chrisvoncsefalvay/vaers-outcomes huggingface dataset:
temperature excursion; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (Pfizer Covid 19 Vaccine-Solution for injection), (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), outcome "unknown", described as "temperature excursion". Additional information: Verbatim and Event Description: (Name withheld) is a HCP who wants to know if the vaccine they have received can be replaced because these pediatric vaccines are already on a temperature excursion. Caller is a HCP as per representative but was not able to verify from the caller itself. Cap color not confirmed.  Follow-up attempts completed. No further information is expected.  Follow up(13Jan2022): New information received from a Pfizer sponsored program (159558). A contactable Other-HCP reported that included reporter details, suspect product details verbatim and events description.  Follow-up (07Feb2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
PATIENT DOESNT REPORT ANY ADR HOWEVER, THE MODERNA 2ND SHOT WAS ADMINISTERED ON DAY 22 NOT THE RECOMMENDED DAY 28
Chills; Headache; Memory loss; Thought he was having a panic attack; This is a spontaneous report from a contactable physician via Pfizer sales representative. A male patient of an unspecified age received unknown dose of meningococcal group B RLP2086 (TRUMENBA), via an unspecified route of administration on 21Sep2016 (Batch/Lot Number: N16808; Expiration Date: 31Jul2017) as SINGLE for meningococcal immunisation. The patient medical history and concomitant medications were not reported. Caller said that the reporter said that the patient had the vaccine and went to a buffet and experienced headache, chills, thought he had memory loss. He went to the hospital and they did a CT scan and it was normal. The patient stayed in the hospital overnight. The caller said that the reporter said that the nurse who gave the shot put the shot in the patients arm and went to push and nothing came out. She took the needle out of the patient's arm and inspected it and removed the needle. She gave him a different dose of the vaccine, not the one that would not push. The caller said that the reporter also reported that the patients mom thought he was having a panic attack and she thought he had anxiety before. The mom thinks he had 2 doses of the vaccine, but with the first one the needle was not working. The patient underwent lab tests and procedures which included computerised tomogram as normal. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Arthritis Flare, fatigue, and Sinus Infection (beginning 2 days after shot) and progressively worsened throughout week..
Patient developed hives while at babysitter. Called doctor office and wanted child to be seen. Dr. diagnosed child with hand, foot, and mouth disease and started amoxicillin and told father to give her BENADRYL.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28 Jan 2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28 Jan 2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28 Jan 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28 Jan 2022) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2022 at 4:06 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Jan-2022 at 4:06 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28 Jan 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28 Jan 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28 Jan 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28 Jan 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Ethnicity was reported as (withheld). No concomitant medications were reported. The patient received Moderna vaccine on 28 Jan 2022 16:06:49, past its 30 day of expiry date. Vaccine went into 2-to-8-degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. No treatment medications were provided.   This case was linked to MOD-2022-542869 (Patient Link).
Patient reported in chart notes a history of fainting after vaccinations. Pharmacist asked patient about this before administering vaccine, and patient said she often faints in regards to blood draws or vaccines. Patient was prepared to sit in waiting area for at least 15 minutes. Patient was given vaccine and pharmacist confirmed patient was feeling okay. Patient returned to waiting area to sit, then allegedly decided to stand up and go to the in-window when beginning to feel faint. She fainted in this process. RPh and store manager immediately rushed to patient, who returned to consciousness right away. Patient stated to RPh that she did not hit her head nor did she have any pain in her legs or trouble breathing. She felt  mostly embarrassed. Store manager called paramedics, who arrived, examined patient, and the patient let them leave and proceeded to shop in the store aisles until her husband arrived.
SYMPTOMS OF AUTOINOCCULATION ON ARM AND FACE OCCURED 35-38 DAYS AFTER INITIAL VACCINATION. INITIALLY, THE PATIENT WAS DIAGNOSED AND TREATED FOR SCABIES ON 3/10/03. IT IS THOUGHT THAT HE MAY HAVE AUTOINOCULATED HIMSELF AT THAT TIME. HIS SCABIES HAS SINCE RESOLVED, BUT FOLLOWING DIAGNOSIS, HIS AUTOINOCCULATION SIGNS DEVELOPED.  HE HAS NOT MISSED ANY WORK DAYS.  SIGNS/SYMPTOMS CONSIST OF 10MM-12MM AREA OF PUSTULES AROUND INITIAL VACCINATION SITE AND PRURITIS.
swelling; redness at injection site; a lot of pain at injection site; A spontaneous report was received from a consumer concerning 30 years old, Female patient who experienced side effects of swelling, erythema at injection site and a lot of pain..   On 25-Jan-2021 the patient received the first dose of two planned doses of mRNA-1273 Vaccine, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  Patient received vaccine in left arm shoulder deltoid muscle  10 days after receiving the vaccination the patient experienced side effects of swelling, erythema and a lot of pain at injection site on 04-FEB-2021  Concomitant product use was not provided by the reporter.     Treatment information was not provided.   The Patient is fine now, the side effects resolved in 48 hours.  The outcome of the events was resolved/recovered.
