chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a consumer refers to a 1 year old female patient (reporter's granddaughter). On 15-AUG-2014 (also reported as today) the patient was inadvertently vaccinated with a dose of ZOSTAVAX (route, dose and lot # not reported) instead of VARIVAX. No adverse effects reported at the time of the report. Additional information is not expected as there is no consent to contact physician.
booster; headache; nausea; chills; body aches; fatigue; This is a spontaneous report received from a contactable reporter (Other-HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "headache"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "body aches"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue".  Additional information: On day 2 after receiving Pfizer Covid booster, the patient experienced headache, nausea, chills, body aches and fatigue. The patient was still experiencing headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
slept for 18 hours; This spontaneous report as received from a nurse and refers to a 12-year-old female patient. The patient's current conditions included asthma, allergy to latex and unspecified seasonal and environmental allergies. Concomitant therapies included montelukast sodium (SINGULAIR) and fluticasone propionate (FLONASE) and unspecified PROAIR.  On 18-JUL-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) one dose, lot #1614897, expiration date 20-SEP-2019 (exact dose, site and route of administration were not reported) for prophylaxis. After receiving the dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient went home and on the same day, she slept for 18 hours. There was no treatment given , no lab diagnostics performed and patient did not sought medical attention. The outcome of sleeping for 18 hours was reported as recovered/resolved on an unknown date in 2019. The relatedness between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and sleeping for 18 hours was not provided.
Diarrhea several times a day (up to 6). Sunken fontanel and fear of dehydration. Visit at emergency. It took more than a month for the diarrhea to stop. Baby was 100% breastfed.
Only side effect was a sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles vaccine (received few years ago).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 9 months after receiving Shingles vaccine, the patient experienced pain in arm. The patient was treated with ibuprofen and non-drug therapy (Heating Pad (Nos)). On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced sore arm. The patient stated that the ibuprofen and a heating pad works for the pain. For 2nd dose refer case US2021AMR202751, reported by the same reporter. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202751:Same patient Same reporter
Nurse diluted vaccine with 0.8cc diluent instead of 1.8cc
Red rash, swelling and itching that appeared 7 days after the vaccination. The site of the rash is also warm.
HERPES ZOSTER IN HEALTHY CHILD PREVIOUSLY VACCINATED AGAINST VZV.  RASH LOCALIZED, ON ONE SIDE OF THE BODY IN C4 DERMATOME.  CHILD HAD MILD PAIN.
(L) arm around lesion with central clear 4 - 5 cm area of hyperpigmented red. DX:cellulitis
All Symptoms Arose When Awoken The Next Morning ?Migraine ?Bone Pain (Like Shin Splints) ?Swollen Lymph Node Under Left Armpit ?Dizziness ?Brain zaps (a symptom of Lexapro Withdrawl, although I did not discontinue or change my dosage)
Information has been received from a nurse concerning a female (age was not reported) who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, immediately after the patient received the vaccine she passed out. The patient woke up about a minute or so after being vaccinated and was fine prior to leaving the office. Additional information has been requested.
Pt here for vax, mother stated had "knot" in left leg from where last vax was given. Pulled record, noted discolored area and hardness at site on upper left leg were Comvax received on 09/17/99. Mother states after vax was given site became red and swollen. Diagnosed 12/31/1999 with shot nodule.
The pt experienced a atrophic scar of right deltoid about 4 cm in diameter.
57-year-old who presents to the emergency room with a 5-6 day history of progressive weakness in his extremities and painful tingling and numbness as well.  He first developed the symptoms 5-6 days ago in the left upper extremity which was associated with chest pain and secondary anxiety and shortness of breath.  Patient was admitted to the hospital overnight.  He also complained of generalized weakness in his legs as well as a near syncopal episode in the emergency room at the time.
