chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed serious tinnitus in my left ear, numb sensations in my left check and gums and sore jaw. These symptoms continue. Also had strong soreness in last shoulder and numbness in left arm that has mostly subsided. The shot was in my left arm.
pt recvd vax & devel a react descrived as an infection @ the inject site manifested by a low grade temp, infect site erythema, sharp pain & swelling for 3 days; treated w/Ampicillin, gentamicin, Augmentin, Bacitracin; abscess developed;
HEADACHE; SHAKING; ACHY; NAUSEA; LOW GRADE FEVER; CHILLS; VOMITING; This spontaneous report received from a patient 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 was not reported, administered on 05-MAR-2021 14:20 to left arm for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the patient experienced headache, shaking, achy, nausea, low grade fever, experienced chills, and vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, nausea, low grade fever, chills, and vomiting on 06-MAR-2021, and had not recovered from headache, and achy. This report was non-serious.
My shot was around 12 noon. I didn't eat before so they gave me crackers and juice at the site. Afterwards I ate a real meal and two hours later I got dizzy. It was tolerable.  At 9:30 PM I got a fever. Then I felt pressure all over my body, pressing me down; I felt so heavy I could barely move. That's when my joints started to ache and I had piercing pain in my right knee and the bones in both hands. Then I got really dehydrated. No matter how much water I drank, it wasn't enough. Then I got chills, then a headache. It felt like I had sold my soul to Satan and he was sucking it out through my limbs, very slowly. I thought I might be an anomaly that died from a bad reaction. I tried to sleep so I wouldn't feel the pain anymore. That attempt took 3 hrs. The next day my migraine and joint soreness persisted. I felt so weak I didn't get up for hours. Thr second night I still felt unquenchingly dehydrated. Third day I only felt soreness in my arm from the actual shot.
Pt developed pruritus, redness and swelling at injection site (right arm). Onset about 6 hrs post vaccination. Pt will treat w/hydrocortisone 1% cream and BENADRYL.
Rash and itching all over body, Benadryl lotion and Benadryl allergy caplets.  After several days rash and itch went away.
This child developed severe otitis media with TM rupture 4 days after immunizations. Physical exam on day of vaccination showed ears completely closed.
2 days after vaccination right arm around and just above elbow swollen with redness, warm to touch painful per client. Saw PMD with instructions to take OTC pain meds and cold compresses.
Information has been received from a physician concerning a 20 year old female patient with no pertinent medical history and no drug reactions/allergies, who in December 2007, was vaccinated with the third dose of GARDASIL (Lot # not reported). Concomitant therapy included NUVARING. The physician reported that the patient was testing positive for high grade HPV. PAP tests were performed in July 2008 and in October 2009 results were normal, PAP test was performed on 19-NOV-2010 result was abnormal. The patient did not seek medical attention. At the time of the report, the patient had not recovered. The physician said this was the 15th patient she had seen who had received 2 doses of GARDASIL at least 3 years ago but was now testing positive for HPV. This is one of several reports received from the same source. Additional information has been requested.
discovered that the vaccine vial used in administration had been first punctured on 28Jul2021 around 6:00pm. This would be outside of the allowed 12 hour window storage and handling guidelines for administration of the vaccine at room temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (discovered that the vaccine vial used in administration had been first punctured on 28Jul2021 around 6:00pm. This would be outside of the allowed 12 hour window storage and handling guidelines for administration of the vaccine at room temperature) 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 29-Jul-2021 at 6:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (discovered that the vaccine vial used in administration had been first punctured on 28Jul2021 around 6:00pm. This would be outside of the allowed 12 hour window storage and handling guidelines for administration of the vaccine at room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (discovered that the vaccine vial used in administration had been first punctured on 28Jul2021 around 6:00pm. This would be outside of the allowed 12 hour window storage and handling guidelines for administration of the vaccine at room temperature) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment details were reported.
I had a slight headache. Woke up the next morning and still had a slight headache. Extreme muscle pain. I had a fever of 101.5. Also extreme fatigue at the point. Sunday morning, I got up and still felt bad. Took a nap and woke up around noon, and all the symptoms were all gone. A week later, a little rash started popping up, about a 3in round area, right next to my left armpit, directly across from the injection site. I began experiencing lots of itching and the rash area was really sore. As of today, the rash is still her, but it is almost gone.
Pain in upper left back into shoulder under arm and down left arm, elbow down to right above my wrist. Radiating deep ache, 3 MRI's, Doppler, EMG, 2 xrays, CT. Emergency Room-twice-pain for 5 weeks-physical therapy.
