chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A male patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose. The patient's medical history and concomitant medications were not reported. The patient had a reaction a few hours after receiving the vaccine. He started shaking uncontrollably for about 45 minutes, similar to a seizure, and was cold but felt it on the inside of his body. After the shaking stopped he was extremely exhausted.
misread exp date as 1-11-09 instead of 1-11-08 (ProQuad) No adverse effects-primary care physician aware. Guardian aware- 2nd dose of MMR and Varicella.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient experienced vasovagal syncope. Patient rested until symptoms passed. Patient was recovered was able to leave feeling well.
made the arthritis in both shoulder feel bad; knocked him down; could not even stand up; made the arthritis in both shoulder feel bad; Made the ringing in his ears a lot worse; muscles hurt so bad; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (made the arthritis in both shoulder feel bad), DEPRESSED MOOD (knocked him down), DYSSTASIA (could not even stand up), ARTHRITIS (made the arthritis in both shoulder feel bad) and TINNITUS (Made the ringing in his ears a lot worse) in a 77-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS71460) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ringing in ears (ringing in the ear), Cancer (NOS) (cancer twice) and Shoulder arthritis (arthritis in both shoulders). Concurrent medical conditions included Asthma and Type 2 diabetes mellitus.    On 22-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In September 2022, the patient experienced FEELING ABNORMAL (made the arthritis in both shoulder feel bad), DEPRESSED MOOD (knocked him down), DYSSTASIA (could not even stand up), ARTHRITIS (made the arthritis in both shoulder feel bad), TINNITUS (Made the ringing in his ears a lot worse) and MYALGIA (muscles hurt so bad). In September 2022, TINNITUS (Made the ringing in his ears a lot worse) had resolved. At the time of the report, FEELING ABNORMAL (made the arthritis in both shoulder feel bad), DEPRESSED MOOD (knocked him down), DYSSTASIA (could not even stand up), ARTHRITIS (made the arthritis in both shoulder feel bad) and MYALGIA (muscles hurt so bad) outcome was unknown.            Concomitant medication included medication or inhalers (unspecified) for the asthma.  After receiving Moderna booster, the patient stated that it made the ringing in ears a lot worse but it has now gone back to normal. Caller reports it felt like he took a bunch of aspirin.  The 3rd shot and the Bivalent really knocked him down, muscles hurt so bad, couldn't even stand up, made the arthritis in both shoulder feel bad. Patient recommended that for the older people that Moderna should split those doses.  No Treatment medication as reported.   This case was linked to MOD-2022-651284, MOD-2022-651287 (Patient Link).
Two days post vaccine patient developed a small rash in the center of her chest. 4-5 days post injection she became very agitated and unsettled, (waking every hour in the night). 5 days post injection her disposition was very fussy and fever started to climb from 101.5-104.0 within an hours time. She was brought to the hospital ER and evaluated for mild rash and fever. She was discharged and prescribed topical ointment for rash (Dx ringworm) and TYLENOL and MOTRIN regimen to be administered q4h. Patient's fever went back up to 103.9 the night of the 5/6 day post injection she was taken to our PC Pediatrician and evaluated and told she had eczema and a mild virus. We were prescribed a topical steroid which was filled and not picked up or applied. 6/7 days post injection a physician explained that she was having a reaction to her injection. On days 6-9 (today) she has continued to maintain a high fever of 100.-103 pm and 99.9-101am. Her rash has since spread head to toe and she has welts on her arms, hands, face, legs and feet. Her fever on day 9 (today) was normal in the am. Rash is still present.
This spontaneous report received from a medical assistant concerning a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-MAY-2017, the patient received an improperly stored dose of PROQUAD (dose, frequency not reported) (Lot: M043306, expiry date: 24-APR-2018) reconstituted with sterile water diluent (unknown lot number and expiration date). Temperature and Time frame: -14°C to -10°C for 9 hours 43 minutes, -14°C to -10°C for 15 hours 46 minutes, -14°C to -10°C for 12 hours 31 minutes. Previous temperature excursion was -14°C to -10°C for 6 hours 26 minutes. The call was because of data logger. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA000847: US-009507513-1706USA000300: US-009507513-1706USA000301: US-009507513-1706USA000303:
dizziness; weird clicking sound when I would move my head; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), TINNITUS (weird clicking sound when I would move my head) and FATIGUE (Fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included Dizziness and Fatigue.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), TINNITUS (weird clicking sound when I would move my head) and FATIGUE (Fatigue). At the time of the report, DIZZINESS (dizziness), TINNITUS (weird clicking sound when I would move my head) and FATIGUE (Fatigue) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-065484 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065484:1st dose vaccine
Patient received incorrect formulation for age group. At 5yo patient should've received a bivalent vaccine, not a monovalent primary series.
