chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue, fever, headache, flushing, body aches, hoarseness starting 10-5-16 and still continuing.
Narrative:  72 y/o M w/ hx of COVID+ 6/9/20 received COVID Vaccine (Moderna) Dose #1 on 7/22/21 @15:37. Developed fever for 48 hrs (102.1, 101.4 on 7/23/21) and received APAP 650mg q6h x 3 days; symptoms resolved.
Pt received Pfizer vaccines on 02/18/21 and 03/16/21. Pt presented to the ED with complaints of AMS and cough. Pt was found to be COVID positive. Pt was not hypoxic.
she noticed that her daughter only ate about half of her dinner last night (decreased appetite); her arm hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 16 year-old female patient received bnt162b2 (BNT162B2), administration date 17May2021 (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: DECREASED APPETITE (non-serious) with onset 2021, outcome "unknown", described as "she noticed that her daughter only ate about half of her dinner last night (decreased appetite)"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "her arm hurting". that her daughter only ate about half of her dinner last night (decreased appetite), she complained of her arm hurting and that her daughter is still sleeping at this time. The caller wants to know if there are any other side effects that she should be concerned about for her 16 year old daughter who received the Pfizer COVID-19 vaccine yesterday that are different from side effects for adults.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Worsening pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Worsening pain) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pain. Concurrent medical conditions included Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 23-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced PAIN (Worsening pain). At the time of the report, PAIN (Worsening pain) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication reported
Patient received full dose of 0.5mL for his booster dose/ 0.5mL administered to patient instead of 0.25mL; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Patient received full dose of 0.5mL for his booster dose/ 0.5mL administered to patient instead of 0.25mL) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Patient received full dose of 0.5mL for his booster dose/ 0.5mL administered to patient instead of 0.25mL). At the time of the report, ACCIDENTAL OVERDOSE (Patient received full dose of 0.5mL for his booster dose/ 0.5mL administered to patient instead of 0.25mL) had resolved.            No Treatment drugs were reported. No concomitants were reported.  Company Comment: This is a case of Accidental Overdose concerning a male patient of an unknown age with no relevant medical history, who experienced no other associated adverse events. The event occurred on an unknown date after receiving the third dose number of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge is unknown since no information on other doses were disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This is a case of Accidental Overdose concerning a male patient of an unknown age with no relevant medical history, who experienced no other associated adverse events. The event occurred on an unknown date after receiving the third dose number of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge is unknown since no information on other doses were disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
constant headache in front upper of head. face cheaks feeling like on fire. blood pressure got extreamly high. bad tingling of feet, hands, and penis. lack of energy.  all symptons started 3 weeks after 2ed shot and now have lasted for over 9 weeks. have had mri of head, nuclear stress test , multiple artery ultra sounds, calcium test, uren sample and blood work. all test are results are normal.
Chills first two night with headache, on Wednesday starting getting rash, it?s on my arms and right side of face and I?m miserable from the itching.
On March 6, 2019 I had the vaccine. On the same day, I had mild fever, headaches and dry lips. By March 8th I was free from those side effects. But, on March 11, I started having more side effects which were worse than the precedents: High fever (101.2), headaches, unusual fast heart rate (up to 94 bpm), low blood pressure (as low as 90/53), hard swollen lump on the shoulder, a blister full of fluid. On March 15, 2019, I went to see my doctor for fear of permanent side effects, especially my heart rate. He reassured me that none of those side effects will be permanent. Anyway, by the 18th of March, my arm got stiff. I did not call my doctor to report this unexpected debilitating and painful side effect. The dosage I had was 0.5 mL. At night it was worse. I slept in a sitting position for 3 nights. On the 4th night (March 21st) I tried to sleep in a normal (lying) position. When I woke up on the 22nd the little motion that I gained regressed. I was scared and depressed because the pain got worse on that day. So, since that time I have been sleeping again in a sitting position with a few pillows under my right arm. I think that helps prevent more damage to the arm. For a couple of days during the week of the 18th of March, I felt that my right eye was getting smaller and the site was weakening. For a few days and as of March 18, I was unable to use a fork or spoon to feed myself with my right hand until March 22. I also could not comb my hair. The arm was locked and painful. Besides tenderness to the touch, I had constant pain and shocks in the shoulder and (right) clavicle to the point of crying. I was taking TYLENOL to help me fall asleep and to minimize the fever. It was depressing. By the 23rd I gained about 1/4 motion of the arm. Today, the motion is up to a 90 degree level. Yet, it feels locked beyond that point. I have not had any type of vaccine since I was 11 years old (re: Item # 23). Had I known about all of these painful reactions to the pneumococcal vaccine, I would not have taken it.
