chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came into clinic 01/12/22 for immunizations. Parents speak a different language. After RN assessed patient's electronic vaccine record, she reported that patient was due for 2nd dose of Hepatitis B vaccine, Flu vaccine, and the 1st doses of COVID and Hepatitis A vaccines. The mother accepted patient to receive the Hepatitis B and COVID vaccines but declined the others.  After the two vaccines were administered and the patient was waiting for 15 minutes following the vaccines, the mother showed the nurse the patient's vaccine record. Vaccines were up to date according to the documentation from the clinic. The parents were confused as to why patient needed additional vaccines. The parents stated that at their initial visit on 12/06/21, the vaccine record was given to clerical staff. The parents stated the staff member looked at the record and then handed it back to parents stating no copy was made. According to prior to administering vaccines on 01/12/22, the record showed DTaP, IPV, MMR, and Varicella administered on 07/12/2017 historically. Since 12/06/21, patient received 2 Hepatitis B vaccines, one TDaP vaccines, one IPV vaccine, one MMR vaccine, and one Varicella vaccine that patient did not need after record was received and updated. Parents were informed.
Chills, Fever, Fatigue, slight headache, loss of appetite It only lasted one day
Patient had pre-existing tinnitus but it was very slight.  After receiving the COVID vaccine, he told her the tinnitus (ringing in ears) got much more severe; This is a spontaneous report from a non-contactable consumer. A male patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history included tinnitus from an unknown date and ongoing. Concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Any other vaccines taken within four weeks prior to the vaccination was not reported. On an unknown date, the patient experienced tinnitus but it was very slight. After receiving the COVID vaccine, the tinnitus (ringing in ears) got much more severe. The patient had a pre-existing tinnitus but it was very slight. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event tinnitus (ringing in ears) got much more severe was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Persistent headache present daily for the last 18 days. Temporary relief with ibuprofen. Left calf pinpoint cramp, no swelling. Fatigue, low energy.
pt was supposed to recv 2nd shot in post-exposure rabies regimen;incorrectly given pre-exposure shot intradermally;severe h/a w/in 10min, exp epileptic sz, still under treatment for sz;
Information has been received from a consumer concerning his 5 year old son who on 01-JUN-2009 was vaccinated with a second dose of MMR II 0.5 mL. On 08-JUN-2009 the patient experienced fever, diarrhea, body aches and autistic behavior was amplified. On 11-JUN-2009, the patient recovered. Upon internal review, autistic behavior was amplified was determined to be an other important medical event. Additional information has been requested.
p/vax pt devel fever, fussiness & poor appetite;taken to Er & evaluated for sepsis;pt hosp x 48hr;all cultures were negative;the MD indicated that the outcome of this event was unremarkable;
KINRIX was given (5th Dtap and 4th Polio) in RT, the next day mom noticed her thigh was swollen and she had a large area of erythema covering approximately 50% of the front of her thigh. Today mom called to report that although the swelling and erythema eventually resolved, her thigh is still discolored. It appears bruised 5 weeks later.
Vaccime side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccime side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccime side effects). At the time of the report, VACCINATION COMPLICATION (Vaccime side effects) 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.
Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.   This case was linked to MOD-2021-369083 (Patient Link).
Wearing long-sleeves, so, I don't know when the whelps started.  Noticed on my hands, bumps appearing on the backs of my hands. Around 3:00 I noticed my arms were affected. By 6:00 PM I was feeling like I couldn't clear my throat. Coughing. I realized I was having an allergic response. I took Zyrtec and a drank a lot of iced tea and water. Eyes started feeling puffy. Before 9:00 PM. I woke with a cough, still tightened throat, eyes still a little puffy, and rash was still very evident. At 5:55 PM on 10/30/2013, same symptoms are present. Additionally, the arms never itched, however, now my neck is and no rash on my neck. I will take Benadryl now that I am not driving. I have to get a flu shot every year in my field of employment (hospital sales). I usually get the Sanofi-Pasteur vaccine and have NEVER had a reaction.
4 hours after shot, I had soreness in the harm for 2 days and then it went away. I experienced chest pain and breast density 12 hours, 1 week, and then 2 weeks after the shot.
