chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Achy; Sore arm; Feel tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Feel tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN (Achy), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Feel tired). At the time of the report, PAIN (Achy), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Feel tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 18-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Feel tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN (Achy), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Feel tired). At the time of the report, PAIN (Achy), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Feel tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Pt reports she was in Hospital until 2 days ago when she received 2nd Moderna COVID vaccine. She states that several hours later she began feeling globally weak and with coordination difficulties intermittently (gives example that she would be feeding self, then have difficulty getting utensil to mouth and noted sudden collapse of LE when standing, "they just gave out" and feels that difficulty coordinating her legs led to inability to stand- adamant that it is coordination rather than fatigue or weakness at issue). She feels symptoms in extremities are bilateral and symmetric. Denies prodrome prior to falls, denies LOC but states she fell onto her face and did not "catch" herself "it happened too fast". She has been able to ambulate with assistance to bathroom and in her house in recent days. Denies paresthesias, numbness to groin or perineum. She has been constipated, which is new for her with last BM 4/17 no GIB. Pt denies dysuria or difficulties with urination, though she tells me she has not voided since yesterday. She states she has been eating without n/v or early satiety. No change in chronic cough or DOE. She has not had fevers or chills,  denies myalgias or arthralgias.
Cellulitis; they have that as part of her allergic reactions to pneumonia shot; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), in 2017 as dose number unknown, single (Batch/Lot number: unknown) at the age of 73 years, in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu shots, for immunization. The following information was reported: CELLULITIS (hospitalization) with onset 2017, outcome "unknown"; ALLERGY TO VACCINE (hospitalization) with onset 2017, outcome "unknown", described as "they have that as part of her allergic reactions to pneumonia shot". The events "cellulitis" and "they have that as part of her allergic reactions to pneumonia shot" required physician office visit. Clinical course: The patient had reacted Prevnar 13 and put her in the hospital before. The only other shot was for pneumonia, was in hospital. Flu shots were fine, never had reaction until pneumonia shot, the Prevnar 13, when that came out, was the left arm. Cellulitis set in within 20 minutes, almost immediately. Thought that was what caused her to be hospitalized, the cellulitis. That was in 2017, she thought. They only kept her, probably 1 or 2 days. Went to (Hospital name withheld). They have that as part of her allergic reactions to pneumonia shot.    Causality for "cellulitis" and "they have that as part of her allergic reactions to pneumonia shot" was determined associated to device constituent of pneumococcal 13-val conj vac (dipht crm197 protein).  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht crm197 protein), pneumococcal 13-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
While preparing for a vaccine clinic for 35 patients, 6 vials of Pfizer vaccine were removed from storage to be drawn up. The first two vials were diluted and drawn up correctly. One of these vials was subsequently  re-diluted and drawn up into 5 syringes (thinking it was vaccine) resulting in 5 patients likely getting a dose of mostly diluent and not vaccine. This error was discovered while reconciling recordkeeping and discovery of an extra vial on hand. Plan moving forward includes offering re-vaccination to all patients at the clinic that day as we are unable to determine which 5 patients may have received diluent instead of full dose vaccine.
I received the shingles vaccine and a week later on 9/7/20 I started getting a rash on inside of my mouth and lip. I developed a stabbing pain in the left side of my face as well as my ear. I had an appointment with him on 9/9 so I mentioned the symptoms to him and he diagnosed me with shingles. My doctor prescribed medication for the shingles as well as pain medication.
Pt recv vax on 12/16/98; on same day pt exp unconsolable shrilling cry x 3 hr
Patient given adult Hep B #3 in right deltoid on 4/30/07. Stated always has trouble with right arm after shot was given and c/o pain during and after administration. 5/1/07 c/p pain, no redness or swelling, unable to do ROH 5/1/07 saw PHD. Doctor treatment analgesics and muscle relaxers. 5/7/07 Reports is better.
