chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a Pfizer-sponsored program. A contactable healthcare professional reported that a 78-year-old female patient received PREVNAR 13, (lot number and expiration date unknown), via an unspecified route of administration on 07Feb2019 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The reporter asked if there were any reports linking pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and petechiae as the patient developed petechiae on 11Feb2019 after receiving the vaccine on 07Feb2019 at a pharmacy. She was treated in the ER and was not admitted. The outcome of the event was unknown. Information on the lot/batch number has been requested.
Started feeling chest tightness and heart palpitations within 2 hours of receiving the vaccine injection.
72 hours after the injection I have a dinner-plate sized red rash around the injection site; It is hot to the touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Mar2021 13:00 (Lot number: EN6202) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "HBP" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE; HYDROCHLORIC ACID; AMLODIPINE. Vaccination history included: Bnt162b2 (Lot number : ER2613, Dose number :1, Vaccine location : Upper Right Arm), administration date: 02Mar2021, when the patient was 66 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE RASH (non-serious) with onset 26Mar2021 06:15, outcome "unknown", described as "72 hours after the injection I have a dinner-plate sized red rash around the injection site"; VACCINATION SITE WARMTH (non-serious) with onset 26Mar2021 06:15, outcome "unknown", described as "It is hot to the touch". Therapeutic measures were not taken as a result of vaccination site rash, vaccination site warmth.  Additional information: Patient has no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. Patient reported that red rash was not painful.  No follow-up attempts are possible. No further information is expected.
YOUTH COMPLAINT OF CHILLS, ONE TIME DOSE OF TYLENOL 650 MG ADMINISTERED BY RN. NO OTHER COMPLAINTS
After receiving the 3rd  vaccine shot on 10/27/21, I started to notice a visible change in the appearance of skin on my fingers in late November and December 2021. They had a dry, ashy appearance that I attributed to the colder weather. In January I noticed that rather than ashiness, it was depigmentation . Since mid-January I have developed patches of depipmentation on all of my fingers, especially the knuckles.
experience headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 10:00 (Batch/Lot number: unknown) at the age of 72 years as 1st dose, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 04Mar2021, outcome "recovered" (05Mar2021), described as "experience headaches". Therapeutic measures were taken as a result of headache. Additional information: Since the patient was the reporter, she experiences with the COVID vaccine. When she took the first COVID vaccine on 04Mar2021 she experiences headaches. Reporter Details was Declined to provide a physical mailing address, Patient Details was Declined to provide specific "other" ethnicity Primary Healthcare Professional Information includes Unable to provide mailing address, phone number, or email address, Event Details includes Headaches started around 4:30 PM or 5:00 PM after patient received vaccine on 04Mar2021. She took Tylenol about 10:00 PM that same night and when she woke up the next day the headache was gone. Caller confirms she recovered completely. Suspect Product details includes, Probed for NDC, lot number, and expiry date and says that they treated her bad, there is nothing on her COVID vaccine record card, patient hasn't taken her second COVID vaccine yet, she will get that on 25Mar2021. On her COVID vaccine record card it was the first dose and the date of 04Mar2021, no information regarding emergency room, physician office visit, patient has not undergone any other prior vaccinations within 4 weeks. Patient wanted to respond to the pamphlet that she got from Pfizer that had asked that if she had any side effects to report them. Vaccination Facility Type: At a centre.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I82.409 ACUTE DVT, UNSPECIFIED VEIN 8/8/2023 ACUTE DVT, UNSPECIFIED VEIN I82.409 ACUTE DVT, UNSPECIFIED VEIN 8/8/2023 ANEMIA OF CHRONIC DISEASE
Myocarditis and a Right Bundle Branch Block that was not there before the vaccine. I now have an arrythmia. I never had heart problems before. I went to the emergency room for chest pain and an ERKG discovered the issue. I had no other symptoms related to the vaccine as of today.
Pt. was given PEDIARIX (exp: 3/17/11) & Rotavirus (exp. 3/4/11) that were expired on 3/23/11.