Red swollen bumps that itch.  They are located  at the waistline  below belly button. The area covered is about 7? x 4?. He felt it about an hour after the vaccination. It has been 2 days, itching isn?t as severe and it is improving
Patient was given TDAP vaccine on 3/17/22.  A second dose was given on 3/28/22 .  Pt is 29 weeks pregnant, only one dose was indicated for pregnancy recommendation.  Vaccine company contacted, they indicated that if there was any reaction to receiving a duplicate vaccine it would injection site pain, headache, N/V, fatigue, cough, etc.  Patient has no such symptoms or adverse reactions reported at this time.
Low grade fever, muscle aches, joint aches, headache,  nausea, lethargy. Red bump and swelling at the injection site.
This is a spontaneous report from a contactable consumer and then from a contactable other HCP. A 54-year-old male patient received PREVNAR 13 (lot#F88044 and Exp date 9.13), at 0.5ml intramuscular single injection in the deltoid muscle of left arm as a health measure on 21Mar2012 10:30. There were no other vaccines given on the same day. Medical history included gout from an unknown date and unknown if ongoing, hypercholesterolaemia from an unknown date and unknown if ongoing. Concomitant medication included colchicine, LIPITOR. The patient previously took tetanus toxoid, typhoid vaccine, hepatitis B vaccine, hepatitis A vaccine and Yellow fever vaccine. There were no other illnesses reported at the time of vaccination. There were no other vaccines taken within the last four weeks. On 21Mar2012, after the injection with PREVNAR 13, the patient experienced pain at the site of injection. The patient experienced left upper arm cellulitis (medically significant) on 22Mar2012. On 27Mar2012, he developed a red patch at the site of injection. The patient also developed infection (non-serious), erythema (non-serious), edema of left upper arm from deltoid muscle down to above elbow (non-serious) on an unspecified date. The events, infection\Cellulitis Lt. Upper arm required an emergency room or doctor visit. Relevant lab data was none. Therapeutic measures were taken as a result of the red patch at the site of injection and cellulitis included treatment with KEFLEX and warm compresses. The clinical outcome of the events is recovered. Follow-up (13Apr2012): New information received from contactable Other HCP includes additional events which upgraded this case to serious, medical history, concomitant medications, clinical course and outcome.
I developed a sudden scotoma in my left eye. I also see blue blobs of light from my left eye a 1-3 times per day on average that come and go.  There is no treatment. After visits to a opthamologist and retina specialists, the ophthamologist diagnosed Acute Ideopathic Blind Spot Enlargement. She said it's unusual, but she's apparently not concerned about it.  I still have the scotoma and blue blobs.  The information Dr. gave me on AIBSE states it is can be from a viral illness or from vaccination.
swollen, red, hot, welted injection sight (3.14.2021). Hives on arms, chest and back (3.15.2021)
first dose J and J COVID vaccine, second/booster dose Moderna vaccine; Feel like the heart is stronger, inflammation from  heart is gone, patient have no pain, able to walk and do activities that were previously not possible; Feel like the heart is stronger, inflammation from  heart is gone, patient have no pain, able to walk and do activities that were previously not possible; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Feel like the heart is stronger, inflammation from  heart is gone, patient have no pain, able to walk and do activities that were previously not possible), PRE-EXISTING CONDITION IMPROVED (Feel like the heart is stronger, inflammation from  heart is gone, patient have no pain, able to walk and do activities that were previously not possible) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose J and J COVID vaccine, second/booster dose Moderna vaccine) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Janssen COVID-19 vaccine (First Dose). Past adverse reactions to the above products included No adverse event with Janssen COVID-19 vaccine. Concomitant products included SACUBITRIL, VALSARTAN (ENTRESTO), DIGOXIN, SPIRONOLACTONE, CARVEDILOL, ASPIRIN [ACETYLSALICYLIC ACID] and OXYCODONE for an unknown indication.    On 15-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose J and J COVID vaccine, second/booster dose Moderna vaccine). In December 2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Feel like the heart is stronger, inflammation from  heart is gone, patient have no pain, able to walk and do activities that were previously not possible) and PRE-EXISTING CONDITION IMPROVED (Feel like the heart is stronger, inflammation from  heart is gone, patient have no pain, able to walk and do activities that were previously not possible). On 15-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose J and J COVID vaccine, second/booster dose Moderna vaccine) had resolved. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Feel like the heart is stronger, inflammation from  heart is gone, patient have no pain, able to walk and do activities that were previously not possible) and PRE-EXISTING CONDITION IMPROVED (Feel like the heart is stronger, inflammation from  heart is gone, patient have no pain, able to walk and do activities that were previously not possible) was resolving.            No treatment medication was reported.  The patient reported that the booster dose of the vaccine had made the patient feel stronger and made the patient felt like a new man and felt fantastic. The patient was feeling no pain to the extent of not even requiring pain medication. The patient was not running out of breath during physical activity.