Oral thrush comes and goes. I will up my probiotics and Greek yogurt to try and combat it. I ended up getting really sick and was prescribed Flagyl and that made it go away. It's been 2 weeks and came back again and I've been trying the Greek yogurt and probiotics to keep it at bay.
Symptoms and sequelae of the Flu with severe laryngitis approx. 72 hours, post vax, had loss of speech, low-grade fever, joint pain, amber colored sputum, rhinorrhea and severe chapping of lips. Currently on Motrin 800mg TID. (Note: Pt has had these symptoms every year with this vaccination but symptoms have gotten progressively worse.)
PERSISTENT BODY ACHES, HEADACHES AND CHILLS LASTING FROM AROUDN MIDNIGHT THROUGH MOSST OF THE FOLLOWING DAY, EASING OFF IN THE EVENING. TEMP AS HIGH AS 99.3. HEATING PAD TO LOWER BACK, ONE EXTRA STRENGTH  TYLENOL TAKE ~4 HRS AFTER ONSET OF SYMPTOMS.
Pneumovax 0.5 ml Im x 1 given on 3/30/07 at 1400.  Pt developed redness, swelling of upper arm after vaccine given.  At 2258, documented temps of 101.5, chills noted.  Cooling measures provided, typlenol 650mg given. AT 2357 pt given ice packs, cooling blankets, cool washcloth.  7/17/07 Received hospital records which reveal patient experienced post radical prostatectomy stress incontinence & had artificial urinary sphincter placed some time ago which had now malfunctioned.  Admitted for surgery for that problem from 3/27-4/6/07.  Found to have low grade infection within scrotum at time of surgery & all components were removed.  Had fever & wound cellulitis post operatively & was taken back to OR for I&D of scrotum.  Wound c/s (+) for morganella & acinetobacter & was treated w/IV antibiotics.  Defervesced & wound progressed well.  D/C to home w/open wound care, Foley catheter & continued oral antibiotics.
Tremors in face subsided from first Pfizer shot received on 4/28/2021 Lot: EW0164. However, vibrations/tinnitus in left ear continues as well as light all-over body twitching.
Janssen COVID-19 Vaccine, arms and legs were fully numb and cold, chest and back were hot, fever, headache, could not look to the edge of my vision, could not hold down food or water, intense pain in the lower back, bad balance, chills, aches,.
No adverse event; First dose was administered on 01FEB2021 and 2nd shot on 26FEB2022; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 01FEB2021 and 2nd shot on 26FEB2022) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high since 1985 and HIV infection (HIV for 20 years, took medications (could not pronounce the name)). Concomitant products included PROPRANOLOL HYDROCHLORIDE (INDERAL) for Blood pressure high.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Feb-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 01FEB2021 and 2nd shot on 26FEB2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 01FEB2021 and 2nd shot on 26FEB2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, CD4 lymphocytes: Normal prior to vaccination and after vaccination.. On an unknown date, SARS-CoV-2 test: (Negative) Negative. On an unknown date, Viral load: Normal prior to vaccination and after vaccination..         The treatment medication was not reported.   This case was linked to MOD-2022-651069, MOD-2022-651070 (Patient Link).
PATIENT REPORTS FEVER, CHILLS, NAUSEA, FOR 2 DAYS AFTER INJECTION -- SHE PRESENTS TO OUT CLINIC HX OF THESE COMPLAINTS AND HAS FEVER BLISTER AND REDNESS AROUND INJECTION SITE.   I FEEL LIKE SHE WILL RECOVER COMPLETELY SOON; HOWEVER, CONTINUES TO HAVE NAUSEA AND THE REDNESS AT INJECTION SITE.   I WAS INSTRUCTED TO REPORT THIS TO YOU.
Complained of red, "itchy" rash at injection site approx 3-4 diameter (fine rash)
Patient received Fluzone HD NDC 49281 0120 65 on 9/10/20. She says she got a cellulitis from the flu shot, which required an ER visit and is currently taking Keflex. Patient showed me the area of cellulitis, which was not in the deltoid muscle, but about 2 to 3 inches below, indicating the shot was given at an inappropriate site.
Symptoms began with diarrhea on 10/23, progressing to nausea and stomach upset on 10/24, vomiting on 10/25 with excessive amounts of bile (not food) being vomited.  I put myself on clear liquids for 24 hours then advanced my diet to basically bananas, applesauce, rice, toast, weak tea, etc. I continued to experience nausea until 10/27/10. No one else in my immediate family had been ill or had the GI flu that I am aware of.
First dose of Shingrix over a year ago / Never received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2020 year over a year ago from the reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received 1st dose in his doctor's office and till the time of reporting never received the second dose, which led to incomplete course of vaccination. The health care professional did not provide more information about the patient since she received the question by phone. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019000163:same reporter
patient was given Fluzone High Dose vaccination that was already expired, no AE; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA278111 (same reporter).  This case involves 77 years male patient who received 0.5 ml dose (4th dose) of expired vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UI995AB, expiry date: 01-Apr-2019) via intramuscular route in the right arm on 03-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender: none.
Systemic: Allergic: Itch Generalized-Severe, Additional Details: Patient had the vaccine given on 9/2/21 and she was observed for 15 minutes with no reaction, patient came back in on 9/8/21 to repoert that about a day or two after getting the vaccine she developed a rash from the neck to belly button that stayed for about 2 days. she just took benadryl and did not contact dr.
Pain in arm instantly - rash on arm w/heat. Applied ice and received BENADRYL.
After Friday the 19 I was not able to eat drink there was no skin on gums in lips or cheeks was not able to sleep. Was diagnosed with an autoimmune disorder. Was in so much pain. Immune deficiency. May have to have steroids.
Immediate reaction to the vaccine, about 2 minutes following the vaccine, I felt my heart rate accelerate and also felt flush feeling. The heart rate went up to 140-150. Also felt little tingling on both my finger tips. Waited about 30 minutes at site, the heart rate will go down to 120 but then it will go back up again. Felt little lightheaded. Decided to go to ER to check and be monitored. Felt a little prickling feeling at tongue, mouth area.
Diarrhea beginning early March 5th continuing through today, March 13 with only two diarrhea-free days in that time.   Cramping, urgency and liquid or extremely soft stools.   Diet(s):  liquid only; jello, plain yogurt, saltines; BRAT diet; normal diet.  Only difference in outcome is that I'm very hungry on any other than the normal diet.   Imodium approximately 2x a day.
pt recv vax & lab eval on 1MAY96 revealed that pt did not have a titer for rubeola;pt had no reactions to MMR vax;
This spontaneous report has been received from a physician regarding to a female patient of unknown age with no concomitant therapies, medical history and drug allergies. On 29-JAN-2019, the patient was vaccinated with the first dose of GARDASIL 9 (lot # R024264 and expiration date 29-OCT-2019) (dose and anatomical location of vaccination was not reported) for human papillomavirus (HPV) prophylaxis. On an unspecified date in 2019, reported as "starting on an unspecified date following injection", the patient had been experiencing discomfort at the injection site as well pain in her wrist. On approximately 12-FEB-2019 (reported as two weeks after vaccination), the physician reported that the injection site was indurated 3 cm. On 21-FEB-2019, the patient called to the physician office and reported that she was still experienced pain at the injection site and wrist and there was a small lump under the skin at the injection site. No laboratories were performed, no intervention to prevent serious criteria was need, no significant disability or incapacity was present, no hospitalization was needed and no life threatening occurred. At the reporting time the patient was not "fully recovered" also reported as "not recovered". The causality assessment between of GARDASIL 9 and all the events was not provided.
Increasing  severe  lower  back pain -   ache  all the time - difficult to walk  as of  a week after shot -  -putting   topical relief measures to no avail  .  continued to get worse  -  as of 2/12 - could not walk  without crutches  .   went to E. R. on 2/13/21  in ambulance -  could not  walk - could not get  up out of a chair at all ....    tests  done -   said severe inflamation in  lower back  -  arthritis - inflamed -   - disc  impacted    .The patient had no  symptoms of this  condition prior to  the vaccine .   normal  walking -  driving ,  going up and down stairs just  fine  before vaccine .
