chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; temperature excursion; This spontaneous report was received from a medical assistant and refers to a 13-month-old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 16-FEB-2023, the patient was vaccinated at a private doctor's office/hospital with an improperly stored dose (reported as "temperature excursion", which occurred on 20-JAN-2023) of varicella virus vaccine live (Oka/Merck) (VARIVAX) (product storage error) in his right thigh as prophylaxis (lot # W006412, which had been verified to be a valid lot number and expiration date was reported and confirmed upon internal validation as 23-FEB-2024; dose and route of administration were not provided). Temperature excursion details: total time in the range of 6 Degree Fahrenheit (°F) to 14°F (-14 Degree Celsius (°C) to -10°C): 1 hour, total combine excursion time: 1 hour, 0 minutes, 0 seconds as recorded by a data logger. No adverse events occurred. No PQC.  This is one of several cases received from the same reporter (original case #2303USA002114).; Sender's Comments:  US-009507513-2304USA007931: US-009507513-2304USA007889: US-009507513-2304USA007686:
This spontaneous report as received from a physician via company representative and refers to a 14 year old female patient. The patient's medical history and current conditions were not provided. On an unknown date, the patient was vaccinated with first and second doses of GARDASIL (lot #, expiration date, dose and route were not reported). On an unknown day in July 2015, the patient was vaccinated with a third dose of GARDASIL (lot #, expiration date, dose and route were not reported). The full three dose series was completed. Secondary suspects and concomitant therapies were not reported. On an unknown date, the patient had been diagnosed with postural orthostatic tachycardia syndrome (POTS). The patient seek medical attention via visiting various practices for medical assistance. It was not specified what events prompted the patient to require medical assistance. At the time of the report the patient was "alive and well" however her recovery status regarding her diagnosis of postural orthostatic tachycardia syndrome was unknown. The relatedness between postural orthostatic tachycardia syndrome and GARDASIL was not reported. Additional information has been requested.
Patient had side effects after both of her vaccines such as muscle aches, fever, fatigue, and disoriented.
Mother states child with "stomach ache' and diarrhea at intervals since Monday PM. Denies elevated temperature, vomiting.  Recommended that physician be notified if no improvement by 05/15/08.
Erythematous induration of right upper arm, warm to touch, pt also c/o shoulder and acting funny on occasions. Pt sibling received the same vaccine and no reaction.
heart failure; shingles; COPD; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): US-PFIZER INC-202200158713 (Pfizer).  A 98 year-old male patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PREDNISONE. The following information was reported: CARDIAC FAILURE (medically significant), outcome "unknown", described as "heart failure"; HERPES ZOSTER (non-serious), outcome "unknown", described as "shingles"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "COPD". It was also reported that the patient received a trivalent dna influenza vaccine, had body aches and pain, given Tylenol (it helped) (2-3 days), was given oxygen (after this was vocal) was 88%. Then he got worse, quiet and died on 23Dec2021.    The lot number for bnt162b2 was not provided and will be requested during follow up.
This case was reported by a consumer via call center representative and described the occurrence of pain in a female patient who received SHINGRIX for prophylaxis. On 4th June 2018, the patient received the 1st dose of SHINGRIX. On 5th June 2018, 1 days after receiving SHINGRIX, the patient experienced pain, tiredness and fever. On an unknown date, the outcome of the pain, tiredness and fever were not recovered/not resolved. The reporter considered the pain, tiredness and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. The patient was vaccinated on 4th June 2018 and was experiencing pain, tiredness and fever the next day on 5th June 2018.
swelling in her armpit and its warm and a knot; swelling in her armpit and its warm and a knot; swelling in her armpit and its warm and a knot; soreness in her arm; This is a spontaneous report from a contactable consumer(patient).  A female patient of unspecified age had received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: EX3599) via an unspecified route of administration in arm left on 26Jul2021 15:350 as DOSE 1, SINGLE for covid-19 immunization.The patient medical history and concomitant were not reported. On an unspecified date the patient had experienced swelling in her armpit and its warm and a knot . The patient knew she would have soreness in her arm but she has so much swelling in her armpit and its warm and a knot, wasn't sure if this was a side effect and had a question if it was swollen lymph node. The clinical outcome of the events was unknown.  Information on lot/ batch number has been requested.