Soreness in feet and joints; aches constantly. Tired and run down feeling. Vaccines on 4/97-4/98. Started feeling lousy on 6/02. Initiated inflammatory drugs which helped some.
Around 1230am I was at work, profuse sweating, nausea,  woozy, , I left work. Next few hours, arm was very sore, got red and inflamed for 5 days, itchy too. Headache, nausea, tiredness continued. All symptoms except the red inflamed sore arm were gone by day 4. Painful to touch or lift my left arm for 5 days, after that, the redness went but area was still itchy and tender to touch.
The patient came in for sick visit he had fever and sore throat, so the doctor prescribed him with amoxicillian 500mg TID, he was also due for his immunization, was given to him on 4-29-2019 at 12:00.
Soreness started late Thursday 3/7 then became red and swollen and painful at site on outside of left arm. Pain and swelling moved down arm around inside of arm and swollen around elbow. It is now Monday evening and arm is still sore, swollen and red especially around inside of elbow. Have not called dr. yet. But pharmacist said to use ice pack for swelling and take Claritin for itch (itches off and on).
Client  arrived for Booster Dose COVID Vaccine.  Client  notified Vaccinator , that he felt a little lightheaded and nervous with needles.  Vaccinator provided water prior to vaccination. Vaccinator had client  sit in the zero gravity chair for vaccination.   Client  received the Booster Dose COVID vaccine (Pfizer, Lot # FJ369, expiration date 03/16/2022) at 1206PM. Client  immediately following vaccination states he felt fine.  At 1208 Client  called over to Vaccinator  stating that he was not feeling well.  Client was pale, sweating, and feeling lightheaded.  On arrival, Client  fainted while in zero gravity chair for approximately 3 seconds.  Vaccinator  assessed Initial vitals (P 49, O2 87, A&O x4).  At 1211 second assessment of vitals (P 60, 02 94, BP 92/59, and A&Ox4).  Client has no pertinent medical history, NKA, and not taking any medications.  Client color returning to normal, decreased sweating, and reports he is feeling better.  Client provided juice and crackers.  At 1219 Client  tolerating juice and crackers.  Vitals assessed (BP 124/73, P 63, O2 97, color within normal limits). Vaccinator  had client  sit up in zero gravity chair. At 1229 Vaccinator  assessed vitals (BP 120/76, P 65, O2 97, color within normal limits).  Client  states he is feeling better.  Client educated on signs and symptoms of when to seek medical care and to follow-up with primary care provider.  At 1236 Client  left with steady gait.
Severe headache on 3/19/21 and body aches. Arm pain also began on 3/19/21 where injection was given. Area is red with bruising where the shot was given. It feels like there is a lump at injection sight. Painful to touch and move arm. The area has gotten larger in size everyday since the vaccine was given.
Patient felt lightheadedness and dizziness about 10 minutes after receiving COVID 19 vaccine. Patient bradycardic and hypotensive.
vaccine coordinator reports no adverse effects for all patients; Administration of 6 separate doses of an improperly stored vaccine to 6 separate patients; This spontaneous report was received from a vaccine coordinator concerning patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, historical drugs or allergies were not provided.  On 24-APR-2019, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number: R021636 and expiration date 12-MAY-2021, intramuscularly (strength, dose, anatomical site, frequency were not reported) for prophylaxis.  The administered dose of the vaccine experienced a temperature excursion of 50 degrees Fahrenheit (°F) for 1 hour. There was no previous temperature excursion and the call was because of a data logger. No adverse effects reported. No product quality complaint was involved.  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA012683: US-009507513-1904USA012710: US-009507513-1904USA012721: US-009507513-1904USA012754: US-009507513-1904USA012756:
Lot # had been extended and vaccine had remained in freezer until date of administration.  Vaccine was given 2 days after exp. date.  Moderna consulted and deemed the vaccine still viable so revaccination was not neccesary.  No adverse effects reported by patient.