On the back of their card 1st dose on Nov-2021, Jan-2021, Aug-2021, Apr-2022; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (On the back of their card 1st dose on Nov-2021, Jan-2021, Aug-2021, Apr-2022) and NO ADVERSE EVENT (No adverse event) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046621A) for COVID-19 prophylaxis.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (On the back of their card 1st dose on Nov-2021, Jan-2021, Aug-2021, Apr-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (On the back of their card 1st dose on Nov-2021, Jan-2021, Aug-2021, Apr-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (On the back of their card 1st dose on Nov-2021, Jan-2021, Aug-2021, Apr-2022).    No concomitant medications were provided. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-720281 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720281:Product Bivalent
Hemiparesis of right side of body.  Brain infarct. Follow uP: Deaf
pt stated after she received the vax she got a strange taste in her mouth.  At 1 AM pt woke up with a heavy feeling in her left arm.  Her left arm, hand and fingers started to swell.  At 3 AM her head felt warm and the entire left side of her face was swollen, including lips, gums, nose and eyelids.  Her teeth felt strange.  At 5AM she could feel a sensation going down the left inside of her body moving from her neck to her toe.  Then the right side of her face started to swell from the neck to the top of her head.  Pt woke up at 7 AM next day and the swelling was starting to go down on the right side.  On 2/26/2021 she is noticing the swelling is going down out of her left side.  She never really had any pain or discomfort just swelling.  Pt. has not contacted her PCP at this time.
Post vaccination the patient developed a red, swollen, tender, indurated area 6x6cm at the injection site. The patient was treated with Keflex.
THE PATIENT WAS ADMINISTERED THE VACCINE AT THE AGE OF 12. NO ADVERSE REACTIONS REPORTED
Missed her period after receiving the vaccine; This is a spontaneous report from a non-contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1, via an unspecified route of administration, administered in the left arm on 11Feb2021 11:00 (lot number: EM9810) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient was not pregnant at the time of vaccination. The patient didn't have any other vaccines within four weeks of the vaccination. The patient reported that she missed her period after receiving the vaccine. The patient did not receive any treatment for the event. The patient had no COVID prior to vaccination and was not tested post vaccination. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Next day after receiving the PNEUMOCOCCAL POLYSACCHARIDE VACCINE I felt an extreme pain in my left arm, all the way to my hand and fingers. The pain was very strong in my left chest and shoulder, as well as under the left arm. The skin had patches of red on all my left upper side and upper arm. I took some TYLENOL 650 mg to be able to stand and move a little bit. This excruciating pain lasted 48 hours, then eased out.
Feeling a little more sluggish and tired than usual; Feeling a little more sluggish and tired than usual; Started itching; Fever came back in the area; Redness; knot- it feels thick; And spreading and covers 4top to bottom x 6inches front to back of the upper arm; Red; Knot- thickness; The area was feverish; Spread out to a size of 2 top to bottomx4 front to back inches; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red), SKIN MASS (Knot- thickness), VACCINATION SITE WARMTH (The area was feverish), PERIPHERAL SWELLING (Spread out to a size of 2 top to bottomx4 front to back inches) and PRURITUS (Started itching) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced ERYTHEMA (Red), SKIN MASS (Knot- thickness), VACCINATION SITE WARMTH (The area was feverish) and PERIPHERAL SWELLING (Spread out to a size of 2 top to bottomx4 front to back inches). On 11-Sep-2021, the patient experienced PRURITUS (Started itching), VACCINATION SITE WARMTH (Fever came back in the area), ERYTHEMA (Redness), SKIN MASS (knot- it feels thick) and PERIPHERAL SWELLING (And spreading and covers 4top to bottom x 6inches front to back of the upper arm). On 16-Sep-2021, the patient experienced SLUGGISHNESS (Feeling a little more sluggish and tired than usual) and FATIGUE (Feeling a little more sluggish and tired than usual). On 09-Sep-2021, ERYTHEMA (Red), SKIN MASS (Knot- thickness), VACCINATION SITE WARMTH (The area was feverish) and PERIPHERAL SWELLING (Spread out to a size of 2 top to bottomx4 front to back inches) had resolved. At the time of the report, PRURITUS (Started itching), VACCINATION SITE WARMTH (Fever came back in the area), ERYTHEMA (Redness), SKIN MASS (knot- it feels thick), PERIPHERAL SWELLING (And spreading and covers 4top to bottom x 6inches front to back of the upper arm), SLUGGISHNESS (Feeling a little more sluggish and tired than usual) and FATIGUE (Feeling a little more sluggish and tired than usual) outcome was unknown.        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 usually has reactions to flu shots, bee stings.  No Concomitant medication were reported. No treatment medication were reported.
Fever 101 degrees F, body ache, very tired symptoms 07/13/02-got worse. On 07/14/02 he asked to go the hospital
Swelling and pain from shoulder to elbow, low grade fever. Severe pain when trying to move arm or use it. Symptoms still present but less severe 24 hrs later.
Foggy head within 1 hour of shot,   Fever, chills, headache, ached head to toe(worse than I have ever ached before)  tired.  Started at about 8 p.m. 4/29/21,  subsided some by 5/1/21 10 a.m.  Felt much better 5/2/21.
COVID-19; COVID-19; Vaccine brand other=Moderna; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jan2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 28Jan2021 at 08:30 as dose 2, single (Lot number: EL1283) at the age of 59 years, in left arm; elasomeran (MODERNA COVID-19 VACCINE), on 07Jan2022 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Jan2022 at 14:00, outcome "unknown", described as "Vaccine brand other=Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case, an association between the reported events Covid 19 and vaccination failure and suspect product bnt162b2 cannot be ruled out.
