chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse and a consumer concerning an 11 year old female who on 13-Aug-2008 was vaccinated with the first dose of VARIVAX (Merck) (lot# 660079/0331X), in the right upper arm. On the same day, the patient received the first dose of (ADACEL lot# 02995AA), subcutaneous route, in the right deltoid and The patient was vaccinated with a second dose of MMR II, lot# 658931/0239X, subcutaneous route in the right upper arm. On 14-Aug-2008, the patient experienced redness, itching and swelling on back of her R arm and a large bump the size of a quarter at the injection site. The patient may have also experienced fever and / or pain and burning while getting injected with the vaccine. At the time of reporting , the patient sought medical attention by calling the office. This is one of several reports provided by the same source. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements and was released. No additional information is expected.
Pityriasis rosea rash on upper torso and back, began 14 days after vaccination, rash is ongoing currently on 1/25
pt recvd vax & exp a lichenoid rash; approx 3 months p/dose 2 presented to dermatologist w/ a lichenoid papular rash of the wrists & back; pt had Gianotti-Crosti synd;
headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) in a 47-year-old female patient 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, 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 experienced HEADACHE (headaches). At the time of the report, HEADACHE (headaches) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-358529 (Patient Link).
extreme tiredness, chills, fever of 100.5, loss of appetite; took 2 Tylenol 2x; recovered after 36 hours
Chills, fatigue, lowgrade temperature, nausea, headache, trouble sleeping, body aches lasted about 16 hours. Injection site soreness lasted about 36 hours.
Severe joint pain all over began around 10 hours post vaccine most of which resolved around 24 hours later. Unfortunately I have continued hand and wrist joint pain for weeks now making it hard to complete tasks sometimes. I will need to see a doctor when my schedule allows it.
Redness - 3cm, itchiness, swelling - lump 4 1/2 cm R upper thigh.
I could feel the injection - like a sensation going through the body through the veins - I went to 5 doctors (one was nurse practitioner). The day after the second vaccine, the next day, I had all the flu-like symptoms. On the 12th, I had shoulder pains - I couldn't lay down. Monday Express Care 15th - Memorial - take Aleve for extreme pain in right shoulder joint. And  pain in feet too.  But it moved to my left shoulder and moved down my arms and to hands. Physical therapy -on 16th, started physical therapy. Friday, 26th, going to Physical therapist - they were trying to get me to move my arm - but I had numbness in right hand - in my fingertips. I lost the strength in my hands, too. And then I loss my balance a bit, too. I couldn't sleep at night. Pain was always there.  I called a doctor and the nurse made an appt for any doctor to see as soon as possible - Dr. - Orthopedist primarily - he told me it was a problem with my neck. He took me to take two Valium - no relief from that. He also took an x-ray in his office - said it was a cervical disk disease. He thought it was my neck. He didn't know though. I was in misery. On 27th, I had the worse pain in shoulders, and hands and in my hips. I went back to Express Care - and saw a nurse practitioner. - She gave me small dosages  of Prednisone; Dicloferic gel - to put on my shoulders (Prescription). I walked around rotating ice and heat. She told me to go to ER if it got worse. I had no change with those. I went to get a massage on March 1st - was up all night after that.  I got an appt with Dr. on March 16th. Got another massage with someone else - couldn't get my shoulders to move in shower. MRI -I got a copy but it wasn't my head.   On the 6th of March  - ER - Dr. at ER - I couldn't pull my pants off.  He gave me Dexamethasone 4 mg;  Ondansetron  - for nausea.  He also gave me Hydrocodone  - pain. I cancelled Physical therapy on my shoulder and went to  Dr. - on March 10th - Medical Center -in (medical center) (He's no longer at Medical Center now anymore.) I was so miserable and he gave me Meloxicam. I finally get into Dr.  on March 16th and I think I was on the last medication. Dr.  - took blood test and I got the results and it says I have PMR - Poly Myalgia Rheumatica. He started me out 20 mg of Prednisone and I took it for a month. But it gave  me insomnia and made me agitated. Dropped it down to 10 mg. Terrible pain in my left leg started - June 30 around then. I took 1000 mg of Tylenol when getting physical therapy. (Dr. had signed me up for physical therapy for leg.) I have been going to physical therapist since July 13th. I just ended 8 sessions of it. I can walk again.
This 6-year old had no prior history of respiratory problems, specifically no history of asthma, croup, bronchiolitis, bronchitis or pneumonia. One day after receiving the FluMist live virus nasal influenza vaccine, the child began developing coryza. By the following day he began having difficulty breathing. By the time his mother brought him to the emergency department, 2 days after the vaccination, he was in respiratory distress. His respiratory rate was in the 50's with labored respirations, suprasternal, infracostal and rib retractions. This required emergency treatment with nebulized bronchodilators and supplemental oxygen. He was transported by critical care ambulance to hospital for admission.
