chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen cervical lymph nodes on right side; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen cervical lymph nodes on right side) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen cervical lymph nodes on right side). At the time of the report, LYMPHADENOPATHY (Swollen cervical lymph nodes on right side) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.    This case was linked to MOD-2021-172105 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: For appending non-significant follow-up
This spontaneous report as received from a physician via company representative, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 03-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J009689 with expiration date of 29-JAN-2015 (route of administration was unknown), which was stored at 34 Fahrenheit (F) Degrees (1.111111111 Celsius) for a total of 144 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effect were reported nor product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
BODY ACHES; CHILLS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 01-APR-2021, the patient experienced body aches. On 01-APR-2021, the patient experienced chills. The action taken with covid-19 vaccine was not applicable. The patient recovered from body aches, and chills on 02-APR-2021. This report was non-serious.
Patient described "pain in arm with striations." Patient was diagnosed with Pneumonia on 9/07/09.
2nd/3rd wk JAN broke out like having measles;last week JAN lt side of neck was swollen-acts like mumps;rt thumb swollen-can't write easily;lt foot swollen;lt hip uncomfortable;bad stomach cramps;swollen wrist;numb;rheumatoid arthritis;vomit
Patient presented to the ED on 3/31/2021 and was subsequently hospitalized. She died on 4/16/2021.
Within 5 minutes of receiving the first COVID vaccine, Patient felt swelling and tingling in her tongue. She did not have any issues with her breathing, but her tongue felt heavy, swollen, and tingly for roughly an hour.  She did not take any medication after this reaction. Within 5 minutes of receiving her second COVID vaccine, she felt swelling, tingling, and numbness in her tongue. She also felt a flash of heat in her head that went away quickly. Following the flash of heat, her arms, legs, and fingers were ice cold and she had an internal tremble. I gave her 12.5mg of liquid diphenhydramine at 9:21am. This was 8 minutes after her vaccine. After several minutes, she started to feel better. Her tongue still felt heavy and she was still cold, but she could tell the reaction was going away.
Received pfizer vaccine on 7/23/21 and 8/13/21. Presented to ER on 1/17/22. and admitted due to sob and positive COVID-19 infection. He has been feeling sob for the last day or so. The beginning of his sx is not very clear. Pt is vaccinated with Pfizer twice 8/21. Pt is on 4 liters NC. He has CTA which showed RLL PNA with no PE. Pt denies fever or chills. No NVD. No dizziness. He feels weak all over. He has chronic back pain. Pt probably has bacterial PNA more than COVID-19 PNA. He was hypoxic and started on dexamethasone, ceftriaxone, and doxy. Discharged on 1/21/22 with Augmentin and doxycycline for 5 days dexa for 5 more days Ct with home meds Oxygen walk 1 liter with activity
Developed cellulitis to injection sites (bilat vast. Lat. sites). Within 24 hours of injections, requiring antibiotics and steroids. Developed rash to back 6 days later - may or may not be vaccine related.
pt recv vax AUG95 & on 3JUL97 pt exp herpes zoster on lt trunk & back;
Basal Cell carcinoma on face; This is a spontaneous report via Pfizer from a contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was due to get second dose next Tuesday and had a procedure to remove a basal cell carcinoma from her face this past Monday. She would like to know if she will be able to get second dose. She has not gotten an antibiotic since Monday. She would like to know if getting an antibiotic will interfere with getting second dose. On 15Mar2021, the patient had the procedure done to remove basal cell carcinoma on face which was found post 1st COVID vaccine and would like to know if that procedure will jeopardize the efficacy of vaccine. The outcome of the event was unknown.  Information on Lot/Batch number has been requested.
No additional adverse effects reported.; one male patient was administered improperly stored PROQUAD; This spontaneous report has been received from a nurse concerning  a 4 year old male patient . The patient's concurrent conditions, concomitant therapies and  previous medical history were not reported.  Information was extracted from data logger.  On 16-JUN-2020, the patient was vaccinated with  one dose of improperly stored (product storage error) measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S030210, expiration date 25-MAR-2021, therapy type rHA for prophylaxis  (strength and patient route of administration were not provided). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was reconstituted with properly stored sterile diluent (DILUENT MRK INJ).  The storage temperature was reported to be in between  6°F to l 4°F, more specifically  in 11.97 °F for  a period of 10 minutes. No additional adverse effects were reported.
Heart palpitations that started instantly after (hx of pots), chest pain- did not report this because this is something that happens to her related to the POTS, sweats, dry mouth, arm pain- left side. Whole body was "on fire" starting the next day- felt sweaty all over. Lingering constant headache in the front of the head, exhausted and forgetting things. Reports she feels a "burning brain feeling" which she has had in the past. Foggy brain.
increase in blood sugar; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Lot number: ER8733) as dose number unknown, single for covid-19 immunization.   Relevant medical history included: "diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "increase in blood sugar". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient was diabetic and every morning he take his sugar count and it was always in 90s in that area. Caller stated after he got the shot which he got on Wednesday his blood sugar was 162 and then 148. Caller asked if there was an increase in sugar for the vaccine.   No follow-up attempts are possible. No further information is expected.
Infant vomited x4 and became lethargic, pale, still. 4 more non-bilious emesis preceded by shriek of pain. Taken to Emergency Department at 2 pm. Seen by MD at 7 pm.  Ultrasound revealed intussusception.  Reduced with contrast enema.  Admitted for 24 hours observation.   Additional vomiting during night; repeat ultra-sound was negative.  No additional symptoms or sequelae.
Mild early cellulitis, left deltoid 14 x 16 cm area of redness, swelling, unilateral good motion. Duricef given; changed to Cefzil.
Patient phoned with complaint of redness and swelling RT deltoid area 6-14-07. Then on 6/15/07 presented to ER where she was DX with cellulitis and treated same arm.
pt recvd vax & devel soreness, redness, warmth, induration & multiple buli @ the site of inject; pt was treated w/Keflex & a Medrol dose pack;
pt recv vax 15OCT96 & 11DEC96 pt devel a fever of 100.4, malaise, myalgia, & cough productive of small amounts of yellow sputum;also exp 2 noc of profuse sweating;pt has not yet recovered;t103, chills, myalgia, felt sick;
2 PLUM-SIZED LOCAL REACTIONS TO LEFT THIGH AFTER ADMINISTRATION OF MMR AND VARICELLA VACCINE.
Received 1st dose of the Moderna COVID-19 vaccine from a vial that had been first punctured on 07Jul2021 @ 3:42p with the syringe having been at room temperature approximately 24 hours when administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received 1st dose of the Moderna COVID-19 vaccine from a vial that had been first punctured on 07Jul2021 @ 3:42p with the syringe having been at room temperature approximately 24 hours when administered) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received 1st dose of the Moderna COVID-19 vaccine from a vial that had been first punctured on 07Jul2021 @ 3:42p with the syringe having been at room temperature approximately 24 hours when administered). On 08-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Received 1st dose of the Moderna COVID-19 vaccine from a vial that had been first punctured on 07Jul2021 @ 3:42p with the syringe having been at room temperature approximately 24 hours when administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  No treatment information was provided.
On 4/3 at 1030pm A big red round mark appeared around the injection site, it is warm to the touch, raised and itchy. Today 4/4 at 12:00 pm my arm is sore and red site is tender to touch
Information has been received from a physician concerning a 65 year old female with coronary artery disease, Crohn's disease, osteoporosis, and hyperlipidemia who on 21-Dec-2006 was vaccinated SC in the left side of the abdomen with a dose of Zostavax vaccine (lot#652947/1212F). Concomitant therapy included calcium (unspecified), famotidine, rizatriptan benzoate, Vicodin, simvastatin, alendronate sodium, "Asapchol", and "Toperol". On 27-Dec-2006, the patient developed radiating arm numbness and back pain. Unspecified medical attention was sought and the patient was being seen a neurologist on 28-Dec-2006. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
kidney infection; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a non-health professional and describes the occurrence of KIDNEY INFECTION (kidney infection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced KIDNEY INFECTION (kidney infection) (seriousness criterion medically significant). At the time of the report, KIDNEY INFECTION (kidney infection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatments to the events are not reported.  Based on the current case data, this case has been classified as invalid. It can be considered for assessment if only the follow up information provides some valid data.; Sender's Comments: Based on the current case data, this case has been classified as invalid. It can be considered for assessment if only the follow up information provides some valid data.
Pt experienced pain/redness in shoulder extending from shoulder to distal bicep. Woke up in middle of night with some pain and discovered that it was red and sore. Pt given some BENADRYL next day to see if redness would go down. Pt will call back next week if hasn't gotten better.
The first hour after receiving the first dose of Pfizer-BioNTech vaccine, I developed a headache, body aches, and lower abdominal cramping. Two days following the vaccine, my milk supply decreased by 8oz. My infant, who is exclusively breastfed, became irritable, restless, and unable to pass a bowel movement for two day. Excluding the headache that alleviated 48 hours after first dose, all symptoms are still present at the time of this report.
20-30 min p/vax pt dizzy, nauseated, pressure on temples; severe h/a; "heavy" feeling in body; next few wks exp blurred vision, fatigue, muscle aches, arthralgia & burning sensation in hands/feet;
Information has been received from a physician concerning a 47 year old female, with a history of drug reaction or allergy to an unspecified antibiotic, who on 30-JAN-2007 was vaccinated with Recombivax HB. On 01-FEB-2007, two days after receiving Recombivax HB, the patient developed Bells Palsy. The patient went to the emergency room, but was not admitted. At the time of this report the patient had not yet recovered, and the Bells Palsy persisted. The event of Bells Palsy was considered to be disabling. There was no product quality complaint. Additional information has been requested.
Erythematous rash with warmth size 7x5cm on lt thigh, onset after 181 q shot
Report received from a Pharmacy Buyer on 31-Oct-2008.  A patient (age/sex/initials not reported) received AFLURIA (CSL Influenza vaccine) on an unknown date.  On an unknown date, patient experienced vertigo.  Per the Pharmacy Buyer, she does not know any more details.  Pharmacy Buyer to have the Pharmacist call CSL Biotherapies and provide additional information.  Pharmacy Buyer would not provide name nor phone number of pharmacist.  No serious criteria mentioned.  Causality: unassessable/unclassifiable.  Follow-up information received on 03-Nov-2008 from a pharmacist.  A 49 year-old female received AFLURIA (CSL Influenza vaccine; lot 02349111A, exp date 30-Jun-2009) on 24-Oct-2008.  On 28-Oct-2008, she was experiencing vertigo.  Patient's physician does not believe the vertigo was caused by the AFLURIA, physician believes the patient's viral syndrome which she had two weeks prior to the flu shot was the cause.  Patient had not yet recovered.  Assessment:  The company considered this event unlikely to be related to the suspect drug.  Informaiton derived from this AE report does not change the current safety profile of AFLURIA (CSL Influenza vaccine).
cellulitis p/DTP/A; rt upper arm 3x6cm of redness; DPH given; recvd Claforan IM & Augmentin;
Initial information received on 29-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an elderly patient (age was reported as 95) who was vaccinated with doses of FLUZONE HIGH DOSE (lot number: UJ039AA and expiry date: 15-May-2019) on 11-Oct-2018 and 25-Oct-2018 respectively. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to extra dose administered and inappropriate schedule of drug administration. It was not reported whether the patient experienced any adverse event was reported following the vaccination. 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. Documents held by sender: none.
Information has been received from a physician concerning a 2-month-old patient who on an unspecified date was vaccinated orally with a first dose of ROTATEQ.  It was noted the patient received "routine vaccinations for second month visit given on the same day" as ROTATEQ.  On an unspecified date the patient experienced severe diarrhea for 3-4 days and was hospitalized.  On an unspecified date the patient had blood work performed.  At the time of the report the patient's status was unknown.  A product quality complaint was not involved.  Additional information has been requested.
Varicella vaccine break through. Had 2 doses of varicella vaccine. Diagnosed with varicella in office on 6-25-09.
Shingle; This case was reported by a physician via sales rep and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 11-MAY-2022 Reporters comment: In 2018, within a few days after receiving Shingrix, the patient within the reporter's clinic experienced a case of shingles. The reporter did not consent to follow up. Additional supportive information: This case had been linked with case US2022AMR077357, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR077357:Same reporter. Patient 2 of 2.
SOB, nasal congestion and rhinorrhea with postnasal drip, productive cough with copious clear sputum, pins and needle feeling in his chest bilaterally with inspiration.
No adverse reaction. Individual had their first dose March 27th, identified they were under 18. Following CDC guidelines will be giving 2nd dose of Moderna on 5/1.
This was a booster vaccine.  Loss of hearing in right ear the day following the booster shot.  Experienced same exact symptoms several months after vaccine #1 and #2 (January 2021).   Treated by a specialist (August & September, 2021)  and prescribed a steroid, twice, until it finally righted itself.
these little spots of blood under the skin like its trying to come up; rash around that area where I was given the vaccine; like my arm started itching; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like arm started itching, little spots of blood under the skin like its trying to come up and rash around that area where I was given the vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient experienced the event, like arm started itching. On an unknown date, the patient experienced the events, little spots of blood under the skin like its trying to come up and rash around that area where I was given the vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, arm started itching, little spots of blood under the skin like its trying to come up, rash around that area where I was given the vaccine was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
3/5 10pm  My lungs felt like I had taken antihistamines.               3/5 11pm  -  3/7 9am  Entire body aches, chills and everything taste the same.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/26/2023 ANEMIA ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/26/2023 GI HEMORRHAGE ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/26/2023 LOWER GI HEMORRHAGE ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/26/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/26/2023 PERICARDIAL EFFUSION ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/26/2023 PERICARDIAL EFFUSION
Information has been received through the manufacturer pregnancy registry from a health professional concerning a 34-year old female who on 13-Feb-2004 was vaccinated with a dose of varicella virus vaccine live (lot number not available). The patient's last menstrual period was 11-Jan-2004. The patient was pregnant at the time of vaccination. No additional information was available unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Inflammation and redness at injection site that required steroid injection. Resolved 1 week after steroid injection.
COAGULOPATHY, UNSPECIFIED TYPE ACUTE DVT, UNSPECIFIED VEIN ACUTE PULMONARY EMBOLISM
It started with a very painful headache about 8 hours in. Then chills.   Overnight, I experienced the worst period cramps of my life. I could actually feel my uterus repeatedly, violently contracting when I placed my hand on my pelvis. Very heavy bleeding. Along with other muscle spasms in my legs and arms.   Most of Friday I was glued to the bed. Any movement was exhausting. The only way I could get any rest from the chills was with an electric blanket at max heat. I was trying to hydrate but then I always had to pee really bad and when I went to the bathroom not much came out.   Around 9pm on Friday, shortly after I took some ibuprofen, the chills turned into sweats. I was finally able to eat a little something and was able to pee. 12 hours of sleep later I was fine.   Day 4 I still have pain in my arm at the injection site but it lasted 4 days with the first shot as well.