chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 48 hours began to ache at major joints, experience lethargy.  Following weeks joint pain ebbs and flows but remains constantly higher than before the vaccine. It isn't debilitating, but it does interfere with the quality of life and activity. I reported the issue to my pain management provider, and we are monitoring it at this time to see if it will subside.
Pt had already completed her 15mins Post vaccination monitoring, when she stop by the rest room, while in the rest room she stated that she saw rashes all over her abdominal area has evidence by this nurse. SN gave her Benadryl 50mg IM on her Rt deltoid-well tolerated. SN educated Pt to call a cab home due to dizziness which is a side effect of Benadryl, she was also educated to call 911 or go to the nearest emergency room if rashes continues or she experience other adverse reaction such as difficulty breathing-she verbalize understanding.
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. The patient was vaccinated with a dose of ZOSTAVAX (lot number unspecified) in July 2011. Route was not reported. No other co-suspects were reported. No concomitant medications were reported. "Recently" the patient came down with shingles. No treatment information was reported. The patient sought medical attention (not specified). The outcome of shingles was not provided. This is 1 of 2 reports from the same source (other case ID 1211USA004986). Additional information has been requested.
The patient initially was seen on 10/26 with a 10 day history of myalgias, arthralgias, malaise, fatigue, lightheadedness, and productive cough. This interestingly began about 2 weeks following his influenza vaccine. At that time he was afebrile, and oxygen saturations improved following a Duoneb treatment. Labs revealed a WBC of 3.7 with 71 segs, 3 bands, 14 lymphs, 10 monos. Creatinine was at baseline at 1.8, with eGFR of 38. BNP was 80. Chest xray showed no acute process. Patient was treated symptomatically with increase in scheduled nebulizer treatments, cough suppressants, mucolytics. Increased Vitamin D and Vitamin C supplementation, and close followup.  He then presented to the ER last evening after his son noted increasing weakness, lower extremity edema, and slurred speech. The patient had O2 sats of 87% on room air, which came up to 96% with 2 liters of oxygen. BNP was elevated at 270. Creatinine was up to 2.1, BUN 53, and elevated AST at 67. WBC 4.8 with 72 segs, 11 bands. Urine was negative except for 5-10 RBCs/hpf. He was given rx for Lasix 20mg. Blood cultures were drawn and are pending. Hospitalization was offered per the ED notes, however patient declined, likely due to the severity of his wife's dementia and reluctance to leave her alone at home.  The patient had already scheduled a follow up appt with myself today. His son came in and asked for help transferring patient into a wheelchair from their van, due to increased weakness. He stated he had almost dropped him trying to get him in the van at home. Notes patient seems lethargic and color poor, no further slurring of speech since yesterday. Reports cough had essentially resolved since his last visit. I did go out to their van, and observed patient sitting in passenger seat, indeed lethargic, but awake and oriented. Patient looked grey. PRIMARY DIAGNOSIS: Staphylococcus hominis sepsis SECONDARY DIAGNOSIS: COPD exacerbation; Acute bronchitis; CHF exacerbation; Bilateral lower extremity weakness and upper extremity tremors; Acute on chronic renal failure; AODM; Iron deficiency anemia; GUIAC positive stool  Patient required discharge to skilled nursing facility for extended rehab due to persistent lower extremity weakness. At baseline patient was able function quite well at home.
Received 1st dose on April 1 @ approximately 3:45pm.  The next few days only side effects were a very sore arm and slightly tired.  On April 9th, 8 days after receiving the 1st vaccine around 12pm noon I became extremely fatigued.  By 10pm on April 9th I had a fever of 100.2.  At 3am on April 10th I had chills and my fever broke.  On April 10th my lymph nodes on the left side of my face under my left ear and under my left armpit became very swollen and tender and sore, and remain swollen and sore as of the writing of this email on April 12th.  I?ve had no further fever.
No sleep for two days; severe cold; chills; coughing; cant eat; having trouble swallowing; fever; A spontaneous report was received from a consumer concerning a 86 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events no sleep for 2 days/insomnia, severe cold/nasopharyngitis, chills, coughing, cant eat/decreased appetite, having trouble swallowing/dysphagia, fever/pyrexia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 23 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) No sleep for 2 days, Severe cold, Chills, Coughing, Cant eat, Having trouble swallowing, Fever.  Treatment details included Patient have been taking Zical since reactions started.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), no sleep for 2 days/insomnia, severe cold/nasopharyngitis, chills, coughing, cant eat/decreased appetite, having trouble swallowing/dysphagia, fever/pyrexia  was unknown.
