chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via sales rep and described the occurrence of pain in arm in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm. 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: The age at vaccination was not provided. The reporter did not agreed to follow.
DIZZY, NAUSEATED, PALE HEAD BETWEEN KNEES, FLUIDS
headache at brain stem location.   Tylenol did not touch it.  Liquid gel advil took care of headache.   Also chills and fever.  Fever 100.4.  While in shower Monday am, felt like headed and immediately laid on floor.  After a few minutes crawed to bed.  Joint pain also was felt throughout the day.  Approx 6 pm began feeling better.   I obviously have a concern about second shot.  Talk on street is second shot symptoms worse than first.
This is an instance of breakthrough COVID-19 disease after which death occurred. The individual received the Moderna product on 01/06/2021, 02/02/2021, 02/03/2021, 11/01/2021, and 04/28/2022. They tested positive for COVID-19 on 09/30/2022. The test was done at a hospital but I see no indication that they were admitted to the hospital. The individual died on 10/18/2022. "History of COVID-19" is listed on the death certificate. The individual was a resident of  a  long term care facility.
This is a spontaneous report from a contactable nurse reported for two patients. This nurse reported similar events for 2 patients. This is the 2nd of 2 patients. An 88-year-old female patient received PREVNAR 13 (lot number R94917, expiration date 23May2018) at 0.5 ml single dose intramuscular on 23Jun2017 for risk of pneumonia. Medical history and concomitant medications were not reported. In Jun 2017 the patient had swelling at the injection site that resolved spontaneously. It was described also as red, ball like, hot to touch, erythematous and resolved slowly with oral BENADRYL. The patient also went to Urgent care. The reporting nurse mentioned that the patient may have also taken Prednisone for the swelling and redness, but unsure. Final outcome was reported as recovering. Sender's Comments: Linked Report(s): US-PFIZER INC-2017334461 same reporter, drug and AE, different patient.
Lt arm red around injection site to area of 3 1/2 x 3 in. Band Aids still intact on arm. Latex free. BENADRYL cream and liquid Rx.
Feeling hot; Can't fall asleep; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: GN 6199) via an unspecified route of administration in the right arm on 04Mar2021 at 12:00 as a single dose for COVID-19 immunisation. Medical history included diagnosed for HIV  on Sep2000. The patient had no known allergies (reported by patient "Not that l know of"). Prior to vaccination, the patient was not diagnosed with COVID -19. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN), atazanavir (MANUFACTURER UNKNOWN), emtricitabine (MANUFACTURER UNKNOWN) and azithromycin (ASTRO); all from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 06Mar2021 at 16:00, the patient experienced feeling hot all after taking prescribed medication, symptoms started on 06Mar2021 and can't fall asleep. He needs help and symptoms worsened at night. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events feeling hot and can't fall asleep was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
The patient reported pain at the time of injection, and lingering pain since receiving the vaccine. She saw a doctor, and got a prescription for prednisone for pain and inflamation. She said she thought the pharmacist gave the injection too high on the arm.
Leg pain that started off as soreness that evolved into tingling sensations. Recently the bottom of left foot has been numb. Have found to be exhausted after short walks and short of breath.
Inj. around noon; afternoon felt tired and moving slow with gradual worsening, peaking around 6 pm with intermittent HA, 4/10, lightheaded, ears/eyes red, ears ringing, pulse low, BP fine. Throat started to have tingling feeling around 8 pm and difficult to breathe that lasted 1-2 mins; felt as though may pass out. At 9 pm started with cold chills. Couldn't sleep - arm sore x 1 day.
