chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9, lot # N002720, expiration date 12-MAY-2019 (dose and route were not reported) for prophylaxis. The vaccine was exposed from 32 Fahrenheit degrees (°F) to 35 Fahrenheit degrees (°F) for 1 hour. There was no temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643.
Feeling bloated; Body aches; Abdominal cramping/Mild abdominal pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal cramping/Mild abdominal pain), ABDOMINAL DISTENSION (Feeling bloated) and MYALGIA (Body aches) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced ABDOMINAL PAIN (Abdominal cramping/Mild abdominal pain). On 01-Aug-2021, the patient experienced ABDOMINAL DISTENSION (Feeling bloated) and MYALGIA (Body aches). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 800 mg, a couple of times. On 01-Aug-2021, MYALGIA (Body aches) had resolved. At the time of the report, ABDOMINAL PAIN (Abdominal cramping/Mild abdominal pain) and ABDOMINAL DISTENSION (Feeling bloated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included unspecified sleep medication.
Patient developed fever, nausea, vomiting, severe headache upon waking on 2/23/2004, 6 days after YF immunization. She was evaluated in ED, had CT (reportedly normal), LP (clear CSF), treated with compazine and morphine for symptoms and discharged home.
A report was received from a health care professional on 1/2/04 concerning an 18 month old female vaccinee who inadvertently received Fluvirin vaccine on 12/2/03. On 12/2/03 the vaccinee received 0.25ml Fluvirin. No adverse events were reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
130ish heart rate all night long, shivers, maybe a fever (didn't get up to take it but felt like I had a high fever), headache that wouldn't go away, body/muscle aches, a little raw throat, about 6 inches of hot redness around area. I felt better around 3:00 p.m. I had to call in sick since didn't sleep most of night and still felt terrible at 6 a.m.
pt immunized w/HIB/OPV 24SEp92 & 2 days later started w/temp to 104;
3/24/2021 9:59 AM VACCINE AT 9:30 AM - SYNCOPE- COLD CLAMY, VASOVAGAL RESPONSE CAME TO WITH REPONSE. BP TAKEN NO MEDICAL PROBLEMS.
Systemic: Dizziness / Lightheadness-Mild, Systemic: near syncope event-Mild, Systemic: Shakiness-Mild, Additional Details: at 10:30. patient was sitting outside exam room after vaccine.  Patient reports lightheaded. patient appeared pale. Patient was assisted to lying position with legs elevated BP 12060, HR 58 RR 20. patient was given water. After 10 min patient  feeling better and assisted to exam room to lie down. After 5 min BP 120/80 RR 18 HR 72 temp 97.2, 10 min BP 120/78 HR 74 temp 97.2, after 15 min BP 120/78 HR 74 temp 97.2 patient reports absence of symptoms dizziness, SOB, chest pain. Mom drove pt home.
This spontaneous report has been received from a nurse referring to a patient of unknown age. The patient's pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patient was inadvertently administered a dose of improperly stored PROQUAD (lot # R007684, expiration date: 11-SEP-2019; route was unknown) for prophylaxis. The MERCK STERILE DILUENT (batch/lot# and expiration date were unknown) used to reconstitute the PROQUAD was properly stored. The vaccine was exposed to temperature of -1.9 degrees Celsius for 3 hours. Data logger was involved. There was no previous temperature excursion. No adverse effect was reported. Furthermore, no product quality complaint was involved.
On 01/31/2023 I became extremely tired and woke up having a bad headache cough and fever. After reaching out to a doctor I was prescribed Paxlovid. Symptoms lasted about 2 weeks with an ongoing cough.
It was reported in a published article that a female patient in 1983 was vaccinated with a first dose of MMR (second generation) because of a measles outbreak in college. She tested immune to measles in 1991, 1992, and 1997. During her first pregnancy in 1991, she tested immune to rubella and had a healthy, normal son. At the birth of her second son, in May 1993, she was found to be rubella susceptible and was given a second dose of MMR (second generation) in the postpartum period. The patient now had markers for lupus. Upon internal review, lupus was considered to be an important medical event (OMIC). It was unknown if medical attention was sought. It was reported in a published article, title as stated above, that this patient had developed measles, rubella and mumps despite being vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Because of a diagnosis of "some immune problem", the patient received injections of gamma globulin for awhile. It was reported that the patient received the hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown) series in 1998-1999. Upon internal review, lupus was considered to be an important medical event. The reporter indicated that the patient's son had autism (WAES #0306USA00452). It was unknow if medical attention was sought.
