chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm is swollen; itching; bones hurt; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In September 2022, the patient received the 1st dose of Shingles vaccine. In September 2022, less than a week after receiving Shingles vaccine, the patient experienced swelling arm, pruritus and bone pain. Shingles vaccine was discontinued. On an unknown date, the outcome of the swelling arm, pruritus and bone pain were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, pruritus and bone pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient got his/her first shot and left arm was still swollen a week later (itching, bones hurt). The patient said he/she was not getting the next one. Additional Supportive Information: The follow-up would not possible, as no contact, details were available.
On the following day of vaccine employee started to experience body aches, headaches, and chest tightness.
Pfizer vaccine administered at 3:00 pm.  At 3:25, patient reported "tingling" in throat.  Pt denied all other symptoms.  No dyspnea, hives/rash, GI symptoms noted.   Patient administered cetirizine (10mg) and diphenhydramine (25 mg) at 3:36 pm.
Pt received flu shot and could not lift shoulder next day. Went to doctor. MD said shoulder "bursa punctured" and Rx steroids were given.
I had covid 19 last year and was hospitalized from 06/21/20 through 09/23/2020 at the Hospital. Some hours after receiving the vaccine I started feeling chills, headache, started vomiting and my blood pressure started bottoming up that is when I was rushed to the ER. I was admitted and stayed 2 days. They said it was not related to the vaccine. First they told me it was sepsis. Then they told me it was pneumonia, not sepsis. Then said it was a bacterial infection. I sincerely do not know what I had. I am doing better now. My PCP did not recommend me to receive the second dose.
Product storage error; The patient received a dose more than 30 days in the fridge of the Moderna COVID-19 Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received a dose more than 30 days in the fridge of the Moderna COVID-19 Vaccine) and PRODUCT STORAGE ERROR (Product storage error) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Nov-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) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a dose more than 30 days in the fridge of the Moderna COVID-19 Vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (The patient received a dose more than 30 days in the fridge of the Moderna COVID-19 Vaccine) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  The patient received a dose of the Moderna COVID-19 Vaccine which was kept more than 30 days in the fridge.
Red, rash-like circle developed on arm one week post-injection.  There is also some swelling and soreness.
p/24hr inflammation (soreness/swelling) in lt deltoid;pt mom instructed to use warm then cold packs & anti-inflammatory for soreness;no reaction to prev immun;
Date the vial was initially stored in the refrigerator was 03-Jan-2023; No adverse event; Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 03-Jan-2023) and NO ADVERSE EVENT (No adverse event) in a 6-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018c22a) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 03-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 03-Jan-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 03-Jan-2023) 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 EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 03-Jan-2023).    No concomitant medications were reported.  It was reported that 2 patients of age 6 Years received expired dose of vaccine. Monovalent vaccines of vial size 2.5 ml from carton 4 were administered. The vial was initially stored in the refrigerator on 03-Jan-2023. Beyond use date was reported as 01-Feb-2023 The vial did not undergo any temperature excursion.  No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-709273 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-709273:2nd patient
Chest and heart congestion, chest tightness, coughing, nausea, sleeping difficulties, diarrhea, weakness, flare up of acid reflux, and extreme muscle fatigue and pain making it difficult to walk last 2 to 3 days. She rested alot and  is finally feeling back to normal 7 days later.
This spontaneous report as received from a licensed vocational nurse refers to multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # L007226, expiry date 03-MAR-2017 or lot# L019126, expiry date 27-MAY-2017 (routes and doses were not reported). No adverse effects were reported. Additional information has been requested.
Persistent headache, starting the day after vaccine and continuing for approximately 6 weeks, intermittent headaches since.  I don't typically get headaches, so this is very unusual.
Patient received the vaccine on 1/17/2019 and complained of the usual muscle soreness for about 3 days after the SHINGRIX Vaccine. On 2/13/2018 patient complained about cramping at the injections site and tingling. Pharmacist spoke to patient on 2/13 and 2/14 to verify symptoms.