Redness, itching at injection site as soon as injected Itching of throat about 3-5 mins after  Redness of cheeks about ( I noticed after I left, my face felt hot on my cheeks)  The clinic watched me for 20mins to watch for anaphylaxis and then released me. I went home and took Benadryl and itching of arm, throat,  and redness went away.
Per standing order RSV to be given to 60 and older.  The patient was 58 years old. No adverse signs or symptoms observed after injection was given.  Dr. notified and made aware of the deviation to the standing order.
Patient waited approximately 20 minutes after receiving vaccine as is standard. Patient began to drive home when she started to notice tingling in her lips, feeling flushed, and then as though her throat was closing. She contacted 911 and they responded road side.  Patient was initially being monitored only, then her BP dropped. Decision was made to transport patient to ED. En route she received epinephrine and was placed on O2 by way of non-rebreather mask.  Upon arrival to the ED patient continued to be dyspneic. She was given solumedrol, benadryl, Pepcid, and mag. Patient was stabilized and no additional epi was required.  Patient was admitted to hospital in observation status.  She was stable overnight. She did have one episode of itching and nausea, she was given diphenhydramine and Zofran and these symptoms resolved. Patient was monitored until around 1PM the day after event and was released to home in stable condition.
A non-serious report of vaccine administration error was received from a nurse concerning a 21-month-old. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No relevant medical or drug history information was reported. The infant was given FluMist on 29-Oct-2007. FluMist was administered to the 21-month-old in error as the vaccine is indicated in patients 2 years to 49 years of age. No adverse events were reported from this error. No additional information is available. Rechallenge is not applicable. Causality assessment is not applicable. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 4/15/08. Patient date of birth and lot # for vaccine is not provided, 03/07/08.
Child received Hep A #1 left thigh in late AM 4/9/14. Mom called about 3 hrs later stated that child had hives over left thigh extending over buttocks. No difficulty breathing. Exam confirmed above, no wheezing. Slight bruising at site. Hives appeared around the Hep A site.
X 1 - twitching & shaking which lasted x 5-10sec - eye rolled back in head - jerking actions - no fever - eating good.
40C fever around 24hours after injection, chills, muscle aches, starting around 12hrs after injection, vomiting and nausea 24hrs after injection, fatigue remained for a week, other symptoms went away after around 60 hours.
Local vaccine reaction. Lt thigh erythema, warm, some induration centrally. Red, swollen area 5 1/2 inch x 6 1/2 inch. Apply ice, MOTRIN. Observe.
pt has devel measles-like sx; onset of rash 14 day p/vax; pt had raised rash, conjunctivitis, dry cough, koplik spots; fever, t99.2, joint aches; 22JAN93 joint pain & swelling in fingers & hand;
PATIENT  REQUESTED AND RECEIVED MODERNA COVID VACCINE 8/5/2021 AFTER FILLING OUT CONSENT AND SCHEDULING ONLINE.  PATIENT WAS AWARE THAT THEY HAD 1/5/2021 AND 2/3/2021 AT ANOTHER PHARMACY.  HE DID NOT INFORM THE PHARMACY AT THE TIME OF THE IMMUNIZATION.  PHARMACIST WAS MADE AWARE OF ADDITIONAL VACCINATION WHEN ACCESSING STATE SHOTS TO REPORT.   NO ADVERSE REACTIONS OCCURED OR REPORTED.
Patient reports feeling the mouth swollen with burning and red. At 6:23pm she consults with Doctor, who orders 25mg of BENADRYL in tablet PO, which she took at 6:27pm, she was evaluated in consultation with Doctor, who indicated that she be re-evaluated in 30 minutes. When re-evaluating the patient, she didn't have a swollen or red ball and reported feeling much better. Doctor discharges the patient at 7:00pm.
high blood pressure of around 188/99; feeling warm; vomiting; chills on an off; This spontaneous case was reported by a patient and describes the occurrence of BLOOD PRESSURE INCREASED (high blood pressure of around 188/99), FEELING HOT (feeling warm), VOMITING (vomiting) and CHILLS (chills on an off) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Thyroid disorder.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (high blood pressure of around 188/99), FEELING HOT (feeling warm), VOMITING (vomiting) and CHILLS (chills on an off). On 09-Jan-2021, FEELING HOT (feeling warm), VOMITING (vomiting) and CHILLS (chills on an off) had resolved. On 11-Jan-2021, BLOOD PRESSURE INCREASED (high blood pressure of around 188/99) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jan-2021, Blood pressure measurement: 188/99 (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Concomitant product use was not provided  by the reporter.  Treatment information was not provided.; Sender's Comments: This case concerns a 72-year-old female who experienced NS unexpected events of blood pressure increased, feeling hot and NS expected events of vomiting, chills.  Event onset occurred 4 days after the first dose of mRNA-1273. Treatment not reported. Events resolved. Based on 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.
