chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a certified medical assistant concerning an unspecified number of patients (demographics unknown). On 18-SEP-2014, the patients were inadvertently administered with improperly stored GARDASIL (Lot # K006095; expiration date: 02-FEB-2017) (dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
No adverse events noted. Moderna vaccine (approved for 18+) inadvertently administered to 17 year old patient. Per CDC guidelines, will proceed with 2nd dose.
Day after getting shot I suddenly began to itch all over from head to foot, stinging itches. Horrible lasted 45 minutes till I used medicated powder. Never had a reaction in past Had red rash all over.
LIGHTHEADED AND DIZZINESS. FELT BETTER AFTER EATING. PATIENT STATES THEY HAVE NOT EATING ALL DAY AND THINK ITS BECAUSE OF NOT EATING.
This 18 year, 5 month old patient presented for annual exam. Order was given for Hep A vaccine #1. Nurse gave adult Hep A instead of pediatric dose.
I had a headache quite severe and arm pain; I had a headache quite severe and arm pain; Dizziness; Hot flashes; This is a spontaneous report from a contactable consumer for herself.  A 55-years-old female patient started to receive bnt162b2 (BNT162B2; Lot # EJ1685) vaccine , via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunisation .  The patient medical history was not reported.  Concomitant medication included liraglutide (VICTOZA).  The patient had a headache quite severe,  arm pain, dizziness and hot flashes  on 19Dec2020 with outcome of recovered.  The patient also stated that everything was fine by Sunday.
This spontaneous report was received from a pharmacist refers to patient of unknown age and gender. The patient's concurrent conditions, medical history and drug reactions and allergies was unknown. The patient's concomitant therapy included sterile diluent. On 09-DEC-2017, the patient was vaccinated with one dose of improperly stored ZOSTAVAX (units and frequency were unknown) (Lot # N020943 and expiration date 26-OCT-2018) for prophylaxis. Reporter informed that, there was temperature excursions for the ZOSTAVAX (Lot # N020943 and expiration date 26-OCT-2018) at a temperature of 6°F to 14°F and time frame 10 hours 45 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported.
Left deltoid injection site erythema, induration, and warmth with an annular ring appearance approximately 4 inches in diameter. Very pruritic. No systemic symptoms suggestive of infection.
pt reports she had a rash form starting 2 days after the covid vaccine on 12/13/21, pt presents with red blisters mostly on chest and a little on the arms. pt states rash has started to improve, no other side effects were experienced. pt was not going to report incident until a friend told her to.  recommended observing the rash and informing provider on monday
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness) and PAIN (achiness) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (soreness) and PAIN (achiness). At the time of the report, PAIN (soreness) and PAIN (achiness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported by reporter. No treatment medications provided by the reporter.
My housemate contracted Covid and tested positive on 04/27. I had a fever and other Covid related symptoms, but multiple Covid tests came back negative. I took an at home test, a rapid test at a local urgent clinic, and a PCR test and they all came up negative. I had sore throat, headache, and nausea with body aches and chills as well. The urgent clinic advised that I just treat my symptoms with over the counter medication and rest and hydrate. I rested and took their advise and began to feel better after around 36 hours.
pt became ill w/what seemed to be flu sx over christmas 24DEC, 25DEc & 26DEC;very sick w/body aches, sore throat & fever;
48 hours post immunization, patient had 4 inch diameter erythema, swelling to site (+) pruritic.
Muscle Pain; Joint Pain; Feverish; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration on an unknown date (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date the patient experienced muscle pain, joint pain and feverish. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were not taken as a result of the event. The clinical outcome of the events muscle pain, joint pain and feverish was recovered on an unknown date at the time of this report.   No follow-up attempts are possible. No further information is expected.
Patient is a very pleasant 83y.o. year old  male presented to the ER on 10/2 with complaints of constipation as well as lower back pain related to a fall the day prior. The patient states he was getting into his car on 10/1 when he passed out and fell to the ground. His wife and daughter assisted him back into his car, and brought him home. He did sustain an abrasion type injury to the left side of his neck during the fall, but otherwise denied any complaints. He states that the primary reason he was brought to the hospital was because he was constipated. He denies any fever, chills, shortness of breath, cough, or chest pain. On evaluation in the ER he had stable vital signs other than mild tachycardia at 99, and was maintaining an O2 sat of 97% breathing room air. He was afebrile and has remained so since presentation. Laboratory revealed a minimally elevated WBC count at 11.9 with neutrophilia, mild lymphopenia. Electrolytes were normal, as well as his renal function and he had a mildly elevated alkaline phosphatase and direct bilirubin level. SARS CoV 2 was positive by NAA. UA revealed cloudy yellow urine with hematuria, pyuria, no bacteriuria. Imaging included a CT abdomen/pelvis which revealed a previously noted T9 vertebral body fracture, a fecal home a with "findings concerning for early stercoralis colitis", bilateral renal calculi without hydronephrosis, prostatomegaly, and an infrarenal aortic aneurysm minimally enlarged from a previous scan in 2012. A CT chest revealed the T9 vertebral body fracture as previously noted with hardware in place from recent fusion T8-T10, and "increased reticular opacities . . . " Blood cultures were obtained, and the patient was admitted to the hospital and placed on ceftriaxone and metronidazole. He underwent disimpaction earlier today, and states he is much more comfortable following the disimpaction. ID is consulted regarding his Covid.