Redness , swelling growing from vaccine site, radiating out 8?.  Possible infection, prescribed Cephalexin
patient had pain in the arm of flu shot the day of and the following day; then it became swollen and the skin in the area was hard-like as per patient- Able to move arm and no issue with mobility and feeling in the hand is okay
PT REPORTED RAISED KNOT ON INSIDE OF RIGHT ARM ABOVE ELBOW. DID NOT FEEL WARM. ONLY HURT IF PRESSURE/TOUCH WAS APPLIED TO AREA
Multiple illnesses in rapid succession over the course of a month, in order of appearance: slight cold, pink eye, middle ear infection, laryngitis, bronchitis, and dry eye disease. Being referred to a rheumatologist for possible autoimmune disorder.
This is an initial spontaneous report from a contactable reporter. This mother reported that her 3-month-old, son who received PREVNAR 13 on 13Apr2012 (dose and frequency unknown) as a vaccination. The consumer did not have any relevant medical history and was not taking any concomitant medications. The consumer developed fever and irritability on receiving PREVNAR 13 on 13Apr2012. The relevant laboratory data was none. Last action taken with PREVNAR 13 was unknown in response to the events. The consumer was given TYLENOL (dose and frequency was unknown) for fever on an unknown date in Apr2012. The consumer was still suffering from the reported events at the time of report.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "mild asthma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) High; SARS-CoV-2 test: (2022) Positive, notes: subsequently tested positive for COVID; (28Oct2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid from 21Oct2022 to 25Oct2022. The patient got COVID rebound after completing paxlovid treatment. Tested negative on about day 8, then began feeling symptoms again and subsequently tested positive for COVID.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201282917 same patient, different drug, different event;
Significant pain at site of injection that has lasted 2 weeks. There was no skin changes or warmth.
Pt got second dose of Moderna for COVID-19 on 04/06/21.   c/o hives, itching, dizziness, and tongue tingling that developed on 04/07/2021.  States that sx improved with use of otc Benadryl.   Came into clinic on 04/08/21 with same sx, dx with allergic urticaria and was prescribed Prednisone dose pack 10mg.
On 12-6-12 patient noted an itchy, red skin eruption on (L) lateral chest wall (armpit area). On 12-7-12 employee developed a similar skin eruption on buttock, abdomen and neck. Some eruptions were fluid-filled. On 12-10-12 areas were scabbed over. No treatment.
Information has been received from a physician concerning a patient who in approximately 2008, "less than one year ago", was vaccinated with a dose of MMR II. Concomitant therapy included tetanus toxoid. In approximately 2008, "after receiving the vaccine", the patient developed symptoms. The patient developed fever of 102 degrees F with weakness. The outcome was unknown. It was not specified if the patient sought medical attention or not. Additional information has been requested.
Reaction was mild erythema with swelling stated as a +1-2 with firm edema. Reaction occurred 10-15 min after administration. No fever, loss of consciousness, or sudden light headedness. All S/S were gone and recovered in 24 hrs.
COVID 19 bivalent booster given as a 1st dose. No adverse event to report.
Rash red bumps all over body, signs appeared approximately 3 weeks after immunization, last for 1 week, then scabbed over.
Within 5 minutes heart rate increased to 175bpm, hives appeared on my chest, neck, and back. Dizziness and severe nausea started and blood pressure decreased. Trouble concentrating and tingling in hands and feet. I was taken to the Emergency Room and hooked up to an IV and Heart Monitoring. I was given IV Benadryl, Prednisone, Pepcid, and Zofran. I was going to get an injection of Epinephrine but my heart rate and blood pressure increased significantly after the first batch of IV meds and they were concerned that the Epinephrine may have made things worse. I was monitored for 4 hours and then discharged with instructions to take Benadryl 50mg every 6 hours for 5 days, Prednisone 60mg every day for 5 days, Pepcid 40mg twice a day for 5 days and given a prescription for an Epi-Pen. I remained very nauseous and dizzy foe the next 48 hours. My injection site became swollen, red, and tender 48 hours after my injection and then re-flared up 11 days after my injection on 01/17/21.
Itching, lump (egg sized), swollen, redness, inflammation at injection site immediately after the shot and lasted 4 days. No fever/aches. Lump is gone but itch still there.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE PULMONARY EMBOLISM HYPOXIA
Hospitalized with pneumonia. Treated with O2 high flow, remdesivir, dexamethasone,
This spontaneous report as received from an other health professional refers to a patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL lot # K023432 for prophylaxis. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected. Sender's Comments: US-009507513-1708USA002370: US-009507513-1708USA002371: US-009507513-1708USA002372: US-009507513-1708USA002373: US-009507513-1708USA000870.