At 3 am , chills, fever, headache, arm aches and bruised arm and body aches
Oral herpes after covid booster. I have never had a cold sore before. I woke up on the morning of May 27th with a swollen lip that apparently is a cold sore. This morning I have two little sores (not canker sores) in the inside of my lip. They look water filled. I'm single and I do not know how I would be getting this nor do I share anything (straws etc) with anyone. I researched side effects of the Pfizer vaccine and found that other people have reported getting oral herpes and shingles after getting the vaccine. I had the J&J vaccine 06/17/2021 and just got a sore arm.
In Oct90 10 out of 59 pts were found to have either insuff or neg antibody levels during testing for anti-HBs. (See also EBU910168 - EBU910170 - EBU910177)
Patient is pregnant- received COVID 19 vaccine; slightly sore arm; This is a spontaneous report received from a contactable consumer, the patient.    A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported), via an unspecified route of administration in Mar 2021 as unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was pregnant and received COVID 19 vaccine in Early March, due in June. She had slightly sore arm. Patient had 3 children. Event took place after use of product. The outcome was unknown.  Follow-up attempts completed. No further information expected
expired Menactra was given to patient /no AE; Initial information was received on 06-Aug-2020 regarding an unsolicited valid non-serious case from other health professional. This case involves a 13 year old male patient who received an expired dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) for Immunisation.  On 06-Aug-2020, the patient received a 0.5 mL once dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U5869AB, expiry date- 05-Aug-2020) (Pharmaceutical form- SDV) via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.  No adverse event was reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
70 year old M reported skin erythema, worsening and painful around injection site on 01/19/19 after receiving SHINGRIX shot 01/18/19. Patient was advised to go to local ER due to being 100 miles away from facility. Patient went to ER on 1/20/19 in which no interventions were documented upon discharge from ER the same day. Erythema Multiforme, Urticaria Pruritus.
This was a booster as I am immunocompromised. I received the Pfizer vaccines (2 doses and 1 booster) without any notable reactions before this dose of Moderna. My arm became very swollen and sore, I had a rash on my trunk and arms, and my eyelid became very swollen. My care provider prescribed a low dose of prednisone for another condition. I believe that this Rx also helped alleviate the adverse reaction to the vaccine.
Flu; bronchitis; Initial information received on 14-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer (patient).  This case involved a female patient of unknown age who experienced flu (Influenza) and bronchitis, while he/she received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced flu (Influenza) and bronchitis (Unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for both the events, at the time of reporting.  There will be no information available on the batch number for this case.
He got his vaccine and the next day had extreme fatigue and it did go away after a couple of days.  Starting last night he has had diarrhea all night long, nausea and a runny nose that started yesterday.  He is very tired, possibly due to the diarrhea.  He has not called his doctor or taken anything for it.
Woke up with low grade fever, 98 and the last temp was 100.9, had some chills, headache.  No soreness in her arm.  Took Tylenol for these symptoms which alleviates the symptoms.
Weakness, Slurring of speech, later discovered to have Guillain Barre.
This spontaneous report was received from a registered nurse referring to a patient of unknown age. On 17-AUG-2017, the patient was inadvertently vaccinated with an improperly stored dose of GARDASIL 9 lot # N000326, expiration date 14-OCT-2019) for prophylaxis. No adverse effects reported. The vaccines were exposed to a temperature of 32°F to 35°F during a time frame of 130 minutes. There was no previous temperature excursion.
