chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: GH9694), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Lot number: FK9894), in left arm 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: "laryngopharyngeal reflux" (unspecified if ongoing); "mixed hyperlipidemia" (unspecified if ongoing); "GAD" (unspecified if ongoing); "Iodine contrast allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.
I had increased symptoms of chills, body aches and fatigue with my dose 4 COVID-19 vaccine. I then on 01/09/2023 had a severe bronchial cough similar to when I had previously had COVID-19 so I called my doctor and he refilled an inhaler prescription albuterol sulfate my cough subsided but fatigue and no energy continued chills have subsided. As of the report date fatigue and lack of energy continues but gradually improving.
Palpitations - patient stated he may have anxiety attacks when getting shots. Patient sent to ER for evaluation
A little achy getting the booster shot; Not feeling well from the booster shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (A little achy getting the booster shot) and IMMUNISATION REACTION (Not feeling well from the booster shot) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Rheumatoid arthritis. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 06-May-2021 to an unknown date for COVID-19 vaccination. On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 06-Jan-2022, the patient experienced PAIN (A little achy getting the booster shot). In January 2022, the patient experienced IMMUNISATION REACTION (Not feeling well from the booster shot). At the time of the report, PAIN (A little achy getting the booster shot) and IMMUNISATION REACTION (Not feeling well from the booster shot) was resolving.     No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
8:36 AM received vaccine, verbalized painful shot became pale after Hep A vaccine. Waited awhile when felt better and color came back gave HPV 9 - client became pale, c/o being hot then passed out, muscles stiff then awoke startled sat up crying. Verbalized that she did not like how she felt, had severe stomach ache and nausea. Blood pressure decreased 98/43, O2 sat 95-100%, she verbalized feeling like she had a nightmare "someone was after her" when she passed out. She immediately responded to nurse and her mother within 10 seconds. Ice packs applied and client fanned for c/o being hot. Outer shirt removed to make more comfortable. Client's vital signs monitored and told client to take time before leaving clinic. Client laid on exam table, then slowly sat on side of bed before standing and walking around room. Sipped on can of Coke after had spell. Client left clinic in stable condition at 9:42 AM. Blood pressure 110/77, O2 Sat 100%.
Has caused my sugar to spike to 174-188 each morning; serious condition; feel terrible; very nervious; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Dec2021 at 11:00 (Lot number: 331308A) at the age of 78 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "kidney(stage 3)" (unspecified if ongoing), notes: kidney(stage 3); "Known allergies: Penicillin" (unspecified if ongoing), notes: (deathly); "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes; "Known allergies: sulfa injections" (unspecified if ongoing). Concomitant medication(s) included: JANUVIA; LANTUS. Past drug history included: Demerol, reaction(s): "Known allergies"; Codine, reaction(s): "Known allergies"; Keflex, reaction(s): "Known allergies", notes: (deathly). Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0181, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 23Jun2021, when the patient was 77 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0185, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 02Jun2021, when the patient was 77 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 27Dec2021 at 11:00, outcome "unknown", described as "Booster"; BLOOD GLUCOSE INCREASED (medically significant) with onset 28Dec2021 at 08:30, outcome "not recovered", described as "Has caused my sugar to spike to 174-188 each morning"; CONDITION AGGRAVATED (non-serious) with onset 28Dec2021 at 08:30, outcome "not recovered", described as "serious condition"; FEELING ABNORMAL (non-serious) with onset 28Dec2021 at 08:30, outcome "not recovered", described as "feel terrible"; NERVOUSNESS (non-serious) with onset 28Dec2021 at 08:30, outcome "not recovered", described as "very nervious". The patient underwent the following laboratory tests and procedures: blood glucose increased: (unspecified date) normals of 113- 140 each day; (28Dec2021) 174-188, notes: spike; (28Dec2021) high, above 200, notes: my sugar spikes very high, above 200. The patient did not have any other vaccines in four weeks. The patient has not been covid tested post vaccination. Therapeutic measures were taken as a result of blood glucose increased, condition aggravated. Therapeutic measures were not taken as a result of feeling abnormal, nervousness. Details were reported as follows: "Has caused my sugar to spike to 174- 188 each morning when I get up since the injection. Even after taking my medications, my sugar will not go down. This has caused me a serious condition that, no matter what I do to bring it down to my normals of 113- 140 each day , I feel terrible and very nervous and now afraid to eat because my sugar spikes very high, above 200".