A spontaneous, non-serious report of rash that looks like contact dermatitis was received from a nurse concerning three or four children after receiving FLUMIST. 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 for FLUMIST. On an unknown date in 2009, the children received FLUMIST. On an unknown date in 2009, three or four children presented with a rash that looked like contact dermatitis. The outcome of the event, rash that looked like contact dermatitis, was unknown.
Augmentin 400mg Bid x 14 days given by ER phsician.  diagnosed with cellulitis per pertussis.  Febrile.  ER visit was pm of 9/4/03
Injection site cellulitis; This case was reported by a pharmacist via call center representative and described the occurrence of injection site cellulitis in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced injection site cellulitis. On an unknown date, the outcome of the injection site cellulitis was unknown.   It was unknown if the reporter considered the injection site cellulitis to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The pharmacist reports that a patient developed cellulitis at the injection site the day after receiving the 1st dose of Shingrix.  The dose was given approximately one month ago. The patient was told by urgent care that she would need to repeat the 1st dose. The reporter consented to follow up. Pharmacist did not have many details at the time of the call.
Patient called to say she has redness, swelling, itching and pain at injection site.  Treated with taking a pain reliever. Called patient back on 2/23/2017 at 3:30pm- patient says no more pain, still some swelling and redness around area.  The patient will take an antihistamine to help this time.
Pain/Aching/Burning sensation in upper left arm, traveling down arm into elbow and wrist. Tingling and numbness in fingers. Pain going into shoulder and into shoulder blade, pain also sometimes going through armpit and left side of upper body. Have had several sets of x-rays, EMG test, cortisone shot.
neck felt really weird, her whole neck was hurting; very tired; Fever; pain in the stomach; Dry heaves; back was hurting; no energy; knee hurting; got so sick; delusional; This is a spontaneous report from a contactable consumer (patient). A 80-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot: EL2346) via unspecified route of administration on 15Jan2021 09:57 as single dose in arm right for COVID-19 Immunization. Medical history reported was thyroid, blood thinner and degenerative disc disease, all ongoing. Concomitant medications reported was rivaroxaban (XARELTO) ongoing as blood thinner taking for many years, levothyroxine ongoing for thyroid it was 25 and they no product taking for 5 years and prednisone from 21Jan2021 till 26Jan2021 for degenerative disc disease as Blister pack take six, then five, and down to one daily by mouth for six days. No prior vaccinations within 4 weeks was reported. Consumer called to report side effects. Stated she received the first dose of the Pfizer COVID 19 vaccine 15Jan2021 at 09:57AM in the right arm. Six days later all of the sudden in the evening she got so sick with pains in her stomach; dry heaves but she didn't throw up; felt horrible with no energy. She didn't even brush her teeth or undress to go to bed. In the night she had a fever, but she was so sick she couldn't reach overtake her temperature. She heard a voice saying, "what is your temperature". She thought she was delusional. She woke up and her knee was hurting, and her back was hurting. She had a knee replaced in Jul2020 and sometimes has trouble with it. She was diagnosed with degenerative disc disease and the doctor put her on prednisone pack for her back pain. The next day she felt better but her stomach was still bothering her, and she was so very tired. She hasn't been out, and it wasn't like she picked up anything. The next night Saturday her neck felt really weird, her whole neck was hurting. She was tired until Wednesday. Outcome of the event pain in the stomach was recovered on 24Jan2021, Dry heaves recovered on 21Jan2021, no energy, neck felt really weird, her whole neck was hurting was recovered on 22Jan2021, very tired was recovered on 27Jan2021, back was hurting, knee hurting, fever was recovering and for remaining events its unknown.  Follow-up attempts are completed. No further information is expected.
headache; nausea; vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17May2022 at 09:30 as dose 1, single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 18May2022 at 02:00, outcome "unknown"; NAUSEA (non-serious) with onset 18May2022 at 02:00, outcome "unknown"; VOMITING (non-serious) with onset 18May2022 at 02:00, outcome "unknown". The events "headache", "nausea" and "vomiting" required emergency room visit. It was unknown if therapeutic measures were taken as a result of headache, nausea, vomiting.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not diagnosed with covid prior vaccination. And post vaccination, patient had not tested with covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.