Following the 2nd shot, I noticed two adverse effects; the first was a fair amount of depression for up to a week. The second is a breakout of acne on my neck and both shoulders which has not subsided as of the date of this form (4/20/21).
slept for 11 hours; felt fairly ill; This is a spontaneous report from a non-contactable consumer. An adult patient of an unspecified gender received the 2nd dose of bnt162b2 (BNT162B2), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The day after vaccination the patient experienced slept for 11 hours (non-serious) with outcome of recovered, felt fairly ill (non-serious) with outcome of recovered. It was unknown if therapeutic measures were taken.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Varivax was given less than 28 days from patient's last MMR vaccine, which was administered on 5/11/2023.  Patient did not report any adverse effects.
Lethargy - not able to get up out of bed for 12 hours and again for 7 hours during the day. Could not move my left arm. Headache (not prone to them). Shortness of breath (no history of any heart issues). Totally healthy.
Pox like rash started 9/9 - 9/10 pruritic. Elocon used a first, initially thought to be contact dermatitis when seen. Dx made for Varivax reaction on 9/13/00.
pt recvd 3rd doses of Hep B vax on 5NOV91; immed following 3rd vax pt devel aches & pains in arm @ inject site for 5 mins; pt recovered; no further details were provided;
FATIGUE AND SORENESS AT INJECTION SITE   Narrative:  FATIGUE RESOLVED WITH NAP THAT DAY. SORENESS LASTED 3 DAYS
Narrative:  78 yo M with a h/o HFpEF G1DD (3/2021), non-obstructive CAD (per 2/2018 cath), paroxysmal atrial fibrillation s/p synchronized cardioversion (4/2020), hx of heavy EtOH use in recent remission, ILD likely 2/2 occupational asbestos exposure vs seronegative RA, HTN, DM, PVD, HLD died on 12/7/21 at ER (non-agency hospital). Pt had received covid vaccines on 2/4/21 & 3/8/21. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
Pain and redness in shot area for 2 days, redness moving to another area lower on the arm on day three. On the evening of third day developed tickle in throat that could not be stopped for 30 mins. Lower arm redness still there on day four.
pt recv vax 6APR95 & on the morning of 8MAY95 pt tried to pick up toothbrush but was unable to elevate rt arm or move rt neck it was so painful;also neck stiffness;
Local area (MMR) Hives to back, legs, head BENADRYL given No swelling, airway was clear.
cheek swab that was positive by PCR testing/ The child was born on 6/23/2021 with redness to the left cheek. On 6/24/2021, the baby developed lesions on the left cheek that tested positive by PCR for varicella.; the patient was exposed to siblings who received the VARIVAX vaccine; This spontaneous report was received from a nurse practitioner and refers to a 1-day-old male patient. He was a full-term newborn. The patient had no history of herpes zoster, herpes zoster ophthalmicus or chickenpox, he had no allergies. There was no information about the patient's concomitant therapies provided.  The patient's mother had varicella as a child and was not immunized. On an unknown date in approximately May 2021 (reported as "about a month before delivery of the baby"), the mother was exposed to someone who had shingles, but she remained asymptomatic, the patient experienced perinatal exposure to shingles.  On 23-JUN-2021, the patient was born with redness to the left cheek. On an unknown date in approximately June 2021, the infant was exposed to his siblings who were fully vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (exact dose, injection site, route of administration, lot # and expiration date were not reported) for prophylaxis (also reported as "baby got varicella from his mother").   On 24-JUN-2021, he developed lesions on the left cheek that were tested positive by polymerase chain reaction (PCR) for varicella. On an unknown date in June 2021, the patient experienced also blistered lesions on (approximate numbers): back (8), right cheek (1), left cheek (1), trunk (4) and extremities (6). The patient received acyclovir as a treatment. The outcome of the events was reported as recovered on an unknown date in approximately June 2021. There was no causality assessment provided by the reporter.
My symptoms started on September 11, 2022 and I experienced below both knees I felt tingling surrounding  the legs and feet.  The Dr. called it Peripherl neuropathy. I was told to take vitamin B-12.