Information has been received from a registered nurse concerning a 4 year old female with asthma and no allergies who on 16-OCT-2003 was vaccinated SC with a first 0.5mL dose of varicella virus vaccine live (Oka/Merck) (lot# 644796/0336N). Concomitant therapy included fluticesone propionate (FLOVENT). On 13-Apr-2007 the patient was seen with a rash on the right side of the face, neck, shoulder and back. The patient had 30 to 40 itchy lesions that developed initially on her neck and face. It eventually spread to her right neck and upper back with none on her trunk. They are described as being scattered papules with some scabbing and no clear vesicles or pustules. The patient had known exposure to chickenpox. On 20-APR-2007 the rash was unchanged. The lesions were determined to be a contact dermatitis coupled with eczema. Unspecified medical attention was sought. No lab diagnostic testing was done. The patient is being treated symptomatically with acetaminophen (TYLENOL) and calamine + camphor + pramoxine hydrochloride (AVEENO) bath. The patient is recovering. No further information is available. No product complaint was involved. No further information available. Follow-up information has been received from a registered nurse concerning a now 5 year female on 23-APR-2007 stating that the patient was diagnosed with contact dermatitis coupled with eczema (formally reported as follicular eczema flare as rash noted to start shortly after metal hair beads had been put in hair rather than chicken pox). No further information. Additional follow-up information has been received on 05-NOV-2007 from a registered nurse stating that the above reaction was determined to be eczema and not breakthrough chickenpox. The child had known exposure to chickenpox. The nurse stated that she did not have any other information to report.
Pt began feeling hot, feverish, sweaty with swelling in arm and right side of neck stiff. Large indurated area on posterior arm/deltoid on right (nondominant).  Referred to facility on 1 Aug 13.
Shooting pain from mid-upper (R) arm to elbow starting 12/18/14, now continuous ache and weakness to (R) hand.
Redness & hot to touch around vaccination site , also can feel a sm lump in same area
3 1/4 inch diameter erythema and induration starting about 24 hours after vaccine and resolving by 48 hours.  Non painful.  Treated only with cool compresses.
Received vaccine on 11/12. Reported evening of 11/13 a rash. Reported to provider on 11/14. Rash on both legs, no temperature, no itching or swelling.
Patient has recurrent headaches, abdominal pain, and chest pain since completing HPV series 10/14/2013. She has been worked up by cardiology, neurology, and has had many screening labs. Concern for possible adverse reaction to the HPV vaccine as symptoms began shortly after series completed.
The cramping during my periods has become extremely painful, to the point that I'm sweating and  vomiting for about five or six hours each day during the first three days of my period. I also had a UTI five days after the shot.
Patient received a Janssen vaccine on 3-26-2021 and took another Janssen vaccine today (4-7-2021).
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2006, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated at an emergency medicine facility for a severe vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Pt.'s father called clinic on 2-17-10 and stated pt. had been "fussy" for 2 days and now had "pimple like" bumps to face, groin and back. States is unsure of any fever. Will follow up with PCP.
Left arm soreness for 24 hours. On 1/6/21 evening, I noticed raised red rash at the site of injection. It is itchy.  This is new.
Muscle pain; Joint pain; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th May 2022, the patient received the 1st dose of Shingrix. On 19th May 2022, less than a day after receiving Shingrix, the patient experienced muscle pain and joint pain. On an unknown date, the outcome of the muscle pain and joint pain were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain and joint pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-MAY-2022 Reporter's Comment: The patient's wife reported this case. The patient received dose of Shingrix vaccine yesterday (day before reporting) and experienced joint and muscle pain which had not resolved.  The reporter did not consent to follow-up. Additional supportive information: This case has been linked with case US2022081903, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022081903:Same Reporter
Fever (102.2) Fever, Fatigue, Chills, Myalgias, Arthralgias. Right arm is swollen, tender and erythematous.
Patient complained of dizziness while lying down 10 min after receiving HPV vaccine and had transient memory loss for about 20 minutes. He remained responsive but would not answer simple questions. He improved, went home, presented to the ER 10 hours later with memory loss again, resolved and sent home.
This case was reported by an adult female nurse and described the occurrence of eye pruritus that she experienced after she was inadvertently exposed to diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). On 28Apr04, the nurse was administering Infanrix (lot DTPA 622A2) to a pt. The reporter stated that, during the admin of Infanrix, the syringe came off the needle and vaccine squirted into (my) eye. She also stated that , the syringes were not the prefilled syringes made by manf. The nurse's eye was washed with water and flushed with an eye wash. Following the flush, the nurse's eye was itching slightly. The reporter stated that she did not know if the eye itching was from exposure to the vaccine. The eye itching was unresolved.
Red, Hard, itchy, painful, and swollen at the injection site.  Going to see PCP today
One day subsequent to receiving varicella virus vaccine live the pt presented with 103F temperature, nausea, and vomiting. The pts fever increased to 105.5F and the pt was given Advil. The fever decreased to 101F. No rash or lesions were present.
