chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Shaking; Became really hot; Nauseated; Dry heave; Weakened; Elevated body temperature; Tired; Lightheaded/Dizzy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 (Lot number: EN6205) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cardiomyopathy", start date: 2014 (ongoing), notes: Verbatim: Cardiomyopathy; "Defibrillator", start date: 2014 (ongoing), notes: Verbatim: Defibrillator; "Pacemaker", start date: 2014 (ongoing), notes: Verbatim: Pacemaker. Concomitant medication(s) included: CARVEDILOL, start date: 2015; LISINOPRIL, start date: 2015; FISH OIL, start date: 2015; ASPIRIN, start date: 2015. Past drug history included: Statins, notes: Illness/AE: Allergy to statins. The following information was reported: CHILLS (non-serious) with onset 09Mar2021, outcome "recovering", described as "Chills"; TREMOR (non-serious) with onset 09Mar2021, outcome "unknown", described as "Shaking"; FEELING HOT (non-serious) with onset 09Mar2021, outcome "unknown", described as "Became really hot"; NAUSEA (non-serious) with onset 09Mar2021, outcome "unknown", described as "Nauseated"; RETCHING (non-serious) with onset 09Mar2021, outcome "unknown", described as "Dry heave"; ASTHENIA (non-serious) with onset 09Mar2021, outcome "unknown", described as "Weakened"; BODY TEMPERATURE INCREASED (non-serious) with onset 09Mar2021, outcome "unknown", described as "Elevated body temperature"; FATIGUE (non-serious) with onset 09Mar2021, outcome "unknown", described as "Tired"; DIZZINESS (non-serious) with onset 09Mar2021, outcome "unknown", described as "Lightheaded/Dizzy". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: This consumer had the first dose of the Pfizer-BioNTech COVID-19 Vaccine 08Mar2021. He reported having chills; shaking; then became really hot; nauseated; dry heave; weakened; elevated body temperature; tired; lightheaded; dizzy. He asked for information on these events and recommendations on treating the events. Starting 09Mar2021 around 02:00 had a pretty good bout of major chills and shaking then he became really hot. He did not check his body temperature then. He checked his body temperature today and his has a little elevated body temperature of 99.8 degrees Fahrenheit. He has been nauseated and weakened all morning, had a dry heave about 2 hours before this report. He still gets chills a little bit, but not major with shaking like initially, chills have lessened considerably. He feels a little bit better but was lightheaded, weakened, tired and dizzy.He has had the flu vaccine, shingles vaccine and pneumonia vaccine in the past but that has been a while. Parents are both passed away. One brother does have Diabetes and takes medication for that.  No follow-up attempts are possible. No further information is expected.
by 4pm he had "excruciating" pain in the arm from site of inj. to elbow, sl. erythema, no swelling, afebrile. pain was constant, sharp,  >10 on pain scale. pain then radiated across shoulder to mid-chest and mid-back on the left side. experienced shortness of breath when lying supine. slept in lounger. couldn't raise arm until about 48 hours later. developed a bruise of 2"x6" at inj. site. took tylenol for the pain over the weekend. site is still discolored, reddish/purple.
3 days after receiving immunizations pt. presented with (L) sterile abscess 10 cm x 10 cm, warm to touch, swollen, and painful. Also (R) indurated area 4.5cm x 5cm, both corresponding to subcutaneous location of immunizations.
Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a pt who developed nasal congestion. Relevant medical history was not provided.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on an unspecified date.  Dose regimen was not provided.  Concomitant medications were not reported.  The pt developed nasal congestion (nasal congestion). The reporter indicated that this event occurred with "several" pt's; however, they are not presently identifiable.  Additional reports will be generated when identifying information is received.  No additional information was available at the time of this report.
SEVERE VERTIGO; POST CONCUSSED FEELING; COULD NOT WORK; This spontaneous report received from a patient concerned a female of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On an unspecified date, the patient experienced severe vertigo, post concussed feeling, and could not work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe vertigo, post concussed feeling and could not work was not reported. This report was non-serious.
Got the vaccine, had the initial soreness of the arm the next day to the point that she could not touch it.  She went out of town, and got up yesterday morning and when she woke up she had two little areas on her right arm, a little itchy and thought it might have been a bug bite.  She started massaging her arm a little bit.  She told her husband about it and then a few hours later noticed that it was spread up her arm, and has been itching since she was on her way back home.  It is red, looked like big welts.  The swelling has gone down but still has the red marks on the arm itself.   She has not taken anything for the reaction.