I felt very dizzy and my breathing was tight approximately 2 minutes after receiving the shot. This passed in about 20 minutes and I dismissed it as anxiety. Then, 3 or 4 hours after the shot, my right eye began swelling. The eyelid feels and looks like it is sunburned and the eye swelling is very noticeable. It has been 7.5 hours since the shot and my eyelid is burning. I also have a headache behind my eyes and am very tired, and my arms are itchy.
PAIN IN THE LEFT ARM / SHOULDER AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 67 year old male. 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: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 13:30 for prophylactic vaccination. No concomitant medications were reported.  On 22-MAY-2021, the subject experienced pain in the left arm / shoulder at the injection site. Treatment medications (dates unspecified) included: camphor/menthol/methyl salicylate, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in the left arm / shoulder at the injection site. This report was non-serious.
Mom stated pt. had fever, described as low grade; About 2-3AM Dad woke up decided to check on pt.;Noted very deep sleep-he aroused pt. but had difficulty said pt. color was bluish & pt gasped to get breath & was fine p/;
Pt. suffered neck and axillary lymph node swelling. Painful for 1-2 weeks.
Allergic rash, hives. Began at injection site. Also on torso, neck and arms.
around 3pm  fluttering sensation in chest area (mid section)  upon taking pulse  it was a strong beat, counted three beats and stopped ,again three beats and stop.  Next day pulse was fine just noticed I would take in frequent deep breaths. Blood pressure was  normal.
Immediatly after injection, the site was burning, and stiffness on the side of neck region below the ear till shoulder. One of the nurse mentioned, I may have got injected on the nerve. I need to know what should I do ?
I am post-menopausal and have not had a period since June 2022 but I started having a light period about 45 hours after receiving the vaccine. This did happen with some of my earlier Pfizer covid vaccines but I was perimenopausal then.
Swollen, bright pink cheeks, swollen tongue and interior of mouth, swollen neck, very weak voice and very weak overall.  Per order of a MD steroid dose pack taken as well as Benedryl 50 mg three times daily.  Symptoms worsened, nauseated and temperature elevated 1.2-4 degrees above normal.  Went to emergency room.  Given intravenous solumedrol, Pepcid and Benedryl, then sent home on prednisone 40 mg a day for four days.  Symptoms continued.  MD took another steroid dose pack.  Still worse after first four doses.   Then took doctor's orders, prednisone 60 mg for three days,  40 mg for three days, 20 mg for three days then 10 mg for three days while continuing to take Benedryl 50 mg three times daily.  I continue to take Benedryl for pink swollen cheeks.  I am still weak and have swollen cheeks and neck as well as reduced voice.
Myalgia, Arthralgia, Fever, FEVER 102 Narrative:
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No  concomitant medications were provided.  No treatment medications were reported but patient wanted to know if they could take Tynol for their headache.   Reporter did not allow further contact
Raised area 2inches in size, red and slightly itchy; Itchiness; Raised area on arm that was red and warm to touch; Raised area on arm that was red and warm to touch; Soreness that lasted 3 days; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), ERYTHEMA (Raised area on arm that was red and warm to touch), VACCINATION SITE WARMTH (Raised area on arm that was red and warm to touch), PRURITUS (Raised area 2inches in size, red and slightly itchy) and VACCINATION SITE PAIN (Soreness that lasted 3 days) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness that lasted 3 days). On 31-Jan-2021, the patient experienced PRURITUS (Itchiness), ERYTHEMA (Raised area on arm that was red and warm to touch) and VACCINATION SITE WARMTH (Raised area on arm that was red and warm to touch). On an unknown date, the patient experienced PRURITUS (Raised area 2inches in size, red and slightly itchy). The patient was treated with Over counter cream at an unspecified dose and frequency. On 27-Jan-2021, VACCINATION SITE PAIN (Soreness that lasted 3 days) had resolved. At the time of the report, PRURITUS (Itchiness), ERYTHEMA (Raised area on arm that was red and warm to touch), VACCINATION SITE WARMTH (Raised area on arm that was red and warm to touch) and PRURITUS (Raised area 2inches in size, red and slightly itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Severe Migraine; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 05Aug2021 at 14:15 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included lupus and known allergies to peanuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol/ diphenhydramine hydrochloride (TYLENOL PM), for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 05Aug2021 at 17:30, the patient experienced severe migraine. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event severe migraine was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Booster dose for pfizer.  No reactions to previous two doses.  The patient went pale and fainted, when booster given.  He has fainted before but not during previous vaccinations.  Given water and a snack then he laid down with his feet up.  Color came back to his face.  He was feeling better shortly after.
