chrisvoncsefalvay/vaers-outcomes huggingface dataset:
low grade fever; chills; MILD nausea; stomach upset / mild stomach discomfort; This case was reported by a physician and described the occurrence of low grade fever in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, 1 day after receiving Shingrix, the patient experienced nausea and upset stomach. On 27th August 2020, the patient experienced low grade fever and chills. On 28th August 2020, the outcome of the low grade fever and chills were recovered/resolved. On an unknown date, the outcome of the nausea and upset stomach were recovered/resolved.   It was unknown if the reporter considered the low grade fever, chills and nausea to be related to Shingrix. The reporter considered the upset stomach to be related to Shingrix.  Additional details were provided as follows: Immunololgist reported that patient received the Shingrix and within the first 24 hours he developed a low grade fever and chills that dissipated. It was reported that low grade fever and chills started within 5-6 hours after Shingrix administration. On next day 15 to 20 hours post injection patient experienced mild nausea, stomach upset, mild stomach discomfort which was lasted for a few hours and then resolved. The reporter consented to follow up.
Approximately 2 minutes after receiving the vaccination patient was in the store and passed out falling to the ground. Patient came to within seconds of passing out and reported no difficulty breathing. 911 was called and he was evaluated in the ambulance. Unknown outcome after taken to the ambulance.
This spontaneous report was received from a nurse and refers to an unspecified amount of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unspecified dates, the patients were vaccinated with doses of improperly stored oral, ROTATEQ lot # K006805 with expiration date 24-MAR-2016, route of administration defaulted to oral (dose was not reported). No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
Initial report received via search of the literature on 20 September 2012. The following information is verbatim from the abstract: "Background. Administering 2 separate vaccines for seasonal and pandemic influenza was necessary in 2009. Therefore, we conducted a randomized trial of monovalent 2009 H1N1 influenza vaccine and seasonal trivalent inactivated influenza vaccine given sequentially or concurrently in previously vaccinated children. Methods. Children randomized to 4 study groups and stratified by age received 1 dose of seasonal TIV and 2 doses of 2009 H1N1 vaccine in 1 of 4 combinations. Injections were given at 21-day intervals and serum samples for hemagglutination inhibition antibody responses were obtained prior to and 21 days after each vaccination. Reactogenicity and adverse events were monitored. Results. All combinations of vaccines were safe in the 531 children enrolled. Generally, 1 dose of 2009 H1N1 vaccine and 1 dose of TIV, regardless of sequence or concurrency of administration, was immunogenic in children ?10 years of age; children <10 years of age required 2 doses of 2009 H1N1 vaccine. Conclusions. Vaccines were generally well tolerated. The immune responses to 2009 H1N1 vaccine were adequate regardless of the sequence of vaccination in all age groups but the sequence affected titers to TIV antigens. Two doses of 2009 H1N1 vaccine were required to achieve a protective immune response in children <10 years of age." This report involved a 3-9 year-old subject that had received a first dose of PANDEMIC INFLUENZA VACCINE (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have polymerase chain reaction-confirmed H1N1 influenza virus infection. The subject's past medical history had not been reported. No further information was available at the time of the report. The subject's outcome was not reported. Documents held by sender: none.
This non-serious spontaneous case, initially received from other health professional (nurse) on 15-Mar-2018, concerning a 28-year-old, adult, male patient. On an unspecified date first temperature excursion of the vaccine occurred. On 30-Jan-2018, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XT59906, expiry date: 06-Jun-2018) after first temperature excursion. On an unspecified the vaccine was stored out of range for 65 hours and 35 minutes, reaching a highest temperature of 60 F which was the fifth (5th) excursion with those vaccines. Follow-up report received on 04-Apr-2018: Route of administration (intramuscular) was added.
This vaccine was the booster shot.  I awoke at 2:30 a.m. on Wednesday 12/1/2021 with chills, headache, stuffy head and bodyache.  Within minutes of waking  I vomited.   Then within fifteen minutes, I had dry heaves.  I could not get back to sleep.. I had to call my employer and state I was unable to come to work.  These chills, headache and bodyache lasted throughout the entire day and night. I was finally able to get some sleep.  The bodyache has continued into 12/2/2021, but I was able to return to work.  I feel very washed out. I got sick with similar symptoms from the second vaccine (same manufacturer), but this time was worse than than the first.  I won't be inclined to get another booster shot anytime in the near future.