Patient received second dose of moderna covid vaccine.  After administration patient went to observation area and sat down.  About 2 or 3 minutes after vaccination the patient got up and walked to the pharmacy counter and fainted in front of the counter.  He may have hit his head.  He was conscious and remembered walking over but lost vision and fainted.  He sat up on his own in front of the counter and was given an ice pack.  He said he would feel better laying down so we  had him lay down in the IMZ area on a mat.  Paramedics arrived shortly after.  Paramedics assisted the patient and determined no medical care was necessary but recommended the patient not drive himself home.  The patient waited in the IMZ area until his dad arrived.  He said he did not eat today so he was given a powerade and a protein bar at no charge.  The patient then left with his dad.
INCONSOLABLE CRYING X 6 hr; HIGH PITCHED CRYING; SCREAMING
DVT in left leg, diagnosed in ER after three days of leg pain and swelling; was prescribed Xarelto, 15 mg twice daily; still have swelling and pain; elevate leg with heat; intermittent ambulation
Pt received Varicella Immunization on 9/15/09. Pt returned to office on 9/22/09 with red bumps on legs, back and face. Mother reported on 9/23/09 that bumps are now vesicles.
got COVID 19; Initial information was received on 12-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case is linked with 2020SA358007 (Same reporter).  This case involved an unknown age male patient who got COVID-19 (corona virus disease), after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, patient got COVID-19, unknown latency following the administration of INFLUENZA VACCINE.  Laboratory test included COVID-19 test.  Final diagnosis was COVID-19.  It was not reported if the patient received a corrective treatment.   At the time of reporting, the outcome was unknown for the reported event.   There would be no information available on batch number for this case.
Information has been received from a nurse referring to unspecified amount of patients of unknown age and gender. The patients' medical history, concomitant therapy and drug reactions were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L046319, expiration date 28-SEP-2017, dose was not provided) orally, which were exposed to 50 Fahrenheit (F) for 40 minutes. Previous temperature excursion: 50.2 F for 1 hour and 10 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
2/22 c/o left arm pain, swelling and erythema s/p shingrix vaccine on 2/16/22. Pain Initially. Followed by swelling the next day. Applied ice for 2 days then followed by heat. Also tried benadryl with minimal improvement. Denies n/t and pain mostly resolved now. Does feel TTP and tight from swelling. Rx cephalexin BID x10 days. Ok to take benadryl or try topical prn discomfort/swelling. ok to continue ice prn. Recommend report to CVS as vaccine reaction since immunization administed by them. Vaccine LOT-X54CN
Patient was seen on 10/21/15 for an office visit and flu shot.  On Thursday 10/22/15 patient starting to experience fever and chills.  On 10/23/15 around 5 PM she was at a store and felt the fever and chills again.  Also she experienced like her chest neck and shoulders were being crushed. During these episodes the left shoulder area where the vaccine was administered was hot to the touch and swollen about the size of a half dollar. When she woke up on Saturday 10/24/15 she experienced another episode and at that point she went to the ER.  She was given saline through IV and labwork was performed.  No Medications were given to her.
Mom reports 12 days p/immun pt unable to crawl, bear wt on legs or roll over; Seen by MD & hospitalized 8AUG91; Seen by neurologist poss transverse myelitis from polio vax;
Allergic reaction; Rash (red raise bump urticaria); This spontaneous case was reported by a physician and describes the occurrence of HYPERSENSITIVITY (Allergic reaction) and URTICARIA (Rash (red raise bump urticaria)) in an elderly male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058628) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna (1st dose, lot number 042L20A) on 17-Jan-2021, Moderna (2nd dose, lot number 011M20A.) on 14-Feb-2021, Moderna (3rd dose, lot number 071F21A) on 26-Oct-2021, Moderna (4th Dose, lot number 048L21A) on 20-Mar-2022, Moderna (5th dose, lot number AS7143C) on 26-Sep-2022, Moderna (6th dose and lot number AS7184B) on 10-May-2023. Past adverse reactions to the above products included No adverse event with Moderna, Moderna, Moderna, Moderna, Moderna and Moderna. Concurrent medical conditions included Allergic reaction to food, Allergy to nuts, Seafood allergy, Iodine allergy, Nickel allergy, Drug allergy, Penicillin allergy and Blood pressure abnormal.    On 16-Oct-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction) and URTICARIA (Rash (red raise bump urticaria)). At the time of the report, HYPERSENSITIVITY (Allergic reaction) and URTICARIA (Rash (red raise bump urticaria)) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant or treatment medications were provided.  The pharmacist told the patient that the patient might have an allergic reaction to the vaccine because the vaccine contains sucrose. The patient had a rash (red raise bump urticaria) that lasted 3 days.
