles and moving small joints along my spine back into place. It took several weeks for the pain to begin to ease off and my spine to begin to straighten up.
Caller received Pfizer vaccine primary series, Pfizer booster 24Aug2021. On 06May2022 caller received second booster and was exposed to COVID five hours later/tested positive; Caller received Pfizer vaccine primary series, Pfizer booster 24Aug2021. On 06May2022 caller received second booster and was exposed to Covid five hours later/tested positive; Off Label Use; Booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), on 24Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 06May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunosuppressed" (unspecified if ongoing), notes: no reaction to antibodies; "single kidney" (unspecified if ongoing), notes: single kidney; "hypertension - labile BP" (unspecified if ongoing), notes: hypertension - labile BP; "autoimmune thyroiditis" (unspecified if ongoing); "Raynaud's" (unspecified if ongoing); "Celiac disease" (unspecified if ongoing), notes: 18-19 years. The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (non-serious) with onset 06May2022, outcome "unknown", described as "Booster"; OFF LABEL USE (non-serious) with onset 06May2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 08May2022, outcome "not recovered", described as "Caller received Pfizer vaccine primary series, Pfizer booster 24Aug2021. On 06May2022 caller received second booster and was exposed to COVID five hours later/tested positive"; COVID-19 (medically significant) with onset 08May2022, outcome "not recovered", described as "Caller received Pfizer vaccine primary series, Pfizer booster 24Aug2021. On 06May2022 caller received second booster and was exposed to Covid five hours later/tested positive". The patient underwent the following laboratory tests and procedures: Blood immunoglobulin A: (unspecified date) low, notes: naturally; Creatinine renal clearance: (unspecified date) 45; SARS-CoV-2 test: (2022) Positive; (08May2022) Positive; (13May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course included the reporter received Pfizer vaccine primary series, Pfizer booster 24Aug2021. On 06May2022 caller received second booster and was exposed to COVID five hours later. The reporter tested positive 08May2022 and tested positive 13May2022 and thereafter, with test becoming "more positive" (stronger appearance of positive line) with succeeding days.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
Around 2:00 am woke up with chills.  Woke up at 7:30am with fever of 102.0.   Achy, lethargic.  Couldn't get out of bed.  Slept till 3:00pm at which time fever was gone and I felt fine.
Local reaction at site of injection -red, rash, raised, high fever 102-103 degrees for 7 days.  Respiratory symptoms developed after 4 days.  5th days with croup like symptoms for 3 days with fever.
Patient had three immunizations on 2/25/08.  He received two immunizations in the left thigh and one in the right thigh.  He awoke on 2/26/08 with a hard red bump at the top immunization site on the left thigh.  The thigh then became progressively more red and now the child has a red bump the size of a baseball according to the mother.  The thigh is also swollen and painful.  The child does not want to walk on the affected leg.  There is no fever but the child has a decreased appetite.  Mother advised to apply cool compresses to area.  Mother advised she was administering Motrin as directed every four to six hours.  Mother advised to call physician for further instructions.  Mother advised she had called the physician and was waiting for him to return her call.  She just wanted to know what immunizations were done in the affected thigh so she could advise the physician.  I requested the mother call back to let us know the outcome of this situation once she spoke to the physician.
YELLOW SKIN AT INJECTION SITE; OOZING AT THE SITE OF INJECTION; This spontaneous report received from a patient concerned a 74 year old male. 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: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid. On an unspecified date, the subject experienced yellow skin at injection site, and oozing at the site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the yellow skin at injection site and oozing at the site of injection was not reported. This report was non-serious.
Immunocompromised patient only received half dose instead of full third dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient only received half dose instead of full third dose) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient only received half dose instead of full third dose). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient only received half dose instead of full third dose) had resolved.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant and no treatment information was provided .Pharmacist accidentally gave an immunocompromised individual a booster 0.25ML shot instead of the 3rd full dose (0.5ML).
20JUN95 pt taken to ER t105; parents states had given APAP; was given cool bath & ped Ibuprofen; dx w/sinus infect & rx for ATB given; dc from ER w/rx for ped motrin;
I missed three menstrual cycles after the first vaccine. I was vaccinated 1/27/2021, had a cycle 02/01/21-02/05/21, but missed March, April, and May. It returned 06/01/21.
Pt c/o numbness and tingling in hands and legs within 15 minutes after receiving the Moderna, covid-19 vaccine. B/P 187/77 at 10:29, 190/72 at 10:37, 189/76 10:42, 199/78 @ 10:50am, 187/69 @ 11:00 am. Instructed pt to f/u with PCP regarding b/p. Released to sister to home.
Itching, redness, hives to right side of face and neck, abd pain.  Right upper back pain started almost immediately after vaccination.  Continued through the night.  Itching, redness, and hives resolved in approximately 2 hours with administration of dexamethasone.  Abd pain continues today. Right upper back pain is full today, instead of sharp, and is intermittent today.
he his having homoerotic dreams that he did not have before getting the vaccines; states they started after the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administration date 08Oct2021 (Lot number: 301458A) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABNORMAL DREAMS (non-serious) with onset Oct2021, outcome "unknown", described as "he his having homoerotic dreams that he did not have before getting the vaccines; states they started after the first dose".  Additional Information: Investigation Assessment: Not Provided. Patient had reported that he was having homoerotic dreams that he did not have before getting the vaccines and they started after the first dose. It has impacted his marriage, stated he was really having an issue with the fantasies he was experiencing.  No follow-up attempts are possible. No further information is expected.
pt recv vax 23JAN97 3PM & 29JAN97 pt woke up w/raised large blotchy rash over lt shoulder,back, bottom, stomach & legs;rash is itchy;mom could not tell whether it looked like hives or not;no fever or other sx x/cold;DPH given;