chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He had open heart surgery for an infection in his heart. He started running a fever and had a headache. He took Tylenol for the symptoms. He had chills and fever and was delirious and he did not have any appetite and was sleepy all the time. After about 4 days I took him to the emergency room for the first time. They did chest x-ray and blood work. This was in May 2022. They found some pneumonia. They gave him antibiotics and sent him home. We returned to the emergency room, and they admitted him. They kept him for 7 days and did a full round of antibiotics and sent him home. The symptoms improved for a short time. In July of 2022, he complained that his back hurt. He went to his pain management doctor who gave him a couple of shots in his back, but they did not help. We were also seeing the primary care physicians. They prescribed Gabapentin and did some MRIs on his back but were unable to provide a diagnosis. They just gave him couple of shots in his back for the pain and no additional antibiotics. He has since recovered but it was a long process. He ended up back in the hospital in September of 2022 because he got the same symptoms of delirium, headache and fever. He was transported by ambulance to the hospital and was admitted for 9 days. During that visit they identified that he had a strep infection in his spine. They started him on IV antibiotics again. He continued on IV antibiotics for 8 additional weeks, and he started to feel better after 3 weeks. We finished the IV antibiotics, and he was placed on Oral antibiotics. The day after Christmas 2022, he started complaining about shortness of breath that got worse fast. I took him to the cardiologist who did a couple of tests and they advised that he was in heart failure and that he needed to go to the hospital for surgery since the infection had spread to his aortic valve.  He was discharged from the emergency room the same day. He had in patient surgery on January 27, 2023, and was hospitalized for 8 days. He was sent home on another round of IV antibiotics and placed on heart medication called Entresto; Farxiga; and Corlanor. He has improved dramatically since then. He just started cardiac rehab, so we do not know if he has recovered yet.
C/o injection site mild soreness ache slight redness x 3 days post 8/19/11. On 8/24/11 redness painful tenderness site 1 3/4" x 3" without fever or s/s of infection. Inst to apply cool compress & start analgesic. 8/29/11 decrease in symptoms feeling better.
5 from Moderna that had similar reaction hives the whales/In some cases had another similar reaction where they had the hives, the welts/The hives reappeared; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (5 from Moderna that had similar reaction hives the whales/In some cases had another similar reaction where they had the hives, the welts/The hives reappeared) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (5 from Moderna that had similar reaction hives the whales/In some cases had another similar reaction where they had the hives, the welts/The hives reappeared). At the time of the report, URTICARIA (5 from Moderna that had similar reaction hives the whales/In some cases had another similar reaction where they had the hives, the welts/The hives reappeared) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Case contains information of 4 of 5 patients reported.  Concomitant products were not reported.  It was reported that it was whether patient had any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that a total of 12 patients on a study based on 7 from Pfizer and 5 from Moderna that had similar reaction hives the whales. And that they proceeded to get another vaccine. In some cases had another similar reaction where they had the hives, the welts. But they At the time when they had them they took an antihistamine and relieved it. It was just resolved simply by taking an antihistamine. The hives reappeared. They didn't have any respiratory problems. They didn't have any cardiac problems, which was good.   This case was linked to US-MODERNATX, INC.-MOD-2023-710286 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710286:Master case (1 of 5 patient)
I had what felt like food poisoning symptoms.  Started with uncontrollable shivering, followed by fever, headache, nausea & vomiting.  Headache was migraine-like.  Worse symptoms lasted ~20 hours.  I had a low grade fever for another 24-36 hours + headache.
4 CM erythema at inj site (R upper arm) with tenderness/warmth/swelling. Rec observation/ice/motrin prn.
Inadvertently given only the liquid portion of the Menveo vaccine; Inadvertently given only the liquid portion of the Menveo vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA911A, expiry date 28-FEB-2025) for prophylaxis.   On 16-MAY-2023, the patient received Menveo. On 16-MAY-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Inadvertently given only the liquid portion of the Menveo vaccine) and inappropriate dose of vaccine administered (Verbatim: Inadvertently given only the liquid portion of the Menveo vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-MAY-2023 The reporter declines to provide initials and date of birth on call, stating that she was not sure she can give those details.  The reporter did consent to follow up. The reporter gave by error Menveo liquid portion only ,which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Patient was administered a pfizer covid vaccine at the wrong concentration.  The  initial vial was mixed with 0.8ml of diluent instead of 1.8ml of diluent.
