chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 15 minutes of receiving the vaccine in my right arm I felt a little unsteady. I waited the 30 minutes required and after the 30 minutes I remove my mask and my face was bright red it was the deeper read over my cheeks and nose area the cheek areas were burning. I also had redness on my chin and neck and top of my chest. IWho is advised by my physician and I did take a dose of Benadryl and a dose of Pepcid 30 minutes before receiving the vaccine. I had the same reaction when I got shot number one. However my face was swollen with the second shot.
Patient is a Certified Nursing Assistant in the hospital. COVID-19 testing was as the direction of Employee Health for COVID-19 symptoms on two days since vaccination: symptom onset date of 3/30/2021 (symptoms = diarrhea and headache) on 4/16/2021 (symptoms = chills, cough, nasal congestion, runny nose and sore throat).
24MAY91 father called w/in few hrs p/vax to report generalized skin flushing, sneezing, no resp disturbed; Referred to ER & advised DPH stat;
Pt was sitting in chair being monitored after vaccination, when he fainted, fell out of chair and hit head on floor.  He came to after falling to floor. He was assessed by Nurse Practitioners and monitored for 45 minutes. Ice pack was placed to small abrasion on left forehead.  Orthostatic vital signs were WNL. He was neurologically intact without any further symptoms and released to room mate who picked him up from vaccine clinic. Pt states that he remembered feeling a little light headed and was going to ask for some water when he woke up on the floor being assessed by staff.
Since receiving my second dose of the Pfizer vaccine I have not had a headache; This is a spontaneous report received from consumer (patient) from a Pfizer sponsored program. A patient of unspecified age and gender received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 2, single for covid-19 immunisation. The patient medical history included headache, migraines from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Patient stated that had severe headaches and migraines all my life. Since receiving my second dose of the Pfizer vaccine I have not had a headache since. The outcome of the events was unknown.  Follow attempt needed. Information related to lot/batch no. has been requested.
Patient called c/o nausea, vomiting, shakes, and headache. Also has very, sore right arm and decreased ROM. Advised rest, fluids, TYLENOL or Ibuprofen, and ice locally. Call back prn.
patch with a circumference of about 2 inches; painful to the touch; swelled up; left a bruise like mark; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on an unknown date as a single dose for COVID-19 immunisation. Medical history was not reported. 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 four weeks prior to the vaccination. Concomitant medication was not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on an unknown date as a single dose for COVID-19 immunisation. On an unknown date, the patient experienced a patch with a circumference of about 2 inches, painful to the touch, swelled up and left a bruise like a mark. The clinical course was reported as follows: Above the injection sight of the second dose there was a patch with a circumference of about 2 inches, give or take that got swelled up. It was painful to the touch for about 2-3 days and once the swelling went down it left a bruise like mark in the same spot. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visits, emergency room/department or urgent care. The clinical outcome of the events patch with a circumference of about 2 inches, painful to the touch, swelled up and left a bruise like a mark was resolved with sequelae at the time of the report.  No follow-up attempts are possible; information about the lot number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Amended patient data.
This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (some doses may have been administered past 30 days from being thawed/the vaccine given to patients after being refrozen) and product storage error (some doses may have been administered past 30 days from being thawed/the vaccine given to patients after being refrozen) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 026A21A) for COVID-19 immunization. No medical history reported. On Apr 15, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 15, 2021, patient administered expired product (some doses may have been administered past 30 days from being thawed/the vaccine given to patients after being refrozen). In 2021, patient experienced product storage error (some doses may have been administered past 30 days from being thawed/the vaccine given to patients after being refrozen). On Apr 15, 2021, administered expired product (some doses may have been administered past 30 days from being thawed/the vaccine given to patients after being refrozen) resolved. In 2021, product storage error (some doses may have been administered past 30 days from being thawed/the vaccine given to patients after being refrozen) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
I felt like I had Covid again for the first two days then I felt better.  However the next week I had a blinding headache for a week then my sense of smell changed.  Coffee to flowers smell like chemicals.  I noticed my taste was also reduced.
