chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bump on arm, size of silver dollar; red; hot; little off; I chilly; Initial information received on 30-Nov-2022 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a 60-year-old female patient who experienced bump on arm, size of silver dollar, red, hot, little off and I chilly after receiving vaccine diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 28-Nov-2022, the patient received suspect diphtheria-2/tetanus/5 AC pertussis vaccine suspension for injection at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On an unknown date the patient developed a non-serious bump on arm, size of silver dollar (peripheral swelling), red (erythema), hot (feeling hot), little off (feeling abnormal), i chilly (chills), (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken: Not applicable.  Ice, Ibuprofen as necessary as corrective treatment was received for the events (bump on arm, size of silver dollar, red, hot). It was not reported if the patient received a corrective treatment for the events (little off, I chilly).  Outcome: Recovered / Resolved on an unknown date for all the events.; Sender's Comments:  US-SA-2022SA487992:
Patient was administered Bivalent Pfizer 5-11 vaccine instead of monovalent primary series Pfizer 5-11 vaccine. This was the patient's first dose according to parents. Patient was observed for 15 minutes with no issues. Parents were told of possible vaccine related side effects and to report any out of the ordinary adverse effects to us or their pediatrician. Parents were also given the guidance per CDC guidelines stating: If a bivalent Pfizer-BioNTech vaccine is administered for a primary series dose: Do not repeat the dose. The primary and booster dosages are the same; the bivalent dose can be counted as a primary series dose. Continue with the recommended vaccination schedule (i.e., complete the primary series with a monovalent Pfizer-BioNTech vaccine, then administer a bivalent booster dose at least 2 months after completion of the primary series). Parents were advised that the timeline for the 2nd dose will remain as planned at 3-8 weeks from the first dose received. Patient said that they would be going to their normal clinic to administer the second dose as their stop in local Vax Clinic was done on a spur of the moment. They were advised to let the provider no of what the child received along with the guidance given, and to have the provider reach out to us if they have questions. Parents and child left clinic on own accord with no issues.
No adverse Event; got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD).    No concomitant medications were reported.  It was reported that, the patient received vaccine after the beyond use-by date.  No treatment medications were reported.
Tendonitis - have had PT, very sore arm which still isn't healed and can be exacerbated -
Bilateral upper arm pain/tenderness with "red dots/lumps". Also c/o diarrhea starting within 1-2 days of vaccination. Advised mother to use cold compresses for arm pain and Tylenol for discomfort, if needed. Asked her to call her physician over the weekend if side effects worsened and to inform us Monday.
Swelling, redness, warmth to site. Given Medrol dose pack to take if not improving. Told to keep cool. Ice pack if feels good.
He has had blood in his stool, since yesterday, three separate times; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (Lot number and expiry date were not reported), via an unspecified route of administration on 18Apr2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received his first dose of the covid vaccine yesterday (18Apr2021). He has had blood in his stool, since yesterday (18Apr2021), three separate times. He was asking if this is normal. He has been waiting for a long time already. The outcome of the event was unknown.    Information about lot/batch number has been requested.
sweating; fever is still 100.8F; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating) and PYREXIA (fever is still 100.8F) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced HYPERHIDROSIS (sweating). 28-Apr-2021, the patient experienced PYREXIA (fever is still 100.8F). The patient was treated with PARACETAMOL (TYLENOL) on 27-Apr-2021 for Pyrexia, at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (sweating) and PYREXIA (fever is still 100.8F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Body temperature: 100.8 (Inconclusive) 100.8F.         Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator   Patient fell asleep after 2 hours, then patient woke up and felt bad again with the fever, sweating, then repeat.Patient took Tylenol at 11:00pm on 27Apr2021, at 5:00am and 9:30am on 28Apr2021, patient felt ok for 1 hour, the fever is still 100.8F, and patient took Tylenol, after 2 hours the Tylenol did not work.
This spontaneous report as received from a physician via a company representative refers to female patient of unknown age. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date in 2017 (reported as "about one year ago"), when she was 12 years old, the patient was vaccinated with the second dose of GARDASIL 9 (0.5 ml, intramuscularly for HPV prevention (lot number and expiration date were not reported). On an unknown date (reported as "an unspecified duration after getting the second dose"), the patient experienced severe blistering at the injection site. She decided not to get the third dose of GARDASIL 9 due to her adverse experience after the second dose. The outcome of injection site vesicles was reported as recovered on an unknown date. The causality between the event and therapy with GARDASIL 9 was not reported.