his left eyelid almost swollen shut; rash does itch; rash in mostly on his face, neck, right arm, groin area slowly getting worse; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING OF EYELID (his left eyelid almost swollen shut), RASH PRURITIC (rash does itch) and RASH (rash in mostly on his face, neck, right arm, groin area slowly getting worse) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced SWELLING OF EYELID (his left eyelid almost swollen shut), RASH PRURITIC (rash does itch) and RASH (rash in mostly on his face, neck, right arm, groin area slowly getting worse). At the time of the report, SWELLING OF EYELID (his left eyelid almost swollen shut), RASH PRURITIC (rash does itch) and RASH (rash in mostly on his face, neck, right arm, groin area slowly getting worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment details provided for these events.
Patient is having generalized petechiae with minor hives 3 weeks post vaccine. Also reports daily upset stomach.
Tested positive for covid; Tested positive for covid; This is a spontaneous report from a contactable consumer. The reporter reported reports for four patients.  A patient of unspecified age and gender received bnt162b2 (BNT162B2) unknown dose number, via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient was tested positive and became ill from  covid-19 on 24Jul2021 with outcome of unknown. The patient was hospitalized because of the event.  The patient underwent lab tests and procedures which included two  sars-cov-2 test: positive   on Jul2021.  Informatio about Lot number has been requested.
No additional clarifying statements or AE details were provided; The HCP reports that a patient was administered a dose of VARIVAX that was involved in a temperature excursion.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies/reactions or concomitant medications was not provided.  On 20-FEB-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), for prophylaxis (lot #W021740 had been verified to be a valid number; expiration date 10-JUL-2024, and upon internal validation established as the same date) (dosage, vaccination scheme, frequency, route of administration, anatomical site of injection, lot number and expiration date were not reported). The administered dose of the vaccine was stored at a temperature of 14.7 degrees Fahrenheit (F), for a time frame of 1 hour and 3 minutes, as recorded by a digital data logger. There was no previous temperature excursion reported. There was no adverse effect reported.; Sender's Comments:  US-009507513-2303USA008911:
Tingling in fingers; Headache for a week.; This is a spontaneous report from a contactable consumer. A 53-years old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in left arm on 19Mar2021 at 15:45 (at the age of 53-years old) as a single dose for COVID-19 immunisation. Medical history included diabetes. Allergies to medications, food, or other products was unknown. Concomitant medication included Metformin (MANUFACTURER UNKNOWN) within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. On 20Mar2021, the patient experienced tingling in fingers and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic treatment received for the events. The clinical outcome of the events tingling of extremities and headache was not recovered at the time of this report.    Information about lot/batch number cannot be obtained. No further information is expected.
Symptoms occurred during viral cold. Pt has papular rash on abdomen, back 7 days after vaccines given. Lesions do not itch and are not hives.
parent called stating child had red rash on thigh where recv IPV on 6OCT98;noticed approx 24hr p/vax;child scratching area whole upper thigh w/rash;advised to apply DPH cream to arm;
On 2/27/21, pt had new onset chest congestion, exhaustion and shortness of breath, but no fevers (measured at home) nor orthopnea. Visited primary doctor who urged her to visit ED. On ED visit on 3/4/21, she was found to be in afib RVR (heart rate to 170s) that was refractory initially to dilt push, dilt oral, dilt gtt. On 3/7/21, stroke alert was called because of new right arm dis-coordination, and on 3/8/21, MR brain showed an acute right cerebellar artery infarct (which did not leave deficits). Prior to the vaccine, pt had absolutely no symptoms of heart failure or cardiac diagnoses. She was hospitalized from 3/4/21-3/13/21, 3/18/21-3/23/21 for afib RVR, congestive heart failure, and acute kidney injury which required dilt and diuretics. However, she was later hospitalized on 4/8/21-4/11/21 again for afib RVR, congestive heart failure and acute kidney injury. Finally after continued outpatient amiodarone, she returned to normal sinus rhythm. Patient has shared that she has never experienced such drastic health changes in her life and these frequent hospitalizations occurred after her Janssen shot.
Rash, in hospital for past 4 days on other medication to treat adverse reaction (unknown drug).
Patient arrived back at pharmacy on 9/2. She was still complaining of pain & unable to lift arm above shoulder without pain. Arm was slightly swollen.