Called to COVID -19 post vaccination observation area to see this patient. Received 1st vaccination of COVID 19 Moderna vaccine (lot 024M20A, exp 8/3/2021) at approximately 10a Was in observation area for 30 minutes (due to prior hx of anaphylaxis with immunotherapy shots as teenager). Pt initially felt well, until approximately 30 minutes after the vaccination, when she started to have sensation of constriction in chest, feeling of heart beating quickly, and mild lightheadedness. Pt awake and alert and appropriately responsive.  Denied any itching, rash, sob, throat discomfort or swelling or facial swelling. No rash or redness noted at vaccination site.  Pt transferred to clinical reclining chair via wheelchair, with assistance, in private area. VS normal with HR 71 and BP 136/79 Sat 97%, normal respiratory effort, speaking in full sentences. Given po apple juice. Pt with persistent feeling of chest constriction, feeling face slightly flushed/warm (no rash, no visible erythema or flushing). Hx of coronary vasospasm with hx of elevated troponin 4 yrs ago post surgery, cardiac cath 2 yrs ago due to intermittent chest pain. Coronary vasospasm noted on cath per pt, current meds are diltiazem, ASA 81, a statin, and nitroglycerin prn. Last episode of chest pain was approx one year ago.  Repeat VS HR 73 BP 130/89 Sat 99% on RA, awake and alert and appropriate 911 called due to chest discomfort with hx of coronary vasospasm in past. Paramedics given report including pt's medical history as above.  Paramedics arrived at approximately 10:45a and evaluated patient: ECG done, normal per paramedics. Under their observation CP improved, slight flushing sensation improved, pt feeling better without intervention, no evidence of anaphylaxis. Per paramedics pt offered ambulance transfer by EMS, declined.  Per paramedics/EMS, no indications for transfer to ED as ECG normal and pt feeling much better without intervention. Per their evaluation pt can be allowed to go home. They state that they have seen this often in patients post vaccination. When asked, they state that this is not an indication of severe reaction, and there is no contraindication to second vaccine. They discussed this with patient.  Pt observed for an additional 20 minutes. 11:15a pt feeling very well, no chest pain or flushing or itching. Ambulating without difficulty. Pt left at 11:19a feeling well.
Complained of scratchy, tight throat (need to keep clearing throat, 4 hrs post vaccine administration 25 mg BENADRYL  Po. - GI problems with 102 degree Temp - Po. - perspired profusely with chills for  12 hrs
This spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2013, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date in 2015, patient was diagnosed with shingles and/or other zoster-related injuries (Herpes zoster) (injury) after and despite being inoculated with the ZOSTAVAX vaccine (Vaccination failure) and suffered serious physical, emotional and economic damages. On an unknown date in 2015, the patient had physician office visit for treatment of shingles (Herpes zoster). As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. Outcome of the events was unknown. Causality assessment was related.
Patient reported on 11/6/18 she had hives appear around her injections site on her right arm. When she presented to the pharmacy on 11/8/18 it was a red, rashy area 2.5 x 3.5 inches. She also complained that it itched.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient allergies were unknown. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator, or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported.  Total 280 patients received Moderna Covid 19 stored at minus 82 degrees Fahrenheit. The patient was administered vaccine that was stored at temperature between minus 80 degree F to minus 84 degree F.  No concomitant medications were reported. No treatment details were reported.
This spontaneous report was received from a medical assistant regarding a 25 year old female patient. Concurrent conditions, medical history and concomitant medications were not reported. On 09-SEP-2017, the patient was vaccinated with GARDASIL 9, for prevention of HPV; dose number, frequency, route of administration, lot # and expiration date were unknown. It was reported that on 12-SEP-2017, the patient experienced grand mal seizure which caused hospitalization (on an unspecified date in 2017). The patient received treatment with oxcarbazapine. It was unknown if laboratory tests were performed. The outcome for the event grand mal seizures as well as the causality were unknown by the reporter. Upon internal review the event grand mal seizures was considered to be medically significant.
passed away; This is a spontaneous report from a contactable consumer (patient's granddaughter). An 82-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN9581), via an unspecified route of administration on 08Feb2021 at 14:30 into right arm at single dose for COVID Prevention. Medical history included Heart valve replacement from 5 years before 09Feb2021 (2016), on Oxygen at night (reporter did not know the liter amount that the patient used at night). The patient's concomitant medications were not reported. Patient had no other vaccines on the same day as the COVID vaccine. It was reported that patient received his first dose of the Pfizer vaccine around 14:30 on 08Feb2021 and he was fine before that, and by 16:30, he had passed away on 08Feb2021. Reporter reported that the cause of death was unknown at this time and that the family would be having an autopsy performed but that it had not yet been performed. No investigation assessment could provide. The patient died on 08Feb2021 at 16:30. An autopsy was not performed.; Reported Cause(s) of Death: passed away
palpable nodule;swelling & redness @ site extending into shoulder;pain;swelling under lt eye;
No additional AE reported; Caller reports that the third dose of ROTATEQ was accidentally administered on 1-JUL-2022 at 9 months age; Caller reports that the third dose of ROTATEQ was accidentally administered on 1-JUL-2022 at 9 months age; Caller reports that dose 1 was administered on 23-NOV-2021 and dose 2 was administered on 15-FEB-2022; This spontaneous report was received from a nurse and refers to a 9-month-old at the reporting time patient of unknown gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 23-NOV-2021, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally (exact dose, strength, lot # and expiration date were not provided) for prophylaxis. On 15-FEB-2022, the patient was vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally (exact dose, strength, lot # and expiration date were not provided) for prophylaxis (product use issue). On 01-JUL-2022, the patient was accidentally vaccinated with the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml, lot #: U037815, expiration date: 28-MAY-2023, administered orally (strength was not provided) for prophylaxis at 9 months of age (product use issue; product administered to patient of inappropriate age). There was no additional adverse event reported.