chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Limb Contusion; Pain of extremities; Headache; This spontaneous case was reported by a physician and describes the occurrence of CONTUSION (Limb Contusion), PAIN IN EXTREMITY (Pain of extremities) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced CONTUSION (Limb Contusion), PAIN IN EXTREMITY (Pain of extremities) and HEADACHE (Headache). At the time of the report, CONTUSION (Limb Contusion), PAIN IN EXTREMITY (Pain of extremities) and HEADACHE (Headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment medication was not provided.   Reporter did not allow further contact
Information has been received from a physician concerning an "over 60 year old" male consumer who was on an unspecified date vaccinated with a dose of Zostavax.  Subsequently the patient broke out in four vesicles or lesions around the injection site.  Unspecified medical attention was sought.  The patient recovered.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
The patient received the new Pfizer Comirnaty vaccine (it is not yet in the drop down menu).  Patient stated that after 24 hours  she developed a severe headache,  terrible chills, upset stomach, severe muscle aches and extreme fatigue - so extreme she could not get out of bed.  It lasted 2 days. Patient came in today 11/04/2023 and said she would like to report an adverse reaction to the vaccine.
1st day, extreme achievement, fatigue, 101 fever 2nd day: achy, feverish, stiff neck, chest heaviness/pain 3rd day: stiff neck, achy, chest discomfort 4th day: chest discomfort
This spontaneous report as received from a physician refers to a 17 year old male patient. On an unknown date the patient was vaccinated with the series of RECOMBIVAX HB (dose, route and lot number not provided). The physician reported that the patient was a non responder to RECOMBIVAX HB series. The patient sought unspecified medical attention. The patient had unspecified lab work that showed "less than 5" on an unspecified date. The outcome of non responder to RECOMBIVAX series was unknown. The causal relationship was not reported. This is one of several reports from the same source. Additional information has been requested.
1OCT96 2hr p/vax pt was febrile 104 then in ped clinic the following morning  2OCT96 t105.5 R;tx w/alternating doses Ibuprofen & APAP, tepid baths;fever resolved 3OCT96;
Mother states patient walked into kitchen and fell backwards and then seizure - lasted less  than 1 minute. States he told her he fell out of bed just prior to this. The night shots given had fever of 102. and same the next day - states she gave him Ibuprofen routinely - no fever yesterday, or this AM
bad headaches; Positive test result for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive test result for COVID-19) in a female patient of an unknown age 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced COVID-19 (Positive test result for COVID-19) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (bad headaches). At the time of the report, COVID-19 (Positive test result for COVID-19) and HEADACHE (bad headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications and treatment information was not provided. The patient wanted to know whether she can take her second dose of vaccine as planned.  Company comment This case concerns an adult female with a serious unexpected event of COVID-19 and nonserious expected headache. Latency unknown after first dose mRNA-1273. . Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns an adult female with a serious unexpected event of COVID-19 and nonserious expected headache. Latency unknown after first dose mRNA-1273. . Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient came in for 11 year old physical, administered Menactra, Tdap vaccine on right harm. HPV vaccine was administered in left arm. Right after HPV was given patient stated she did not feel well, eyes rolled back and fainted. Parents and I laid her back on the table. Two MD's and LVN  ran in to assist the patient. Patient was responsive very quickly and was given water and legs were elevated. Blood pressure was re-checked and was WNL . We observed patient for about 20mins until she and parents felt comfortable leaving the clinic. Patient has a history of syncopy episodes.
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, multiple unspecified patients were vaccinated with improperly stored doses of PROQUAD (Merck) (dose, route of administration, lot # and expiration date were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
nose became swollen on the sides; throat felt sore on the right side; This spontaneous case was reported by a consumer and describes the occurrence of NASAL OEDEMA (nose became swollen on the sides) and OROPHARYNGEAL PAIN (throat felt sore on the right side) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced NASAL OEDEMA (nose became swollen on the sides) and OROPHARYNGEAL PAIN (throat felt sore on the right side). At the time of the report, NASAL OEDEMA (nose became swollen on the sides) and OROPHARYNGEAL PAIN (throat felt sore on the right side) had resolved.            No concomitant medications provided. No treatment information provided. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Updated Event outcomes of Nasal Edema and Oropharyngeal pain from unknown to Recovered. Updated Rechallenge to Negative Rechallenge on 21-Apr-2021.
Skin burning and prickly all mucus  membrane  areas are  burning and painful feels like my cold sore is coming to life.
wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.  This case contains information about patient 5th out of 10 infant patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-731451 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731451:Same reporter, master case
The incorrect vaccine was given to the patient.  The patient was not harmed.  The two vaccines are the same except that Varivax is 1/14th the concentration of Zostavar.  The patient was still able to receive the correct vaccine according to the manufacturer.  This was the first time that Zostavax had been administered in our facility, even though the information had been included in a recent facility newsletter, staff were uncertain about the process for obtaining, reconstituting, and administering the vaccine.  In addition, the provider (at an outlying clinic) had entered the order incorrectly (for Varivax rather than Zostavax).  Once these issues were sorted out, there was a rush to administer the drug to the patient because he had had a long wait after a long drive to the clinic.  In haste, the wrong vial was taken from the freezer - and the two products were right next to each other in the same freezer.  The two products look similar in the sense that they are both single dose vials packaged as one vial per box.  The products have different colored packaging BUT they are in the same size box.  The two vaccines should be separated within the freezer.  There should be clear and obvious signage as to which is which.  All staff should be educated to double check orders when pulling the vaccine from the freezer to ensure that the correct one is pulled.