High fever for 3 days (02/06/2002-104.6, 02/05/2002-103). Prescribed fluids, Tylenol and Motrin.
evening of 7MAY01 seen by MD pt could not walk; lt thigh was swollen; 2 needle marks on lt thigh (outer); no tx but watch pt; MD never touched pt never looked @ pt;
Headache - Mild (5/18 All Day)  Back, shoulder, neck muscle pain - Medium (5/18 All Day) Fatigue - Medium (5/18 All Day progressing from mild to medium, peaking at 4 pm) Injection Site Pain - Mild (5/17 approx 6pm till sleep) Injection Site Pain - Medium (5/18 peak at approx 10 am) Treated with water and rest  10th pregnancy, due 8/31/21
Vaccine administered on 10/29/21. Vial expired 10/11/21. Vial was kept in freezer until 10/28/2021 and removed to fridge on 10/28/2021 for administration on 10/29/2021. No adverse effects reported from patient to date.
Patient reported lip swelling and burning with scratchy throat approximately 30-40 min after receiving vaccine. She states she did not seek immediate medical attention but took 2 Benadryl tablets. She states her symptoms resolved within 3-4 hours and did not have any further issues other than arm soreness where she got her shot. She later reported symptoms to her primary health provider during office visit but did not have anymore problems
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No any concomitant medications were reported. No any treatment medications were reported.  It was reported that expired vaccine were given as booster shot to patient. The vaccines were stored in freezer and took out one to two vial and placed in fridge each day as needed.
common sore arm for 1 day.  Pain in my hand for 1 day.  Began to have a fever by 3 pm throughout the night (99.6 F) Temperature normal in late morning.
The right jaw into my ear have been in issue since day 2 openings mouth hurt. My eats are in burning pain , and the right ear burns and hurts so much it wakes me up. Ears ring. I had to call doctors spend money we don't have. This is crazy and just want tye pain in my ear to stop into my jaw
pt recv vax 8MAR93 & approx 4 1/2yr p/vax 27OCT97 pt noticed hair loss;
Pt received Booster dose of Moderna COVID Vaccine at 1458. Pt with shallow breaths, tachypnea approx. 10 minutes after administration. +Diaphoresis, anxious-appearing. Pt daughter translating, states pt has anxiety during medical treatments. Pt vital signs taken, rapid response called. HR 115, Sp02 100%, BP 148/80. Blood glucose checked, 127. Pt AAOx4 throughout event. Lungs clear to auscultation bilaterally.  No treatment required. Pt discharged home with family after being seen by provider. Pt stated she had not taken her amlodipine day of event; Provider instructed to take dose upon returning home. Pt calm, breathing normally after being seen by provider.