Initial information received on 18-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 4.5 years old patient (unknown gender) for whom ADACEL was administered to a patient that is 4.5 years of age and also when dtap can be administered was reported, while he/she received vaccines ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The subject did not received other vaccines. On 28-Feb-2019, the patient received a 0.5 ml dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine lot U6069BA expiry date: 14-Sep-2020 via unknown route in the right arm. It was as an actual medication error case due inappropriate age at vaccine administration. It was reported ADACEL was administered to a patient that is 4.5 years of age and also when dtap can be administered and this would have been dose number 5. Lab data was not reported. Final diagnosis was ADACEL was administered to a patient that is 4.5 years of age and also when dtap can be administered. It was not reported if the patient received a corrective treatment. The outcome of event was not applicable. 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. List of documents held by sender: none.
Hib vaccine #1 given to left leg this AM (07/24/02). Mom noted rash swelling and redness approximately 5 hrs later. Brought to office. Induration at ste measures 2cm diameter. No erythema or warmth at this time.
Felt fine except for Redness and itching at injection site. On third day (03/14/2021) I became lethargic and achy and began having intestinal issues similar to flu symptoms in previous years. I began ingesting only water, gatorade and diluted Jello along with crackers and toast. The symptoms finally subsided on 03/18/2021.  I previously was diagnosed with  COVID-19 on November 26/2020. The symptoms at that time were more cold like and not severe. I had been leading a healthy, normal life in the interim.
Stopped getting my period. Spotted for 8 days in early june ans then nothing beyond that.  Not menopausal.
pt recv vax 26MAR96 & 29MAR96 pt devel red rash on lt arm & across chest lt breast swelling;lt arm swelling;lt side of neck stiff;breathing diff;diff swallowing (numbness lt side of face);nauseous;flu like sx;lightheaded;tx w/DPH;claritan;
A 57 year old female was treated since January 2001 with OncoTICE. Reportedly she experienced bladder pain, bladder inflammation and frequent urination after each treatment. The adverse events worsened gradually after each treatment and became unbearable after the second instillation in April 2003 and ONCOTICE was discontinued. Rifambin, isoniazid, B6, ethambutol and Cipro at various time points without relief.
Swelling of right arm, shoulder, neck, fever. Unable to driver to go to school.
All my life since my menstrual cycle started  had regular periods, and after the vaccine I went for a while without my periods and ,my periods became irregular, increasing  painful and heavy,
very sick; has a temperature; Swelling; throwing up; arm is real sore; This is a spontaneous report from a non-contactable consumer (daughter). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on 04Mar2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient goes to a couple different doctors and she was fine, healthy, everything until she got her second shot. The patient experienced very sick, has a temperature, was swelling, was throwing up, her arm was real sore and she can't get up on an unspecified date. The patient was still swelling and the reporter wanted to know what to do to counteract side effects. The outcome of the events was unknown. The reporter said that she needed to know what she needed to do to try to help the patient. The reporter said that she was going to take her mother into the hospital, she didn't like these shots in the first place, she was not for them at all, she doesn't trust them, they don't have enough information to be giving them to people.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse concerning a 6 year old disabled male with a significant past medical history and his own nurse who on 05/13/1998 was vaccinated subcutaneously with a 0.5ml dose of varicella virus vaccine live (Oka/Merck) (lot#625372/0057H).  On 05/03/2004 the patient's nurse, who is his caregiver, contacted the doctor's office and reported that the child had more than 50 lesions/blisters.  It was noted that the nurse will call them back to confirm if it was chickenpox.  Unspecified medical attention was sought.  There was no product quality complaint.  Follow up information received from a registered nurse indicated that none of the patient's medical history is relevant to this mild breakthrough.  It was noted that on 04/30/2004, the patient broke out with 3 lesions, 2 on his face and one his arm.  The outcome was reported as recovered.   The reporter also indicated that one other patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) and developed chickenpox (WAES#0404USA02328).  Additional information has been requested.