On 4/14/2021 patient developed pain in left shoulder blade with numbness in the front of chest and under left arm and biceps, and broke out rash on Sunday 4/18/2021 and on Monday, 4/19/2021 he developed blisters and  he went to Urgent care and was diagnosed with Shingles.  He received a prescription for the rash, (Valacyclovir TID x 7 days),  but he used Calamine lotion and applied that to the rash which improved.  .  Went to see his health care provider a week later on 4/26/2021. and received pain medication Tramadol, which was very helpful with reducing the pain.  He was advised to get the 2nd dose of Pfizer vaccine on 4/29/2021.  As of this date no complaints.  He was encouraged to use V-Safe and he is being followed by them at this time.
Difficulty breathing, wheezing, hoarseness, stuffy nose, vomiting of 6 days duration. Two days post vaccination an onset of a fever (102-104) duration of 1.5 hours, aw well as all of the above). Currently has hoarseness, stuffy nose, minimal vomiting, irritability, and loss of appetite of 3 days duration.
Red rash below injection site about 3 days after. Eight days after injection red rash returned with swelling and itching.
There was an excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
ITCHY RED RAISED, SPLOTCHY RASH ON LOWER POSTERIOR REGION BACK SIDE  OF BOTH THIGHS, BUTTOCKS AND LOWER BACK; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol consumption, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine(suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 31-MAY-2021, the subject experienced itchy red raised, splotchy rash on lower posterior region back side of both thighs, buttocks and lower back. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from itchy red raised, splotchy rash on lower posterior region back side of both thighs, buttocks and lower back. This report was non-serious.
Broke out in terrible rash starting about 7 days after a third dose of Moderna vaccine. Rash has not gotten any better. Covers my body (hives) and gets worse at night time. Very random spots from back to legs to shoulders, etc.  No previous history to allergies and breaking out in hives.
On the afternoon of 5/28/2019, patient was brought to the clinic by his father for rabies vaccine was but mistakenly given the inactivated typhoid vaccine. The staff member who gave the injection notified the reporter. The reporter searched but was unable to find information on the possible adverse outcomes related to giving the vaccine to a patient under the age of 2. She then notified another provider in the clinic, but were unsuccessful in the attempt to contact CDC to get more information. Eventually, the following day, clinic manager was able to communicate with someone at CDC's Immunization Services Division. Today (05/30/2019), the mother was notified by the clinic and she reported that her son is "fine." The clinic is reviewing the process of vaccine administration to ensure this does not occur again.
the patient inadvertently received a dose of MMR II instead of meningitis vaccine; This spontaneous report was received from a nurse referring to a 11-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant medications were not reported.   On 28-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, dose, frequency, route of administration, anatomical location were not provided) (lot number R030764 was an invalid lot number, expiration date 22-APR-2020), who was reconstituted with sterile diluent(DILUENT MRK), instead of meningitis vaccine (MENVEO) (wrong product administered). Nurse reported the patient receive dose of meningitis vaccine MENVEO on an unspecified date in November 2019.
Patient was given Janssen instead of the Pfizer COVID-19 vaccine. Patient was notified before she left the clinic. Dr. would like to do a pediatric Pfizer vaccine 2 months after the Janssen vaccine was administered.
Pt never had pneumonia shot. Asked if wanted when got flu shot. Pt said yes. Administered PNEUMOVAX in (L) deltoid & flu in (R) deltoid. W/in 2 minutes pt alerted us of extreme SOB. Called 911, sat pt down. Administered adult EPI PEN in (L) thigh. Pt could breathe. EMT took vitals. All good. Transported to hospital.
10/3/03 ER report-acute allergic reaction, erythema face, edema eyelids x 1 week. ER meds: Solumedrol IM, Benadryl. 10/7/03 PC from hospital.
ADMINISTERED PFIZERVAC COVID 19 5-11Y INJ   LOT #FL2757 ON 10/9/2022 ACCECTED LOT # FL2757 EXPIERD  9/30/2022 WITH THE MANUFACTURER DATA TO SUPPORT THE STABILITY AND EFFICACY TILL 10/19/2022 NO REACTION HAPPEND
chest congestion, sinus congestion, headaches, body aches, cough. starting on 10/9/21
Dizziness, Palpitations, HYPERtension, Tachycardi, flushed Narrative: 3:44 v/s 181/100, 99, 100% 3:46 v/s 173/91, 95, 100% 3:48 v/s 164/90, 86, 100% Administer the 1st dose of Pfizer vaccine, 5 mins later staff verbalized she was not feeling well. She stated, she was feeling anxious. Noted staff slightly flushed to upper chest area, complained of tingling/ warm sensation to face. Staff also sated, she felt palpitations. Resp. even and unlabored at 100% in room air. Denies any chest pain, SOB and no distress noted. Staff is alert, oriented x4. Informed staff we will send her to the ED via w/c but she refused and stated she will walk over there. Another staff RN escorted her to the ED. She was informed to go to the ED to for further evaluation.