had my second shot and am very ill; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had my second shot and am very ill) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had my second shot and am very ill). At the time of the report, VACCINATION COMPLICATION (had my second shot and am very ill) outcome was unknown.            NO Concomitant drug reported. NO Treatment drug reported.
feeling swelling; pain in her neck at the right side of her body; This is a spontaneous report from a Pfizer sponsored program Support. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number, and Expiration date were not reported), via an unspecified route of administration on 26Feb2021, as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced feeling swelling and pain in her neck at the right side of her body on 27Feb2021. Patient wanted to know what she can do about it and if she should be concerned about the symptoms. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a healthcare worker and refers to unspecified number of unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On unknown dates, the patients received unspecified number of improperly stored doses of VARIVAX (Merck) lot # L026408, expiration date: 15-JUL-2017 (dose, route of administration and anatomical location were not reported). There were no concomitant medications provided. There were no adverse effects reported. Additional information has been requested.
HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 2/9/2022 SEPSIS UNSPECIFIED ORGANISM
This patient got the Jansen covid vaccine on 7/10/21 and got the booster dose of the same Brand, Jansen, on 11/19/21. We are not sure exactly if this is from the Jansen vaccine whose booster dose was given 2.5 months earlier but on 2/9/22, he went man down saying that he has been dyspneic for 36 hours. First responder noted O2 sats of 78%. Patient was transferred to the outside hospital ER for further treatment and care. He ended up being intubated, admitted to the ICU and was diagnosed with PE and DVT. He now has ARDS and needing mechanical ventilation still for almost 3.5 wks now, blood pressure support and tracheostomy .
This spontaneous report as received from a physician via a company representative refers to unspecified number of patients of unknown age. Current conditions and medical history was not reported. On an unknown date, patients were vaccinated with PNEUMOVAX 23 injection (route, lot number and frequency were not reported). Concomitant medications were not reported. On an unknown date, patients were administered PNEUMOVAX 23 which measures slightly more than 0.5 milliliter (ml) (such as 0.52 ml or 0.51 ml). No adverse effects were reported. Product quality complaint (PQC) was filed for this case, but it was determined that the caller was reporting feedback and user error rather than a PQC. Additional information has been requested.
kidney or urinary tract excused here; infection in urinary tract; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (30th) at single dose for covid-19 immunization. Medical history included wear hearing aids in both ears. The patient's concomitant medications were not reported. Patient found out here evidently had either a kidney or urinary tract excused here. Patient had either an infection in urinary tract. Outcome of events was unknown.  Information on the Lot/Batch number has been requested.
PATIENT CAME IN TO  GET SECOND DOSE OF COVID VACCINE BUT NEVER VERIFIED WHAT VACCINE WE HAD. SHE SAID SHE MADE AN APPOINT ONLINE, BUT MY TECH COULDN'T FIND HER IN THE SYSTEM SO WE ADDED HR AS A NEW PATIENT. AT THAT TIME TECH FAILED TO SEE WHAT TYPE OF VACCINE WAS GIVEN AS THE FIRST DOSE. PATIETN GOT MODERNA AS A SECOND DOSE EVEN THOUGH SHE WAS GIVEN PFIZER AS A FIRST DOSE. PATIENT WAS ON HER WAY HOME WHEN SHE NOTICED  ON VACCINATION CARD THAT SHE GOT TWO DIFFERENT VACCINES.   PATIENT WAS PHYSICALLY FINE, BUT PATIENT WAS CLEARLY AGITATED.  I ASSURED HER THAT SHE WOULD BE FINE, I TOLD HER  I WOULD LIKE TO CALL HER PCP TO NOTIFY HIM ABOUT THE SITUATION TO WHICH SHE REFUSED. I  ALSO TOLD HER THAT I WOULD CALL HER LATER TODAY, TOMORROW,  AND COUPLE OF WEEKS FROM NOW TO GET AN UPDATE ON HOW SHE WAS FEELING TO JUST TO TALK WITH HER FURTHER.
