chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a Registered Nurse (R.N) concerning multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (Lot # M042853; expiration date 17-JUL-2019), (Lot # N003703; expiration date 29-OCT-2019), (Lot # N004799; expiration date 15-NOV-2019) for prophylaxis (dose and route not reported). The temperature was 9°C to 25°C for 210 hours and there was no previous temperature excursion. The call was made because of a data logger. Adverse effects reported and there was no PQC involved. This is one of several cases from the same source. Sender's Comments: US-009507513-1708USA003629: US-009507513-1708USA011937: US-009507513-1708USA003635: US-009507513-1708USA003631: US-009507513-1708USA003632: US-009507513-1708USA003633: US-009507513-1708USA003634: US-009507513-1708USA003627: US-009507513-1708USA003630.
A slight fever, severe muscle and joint pain, very difficult to get up the next morning, lack of energy.Next morning, rash on arm below injection site and on both shins and calves. Very itchy in those areas including my scalp.
1146--Patient walked in to vaccine clinic from waiting area. C/o generalized itching in her arms. No rash or hives visualized. . Denies any respiratory problems, swelling in throat, lip or tongue. States she feels like she has to clear her throat every once in a while. Offered Benadryl but patient declined.  1201--stated the itching is worsening, noticed a rash that appeared on her upper right chest close to her shoulder. patient verbalized she would like Be. nadryl since the itching is getting worse. Benadryl 50 mg/ml  IM right deltoid given, lot 041020 exp 4/30/23. BP 120/82, HR 99 O2 sat 100%. Denies any respiratory symptoms. 1216--itching improved, rash starting to resolve BP 132/98 HR 95 O2 sat 100%  1224--patient stated she is starting to "feel funny" BP 144/109 HR 96. Rapid Response called via vocera. 1227--Rapid Response at chairside assessing patient 1230--BP 135/108  HR 106 O2 sat 99%, patient still in no apparent distress 1235--rapid response decided to bring patient to ED. Patient to ED via wheelchair accompanied by RN. Patient's coworker who accompanied patient here to the vaccine clinic will report to patient's supervisor that patient will not be returning to work today.
01/09/2021 0400 to 1100 severe muscle/joint ache, 99.4 temp, headache,chills/shivering. 01/09/2021 2100 muscle aches, 99 temp 01/10/2021 0500 mild muscle ache, mild headache
This initial spontaneous case, was received on 18-Oct-2017, from a pharmacist, concerning a 10-year-old male. The patient had no medical history or concomitant medications. On 16-Oct-2017, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 1618701, expiry date: Ap-2017). It was reported that, the patient was administered with expired vaccine (explicitly coded as expired vaccine used) and did not experience any adverse events later. It was reported that, the patient was revaccinated. The reporter assessed the events as non-serious. Non-significant follow up received on 30-Oct-2017: It was reported that, the patient did not experience any adverse event later and was revaccinated.
She awakened in the middle of the night feeling much pain in arm where injection was. Felt like she would throw up but couldn't move from the bed. Felt like her face was drawn and tight. This morning, she has been very shaky, sounds like some congestion in her chest (cough), very tired, very dry mouth. She is never sick, so this is alarming to her and to me.
Developed palpitations that lasted 30-60 minutes with some chest discomfort that were worse day 3-4 after symptoms started and by 9/9/21 she had no symptoms by the time of office visit that day and day prior symptoms were about 50% better
Mild swelling, redness, pain, warmth, "heavy arm", headache and sweaty however lower in arm than site injection. Started couple hours after injection. Redness gone by next morning. Reassured expect continue to improve over next 72 hrs. ZYRTEC given daily and advised to ice 3x/day as needed. Unsure if from vaccine itself or because of previous B12 injection in arm within last week.
Erythema and edema around injection site 12cm X 15cm. Possible cellulitis. Soldier did scratch site after vaccination. Anticipated recovery.
Patient received ZOSTAVAX injection in her left arm and immediately had a hard lump appear about 1 inch from site of injection. Bump was surrounded by redness no pain or discomfort. Patient sat for additional time no further progression and remained for 30 min.
She started getting fevered and coughs after the second dose. She seemed to get better until 2 days after the shot when she collapsed at work. We found out she had had a brain aneurysm. She then passed away about 3 days later on 4/9/2021
Guillain Barre Syndrome like symptoms. Polyneuropathy. Progressive bilateral lower extremity weakness and numbness.
