chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10/01/2003: Had office visit.  Observed right arm 6.5 inch left arm 7.5 inch (+) swelling, (+) warm, (+) tender for 24 hours.
Seen in office for 12 mo WCE on 07-11-14; Rec'd all 12 mo vaccinations. Developed redness at site (RA); Now with 1 1/2 x 2 cm area erythema with 2-3 (+) papules; No induration or tenderness on exam 7/22/14. Afebrile 7/22/14; Max (T) = 100 F; Tx with ibuprofen q 6-8 hours.
This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 04-MAR-2021, the patient experienced cold symptoms, and flu symptoms. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cold symptoms and flu symptoms was not reported. This report was non-serious.
They are totally asymptomatic. They had their first Pfizer vaccine 2 weeks ago and now have a positive PCR test; They are totally asymptomatic. They had their first Pfizer vaccine 2 weeks ago and now have a positive PCR test; This is a spontaneous report received from a contactable other healthcare professional via Medical Information Team. This other HCP reported similar events for 4 patients. This report is for 4th of 4 patients.  A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration Date was not reported), via an unspecified route of administration on an unspecified date in 2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. The reporter stated that, it is affecting 4 patients currently. They are totally asymptomatic. They had their first Pfizer vaccine 2 weeks ago and now have a positive PCR test. The outcome of the events was reported as unknown.  Information about lot/batch has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and asymptomatic COVID 19 and the suspect drug. ,Linked Report(s) : US-PFIZER INC-2021304208 Different paitent, same drug, same event (split)
Information has been received from a physician concerning a patient who on 06-FEB-2008 was administered varicella vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). No symptoms were reported. The physician stated that "this was not production confusion, rather the wrong product was ordered". Current patient status was not reported. A product quality complaint was not reported. Additional information has been requested.
weak since getting the shot; red and itchy at injection site; red and itchy at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak since getting the shot), VACCINATION SITE PRURITUS (red and itchy at injection site) and VACCINATION SITE ERYTHEMA (red and itchy at injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced ASTHENIA (weak since getting the shot), VACCINATION SITE PRURITUS (red and itchy at injection site) and VACCINATION SITE ERYTHEMA (red and itchy at injection site). At the time of the report, ASTHENIA (weak since getting the shot), VACCINATION SITE PRURITUS (red and itchy at injection site) and VACCINATION SITE ERYTHEMA (red and itchy at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter.   Treatment information was not reported.
Patient was sitting on the table & seized up, fell to his side and started shaking. Approximately 1-2 minutes after the vaccine was injected.
91 YEAR OLD FEMALE FELT TINGLING AND NUMBNESS IN BOTH HER LEGS AFTER RECEIVING THE VACCINE. ON SITE EMS RESPONDED. BP 180/90. SHE STATED THAT SHE DID NOT TAKE HER MEDICATIONS THIS MORNING. IT WAS RECOMMENDED FOR HER TO GO TO HOSPITAL FOR FURTHER EVAL AND SHE REFUSED. SHE WILL GO TO E.R IF SYMPTOMS PERSIST BUT FOR NOW, SHE WILL GO HOME HAVE BREAKFAST AND TAKE HER MEDICATIONS.
outside dosing window; possibility of shingles; bladder infection; swollen armpit; sore throat; stomach discomfort; ear pain; jaw pain; shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (shoulder pain), OROPHARYNGEAL PAIN (sore throat), ABDOMINAL DISCOMFORT (stomach discomfort), EAR PAIN (ear pain) and PAIN IN JAW (jaw pain) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced ARTHRALGIA (shoulder pain), EAR PAIN (ear pain) and PAIN IN JAW (jaw pain). On 01-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), ABDOMINAL DISCOMFORT (stomach discomfort) and SWELLING (swollen armpit). On 20-Apr-2021, the patient experienced CYSTITIS (bladder infection). On 27-Apr-2021, the patient experienced HERPES ZOSTER (possibility of shingles). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (outside dosing window). On 03-Apr-2021, ARTHRALGIA (shoulder pain), OROPHARYNGEAL PAIN (sore throat), ABDOMINAL DISCOMFORT (stomach discomfort), EAR PAIN (ear pain), PAIN IN JAW (jaw pain) and SWELLING (swollen armpit) had resolved. On 04-May-2021, CYSTITIS (bladder infection) and HERPES ZOSTER (possibility of shingles) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (outside dosing window) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-114336 (Patient Link).
fever (101.4), horrible headache with use of medications to relieve, generalized body aches, sore L arm
Mom reported (@ 4mo well visit)crying for 48 hours within 24h after receiving 2 month immunizations. Cried > 3h inconsolably. Mom did not call office. Tylenol did not help.
