chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RAN A LITTLE TEMPERATURE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced ran a little temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of ran a little temperature was not reported. This report was non-serious.
Pt fainted (passed out) with dizziness. We called 911 & she refused to take EPIPEN. Paramedics ck'd the BP & everything was fine patient's parent said, she has severe needle phobia.
Pt experienced deep cough, thick mucous, unknown fever, no chills, no aches.  Dry cough 4 days ago - progression, swollen neck, glands, sore throat earlier. Duration 4 days.
Extreme crying x 2 days after immunization with periods of crying >3 hours.  Twin with same reaction.
1/8fever,  chills, cold sweat, body aches, pain,  1/9 dizziness, vomiting bile, Hives on chest and belly  twitching  lips and slurred speech,
This is an initial spontaneous report from a contactable consumer. This 67 year old male consumer was administered PREVNAR 13 unknown dose intramuscular injection in the right upper arm on 11Jun2012 at 09:30. Relevant medical history included high blood pressure and infection in tooth which were still ongoing. Relevant concomitant medications included amoxicillin for infection in tooth which he was still taking it. Vaccines given on the same day were none. Vaccines taken within the last four weeks were none. On 11Jun2012 while on PRENAR 13 unknown dose at an unknown time he experienced muscle soreness at the site of injection, joint soreness, slight fever, minor sleeplessness and blood pressure was elevated. Relevant lab data was none. At the time of the report it was unknown he was on PREVNAR 13. At the time of the report clinical outcome of blood pressure was elevated was unknown. At the time of report he had not recovered from the other above mentioned events. Follow-up (07AUG2012) Follow-up attempts completed. No further information expected.
D DIMER TEST CLIMBING; BLOOD CLOTTING TEST CLIMBING; This spontaneous case was reported by a consumer and describes the occurrence of FIBRIN D DIMER INCREASED (D DIMER TEST CLIMBING) and BLOOD TEST ABNORMAL (BLOOD CLOTTING TEST CLIMBING) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 11-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced FIBRIN D DIMER INCREASED (D DIMER TEST CLIMBING) and BLOOD TEST ABNORMAL (BLOOD CLOTTING TEST CLIMBING). At the time of the report, FIBRIN D DIMER INCREASED (D DIMER TEST CLIMBING) and BLOOD TEST ABNORMAL (BLOOD CLOTTING TEST CLIMBING) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2022, Fibrin D dimer: 893 893. On an unknown date, Blood test: climbing. On an unknown date, Fibrin D dimer: 147 147, 563 563 and 827 827.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. On unknown dates, the patient experienced D DIMER TEST CLIMBING and BLOOD CLOTTING TEST CLIMBING. Blood test, blood clotting test started climbing and patient dicontinued Rinvoq. in Dec 2021. She states that it may have been vaccine that caused D Dimer was 147 that climbed to 563, then 827 and it was checked on 21 Jan 2022 and it was 893.  No treatment medication was reported. Her doctor took her off of this medication as a precaution. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.    Causality for RINVOQ(UPADACITINIB): The reporter's causality for the event(s) of D DIMER TEST CLIMBING and BLOOD CLOTTING TEST CLIMBING with RINVOQ(UPADACITINIB) was a reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Currently pregnant, estimated date of delivery is 10/14/21  At the time of injection, some blood spilled out. The nurse said this does not happen frequently but I wanted to report this as an adverse event in case this is significant in any way.
Fever (100.8) myalgias, headache, nausea, fatigue. Treatment consisted of acetaminophen and codeine
Neurological symptoms present 96 hrs after receiving GARDASIL #1 injection. Altered mental status - w/o known etiology.
This spontaneous report was received from a 66 year old female patient referring to herself. Information about concomitant medication and medical history was not provided. On 03-JUN-2016 the patient was vaccinated with PNEUMOVAX23 (Lot # M005287, Expiration date unknown) as routine vaccine. The patient reported that she developed an allergic reaction (hives) after receiving the PNEUMOVAX23 within 24 hours, which lasted for about 10 days. The patient had sought medical attention via spoke with her physician. The patient was received treatment and recovered at the time of report in June 2016. No further AE information provided. Additional information has been requested.