Pt has a red rash at injection site says dark red, then had a lighter ring around it that was getting larger. Estimate placing hand in "C" shape and placing on arm is how big. Pt says has pain and low grade fever. Recommended ice and TYLENOL and monitor. Redness started going down on day 3. States like bump site of angry in arm.
Patient stated that 2 days after receiving 2 vaccines there appeared red round spots on the forehead and top of head of the patient. Then 6 days later he came down with a 102 degree F fever and went to the ER at hospital. The prescriber told him that he is septic and has a low BP and low blood count, and prescribed LEVAQUIN. Patient said he will return to hospital if he doesn't recover.
cough; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer sales representative. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on an unspecified date (lot number not reported), as dose 1, single, for COVID-19 immunisation. Relevant medical history included seasonal allergies, cough (typically develops a cough around this time of year), osteoporosis and overweight, all from unknown dates, not reported if ongoing or not. Concomitant medications were not reported. On an unspecified date, 2 days after the first vaccination, the patient developed cough. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt developed itchy rash on Rt check of face 7/27/2021 at 10:00 PM.  No other symptoms noted at the time or today.   Pt given Zyrtec 10 mg now and Benadryl 25 mg caplet given to patient to take when she arrives home.  Pt is to contact her PCP regarding rash.
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by State or COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
5-10min p/vax pt tearing-swelling lower eyelids & scratchy urticaria rash;
About 7 hours after the shot I had a migraine and arm soreness  About 20 Hours after the shot I woke up with chills but sweating and felt fatigue, muscle soreness, dizziness, migraine About 24 hours after the shot I felt abnormal breathing
Quarter size welts appeared around injection site from elbow to shoulder, sore stiff arm and whole body, headache, shakes, nausea. Welts got worse for 2 days, just starting to subside. Headache still part of time.
muscle ache; decrease smell; Arm immediately became heavy; headache; brain fog; complete exhaustion; This is a spontaneous report from a contactable other HCP.   A 50-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm right on 22Jan2021 14:00 (Lot Number: EL3302) as single dose for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No other vaccine in four weeks. No covid tested post vaccination. The patient experienced arm immediately became heavy (and lasted for apprx 24 hours) on 22Jan2021 14:30. Within 20-30 min of injection patient developed headache (circular around head -temple level), brain fog, complete exhaustion all on 22Jan2021. All symptoms lasted for 6 days. The events recovered on 28Jan2021. Other brief 2-3 hour symptoms were muscle ache between neck and shoulders, decrease smell. These last events recovered on an unknown date  No follow-up attempts are possible. No further information is expected
Fine rash on torso (posterior/anterior) itching. Treatment provided. BENADRYL ELIXIR as directed.
The vaccine experienced a temperature excursion of 48.4 degrees Fahrenheit on 5/10/21 at 7:05am. Due to this excursion the vaccine was expired when administered. The patient had not experienced any side effects at the time this report was submitted.
weird side effects; sore arm; kind of crampiness; general muscle ache; has been spiking very very low grade fever; achyness; a lot of fatigue; a lot of muscle aches; This spontaneous case was reported by a physician and describes the occurrence of ADVERSE EVENT, PAIN IN EXTREMITY, MUSCLE SPASMS, MYALGIA, and PYREXIA in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included SYNTHROID for Hyperthyroidism.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced ADVERSE EVENT, PAIN IN EXTREMITY, MUSCLE SPASMS, MYALGIA, PYREXIA, MYALGIA, FATIGUE, and MYALGIA. The patient was treated with TYLENOL for Ache, at an unspecified dose and frequency. At the time of the report, ADVERSE EVENT, PAIN IN EXTREMITY, MUSCLE SPASMS, MYALGIA, PYREXIA, MYALGIA, FATIGUE, and MYALGIA outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had been spiking very low grade fever that comes and goes it had not gotten above 99.7. No concomitant medication was provided.