Patient is a 66-year-old male With history of colon cancer with metastasis to the liver and recent COVID diagnosis on August 31 presenting to the emergency department via EMS from home for increased shortness of breath and generalized weakness.  Patient was seen at facility on Sunday for cough with his COVID, he was given azithromycin to go home with.  Family states ever since then he has been declining at home.  He has been very weak and unable to get out of bed much.  He is normally alert and oriented x4 and active, however today family had a hard time even getting him off the couch and noticed he seemed to be breathing fast so they called 911.  Per EMS, patient was 90% on room air at his home, and he was tachypneic.  They gave a DuoNeb breathing treatment in route along with Solu-Medrol 125 mg IV.  Patient states he feels very fatigued and generally weak, he denies any chest pain, abdominal pain, nausea, vomiting or diarrhea.  His last chemotherapy dose was 2 weeks ago, he is scheduled to have another 1 tomorrow, however this will be canceled. Associated Symptoms: cough, fatigue, shortness of breath, weakness
I had previous anaphylaxis events that were treated and did not require hospitalization. I brought epinephrine pen and premedicated with Xyzal 5mg 9 hours before and Benadryl 25mg 1.5 hours before vaccine. 20 minutes after vaccine I felt flushing, nausea, low blood pressure. They had released me from the drive through vaccination site and I was driving and felt panicky, so I pulled over. I waited 10 minutes because I wasn't sure if it was anaphylaxis or not. I felt OK after 10 minutes, so I drove to nearest ER and waited in parking lot several hours then drove home. I probably should have administered epinephrine and called 911 when I had that reaction. Continued with 25mg Benadryl every 4 hours and nightly Xyzal 5mg. The next morning (24 hours later)  I woke up scratching my face. I had a diffuse sandpaper rash all over my head and neck and was very itchy. Doubled my dose of Benadryl to 50mg every 4 hours. Also took 400mg of quercetin. The itching resolved and the rash was gone the next day, which was 48 hours after vaccine. I was fatigued for several days but fatigue is my baseline as a narcoleptic plus I was taking benadryl. I continued the Benadryl for a total of 4 days. I normally do not develop rashes unless I rub against hay and I did not have any contact with hay.
booster; arm soreness; Somewhat disruptive during sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient in her 40's received bnt162b2 (BNT162B2) (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 (Manufacture Unknown.), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness"; INSOMNIA (non-serious), outcome "unknown", described as "Somewhat disruptive during sleep". Additional Information: The reporter reported that somewhat disruptive during sleep. No other side effects post booster dose. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient began to experience vaginal bleeding and uterine cramping.  Ultrasound performed at obstetrician's offices showed that she is having a miscarriage.  12/4/09 PCP Medical records received for  DOS 11/12/09. Pt. asymptomatic, requesting birth control. LMP: 10/13/09. Rx: Nuvaring; DOS: 11/23/09.  Pt pregnant, experiencing acute stress; DOS 11/30/09 pt. having bleeding and uterine cramping. OB provider confirmed miscarriage. DX: Spontaneous abortion
rise in Cr; Developed decreased PO intake; mild acute kidney injury; pancytopenia; lymphopenia; thrombocytopenia; This is a spontaneous report from a contactable Physician. A 78-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 10Mar2021, single dose for covid-19 immunisation. The patient's medical history was not reported. The patient had unspecified concomitant medications. The patient had the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for Covid-19 Immunisation. On 13Mar2021, the patient developed decreased PO intake, then mild acute kidney injury with rise in Cr and pancytopenia/lymphopenia/thrombocy topenia. The events caused hospitalization. Treatment for the events were IV fluids, Hematology consult. The outcome of the events was recovered. The patient had negative covid swab test on 12Mar2021.; Sender's Comments: Based on the narrative information provided, a causal association between the reported events and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Approximately 10 days after first COVID vaccination patient reported red, inflamed, hot and itchy spot at injection site. Lasted approximately 1 week. No other symptoms reported. Received 2nd dose 02/26/2021.
Patient received Flu vaccine 9/13/11, started feeling ill 9/14/11 with fever, aches & fatigue. Improved by 9/16/11. Then Mon. 9/19/11 came into office with fever 103.1, vomiting, achiness, fatigue, headache, cough.
Patch of redness over the dorsum of the right thumb and inferior to left scapula. Slight itchiness. No other symptoms. No dizziness or SOB. Normal vital signs. Spontaneously recovered after 45 minutes.
Information has been received from a doctor of pharmacy concerning a 62 year old female patient who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (Lot #, expire date and route not reported) instead of ZOSTAVAX (Merck). The pharmacist reported that the physician wrote the prescription for VARIVAX (Merck) in error. No adverse reaction was reported. Follow up information has been received from the pharmacist indicating that the patient received a dose of ZOSTAVAX (Merck) (Lot # not reported) 30 days after the dose of VARIVAX (Merck) was administered. No adverse experiences were reported after receiving ZOSTAVAX (Merck). No further information is available.
swelling lips, throat with in two hours of shot, had to return to ER a second time because symptoms returned
None. The local Health Department requested a report as this vaccine dose was given 19 days after the recommended 30 day refrigerator limit for the Moderna vaccine. The expiration day was listed on the form for the date of 7-11-2022. The patient had no untoward effects. Moderna will be contacted to ascertain efficacy.
Pain, hard lump, red, warm, bruising, entire upper arm swelled up, some itching.