Shortness of breath,  pressure on my chest,  high blood pressure after 10 days of getting  covid 19 vaccine
Since 1 February he has complained of recurrent episodes of generalized itching and rashes described as raised, red, itchy whelts which can occur anywhere on his body, sometimes at sites of pressure or where his skin is scraped or scratched. Lesions last less than 24 hours, spare his palms and soles, and resolve without post-inflammatory changes. He denies laryngeal, pulmonary, GI, neurologic, and cardiovascular symptoms with these episodes. Episodes not associated with heat, exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, known infections, or insect bites/stings. He received his Moderna COVID-19 vaccine booster dose on 19 January, 13 days prior to onset of symptoms. He has used oral antihistamines and two courses of oral corticosteroids with benefit. He denies constitutional symptoms. UCT score today is 26 (3, 3, 3, 3, 4, 3, 4, 3). No history of adverse reactions to prior vaccines.
From telephone contact it was reported that a 38-year-old female received TD in the left deltoid on 2/7/02. She returned with swollen, red, and warm deltoid. She also had low grade fever and chills. Doctor put her on Keflex 500mg BID x 10 days to which she responded.
Chills, fever, body aches, stomach cramps, diarrhea, headache, fatigue
Following vaccine, pt became nauseated and lightheaded.  Offered water.  Refused need to lie down
Initial report received from a healthcare professional on 02 December 2014. A 72-year-old male patient, whose medical history and concomitant medication were not reported, had received intramuscularly a dose of FLUZONE HD, (dose and batch number not reported) in left deltoid on 16-OCT-2014. On 16-Oct-2014, patient experienced left arm soreness and limited range of motion of his left arm. Reporter denied illness at time of vaccination and pre-existing physician diagnosed allergies. Patient was evaluated by a physician and under went an MRI of the left shoulder. Reporter did not have test results. Corrective treatment was not reported. At the time of this report, the outcome of the event was reported as unknown. Documents held by sender: none. Follow up information was received from a pharmacist on 03 February 2015: No new information was reported.
Not feeling great; Really sore arm; Patient is pregnant; A spontaneous report, was received from a consumer (patient), a 37 years-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 Vaccine (mRNA-1273), and experienced not feeling great (malaise), really sore arm (injection site pain), and patient is pregnant (exposure during pregnancy).  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of Covid-19 infection on 30-Dec-2020 while pregnant. The due date was estimated as 27-Jun-2021.   On 30 Dec 2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025J20-2A), intramuscularly in left arm for the prophylaxis of COVID-19 infection.  On 31-Dec-2020, the patient woke up in the morning with a really sore arm and was not feeling great. The patient was feeling a lot better by 03 30 pm on the same day.  The patent was pregnant and was exposed to vaccine. The patient's estimated due date was 27 Jun 2021. The patient took paracetamol for the adverse events.   Action taken with second dose of mRNA-1273 in response to the events was not reported.  The events, really sore arm and was not feeling great, were reported as recovering/resolving, and that of patient is pregnant was recovered on 30 Dec 2020.; Reporter's Comments: This is a case of product exposure during pregnancy for this 37-year-old female. Patient experienced malaise and vaccination site pain. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
not feeling well since early August, tested negative for COVID on 8/5/21. Continued to not feel well, tested positive on 8/22/21 cough, nasal congestion, chest congestion, headache, chills, wheeze, fatigue.
It started with a UTI in late July 2021. I had test done no bacteria was found. A few weeks it cleared up feeling fine all summer. Then after booster some weird things occurred. The first things I noticed week after the booster I experienced vertigo. It was 2 nights later I had to hold on to the wall. Next day this is around November 4th or 5th, 2021 started feeling unwell on a trip. My sister said she noticed I was going downhill. Later that evening I started vomiting. I haven't exp. anymore nausea or vertigo since. I have had UTI symptoms again the doctor suspected I have interstitial cystitis. I have a follow up appointment on November 30, 2021; for additional tests (blood in urine) and CT scan.
Experienced sore arm pain (3/10); This is a spontaneous report from contactable Pharmacist (patient).   A 42-year-old male patient received bnt162b2 (BNT162B2) at single dose on an unspecified date for Covid-19 immunisation.  The patient medical history and concomitant medications were none.  The patient experienced sore arm pain (3/10) on an unspecified date one day after receiving COVID-19 vaccine. The outcome of event was unknown.  No follow-up attempts are possible. Information about lot/Batch number cannot be obtained.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing), notes: other medical history: HBP. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient has received the vaccine and also other medications in 2 weeks.  The patient has received treatment as a result of AE which was Paxlovid from 06Oct2022 to 11oct2022.    The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
About a week after the first dose the red mark surrounding the injection site reappeared. Spot was about 2 inches long and 1 inch tall. Was itchy for a few hours and then felt like a knot for 3 days.  Took 2 weeks for the mark to go away.