Swelling eyelids, increasing tearing and nasal congestion - injection conjunctiva - 1/2 in after injection.  Pulse ox 95 - 97.  Benadryl 25mg given IM - felt better, tearing and nasaling ceases.
No affects day of vaccination (3/5/21, 2:00pm). Slight head & body aches the next morning increasing slightly throughout the day. I self medicated with Tylenol 500mg/4hrs. Around 10:00am, a cough started increasing throughout the day becoming more pronounced and persistent until appx 6pm when I started expectorating a small amount of clear/slight yellowish phlegm. I self medicated with Vicks NyQuil throughout the night with the cough persisting. The next morning aches were at bay with the Tylenol but the coughing persisted and continues today (3/8/21).
Before the vaccine his lungs were full of fluid after the vaccine his lungs were clear; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Before the vaccine his lungs were full of fluid after the vaccine his lungs were clear) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 030M21A) for COVID-19 vaccination.     Concomitant products included TEMAZEPAM, HYDROXYZINE PAMOATE, ROSUVASTATIN CALCIUM (CRESTOR) and LISINOPRIL for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Before the vaccine his lungs were full of fluid after the vaccine his lungs were clear). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Before the vaccine his lungs were full of fluid after the vaccine his lungs were clear) outcome was unknown.            Treatment information was not provided. The patient reported that no drug treated the fluid that got filled in his lungs but after the administration of vaccine it got clear.  The fluid accumulation in the lungs never happened since vaccine administration.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow up document received on 12 Jul 2021. The narrative and contact details were updated. On 03-Aug-2021: Follow-up contains No New Information.
severe itchiness; redness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (severe itchiness) and ERYTHEMA (redness) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PRURITUS (severe itchiness) and ERYTHEMA (redness). At the time of the report, PRURITUS (severe itchiness) and ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
This spontaneous report was received from a physician via field employee refers to multiple unspecified patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, multiple unspecified patients were vaccinated with improperly stored RECOMBIVAX HB injection 10 y (unspecified) lot # L027733 (expiry date: 13-SEP-2017), L025738 (expiry date: 14-AUG-2017), L016427 (expiry date 13-APR-2017) (dosage not reported). This vaccine was lot # L027733 was stored at temperature 31.3F, time frame was 211.45 hours and no previous temperature excursion was reported. This vaccine with lot t# L025738 was stored at temperature 31.1F, time frame was 419 hours and no previous temperature excursions was reported. This vaccine with lot # L016427 was stored at temperature 31.1F, time frame was 552 hours and no previous temperature excursion was reported. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Fever up to 103.4 F started 8 hours after vaccination with nasal live attenuated influenza vaccine. Fever lasted for 30 hours. N0 other localizing symptoms.
Breakthrough Covid-19 infection; Breakthrough Covid-19 infection; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 03Nov2021 (Lot number: EW0217) at the age of 37 years as dose 3 (booster), single, intramuscular, administered in arm right, administration date 17Feb2021 (Lot number: EL3247) as dose 2, single and intramuscular, administered in arm right, administration date 28Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunization at Workplace clinic. The patient's relevant medical history and concomitant medications were not reported. No other vaccine in four weeks. No covid prior vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Jan2022, outcome "recovered" (Jan2022) and all described as "Breakthrough Covid-19 infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Jan2022) positive, notes: Nasal Swab (covid tested post vaccination reported as Yes). Therapeutic measures were not taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Within one hour of injection, swelling, redness, warmth at injection site. Left hand tingling and tightness of site evening of injection, which abated.  48 hours after injection, site remains, red, swollen and tightness of skin present.