This spontaneous report was received from a physician assistant who refers to a 20 year old no pregnant female patient with none pertinent medical history and none drug reactions/allergies. The patient was vaccinated with 2 first doses of GARDASIL (doses, route and lot numbers not provided by the reporter) on an unknown date in 2010 (reported as 3 years ago). On 02-JAN-2013 was in the doctor office to get her third dose of GARDASIL (dose, route and lot number not provided by the reporter). None concomitant medications were reported. On an unknown date (reported as recently the patient underwent Pap smear test (resulted in a positive HPV). At the time of the report patient's state was reported as not recovered. The patient sought medical attention via doctor visit. Additional information has been requested.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They gave expired vaccine to 9 patients) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.No Medical History information was reported.On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They gave expired vaccine to 9 patients). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (They gave expired vaccine to 9 patients) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Concomitant and Treatment medications were not reported. The vial was initially stored in the refrigerator on 11Nov2021 and the vial was first punctured at 10 AM on 18Nov2021.
acute onset of stuttering   ***as my office did not administer the vaccine, I do not know the exact type and manufacturer of the flu vaccine
Experiencing dermatographia. Symptoms began approximately 8 days after receiving the booster vaccine, and symptoms are only alleviated by taking Zyrtec. As soon as dose of Zyrtec reaches 24 hours, symptoms reappear. Intense itching with raised hives several inches in length.
This is a spontaneous report from a Pfizer sponsored program "Pfizer First Connect" received from a contactable pharmacist. This pharmacist reported 2 reports for different patients (mother and son). This is the 1st of 2 reports. A 58-year-old female patient of unspecified race/ethnicity received TRUMENBA (NDC# 00005010005, Exp date Jul2017, Lot# N16808 or NI6808), via an unspecified route of administration in left arm, on 23May2017, at single dose, for immunisation. Patient was vaccinated at the pharmacy/drug store. Relevant medical history and concomitant medications were not provided. The patient experienced did not feel good, body aches, pain in arm, malaise, cold and sweating all in May2017. After vaccination the patient was good. Several hours after vaccination, around midnight or 2:00 AM the following morning, she woke up and did not feel good. She had body aches, pain in her arm, malaise, was cold and had sweats. Therapeutic measures were taken as a result of body aches and pain in arm and included treatment with Naproxen, Tylenol or some kind of NSAID. The events recovered on an unspecified date.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017236185 Same reporter/drug/event, different patient.
abdominal cramping; Diarrhea; she could hardly walk this morning; muscle ache; arm is a little sore; nausea; GI problems; This is a spontaneous report from contactable consumer (patient). This 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL0142), via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications included ongoing evolocumab (REPATHA, Expiration Date: 04Nov2021), ongoing amlodipine besilate (NORVASC, Strength: 10 mg) as high blood pressure medication, and ongoing amlodipine (Strength: 5 mg) as high blood pressure medication. The patient previously took first dose of BNT162B2 (Lot number: EJ1685) for COVID-19 immunisation. On 12Jan2021, patient got the second dose of the Pfizer COVID vaccine. She did fine all day, but then she started to feel a little nauseous off and on. Then at 4 o'clock before she left for work she developed muscle ache on 12Jan2021. It persisted to the point she could hardly walk this morning (13Jan2021). Patient has not had a fever. She hasn't really had a headache. It has just been muscle aches. Her arm was a little sore on 12Jan2021 but not bad. She has had muscle ache and GI problems with it. She had waves of nausea like she could throw up. She was hydrating really well. The nausea came and went. The muscle aches started at 3:30 to 4 with muscles aching. She got the vaccine to help prevent the spread of COVID and to protect herself as well. Patient experienced abdominal cramping and diarrhoea on 13Jan2021. Outcome of nausea and arm was a little sore was recovering, outcome of muscle ache, abdominal cramping and diarrhea was not recovered, outcome of other events was unknown.