1.5cm x 3cm erythematous lesion noted at injection site of right lateral thigh. Mild induration. No pustule. Mildly tender to palpation (infant squirms) playful and smiles.
Woke with fever 102.5, shivering had body aches swollen glands in throat weakness dizzy for 24 hours. Then weak following 24 hours. 5days after had menstrual period start even though had just ended prior  2 days prior.
Headache; Chills; Feels Cold; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (Chills) and FEELING COLD (Feels Cold) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced HEADACHE (Headache), CHILLS (Chills) and FEELING COLD (Feels Cold). At the time of the report, HEADACHE (Headache), CHILLS (Chills) and FEELING COLD (Feels Cold) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication provided were Actemra infusion(monoclonal antibody infusion for Arthritis). Treatment medication were not provided.
I had a clear running and stuffy nose. By Tuesday I was sneezing. The next day I had a low-grade fever of 99. I tested positive COVID-19. My doctor prescribed me PAXLOVID. By the second day of me taking PAXLOVID I started feeling better.
TOOK ONE DOSE OF UNREFRIGERATED VIVOTIF; This spontaneous case report (PVX2019-1942) was received from a consumer on 26-Jul-2019. It described a female consumer who "took one dose of unrefrigerated Vivotif" (PT: Product storage error). The consumer was receiving oral Vivotif (lot number: 3003281) for typhoid fever prophylaxis.  Case report: The consumer stated that she picked up Vivotif on the night of 24-Jul-2019 and left it unrefrigerated until 26-Jul-2019. The consumer took the first unrefrigerated dose of Vivotif on 25-Jul-2019, empty stomach.   Action taken with Vivotif was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took one dose of unrefrigerated Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took one dose of unrefrigerated Vivotif" was considered as not applicable.
1.  Pain around left eye.  Lasted 1-2 days following each vaccine dose.  No treatment was necessary. 2.  Elevated TSH detected 4/21/21 after several years of stable levels in the normal range.  Treated with increased dosing of Synthroid. TSH is back in the normal range. 3.  Tenderness/pain in left armpit.  No treatment was necessary. Pain resolved within a few weeks.
Extreme body pain, aches fatigue and mild fever that have been lasting now 3 days. The second dose I had a worse reaction but it lasted about 6-8 hours and stopped. This one is continuing on.  I am reporting so you have this as information. I am not seeking medical care yet...hopefully it subsides.
p/vax pt rt upper deltoid are rt arm site of inj felt numb immed p/vax;rt arm felt very sore & by 12noon rt arm felt achy down to elbow;felt numb sensation from inj site to rt elbow;numbness spreading to rt side of neck down rt forearm;
p/vax pt had sz @ daycare; to hosp;fever;checked for infect & sz disorder;dx complex febrile sz;
Received injection 2/14/14, presented to walk in care the following day with arm pain. Stated it started 3 hrs after injection. 2/24/14 - decreased ROM, mild warmth and swelling. MRI - tear of supraspinatus tendon, large joint effusion. Referred to orthopedic surgeon.
Patient came into the store with her mother to get her firs Covid 19 vaccination. At  we carry Pfizer brand. She received the vaccination and was walking around the store she passed out and hit her lip on way to floor. Upon seeing the patient on the floor I came over to the mom to provide assistance. She was awake, however, very lethargic. I was very concerned that the patient was not coming out of the syncope fast enough. Therefore, I called 911. The fire dept. was first to arrive. They checked her vitals and asked her many questions. All vitals were in normal limits and she correctly answered their questions. The EMTs arrived and re checked vitals. All vitals still showing normal limits. They are to put her in the ambulance and take her to hospital. The patient refused and the EMTS  walked the patient to her car and I returned to the pharmacy. I called patient at 6:00pm that night and mom informs me that  did go the ER later because of a rash all over body. Mom states that  is feeling  better after hospital visit.
Immediately following the last vaccine (HPV) child became pale, her eyes rolled up and she slumped down in the chair and had  myoclonic jerks.  She was laid flat and her legs were elevated.  She never had complete loss of consciousness.  She was oriented throughout.   After 5-10 mins the pallor in her face resolved and she was able to sit up.  She was discharged in the care of her mother.