I started getting symptoms of scratchy throat. I thought it was allergies so I took Flonase. The same the next day with a runny nose. On 4/28/2022 I did 2 at home COVID-19 test that indicated positive. My throat progressed to very slow, congestion, cough, and fever. I did 2 virtual visits with my doctor. I was prescribed cough syrup. I still have symptoms to this day except fever. I did another COVID-19 test today and it is still positive.
I21.4 ACUTE NON ST ELEVATION MI 3/2/2022 RHABDOMYOLYSIS I21.4 ACUTE NON ST ELEVATION MI 3/2/2022 ASPIRATION PNEUMONIA
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 54-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (on 15th January 2019, received 1st dose (for tolerance refer case US2019052669)). On 21st March 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). In March 2019, less than a week after receiving SHINGRIX, the patient experienced pain in arm. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: After the 2nd dose of SHINGRIX, the patient's arm got really, really sore. The reporter stated that, the patient's arm was not looking like bad sunburn as it looked after the 1st dose, but it had only been 1 day so it might still appear. The patient gave consent to follow up. Note: clarification has been raised regarding event confirmation after each dose. For now, events are considered as per case narrative.
Tremors started to get worse by 9:30pm.  Around 11:30pm pain started on lower part of abdomen and back.  Tried to get up but could not; she had no strength on legs in bathroom. Patient had to wait for husband to arrive and by then she wet the bed.   Patient noticed that arm was fine at vaccination site however at about 4 inches from elbow got a red huge rash that was hot.  Patient went back to bed.    A second time at night, patient tried to get out of bed and could not--she wet bed again.  She went back to sleep. Husband slept in room next door to be closer in case patient needed help again.   Patient has never gone to the bathroom so much in one night especially since she takes Myrbetriq; she just couldn't hold it long enough to get to the toilet.  Next morning, patient felt so weak that needed help to get out of bed and could not walk without the walker. Patient took normal medicinesno medications out of norm. Patient did take some Tylenol but did not help. Since Saturday morning, tremors continue and they are getting worse. Because of tremors patient could not even eat cereal by herself this morning.
PATIENT REPORTS SEVERE PAIN IN THE ARMPIT ON THE SAME SIDE SHE RECIEVED THE SHINGRIX DOSE. THIS WAS THE 2ND DOSE AND SHE STATED MINIMAL TO NO PAIN ON THE ARM ITSELF AT THE SITE OF INJECTION, BUT 'FAIRLY SIGNIFICANT' PAIN RAIDIATING FROM HER ARMPIT. PAIN LASTED FROM 10/22(DAY AFTER SHOT) UNTIL ABOUT 10/26TH WITH LESSENING SEVEREITY. PT DIDN'T CALL PHARMACY AT THAT TIME, HOWEVER, PT WAS IN FOR A FLU SHOT LATER ON AND REPORTED HER EXPEREINCE WITH HER 2ND SHINGRIX DOSE AT THAT TIME.
Ms. Young was observed post Covid-19 immunization for 15 minutes. During the observation period, she experienced an adverse reaction with the following symptoms: Facial rash/bilateral checks. No itch. Warm to touch. Assessment : Patient left after check out in while in her car noticed the rash/flushed face on her face. Patient returned at 12:23pm and rash was noticed by RN to be red to the cheeks bilateral and warm to touch. It was noted that rash followed the outline of the patient's mask. Patient reports she has worn the mask before with no issues. Mask no washed in the past 2-3 days per patient.  Alert and oriented. Patient reported itchy throat at 12:35. No difficulty swallowing. At 12:51 patient states she no longer has an itchy throat. Rash in still present. Not worsen in appearance. Patient reports no other symptoms. Patient stable and orientated x4. Walked patient out to door at 12:58 and gave Pfizer information sheet along with symptoms to look out for such as worsening in rash, difficulty breathing, swelling of the face and neck, fast heartbeat and dizziness or weakness. Actions taken: Vitals sign taken VAERS form completed Paramedic on site. Vitals Signs at 12:36, BP= 116/64 HR = 76, 02 = 100, Temp: 97.9F (Temporal) ,Vitals Signs at 12:55, BP= 119/54, HR = 72, 02 = 100. Medications administered: Loratadine (Claritin) 10 mg  by mouth. Time: 12:25 pm. Administered by, RN. Famotidine (Pepcid) 20 mg by mouth. Time: 12:30. Administered by, RN, Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Instructed to follow up with PCP  for evaluation for second dose. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat. The Patient was provided with Vaccine Information Sheet and instruction to access the system. Immunizations Administered, Name, Date Dose VIS Date, Route Pfizer COVID-19 Vaccine, 4/19/2021 12:00 PM, 0.3 mL 2/25/2020 Intramuscular, Manufacturer: Pfizer, Inc, Lot: EW0164, NDC: 59267-1000-2.