Breakthrough COVID-19 case: I had a sore throat and a cough. I took a rapid test and it came back negative. The next day it morphed into what I would describe was allergies. Runny nose, congestion, watering eyes. I would feel like I needed to sneeze, but couldn't and my eyes would water. I took TYLENOL. It did help a bit and I was able to go back to sleep. I tested again on 06/10/2022 and it came back positive. I contacted my OBGYN because I'm pregnant. I ended up getting monoclonal antibodies. I tested again on 06/15/2022 and it came back with a slight positive.
This non-serious spontaneous case, initially received from other non-health professional on 22-Jan-2018, concerns a 48-year-old male patient. This case was linked to case 201800136. The patient had no medical history. The patient did not receive any concomitant medications. On 21-Jan-2018, 48-year-old (under age of 65) patient was administered with FLUAD (dose; 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 178703, expiry date: 30-Apr-2018) (explicitly coded as inappropriate age at vaccine administration). It was reported that, no adverse side occurred after the vaccination.
Pt developed Hives on body 20 minutes after receiving Influenza TIV and HPV immunizations.
Pain, muscle fatigue, flu like symptoms.  Shingrix shot was given in her left arm and she is left handed.  The pain was so intense she lost use of her left arm for a week.  Within 2 hours a sore arm.  Within 6 hours my brother took mom  to a local urgent care at 8:30pm, said take a pain pill.   My brother put her to bed.  She did not answer her phone in morning. I found her on the floor as she was not able to get up to go to the bathroom and ended up on the floor.  No use of left arm and entire body had muscle fatigue.  Used walker to move her to my house for rehab.  After a week she could walk again without walker but still had Flu like symptoms. Almost 2 weeks now and she is still a little off balance in feeling.
Patient was administered dose #1 on 1/20/21; dose #2 on 2/10/21 and a third dose on 03/03/21. This vaccine is a 2 dose series and the third dose was given in error.
Vomiting (multiple episodes), hurt all over, chills, diarrhea, fever (did not take temperature) x 6 hours. Headache and abd'l soreness persisting after 24hrs. No tx.
Pt came to vaccine clinic and accidentally received Moderna as the 1st dose in a 2 dose series and is under age 18. Pt should've received Pfizer which is approved for this age-group. CDC COVID-19 Vaccination Administration Error sheet consulted. Sheet advises, "if aged 12-17 years and a vaccine other than a Pfizer-BioNTech COVID-19 vaccine was inadvertently administered: (If Moderna administered as first dose) it is suggested to give Pfizer-BioNTech Covid-19 Vaccine (>12 years formulation-  purple cap/COMIRNATY). Pt was monitored for 15 minutes with no adverse effect.   Call to pt on 12/6 when mistake was realized - no answer. Message left asking pt to call back. Unknown if any adverse events at this time  post-observation. Will continue to call pt at number provided to inform of error.
On day 12 developed rash ring at injection site. Itchy. Gone within 3 days.
A report was received from a health care professional on 1/30/04 concerning approximately 40 vaccinees under 4 years of age and of unknown gender, who inadvertently received Fluvirin on unspecified dates in December 2003 and January 2004. On unspecified dates in December 2003 and January 2004 the vaccinee inadvertently received Fluvirin. No adverse effects were reported at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
PHIZER COVID VACCINE #3 GIVEN 9/27/2021, LOT #30135BA; Pt presented with hypoxia and confusion; tested positive for COVID on 5/27/22; NIPPV; ICU; given Decadron, Remdesivir, Baricitnib; O2 supplementation continued; transitioned to DNR; problems with aspiration; passed away in the hospital
ROUND RED MARKS ON UPPER RIGHT ARM WHICH WENT AWAY AFTER A WHILE VEINS IN LOWER PART OF RIGHT ARM ARE BROWN IN COLOR AND ARM IS MARKED BY THEM-GOES AWAY AFTER MASSAGE BUT COMES BACK AGAIN EVERYTIME (POSSIBLE BLOOD CLOTS) IT IS STILL THERE 8 MONTHS AFTER SECOND DOSE
pt was diagnosed positive for COVID on 1/13/22 and saw PCP, he received azithromycin; sx of extreme weakness, body aches, diarrhea, mild SOB; pt presents to ED on 1/17/22 with hypotension, extreme weakness, tachypnea; given Decadron; admitted; given remdesivir, tocilizumab; O2 needs increased; O2 supplementation; transferred to ICU; pt required intubation on 1/29/22; vasopressors and ABX given; AKI worsened; pt experienced A Fib with RVR; pt's condition continued to deteriorate and passed away in the hospital
Arm became red and swollen from shoulder to elbow and was very sore and warm to touch.  After about 4 days the redness and swelling eased but the soreness has continued and there is pain when lifting arm.