Systemic: Flushed / Sweating-Mild, Systemic: O2 levels dropped. No flushing/sweating but system would not let me uncheck section-Medium, Additional Details: her oxygen saturations were 93-96% on room air all of January, she received her first vaccine January 20, 2021.  She received her second vaccine February 3, 2021.  Her sats for February were 92-94% up until the sixth of February when she noticeably dropped to 91% on room air,  she started being supplemented occasionally with oxygen on the 8th. She continues to be supplemented with oxygen. Not sure if related to vaccine or not
Information has been received from a registered nurse (RN) concerning a 32-month-old white male with no known allergies and no pertinent medical history who on 19-NOV-2004 was vaccinated SC with the first dose of Varivax (Lot #646819/1065N). There was no concomitant therapy or illness at the time of vaccination. The RN reported that on 10-APR-2006, the patient was seen by his physician with a runny nose, vesicular lesions with red base on his abdomen, axillary area, behind his ear and on his back. He had no fever. He complained of itching. There were approximately 25 lesions. There were no laboratory tests performed. A diagnosis of chickenpox with impetigo was made. The patient was treated with Benadryl and Aveeno Bath. The patient's chickenpox and impetigo subsequently resolved. Additional information is not expected.
Patient suffered a vasovagal (syncope) reaction after vaccine given. Sent to ER
3-5 min  hives left arm ;shoulder to wrist Woke up nxt morn w swollen joints in all joints swollen fingers & toes  unable to bend elbows ankles fingers toes neck etc Same  results as if ingested milk Hives on torso & limbs
9 am- received COVID 19 VACCINATION IN RIGHT DELTOID AREA OF THE ARM. 9:15-16 AM- SLIGHT DIZZINESS EXPERIENCED. I WAS RECLINED IN A RECLINER CHAIR. THIS SUBSIDED. I HAD PREMEDICATED AT 8:20AM WITH BENADRYL 3/4 TAB OF 25MG. TYLENOL 250MG ES 1/2 TAB AND PEPCID 1/2 TAB 20MG ALONG WITH MY DAILY CROMOLYN SODIUM 200MG. I BECAME SLEEPY AND TIRED AT 2PM W/ INTENSE HEADACHE. AT 8:30PM, APPROXIMATELY TO 1145PM, I HAD TO USE A TOTAL  OF BENADRYL 125MG, PEPCID 80MG, TYLENOLES BECAUSE OF EXPERIENCING THROAT TIGHTNESS WITH SOME DIFFICULTY SWALLOWING, TONGUE THICKNESS, WEAKNESS AND PERSISTENT STABBING HEADACHE. EXPERIENCED TONGUE THICKNESS AND LIP SWELLING SWELLING THE FOLLOWING AM.
12 hours after injection- mild fatigue, injection site pain 24 hours after injection - fatigue, joint pain, nausea 48 hours after injection - headache,  fatigue, joint pain, nausea
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 31Dec2012. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Vaccine received and other medication with in 2weeks: Yes, known allergies: Amoxicillin and other medical history: Obesity.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Three degrees of fever that afternoon, joint pain, stomach pain, sweating, shakiness, fatigue. I still have some fever two days later.
patient received a dose ofV ARN AX following a temperature excursion.; No adverse effects were reported.; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. There was no information reported regarding the patient's concomitant medications, pertinent medical history and drug reactions or allergies.   On 30-JUL-2019, the patient received a dose of (VARIVAX) (dose and route were not provided; lot number R017636 and expiration date 20-JUN-2020 have been verified to be valid (expiration date was also reported as: 23-OCT-2020) for prophylaxis, following a temperature excursion. The temperature excursion was from 6 Fahrenheit degrees to 14 Fahrenheit degrees (-14 Celsius degrees to -10 Celsius degrees) (-12.48 Celsius degrees), within a time frame 120 hours. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported.
