chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed a lymph node on the right side of my neck; This is a spontaneous report from a contactable consumer or other non hcp.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: unknown) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated, "I had my first vaccine on the first of this month, it had been two weeks now and yesterday, I developed a lymph node on the right side of my neck, it was not very severe. But I figured that I should call it in to see what your views on it were. Let me ask you one question, I was due to get my next shot next week, is it okay if I go do that? "Consumer was informed about the role of Pfizer Drug Safety and also informed about Pfizer Medical Information department in response to probing, consumer stated, "No, I don't know that is it. I will just call this number and see what they say. I will call you back." Further probing could not be initiated as consumer was unwilling to further answer the questions. Hence, further details were unknown and limited information was available over the call. The patient did not receive any treatment for the events. The clinical outcome of the event was unknown at the time of report. Information about lot/batch number cannot be obtained. No further information expected.
Red band encircling arm 2cm above and below site of injection, severe tenderness and area of 1 by 1 cm hardness at site. Pt also developed oral sores resembling canker sores at same time - but sure if related vs a viral illness.
ACUTE DVT OF LEFT POPLITEAL VEIN 7/26/2022 ASTHMA, UNSPECIFIED  ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/26/2022 ASTHMA, UNSPECIFIED  ACUTE DVT OF LEFT POPLITEAL VEIN 7/26/2022 COLON MASS  ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/26/2022 COLON MASS  ACUTE DVT OF LEFT POPLITEAL VEIN 7/26/2022 COLON MASS  ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/26/2022 COLON MASS
on 4/3 I experienced a fever (ranging between 99.5 and 100.3), headache, fatigue, and body aches. This began when I woke up around 7 AM and continued until about 9:00 PM. The next day on 4/4 I noticed a rash on my upper thighs and butt. They were just a bunch of red spots with white circles around them.  I took benadryl and it was resolved in a few hours.
Tinnitus  I have been experiencing mild Tinnitus since my first Covid vaccination. After this vaccination, it became much worse.
flu every time right after got the shot; Initial information was received on 07-Dec-2020 regarding an unsolicited valid non-serious social media case received from a consumer (patient).  This case involves patient who experienced flu every time right after got the shot (influenza), after receiving vaccine INFLUENZA VACCINE  Relevant medical history, concomitant medications and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu every time right after got the shot (influenza), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was influenza.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
Headache, Myalgia, Joint pain, swollen lymph areas, severe fatigue
fever; sore throat; chills/woke up today shivering; Chill/woke up today shivering; This is a spontaneous report from a contactable consumer (patient).    A 37-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FA7485) via an unspecified route of administration, administered in Deltoid Left on 28Jul2021 at 14:00(age at time of vaccination 37-years-old) as dose 2, single dose for covid-19 immunisation. The patient had no other medical history and no concomitant medications. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0202) via an unspecified route of administration, administered in Deltoid Left on 07Jul2021(age at time of vaccination 37-years-old) as dose 1, single dose for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Caller stated that on 29Jul2021 the patient experienced chills, fever and sore throat after receiving second dose Pfizer Covid 19 Vaccine. The caller also stated that woke up today shivering, 29JUL2021. The caller took his wife to work at the hospital at 0700 and the shivering started off pretty, well wouldn't say horrible but decent. The caller stated that he took Tylenol and Ibuprofen and four hours later the chills started getting really bad again. caller stated that he was watching the time. He took second dose of Tylenol and this seems to have curved the chills. The patient took his temperature after taking Tylenol. Caller's normal resting temperature was 97.2. The patient took his temperature 30 minutes after taking Tylenol and his temperature was 98.6. The caller is assuming the temperature was 99 but doesn't know to be honest. The patient did not visit Emergency Room/Physician Office. Therapeutic measures were taken as a result of events included treatment with Tylenol 500mg took twice, once in the morning and once at 14:00 (lot number: 1683583, Expiration: Mar2023) and Ibuprofen 400mg, took twice, 1600 and before bed last night (Lot number: P88291, Expiration: FEB2016). The caller stated that Ibuprofen may have been super week because the expiration date was 2016 and he stated the Ibuprofen worked but seemed too maybe be weaker. The patient underwent lab tests and procedures which included body temperature: 97.2 on Jul2021 Normal resting temperature is 97.2, body temperature: 98.6 on Jul2021. The outcome of the events fever, sore throat, chills was not recovered and woke up today shivering was unknown.
Headache for 48 hours and tingling and numbness in hands/fingers and toes. Fingers feel stiff and swollen.
Large Bruising over upper torso. Increased D dimer from previous test a few month earlier.   Increased inner  Cranial-pressure which was believed to cause optic nerve edema.
shot administered on 28SEP95 spots appeared all over the body on 8OCT95 in the morning;not febrile;parent suspects it from measles shot
No additional AE; an expired MMRII vaccine and expired DILUENT were given to a patient inadvertently; This spontaneous report was received from a registered nurse concerning a 5-year-old male patient. The patient's concurrent condition, medical history and concomitant medication were not reported.  On 25-JUL-2023, the patient was inadvertently vaccinated with expired measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) injection, 0.5 mL (lot #U022175, expiration date: 14-JUL-2023, route of administration and anatomical location not provided); and with expired sterile diluent solution for injection/infusion, 0.5 mL, once (lot #U002746, expiration date: 25-JUN-2023, strength, and route of administration not provided) as prophylaxis (expired product administered). Neither products had experienced a temperature excursion. No additional adverse event (AE).
Phone call from patient's wife at 11:10 AM saying her husband can't lift both arms and they are very painful. Patient's EMR office visit notes of 2-28-19: History of Present Illness: Onset: 1 day ago.  Severity level is 8. It occurs constantly and is fluctuating. Location: bilateral shoulder. There is no radiation. The pain is aching and throbbing. The pain is aggravated by movement. There are no relieving factors. Associated symptoms include decreased mobility, nocturnal pain and swelling.  Additional information: received Tdap and flu vaccines in shoulders and having severe pain from injection site. Physical Exam: Body areas examined left and right upper extremities: tenderness with slight hardness of bilateral upper arms in conjuncture with previous injections sites, extreme tender to touch, no redness, not warm to touch, no streaks. Soft tissue discomfort noted in the left and right anterior and posterior shoulders. Assessment/Plan: Pain in both upper extremities. Toradol 60 mg IM given in office. Take ibuprofen every 6 - 8 hours for pain. Apply heat and ice to area, massage area as able. Discussed signs and symptoms to go to ER for cellulitis. 3-12-19 @ 11:29  I called to see how pt's arms are doing in preparation of filing a VEARS report re: bilateral arm pain after receiving immunizations (Tdap in right arm & IIV4 & PPSV23 both in left arm).  I talked to the pt's wife, pt was not available. She said his right arm is back to normal. His left arm is still slightly tender when he massages it, still some warmth; but much improved. She said he is not taking any pain relievers.
Patient was given Pfizer as their 2nd dose  19 days after their 1st Moderna dose. Attempted to contact patient to inform of vaccine administration error.  Left message requesting a call back.
Facility clinic thru Specialty Rx  pharmacy provider gave the HCW a booster Pfizer vaccine in the right arm  5.5 inches below the acromion process, which is below the deltoid muscle. The injection went into the tissue below the deltoid resulting in pain, discomfort, itchiness, redness, and warmth to area from site of injection. The area of redness measures 4.5 inches X 2.5 inches.
The patient has a weird lump and bruise but not the arm where she had the injection; The patient has a weird lump and bruise but not the arm where she had the injection; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team.  An 86-year-old female patient received BNT162b2 (BNT162B2), on 14Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 86 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Blood pressure; "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; HYDROXYUREA. Vaccination history included: Moderna covid-19 vaccine (DOSE 1), for Covid-19 immunization, reaction(s): "None"; Moderna covid-19 vaccine (DOSE 2), for Covid-19 immunization, reaction(s): "None"; Moderna covid-19 vaccine (DOSE 3), for COVID-19 immunization, reaction(s): "None". The following information was reported: MASS (non-serious), CONTUSION (non-serious) all with onset 19Apr2022, outcome "unknown" and all described as "The patient has a weird lump and bruise but not the arm where she had the injection".  Additional information: Patient who is 86 years old and after receiving the Pfizer-BioNTech Covid 19 Vaccine, the patient had a "lump in bruise" in the opposite arm where the patient received the vaccine. Wants to know if this is a reported adverse event due to the vaccine. Patient had weird thing happen. She is some one who had 3 shots of Moderna and then had the Pfizer Booster. The patient has a weird lump and bruise but not the arm where she had the injection. The lump and bruise are high up on her arm but not on the same arm of injection. Concomitant medications includes Vitamins. Additional Vaccines Administered on Same Date of the Pfizer Suspect: none. If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect. Did any AE(s) require a visit to: Emergency Room? No; Physician Office? No.  Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): none. AE(s) following prior vaccinations: None. Family Medical History Relevant to AE(s): none  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received
Patient came back to pharmacy the morning of 8/02/2017 and reported that her arm around the injection site was red and itchy. Patient was instructed to take on oral antihistamine to help with the possible reaction and to she her doctor if it dosen't resolve.
After the second shot I had fatigue for a day but nothing bad. The Item that I am sending this on happened over a month later. I give blood on a regular basis for the last 10 years and have never had an issue. I donated blood on 03-10-2021 and then received a letter to say that I had a false positive for Hep C. They said they had one test that came back with the anti-HCV or antibodies for the Hep C virus. Two more test were run and both came back negative. They did additional test for the Hep C virus genetic material (HCV Nucleic Acid Test or NAT which was also negative. I do not know if there is a correlation with the vaccine but it seemed odd that this happened for the first time after getting the vaccination. I am reporting this for information and have also reported this to Moderna.
On 9/27/17, the employee reported two raised, red spots slightly below the injection site. She reported she had not had any reactions to any previous flu vaccines. There was no itching or discomfort. Employee was advised by workplace nurse to ice it and take BENADRYL that night, then report back. Employee reported back on 9/28/17. The two spots had now combined into one bigger one. There was still no discomfort but it was now a little itchy. The employee had not applied ice nor taken BENADRYL the night before, and was told by the workplace nurse to try those measures that night and then report back again. Employee reported back on 9/29/17. The spot was less red and less raised, with no discomfort and no itching. The employee was advised to see her primary care provider if she felt it was necessary, but that she did not need to report back to us unless she had concerns or if the spot worsened. The employee said she had no concerns; she did not report back. I spoke with the employee on 12/1/17 to let her know this report was being filed. She did mention she still has a mark, like a bruise, in the spot where the red mark was. There is no discomfort and no itching.
First Dose with Heplisav-B and Second Dose with Engerix; Initial Report Received on 10-Mar-2022  A registered pharmacist in the reported that a 51-year-old female patient (race and ethnicity unknown) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and Engerix-B as the second dose.  No medical history or allergies at the time of vaccination were reported.   No concomitant medications at the time of vaccination were reported.  On 21-Nov-2021, the patient received dose 1 of HEPLISAV-B (Lot # 935848, expiration date 02-Dec-2022, NDC # 43528-003-05, route and injection site unknown).  On 28-Jan-2022, 69 days after having received the HEPLISAV-B vaccine, the patient received Engerix-B (Lot #, expiration date, NDC #, route, and injection site unknown) as the second dose.  No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Patient was vaccinated with Tdap on 1/28/08.  Patient states on 2/2/08 at approximately 2:00 AM, she experienced pain, her "arm was throbbing".  Through workers compensation physician, patient was instructed to take Vicodin 1-2 for pain relief during the night and Advil 600mg during the day.  She was given exercises to stretch the muscle and ice was recommended at night for 20 minutes.  Follow up on 2/21/08.
baby yesterday that died because its breastfeeding mother got the vaccine and its been linked back to the vaccine.; baby yesterday that died because its breastfeeding mother got the vaccine and its been linked back to the vaccine.; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A patient of unspecified age and gender received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via transmammary on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter wanted to know the data for the risks, adverse reactions, and side effects associated with the Pfizer-BioNTech Covid-19 Vaccine. She wanted to know the exact percentage of each. She also wants to know information about blood clots, and deaths associated with the vaccine. She said there was a baby yesterday that died because its breastfeeding mother got the vaccine and its been linked back to the vaccine. The reporter said she has rheumatoid arthritis, and was on Embrel, and Methotrexate. She wants to know the possible interaction and risks of her medications and condition with the Pfizer-BioNTech Covid-19 Vaccine. The reporter wanted the complete list, and the breakdown of the ingredients for the approved Comirnaty, and the approved Pfizer-BioNTech Covid-19 Vaccine. The baby died on 09Sep2021. It was not reported if an autopsy was performed. The outcome of the event was fatal.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: baby yesterday that died because its breastfeeding mother got the vaccine and its been linked back to the vaccine.
Had vertigo symptoms, ie extreme dizziness, nausea and headache which lasted til Sunday. Took Meclizine and Mometasone for symptoms
This is a non-serious spontaneous case, initially received from other non-health professional on 14-Nov-2018, concerning a female patient of unspecified age. On an unspecified date, the FLUCELVAX QIVc vaccine underwent first temperature excursion with maximum temperature (Tmax) 8.2 degree centigrade for 4 minutes. On 22-Oct-2018, vaccine underwent second temperature excursion with Tmax 9.8 degree centigrade for 23 minutes. On an unspecified date, two temperature excursions were identified after an audit. On 06-Nov-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252672 and expiry date: 30-Jun-2019) which underwent temperature excursion. The patient did not experience any adverse events after vaccination. This case is linked to 201805262 (same reporter).
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 01-MAR-2018, 03-MAY-2018 and 05-JUL-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N003984 and expiration date 19-NOV-2018; lot# N024295 and expiration date 24-MAR-2019; lot# N028258 and expiration date 30-MAY-2019) orally for prophylaxis, respectively (Incorrect product storage). The Merck Sterile Diluent (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001958.
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Severe, Additional Details: Patient was provided Covid vaccine after admistration vision became blurry and pt was light headed. I get immediate care from NP in  Clinic who took her pulse and blood pressure. I went to get water to hydrate her and NP stated she fainted and was shaking ( 45 secs). 911 was called and paramedics admistered IV fluids and took vitals. Pt did not want to go to hospital was better and left with hospital.
This spontaneous report as received from an unknown type reporter refers to a 11 years old patient of unknown gender. On 06-MAY-2014 the patient was vaccinated with a dose of GARDASIL (lot#/batch# reported as J006350, expiry date: 31-MAR-2016) dose, frequency and indication unspecified. The reporter stated that GARDASIL was involved in temp changed. At the time of report, the outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Hives: chest, back of thighs, feet - applied Caladryl lotion - symptoms gone in 12 hours. Dizziness
Information has been received from an investigator via agency concerning a patient who was enrolled in a study. On an unspecified date the patient was vaccinated with PNEUMOVAX 23 (lot # not reported). Concomitant therapy included MMR II, PREVNAR and RECOMBIVAX HB. It was reported that the patient experienced immunization/vaccine reaction. The investigator felt that immunization/vaccine reaction was related to PNEUMOVAX 23. Immunization/vaccine reaction was considered to be an other important medical event. No further information is available.
Patient did not sit after GARDASIL 9 injection. Patient fell to the floor approx. 3-5 minutes after injection eyes rolled to back of head, pt unresponsive, legs and arms tensed. pt recovered approx. 2 minutes.
joint pain; 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 ARTHRALGIA (joint pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 ARTHRALGIA (joint pain). At the time of the report, ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
Pt. administered unknown amount of vaccine secondary to faulty needle. administered authorized dose in opposite arm (right). pt with no adverse effects and went home after 15 minute observation.
6 days later I had a bump on the vaccine site of the size of a quarter. It was itchy, hot to the touch & swollen. The next day I seen my doctor he prescribed me antibiotics, steroids & a cream, It lasted about a week.
On the night that I received dose 1 of my vaccination, I consumed 4 alcoholic beverages over 3 hours. After 3 hours, I threw up, lost my ability to walk on my own, and briefly lost my vision (5 seconds). I drink socially about 1x per month, sometimes consuming many more drinks than I consumed on this particular night. Never before did I encounter these effects from alcohol when consuming 1-1.5 drinks per hour.   The next day I felt very tired, sluggish, and run down all day long.
Urgent removal notice due to potentially received short-dated and recently expired. Vaccine have been administered with this lot after the expiration date