Per patient's wife, patient started experiencing symptoms which included rash on the under part of the arm - not at the site of the injection, slow heart rate, and fever/chills, approximately 8 hours after receiving vaccines (Fluzone HD and Pneumovax).  Both were given in the Left Deltoid approximately 1 inch apart. According to wife, symptoms lasted approximately 48 hours. Patient is doing better and did not seek medical attention during this time.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A, 012M20A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021 at 1:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021 at 3:09 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021 at 4:21 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No Treatment medication information was provided
Difficulty breathing, hoarseness, wheezing, weakness, fast heart beat, headache, aches, bloodshot red rimmed eyes, fever.
On 10/18/10 patient slept for 17 hours, awoke confused, eyes blinking, babbling without usual speech, unsteady gait, confused, unable to answer questions for 2 hours - Resolved.
Persistent soreness, tenderness pain continuing over for over 14 days after vaccination. Unable to use arm to lift.
PATIENT FAINTED FOR 30-40 SECONDS..CALLED AMBULANCE..HE WAS AWAKE AT THE TIME OF AMBULANCE ARRIVAL.CHECKED EKG..HE WAS OK..WAS NOT TAKEN TO HOSPITAL
Prior to event, I felt oddly "ramped  up" for a couple days. On 22/06/21, I had onset of chest pressure-pain,  strong light-headness, minor nausea, abnormally very high blood pressure. Went to ER, where they treated as potential CAD. Very high BP and symptoms persisted, so sent to hospital. Nitroglycerine helped a lot with chest symptoms. All symptoms declined in hospital and so released after 3rd day. Tropnin not detected. While in hospital, tests were administered to determine cause of event (see below). Underlying cause for this event was not ever determined by tests in hospital or by follow up appts. I took my 2nd Moderna Covid-19 shot on 2/29/21 and there was no repeat of the heart-issues, although I did experi
Redness on arm slightly below site of injection. Pt has some itch with the redness but mainly hot and red.  Pt was advised to take benadryl and place ice on the injection site. She also can try hydrocortisone cream if the itching is bothersome.  Pt is calling her MD to let her know and follow up/
Patient came in to receive travel vaccines, while talking to patient she became very anxious about having to get vaccines. Had patient sit in the recliner to receive vaccines, after receiving vaccinations had patient sit in recliner for five minutes, then had patient stand in front of recliner for five minutes. Was talking to patient and patient's mother when patient fainted into the recliner, patients arm began to draw up and tighten. Patient started moaning with slurred speech, elevated patient's feet, placed ice pack behind patient neck, and fanned patient. Called out patients name and she began to regain consciousness. Gave patient sips of orange juice and crackers to take with them, legs still elevated. Mother stated that patient did not have anything to eat yet. Had patient stay in the recliner for ten minutes and then had patient stand. While patient was leaving stayed in front of patient and had parent behind patient.