This spontaneous report was received from an other health care professional refers to a 52 year old female patient who works in women's service. The patient's concurrent conditions included sulfa allergy, penicillin (PCN) allergy, ciprofloxacin allergy, osteoporosis and dyslipidemia. The patient's medical history was not reported. On 29-JUN-2015, at 10:40am, the patient was vaccinated with the first dose of ZOSTAVAX, subcutaneous injection in the left arm, lot # L006382 (expiration date was not provided). There were not concomitant medications reported. On 30-JUN-2015, at unspecified time pm, the patient experienced erythema, cellulitis, pain and edema in her left arm and was diagnosed with cellulitis. The patient sought medical attention and received treatment for the adverse events with oral unspecified antibiotics. At the time of the report the outcome of cellulitis was recovering/resolving. The reporter did not assess the relatedness of cellulitis with ZOSTAVAX. Additional information has been requested.
Vesicular rash compatible with chicken pox 11 days after receiving Varicella vaccine.
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 17-NOV-2015, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 single dose: 0.5 ml (lot # L013428, expiration date: 03-FEB-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursion: first lasting for 72 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.56 degrees Celsius), second lasting for 24 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.11 degrees Celsius), third lasting for 88 hours, with the lowest recorded temperature of 30 degrees Fahrenheit (-1.11 degrees Celsius) and fourth lasting for 136 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-0.56 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Within a few minutes of injection, my left arm began itching, followed by neck and my face. I reported to the pharmacist and he instructed me to take Benadryl. I had no other symptoms at the time. After leaving I began to have a scratchy throat and some wheezing, I continued with the Benadryl and self monitored until symptoms began to subside within two hours.
12:50pm Administered 2nd Hep B Vaccine to the Left Deltoid IM. Employee presented @ 1:10pm with c/o having  intense left arm itching , sweating and nausea. Assessed employee, no signs of respiratory distress, no hives or swelling noted to arm or face. Vital sign were taken, BP 145/102, HR 85. Employee  self medicated with Benadryl 25mg by mouth with 8oz of water. Fanned and continued to monitor sx. Complained of feeling a bit lightheaded. No vomiting noted. Continued to c/o itching to the left arm only.  Employee was released to go home after speaking  to Help Line. Reassured, advised to seek medical follow up care if feels the need. Reevaluated employee vital signs @ 2:01pm 121/78, HR 73. No respiratory distress noted, no hives or swelling noted. Ambulated out to meet spouse with no problems.
Infant had fever of 102.4 rectally on morning after immunizations.  Baby was awake and interactive with Mom when suddenly became stiff, eyes rolled back and he stared to the side.  Episodes lasted less than 1 min but he had 3 episodes, each about 5 min apart.  She was unable to engage infant during the episode.  Was brought to ER where temp was 102.2, given Tylenol.  Normal exam in office
Information has been received from a 74 year old male and his wife, with no known medical history or drug reactions/allergies reported, who on 15-AUG-2006 was vaccinated subcutaneously with another dose of Pneumovax 23. Concomitant therapy included baby aspirin. The patient had been hospitalized for chest pains and when he was discharged the hospital asked him if he had been vaccinated for pneumonia. The wife confirmed that the patient was not hospitalized as a result of the vaccination, but rather received it upon discharge as part of the hospital's policy. The patient count not remember if had received it and he got a shot. That evening, on 15-AUG-2006, the injection site got swollen. The following morning, on 16-AUG-2006, the patient's arm was bright red. It was reported that he could not bend his left upper arm, and his whole arm was swollen and red. When the patient called his doctor, he stated that he had received the shot last November. The patient's clinical outcome was reported as not recovered. Additional information has been requested.
Left arm injection site is  hard, hot to the touch, itching.  Also itching around my ear and in my hair on the left side.  Very small red area surrounding the injection, smaller than a dime.
-Large, red, swollen circle on left arm around injection site. Warm and painful to the touch. Ached and was painful laying down to sleep. Worse 24-48 hours after injection, roughly 2-3 inches across. Also, I was fatigued, kept experiencing hot/cold spells, achy shoulder/neck.  Overall not feeling well.  -48-72 hours after, more spread out swollen circle on arm (4-6 in), still very warm and painful. Clothing continued to bother it and sleeping was painful.  Overall felt much better but still easily fatigued.  -Over the course of the next few days, arm became less red and slowly less painful. Swelling seemed to be dispersing.  Began to itch on day three/four.  Affected area is pink and still slightly warm on day 4. Slightly painful in the center, more itchy around the edges. Still around 4-6 in around. Overall feeling normal.