pt recv vax 31AUG98 & 9SEP98 afternoon started c/o muscle aches then h/a;also had photosensitivity & stayed @ home;10SEP no fever but took APAP for h/a & muscle aches;12SEP rash appeared on face, neck,chest & few only on extrem;
change in ear pressure; ringing noise; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 23Mar2021 at 16:45 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's disease and celiac disease. Concomitant medications included levothyroxine sodium (SYNTHROID) 125 mcg, vitamin D (MANUFACTURER UNKNOWN) and cyanocobalamin (VITAMIN B12). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 23Mar2021 a few minutes following the vaccination, the patient experienced a change in ear pressure (like experienced during a change in elevation) and the event lasted for about an hour. Then he developed a ringing noise which had lasted for the past 9 days. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of sensation of pressure in ear and ringing in ears, included treatment with CLARITIN and FLONASE. The clinical outcome of the event change in ear pressure (sensation of pressure in ear) lasted for about an hour and recovered on 23Mar2021. The clinical outcome of the event developed a ringing noise which had lasted for the past 9 days was not recovered.  No follow-up attempts are needed. No further information is expected.
She received the Swine flu vacc on Sat and began wheezing on Sunday. Required XOPENEX inhaler bid until Tues night. Called for refill of XOPENEX neb.
Patient experienced extreme pain at the injection site and has since been seen in urgent care where she was diagnosed with adhesive capsulitis of the left shoulder.  Patient is receiving physical therapy once a month to treat frozen shoulder.
I became very dizzy after my second dose. I was so dizzy I asked restaurant to stop preparing my food and just put something already prepared in a box for me because I was so dizzy and concerned about getting home. I had extreme pain in my spine and all of my joints. I had a fever that lasted for about 10 days. I had ringing in my ears, exhaustion and heart complications. The exhaustion and heart complications went on for months.
Within the first 10 minutes of receiving the vaccine I felt extremely lightheaded, eyes were blurry for 5-10 minutes, and extreme sweating all over my body. These symptoms subsided after 25 minutes. I then became on and off light headed through the remainder of the day. The day after receiving the vaccine I felt a lot of brain fog, forgetfulness, and fatigue. The night of day two I had a sudden onset of nausea and headache which only lasted 20 minutes. During this time I was massaging the injection site because it was sore.
Patient had INFANRIX in right thigh and HAVRIX in left thigh on 8/7/18. Patient came back into office on 8/10/18 with knot on right thigh and heat at injection site. Mom states patient has been fussy and that she thinks his face seems swollen. He was having no breathing problems during his visit to the office and mom states no breathing problems prior to visit. Patient was seen by physician and told to use warm compresses on the right thigh. Physician states he did not see any swelling in the face. Patient allowed to go home.
Right arm swelling at site, pain redness at site within 6-8 degrees of shots ER visit. Return to clinic 9/25/07 Zyrtec and Prednisone.
Initial report received on 11 January 2011 from the investigator participating in the post-marketing observational surveillance study under the reference number M5A16. This is one case in a series of 11 pertussis cases received during the surveillance period from 01 January 2010 to 11 January 2011. A case of pertussis disease in a 14 month old, female subject was identified by the investigator based on review of data from the surveillance system. The subject's vaccine history included 3 doses of PENTACEL received on 13 May 2009, 09 July 2009, and 09 September 2009 (route, site of administration, and lot numbers were not reported). Approximately 9 months after the last dose, on 17 June 2010, the subject developed paroxysmal cough with whoop. Other symptoms included cold-like symptoms and posttussive vomiting. Laboratory testing included positive PCR on 24 June 2010. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 24 June 2010. The subject was not hospitalized. At the time of final contact on 02 July 2010, the subject's cough had resolved. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Company comment: No vaccine protects 100% of individuals against infection. It is therefore not unexpected to find cases of pertussis after vaccination. In this particular case, no medical history has been provided so it is unknown if the child had an underlying medical condition or was taking concomitant medications that could have increased vulnerability to infection or inhibited immune response to vaccination. As 9 months had elapsed since the child's 3rd dose in the primary series and she was soon due to receive a booster, it is possible that waning immunity may have been a factor in this case. Documents held by sender: None.
Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report) was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed.  At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature.  On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, administered with product that was exposed to room  temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.
Narrative:  1st dose Pfizer vaccine on 8/30/21. Next day (8/31/21) reports headache and blurred vission lasting 3 days. These symptoms self resolved.
Patient called within 24 hours of admin and complained of inj site being 'slightly irritated.' Discussed some first aid measures if needed. Told him to call back later that day to check in. He didn't feel it had gotten worse but told him to call back tomorrow if it had.  Another pharmacist on duty (imz pharmacist) took the call on Sunday (48 hours post inj) and didn't realizie the severity of the reaction.  He called his health ins nurse line with concerns of it becoming raised and redness spreading with the skin feeling coarse. He complained of lines of inflammation spreading up toward his neck and down his arm. He did take ibuprofen but didn't feel it was helping.  He appeared at the pharmacy today 2/23 5pm to show a pharmacist his reaction site and it was clearly inflamed and elevated, but he felt it had improved the last 24 hours. The patient was informed we would report the ADR and followed by more discussion about medical attention needed if it didn't improve.  Following up with him tomorrow.
Had same reaction to both shots. Shot #1  given 1/8/2021 Pfizer EL0142 also intramuscular Left arm. About 12 hours after injection ran fever 102, had severe headache and nausea, muscle aches and back ache for next two days. Both shots administered around 9 am in the morning on a Friday.  Onset of symptoms that evening around 8pm or 9pm, Was in the bed for two days until Sunday midday until symptoms subsided. Had no appetite. Headache so bad it required several doses of Migraine medication Maxalt 10mg to withstand. The second shot I was more prepared for reaction and took leftover pain medication from knee surgery Norco to sleep as long as possible. I slept for 18 hours!
Left arm is swollen, red and very painful and hot to touch. This is 2nd pneumo shot.
p/vax pt had one episode of near syncope  & dizziness while driving; kind of like being sleepy;
Patient reports itching, swelling and redness in hands and feet, somewhat relieved by taking diphenhydramine every 4 hours.
4 hours after administration of HPV vaccine dose #2 patient had swelling of tongue to one and one half normal size.  2-3 cankor sores on tongue and Headache rated 5-6 on a scale of 10.  Client took antihistomine and swelling went down but 24 hours later tongue remains swollen.  No shortness of breath, difficulty breathing or eating, rash, or other complaints.
The night I go the vaccine, left hand (On vaccinated arm) felt numb and tingly, as if ?asleep,? and swelled overnight. Moving around the next day helped swelling subside.  Tonight, 2/3, hand feels cold and a little tingly again.
extremely sore left arm; fatigue; lightheaded; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733), via an unspecified route of administration in the left arm on 26Mar2021 at 04:30 (at the age of 22-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 26Mar2021 at 18:00, the patient experienced extremely sore left arm, fatigue and lightheaded. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of events and and included treatment with Advil. The clinical outcome of the events pain in left arm, fatigue and dizziness was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Nausea; Vomiting; Chills; Stomach pain; Slight headache; Uncontrollable shaking; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 68-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247, Expiry date: unknown) via an unspecified route of administration, administered in Left arm on 28Jan2021 at 14:00 (at the age of 68-years-old) at a single dose for covid-19 immunisation. Medical history included bronchiectasis and dysthymia. Allergies to medications, food, or other products included Rash with amoxicillin. Concomitant medication patient received within 2 weeks of vaccination included sertraline hydrochloride (ZOLOFT) and ovata (METAMUCIL [PLANTAGO OVATA]). The patient previously took amoxicillin and experienced rash. The patient experienced nausea, vomiting, chills, stomach pain, slight headache and uncontrollable shaking on 28Jan2021 at 21:30 PM. The event was considered as non-serious. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The patient was recovering form all the events.