This non-valid spontaneous report was received from a physician regarding a patient of unknown age and gender. The patient's pertinent information on medical history, concurrent conditions and concomitant therapies was not provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (formulation, exact dose, frequency, route of administration, lot # and expiration date were not reported). On an unknown date, the patient experienced an auto immune-mediated adverse reaction. The physician also reported the patient's symptoms suggested postural orthostatic tachycardia syndrome. The outcome of the events was not reported. The causality assessment between the patient's immune-mediated adverse reaction and postural orthostatic tachycardia syndrome with GARDASIL 9 was not provided. Upon internal review, the patient's immune-mediated adverse reaction was considered medically significant. Follow-up information was received from the physician who stated that he had contacted Merck Medical Information (JAN-2018) regarding a request to obtain additional information regarding GARDASIL 9 auto-immune mediated reactions and the GARDASIL 9 but never received a response, and that he would be happy to provide additional information on the adverse event or medical events, once Merck helps him with his request. He also provided additional contact details. It was also reported that, on unknown date, an unknown patient experienced adverse events after receiving GARDASIL 9. Follow up information was received from physician via company representative regarding a female patient of unknown age on 23-AUG-2018. The patient was vaccinated with GARDASIL 9 on an unknown date in December 2017. On an unknown date (reported as 4 days later), the patient developed syncope. Syncope/presyncope was continued for several weeks. On an unknown date, patient was evaluated in cardiology. On an unknown date, the patient was evaluated in emergency room and diagnosed with slight leukocytosis.  On an unknown date after 3 weeks of vaccination, the patient was unable to walk a block, unable to sleep and also experienced burning sensation in brain and core (burning sensation and feeling abnormal), gastrointestinal side effects (gastrointestinal disorder), nausea and vomiting, severe gastric pain, vivid nightmares, weight loss, sleep paralysis and medically withdrawn from school. On an unknown date, the patient was diagnosed with postural orthostatic tachycardia syndrome (POTS) by dysautonomia specialist and told POTS was secondary to GARDASIL 9. It was reported that the patient was quite impaired even after 8 months (not recovered). Causality assessment was not provided.
received first dose years ago, not received second; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose years before reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable for this report. The patient had not received the second dose until the time of reporting, which led incomplete course of vaccination. The patient did not have information on the lot/expiration date, date/route of administration, dose and left/right arm. The reporter consented to follow-up herself and with her health care professional.
Within 12 hours of vaccines, she started with splotchy red rash, fever to 101.7, feeling tired; lasted 2 days
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Medium, Additional Details: patient felt dizzy and weak immediately after the vaccine was administered. the pharmacist called 911 immediately. the emt arrived on site within 20minutes and checked patient's vital. patient confirmed that he is feeling better and refused to go to the hospital. left the store after leaving his contact information
No adverse event; They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053c21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day 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 (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.).    No concomitant medicine were reported. No treatment medicine were reported. lot 042J21A should have been reported with a BUD of 17-Feb-2022.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live non significant follow up; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
NOTIFIED PHYSICIAN OF AGE INAPPROPRIATE VACCINATION FIRST, THEN LEFT VOICEMAIL FOR MOTHER WITH NO RESPONSE
Adult dose given to a pediatric patient; Adult dose given to a pediatric patient; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 3-year-old male patient who received HAV (Havrix adult) (batch number 2BA99, expiry date 1st December 2022) for prophylaxis.   On 1st December 2022, the patient received Havrix adult. On 1st December 2022, unknown after receiving Havrix adult, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 06-DEC-2022 Reporter's Comments: Medical assistant reports an adult dose of Havrix was inadvertently administered to a pediatric patient. The reporter consented to follow up. Additional Supportive Information: The pediatric patient received adult dose of Havrix inadvertently, which led to accidental overdose and adult product administered to child.
8/01/06 started with fever on 7/30/06. Rash started 7/31/06. Rash was raised, red and generalized. ProQuad vaccine given 7/20/06.
Vaccines stored in the refrigerator underwent several temperature excursions; No adverse event; Vaccines stored in the refrigerator underwent several temperature excursions; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines stored in the refrigerator underwent several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccines stored in the refrigerator underwent several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     The patient had no allergies to medications, food, and other products.     On 21-Sep-2022 at 1:21 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 21-Sep-2022 at 1:21 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccines stored in the refrigerator underwent several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines stored in the refrigerator underwent several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines stored in the refrigerator underwent several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccines stored in the refrigerator underwent several temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines stored in the refrigerator underwent several temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccines stored in the refrigerator underwent several temperature excursions).    No concomitant medication information was provided.  The patient received the vaccine in the deltoid muscle.  The vaccine was stored in the refrigerator at the time of the excursion. There were 2 unbroken cartons with 20 vials.  The vials of monovalent vaccines were moved from freezer to refrigerator on 07-Sep-2022. All the vials were not visualized.  No adverse reactions reported for the patient as per the reporter's knowledge.  No treatment information was reported.
apparently asymptomatic, tested covid positive on 7/18 per pt, tested positive by PCR at hospital  on 8/1
It was reported that a 68 year old female received a Yellow Fever vaccination on 1/6/00 and on 1/18/00, the pt complained of fever, stomach pain, light headache, sore throat and yellow stools. These symptoms persisted for 10 days and the pt was admitted to the hospital. From correspondence received on 3/14/00, it was reported that the pt complained of extreme irritability and bloating for 1 month, post vax. It was also reported that the pt was admitted to the hospital for 3 days.
C/o pain, redness/swelling L deltoid after receiving Tdap on 8/14/2014.  noted redness over the weekend. used some ice. Took Benadryl 8/19/15. Has ecchymosis prox L arm, appears to be over prox deltoid tendon.  Hematoma over L mid deltoid, is TTP.  Skin not hot, normal warm/dry temp to palpate. Has mild erythema, 1+ edema along lower deltoid, just above where she had Ace wrap.  Neg lymphnodes.
Scattered hives and wheals - treated with oral steroid q. Doubt related to vaccine; suspect food allergy but reporting to be safe.
Patient reported extreme redness in a large circumference on the arm where Prevnar was administered. She also has some injection site pain but no impaired mobility.
Patient received 3 doses of Moderna vaccine/ 3 doses administered/; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient received 3 doses of Moderna vaccine/ 3 doses administered/) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 07D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 28-Jul-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Patient received 3 doses of Moderna vaccine/ 3 doses administered/). At the time of the report, EXTRA DOSE ADMINISTERED (Patient received 3 doses of Moderna vaccine/ 3 doses administered/) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Initial report received from non-healthcare professional who is also a patient on 11 December 2012. A 56-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of Tdap or ADACEL vaccine Sanofi Pasteur (Lot number was unknown, dose number, route and site were not reported) on 11 December 2012. The patient was not sure if she received ADACEL or Tdap vaccine. The same day i.e. on 11 December 2012 after vaccination, the patient experienced stomach pain. Relevant diagnostic tests and corrective treatments were not reported. At the time of this report patient had not recovered from the events. Documents held by sender: none.
Pt recvd DTP/HIB/OPV & mom states pt cried for about 1 hr p/inject; pt recvd 1st immun on 12JUL91 then recvd same immun on 6SEP91 & approx 2 hrs p/inject pt screamed approx 1 hr & could not be consoled;
No additional adverse event; HCP reported an expired dose of RECOMBIVAX HB was administered to a patient.; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapy were not reported.     On 13-DEC-2022, the patient was vaccinated with an expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (expired product administered), lot # T032918, expiration date 12-NOV-2022, 0.5 milliliter for prophylaxis (route not reported). The licensed practical nurse confirmed that the vaccine had no prior temperature excursions. No additional adverse event or product quality complaint were reported.
pain; tingling in finger tips; This is a spontaneous report received from non-contactable reporter (Consumer or other non HCP) communicated to Pfizer Sales Representative.  A 48 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "pain"; PARAESTHESIA (non-serious), outcome "unknown", described as "tingling in finger tips".  Additional information: Description of Event: Pain and tingling in finger tips day after vaccine administered. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
DEVELOPED PSORIASIS PATCHES ALL OVER BODY, MOSTLY ON LEGS AND BACK SHORTLY AFTER; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included psoriasis vulgaris. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. Non-company suspect drugs included: risankizumab (solution for injection in pre-filled syringe, subcutaneous, batch number was not reported) 75 mg, frequency was not reported, from 17-MAR-2021 for psoriasis vulgaris. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included hydrochlorothiazide/losartan potassium, lovastatin, tadalafil, and vitamin d nos. On APR-2021, the subject experienced developed psoriasis patches all over body, mostly on legs and back shortly after. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with risankizumab was not reported. The patient recovered from developed psoriasis patches all over body, mostly on legs and back shortly after on 2021. This report was non-serious.
Left arm itching, swollen and skin on entire left arm was red and across shoulder to neck. Neck pain and headache.  Early evening I developed hoarseness and trouble breathing.  Went to Emergency room. They administered IVwith Benedryl; Prednisone; and Pepcid. After an hour my breathing was better and some of the redness on arm was better.  I went to physician on 2/5/2021 because of neck pain and was prescribed MethylPrednisolone Tablets, 4 MG. 6 day pack and was on day 3 when the symptoms started.
Severe itching involving the injection arm that began within hours of taking the injection and increased daily for a period of 9 days. Itching radiated down arm from injection site to elbow and got more intense until day 7 when it began to subside. Skin on the arm was hot, muscle was hard, but no rash and no fever. Use of topical Cortisone cream on day 4 helped slightly. Benadryl pill taken on day 5 had no effect. Itching has now stopped with no more heat at the injection site. No rash ever developed.                                                                                  . Oral Benadryl pill taken on day 5 didn't seem to reduce itching further.