chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Return of symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Return of symptoms) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Thyroid cancer.   On 24-Mar-2022 at 5:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 09-May-2022 at 7:00 PM, the patient experienced COVID-19 (Return of symptoms). At the time of the report, COVID-19 (Return of symptoms) was resolving.            Concomitant medications were not reported. The patient did not took any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine. On 09May2022 Return of symptoms. Patient treated with antibiotic and device date was 24May2022.  Company comment: This spontaneous case concerns a 43 year old female patient, with relevant medical history of micropapillary thyroid cancer, who experienced the unexpected non serious AESI of COVID-19, unknown days after receiving the fourth dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient took Paxlovid for COVID-19 for 5 days. However, symptoms returned after about 9 days. The event was resolving. No further details on the previous doses of vaccination and COVID-19 test dates before and after Paxlovid treatment were available in the report. Medical history of micropapillary thyroid cancer and the ongoing COVID-19 pandemic could be risk factors for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 43 year old female patient, with relevant medical history of micropapillary thyroid cancer, who experienced the unexpected non serious AESI of COVID-19, unknown days after receiving the fourth dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient took Paxlovid for COVID-19 for 5 days. However, symptoms returned after about 9 days. The event was resolving. No further details on the previous doses of vaccination and COVID-19 test dates before and after Paxlovid treatment were available in the report. Medical history of micropapillary thyroid cancer and the ongoing COVID-19 pandemic could be risk factors for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
She got her vaccine, didn't have any immediate reaction.  On Saturday morning she had an itchiness on her back.  Then by Monday 1/9/23 around the T12 area and proceeded along her left side around to her naval at waste level.  It is basically just the area that is affected is a band.  It is about 2" in width.  She went to the doctor and she diagnosed her with shingles.  She was given a prescription for Valtrex but she has not yet filled it because her symptoms are just annoying and not extremely pain.  She was told that she had a very mild case, has itchiness and a tingling sensation.  Due to the side effects she does not want to get hallucinations and delirium, so has chosen not to take it at this point, and has chosen to ride it out.    She got her vaccine due to her doctor telling her to.  She finds it hard to believe that she got the vaccine on Monday and by Saturday she had symptoms of shingles and was tested to see if she had chicken pox as a child and she had so that's the reason she got the vaccine.
Information has been received from a a registered nurse concerning a female who on 19-Feb-2007 and 34-Jul-2007, was vaccinated intramuscularly with 0.5 mL of her first and second doses, respectively, of GARDASIL vaccine (lot#s unspecified). No adverse event reported. At the time of this report, the outcome was unknown. No additional information was provided. Additional information has been requested.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 09-MAR-2015, patient received improperly stored VARIVAX dose 2, from lot # K007982 (dose and expiry date unknown).  No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Narrative:  74 y/o with PMHx significant for HTN, HLD, T2DM, Obesity, CKD III, OSA, who presented to an OSH with 6 days of cough, SOB, fever, generalized fatigue, transferred after being found to be COVID-19 positive with worsening hypoxia. Hospitalized with ARDS 2/2 severe COVID-19 PNA. On 8/29 in ED was on 6L NC with SpO2 85% was transitioned next day to high flow NC at 100% and 50. Unfortunately, unable to tolerate and was intubated the following day (8/31). Patient remained intubated until date of death (9/25/2021). Received the following COVID treatment: EUA Tocilizumab IV 800mg once (day 1 of ICU care), Remdesivir 5 doses total (received 1st dose in outside ED), and daily Dexamethasone. COVID vaccination: Moderna x 2 (Feb and March 2021)
severe myalgias in back, neck, elbows, knees, hips, wrists, and finger chills  excessive tiredness
Was diagnosed with shingles. Under my left arm and on the left side of abdomen. Was given Valtrex.  To this day I still have some scaring as a result.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. No medical history was reported. On an unknown date the patient was vaccinated with (Oka/Merck) VARIVAX (dose and frequency not provided). No concomitant therapy was reported. Healthcare worker stated that since March improperly stored (Oka/Merck) were administered to unspecified patients. No adverse events were reported. The outcome of the events was unknown. The events were considered to be not related to (Oka/Merck). No product quality issue was involved. Additional information has been requested.