Headache, Fever, severe chills, fever, headache. Narrative:   Other Relevant History:
This spontaneous report was received from a healthcare worker refers to a multiple patients of unknown age and gender. No pertinent medical history was reported. Since 28-JUL-2014, the patients were vaccinated with RECOMBIVAX HB 5 microgram/0.5 ml  (dose, route, lot# were not reported) after being improperly stored. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports from the same source. Additional information has been requested.
Patient did not experience an adverse event, but was given Prevnar when we should have given Pneumovax.
patient noticed itching of bilateral legs on 2/13/22 approximately at 6pm. Itching intensified and became unbearable.  Patient took benadryl which resulted in a tolerable itch throughout the night of 2/13/22.  Redness was noticeable on the legs.  Teh night of 2/13/22 patient became very ill with stomach and back pain.  Joints and muscle pain was extreme resulting in difficulty sleeping and moving.  On 2/14/22 patient woke up with joint stiffness and bruising was seen on both upper thighs.   Bruising got worse over the next two days and began to extend upwards on teh buttocks, covering the front, side and back of thighs extending down to the back of knee area.  Bruising worsened by 2/15/22 and became painful.  Bloodwork was drawn and patient had a venous doppler done on 2/15/22.   Tylenol was taken that evening and pain did decrease the next day.
swollen lymph node in armpit Low grade fever Chills Sore joints Muscle ache Fatigue
Patient describes muscle pain and bruising/"blood clots" on left side.  The onset was 5/9/2021.  Describes as severe pain that increased till seen at healthcare provider's office by healthcare provider.
After receiving my Moderna booster shot, that evening I had severe muscle constriction.  I was unable to move my limbs and almost felt paralyzed.  It subsided by the following morning.  Then my skin became itchy all over.  First my palms, then my arms and chest and back.  Took benedryl which helped but as soon as it wore off it was back.  If I scratch the skin large raised scratch marks appear on my body and stay for hours.  I am still dealing with the reaction today, 6 days later.
Dose was placed into the refrigerator initially on 4-MAY-2023 and administered between 06-JUN-2023 to 09-JUN-2023; No adverse event; 9 patients received vaccine after the 30-day BUD between 06-JUN-2023 to 09-JUN-2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 patients received vaccine after the 30-day BUD between 06-JUN-2023 to 09-JUN-2023.), PRODUCT STORAGE ERROR (Dose was placed into the refrigerator initially on 4-MAY-2023 and administered between 06-JUN-2023 to 09-JUN-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    In June 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In June 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (9 patients received vaccine after the 30-day BUD between 06-JUN-2023 to 09-JUN-2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose was placed into the refrigerator initially on 4-MAY-2023 and administered between 06-JUN-2023 to 09-JUN-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (9 patients received vaccine after the 30-day BUD between 06-JUN-2023 to 09-JUN-2023.), PRODUCT STORAGE ERROR (Dose was placed into the refrigerator initially on 4-MAY-2023 and administered between 06-JUN-2023 to 09-JUN-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (9 patients received vaccine after the 30-day BUD between 06-JUN-2023 to 09-JUN-2023.) and PRODUCT STORAGE ERROR (Dose was placed into the refrigerator initially on 4-MAY-2023 and administered between 06-JUN-2023 to 09-JUN-2023).    No concomitant medication was reported.  Dose was placed into the refrigerator initially on 04-MAY-2023. No treatment information was reported. The case contains information for patient 4 out of 9.   This case was linked to US-MODERNATX, INC.-MOD-2023-729624 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729624:Master case
having trouble with shoulder - left arm; having trouble being able to lift arm - left arm; left arm hurts - can't even lift it over my head; never gotten a shot so close to shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (having trouble with shoulder - left arm), PAIN IN EXTREMITY (having trouble being able to lift arm - left arm), PAIN IN EXTREMITY (left arm hurts - can't even lift it over my head) and VACCINATION SITE DISCOMFORT (never gotten a shot so close to shoulder) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced ARTHRALGIA (having trouble with shoulder - left arm), PAIN IN EXTREMITY (having trouble being able to lift arm - left arm), PAIN IN EXTREMITY (left arm hurts - can't even lift it over my head) and VACCINATION SITE DISCOMFORT (never gotten a shot so close to shoulder). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (having trouble with shoulder - left arm), PAIN IN EXTREMITY (having trouble being able to lift arm - left arm), PAIN IN EXTREMITY (left arm hurts - can't even lift it over my head) and VACCINATION SITE DISCOMFORT (never gotten a shot so close to shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient takes Blood pressure and Cholesterol Medications
Almost constant headache for almost two weeks. Fever with aches lasting almost 1 week.  Pins and needles sensation down left arm approx 1 week, then bee sting sensations all over body increasing in frequency lasting at least 5 days (still taking prescribed medication so do not know current extent of sensations). Pain in left shoulder moving into upper left neck area.