Information has been received from a physician concerning a 7 year old female who on 14-AUG-2003 and 20-NOV-2006 was vaccinated with the first and second dose of MMR II (lot # not reported) respectively. On 04-DEC-2009, the patient was diagnosed and the patient was afebrile. On 05-DEC-2009 the patient experienced mumps. It was reported that the patient had pain in the lower jaw. The outcome of the patient was not reported. It was unspecified if the patient sought medical attention. Follow up information from the physician indicated that on 04-DEC-2009 (previously reported by the same physician as on 05-DEC-2009) the patient experienced mumps. Blood work was not done. Additional information has been requested.
Information has been received from a registered nurse concerning a 12-month-old male who was vaccinated with a first dose of Varivax (Oka/Merck). Subsequently the patient experienced a varicella rash. Follow up information indicated that the patient was transferred to another primary care physician. It was also noted that the patient had a reaction after vaccination with hepatitis A virus vaccine inactivated (MSD) (0603USA04284). No additional information is expected.
Joint pain starting after vaccination and intensifying since then. Took ibuprofen at first but that stopped being effective after about a month. Was put on gabapentin. Still in pain
Patient reports not feeling quite right with vague symptoms x 1 week. Presented to ED on 8/14 and tested positive for COVID. On 8/15 she came back to facility and was hospitalized. She is also in Afib RVR. Diagnosed with COVID pneumonia, and acuts hopyxemic respiratory failure.
it is still very sore and those welts are painful; 3 red welts appeared; it burned and stung; 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 BURNING SENSATION (it burned and stung), URTICARIA (3 red welts appeared) and MYALGIA (it is still very sore and those welts are painful) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter .     On 19-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 19-May-2021, the patient experienced BURNING SENSATION (it burned and stung). On 20-May-2021, the patient experienced URTICARIA (3 red welts appeared). On an unknown date, the patient experienced MYALGIA (it is still very sore and those welts are painful). At the time of the report, BURNING SENSATION (it burned and stung), URTICARIA (3 red welts appeared) and MYALGIA (it is still very sore and those welts are painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
I experienced palpitations and racing heart starting around 2pm the day after my vaccine. The only comfortable position I could find by that evening was laying in bed holding counter-pressure on my chest. It felt like my heart could beat its way right out of my chest. I called nurse line and the nurse determined that my resting heart rate was 120 beats per minute. Nurse advises me to go to urgent care center the following morning which I did,  and was told to come back at 6pm. When I was seen after 6pm on 12/10 they told me my resting heart rate was 90 beats per minute. By then my chest was quite sore and I had developed coughing spasms I believe linked to palpitations. The doctor advised that I continue to take fever reducers (Advil/Tylenol) and rest. The symptoms lasted for 2 more days and the soreness for over a week.
C/O tender erythematous swelling over injection site for 2 days. Treatment: 1. Take BENADRYL 25 mg 1 po q 6 hrs prn.
Patient received dose #2 of Pfizer vaccine on 6/10/2021 and was notified by email that vial was left in freezer past recommended time frame. Medication expired beyond its freezer allowable date. Email recommended patient get re-vaccinated with dose again. Physicians re-administered dose on 9/7/2021 as recommended. No adverse reactions identified on site.
This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided. On 17-JAN-2011, the patient received the first dose of GARDASIL 9 (strength, dose, route of administration, Lot # and expiration date were not reported) for prophylaxis and on 04-APR-2011, received the second dose of GARDASIL 9 (strength, dose, route of administration, Lot # and expiration date were not reported) for prophylaxis, which was administered late. The Nurse also stated that on 06-JUL-2017, wanted to administer the third dose of GARDASIL 9, however, this dose was not administered yet. No adverse effects were reported.