Information has been received from a consumer concerning her approximately 13 weeks (also reported as "about 4 months old") son who on approximately 25-OCT-2011 ("about 4 weeks ago") was vaccinated with a dose of ROTATEQ (Lot# was unspecified) ("injection", dose not reported). There was no concomitant medication. The reporter stated that on approximately 08-NOV-2011, ("about two weeks ago") her son had diarrhea, a red ear and an earache. The patient sought unspecified medical attention. No treatment was given and no lab diagnostics was performed. At the time of reporting, the patient had not recovered. No further information is available.
really sick/very sick; My eyeballs hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 24Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lung cancer" (unspecified if ongoing); "Lung cancer surgery" (unspecified if ongoing), notes: she had Lung Cancer surgery last year. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "really sick/very sick"; EYE PAIN (non-serious), outcome "unknown", described as "My eyeballs hurt".  Addition information: The reporter stated that she had the first dose of the vaccine and was very sick from it, she had all of the side effects that were listed, she was sick for a couple of weeks. She was really sick.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After my second dose of the COVID vaccine, I ended up getting intense full body fatigue, nausea and a headache.
Immediately after the shot, my arm hurt, but I was okay. Then 8 hours afterward, I got chills, fever, massive fatigue, my lower back in the region of my kidneys started to hurt.  I was weak and tired, but my skin felt as if it was crawling all over, from my head to my toes. I was exhausted but could not sleep for scratching. I did not have a rash or hives, so figured this was just the reaction to the shot.  After an unknown time of about 30 minutes or so, I just fell asleep from exhaustion. All day on the 9th, I was exhausted, had fever and had some itching.  I still have heaviness in my lower back around my kidneys. I do not know which Shingles vaccine I received.
Fever; headache; ache; I have no taste at all; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 17Mar2021 at 11:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Patient had no relevant medical history. Patient did not receive any other medications within 2 weeks of vaccination The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number EN6203) via an unspecified route of administration in the left arm on 24Feb2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, was the patient not diagnosed with COVID-19. Patient has no known allergies to food, medications or other products. On 18Mar2021 at 4:00 the patient experienced ache, fever, headache and no taste. She had no taste at all and had the typical reactions of fever, headache, body aches. It's been a week and still patient had no taste. The patient underwent COVID-19 virus test (BD Max) on 22Mar2021 and the result was negative. The patient had not received any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome for ache, fever, headache and taste loss was not recovered.  No follow-up attempts are possible. No further information is expected.
The vaccine was diluted at  8:15 am on 9/8/21 and drawn into syringes. Per Pfizer guidelines  the vaccine should not be administered after 6 hours once drawn into a syringe if kept at room temperature. The patient above received the vaccine after 7.5 hours. No adverse affects were reported.
Patient starting experiencing full body itching and redness at approximately 20 minutes post-vaccination.  Patient reports having taken Benadryl 25 mg PO on her own approximately 1 hr before receiving the vaccine.  Another Benadryl 25 mg PO x1 dose adminstered at 9:05am.  BP 162/80   HR 64  O2=96%  at 09:20am.  Lip numbness being reported at 9:20am.  Itching subsiding at 9:30am.  Patient clinically stable.  Patient released from clinic at 9:30am. Patient also reports itching and redness with 1st dose of Pfizer COVID-19 vaccine.  Patient also reports having Bell's Palsy after receiving the 1st dose of Pfizer vaccine (with photographic evidence) that was noticed approximately 11 hours after 1st dose of vaccine administration.  Patient realized she was having Bell's Palsy after she began noticing having slurred speech and facial drop.  Took muscle relaxant (Robaxin) and prednisone (5 days) prescribed by her physician.  Bell's Palsy resolved in approximately 6 hours.
Pt with a history of non-insulin dependent DM type 2 and CVA, and was admitted due to sepsis secondary to UTI and COVID pneumonia with associated superimposed acute kidney injury.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 25-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  No treatment was received by the patient.   This case was linked to MOD-2021-365019 (Patient Link).