Nausea, chills, fatigue, site tenderness. Tylenol, tea with honey and lemon, Rest. 48 hours duration.
RESPIRATORY DIFFICULTY TIGHT CHEST SOB DIZZINESS LOW MOTION COORDINATION INVOLUNTARY MOVEMENTS
At orientation, patient received the Menactra Vaccine on 5/17/06 at 1:30 pm, 0.5 Ml in the left Deltoid region.  She was with her family back home the next day, 5/18/06 and felt nauseated at about 8 pm and blacked out, then began having a generalized siezure which lasted 3 hours. She was taken to a local emergency room; CT scan and blood work were negative but it was noted that she had a possible insect bite on her leg, thought to be a spider bite.  She was discharged home.
At 9pm, same day of vaccine, had moderate right arm soreness and chills. Took 1 200mg Motrin, applied ice pack to right arm. Slept for 12 hrs. Next morning, took 3 attempts to get out of bed. Felt light headed and very fatigued. Slept for most of the day and night. Felt much better by 3/29-the next day. Starting on 3/30 at 2:30am, I had itchy hives upper and lower flank area, both sides, under breasts, r thigh, neck and ears. Took 2 25 mg benadryl and they went away. Hives back in same areas at 2:30am on 4/1, and 4/3. Treated w 2 benadryl and went away. Same hives back at 7:30am 4/5, 8:30pm on 4/6 and 4:30am 4/8.  Treated w 1-2 benadryl on those dates and went away.  No food, med or laundry changes noted.
Moderna Booster vaccine administered with wrong dose. 0.5ml was administered and not 0.25ml.  No adverse health reaction
hollering/ screaming/bouncing off the walls/threatening "to kill someone" /"is going to eat the car"; threatening "to kill someone"; "is going to eat the car"; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL, ABNORMAL BEHAVIOUR, and ABNORMAL BEHAVIOUR in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced FEELING ABNORMAL, ABNORMAL BEHAVIOUR, and ABNORMAL BEHAVIOUR outcome was unknown. Not Provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact.
Itching rash initially around waist  that spread to lower back and the entire body trunk.  Cannot be completely sure that  initial symptom did not exist before vaccination.
This spontaneous report as received from a healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 07-APR-2016, the patient was vaccinated with 0.5 ml dose of improperly stored (Merck) VARIVAX (which had a lot # of L040419 and an expiration date of 14-OCT-2017; however, dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported. Another batch of (Merck) VARIVAX (which had a lot # of L043624 and an expiration date of 03-NOV-2017) had also been improperly stored but it was not reported whether it had been administered. The vaccines experienced the following temperature excursions on the following dates: 10 F for 2 hours and 15 minutes on 24-MAR-2016; 12.4 F for 2 hours and 15 minutes on 26-MAR-2016; 10.4 F for 2 hours and 15 minutes on 30-MAR-2016; 10 F for 2 hours on 03-APR-2016; and 9.3 F for 1 hour and 45 minutes on 07-APR-2016. . Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Client needed to complete primary series by 4/20 due to immigration requirements. Unable to receive monovalent vaccine due FDA no longer authorizing it as of 4/18/23. No current guidance to switch to administering bivalent vaccine issued yet, received verbal order from medical director to administer.
Patient had booster dose of Pfizer vaccine @8:35 am. 8:45 am patient notified RN of heart racing. HR 143, BP 130/90. Oxygen 98%. Temp 98 degrees. Laid on stretcher, felt some pressure in upper chest, felt need to sit up very straight. Over ten minutes HR was down to 95, though up and down. At 8:55 am patient c/o tingling of the tongue. Gave Benadryl 25 mg p.o.liquid. At 9:00 am HR back up to 150, pressure in chest again. Called 911. Arrived 9:05 am. 9:10 am paramedics took to ED.