Unusual exhaustion within an hour of the vaccine.  Had to go to bed and slept into the evening developing a fever of 103, severe thirst and chills. The fever lasted until 10:00 a.m. the following day, but weakness, thirst, chills and body aches continued for 3 more days intermittently. I would feel like I could finally exercise and then be too weak and tired to go back to routine. My appetite declined for 4 to 5 days as food didn't taste appealing. On Thursday, April 8, I announced to my mom in the morning that I finally felt like I was back at almost 100% and later in the afternoon felt nauseous, incredible pain in my chest and had dry heaves. I finally vomited some and was once again overcome by a fever of 101 and all I could do was sleep from severe exhaustion. I am against medication, but finally agreed to taking ibuprofen and tums. After sleeping into the next day around noon, I finally was able to eat some breakfast but the pain in my chest continued and I could rid it for another day. I intermittently had to sleep and gave up my exercise routine until my body has had time to recuperate. I have not fully recovered, but my appetite is picking up. I still require more sleep than normal.
NO SWALLOWING DIFFICULTIES +INCREASING SWELLING OF HER FACE .. NO CHEST PAIN NO DIFFICULTY BREATHING.. +ITCHINESS OF HER BODY.. +DIFFUSE HIVES/WHEALS OF HER ABDOMEN AND EXTREMITIES  +SWELLING OF UPPER LIP AND LOWER NOTED
My mother had an "adverse event" to the first dose of the Covid-19 PFIZER  mRNA vaccine. Her whole upper arm became swollen (inflammation) and somewhat "hot to the touch" and was reddish in coloring. The inflammation did NOT look like a golf ball, but rather like a small hill on her upper arm, with a slope. After that, she reported to me .... that she was getting "winded", on walks with her best friend. They both live in a senior citizen residence center, which is NOT an "assisted living" facility. Now, the swelling (inflammation) is gone. My mother has now had the 2nd dose of the Pfizer vaccine and yesterday .... she did NOT report, any adverse reactions (yet) from her second injection.
Spoke to Pt who states concerned about possible s/e from J&J vaccine given 4/1/2021 on left arm. Pt states onset of increased headaches, joint pain, and left sided tingling 3 days post-vaccination. Pt reports worsening of tingling on left side of body from head to feet. Pt advised to go ER.
PT indicated on screening form that he occasionally faints after having vaccinations. After vaccination RPH had PT remain in vaccination chair for several minutes to observe for fainting. After pt informed RPH he felt fine RPH moved him to a chair in the waiting area, so He could continue vaccinating others. RPH was then interrupted several minutes later by staff that he "wasn't doing well". RPH went over to him immediately and found him in his chair slouched back having a seizure lasting 20 seconds during which he urinated in the chair and on the floor. When the seizure broke, he was groggy but fairly lucid called 911 and EMS arrived within 5 mins. After EMS arrival he had several more seizures. He was then transported to the nearest Hospital.
expired dose of the Moderna COVID-19 vaccine was administered; expired vaccine was stored in refrigerator (vaccine expired on 01-Apr-2022 and stored in refrigerator on 05-Apr-2022); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose of the Moderna COVID-19 vaccine was administered) and PRODUCT STORAGE ERROR (expired vaccine was stored in refrigerator (vaccine expired on 01-Apr-2022 and stored in refrigerator on 05-Apr-2022)) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose of the Moderna COVID-19 vaccine was administered) and PRODUCT STORAGE ERROR (expired vaccine was stored in refrigerator (vaccine expired on 01-Apr-2022 and stored in refrigerator on 05-Apr-2022)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose of the Moderna COVID-19 vaccine was administered) and PRODUCT STORAGE ERROR (expired vaccine was stored in refrigerator (vaccine expired on 01-Apr-2022 and stored in refrigerator on 05-Apr-2022)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The reporter reported that they received Moderna COVID-19 vaccine vials with a manufacturing date of 01-Dec-2021 and an expiration date of 01-Apr-2022 (Lot: 026L21B). The reporter used Moderna's online expiration tool to confirm the expiration date.  The reporter reported that unknowingly, expired doses of the Moderna COVID-19 vaccine were administered to 20 patients from lot 026L21B. The administration occurred from 06-Apr-2022 to 09-Apr-2022. The vials were initially stored in the refrigerator was on 05-Apr-2022 and the vials did not undergo any temperature excursions.  The patient did not report any adverse reactions.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-537580 (Patient Link).
Large local reaction to left thigh with swelling of lymph node to right inguinal area.
Patient explained that he developed heart palpitations, shortness of breath and difficulty breathing, gas pain and insomnia.
Information has been received from a health professional concerning a white female who on 11-DEC-1997 was vaccinated with a dose of Varivax (Lot# 624249/1103E). It was reported that the patient developed a generalized rash with less than 50 lesions. It was noted that the patient was in contact with another case of varicella. Unspecified medical attention was sought. No further information was available. Additional information is not expected.