Upon receiving the Moderna vaccine (1st dose) a significant rash occurred in the area of the injection site. Additionally, a large blister covered the significant rash
Started out as a rash then turned into hives all over body, difficulty breathly and itchy all over.
This spontaneous report as received from a pharmacist refers to a 66 years old female patient. The patient was vaccinated with, .5 ml PNEUMOVAX23 (route unknown, dose 0.5 ml, product Lot number H013581, expiry 03-MAR-2014) on 02-NOV-2012. No other co-suspects were reported. Concomitant medications Baby Aspirin. On 02-NOV-2012 the patient experienced little was swelling around injection site and induration around injection site, both after receiving PNEUMOVAX23. No treatment information was reported. The outcome of little swelling around injection site and induration around injection site was reported as not recovered/not resolved. The reporters relatedness for little swelling around injection site and induration around injection site is unknown for PNEUMOVAX23. Additional information is not expected.
4" diameter, red raised itchy "hive" to injection shot.  Appeared approximately 36 hours after shot.  No treatment.  Symptoms gone in 48 hours.
I woke up at 11pm or around midnight and had diarrhea and i woke every hour with diarrhea. I had a headache. This all lasted about 24 hours. I was pretty tired.
Patient came in asking for Pfizer vaccine 3/9/2022, was screened and nurse confirmed patient wanted pfizer, medical assitant who was to administer the vaccine had just drawn a moderna dose for another patient who was still to be called back and be screened, consent form of patient was handed to MA which included the type of vaccine the patient wanted and confirmed with the nurse verbally it was Pfizer, Pfizer vaccines are pre-drawn and kept separate on the table from Moderna vial and materials as moderna is drawn up as patient's are screened, MA was confused and administered moderna booster dose of 0.25ml to the patient's right deltoid at 1:51pm, as nurse was still writing on the vaccine card.  nurse then noticed the number of Pfizer vaccines on the table had not changed and confirmed with MA if she had administered the right one, the MA then confirmed she had given the wrong one, pt was pulled to the side and informed of error, pt informed of Moderna vaccine and its side effect,  pt was informed per CDC guidelines she would need the other 0.25ml dose of moderna to be considered a full first dose  she agreed to receive it on right deltoid as well. patient was monitored for 15 min observation time and left with no signs of allergic reaction. was later offered to speak to provider for any other questions or concerns pt refused stated she was fine at the moment.
Toothache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 52 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 Immunization, reaction(s): "No adverse event". The following information was reported: TOOTHACHE (non-serious), outcome "unknown", described as "Toothache".  Additional Information: Caller's husband had a toothache before the booster shot, but in between the second dose and the booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a female patient with no known drug reactions/allergies and medical history, who was vaccinated with the first dose of GARDASIL by an unspecified route in the deltoid area.  There was no concomitant medication.  The physician reported that the patient developed a swollen lymph node one week after vaccination.  The swollen lymph node was warm and tender and about 4 inches from the injections site.  The lymph node is still swollen but much less.  The patient sought medical attention.  At the time of the report it was reported that the patient was not recovered.  Additional information has been requested.
t104 8 hrs p/vax, hard crying for 3 hrs, 2 hrs p/vax; parents gave APAP & advil & pt slept most of the noc; still has temp 103 this AM;
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a health care professional concerned a 54 year old male. Initial information was processed with the additional information received on 07-JUL-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  The patient received combination product ustekinumab (solution for injection in pre-filled syringe, subcutaneous, batch number: Unknown) 45 mg, frequency was not reported, strength was 45 mg per 0.5 ml from JUL-2020 for psoriasis. Product constituent parts included ultrasafe passive (route of admin, lot, serial number, model number, UDI number, and expiration were not reported); and ultrasafe passive accessory (route of admin, lot, serial number, model number, UDI number, and expiration were not reported). The batch number was not reported and has been requested. No concomitant medications were reported.  In JUN-2021, the patient had lab work done and did not have any antibodies to COVID. On 16-JUN-2021, the patient experienced confirmed immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of ustekinumab was not changed. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000185149 and 90000185150.; Sender's Comments: V0: 20210713254 - Covid-19 Vaccine Ad26.Cov2.S- Confirmed immunological vaccine failure - This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS    20210713254 Stelara - Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
pt recvd vax 25OCT93 215PM & 1 hr later devel a heavy or numb feeling in entire lt arm & lt side of neck & face;
Administered ZOSTAVAX on 9/10/15 at 3:15pm. Patient did not complain at the time. She called on 9/12 and said she experienced burning and itching and swollen area at the injection site. RPh on duty told patient to apply ice and hydrocortisone cream to the area.