Patient stated she had red liquid come out with her bowel movement; Caller does not want to receive the second dose; tired blood" or "not enough iron in your blood; This spontaneous case was reported by a consumer and describes the occurrence of ANAL HAEMORRHAGE (Patient stated she had red liquid come out with her bowel movement), PRODUCT DOSE OMISSION ISSUE (Caller does not want to receive the second dose) and BLOOD IRON DECREASED (tired blood" or "not enough iron in your blood) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     The patient's past medical history included Immune system disorder (Weak immune system and frail) and Rash (Rash allergy). Concurrent medical conditions included Leukemia.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAL HAEMORRHAGE (Patient stated she had red liquid come out with her bowel movement), PRODUCT DOSE OMISSION ISSUE (Caller does not want to receive the second dose) and BLOOD IRON DECREASED (tired blood" or "not enough iron in your blood). At the time of the report, ANAL HAEMORRHAGE (Patient stated she had red liquid come out with her bowel movement), PRODUCT DOSE OMISSION ISSUE (Caller does not want to receive the second dose) and BLOOD IRON DECREASED (tired blood" or "not enough iron in your blood) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up received on 17-JUN-2021 contains no new information On 20-Jun-2021: Patient contact information updated and event added
Dose#2 of Hepatitis B vaccine administered ~ 2PM on 8/31.  At 9PM 8/31 she c/o generalized itching and rash, headache, and feeling hot and sweaty.  Evaluated in ED.  Dx as acute allergic reaction. Rx with SoluMedrol, Benadryl, and Pepcid. Sent homewith Rx for 5 day course of Prednisone, Pepcid, and Benadryl.  Sx. resolved after ED tx. No sx except residual headache when seen in f/u on 9/1.
Inability to walk upstairs the night of the shots.  He had to be carried.  Intense pain in his thighs where the injection took place.  Horrible rash all over back and abdomen. Enlarged lymph nodes. Went to pediatrician and dermatologist and was given amoxicillin.  Awful rash continued for 2 weeks and then cleared.
On 12/14/2022, I experienced periodic tingling on my left lower lip.  On the evening of 12/15/2022, my left lower jaw was numb and tooth 19 which had had a root canal was hurting.  I contacted the dentist on 12/16/2022 and he prescribed Augmentin for 7 days.  I saw him on 12/19/2022.  He saw no signs of infections or any problem with the tooth and referred me to the root canal specialist who performed the root canal. I saw the root canal specialist on 12/21/2022.   He performed an X-ray and saw no problem with the tooth.  He then performed a CT scan of the jaw and found no problem with the tooth or any nerve issue related to the tooth.  I contacted my PCP on 12/22/2024.   Due to the holiday, I heard back on 12/26/2022 and was seen on 12/27/2022.
had the flu was when got flu shots; Initial information received on 19-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced had the flu was when got flu shots (Influenza Vaccine).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Vaccine by unknown manufacturer (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination. Information on batch number was requested.  On an unknown date the patient had the flu was when got flu shots (influenza) (unknown latency). Reporter Commented: No flu shots only time I had the flu was when I got flu shots.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (had the flu was when got flu shots).  At time of reporting, the outcome was Unknown for the event had the flu was when got flu shots.
This spontaneous report as received from a female consumer of unknown age. No information provided regarding medical history and concurrent conditions. On an unknown date of 2009, the patient was vaccinated with first dose of PNEUMOVAX23. On an unknown date of 2014, the patient had vaccinated with second dose of PNEUMOVAX23 (route, lot#, dose not reported). No concomitant medications reported. It was reported that on an unknown date of 2009 the patient was vaccinated with PNEUMOVAX23 he did not experience any bad reactions to it. After the second dose of vaccination with PNEUMOVAX23 the patient had developed rash. The event was treated with BENADRYL (dosage/frequency/manufacturer unknown). The outcome of recently received a second dose and developed rash was unknown. Additional information is not expected. The patient did not wish to provide specific information.
expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-year-old female patient who received Hib (Hiberix) (batch number TF4EB, expiry date 26th September 2021) for prophylaxis.   On 1st October 2021, the patient received the 4th dose of Hiberix. On 1st October 2021, unknown after receiving Hiberix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional information was provided as follows: This case was reported by clinical Supervisor. The patient received an expired dose of Hiberix vaccine. The reporter consented to follow up. The case was linked with the case US2021207018, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021207018:Same reporter