Headache, chills, fatigue, nausea, body aches.  Sore arm at the injection site.  Fatigue and body aches started about 8 hours after the injection.    Chills started around 11 hours after.   By 12 hours after injection I had all the above symptoms.   started feeling about  24 hours after the injection.    Within 48 hours, I was normal.   However, my arm was sore for a week.
SYMPTOMS/UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced symptoms/unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of symptoms/unspecified adverse event was not reported. This report was non-serious. This case, from the same reporter is linked to 20210826468.
Pain immediately after shot with soreness continuing through 21 June (today). Redness at shot site, cleared by 20 Jun 2018. New outbreak of Shingles occured the evening of 17 June 2018 and is continuing to get worse. This is my third outbreak in same location (left flank).
1st dose Ears started ringing  3 week after 1 shot.     3rd dose 12/15/21  3day after the 3 booster I lost all motor control and went to the hospital for a TIA but that was ruled out.
Pt recvd vax & exp roseola @ inject site; fever & diarrhea; 15SEp92 presented to ER 8AM for treatment;
fever 103.7 ax;fitful crying, lt thigh swollen & tender-no redness thighsoft;concurrent viral illness nasal congestion x 1wk;
I have had ongoing facial and tongue numbness.  I am unsure if my symptoms are vaccine related, however my symptoms did start within 72 hours of receiving the vaccination.  As of today, my symptoms remain, but seem to be improving.
Within one hour of receiving vaccine, I begin to feel flu like symptoms. Low-grade fever, chills, every hair was sore on my body, very tired / lethargic , and my body ached on every bone. My lower back was so sore and achy. Then it started feeling painful. All of my symptoms ended within a few days with the exception of very tired and lower back pain. The lower back pain lasted for 6 months !
This spontaneous report as received from a 61 year old female consumer concerning herself. The patient had no pertinent medical history and no drug allergies. On approximately 22-APR-2014 (reported as around two weeks ago), the patient was vaccinated with ZOSTAVAX, (lot number and expiration date), dose route and anatomical location unspecified, one single shot. Concomitant therapies included ZOLOFT, atorvastatin, doxofylline and DULERA. On approximately 22-APR-2014 (reported as around two weeks ago), after injection the site was sore and discolored, the patient developed an unspecified itchy, lumpy area on her neck that "looks like chicken pox" and it was also reported that she continued to have pain and discoloration at the site of vaccination. The patient sought medical attention (visited pharmacist) and no treatment was given for the events, lab diagnostics studies were not performed. The outcome of the site was sore and discolored itchy, lumpy area on her neck that "looks like chicken pox" and pain and discoloration at the site of vaccination was reported as not recovered/not resolved. Additional information is not expected.
Patient states about  1 hour to 1.5 hours after receiving vaccine she started feeling tingling around the mouth, face itching. Thought eyes felt puffy but checked in mirror and no facial swelling. Took one dose of benadryl then in one hour took another dose. No problems with tingling/itching after 2nd dose. She did feel sluggish, tired and had low grade fever the next three days.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers to 64 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Patient was here for matriculation vaccines.  Had one dose of each vaccine in childhood.  He now has psoriatic arthritis and is treated with Simponi.  He told me he had psoriatic arthritis.  The vaccines were administered by me.  He waited 15 minutes & went home.  As I realized my error, I contacted my medical director.  I contacted the drug manufacturer.  I also contacted the student to ask for the name of his rheumatologist.  We are still following up today.
I am still having pain in my upper arm. It hurts to put a shirt on, jacket even putting my purse in the car on the passenger seat hurts. It especially gets sore at night while sleeping and repositioning. Upper arm has deep pain like in the bone. It's not sharp just deep and hard pain.
pt. complain of sore throat and tingling of his right hand after the pfizer vaccination  The symptoms were resolved and pt. went home in stable condition.
Inj. given 5/3/11 - following day mom noted redness in 'R' upper arm. Brought to clinic on 5/6/11 - seen by RN & MD. Area about 8cm diameter red/warm. Instructed.