Per Patient, started feeling very fatigue 1 to 2 days following the 2nd dose of the Shingrix shot.  Still feeling very fatigue even up to current date of 7-23-19.  Told patient will notify md and for her to follow-up with md as well.  Spoke to employee from Dr.'s office at 1:30pm on 7-23-19
This is a spontaneous report from a Pfizer Vaccine Representative for a contactable reporter. The physician reported that a 65 year old, female patient (race unknown) received PREVNAR 13 injection on 13Jun2012 single dose on left arm. The relevant medical history was unknown. The relevant concomitant medications included isosorbide mononitrate at 60 mg daily, guanidine hydrochloride at 0.3 mg three times a day, simvastatin 40 mg daily, aspirin at 81 mg daily, metoprolol tartrate at 100 mg three times a day, benazepril hydrochloride 40 mg daily, hydralazine 100 mg three times a day, all since an unknown duration for an unknown indication. The past drug history included pneumococcal vaccine in Nov2007 however she did not experience any pain at that time. On 13Jun2012, few hours after PREVNAR 13 injection was administered, she started experiencing severe pain in her left arm at the site of injection due to which she visited emergency room however she was not admitted and was relieved on the same day on 13Jun2012. The relevant laboratory tests were unknown. Therapeutic measures taken for the reported event was unknown. Clinical outcome of the reported event was unknown at the time of the report. Follow-up (20JUL2012 Follow-up attempts completed. No further information expected.
Pt exp discomfort, warmth, edema around inject site; treated with Tylenol and ice; saw ER; devlpd muscle and joint aches; neurologist 22FEB90 diagnosed flu;
48 hours after flu shot given in left deltoid, the entire upper arm from shoulder to elbow is swollen, warm and itchy.  No evidence of cellulitis, no fever, no systemic reaction.
On 3/4/21 noticed my left calf was swollen. I did not think much of it at first. A week later the swelling had progressed to include my ankle. Saw Dr. and ordered an ultrasound on both of my legs. Right leg was normal & left lower leg had a clot(s) in it. Dr. ran blood work then prescribed Eliquis. Saw him in follow-up on April 14. Swelling down but not gone. Renewed the prescription for Eliquis and set a followup visit for Friday June 18. He ordered additional blood work to be drawn on Wednesday June 16 to have results at the next visit.
ADMINISTRATION OF THE JANSSEN COVID-19 VACCINE AFTER IT HAD BEEN PUNCTURED AND LEFT AT ROOM TEMPERATURE FOR 4 HOURS; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194, and expiry: 09-APR-2022) dose was not reported, administered on 03-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-NOV-2021, the patient experienced administration of the janssen covid-19 vaccine after it had been punctured and left at room temperature for 4 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of the janssen covid-19 vaccine after it had been punctured and left at room temperature for 4 hours was not reported. This report was non-serious.
No adverse event; The patient received Moderna Covid-19 vaccine lot number AS1420B expiration date February 21, 2023. The patient received the dose on February 23, 2023.; More than 35 days in between doses of the primary series; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received Moderna Covid-19 vaccine lot number AS1420B expiration date February 21, 2023. The patient received the dose on February 23, 2023.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between doses of the primary series) and NO ADVERSE EVENT (No adverse event) in a 21-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1420B and AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Oct-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2023, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received Moderna Covid-19 vaccine lot number AS1420B expiration date February 21, 2023. The patient received the dose on February 23, 2023.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between doses of the primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received Moderna Covid-19 vaccine lot number AS1420B expiration date February 21, 2023. The patient received the dose on February 23, 2023.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between doses of the primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient received Moderna Covid-19 vaccine lot number AS1420B expiration date February 21, 2023. The patient received the dose on February 23, 2023.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between doses of the primary series).    No concomitant medications were reported. No treatment medications were reported.
Within a few minutes I started having heart palpitations and felt a little weak.  I was taken to an area where they checked my blood pressure, 180 over 90 I think.  My pulse was either 130 or 120.  My oxygen and breathing were good.  I waited for about 20 minutes for the palpitations to slow down.  My blood pressure remained high through the day and I went to urgent care about 4 in the afternoon.  It had gone down to 130 over 75.  My blood pressure typically is low at 120 or 110 over 70 .  I was very weak for a day or so.  Except for a sore arm I feel fine today, two days later
Received Small pox vaccination on 6 June 2006. Patient had mild fever two days following. On 19 June 2006, patient had red bumps on hands, elbows, and knees. Bumps were red and sore to the touch.
Breakthrough COVID-19 infection. Tested positive on 11/05/2021. Patient fully vaccinated on 03/16/2021.