Information has been received from a registered nurse concerning a 68 year old male with diabetes, hypertension, arthritis, diverticulitis, emphysema and CELEBREX hypersensitivity who on 03-OCT-2006 was vaccinated with a first dose of Pneumovax 23 (lot # 654594/0359F) (0.5 ml), subcutaneously "on the right upper back of the arm in the fatty tissue."  Concomitant therapy included GLUCOPHAGE, FLOMAX, COMBIVENT, ULTRAM, aspirin and ZESTRIL.  On 03-OCT-2006 the patient experienced local injection site reaction.  The patient had six inches induration, redness and tenderness.  The patient also "felt sick" from the first day of the vaccination.  It was also reported that 05-OCT-2006 the patient "had redness at site 3" X 3" and tender to touch noticeable induration."  Unspecified medical attention was sought.  The patient recovered.  Additional information is not expected.
Complained of redness and swelling (9.5 x 8 cm) of left thigh 2 days after immunization.  Appointment was given to have patient seen by MD and was placed on antihistamine.
sick; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (sick) in an 84-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Crohn's disease and Ulcerative colitis and INFLUENZA VACCINE (FLU VACCINE VII) for Flu vaccination.    Concurrent medical conditions included Crohn's disease and Ulcerative colitis.   On 30-Sep-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) at an unspecified dose. On 30-Sep-2022, the patient experienced ILLNESS (sick). At the time of the report, ILLNESS (sick) had not resolved.            No concomitant medications were reported. Patient received first and second dose of Moderna vaccine on 07-Mar-2021 and 07-Apr-2021 resp. via intramuscular route. No treatment information was provided. The reporter assessed the causality for the event sickness due to Humira as not related and the reporter did not provided the causality assessment for the event sickness due to Flu shot.
Began with numbing of thumb on left hand (site of vaccine). Achiness in arm. This has lasted from Sat. 9/28 through today 10/03.  The pain/achiness rendered the arm almost useless.  It is slowly decreasing.  However, the numbness has spread from my thumb to my first and second fingers on that same hand.  That has not abated.
Patient DOB 04/17/1961 received the Moderna booster lot #059H21A expires 01/27/2022 at 07:44am. The client completed her observation period without incident but returned to the vaccine table at 08:50 am with complaints of dizziness, feeling like she was "floating", and "tightness" in her left leg. The client said she was "folding laundry" when she started feeling "dizzy".  She said she looked up from the laundry and the dizziness got better. The client said she did not feel like she was going to pass out but still felt like she was "floating". She said the leg "tightness" started when she was doing laundry. The client reported a history of "feeling dizzy" after vaccination. The client denied any pertinent medical history and does not take any medications. The client was alert and oriented x 4, her breathing was regular and unlabored, and her skin color was appropriate for ethnicity. At 08:56am, RN checked the client's vital signs. BP 120/82, HR 76, RR 20, SpO2 97%, no complaints of pain. RN, gave the client a juice to drink.  At 09:00 vitals were retaken. BP 120/78, HR 72, RR 16, SpO2 97%, and no complaints of pain. The client said the "floating feeling? was going away. She reported that her left leg still felt tight. Vitals were taken again at 09:05 am, BP 118/75, HR 73, RR 20, SpO2 97%, and no complaints of pain. The client said the "dizziness" went away. RN educated the client to report history of dizziness next time she got a shot and to return if symptom came back. RN also talked to the client about following up with her primary care provider if the leg tightness did not resolve. The client felt she may have injured herself while doing laundry. The client stood up and her BP was rechecked. BP 120/84 in standing position. The client walked away with a steady gait and returned to the vaccination table at 10:30am and said she was still feeling fine, then departed again.
Per Spouse Client had the following symptoms after 2nc Covid vaccine Fatigue, vomitting, nausea and fever 101.    Client also had fatigue and nausea with 1st dose of Covid vaccine.  Client sees Dr. was notified of reaction via client.   Spouse voiced client's symptoms improving today.  No treatment.    Client did have Covid illness last fall.
Woke up at 2:30 a.m. on Friday with terrible muscle and joint pain.  All day Friday had a fever between 100 - 101.1 along with the pain.  This lasted until around 8:00 p.m. Friday night.  I had swollen glands under the left arm which is the arm used to administer the shot.  Friday morning and again on Sunday morning I had a substantial bloody nose that lasted about 10 minutes each time.
Second dose given 01/18/2021 Positive covid test 03/28/2021