pt recv vax & exp itching in armpits-ears-chest w/severe case of hives fr throat to thighs by 7PM; tongue swollen by 5AM 24APR95 DPH prompted ER visit; hives erupted proximal distal w/last eruption on neck 19MAY95; muscle discomfort chest
Fatigue; fogginess; headache; her arm hurt a little; rash intensified it was a dark red; itchy arms; tiredness; had rash on her back; hives; it was a dark red color; This is a spontaneous report received from a contactable consumer or other non hcp. A 70-years-old female patient received 2nd dose of bnt162b2 (Batch/Lot Number: EL9263), via an unspecified route of administration on 06Feb2021 as Dose 2,single for covid-19 immunization.Medical history included anaemia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.The patient experienced fatigue, fogginess, headache, her arm hurt a little, rash intensified it was a dark red, itchy arms, tiredness, had rash on her back, hives, it was a dark red color on an unspecified date.The patient underwent lab tests and procedures which included laboratory test: unknown result on 2020.The outcome of the event fatigue was recovered and other events was unknown.Caller says she had the vaccination COVID 19 vaccine on the 16Jan and then 06Feb. The one on the 16Jan did nothing and then the next day she had pain in her arm for like 5 minutes and that was it, the second one was a different story. That day she had a rash on her back and she forgot to tell the person she had rash on her back and she took the thing and she went about her day, the next day she had headache it was severe, she took some Advil later on in the afternoon. No further information provided.The next day her arm hurt a little and it hurt on the other arm, in the same place. She does not know if it was sympathetic pain or what but both arms hurt in the muscle towards the back.The  rash on her back was due to patient eating eggs and she wonder whether allergic reaction is happening due to egg.She had gastric problems and she had difficulty getting out of bed.  No follow-up attempts are possible. No further information is expected. Follow-up (25Feb2021): This is a follow-up spontaneous report received from a contactable consumer. This consumer reported that she had a rash on her back before the second dose, after the vaccine the rash intensified it was a dark red color.The patient mentioned about the adverse events she faced after getting 2nd dose of vaccine such as fatigue,rash and arm hurting.
3 cm- 6 cm lesions at site of DTaP injection, resolved spontaneously.
RIGHT ARM FELT ALIEN TO BODY.   DID NOT WORK NEXT DAY BECAUSE WAS NOT SURE COULD GET ARM TO WORK CORRECTLY AND I AM RIGHT HANDED.     TIME LINE:   DID NOT HURT UNTIL EARLY NEXT MORNING.    CONTINUED TO FEEL ALIEN INTO THE NEXT DAY  (24 HOURS). BY THE 2ND DAY ARM BEGAN TO FEEL NORMAL AGAIN.
Sudden onset of tinnitus in right ear with sudden hearing loss 11/18/09 Medical records received for date 11/11/09. DX: tinnitus, hearing loss rt. ear, vertigo. Pt. presented w/ c/o ringing in rt. ear. drainage and off balance,H1N1 vax and seasonal vax 11/5. Pt states later the same day sudden hearing loss/ringing in rt. ear occured. Referred for hearing test which was WNL.
Patient reported rash, lump, and warmness at the injection site. ZOSTAVAX was administered on 10/22/12 and the rash appeared on 10/24/12. Itching resolved after 3 days after taking BENADRYL. Rash resolved after almost 7 days. Skin is discolored (grayish in color).
urinary tract infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URINARY TRACT INFECTION (non-serious), outcome "unknown", described as "urinary tract infection". Therapeutic measures were taken as a result of urinary tract infection.  Additional information: The patient taking Meloxicam and Tramadol for spasms in neck. The patient started taking both medication after 2nd dose of covid vaccine also said after 1st Pfizer covid vaccine she had a urinary tract infection and had to take an antibiotic.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101593834 Same patient, same drug, different dose
A non-serious report of administration of expired FluMist has been received from a nurse in the USA concerning a four-year-old female. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on 14-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FluMist from the Vaccines For Children Program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. No adverse events were reported. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-000662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006659; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.
Approximately 15 minutes after administration, flushing occurred and vasal vagal response BP 80/42 Pulse 40. It took approximately 90 min before I was able to tolerate standing.  Flushing, vertigo, tinnitus and vassal vagal response continued for 3 days straight.
10 days after shot platelets have now dropped from 245000 to 94000; This is a spontaneous report from a contactable consumer (patient).  A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration (left arm) first dose on 08Jan2021 08:00 at single dose for covid-19 immunisation. The patient's medical history included thrombocytopenia. The patient was not pregnant at time of vaccination. The patient's concomitant medications were not reported.  On 18Jan2021 11:00, ten days after shot platelets have now dropped from 245000 to 94000. The patient was very concerned platelets will drop below 30000 and will require hospitalization. The patient wanted guidance on what protocol to follow to avoid a further drop in platelets. No treatment was given to the event. The event resulted in emergency room visit physician office visit. The outcome of the event was not recovered. The patient underwent nasal swab on 18Jan2021, and the result was negative.  Information on the lot/batch number has been requested.