i was fine before leaving the pharmacy they held me for additional time to see if i had any swelling. Literally felt well, did have arm soreness the next few days. On April 7, I noticed some swelling but I just thought it was because I had a ton of sweets that day. The next morning I woke up, I was covered in hives, and my feet and hands were swollen. i went to urgent care and they gave me two shots one was a steroid, and the other one was benadryl, i was fine went home and the same thing happened this morning i was itching and swollen, and hives everywhere, even my genital area was starting to each. I have sensitive skin, and I just would like to know what to do. Should i get second dose? how do i know if this is related to vaccine or simply a really bad case of dermatitis. Please inform. thank you
Fuzzy-headed feeling; Fatigue; Body aches; Just below the injection site that was a large raised area that was intensely itchy.; Arm Soreness; Extreme Pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Fuzzy-headed feeling), VACCINATION SITE PAIN (Arm Soreness), PAIN (Extreme Pain), FATIGUE (Fatigue) and MYALGIA (Body aches) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm Soreness) and PAIN (Extreme Pain). On 10-Feb-2021, the patient experienced FEELING ABNORMAL (Fuzzy-headed feeling), FATIGUE (Fatigue), MYALGIA (Body aches) and INJECTION SITE PRURITUS (Just below the injection site that was a large raised area that was intensely itchy.). At the time of the report, FEELING ABNORMAL (Fuzzy-headed feeling), VACCINATION SITE PAIN (Arm Soreness), PAIN (Extreme Pain), FATIGUE (Fatigue), MYALGIA (Body aches) and INJECTION SITE PRURITUS (Just below the injection site that was a large raised area that was intensely itchy.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
no adverse affects reported; patients received doses of improperly stored Varivax; This spontaneous report was received from a health professional and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history, concomitant therapies, drug reaction and allergies were not reported.   On an unknown date in April 2019 (reported as 25-APR-2019 or 26-APR-2019), the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneously, lot # R034396, expiration date 27-NOV-2020, (dose was not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 38 degrees Fahrenheit for 72 hours. Sterile diluent was stored properly. There were no previous excursions reported. Data logger was not involved. No adverse effects was reported.  This is one of eleven reports from the same reporter.; Sender's Comments:  US-009507513-1904USA013210: US-009507513-1904USA013265: US-009507513-1904USA013268: US-009507513-1904USA013270: US-009507513-1904USA013272: US-009507513-1904USA013275: US-009507513-1904USA013276: US-009507513-1904USA013278: US-009507513-1904USA000187: US-009507513-1904USA000191:
Patient called on Sunday morning and said when she woke up she had hives right at her scalp line.
08/13/2009 Caregiver noted a red area on R arm when doing morning cares this am. Presented to HD with reddened area with irregualr borders between R deltoid and elbow. Red area is firm and warm. No redness on deltoid area. Afebrile. Referred to MD for evaluation. Pt saw NP on 8-13-2009 and was given Cephalexin 500mg tid x 10 days and to return to NP on 8-15-2009
Redness, swelling, at injection site. Some point tenderness. No exudate. Reported symptoms to clinic on 11 Jul 2004 (3 days post vaccination).
PATIENT RECEIVED BOTH PNEUMOVAX 23 AND FLUZONE HD. HE HAD REDNESS AND SWELLING WITH EXTREME ARM PAIN. IT LASTED THROUGH THE NIGHT, LEGS BECAME EXTREMELY WEAK AND PATIENT COULD NOT STAND ON HIS OWN. PATIENT WENT TO LOCAL HOSPITAL THINKING IT MAY BE HEART RELATED OR STROKE SYMPTOMS. THEY TREATED  HIM WITH CEPHALEXIN 500MG CAPS.
Patient inadvertently received the monovalent covid-19 dose instead of the bivalent covid -19 dose.
Pt complained of a 3 inch hard area, that was warm to the touch and achiness at the injection site.
Nausea on and off for 48 hours Fever peaked at 101.4, 9 hours after vaccination  Chills starting 6.5 hours after vaccination
Constant migraine since one week after first dose, swollen lymph nodes under both arms since first dose,  dizziness and tired.
Red itchy macular rash anterior thigh near site of injection. Began 2-14.
pt states area where vax given was itching severely;stated itching since inj given but reported 10-15mins p/vax;c/o light-headedness, abn resp & feeling a littel warm; c/o difficulty breathing transported to ER
Patient reported having redness and swelling for a few days after getting Fluzone HD vaccination. Large area of bruising appeared afterward on the deltoid muscle around the injection site. Bruising did not subsided 7 days after vaccination, thought it appears less red and more purplish. She has no fever or flu like symptoms. She is able to go to work these days.