Patient called the pharmacy and let me know her arm was red, warm, and swollen but not very painful.
asthmatic with side effects; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (asthmatic with side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHMA (asthmatic with side effects). At the time of the report, ASTHMA (asthmatic with side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by reporter. No treatment medication was reported by reporter.
This spontaneous report as received from a Certified Medical Assistant (C.M.A) referring to an unknown number of patients of unknown age and gender. Pertinent medical history, concurrent conditions and concomitant medications were not reported. On 17-AUG-2016, the patients were inadvertently vaccinated with improperly stored doses of GARDASIL 9 lot # M013636, expiration date 15-FEB-2018, intramuscularly. Anatomical location was not reported. No adverse events were reported. It was not a product quality complaint involved. Additional information is not expected due there is not consent for follow-up.
I developed a severe case of hives 2 days after receiving the H1n1 vacination. It is 3 weeks later and I still have a mild case.
Swollen left eye, open sore on eyebrow- eyelid closing over eye. 4-5 fever blisters active on mouth and surrounding area.  Began with first vaccination- two weeks after and same with second dose 09 days after. Swollen eyelid is new.
Vaccine given in office morning of 9-27-10, by evening patient had broken out in red pruritic rash - sought treatment 9-28-10.
Three days following injection, there was itching, sore arm.  Swelling and redness began with more itching with increased discomfort and swelling.  Called into TeleDoc and was advised to take Benadryl, Ibuprofen, Zyrtec, and apply ice packs.  It was felt this was a localized allergic reaction.  IF this does not resolve, I will see my own PCP.
Bell's Palsy noted on 5/4/21. Did have some mouth pain on 5/3 that was attributed to potential wisdom tooth eruption, then cranial nerve 7 palsy noted on 5/4/21.
Patient had tingling in lips and fingers.  Benadryl 25 mg po given at 1021.   1021: BP 144/74 HR 58 RR 12 O2 sat 100%  1038: BP 144/68 HR 58 RR 15 O2 sat 99%  Pt released home.
Weakness, lack of appetite, vomiting, diarrhea, lethargy. Kidneys began to fail.
Red, warm arm, swollen. Started 10/5/16. Pt. already on prednisone taper dosing (started 10/5 for other issues) and steroid shot on (10/4/16).
Complaints of pain in right arm initially after 1st Gardasil injection. States right arm hurt for 1 month after shot was given.
Severe pain under injected arm, shivering and muscle twitching, nausea & faintness when getting out of bed to use bathroom, loose stools.  Took acetaminophen which seemed to help.  Could finally get out of bed at 10:30 am.
pt devel a sl h/a & started vomiting 630PM approx 20 times; states also had diarrhea; sx resolved by 27MAR94;
Narrative:  A 92yo male with PMH of Dyslipidemia, HTN, CAD, OA, CHD, Rotator Cuff Tear, Sensorineural Hearing Loss He received Pfizer Covid-19 vaccine per policy and protocol First dose on January 14, 2021 and the second dose on February 4, 2021 No ADE reported or documented System showed Patient passed away on March 15, 2021 - no other documentation
Child went to ER for redness and swelling of right arm. Local increase in temperature and itchiness. Instructed to use Benadryl and ice.
Rash and itchiness. First shot for rabies was given to me on August 4th. A day later I felt itchy and and noticed a rash on my arms and legs. The first 3 shots were given to me at emergency room.
I was feeling an extreme headache that evening and soreness in my left arm. Throughout the night, I was waking up with extreme diarrhea. It was coming out clear liquid. The next morning, I ended up throwing up all of my breakfast. I was extremely cold. I did not have a fever. It was 97.3. I didn't throw up after that but I continued to have diarrhea, loss of appetite, and headache. I had a lot of muscle aches throughout my body. I called my doctor that Monday (11/08). They said they were going to call in a prescription of Amoxicillin and they didn't want me to come into the office. I still have the diarrhea, but they said it was probably a side effect from the Amoxicillin.
Patient developed nausea and left upper arm cellulitis after receiving flu vaccine on friday 10-30-20. Treatment: Cephalexin 250mg/5ml for 10 days.
Covid arm. Swollen, feverish, and red staring a couple hours after. Now day 4 post vaccine and it?s roughly the size of an apple and still getting larger.
Patient was vaccinated with Pfizer accidently. When mistake was found child's mother was notified. Vaccine is only for 16 and older. Child was 15 at time of vaccination.