Information has been received from a 50 year old female who on 11/05/03 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. Subsequently, on 11/05/03 her arm was sore at the injection site. On the morning of 11/6/03 her eyes were red and swollen. By 14:30 on 11/6/03 she was itching all over. On the morning of 11/7/03 she reported that the injection site was gone but she had hives over her entire body. She visited her doctor and was given a shot of steroids and a prescription for methylprednisone. She was reported to be recovering with sequelae. No product quality complaint was involved. Upon internal review, arm was sore at injection site, eyes were red and swollen, itching all over, and hives over her entire body were determined to be other important medical events (OMIC). Additional information has been requested.  Follow up on 11/26/2003: "Information has been received from a nurse and a 50 year old female w/allergies to PCN and sulfa medications who on 11/05/03 at a well visit was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (Lot # 645853/0256N).  There was no concomitant medication.  The pt was well at the time of the visit.  Subsequently, on 11/05/03 her arm was sore at the injection site.  On the morning of 11/06/2003 her eyes were red and swollen.  by 14:30 on 11/06/03 she was "itching all over".  On the morning of 11/07/03 she reported that the pain at the injection site was gone but she had hives over her entire body.  The nurse reported that she had developed urticaria.  She visited her MD and was trated with hydroxyzine hydrochloride (ATARAX) 50mg, triamcinolone acetonide (KENALOG) 80mg IM, and was given a prescription for a methylprednisone dose pak.  The patient has since recovered.  It was noted that this was only the second time that the pt was seen at this office.  No product quality complaint was involved.  Upon internal review, arm was sore at the injection site, eyes were red and swollen, itching all over, and urticaria were determined to be other important medical events (OMIC).  Additional information had been requested."  Follow up on 01/12/04: "No further information is expected."
Passed out at a restaurant. Taken to ER by ambulance. Diaphoretic. BP 97/67; admitted to CCU. Information from Discharge summary states allergic reaction. msv
Complaints of fever 100.8 F and tingling sensation in arms began around 2:00 am on 07/26/2012. Tingling of lower extremities began approximately at 12 pm. Tingling of back began at approximately 1:30 pm. Child states skin feels irritated when someone touches him.
Four days after taking the vaccine, the patient tested positive for COVID-19; This is a spontaneous report from a contactable pharmacist. A 29-year-old (age at vaccination) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration on 23Apr2021 as 1st dose, single for COVID-19 immunisation. The patient medical history was and concomitant medications were not reported. It was reported that four days after taking the vaccine, the patient tested positive for COVID-19 on Tuesday 27Apr2021. The clinical course of the event was reported as: the patient had the first dose of the COVID-19 vaccine and four days after taking the vaccine, the patient tested positive for COVID-19. The reporter wanted guidance on the second dose of the vaccine. The reporter also wanted to know if there were reactions if a person who had COVID-19 and had the COVID-19 vaccine. It was also reported that "vaccination of people with known current SARS-CoV-2 infection should be deferred until the person has recovered from the acute illness (if the person had symptoms) and they had met criteria to discontinue isolation." "Participants were excluded if they had a clinical or microbiological diagnosis of COVID-19 before entry into the trial." No investigation assessment provided. The outcome of the event was unknown.   Information on lot/batch number has been requested.
Patient had 2 doses of COVID vaccine on 1/19/21, and 2/16/21, and was hospitalized from 12/17/21 - 12/19/21 for Shortness of Breath and COVID symptoms.
Tingling and numbness in arm injection was given, lasts about 30 seconds and is intermittent. Patient compares it to a TENS device on low setting.
1st dose of the Moderna Covid-19 vaccine given to 1 patient after excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (1st dose of the Moderna Covid-19 vaccine given to 1 patient after excursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (1st dose of the Moderna Covid-19 vaccine given to 1 patient after excursion). On 22-Jul-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (1st dose of the Moderna Covid-19 vaccine given to 1 patient after excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up received and contains no new information
Patient arrived in clinic to receive her second dose of Novavax. Once she received the vaccines she stated that she had an instant headache an felt dizzy. She then informed staff that she had similar symptoms with her first dose, but did not tell us because she had also received the flu vaccine the same day as her first dose of Novavax and thought her symptoms were from the flu vaccine. Patient vitals were obtained, patient was monitored in a room. After 10 minutes patient expressed a shooting pain down her left arm to her thumb. Patient was monitored in clinic or 45 minutes. She took Ibuprofen at that time (10:00am) and patient reported that her dizzyness and arm pain had subsided. Patient was released home.
Fever, chills, body aches, joint and muscle pain, headache and nausea. Began approx 12 hours after injection and lasted well into the following day/present
Case number PHEH2015US00652, is an initial spontaneous report received from a nurse on 05 Jan 2015. This report refers to a 07 years old female patient. Past medical history and concomitant medication were not reported. She received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X14030), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 22 Dec 2014. No adverse event was reported following this administration error (inappropriate preparation of medication).