No adverse event; patient is not certain is she received the Moderna bivalent vaccine today/Patient thinks she may have received the Moderna monovalent vaccine today; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient is not certain is she received the Moderna bivalent vaccine today/Patient thinks she may have received the Moderna monovalent vaccine today) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer Covid-19 vaccine (primary series, Dose 1), Pfizer Covid-19 vaccine (booster dose), Pfizer Covid-19 vaccine (primary series and Dose 2). Past adverse reactions to the above products included No adverse reaction with Pfizer Covid-19 vaccine, Pfizer Covid-19 vaccine and Pfizer Covid-19 vaccine.   On 13-Oct-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patient is not certain is she received the Moderna bivalent vaccine today/Patient thinks she may have received the Moderna monovalent vaccine today). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient is not certain is she received the Moderna bivalent vaccine today/Patient thinks she may have received the Moderna monovalent vaccine today) and NO ADVERSE EVENT (No adverse event) outcome was unknown.       No concomitant medication was reported. The patient did not believe that what she experienced was an adverse event. The patient said that since nothing bad happened this was not an adverse event. The patient wass not certain was she received the Moderna bivalent vaccine . Patient reported that she might had received the Moderna monovalent vaccine. No treatment medication was provided.
Information was received from a nurse via field employee, concerning herself and her concurrent conditions included diabetes. The patient's concomitant therapy was reported as "diabetes".. There was no information about the patient's age. In approximately 2007 (also reported as about 10 years) the patient was vaccinated with PNEUMOVAX 23  for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unspecified date in 2007, for about a week after vaccination, the patient experienced redness, could not rest her arm down by her side and had to keep it elevated (Injected limb mobility decreased) and swelling of the arm all the way into the armpit (peripheral swelling). The patient sought unspecified medical attention at the time of the experience and it was unknown if treatment was given for adverse events. The outcome of the events erythema, Injected limb mobility decreased, and peripheral swelling and the causal relationship between the event and therapy with PNEUMOVAX 23 were not reported. There was no PQC involved. Additional information is not expected because there was no consent to contact reporter.
fever/URI 2wk ago;2 days ago started to lose smile;day of admit could hardly talk secondary to facial diplegia w/o brow wrinkle;c/o watery eyes & sl paresthesia periorally;
6/19/2008-Pt described onset of fever of 102F, myalgias, nausea with dyspepsia, and pain and redness at the injection site 12 hours post vaccine administration.
Developed bumps and was red all over face, neck, chest and arms. Eyes also reddened, few spots in stomach. Went to nurse practitioner next for scheduled PE, thought was from allergies again. Zyrtec didn't help so went to PA Sat. and was thought from immunization. Still had rash so went to Dr, started on steroids, bumps went away, but redness lasted 1-2 weeks.
+ COVID 19 test worsening dyspnea, congestion, cough, myalgias
Pt reports he became extremely weak/fatigued evening of vaccine being administered, lasted 12-18 hours. No treatment needed.
1 person got heart attack; 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 MYOCARDIAL INFARCTION (1 person got heart attack) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (1 person got heart attack) (seriousness criteria medically significant and life threatening). At the time of the report, MYOCARDIAL INFARCTION (1 person got heart attack) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.  Company comment: This case concerns a patient of unknown age and gender with no relevant medical history who experienced serious unexpected event of MI on unknown date after receiving a dose of the Mooderna Covid 19 vaccine on unknown date.Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.   This case was linked to MOD-2021-332598 (Patient Link).; Sender's Comments: This case concerns a patient of unknown age and gender with no relevant medical history who experienced serious unexpected event of MI on unknown date after receiving a dose of the Mooderna Covid 19 vaccine on unknown date.Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.