Coughing every morning; Has been having to take rescue inhaler more often than normal; This is a spontaneous report from a contactable consumer (patient). A 46-Year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution of injection, Lot Number: EW0162) via an unspecified route of administration on 22Apr2021 (at the age of 46 years old) as dose 2, single for COVID-19 immunization (Hospital). The patient medical history included acute anxiety disorder, depression, bipolar disorder, high cholesterol, high blood pressure, chronic head pain and cough in the morning started a year or 2 years ago but continues from an unknown date and ongoing. The patient concomitant medication included Emgality (GALCANEZUMAB) from an unspecified date for chronic head pain. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution of injection, Lot number: EW0150) via an unspecified route of administration on 01Apr2021 (at the age of 46 years old) as dose 1, single for COVID-19 immunization. The patient had not visited emergency room or physician office. Patient had not administered vaccine at military facility. On an unspecified date of 2021, the patient experienced has been having to take rescue inhaler more often than normal while an unspecified date the patient experienced coughing every morning. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Severe swelling of injection site zoster outbreak on face, under eyes. Physician chose not to treat as if appears to be resolving.
Same day post vax, the pt noticed redness around the injection site. Pt also developed swelling of right leg about the size of a golf-ball with shaky walking. Mother advised to apply ice to leg and call her pediatrician.
Pt was given 0.03mL dose instead of 0.3mL.  The mistake was noted while patient was waiting in the office for fifteen minutes to monitor for side effects and a dose of 0.27mL was then administered. No side effects or adverse effects.
Headache; arm is gets very sore; body aches; fatigue; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In July 2021, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced headache, pain in arm, general body pain and fatigue. On an unknown date, the outcome of the headache, pain in arm, general body pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the headache, pain in arm, general body pain and fatigue to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received Shingles vaccine and it was not painful, but arm was gets very sore and side effects not fun.headache, body aches, fatigue but it only lasts a day or so. The patient just had 1st shot in July booster shot set for November. The follow up would not be possible as no contact details were available.
Narrative: Vaccine received 1/20/21. Pt reports feeling tired starting the following day (expected), however, blood sugars went up over 400. Went to ER for evaluation and treatment. Found to have elevated CR and markedly elevated liver enzymes (AST/ALT over 1000) which slowly improved after hospitalization, IVF, and insulin. 1/28/21 labs showed CR back to normal. ALT down to 555 AST 304. Blood sugars 200s.
Vaccination Thursday evening, Out sick from work following day with sweats, body ache and headache Monday am broke out in Shingles on right waste from belly button to spine Progressively got worse for 2 weeks, then subsided for the next 2 weeks Broke out again 5 weeks later but VERY minor and in different spot
hives, wheezing, hx of compromised lungs. Benadryl and EpiPen administered. Hives on left and right side of neck and anterior chest
Pt into clinic 6/20/13 for evaluation of c/o lt arm pain, swelling, and redness post PNEUMOVAX 6/18/13. The Dr and RN evaluated pt. Swelling noted approximately 3 inches above lt antecubital to 5 inches below injection site, area red and hot to touch, pt reports pain to touch. KEFLEX, ice, antihistamine.
Patient noted that she has had a seizure in the past and does faint or nearly faint following an immunization. She stated that she has not had an episode recently but wanted to receive her first dose of Moderna. Following administration, the patient felt faint and asked if she could sit on the floor where it's cooler. She sat, drank water and used an cold compress and within 3 minutes, she fainted. emergency services was called by RPH and technician in pharmacy alerted management.
Headache, Myalgia, Diarrhea, Fatigue, Neck pain Narrative:  Other Relevant History: