chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable pharmacist via a sales representative. This pharmacist reported similar events for 2 patients. This is the second of 2 reports. A patient of unspecified age, race, ethnicity and gender received for immunization on an unspecified date a single dose of PREVNAR 13)and a high dose of influenza vaccine.  The patient medical history and concomitant medications were not reported.  The two vaccines were co-administered on the same arm about one inch apart. On an unspecified date the patient experienced redness from the injection site all the way down to the elbow, it was red, swollen and hot. Outcome was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2016586887 same reporter/product/event, different patient.
"I began  to have flu like symptoms around 1000 am after receiving the vaccine around 730 am Monday 12/28. By the time I arrived home around 3 pm I had chills, achiness but never ran a fever. This went on throughout that evening. When I woke up the next day I felt great until approximately 1000 am and then began having diarrhea. That lasted for about 5 hours. I had some soreness in my L arm where the shot was given however the following  Monday (1-4-21) I had a hard lump where the shot was given and a red rash that appeared. The rash has improved today but is not completely gone."
Neck swelling; This is a spontaneous report from a contactable nurse. A 30-year-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EK4176 and Expire Date: unknown) via unspecified route of administration on an unspecified date in Jan2021 (age at the time of vaccination: 30) as dose number unknown, single for Covid-19 immunisation. The patient was not pregnant at the time of vaccination. Facility type vaccine was Hospital. Patient's medical history was not reported. She had no known allergies. Concomitant medications included Lexapro for unknown indication, taken in two weeks. No other vaccine was administered in four weeks. Prior to and since vaccination, patient was not tested positive for Covid-19. After vaccination, the patient experienced neck swelling on 06Feb2021. The outcome of event was recovering without treatment.   Follow-up (14May2021): Follow-up attempts completed. No further information expected.
My blood pressure started spiking as high as 146/77 or 80+ . I have not had previous issues with high blood pressure. It has remained higher than usual, often going back to more than 140 systolic.  If I lie down and close my eyes it returns to normal, but has continued more than 24 hours now. Kaiser doctor's office thinks it's a reaction to the vaccine.
The patient received the second dose of the Moderna vaccine at the Health Department. The patient experienced a rapid onset of a dry mouth and throat, followed by a restricted airway and elevated blood pressure. The patient was given 2 x 25 mg pf Benadryl, however, due to rapid restriction of the airway .05 of epinephrine was administered by injection. The symptoms subsided slightly. A second injection of .05 mg was administered. The patient was observed and released with instructions to contact his primary care physician.
Significant swelling of arm noticed one week after injection.   Hard to abduct arm due to swelling.  Very mild pain.  Itching.  Denies fever or chills.
left arm hurts a little bit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left arm hurts a little bit) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (left arm hurts a little bit). At the time of the report, VACCINATION SITE PAIN (left arm hurts a little bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Pediatric pt., 6 months 11 days, given FLUZONE 6 months/older dose of 0.5mL IM instead of 0.25mL. Pt and Mother left office before incorrect dose noticed. Provider and Parents notified and requested copy of all immunizations given that night to be sent to parents fax with all information (lot number, manufacturer, exp date, etc). Provider advised parents of precautions and s/s to look for.
Left thigh swollen and hot to the touch - Pt given BENADRYL and alternating Ibuprofen and Tylenol for fevers.
Patient began developing rash 2 weeks after initial dose of Pfizer COVID-19 vaccine.  Rash started with an oval, salmon-colored plaque followed by numerous similar but smaller lesions on trunk.  Rash evaluated in my office 06/03/21 and felt to be consistent with Pityriasis rosea.  Referral to Dermatology for confirmation.
Within 24hs of vaccine -> redness at site of injection Developed. Then redness Down the left arm and itching.
Large red swollen area about 3" in diameter.  Started with burning, then itching.  Also bleeding on the skin surface at the time of injection.  Friday night she took Advil and Tylenol for the symptoms.  Saturday she took Advil and Tylenol as needed and one dose of Benadryl at 8 PM.  Today (10/18) it is slightly swollen and very tender. She has had at least 4 or 5 flu shots in previous years.  The most concerning issue to the vaccine administrator is that 2 other people had the same reaction in this school on the same day.  The vaccine administrator gave about 700 flu vaccines over the course of 5 days in all the schools in the area and this was the only school with any known reaction.  The lot numbers on all 3 reactions were the same, as were about 550 other vaccines given this week.  The other vaccine reaction reports are coming by mail.
This case was reported by a nurse via sales rep and described the occurrence of coldness of skin in a female patient who received BEXSERO. The patient's past medical history included anxiety disorder. On an unknown date, the patient received BEXSERO (intramuscular). On an unknown date, several hours after receiving BEXSERO, the patient experienced coldness of skin, clamminess, fever, looked pale, crying uncontrollable and tremor. On an unknown date, the outcome of the coldness of skin, clamminess, fever, looked pale, crying uncontrollable and tremor were unknown. The reporter considered the coldness of skin, clamminess, fever, looked pale, crying uncontrollable and tremor to be probably related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the 16 to 18 years old patient experienced fever (100.6 degree F), looked pale, was cool and clammy to the touch, was crying hysterically and shaking uncontrollably after vaccination with BEXSERO. The reporter would be on vacation next week from reporting date and back of contact details of practice manager were reported. This case is one of the four cases reported by the same reporter.
Administration Error - Patient received COVID19 Moderna vaccine on 2/2/2021 and was given a Shingrix in less than 2 weeks (on 2/11/2021) as recommended by the CDC. No adverse event was observed.  Reporting for administration error only.
Severe blistering ,emergency admit to burn unit at local hospital.  3 skin grafts, intensive care unit stay for 5 weeks
This spontaneous report was received from a nurse practitioner concerning a female patient of unknown age who on an unknown date, in 2010 received the first dose of 1 GARDASIL (route, lot number and expiration date were not provided) and in May 2012 received the second dose of GARDASIL (route, lot number and expiration date were not provided). No adverse events were reported. Additional information has been requested.
fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 15Feb2021 10:30 (Batch/Lot number: EN6201) as dose 2, single for covid-19 immunisation. Relevant medical history included: "urinary tract infection", start date: 20Jan2021 (unspecified if ongoing), notes: on antibiotics beginning 2 days before first vaccine injection. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Administration time: 10:50 AM, Route of injection: Intramuscular, Site of injection: Left arm, Batch/Lot number: EL9262), administration date: 22Jan2021, for COVID-19 immunisation, reaction(s): "fever", "joint aches/pain", "muscle aches", "white bump near injection site", "hot at night", "headache". The following information was reported: FATIGUE (non-serious) with onset 17Feb2021, outcome "recovered", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue.  No follow-up attempts are possible. No further information is expected.
swollen lymph nodes at the arm; Stopped menstrual cycle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes at the arm) and AMENORRHOEA (Stopped menstrual cycle) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012C26A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes at the arm) and AMENORRHOEA (Stopped menstrual cycle). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes at the arm) was resolving and AMENORRHOEA (Stopped menstrual cycle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications reported.
pentacel instead of acthib was administered in error with no reported adverse event; Initial information received on 20-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 months old and unknown gender patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] instead of HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (yeast), pertussis vaccine acellular 3-component, polio vaccine Inact 3v (VERO), tetanus vaccine toxoid (Pediarix) and Rotavirus Vaccine for Prophylactic vaccination, chlorphenamine maleate, naphazoline hydrochloride (Flucur).  On 14-Jun-2023, the patient received a 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection lot UJ805AA expiry date: 17-feb-2024 via intramuscular route in the right thigh for prophylactic vaccination (immunization) instead of HIB (PRP/T) VACCINE in error with no reported adverse event (wrong product administered) on the same day.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event pentacel instead of acthib was administered in error with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt presented to pharmacy 2 days post vaccination with red, swollen, warm to touch area at injection site. Appeared to be abnormal -> referred to seek medical attention.
Fever up to 101 (during night hours only) past 3 nights. Treated with over the counter antipyretics. Rash started 09/08/04 on face/neck and back, maculopapular, itches, no treatment. On visual inspection throat appears slightly red with one white spot in right tonsil. No complaints of sore throat or cold symptoms.
On 07 Apr woke up around 11:30pm with chills, hot/cold feeling, low grade fever, rib area pain, horrible migraine that started around 11:30pm that night. Didn?t sleep. Took Acetaminophen (500mg) around 4:30am that did not help. Took more (1000mg) around 8am. Started feeling better later that night.  On 13 Apr woke up with sore right leg.
This patient had a pretty large area of swelling and redness after her HPV. MODERATE REACTION.
swelling, itching, redness and iduration at injection site approx 3 cm received 1 day after injection
After several weeks we noticed eczema come up in big patches all over her head her head. We then noticed that she was not getting her first period and kept going to different doctors and did many tests to figure out what was going on. After a lot of of natural remedies and detoxes she was able to get her first period at the age of 17 years and 3 months. Her eczema is a bit better but it is still there and not as aggressive as it used to be.
About 10 minutes after injection, experienced tachycardia 170s, face numbness and flushing. Obtained 12-lead EKG, took anti-histamine
Difficulty breathing (I have asthma); low grade fever; rapid heart beat; upper body aches and pain; sneezing, runny nose.
Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approximately, when temperature data logger registered 34 or 35°F; Dose administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approximately, when temperature data logger registered 34 or 35°F) and POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 4:27 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Oct-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approximately, when temperature data logger registered 34 or 35°F). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approximately, when temperature data logger registered 34 or 35°F) and POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as 65.27.  No concomitant medications were reported. The vial was initially moved to the fridge on 09-Mar-2021 and proposed beyond use date was 08-Apr-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. On the date of administration, at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit and at 10:00 A.M., the temperature recorded was 30 degree Fahrenheit that has been reached by the vial. Temperature recordings were taken using a temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided.
I became Ill that night with the standard temp, chills, body aches, and shortness of breath that I expected would come along.  Over the next few days the symptoms eased and went away except the shortness of breath.  By early August, I had developed a respiratory Illness and had to go get a chest xray and Covid tested. I also ended up having a PFT done once my resp illness was over because the SOB never subsided.  I now have inhalers to add to my medications.  This was not life before.  I also misses several days of work from infusion date to mid August because of being so Ill.
Vaccine breakthrough, asymptomatic.   Inpatient admit 9/1-9/2/21
Woke up with chills, fever of 100, headache, muscle aches. Took Tylenol as advised by the nurse who administered the vaccine and it seemed to help a little bit with the headache.
Well infant at 4 months received vaccinations, 2 hours later, presented office, History of having napped and awoke with profuse vomiting and diarrhea and lethargy, In office, was noted to be pale, hypotonic and poorly responsive. Sent to hospital, Recovered spontaneously quickly and returned to healthy state, The posiblity of an acute anaphylactoid milk reaction, which the mother suggests as a possibility is being explored.
Had 3 hepatitis B shots. First one 8/14/02, second one 10/22/02, third 2/20/03. Had first seizure 11/14/02. Had second seizure 3/21/03. No history of any health problems ever in family.
Shivering, headache, muscle aches, injection site very sore, felt feverish
Patient rec. FLUVIRIN in (R) arm on 11/14/12 states arm feels warm, itchy. Has felt this way once rec. shot & still feels this way. Not getting any worse. Also, rec. BOOSTRIX in (L) arm that day - no issues.
joint pain starting around 2pm the next day. By evening I had major body aches and pains, flu like symptoms. By 9pm I started with fever. My fever got to 102.  Over the weekend, allergy like symptoms. Injection site is red, warm to touch and extends down my arm. I am monitoring for now. Plan to take Benadryl when I get off work.
Patient had no known ill effects or complaints directly after receiving his first COVID-19 vaccine on 02/19/2021. However, on 03/21/2021, he was found deceased on his bedroom floor due to a suspected cardiac arrhythmia. It is unknown if there is any correlation.