Right arm swollen to approximately the size of golf ball with pain at injection site that radiated into shoulder and back.
Developed grand mal seizures with loss of consciousness 10 days after DTaP administered. Seizures are recurrent and ongoing. But seizures continue. THe discharge summaries ad out pt. neuro. evals received on 4/5/04 state myoclonus and developmental delay.
Local redness and swelling, followed by one week serum-sickness type hypersensitivity reaction.  Full recovery thereafter.
INFLAMMATION ISSUES; This spontaneous report received from a consumer via other manufacturer (Novavax) concerned a 61 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on APR-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 2021, the patient experienced inflammation issues (Dose number in series 1). The patient also received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on NOV-2021 for covid-19 prophylaxis. It was unknown whether the patient experienced any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inflammation issues was not reported. This report was non-serious.
Muscle pain; Tenderness (injection site); This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain) and VACCINATION SITE PAIN (Tenderness (injection site)) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Muscle pain) and VACCINATION SITE PAIN (Tenderness (injection site)). At the time of the report, MYALGIA (Muscle pain) and VACCINATION SITE PAIN (Tenderness (injection site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-031843.
Patient received her second dose of the COVID-19 Moderna Vaccine on day 21, which is 3 days too soon.  The patient is currently feeling fine and has not had any adverse effects, however since we inadvertently gave her this shot 3 days too soon, it needed to be reported.
pt c/o local redness & swelling in arm p/vax 10NOV97, cont w/pain redness inc to lt elbow & arm w/severe swelling 11NOV97;seen by MD & referred to MD dx w/cellulitis lt arm & started on oral keflex;
Patient had a small area of redness and swelling (dime size) in the evening on 12/21. On 12/22 area grew larger and patient felt slightly lethargic. On 12/23 area was about 5" x 5" and patient saw primary care provider, where she was diagnosed with cellulitis. Patient got antibiotic and steroid to treat, which was picked up on 12/23. This is also when patient reported the adverse reaction.
pt recv vax 27JUL95 & devel a local rxn characterized by reddened area, w/rash, area about hand-sized, affecting inj site & shoulder;this is 1 of 5 patients from this site who exp above rxn
need to restart the regimen or is ok to get a second dose now; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received a first Shingrix injection over a year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: need to restart the regimen or is ok to get a second dose now). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 22-MAY-2023 Sales rep submitted the following for a physician. Physician wanted to know if a patient received a first Shingrix injection over a year ago, do they need to restart the regimen or is ok to get a second dose now. The reporter was unsure what the recommendation should be.
Erythema multiforme minor.  Initial report from a health care provider on 12/Oct/2005.  A 20 year old male patient with no pre-existing medical history received an intramuscular dose of Menactra in the deltoid on 17/Aug/2005 at 3:30pm.  The exact administration site was not reported.  Seven days later, he developed erythema multiforme minor on the forearms, torso and thighs.  The patient has no illness at the time of vaccination, no pre-existing medical conditions and was on no medications. The patient was treated with diphenhydramine.  Per the reporter, the patient had recovered. Follow-up received 24-Oct-2005. No additional information received. Further information requested. Follow-up information received from a literature citation on 27 Novembr 2006. The patient had developed puritic, hive-like eruptions on his forearms, trunck, groin, and legs, one to two weeks after receiving MENACTRA. He was examined at a family practive clinic, and physical examination revealed erythematous, iris-like, urticarial lesions on the forearm, trunk, and groin. These lesions collected in some areas to form plaques 2-4 cm. in diameter. The centers were pale and edematous and were surrounded by polycyclic erthematous rings. the lesions were consistent with mild erythema multiforme minor eruption. The patient had no evidence of any previous infection, had not received any other recent vaccination, and had not taken any concomitant medications. Because the disease was mild, laboratory evaluation and steroid therapy were not  indicated. The patient was treated with diphenhydramine and cool compresses. The lesions had completely resolved at his four week follow-up visit.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot# K022886, K023328 and L007720 (dose was not reported). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
14 days after shot developed irregular A-Fib heartbeat for the first time in my life. 170 BPM heartbeat for over 4 hours. Thought I was going to die. Admitted to Hospital Emergency 2/4/2021 - 2/5/2021.