Patient came into doctor office at 1530 with SOB, increased pulse rate, temperature, and red rash on trunk and legs. Nebulized breathing treatment of Albuterol given twice and patient responding well. Patient left at 1645 with mom. Patient given Pediatric Singulair and instructions if he gets worse.
Symptoms started on the day after the 2nd shot and continue to date.  Had upset stomach, affected her taste (things tasted bad when everyone else thought the food was good), loss of appetite, nauseous, chilled (used 3 blankets), ached all over, headache, couldn?t think clearly, stabbing ? sharp, jabbing pains in her muscles, even the buttocks (like someone was poking her with a knife or a fork); muscles, bones and joints ached, no energy.  Was ?just ill.?  Was fine after first shot.  Still not well from the 2nd shot.  Has a hard time walking since this 2nd shot.  Takes Tylenol for relief.  Was treated with antibiotic x 1 week and also Benadryl.    Jabbing pain has resolved but aches and pains in joints and muscles continue.  Fogginess is getting better but not totally resolved.  Smell is still not accurate, things smell worse than they do for others.  Nausea has resolved.  Appetite is ok but gets full very quickly more than before.  Hasn?t felt up to even calling to report her symptoms until today (03.30.21).    On January 20, 2020; she thinks she may have had COVID.  Was sick at that time just like she is now.  Was tested for Flu A at that time and was Negative.  Took her 1 month before she got better.
Woke up with headache, sweats, chills, joint pain, and low grade fever. Stayed in bed for a day and a half the took it easy for the next two days. Back to normal the following day (Saturday).
I developed chills and fever the same night I took the Pfizer Booster. (11/16/2021). The next night, (11/17/2021), they got worse. I was shaking like a leaf on a tree. I did not take my temperature. I really felt too badly to get up and eat or drink or even find the thermometer. I took Aleve and Tylenol and Vitamin C.  I felt better around 3 AM today (11/18/2021). I think I still have a bit of a chill. It's not unbearable, like last night.
From initial information received on 21Oct03 from a health care professional regarding an adverse event occurring, it was reported that a 52 year old female pt received a dose of TET TOX ADS USP, lot number U0823AA, administered IM in the right arm on 14Oct03 at 3:30PM. On 17Oct03 at 7:30AM, the pt experienced acute vomiting due to dizziness, equilibrium loss (could not walk), soreness at the administration site, swollen glands, total muscle weakness, restlessness, poor focus, sweating, inability to sleep, and was unable to see straight. The pt had also received Tubersol 5 TU, lot number C1619AA, administered ID on 20Oct03 and the results were reported as being within normal limits. Reportedly, the pt did not recover from these events.
patient complaining of arm pain and not being able to fully move arm/extend arm. stated he was also dizzy and lightheaded. states no swelling or redness as injection site
High fever 102 x 3d; severe headaches, leukocytosis, arm induration at vaccine site.
This is a spontaneous report from a contactable physician via a sales representative. A 76 year old male patient received PREVNAR13, exp date 21MAR2016, NDC: 00051971-2) intramuscular at 0.5 ml, single dose on 17NOV2014. The reporter didn't know what was the lot number that could be J49845 or J49847. Patient medical history and concomitant medications were not reported. A few days after PREVNAR13 was given, patient had severe swelling and a rash on the arm in which the vaccine was given, and a knot at the site of the injection. Reporter saw patient at 5 to 7 days after the vaccine and it was still there. he was going to see the patient again on Monday 01DEC2014. Sales representative reported that no emergency room treatment was required for the adverse event however there was doctor visit as they wanted the doctor to look at the side effects. Sales representative reported that no other vaccine was administered besides PRENVAR13 on the same day and that the physician believes that the adverse events was caused due to  PREVNAR13. Follow-up (16MAR2015): Follow-up attempts completed. No further information expected.
This report is not regarding an adverse event. It is about an administration error.  Patient did not receive full recommended dose of MMRV (ProQuad) due to mechanical issue of the syringe/needle. After consulting with the CDC, we were advised to repeat the recommended dose of MMRV on the same day or wait 28 days before repeating if it's not being given on the same day.  So,  patient received the repeat dose on the same day with no issues.