Swollen face; big itchy swollen patches on her whole body; dizziness; weakness; itchy swollen patches on her whole body; patches on her whole body; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swollen face), SWELLING (big itchy swollen patches on her whole body), DIZZINESS (dizziness), ASTHENIA (weakness) and RASH PRURITIC (itchy swollen patches on her whole body) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No past medical history was reported.  Concomitant products included LEVOTHYROXINE SODIUM (EUTHYROX) for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced SWELLING FACE (Swollen face), SWELLING (big itchy swollen patches on her whole body), DIZZINESS (dizziness), ASTHENIA (weakness), RASH PRURITIC (itchy swollen patches on her whole body) and RASH (patches on her whole body). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Adverse event, at an unspecified dose and frequency. At the time of the report, SWELLING FACE (Swollen face), SWELLING (big itchy swollen patches on her whole body), DIZZINESS (dizziness), ASTHENIA (weakness), RASH PRURITIC (itchy swollen patches on her whole body) and RASH (patches on her whole body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient developed an abscess on the left thigh where he received his 2nd dose of Pediarix and HIB. It initially started as a hard knot but then became red and fluctuatant about 1 month after the shots. He was seen in the office on 2/21/2 and advised to use warm compresses and started on PO Bactrim. He returned 1 week on 2/28/20 later due to no improvement and the abscess was drained in the PCP office. Abscess recurred and the patient was seen again on 3/13/20. An US of the abscess was done at that time which showed a superficial 2.5 x 2.4 x 0.7 complex irregular collection which is partially fluid-filled and extends to the fascia and along the anterior muscle plane. He was seen by Pediatric Surgery and it was drained again with loculations broken upon 3/20/30.
dizziness; nausea; Temp 102.3; joint pain; injection site pain; general muscle ache; Fatigue; Chills; Generally did not feel well; This is a spontaneous report from a contactable Nurse. A 47-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 06Feb2021 07:45 (Batch/Lot Number: em9810) at single dose for covid-19 immunisation. Medical history included myasthenia gravis Hx chronic reactive airway do and myasthenia gravis from 16 years ago in pregnancy but resolved, allergies to Sulfa. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (Lot no: EL8982) On 16Jan2021 07:45 AM at single dose in left arm. on 06Feb2021 12:00 patient experienced dizziness, nausea, temp 102.3, joint pain, injection site pain, general muscle ache, fatigue, chills, generally did not feel well. Patient had no COVID prior vaccination, COVID not tested post vaccination and no other vaccine in four weeks. Outcome of the events was recovering.
Patient presents nodular reaction on injection site of the filler but they are not visible but palpable; This is a spontaneous report from a non-contactable other hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included hyaluronic acid (Juvederm VOLIFT) taken for an unspecified indication, start and stop date were not reported. Healthcare professional (HCP) reported side effects received today on a patient case injected with Juvederm VOLIFT. HCP reports patient had Covid-19 a year ago with a positive PCR test. The patient was vaccinated for Covid-19 with the Pfizer vaccine 10 days ago, since then the patient presents nodular reaction on injection site of the filler but they are not visible but palpable. HCP has put patient on Corticosteroids. Volume of filler and injection location not provided. The patient underwent lab tests and procedures which included polymerase chain reaction: positive on an unspecified date. Outcome of the event was unknown. No Follow-up attempts are needed. No further information is expected.
On the thirteenth day following first dose, developed a 3-inch diameter rash surrounding injection site; rash lasted two to three days, improved with use of topical Benadryl.    Soreness at injection site persisted for approximately three to three and one-half weeks from first dose.
First day after dose, 3pm very painful arm. Stiff and cannot raise high. 10pm chills.  Cannot sleep comfortably 2nd day after dose 6am temp is 100.4.
Vaccine was administered at 08:30.  Mother then proceeded to take child to school.  School nurse noticed rash and school nurse told the mother to take child back to health clinic.  Child arrived at clinic  at 09:25.  A rash to face-arms, leg noted.  911 was called. Ambulance arrived at 09:40.  Child was stable, no respiratory distress noted 100/70, T: 98, R: 18.
Severe fatigue - severe severe. It is still ongoing actually. I have gone from full-time with an overload to working part-time. Because of the other things going on, I don't have a way of knowing if it was vaccine related. A pretty big upkick in joint pain; muscle pain and stiffness (they call it Fibromyalgia); skin patches that look like psoriasis or eczema. I see all the doctors. I just a repeat endoscopy for the ulcers. Breast doc followed up as well. And I have an upcoming appt with a doctor. With my bone disease, I have very low Vit D levels so I have an appt with primary care to check in about the Vit D levels, etc.  I went to part time work to help myself rest more.