his Spike Protein blood test had results of 16.7 U per mL (which is considered low).; Sore Arm after second dose of the Covid Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 71 year-old male patient received bnt162b2 (BNT162B2), administration date 23Feb2021 (Lot number: EN6201) at the age of 71 years as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose, Lot Number: EZ9765.), administration date: 02Feb2021, when the patient was 71 years old, for COVID-19 immunization. The following information was reported: PROTEIN TOTAL DECREASED (non-serious) with onset 12May2021, outcome "unknown", described as "his Spike Protein blood test had results of 16.7 U per mL (which is considered low)."; PAIN IN EXTREMITY (non-serious) with onset 23Feb2021, outcome "recovered" (24Feb2021), described as "Sore Arm after second dose of the Covid Vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Concerned about administration of his vaccines: Patient stated that with the first dose of the vaccine it was administered so fast he could not believe they had time to push the vaccine into his arm. Stated he had no soreness from it or anything. With his second dose of the vaccine, he said the person who gave it was mixing things and seemed a little confused. Stated he had a sore arm for a day after that one. Patient wondered if they were administered properly and if not is that why his immunity to Covid was low. Prior vaccinations (within 4 weeks) if applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s), additional vaccines administered on same date of the Pfizer suspect if applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect, AE(s) following prior vaccinations, patient's medical history (including any illness at time of vaccination), family medical history relevant to AE(s) reported as none at the time of report.   No follow-up attempts are possible. No further information is expected.
Patient reported pain and swelling at the site of the injection, as well as red patches. The red swollen patch was about a 5 inch circle. 6/21/18 patient reported a fever, and was recommended to take ibuprofen.
FEVERISH INJECTION SITE; INJECTION SITE REALLY IRRITATED; ARMPIT SWELLING (CAN'T PUT RIGHT ARM DOWN DUE TO A HUMP IN THE ARMPIT THAT STICKS OUT WHEN ARM LIFTED UP); CONSTANT LEFT HIP PAIN/SHOOTING PAIN IN THE JOINTS; FEVERISH INSIDE; INJECTION SITE SWELLING; INJECTION SITE REDNESS (RED CIRCLE AROUND THE INJECTION SITE, THE SIZE OF A TANGERINE); ARM/HAND SHOOTING PAIN AND CONSTANT BIKINI LINE PAIN; ARMPIT MUSCLE TIGHTENED; UNABLE TO WALK; ITCHY INJECTION SITE; SLUGGISH; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: seafood allergy, and other pre-existing medical conditions included: The patient had no medical history. The patient was allergic to unspecified antibiotic. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 17-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced itchy injection site. On SEP-2021, the patient experienced sluggish. On SEP-2021, the patient experienced armpit muscle tightened. On SEP-2021, the patient experienced unable to walk. Laboratory data included: Pain scale (NR: not provided) 10/10 (units unspecified). Treatment medications included: paracetamol. On 18-SEP-2021, the patient experienced injection site really irritated. On 18-SEP-2021, the patient experienced armpit swelling (can't put right arm down due to a hump in the armpit that sticks out when arm lifted up). On 18-SEP-2021, the patient experienced arm/hand shooting pain and constant bikini line pain. On 18-SEP-2021, the patient experienced constant left hip pain/shooting pain in the joints. On 18-SEP-2021, the patient experienced feverish inside. On 18-SEP-2021, the patient experienced injection site swelling. On 18-SEP-2021, the patient experienced injection site redness (red circle around the injection site, the size of a tangerine). On 20-SEP-2021, the patient experienced feverish injection site. The action taken with covid-19 vaccine was not applicable. The patient recovered from feverish inside on 20-SEP-2021, had not recovered from injection site swelling, injection site redness (red circle around the injection site, the size of a tangerine), injection site really irritated, armpit swelling (can't put right arm down due to a hump in the armpit that sticks out when arm lifted up), constant left hip pain/shooting pain in the joints, feverish injection site, itchy injection site, and arm/hand shooting pain and constant bikini line pain, and the outcome of sluggish, armpit muscle tightened and unable to walk was not reported. This report was non-serious.
second shot received on 3/22 at 11am fever by 11pm 3/22 vomited at 3am 3/23 fever broke 36 hours after starting felt better mid day 3/24 Chest pain and jaw pain by 3/25 at 1am chest pain and jaw pain present again at 6am when awoke could not go back so sleep went to ER no previous history of heart problems  36 year old male -145lbs  they did an EKG elevated troponin level detected given aspirin and nitro  heart cath performed - no blockage admitted for 2.5 days EKGs performed   blood work drawn multiple times discharged on 3/27 at 3pm with unknow cause for elevated troponin Medications prescribed as a precaution  chest pain continued for days after discharge  all symptoms have resolved now  Resent follow up - asked about reporting to CDC given recent heart infatuation information - I was told by the nurse practitioner that I should report my case
That night of the vaccine her arm kept hurting, fever and aches. Her arm pain has never went away. She is unable to do anything with her right arm with it being painful.