Pain "all over the place"/soreness; Wrist warm; Burning feeling; Swelling on the left arm; Pain in joint; pain "all over the place" on his rib cage; Fatigue; Headache; Swelling; Wrist itchy/itchiness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), SWELLING (Swelling), PRURITUS (Wrist itchy/itchiness) and PAIN (Pain "all over the place"/soreness) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included VITAMIN D3 and MULTIVITAMINS & MINERALS PLUS LUTEIN for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 09-Jan-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), SWELLING (Swelling) and PRURITUS (Wrist itchy/itchiness).   On 12-Jan-2021, the patient experienced PAIN (Pain "all over the place"/soreness), FEELING HOT (Wrist warm), BURNING SENSATION (Burning feeling), PERIPHERAL SWELLING (Swelling on the left arm), ARTHRALGIA (Pain in joint) and MUSCULOSKELETAL CHEST PAIN (pain "all over the place" on his rib cage).   The patient was treated with IBUPROFEN at an unspecified dose and frequency.   On 10-Jan-2021, FATIGUE (Fatigue), HEADACHE (Headache), SWELLING (Swelling) and PRURITUS (Wrist itchy/itchiness) had resolved.   At the time of the report, PAIN (Pain "all over the place"/soreness), FEELING HOT (Wrist warm), BURNING SENSATION (Burning feeling), PERIPHERAL SWELLING (Swelling on the left arm), ARTHRALGIA (Pain in joint) and MUSCULOSKELETAL CHEST PAIN (pain "all over the place" on his rib cage) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pain to the left arm where he had the shot; Feeling sick; This is a spontaneous report from a contactable consumer (patient son). A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and Expiry date was not reported), dose 1 via an unspecified route of administration, administered in left arm on 16Feb2021 (at the age of 71-year-old) as 1st dose, single dose for COVID-19 immunisation at Clinic Workplace Clinic. Medical history included ongoing back pain. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]) taken for back pain, 200 mg as needed from an unspecified start date and ongoing. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive any additional vaccines on the same date of Pfizer. Prior to vaccination, patient did not receive any immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Feb2021, patient experienced pain to the left arm where he had the shot and on an unspecified date in Feb2021, he was feeling sick. Reporter stated that patient got the vaccine yesterday and was now having pain to the left arm where he had the shot, and he was feeling sick. Further stated patient was not feeling sick. Patient had pain in his arm. The pain was mild. Reporter asked if the symptoms patient was having are normal and what should be done about the symptoms. Patient did not visit emergency room and physician office for any event. There was no investigation assessment and no relevant tests. The outcome of event feeling sick was recovered on an unspecified date in 2021 and not recovered for pain in arm where he had shot.   No follow-up attempts are possible; information about lot/batch number cannot been obtained
This spontaneous report was received from a medical assistant and refers to a 8-week-old patient (also reported as 7 and a half week old). The patient's medical history and concurrent conditions were not reported. On 19-AUG-2016, the patient was vaccinated with PEDVAXHIB intramuscularly (lot # M001814, expiry date: 15-OCT-2018). No concomitant therapy was reported. No adverse effect was reported. Additional information has been requested.
Patient was inadvertently administered a dose of expired IPOL vaccine, no AE; Initial information received on 28-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 16 years old male patient who was inadvertently administered with a 0.5 ml dose of expired POLIOMYELITIS VACCINE (INACTIVATED) IPV (VERO) [IPOL] (lot number P1A242M  and expiration date:26-Apr-2020) vaccine, via unknown route in unknown administration site as prophylactic vaccination on 25-Aug-2020.  The patient's medical history were not reported.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Injection site pain; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a non-health professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and INJECTION SITE PAIN (Injection site pain) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On 15-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced INJECTION SITE PAIN (Injection site pain). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown and INJECTION SITE PAIN (Injection site pain) had resolved.            No concomitant medication information was provided. It was unknown if patient was enrolled in a covid-19 vaccine trial. No treatment medication was provided. 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.