Patient  tested positive for Covid 19 on 11/17/2023 at his nursing home, he was admitted to hospital on 11/21/2023 for comfort care and died the same day.
fever; chills; extreme weakness; extreme exhaustion; dizziness; sore muscles and joints; sore muscles and joints; This is a spontaneous report from a contactable consumer (Patient). A 74-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in left arm on 04Mar2021 at 09:30 (at the age of 74-years-old) as single dose for COVID-19 immunisation. Medical history included CLL Leukemia, Chronic Pancreatitis, Lymphocytic Colitis. There were no known allergies. Concomitant medication included Horizant, Progesterone, Estrogen, Levothyroxin. The patient did not receive any other vaccines within four weeks of COVID vaccine. The patient did not have COVID prior to vaccination. On 05Mar2021 at 05:00 (next day of vaccination), patient experienced fever, chills, extreme weakness, extreme exhaustion, dizziness, sore muscles and joints. No treatment was received for events. The patient was not tested for COVID post vaccination. The outcome of all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Upon administration felt pain and tingling radiating down to fingertips ,tingling lasted for 1 hour. Doctor did not provide any recommendation. Then pain began from vax site to bottom of arm, restricted movement. Pain ha been chronic for 2.5 weeks and worsened to the point that can't raise arm to any degree. On 11/15 doctor prescribed Bextra 10mg daily.
Positive Covid-19 Test; This is a spontaneous report from a contactable other healthcare professional (reporting for herself). A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 25Jan2021 13:15 (Batch/Lot Number: El1283) as SINGLE DOSE for covid-19 immunisation (66-year age at Vaccination). The patient medical history was none. The patient had no previous allergies. The patient's concomitant medications include metformin for unknown indication. It was reported that patient received first dose of Pfizer covid vaccine on 25Jan2021. Patient received second dose on 17Feb2021 (Lot no: EN6200) on right arm. on 01Feb2021 11:30 AM patient experienced Positive Covid-19 Test. covid test name post vaccination was aegis and type were Nasal swab. The patient did not receive any treatment for the event. The patient did not receive any other vaccines in four weeks. Patient received other medications in two weeks was Metformin. Outcome of the event was recovered on unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
pain on left side of back; pain on left side of buttocks; within 15 minutes she experienced tingling in her left hand and wrist; Later that day she had pain in her arm, pain in her back; This spontaneous case was reported by a non-health professional and describes the occurrence of BACK PAIN (pain on left side of back), MUSCULOSKELETAL PAIN (pain on left side of buttocks), VACCINATION SITE PARAESTHESIA (within 15 minutes she experienced tingling in her left hand and wrist) and VACCINATION SITE PAIN (Later that day she had pain in her arm, pain in her back) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A.) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Dec-2021, the patient experienced BACK PAIN (pain on left side of back), MUSCULOSKELETAL PAIN (pain on left side of buttocks), VACCINATION SITE PARAESTHESIA (within 15 minutes she experienced tingling in her left hand and wrist) and VACCINATION SITE PAIN (Later that day she had pain in her arm, pain in her back). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, BACK PAIN (pain on left side of back), MUSCULOSKELETAL PAIN (pain on left side of buttocks), VACCINATION SITE PARAESTHESIA (within 15 minutes she experienced tingling in her left hand and wrist) and VACCINATION SITE PAIN (Later that day she had pain in her arm, pain in her back) had not resolved.            Concomitant medication was not reported. Treatment includes Advil and heating pad
A week after the immunization she started to notive arm pit sorness, redness and knot about the size of a quarter near site not usre if it is at the injection site.  Was informed that sorness in the arm pit is normal, but since she does not know if the knot was at the injection site she should see her primary care and if it gets bigger or any difficulty breathing to go to emergency room.