Facial palsy (R). Pt states a few hours after vaccine she noticed drooping on right side of face - hospitalized. Referral to neurologist. Not resolved at visit on 4/1/09.  4/13/09 Received hospital medical records of 3/24-3/27/09. FINAL DX: no d/c summary dictated; neuro consult states right facial palsy Records reveal patient experienced left side facial & tongue numbness & pain, right mastoid pain, taste alteration, blurry vision, bifrontal HA, left side rib pain, left arm & leg pain w/weakness x 1 day.  Neuro consult done.  Exam revealed peripheral right seventh nerve distribution weakness w/weakness of right upper & lower face including weakness of right eye closure & widened right palpebral fissure; diminished pin/light touch left face, arm & leg; questionable give way weakness of left arm/leg.  Admitted for observation & additional w/u to r/o brain stem lesion.  Tx w/ASA.  Recommended MRI/MRA but no report included.
Severe sore throat, nasal congestion and simultaneous nasal issues of nasal liquid spraying , seeping, sneezing, coughing, swollen lymph nodes,   Lost hearing in left ear for a day and a half,  completely lost voice, muscle aches, body pains, swollen sinuses, restricted throat airway, intense mucus production. Sick for two complete weeks within 8 hours of having second Pfizer covid shot.  Low fever at onset and chills. I was completely housebound and isolated during previous 14 months of pandemic and was not sick prior to covid shot.  I lost my voice for two weeks. Completely lost voice.  My airway/trachea  made my sore throat feel deep. I never got anything in my lungs. But I did have heart palpitations on and off. I called the hospital and explained my symptoms and the nurse told me I was having ?an excellent immune response and to be proud of it and not worried.?
No adverse effect reported.; Nurse reported that 1 dose of PROQUAD was administered to patient 38 years old on 3/26/2019; This spontaneous report was received from a nurse referring to a 38 years old patient of unknown gender. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reaction/allergy was not provided.  On 26-MAR-2019, the nurse reported that 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5 milliliter (ml) (lot # R020678 with expiration date 15-JAN-2020; strength was not reported) was administered subcutaneously to the patient for prophylaxis (adult use of a child product ). It was unknown whether sterile diluent (lot# and expiration date was unknown) was stored in proper range. No adverse effect reported. The causality of the event was not provided.
The nurse spoke to her and said the needle broke off but she was able to give the entire dose.; getting injected she had a sharp pain and her arm still hurts.; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE CONNECTION ISSUE (The nurse spoke to her and said the needle broke off but she was able to give the entire dose.) and VACCINATION SITE PAIN (getting injected she had a sharp pain and her arm still hurts.) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01Bz11A and 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included CALCIUM PANTOTHENATE, FOLIC ACID, VITAMINS NOS (MULTI-VITAMINS VITAFIT) for an unknown indication.   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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (The nurse spoke to her and said the needle broke off but she was able to give the entire dose.) and VACCINATION SITE PAIN (getting injected she had a sharp pain and her arm still hurts.). At the time of the report, DEVICE CONNECTION ISSUE (The nurse spoke to her and said the needle broke off but she was able to give the entire dose.) had resolved and VACCINATION SITE PAIN (getting injected she had a sharp pain and her arm still hurts.) outcome was unknown.            This report refers to a case of syringe connection issue for mRNA-1273, lot #01Bz11A  with vaccination site pain.; Sender's Comments: This report refers to a case of syringe connection issue for mRNA-1273, lot #01Bz11A  with vaccination site pain.