Headache; Chills; Fatigue; Cough; body ache; Fever; stomaache; muscle pain; wrist pain; ankle pain; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: Unknown) via an unspecified route of administration in the left arm on 27Mar2021 at 13:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), salbutamol (ALBUTEROL) for unknown indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Mar2021 at 01:30, the patient experienced headache, chills, fatigue, cough, body ache, fever, stomach ache, muscle pain, wrist and ankle pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event headache, chills, fatigue, cough, body ache, fever, stomach ache, muscle pain, wrist and ankle pain were not resolved at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
The vaccine had been placed on an administration tray in a cooler and had an ice pack underneath the tray. The vaccine froze and was attempted to be administered before this was realized.  During administration, it was noticed the syringe would not completely empty the contents, so only about 0.15 mL was administered.
Double Vision,  Proptosis, Ocular hypertension, Headache, Right facial pain, Fullness right ear.....All right facial area....All started 3 to 10 dayspost vaccine......ordered MRI head .....ordered Medrol dose pak  started on 5/4/21....ENT consult ordered
A week after getting the second dose, I now have a fever of 102.6 F. I also had a low grade fever the day of my second dose. OTC medicine like ibuprofen is not bringing down my fever this time around. My head hurts too.
925AM 6MAR97 mom returns to clinic p/10min p/vax rt arm recv MMR & was red (3cm area) w/sl induration lt arm recv vax was red (2 cm area) w/sl induration;MD notified DPH & ice packs given;pt observed x 30min
The patient developed tuberculosis at an unspecified time in the recent past; This spontaneous report was received from a pharmacist concerning a female patient of unknown age. No information was provided regarding the patient's pertinent medical history, concomitant medications, and drug reactions or allergies.  On an unknown date, (reported as in childhood), she may have received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) as measles mumps rubella prevention (dosage schedule, anatomical location, route of administration, lot number and expiration date were not reported). The vaccine was reconstituted with diluent (MRK) (lot number and expiration date were not reported).    On an unspecified date, reported as (in the recent past), the patient developed tuberculosis. Furthermore, the patient was treated with rifampin, 300 mg twice daily. According to the reporter, the patient was starting medical school and it had been determined she needed  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccination.   The outcome of tuberculosis was recovering. The causal relationship between the event and therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.  Upon internal review, the event of tuberculosis was determined to be medically significant.
Arm pain; Swelling in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) and PERIPHERAL SWELLING (Swelling in the arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medication history was provided.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain) and PERIPHERAL SWELLING (Swelling in the arm). At the time of the report, PAIN IN EXTREMITY (Arm pain) and PERIPHERAL SWELLING (Swelling in the arm) had resolved.      Concomitant medications not provided.  Treatment information not provided. Patient wants to know if she can use Benadryl to treat a foot swelling after getting bitten by a bug while on the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow up received on 02 Jul 2021 and contains non significant information
vaccination site bleeding; vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (vaccination site bleeding) and VACCINATION SITE PAIN (vaccination site pain) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain). On 19-Feb-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (vaccination site bleeding). On 23-Jan-2021, VACCINATION SITE PAIN (vaccination site pain) had resolved. On 19-Feb-2021, VACCINATION SITE HAEMORRHAGE (vaccination site bleeding) had resolved.            No treatment information was provided.  No concomitant medication was provided.   This case was linked to MOD-2021-018774 (Patient Link).
On 9/1/2021 at about 5:30PM, I started feeling congested and had a runny nose and a scratchy throat. I went to bed early. The runny nose continued to 9/2/2021, on which day I also woke up with a mild headache. When I got up, I took some Tylenol and then read my temperature, which was about 99 degrees. I then called my employer, told them I thought I had a cold, and told them that I wouldn't be at work that day. I slept most of the day that day, and I gradually realized that it might not be a cold, but COVID19. I then called Dr. and arranged a drive thru COVID19 test on 9/3/2021. On 9/3/2021, I was tested for both COVID19 and strep throat, and I tested positive for both. Dr. phoned in a prescription for antibiotics. I also received a call from Dr. at Urgent Care, and she informed me that I qualified to receive an infusion of monoclonal antibodies and asked me to come in straight away, which I did. After getting the antibody infusion, I came home and stayed there 10-12 days. I began working from home 9/16/2021 or 9/17/2021. By then, all of my symptoms had subsided, except I had a persistent cough. I did not want to return to my workplace while I had the cough. I was finally able to return to my workplace on 9/20/2021.