On date of vaccine patient reported no issues. On 10/10/17, the patient returned to the pharmacy with a rash on her upper chest area. We reviewed all adverse effects and provided the patient with diphenhydramine and topical hydrocortisone. She will follow-up with primary MD if symptoms do not resolve.
Rash at site of vaccination and scratchy throat lasting 5 minutes.  Resolved on own and all symptoms are gone.
Lump in armpit area of left arm...arm which vaccine was recently given. Noticed over 24 hours after vaccination. Lump is tender to the touch and hurts when not touched. about the size of two golf ball; Lump in armpit area of left arm...arm which vaccine was recently given. Noticed over 24 hours after vaccination. Lump is tender to the touch and hurts when not touched. about the size of two golf ball; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0172; expiration date: not reported) via an unspecified route of administration in left arm on 08Jun2021 at 14:45 (at the age of 41-year-old) as 2nd dose, single dose for COVID-19 immunization. Medical history of the patient included allergy (unspecified) and mono about 7 months ago (unspecified). Other medications (concomitant) received by the patient in two weeks included birth control, venlafaxine hydrochloride (EFFEXOR) taken for an unspecified indication, loratadine (LORATADINE) taken for hypersensitivity, start and stop date were not reported for all medications.Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0172; expiration date: not reported) via an unspecified route of administration in right arm on 18May2021at 16:00 as first dose, single dose for COVID-19 immunization. On 09Jun2021, at 21:00, about 24 hours after, patient noticed lump in armpit area of left arm (arm in which vaccine was recently given). Lump was tender to the touch and hurts when not touched. It was about the size of two golf balls. No fever, no redness. Patient did not receive any treatment for the event. Outcome of the events were recovering.
Patient reported severe redness, heat and pain in arm, her dr told her to go to ER for treatment, patient confirmed she was treated with antibiotics for cellulitis  infection.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 6:15 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 6:15 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator, or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported.  Total 280 patients received Moderna Covid 19 stored at minus 82 degrees Fahrenheit. The patient was administered vaccine that was stored at temperature between minus 80 degree F to minus 84 degree F. No treatment medication information was provided.   This case was linked to MOD-2021-402935 (Patient Link).
Narrative:  COVID infection following COVID vaccine series 04/27, Pfizer,  dose #1 05/18, Pfizer, dose #2 12/16 COVID swab, result: not detected 1/10  COVID swab, result: detected 1/10 pt cc: exposure: unknown
Local tenderness, redness, swelling at site of injection X 72 hours, then decrease , returned again X 24 +, resolved.
11/16/22: Received message from Appointment Desk stating parent of patient, states child is having a reaction to her vaccines done on 11/10/22. Wanted us to know. Mom is taking child to Urgent Care.  11/17/22: Called mother, left message to call back. Mother called back, states child was taken to urgent care yesterday after developing left gland swelling from ear lobe to shoulder. States child was prescribed antibiotic in case of infection and anti-inflammatory medication. States doctor said it could have been a reaction to the vaccines. States child had high temps and lethargy for 4 days after receiving vaccinations. States child had received all vaccinations previously with no issues. This was the first time receiving the flu vaccine. Advised to continue care per urgent care instructions and follow up with doctor as needed. Advised will submit a VAERS report with information provided.
Both knees began to ache and turn stiff; Both knees began to ache and turn stiff; Can hardly stand up; His knees became puffy, pink, swollen, and warm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 2, single (Lot number: EN6198) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (ongoing). Concomitant medication(s) included: TOPROL XL taken for blood pressure measurement (ongoing); LIPITOR (ongoing); SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE. Vaccination history included: BNT162b2 (1st dose: pfizer EN5318), administration date: 24Jan2021, when the patient was 67-year-old, for COVID-19 immunization, reaction(s): "both knees began to ache and turn stiff", "both knees began to ache and turn stiff", "can hardly stand up", "his knees became puffy, pink, swollen, and warm"; Flu shot (He gets a Flu shot every year.), for Immunization. The following information was reported: ARTHRALGIA (non-serious), JOINT STIFFNESS (non-serious) all with onset 2021, outcome "not recovered" and all described as "Both knees began to ache and turn stiff"; DYSSTASIA (non-serious) with onset 2021, outcome "not recovered", described as "Can hardly stand up"; JOINT SWELLING (non-serious) with onset 2021, outcome "not recovered", described as "His knees became puffy, pink, swollen, and warm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, joint stiffness.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202300053948 Same patient/vaccine/event, different dose;
Initial report received 08 October 2009 from a health care professional. A male patient (age not reported), had received an injection of FLUZONE (lot number, route, site and date of administration unknown), and an unknown amount of time later, the patient had a flu test that was positive for "possibly H1N1". At the time of the report, the type of flu test and strain which tested positive were unknown. The patient's past medical history, usage of concomitant medications, concurrent illness status, and recovery status were all unknown at the time of the report. No further information was provided at the time of the report. Documents held by sender: None.