left hand became inflamed; My left shoulder joint was hurting, down to my finger tips. it was mostly in my left hand/each and every joint in my left hand were hurting; tendons felt like they needed to be oiled. they were squeaking; This is a spontaneous report from a contactable consumer (patient) . This 40-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number LW0158) via an unspecified route of administration in the left arm on 16Apr2021 at 15:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in the 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number ER8733) in 2021, reported as 16Apr2021, for COVID-19 immunisation. The patient reported that five days after he got the second shot in his left arm, on 21Apr2021, his left hand became inflamed. He reported his left shoulder joint was hurting down to his fingertips, reporting it was mostly in his left hand; further stating he couldn't make a fist or hold anything in that hand for a little over 10 days and each and every joint in his left hand was hurting. He reported being unable to hold a pencil in that hand, further stating he had to open and close his hand all day long just to use it. He also stated his tendons felt like they needed to be oiled, reporting they were squeaking. The patient stated that after the day 11, about one finger at a time was feeling better, and the following day another finger was feeling better. He stated his hand was not "100%" where he was before he got the second vaccine. He stated he got blood work done and "all" came back negative and he had a doppler done which also came back negative. He stated he was in constant contact with his primary care physician (PCP) and they were both concluding that it was a result of the shot. The events required a physician office and emergency room visit. The events were reported as non-serious and did not require hospitalization. The clinical outcomes of left hand became inflamed, his left shoulder joint was hurting down to his fingertips, it was mostly in his left hand/each and every joint in his left hand was hurting, and tendons felt like they needed to be oiled/they were squeaking were not recovered. It was also reported that since vaccination, the patient had not been tested for COVID-19.
1st vaccine: Left shoulder pain the day after first vaccination. Continues over 1 month later.  2nd vaccine: severe abdominal pain, primarily right upper quadrant pain.  Fever. Chills. Lightheadedness. Nausea. Vomiting.
rec'd vacccine L Deltoid region 3-4-2021, then by 3-15-2021, had developed erythematous eruption w. pruritus involving upper Left pectoral area after couple days injection site soreness.
The only direct reaction to the vaccine was soreness on the arm, on the muscle. On feb 15 I tested Positive for COVID-19. I got some headaches, body ache that lasted for 3 days, no fever, no sinus, fatigue for 1 week until I tested Negative with a home test. I called my doctor and I received Paxlovid and took it for 4 days..
Local redness and swelling 4 days after vaccines R arm- TDAP 5 1/2 - 6cm. L arm- MENACTRA 4x4 5cm.
injection site is red with a 3-inch oval red mark; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of INJECTION SITE ERYTHEMA (injection site is red with a 3-inch oval red mark) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site is red with a 3-inch oval red mark). At the time of the report, INJECTION SITE ERYTHEMA (injection site is red with a 3-inch oval red mark) outcome was unknown.        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 relevant concomitant medications were reported.; Sender's Comments: 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.
slight tightness of the throat; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (slight tightness of the throat) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included CARVEDILOL (COREG), ISOSORBIDE MONONITRATE and NAPROXEN (MOTRIN [NAPROXEN]) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced THROAT TIGHTNESS (slight tightness of the throat). At the time of the report, THROAT TIGHTNESS (slight tightness of the throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Weakness, feeling like maybe getting a headache. Altered sensation in throat. Seen by EMS on site 16:45 HR 100 regular Spo2=99%   BP=148/116 17:00  HR 98  regular Spo2=100%    BP=131/93 Reported resolved symptoms, c/o "shakiness" prior to departure. Discharged home at 17:05 p.m.  Recorded by  RN.
A family came in for the Pfizer booster shot. I didn't catch the patient is under 16 years of age. We administered the booster shot. The patient did not have any noticeable ADRs and left. I am still reporting this incident because the booster shot is not indicated for anyone under 16 yet.
Muscles got tense and a creepy crawly sensations around the arm and up the shoulder and around to the back. Next day my eye was twitching. The next day I developed Bells Palsy. It was confirmed by my doctor who gave me meds and I have a referral to the neurologist Jan. 21st.
nausea, diarrhea 2AM-4AM 16NOV (recvd vax 15NOV 430PM) sxs resolved tx
No additional AE; HBP called to report a T/E on PROQUAD that was improperly stored and administered. Confirmed no symptoms or side effects reported. See related AE cases 02441596 and 02441599. No additional AE/no PQC.         ?    Names of vaccines involved (includi; This spontaneous report was received from a vaccine administration via health business professional (HBP) and refers to a 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 01-AUG-2023, the patient was vaccinated with improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHa) (PROQUAD) 0.5 milliliter, administered once, lot # X007085, expiration date reported as 04-SEP-2024 (route of administraton and anatomical location were not provided) reconstituted with sterile diluent. Administered dose of vaccine experienced the temperature excursion of 17.8 degrees Fahrenheit for 1 hour and 30 minutes. No previous temperature excursion was reported. No additional adverse event was reported.