On 11/7/01, one day post vax, pt experienced a bad reaction which included severe swelling and redness at injection site. The pt was seen in the ER and was admitted due to additional concerns with his pre-existing cardiac condition. The reporter indicated a concern with the lot number. It was reported that the pt's wife (WAES 01111505) had a similar experience following exposure to pneumococcal vaccine 23 polyvalent. Addtl info has been requested.
About 5 minutes after receiving his vaccine, he started feeling woozy, started sweating profusely and became pale. He was laid on floor, feet elevated and ice pack applied to this neck. After about 2 minutes, he said he felt better. Color started coming back to his face. He was then helped to a chair. He took a couple of sips of water. Said he was feeling better now than when he came in. After about 6 minutes his color had returned to normal for him. He was talking and joking with his girlfriend. Ask him to remain for 15 more minutes to make sure he did not have any other effects. Told him that we would call him tomorrow and check on him. Left after 15 minutes.
Tiredness; This is a spontaneous report from a contactable Consumer. A patient of unspecified age and gender reported that the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization and experienced a metallic taste in the mouth, which was immediately followed by a fainting feeling and palpitations. The patient's medical history and concomitant medications were not reported. After the second dose, tiredness for about one week which had been subsided (recovered).  No follow-up attempts are needed. No further information is expected.
rash on injection site and under breasts/across front torso. started night of vaccine or next day and continued a week. rash would go away and come back on torso/under breasts faintly. notices that rash begins after playing sports in the heat. rash has resolved now and patient doesn't have any ongoing issues. patient is consulting with md to see if can get dose 2.  update: patient came back in pharmacy on 10/7/19 and stated she had an additional rash on torso on 9/11 after playing tennis. she stated the rash lasted 24 hours and resolved. she has not had any issues since 9/11/19.
Patient called in complaining of pain in the arm where shot was given, also redness and slight swelling around injection site.
Local generalized hard, red, raised area noted following week approximately the size of a 50 cent piece.
Burning, tingling, intense on my lower extremities. Legs, and feet, almost like they're on fire. Then occasionally it would come up to my arm or my trunk area. It would like itch like to death. Intense constant. I havent slept since Monday.
Received vaccine on Thursday, Dec. 31, 2021 at approx 7:45 AM.--Moderna COVID-19 Vaccine EUA. Left upper arm started to feel sore a few hours later. Later that day arm became red, swollen from shoulder to elbow, and vary warm to touch, and hard from shoulder to elbow. Woke me up quite a few times during the night with pain. Had a difficult time moving arm in general. No medication taken. On Friday, Jan. 1, 2021, upper left arm still sore. No other symptoms. Friday night, still sore but thought I was getting better as I could move it even though it hurt. No medication. Saturday Jan 2nd, 2021 morning- woke up still sore and swollen, no longer warm to touch. Saturday during the day-feeling better. Swelling going down, started to get softness back. Saturday night at 9:00 PM- felt nauseous so I went upstairs to lay down. Couldn't lay down due to stomach being upset. At approx 9:30 PM- went to restroom with diarrhea but no vomiting. At 9:45 PM-grabbed bag beside bed and started to vomit. Was getting concerned about the amount. At 11:00 PM- went to restroom with more diarrhea and vomiting. Jan. 3rd, 2021 at 12:15 AM- went to restroom with more diarrhea and vomiting. 1:45 AM-more diarrhea and vomiting. Came downstairs at 2:00 AM so I would not wake my family. 2:30 AM-more diarrhea and vomiting. I noticed both the emesis and bowel movement looked the same in color and texture. Very strong odor. 3:15 AM- more diarrhea and vomiting. I noticed I was getting weak. 4:00 AM- more diarrhea and vomiting only I could not stand up to go to restroom as I knew I would fall and may hit my head on table. Approx 4:15-4:30 AM- called emergency room. Male advised to come in at for least IV fluids. I refused as I am a mother and have a child to attend to. Was advised it's hard to tell if it is a reaction to vaccine but from sounds of it, it more than likely was. 5:00 AM- more diarrhea but no vomiting. 6:00 AM- more diarrhea but no vomiting. Went upstairs to lay down. 8:00 AM-fell asleep. Slept on and off entire day. No eating or drinking. Slept entire night. Went to work on Monday Jan. 4th, 2021. Felt bad. Wanted to call off to rest but I did not. Had sips of water that morning. Did not eat until very late Monday evening.  Afraid to eat for a few days. Symptoms finally went away.
6/3/2022 early morning I woke up with fatigue, sinus congestions, sore throat, and headache.  Symptoms continued over the next few days, sore throat diminished.  6/3 At home COVID 19 tested positive.  6/4 PCR test also positive.    6/6 televisit with doctor.  Doctor prescribed Paxlovid, but I was unable to source it.  6/8 Sinus congestion ended.  Up to time of reporting, still experiencing headaches and runny nose.
No adverse event; Moderna Covid-19 vaccine administered to the patient is past it's 30 day beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine administered to the patient is past it's 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 21-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 063B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine administered to the patient is past it's 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine administered to the patient is past it's 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine administered to the patient is past it's 30 day beyond use date).    No concomitant medications were reported.  No treatment details were reported.  Product administered was Monovalent vaccine from Individual vial of size 5.5 ml.  The vial was initially stored in the refrigerator on 01-Oct-2022.  Vial did not undergo any temperature excursions.
I started noticing a bumpy rash on upper arms about a week after the injection.  It is not particularly itchy nor red, it?s many little bumps, but it?s persistent and now seems to be spreading to my lower arms.
Persistent numbness on right side face and neck, right arm for 9 days, 5 hours after receiving the covid-19 vaccine 9 days ago. Symptoms are getting no better, even worse after drinking some alcohol. No weakness, pain, or dysphagia. Numbness is mild on right arm.
Patient's wife states patient woke up 10/16/2017 and is having a hard time moving his left arm and it is painful at the injection site from his immunization he received on 09/29/2017.
Gradually developed Left arm and shoulder pain, which progressively became very severe, leading to a trip to the emergency room for evaluation and pain medication. At this juncture, a subscapular injury exists, which is requiring rehabilitation due to persistent shoulder discomfort and arm aching.
Information has been received from a consumer concerning a 61 year old male patient (250 pounds, 72 inches) with diabetes, high blood pressure, high cholesterol, psoriasis and no drug allergies, who on 15-OCT-2007 was vaccinated with Zostavax (Oka/Merck) "single dose series." Concomitant therapy included influenza virus vaccine (unspecified), GLUCOPHAGE, BYETTA and unspecified medications for high cholesterol and high blood pressure. The reporter, who is the patient's wife, stated that five days after receiving the vaccination (20-OCt-2007) the patient started to itch all over his body from head to toe. The patient sought medical attention at the physician's office. According to the wife, the physician said the patient had an allergic reaction and gave him ZYRTEC. The wife also reported that "a couple of weeks later, the patient started to get sores all over his body" and went to the emergency room. According to the wife, the physician stated that "it was not shingles but some type of reaction," and put the patient on prednisone (manufacturer not specified). The patient stopped taking prednisone because it made him vomit. The patient's itching, sores and allergic reaction persisted. No diagnostic lab studies were performed. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/26/2008. Information from medical records indicated that on 28-DEC-2007 the patient was diagnosed with subacute spongiotic dermatitis with eosinophilic spongiosis of the left abdomen. On 21-JAN-2008 the patient presented for re-evaluation of his rash. Three weeks prior a biopsy demonstrated eosinophilic spongiosis. Differential diagnosis clinically and histopathologically was allergic contact dermatitis versus drug eruptions versus urticarial bullous pemphigoid. Since his last appointment the patient used triamcinolone wet dressing to the affected areas and did well. He had almost complete resolution of the rash when he applied them, but if he stopped using them the rash recurred. He was tolerating the doxepin well. Current medications included amlodipine, atenolol, ATACAND, furosemide, lovastatin (manufacturer unknown), metformin, aspirin and recently BYETTA, all of which he had been on for several years, the most recent addition was lovastatin. He had no allergies. The physician's impression and plan was to continue triamcinolone and wet dressings and decreased the frequency. He was instructed to contact the physician of there was an exacerbation or flare when trying to titrate down. Doxepin was continued for symptomatic relief. To rule out urticarial bullous pemphigoid, a biopsy was performed on the perilesional area on the right flank. Bullous pemphigoid was ruled out. The impression of the biopsy was a negative study. Additional infromation is not expected.
Dec 13th - contact dermatitis on dorsum of hands, progressed to systemic allergic reaction resulting in angioedema, wheezing, hives, tachycardia and treatment at local Hospital ED. Progressed to chemical sensitivity, new onset of synthetic rubber allergy, tachycardia, new food intolerance, diarrhea, weight loss, hormonal imbalances, neurological symptoms (migraines, painful paresthesias in hands, feet and face), insomnia, wheezing, throat horseness and tightness with allergic reactions. Diagnosed with histamine intolerance after COVID vaccine by functional medicine practitioner in Nov 2022.
Tachycardia in the 170s, chest pressure, elevated troponin. Diagnosed with myocarditis.
Patient called my work cell to report that she thought she was having a bad reaction to the vaccine she received in her left arm yesterday.   She feels like there is a "rock" under her skin where the vaccine was given and it is slightly warm to the touch. No redness. Localized swelling reported over injection area. Sore at injection site. Used marker to draw circle around swollen area so she could monitor. Not noticing progression since this morning.
No reported adverse reactions to first dose. Received second dose of Moderna COVID  vaccine on 5/10/21 at unknown time of day. At 09:30 on 5/11 found by her mother with AMS, nausea/vomiting, erythema to L arm . Pt required benadryl, epi x 3 IM with subsequent drip and ultimately intubation.
Large inflamed area at injection site day after injection. Pain and size of irritation continually increased. Patient sought medical attention and was told she had an allergic reaction and mild case of shingles.
She took the shot on Saturday about 1 pm and on Sunday she started running a high fever, coughing, diarrheic, loss of appetitive.. couldn't hold anything down, this continued for a week, we were thinking she was just having a hard time with the vaccine. She started passing out/ extreme difficulty breathing etc. Since she had no insurance decided to go to a Urgent Care that charged $300/ as soon as she stepped in there/ she was sent to ER. At that point, diagnosed with COVID and had sats in the 60's and 70's with a PaO2 of 26mmHg. She was put on 100% O2 with sats rising into the 80's. Wanted to do BiPaP, she refused. After a week and excellent care, she returned home on Oxygen. She was diagnosed with COVID-19 Delta. She had no symptoms prior to that Sunday after the shot. I decided to post because I am unsure whether the shot gave her COVID or not. Maybe she already had COVID and the shot exacerbated it. My grandson developed COVID three days later after her. Everybody in the household had had the shots.
Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 18-Jul-2022; No adverse event; Administered the vaccine to patients after the 30 day by used; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 18-Jul-2022), EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patients after the 30 day by used) and NO ADVERSE EVENT (No adverse event) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 18-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 18-Jul-2022), EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patients after the 30 day by used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 18-Jul-2022) and EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patients after the 30 day by used).    No concomitant medications were reported. The vial was initially stored in the refrigerator on 04-Jun-2022. The vial did not undergo any temperature excursions. No treatment medications were reported.
Patient was given a covid shot . She waited for 15 minutes  and being ok ,, she was sent home. On July 16 , the mother came and told us that her daughter was having side effects from the shot and was gone to ER . She was having HEART PALPITATION, ABDOMINAL PAIN , GAS , and SHORTNESS of BREATH if she walked a short distance . She visited her PCP , who couldn't identify  the cause . Blood tests were done at the doctors office.
Swelling, induration, heat, pain at injection site. Fever, chills, sweats.  Diagnosed as cellulitis.
Narrative: 73 y/o male VACCINATED with medical comorbidities including ESRD secondary to nephrolithiasis and horseshoe kidneys s/p kidney transplant 1/29/20 (tacrolimus, mycophenolate, and prednisone), DVT of the RLE ( completed AC 3 months, IVC filter removed in 6/17/19), HTN, T2DM (7.1% 5/21), and HLD that presents to the facility ED with fevers, chills, lightheadedness after Regeneron transfusion earlier. Patient was fully vaccinated with COVID vaccine Moderna on 1/12/21 and 2/9/21. Date of onset of symptoms: 8/9/21
patient stated he was hypertensive and was sweating and his heart was racing. he asked us to call ambulance. fire department came in and checked his vitals. they did not take the patient.
Mother stated child had rash over body and face beginning at 6PM 11/15/2004. No fever. No SOB. Mother stated rash looks like hives. Taking fluids okay but not eating too well did not know if any one had been sick at school. Call came at 6:30PM 11/16/04.
Tachycardia, shortness of breath, and lightheadedness particularly when climbing stairs. Periodic chest tightness and occasional left arm muscle spasm near injection site. Symptoms have persisted for 3.5 weeks thus far, and continue to worsen.