Pt recvd 1st dose of vax 24JUL92 & approx 3 to 4 hrs p/vax devel urticaria w/itching;
12/24- Had tingling in fingers on both hands and red non-raised skin rash on the right side of neck about two inches long; 12/26- 12/27: Had cold chills but no fever and muscle aches; 12/28 - 12/29: Developed sinus symptoms (runny nose and sneezing); 12/30: continued tiredness and aching; Took Claritin 12/28 for possible allergy symptoms with no relief
This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a 58-year-old female patient who received SHINGRIX for prophylaxis. In March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was recovered/resolved. The reporter considered the injection site reaction to be probably related to SHINGRIX. Additional details were provided as follows: The patient received her first dose of SHINGRIX in March or April 2018 and experienced a reaction at the injection site. For tolerance to the 2nd dose of SHINGRIX vaccine, refer case US2018GSK111506 reported for the same patient.
Fever; Feeling warm; Flushed; Headache; Chills; Swelling at the injection site; Tenderness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feeling warm), FLUSHING (Flushed), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE SWELLING (Swelling at the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, Glaucoma, Asthma and Allergy.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced FEELING HOT (Feeling warm), FLUSHING (Flushed), HEADACHE (Headache), CHILLS (Chills), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (Tenderness at injection site). On 09-Feb-2021, the patient experienced PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) from 08-Feb-2021 to 09-Feb-2021 for Headache and Fever, at a dose of 1 dosage form. On 10-Feb-2021, PYREXIA (Fever) had resolved. At the time of the report, FEELING HOT (Feeling warm), FLUSHING (Flushed), HEADACHE (Headache) and CHILLS (Chills) was resolving and VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (Tenderness at injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Body temperature: 100.8 (Inconclusive) 100.8F. On 09-Feb-2021, Body temperature: 100.1 (Inconclusive) 100.1F.         The concomitant medication included blood pressure medication, glaucoma eye drops, asthma medication and allergy medication. Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2021: Patient history were added. The concomitant medication details added.The product first dose details was added. The event outcome of feeling hot, flushing, headache and chills were updated to resolving and the treatment information updated.
Mailed correspondence from  Lederle Labs regarding events in Ohio. A physician reported that a 4 month old male received (his routine vaccinations at 4 months of age) Prevnar (Lederle), diphtheria -tetanus and acelluar pertussis (Acel-Imune, Lederle), Haemophilus influenzae type B (Lederle ) Hepatitis b (manufacturer unknown) and IPV (Aventis Pasteur SA ) vaccines in 04/16/01 and later that day, developed urticaria with a few target lesions. He was seen by the physician  on 04/17/01 and was treated  with diphenhyramine. The patient has been refereed to an allergist to 'sort out allergy". As of this date, no further information was available. From additional correspondence received on 09/04/01, it was reported that the patient recovered from this experience. Additional patient and vaccine information, and the responsible physician's telephone number was provided. This case is closed.
10 days after vaccination, pt sx were real discomfort from (R) mid back radiating around torso, underarm, and (R) breast area. Rest began a few days later starting with small red patches on back & spreading around torso and breast. No pustules noted. Started on Valtrex on 6/3/2010.
Increased enlargement of liver + spleen. New onset of abdominal pain, especially area of liver/spleen. History of CFS. Now elevated liver enzymes, pain + mesenteric adenitis.  12/08/09 Gastroenterology consult notes received for DOS 11/30/09. DX:  hepatosplenomegaly and steatosis.  Pt presented with elevated transaminases and abdominal pain.  Physician will repeat liver panel in 4 wks to test for persistent elevation of transaminases.  Pt continues with chronic fatigue. Pt scheduled for F/U visit and a possible liver biopsy.  12/08/09 Gastroenterology consult for DOS 11/23/09. Impressions: hepatosplenomegaly, steatosis, elevated ALT.  Pt c/o fatigue for 11 mos, malaise, bilateral upper quadrant abdominal pain, fever; "waxing and waning diffuse tender lymphadenopathy", and weight gain. Pt's Dr considered several possible explanations: mesenteric adenitis, NAFLD, inflammatory/infectious process such as HSM, thyroid, EBV and Wilson's disease.  12/08/09 Visit notes for DOS 11/26/09: Pt seen for chronic fatigue syndrome.