Patient came into vaccination site on 12/28/21 for COVID-19 Pfizer Booster. Patient received first dose on 6/01/21 and second dose on 6/23/21. Patient reported toRN that a day after receiving his second dose he experienced chest pain. Patient states that it felt "like pressure" on his chest. Patient states that he did not experience any SOB or dizziness. Patient states that he took an aspirin and the symptoms subsided within 5 minutes. Patient states that he has high blood pressure that is currently not being treated with medications. EMT took patient vital signs at 1438. BP: 151/101, HR: 88, O2: 98%. RN submitted a medical consult via text message to staff, requesting to proceed with the COVID vaccine Pfizer booster. Per CDC guidance, approval to proceed with COVID vaccine Pfizer booster was obtained from medical consult team, RN via doctor approval. Patient received COVID vaccine Pfizer LOT#: FL3197 at 1503. Patient was educated on adverse reactions of COVID vaccine and educated on normal and abnormal blood pressure and when to seek EMS. RN recommended that patient make appointment with PCP as soon as possible.  Patient verbalized understanding. Patient left vaccination site with her son at 1550 unassisted and with a steady gait.
Chills/wheezing/eyes red crusty eyes in morning short of breath 6 pm to 2 am. 11/12 c/o HA (7) today T - 97.9 degrees F.
Within an hour I had a headache.  By 4 hours my arm was very sore.  At 8-13 hours I felt like I had the flu with body aches, chills, and sweating.  Between hours 14-44 my experience was intense with fever >102 (that was not responsive to Tylenol or Motrin), uncontrollable shaking with an episode of urinary incontinence, fainting, rash on chest/neck, right facial twitching, right arm twitching, nausea, vomiting, diarrhea, chills, profuse sweating, flashing lights in both eyes (open and closed), intense body aches, the sensation that my skin was burning, muscle spasms (back), joint pain (knees/hips), dizziness, agitation, and insomnia.  After 44 hours the intense symptoms resolved and I had fatigue, right facial twitching, right arm pain/itching/redness. I went to see my doctor on 1/28/2021 to document my experience.
Localized swelling at injection site with soreness. 24 hours post injection, began to develop pain  with movement on ulnar side of left hand involving the small and ring finger. 36 hours post injection pain also in wrist with movement, 60 hours post injection, pain also involving the ulnar nerve up to humerus. Radiating pain spread across hand to middle, index fingers and thumb with and without movement. Dr. prescribed prednisone on 1/18/22; started in pm. 1/19/22 am symptoms began resolving. Followed with appointment with Dr. on 1/19/22
Itching began 6PM on 3JAN93; heart began fluttering & pt felt odd woke up, itching fiercely w/hives all over body @ MN; noticed swelling of hands, feet, nose, lips & earlobes & eyes; whole body throbbed; site was red, swollen w/hard lump;
Patient is a prisoner at the county prison.  He had a seizure in his cell and went into cardiac arrest.  EMS was called.  He got back ROSC en route to the ED.  Intubated en route. Lost pulses again and again fot ROSC.  Drug screen was negative.  All CT scans negative.  No medical history. Patient is in critical condition on life support and is not expected to survive the day.
Patient stated she was nervous and received the vaccine without incidence.  After receiving the vaccine while sitting the patient had what appeared to be a vasovagal response.  She became pail and her eyes rolled back in her head.  Patient appeared to have a seizure stuck both arms straight out and was incontinent.  Patients was moved to the floor where her color returned and her pulse improved.  Patient was taken to hospital via ambulance.
Moderna vaccine was administered outside of clinic- reported by patient ? NO LOT NUMBER WERE SUPPLIED ========================================================================= ACUTE PULMONARY EMBOLISM 11/24/2022 SUPERIOR VENA CAVA COMPRESSION SYNDROME ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/26/2022 SUPERIOR VENA CAVA COMPRESSION SYNDROME ACUTE PULMONARY EMBOLISM 11/24/2022 LUNG MASS ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/26/2022 LUNG MASS ACUTE PULMONARY EMBOLISM 11/24/2022 SQUAMOUS CELL CARCINOMA, RIGHT LUNG UPPER LOBE ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/26/2022 SQUAMOUS CELL CARCINOMA, RIGHT LUNG UPPER LOBE