I am due September 12, 2021. At the time of the first dose, I was five weeks and three days pregnant.  I had no noticeable side effect other than a sore arm which went away within 24 hours. At the time of the second dose, I was nine weeks and three days pregnant.  I went to bed early that night (7:30 pm) but attributed it to pregnancy.  I awoke at 3:00 am on 2/11/2021 with a headache, fever, nausea and pain and swelling at the injection site.  My temperature was 100.4. I ate some crackers and went back to bed until 6:00 am.  At 6:00 am, I still had a slight fever (100.4) and the nausea was still there.  I had some toast.  At 7:20, I vomited.  I went back to bed around 9:00 am and slept until noon.  When I awoke at noon, my fever had broken (99.6) but I had an intense headache centering around my left eye and upper neck/base of my head on the left side.  This headache has been continuous up to the time of writing this (4 days post second dose 2/14/2021).  Additionally, I have had an increase in nausea and vomiting.  On Friday, 2/12, nausea was constant throughout the day, and I vomited 7 times (5 of them happening in the morning between 5:00 am - 10:30 am).  On Saturday 2/13, the nausea subsided slightly and I vomited only twice.  Now, Sunday, 2/14, there is still nausea (vomiting once) and the headache.  My injection site is no longer swollen, but is still slightly red and has some bruising.
pt recvd vax;24mar94 had chills x about 5 mins;rolled eyes back & felt asleep x 2 hrs;woke up v; no redness; t 100; to er; had ear infect & MD states rxn to DTP;
Patient was feeling nauseous one day after receiving vaccine; As a result she wasn't drinking and became dehydrated; She complained of headache and back spasms which became progressively worse.; She complained of headache and back spasms which became progressively worse.; She was diagnosed with UTI, pneumonia and sepsis; pneumonia; sepsis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 92-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 92 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII taken for influenza immunisation as dose number unknown, single. The following information was reported: DEHYDRATION (hospitalization) with onset 17Oct2023, outcome "not recovered", described as "As a result she wasn't drinking and became dehydrated"; NAUSEA (hospitalization) with onset 17Oct2023, outcome "not recovered", described as "Patient was feeling nauseous one day after receiving vaccine"; HEADACHE (hospitalization), MUSCLE SPASMS (hospitalization) all with onset 17Oct2023, outcome "not recovered" and all described as "She complained of headache and back spasms which became progressively worse."; URINARY TRACT INFECTION (hospitalization) with onset 17Oct2023, outcome "not recovered", described as "She was diagnosed with UTI, pneumonia and sepsis"; PNEUMONIA (hospitalization) with onset 17Oct2023, outcome "not recovered"; SEPSIS (hospitalization) with onset 17Oct2023, outcome "not recovered". The patient was hospitalized for nausea, dehydration, headache, muscle spasms, urinary tract infection, pneumonia, sepsis (start date: 20Oct2023). The events "patient was feeling nauseous one day after receiving vaccine", "as a result she wasn't drinking and became dehydrated", "she complained of headache and back spasms which became progressively worse.", "she was diagnosed with uti, pneumonia and sepsis", "pneumonia" and "sepsis" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of nausea, dehydration, headache, muscle spasms, urinary tract infection, pneumonia, sepsis. Clinical course: Patient was feeling nauseous one day after receiving vaccine. As a result she wasn't drinking and became dehydrated. She complained of headache and back spasms which became progressively worse. She went to the ER on 20Oct2023 and was admitted. She was diagnosed with UTI, pneumonia and sepsis. Patient was treated with fluids and IV antibiotics. Remains hospitalized at this time. The patient's son, (name withheld), directly reported this to reporter. The treatment included: IV antibiotics and fluids. Patient did not had covid prior vaccination. Patient tested post vaccination and Covid test post vaccination result was Negative.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
My arm was hurting on my vaccination site. I already had migraines and knee problems. Two days after the pain got way worse.