A report was received from a member of staff for a health care professional on 12/5/03 concerning a 3 year old male who inadvertently received 0.5ml Fluvirin vaccine on 12/3/03. On 12/3/03 the vaccinee received Fluvirin. No adverse symptoms occurred. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Pain radiating into hand immediately after the injection.  Severe headache, nausea, chills, pain at injection site, severe/debilitating pain  in left side of back, left side, and left side of neck.  Could not stand up or walk. Symptoms subsided after 24 hours.  5 days later- itching at injection site
Rash on arms, fingers, chest, and thighs; A spontaneous report was received from a healthcare professional concerning a 37-year old, male patient who received Moderna's COVID-19 vaccine and developed a rash on his arms, fingers, chest and thighs.    The patient's medical history, as provided by the reporter, included hypertension.  Concomitant medications reported included an unknown hypertension medication.   On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (011J20A) intramuscularly for prophylaxis of COVID-19 infection.   On 02 Jan 2021, the patient got a rash on his arms, fingers, chest, and thighs.  Treatment for the event included diphenhydramine hydrochloride, methylprednisolone, and a third, unknown, medication.    Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event was unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event 11 days after vaccination , a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time.  Further information has been requested
I first tested positive on 16Apr2022; I first tested positive on 16Apr2022; This was a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter was the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing), notes: somewhat high cholesterol treated with simvastatin. The patient had no known allergies. Concomitant medication(s) included: SIMVASTATIN taken for blood cholesterol increased. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Apr2022, outcome "unknown" and all described as "I first tested positive on 16Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Apr2022) Positive, notes: I started Paxlovid the same day I first tested positive (on 16Apr2022); (23Apr2022) Negative; (24Apr2022) Positive, notes: tested again using two different brand test kits and both came back very quickly and brightly positive. That was on 24Apr2022; (24Apr2022) Positive, notes: tested again using two different brand test kits and both came back very quickly and brightly positive. That was on 24Apr2022. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recv vax 330PM & went to clinic 7PM started having stomach pain & cramping, vomiting & diarrhea;no fever;was taken to ER & was told it was a rxn to hep B vax;given shot & slept well during the noc;better this morning;
01/22/22 presents to ED for "Fatigue, diarrhea, cough, dyspnea". PMHx of "HTN, HLD"
Symptoms: Red spots on body, fever that peaked at 104.1 F, sick and lethargic baby. Treatment: Motrin and Tylenol as directed by doctor.
Today is 10 days post my first vaccine injection. For the first 3 days, my arm was red, tender-to-the-touch, swollen and warm. After 3 days, those symptoms dissapated completely. This morning, I woke up with a red, raised bump that is tender-to-the-touch and warm. It feels like I just got another injection, but I did not.
This spontaneous report was received from a Medical assistant via a company representative referring to a 17 year old female patient. The patients' medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with VAQTA 25/0.5 (lot number, expiration date, dose, frequency and route of administration were not reported). Information regarding concomitant medication was not provided. On an unknown date, the primary reporter stated that the patient experienced arm pain, back pain, and neck pain after the administration of VAQTA, it was also reported that the patient experienced body aches, nausea, fever of 104F, she was pale, and clammy, additionally on an unspecified date, she was admitted to an unspecified hospital and was given two boluses of immunoglobulin. The outcome of pain in extremity, back pain, neck pain, body aches, nausea, pyrexia, pallor and cold sweat was reported as unknown. The causality between VAQTA and the adverse events was unknown. Additional information has been requested.
Bad migraine; Felt like someone punched me on my arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Felt like someone punched me on my arm) and MIGRAINE (Bad migraine) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa drugs), Iodine allergy, Latex allergy, Shellfish allergy, Arthritis (Very bad arthritis) and Fibromyalgia. Concomitant products included Claritin                                                       As needed for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced LIMB DISCOMFORT (Felt like someone punched me on my arm). On an unknown date, the patient experienced MIGRAINE (Bad migraine). At the time of the report, LIMB DISCOMFORT (Felt like someone punched me on my arm) and MIGRAINE (Bad migraine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details were not mentioned.   This case was linked to MOD-2021-092741 (Patient Link).
Around the time of my vaccination I started to have trouble with belching.  I saw my doctor who treated it as GERD.  When it continued despite the antacids she suggested I have an endoscopy.  All seemed fine and the doctor suggested I increase the pantoprazole,  After several months on the medicine and increased belching, gas and bloating she suggested I cut back on the medicine as it is probably not GERD but a highly reactive esophagus.  I am now taking IBGard before all meals and that helps somewhat.