Vaccine administered around 10 am. Patient began having chills which lasted for 7 hours beginning at 2pm. Also experienced stomach illness.
Body aches; 100.3° F fever; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PYREXIA (100.3° F fever) and FATIGUE (Tiredness) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN (Body aches), PYREXIA (100.3° F fever) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Body aches), PYREXIA (100.3° F fever) and FATIGUE (Tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Body temperature: 100.3 (High) 100.3° F.         No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.
Pain, redness swelling hard lump, headache. Swollen down arm and was spreading.
This spontaneous report was received from a  67 year old female consumer with no pertinent medical history and allergy to "Bactirim" reporting on herself. Concomitant therapies included pioglitazone hydrochloride(ACTOSE), metformin," Lavimire" and acetaminophen, hydrocodone bitartrate("RITIDEROLE" VICODIN). On 24-JAN-2015, the patient was vaccinated in the left arm with a dose of  ZOSTAVAX, 1 time vaccine, lot # K012786, expiration date: 28-NOV-2015 to prevent the shingles. On an unspecified day in March 2015 (reported as about a month and a half after getting the vaccine), the patient experienced shingles. She had had continuous shingles since getting the vaccine. They began to clear up on her body but then they came back. The patient stated that she got them in her left shoulder, upper back, and upper chest. She did not get severe pain but the shingles which were really itchy and the pain feelt like someone was sticking a needle on her. Regular lab test such as "CVC", urine analysis, type and cross match lab study were performed  but the results were not provided.  The patient sought medical attention and the physician instructed her to apply capsaicin cream and take diphenhydramine hydrochloride (BENADRYL) tablets for the pain. At the time of reporting the patient's outcome was unknown. Additional information is not expected because reporter refused additional contact.
A little dizziness; Vomiting feeling; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (A little dizziness) and NAUSEA (Vomiting feeling) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Prostate cancer.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced DIZZINESS (A little dizziness) and NAUSEA (Vomiting feeling). At the time of the report, DIZZINESS (A little dizziness) outcome was unknown and NAUSEA (Vomiting feeling) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Patient took no treatment for events.
Pt. presented to our ED non-verbal and could not contribute to her hx. Pt. had fever of 99.3, WBC of 0.4, Hbg of 8.2, HR 140, BP 79/44, Lactic acid of 2.7, O2 sat. of 86% RA requiring 3L, Pt. received IV fluids, dose of Amiodarone 150 mg, placed on Levophed drip, blood cultures were obtained- showing no growth, Covid test- PCR was negative. Pt. had a not from cancer physician for pallative cares on 4/19/2021. Husband reports pt. wanting to be a full code. Pt. with diagnosis of Septic shock was transferred to hospital of higher care in area. Please note that pt. had received her first Covid vaccine 03/09/2021 - lot # 026A21A. Database reports patient could have possibly received a Johnson and Johnson vaccine on 3/17/2021, but no information available such as lot number or where pt. possibly obtained vaccine from. Then pt. received Covid shot #2 on 4/6/2021.
Information has been received from a consumer concerning her 31-year-old son with allergy to oysters and psoriasis vulgaris who was vaccinated (following the regular dosing regimen) with MMR vaccine. In 1979 at age 11, the pt developed grand mal seizures and was placed on therapy with phenytoin (Dilantin). The dosage was then increased until the pt became toxic. The reporter noted that the pt is currently under the care of a neurosurgeon who is regulating the dosage. The pt's experiences is considered an "other medical event." Additional information has been requested. FU information received from a physician indicated that he has "no information which would indicate the seizure disorder has anything to do with MMR immunization."
Joint pain, fever, nausea, exhaustion, hives, swollen painful lymph nodes in armpit.
Mom states child had full body rash - took her to hospital - MD said it was chickenpox.
Pt received Moderna booster vaccine on 11/1/2021 and 2 days after patient develop weakness of LUE, unable to sustain arm up w/ no shoulder strength.
Day 2-3: fever, chills, body aches, joint and muscle pain, headache, nausea, fatigue and vomiting Day 4-5: felt completely fine Day 5-6: that evening, all of the same symptoms returned, including fever of 102 Day 7-9: felt completely fine Day 10-11: all symptoms returned, including fever of 101 Day 12: today, feel completely fine
mom returned to clinic p/vax;pt noted to be wheezing;rt outer upper brow appeared to have bite mark w/edema of RL lid;sclera appear red in corner;swollen lid & sclera inflamed;fussy;to MD given med whole face became swollen;
Post vax pt developed a local reaction which the reporter did not describe. Manufacturer's Comment: The reporter indicated that 2 pts developed a local reaction; however, they are not presently identifiable. An addtl report will be generated when identifying info is provided.
Information has been received from a physician concerning a 12 month old female who on 10/06/03 was vaccinated with a 0.5ml dose of varicella virus vaccine live. On 10/13/03 the patient's mother called stating the child had a fever, rash, and is ataxic. It was reported that the child was being sent to the emergency room for evaluation. No other specific information is available at this time. Additional information was received the physician and a registered nurse which indicated that after speaking with the patient's parent, it was determined that the patient did not have an adverse event. It was noted that the patient only experienced a fever and was not ataxic. No further information is expected. This report no longer meets the criteria for expedited submission because follow up information indicated that the adverse experience of ataxia did not occur.
3/09/07 noticed lump at injection site the day administered. 3/27/07 injection site became painful to touch and itching noted. Became febrile and upset stomach noted. 4/5/07 seen by employee health 60x40 mm Erythema noted at site with lump noted. T 99.3, P 79, R 16, BP 118/80. States itching at site, + nausea, arm painful to touch, Loratadine 10 mg given. Evaluated by physician 4/5/07 DX cellulitis. RX given for Keflex 500mg + tab Q PO For 10 days.
I started bleeding on the 4th, doctor stated threaten miscarriage. I had blood clots and vomiting'. I was taking to emergency room. I was giving a DNC because I had a miscarriage.
Reaction occurred after second dose of Moderna covid mrna vaccine. Right arm erythema, tenderness, measured about 4cm, encompassing most of deltoid area where she received vaccine. No fluctuance. She reported severe systemic symptoms and was unable to work. Symptoms started 24 hours after second dose and were improving at 72 hours when she came to clinic for evaluation. Etiology seemed inflammatory to me and did not appear to be skin/soft tissue infection.
Information has been received from a pharmacist concerning a 35 year old male with sickle cell anaemia, TORADOL allergy and hospitalization for a sickle cell crisis who on 13-SEP-2007 was vaccinated with a dose of PNEUMOVAX 23 (lot #656222/0381U), 1 vial, IM prior to being discharged from the hospital. Concomitant medication was not reported. On 13-SEP-2007, shortly after receiving the PNEUMOVAX 23, the patient developed an anaphylactic reaction. He experienced facial swelling and throat discomfort. The patient was treated with SOLU-MEDROL, IV and an unspecified inhaler. The patient's hospitalization was prolonged as he was transferred to the Intensive Care Unit (ICU) for 48 hours. Unspecified medical attention was sought. The reporting pharmacist felt that anaphylactic reaction was related to therapy with PNEUMOVAX 23. At the time of reporting, the patient had improved 40%. Anaphylactic reaction was considered to be immediately life-threatening and an other important medical event. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the government and was released. Additional information has been requested.
My daughter developed a large (2 1/2 inch) area of swelling that was itcy and painful and was very warm to the touch.  The area was also hard.  She also has headaches and fatigue.  The site of the mass of swelling was approximately 2 inches below and to the right of the injection site which was in the top center of her left arm.  We took her to the acute care center after the dr told us it was a AE.  We thought she may have been bit by a spider becuase the reaction was not at teh injection site.  The fact that the Chicken Pox vaccine causes secondary bacterial cellulitis was not disclosed to us a the dr's appointment.
This spontaneous report as received from a registered nurse to a patient of unknown age. The patient was vaccinated with an expired 0.6 ml dose of ZOSTAVAX (lot # 670547/0659AA expiration date 04-AUG-2012) SQ on 22-AUG-2012. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
so after injection on the left arm, it bled. Then Thursday morning she woke up and didn't feel right and by thur afternoon fever started lowe grade and then by 4pm it shot up to 103.6 degrees and at that time the patient had a massive headache, body aches, bones felt like cracking and chills, patient developed a huge not on left arm and each day the knot got bigger and bigger. cool and warm compress made left arm worse. pt took covid test and it was negative.  right now it is blistery on top and knot at bottom of blister