56 year old female with hx migranes, no other hx, presents with nausea and vomiting and abdominal cramping, and loose stool x 1, yesterday she was tested positive for COVID 19, she felt worse so was brought tonite with headache and continued nausea and vomiting  q 15 minutes, in ED she was given fluids and zofran which was ineffective and then got reglan and pepcid with some relief. She got toradol for headache. No pulmonary symptoms, no cough or shortness of breath, chest xray no infiltrates, CT head done and was negative.
Patient had a Tdap injection in her left deltoid on August 13, 2019 in the office.  She complains of sharp pain at the injection site and it radiates down to her forearm.  Her left arm is slightly swollen.  She has pain when she moves or lifts her arm.  She has pain when turning steering wheel, and grabbing items.  She has a permanent bandage mark where the band-aid was applied.   Patient was seen in the office on August 30, 2019 for pain and was advised to take OTC ibuprofen at night and during the day as needed. She was advised to  apply alternating heat and ice to the area to relieve pain.  For the hyperpigmentation from the band aid mark she was prescribed triamcinolone (ARISTOCORT) 0.1 % topical cream; Apply topically 2 (two) times daily.
Extremely tired and did not get out of bed until 3:30 pm the day following the shot. Had a constant headache. The second night after the shot I developed a 104 temp. I had a headache the entire next day.
Patient returned to pharmacy on Saturday following vaccination to inform staff about reaction to vaccine. Patient stated next morning had skin redness lateral to injection site on the bicep area and muscle pain.
10 minutes after vaccine was received my throat felt thick, I had a strange sensation in my head, and my heart felt as if it was racing.  It lasted a short time, maybe 2-3 minutes and then resolved.  No treatment.
A rash started a day or two after vaccination. Felt unwell the day after vaccination. Felt nauseous and unwell from Dec. 23rd through 28th. I had a physicians office look at my rash. It was warm to the touch, tender, itchy and very blotchy. She diagnosed cellulitis. I contacted my PCP.  She consulted with the physicians office and called in an antibiotic to my pharmacy for me. I started to finally feel better once I started the antibiotics, but didn't feel back to normal until I was done taking all doses of my antibiotics.
Information was received on 20-MAR-2017 from a lawyer regarding a case in litigation concerning a male patient (age unknown). On or about 20-JAN-2011, the patient was inoculated with the ZOSTAVAX vaccine for the prevention of shingles (lot, expiration date and injection site not reported). The patient was prescribed a dose of 0.65 ml of ZOSTAVAX subcutaneous solution, administered by a physician and filled at a pharmacy. Prior to receiving the ZOSTAVAX vaccine, the patient never suffered from or been diagnosed with herpes zoster or any other zoster ailment collectively referred to as "shingles". On or about 16-DEC-2015, the patient was treated by his physician for a painful rash that spread across the patient's body, including his back and trunk. He displayed red papules and early vesicle formation which the physician assessed as herpes zoster virus, also known as shingles outbreak. The patient was prescribed valacyclovir for treatment of the virus. On or about 22-JAN-2016, the patient was seen for a follow-up visit with his physician for complaints of persistent (sic). The patient was diagnosed with ongoing herpes zoster, which had worsened in severity despite being treated with valacyclovir. The physician noted new open blisters with sensitivity and burning and existing blisters which had begun to form scabs. The physician noted that the patient had extensive scarring on this upper back and chest, typical for chronic singles outbreaks. On or about 22-JAN-2016, the patient was diagnosed with post herpetic neuralgia, a chronic painful condition affecting the nerves that general (sic) caused by repeat herpes zoster outbreaks. The patient was prescribed gabapentin to treat the conditions of herpes zoster and post herpetic neuralgia. The patient will continue to suffer from nerve damage as a result of post herpetic neuralgia. As a result of ZOSTAVAX, the patient has sustained severe and chronic personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a result of use of ZOSTAVAX. Post herpetic neuralgia, herpes zoster, and emotional distress were considered disabling. Additional information has been requested.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 for prophylaxis. On an unknown date the patient experienced incorrect product storage, poor quality drug administered and no adverse event. The outcome of incorrect product storage, no adverse event and poor quality drug administered is unknown. The reporter considered incorrect product storage, poor quality drug administered and no adverse event to be not related to GARDASIL 9. Sender's Comments: US-009507513-1707USA000533: US-009507513-1706USA005754: US-009507513-1707USA000535: US-009507513-1707USA000536.
Gave MCV4 subcutaneously. No treatment, notified mother immediately following injection. Contacted nurse supervisor regarding incident. No treatment. Discussed possibility of redness at injection site, contact information if mother has questions.