This spontaneous report was received from a physician via Pfizer refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient received an unspecified flu vaccine and was told to return to the office for PREVNAR 13. On an unknown date, the patient was at a pharmacy and thought of getting the vaccination due to convenience. The patient requested a PREVNAR 13. However, the patient received PNEUMOVAX 23 since the pharmacist told the patient that both vaccines are same but latter has ten more things (Wrong drug administered and Drug dispensing error). The doctor told that the PNEUMOVAX 23 was given in the office 3 years before so the patient got two PNEUMOVAX 23 three years apart (Inappropriate schedule of drug administration), but never got a PREVNAR 13 and the patient has to wait a year to the PREVNAR 13. It was reported that the doctor's office never give two vaccines at the same time that is the way of their protocol, they never do. So they gave flu vaccine first and then they told the patient to come back for PREVNAR 13. Additional information has been requested.
Information has been received from a Dr concerning two pts who were vaccinated with measles virus vaccine live and mumps virus vaccine live and rubella virus vaccine live (second generation). The pts experienced roseola like rash. The roseola rash improved after two days. Seven days after vaccination, the pts experienced a fever of 101 degrees F. It was also noted the vaccine was improperly stored for 12 hours due to a power outage. Medical attention was sought. No further info is available.
soreness lt deltoid few hrs p/vax; itching, followed by local urticaria >24hrs <36hrs p/vax; 48hrs p/vax local red, tenderness, swelling, urticaria deltoid area only
At approximately 11:30pm I felt a little warm and checked my temperature and it was 99.9.  A couple hours later I took my temp and it was 102.1   Then I started getting shivers. I usually like my office on the cool side, but I wore my coat due to the shivers. Then I got nauseated. At one point I thought I would vomit but I did not.  When I started walking around my hip joints hurt and I'm very tired. There is minor soreness at the injection site and the arm muscles have tightened.   My first dose was on 10/5/20, GlaxcoSmithKline lot 3XR3X, .5ml.  After that does I have about a 101.4 temp but not the rest of the symptoms.
Chief Complaint Fever and cough with shortness of breath.  History of Present Illness Patient is a 73-year-old male who has known history of DVT and pulmonary embolism.  Patient developed fever and cough recently and went to a local Medical Center.  Work-up at that point was negative and he was diagnosed with bronchitis.  COVID-19 test at the time was negative.  He was sent home with supportive care but his symptoms progressively got worse.  His fever got up to 103 max and he came to the Hospital emergency room for further evaluation.  CT showed no PE but bilateral patchy infiltrates.  Covid test was positive for COVID-19.  His white count was normal but ferritin was slightly elevated.  CRP was normal.  He received IV dexamethasone 6 mg and was admitted for further care.  Infectious disease was consulted from the ER.  At the time of my evaluation patient's wife was at the bedside.  He denied chest pain or nausea or vomiting.
Information has been received from a health professional who reported that a prefilled syringe (Lot # 654540/1162F) malfunctioned and the vaccine sprayed across the room. The patient did not miss being vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Additional information has been requested.  This is in follow-up to report (s) previously submitted on 4/6/2007.  In follow-up it was reported by the nurse, that the patient did not receive any of the vaccine from the malfunctioning syringe.  The patient received the GARDASIL from a completely new syringe.  Follow-up information confirmed no known patient was identified or involved with the event.  Therefore WAES #0701USA01666 is being deleted from our files.  This report was previously sent in a quarterly submission to PLA V501 on 06-APR-2007.  Additional information is not expected.
Initial unsolicited case received from a physician on 19 Sep 2017. This case involves 42-year-old male patient who was vaccinated with 0.5 ml one dose of ADACEL (Batch number: C5243AA, expiry date and dose in series not reported) intramuscularly in right deltoid on 05 Sep 2017 for immunization. Patient medical history and concomitant medications were not reported. On 07 Sep 2017, two days after the vaccination, the patient developed diffuse tenderness of the entire right arm with limited ROM and decreased use of the right arm. On an unknown date, after the vaccination, the patient developed shoulder pain and neck pain. The patient wife was concerned of cellulitis although no symptoms were seen. On 11 Nov 2017, patient was evaluated in ED (emergency department) with right arm shoulder and neck pain. On 18 Sep 2017, patient was again evaluated in ED by the physician which showed symptoms were ongoing but diminished with opioids/steroids, and ULS of right shoulder negative for infection and again on 19 Sep 2017, the patient was evaluated by orthopedic. Other relevant lab tests were not reported. Other corrective treatment include KEFLEX, steroids and narcotics which he continues to take orally. The outcome of all the events were recovering (Also reported as not recovered). List of documents held by sender: none.