90-year-old male with past medical history of hypertension and other medical conditions presented to the hospital with complaints of generalized weakness and shortness of breath.
Presented to ER on 11/27/21 and 10 day prior was having some  trouble breathing, cough, so tested twice for COVID and they were positive.   Her son, their kids, wife, etc., also positive.  Patient did not feel too  well, could not get any better.  Called the primary care provider and she was  told to take Tessalon Perles but did not seem to help her much.  She kept on  getting worse.  She came to the emergency room day on 11/26.  A workup  was done.  Patient was treated with antibiotic, steroids, bronchodilators and regerone.  Discharged on  antibiotics, steroids and inhaler, etc., but went home and did not feel any  better, so prompted to come back, started having hemoptysis.  She is complaining of generalized weakness,  shortness of breath, and cough, now productive of hemoptysis.  In the ER, she  was evaluated.  Day before, she had normal WBC count, but now it is mildly  elevated, probably due to steroids, but she is also quite hypoxic requiring  5-6 L of oxygen and the CT was done due to elevated D-dimer without contrast  since she is allergic to dye, which shows extensive bilateral COVID  infiltrates and then V/Q scan was done, which was indeterminate as far as PE  is concerned.  Venous Doppler study of both lower extremities are negative.   Patient's main complaint is now cough, hemoptysis, weakness, etc. Placed on azithromycin and ceftriaxone.  On oxygen so placed on remdesivir and steroids. Oxygen saturation and respiratory distress continued to worsen and she required mechanical ventilation.  Was intermittently prone.  Inflammatory markers followed.  Had elevated LFTs likely secondary to illness the trended down over the course of her hospital stay.  Had an episode of hypotension on 12/05/2021 and was off of her blood pressure medications at that point but did respond to fluid bolus.  She was extubated on 12/08/2021.  Initially was doing pretty well on 3 L of oxygen.  Started having significant amount of coughing and dysphonia.  Was very cautiously trialed on some p.o. but swallow study revealed that she aspirated with even minimal p.o..  Was noted on 12/11/2021 to have hematuria and urine cultured positive for Pseudomonas.  Was placed on Maxipime.  On 12/12/2021 required intubation.  Was extubated on 12/15/2021.  Had been started on vancomycin in addition to cefepime for aspiration pneumonia.  Continued to have very poor swallowing with aspiration and underwent PEG tube placement on 12/16/2021.  Continued very weak and was felt with need significant rehabilitation.  Case Management consulted to facilitate placement in rehab type setting.  Continue to work with speech therapy to optimize swallowing.  There was some improvement prior to discharge.  By 12/28/2021 all antibiotics courses had been completed.  Nursing home placement proved difficult but it was felt by patient's daughter and the rest of the family that they could care for her at home and arrangements were made to continue with tube feedings and appropriate follow-up with physical therapy, speech therapy etc..  She was discharged to home with home health care to follow on 12/30/2021.
On August 16, patient had high fever, cough and congestion. Took him to the doctor and was prescribed Albuterol inhalation. After 2 days , patient developed 2-4 pimple like rash in the face, trunk area and  after 2 days, it kept on increasing all  over his scalp, face, limbs, trunk.
Swelling redness and warm to touch on (L) upper arm. Cold pack and Tylenol provided to patient, parent stated this help for comfort
Patient received vaccine in left arm IM. PAtient then stood up and fainted on the ground. Patient woke up about 10 seconds after falling. Patient was sweating and felt dizzy. PAtient stayed sitting until they felt better for about 15 minutes.
Hypertensive with BP=203/98; Paulse =120; Temperature =101.3. Patient given comfort measure, 911 called, and transported to ER for higher level of care.