fifty cents size red area @ inject site w/in 5 min c/o light headedness take to ER observed; no meds given reversed by self;
high blood pressure; Rash happened a week or so after the vaccine; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (high blood pressure) and RASH (Rash happened a week or so after the vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included Sinus infection (Prior to getting the vaccine.).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (high blood pressure) and RASH (Rash happened a week or so after the vaccine). At the time of the report, HYPERTENSION (high blood pressure) outcome was unknown and RASH (Rash happened a week or so after the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HYPERTENSION (high blood pressure) to be possibly related. No further causality assessment was provided for RASH (Rash happened a week or so after the vaccine).    Concomitant medications were not provided.  The patient was prescribed unspecified antibiotics for the rash, but did not take the antibiotics because the rash went away. Action taken with mRNA-1273 in response to the event was unknown.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded.
Client received flu vaccine on 12/09/2003 in left arm.  States flu shot given in back of arm, not muscular side part as is typical.  On 12/10/03, noted vax site was swollen and raised (larger than 1/2 dollar size); area hot to touch, tender.  No streaking noted.  Seen at ER on 12/11/03, told area infected.  Prescribed Keflex 500mg 4 times every 7 days.  Symptoms resolved 12/14/03.
Patient went came into the Immunizations clinic on the 12Jan09 to receive the MMR, Varicella, IPV, DTAP, and the HEP A vaccine, waited 15 minutes, and left the facility. On the 20th of January the mother began to notice the child's Rt thigh began to look red and swollen. It began to spread to a rash. The mother began to become concerned and took the child to the United Regional ER on the 22Jan09. The physician there saw the child and determined that due to where it was given(SQ) and the documentation we had, it was the MMR vaccine that she had a reaction to. The child was prescibed Millipred 10mg/5ml, triamcinolone topical cream .1%, and Bactrim Ped oral suspension. The patient's mother cannot report it any better on the 23rd of January, however she has not filled the presciptions from the ER.
Shot was bad enough; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of malaise in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced malaise (Verbatim: Shot was bad enough). The outcome of the malaise was not reported.   It was unknown if the reporter considered the malaise to be related to Shingles vaccine.     It was unknown if the company considered the malaise to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 17-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that, the shot to prevent shingles was bad enough. The follow-up could not be possible as no contact details were available.
pt recv vax in 1995 & in JUL97 pt was tested & was negative;no further details were provided;
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 07-SEP-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0435AE, expiry date 28-FEB-2014) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
rash, hives, itchiness 20 min after receiving vaccine. Gave 50mg Benedrylorally  per protocol. ater 30 min observation, discharged to home in stable condition (with driver)
patient indicated via translator pain in the middle of the chest.  I requested that he remain in the area of the pharmacy longer time--he refused.  I advised him to go to an emergency department if the pain returned or got worse ASAP
1) Large swollen lymph nodes under armpit (vaccination arm/left) lasting for several months.  2) Osteoarthritis in both hands 3) General body inflammation 4) Cervical radiculopathy 5) Tinnitus  6) Loss of menses
fever 21-23SEP, rash started on chest 24SEP, spread to back, some spots on arms;child irritable, dec appetite until 26SEp;seemed to feel fine, but rash still present;rash, however is less red, more pink;
Initial information received on 20-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a nine months old female patient who received 0.5 mL dose of vaccine FLUZONE QUADRIVALENT, lot UT6375NA, expiry date: 30-Jun-2019 via unknown route in the left thigh on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to overdose. It was reported that MA had given a 9 month old patient, female, a .5ml dose of FLUZONE QUAD in the left thigh. It was unknown if any adverse event was occurred. 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. Documents held by sender: none.
Suspected vaccination failure; pretty bad case of them; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that his friend that has a pretty bad case of them even though he was vaccinated previously. This case was considered as suspected vaccination failure since the details dose number, time to onset and regarding laboratory confirmation of shingles not provided.
Patient stated that it had been 6 plus months since her last dose of her 2 step Covid-19 vaccination and I failed to check and ended up giving her booster 47 days early. Patient did not have any reaction
arm pain started same day as receiving  vaccine and continues the next day but milder mild headache started the morning after receiving the vaccine
Patient had a rough time getting the COVID shot alongside her 1 year vaccines.  Patient had her first COVID vaccine on July 30th. Patient also was diagnosed with COVID on July 14th, and we were advised that she could have her 2nd shot at her 12 month appointment on August 3rd.  After the initial shots, Patient had a fever and was quite uncomfortable but recovered pretty quickly.  However, about 8 days after the vaccines, Patient got a pretty significant reaction to her MMRV vaccine, with a mild rash and high fever (104).  The fever needed both Motrin and Tylenol to be managed.  Patient took about 2-3 days to recover. I can't help but wonder if her body was just overwhelmed with all three vaccines after recently having Covid.
Heart attack; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4513732-00.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Batch/Lot number: unknown), on 25Jul2021 as dose 2, single (Batch/Lot number: unknown) and on 20Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Lot number: 1141058), oral for rheumatoid arthritis. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "recovered", described as "Heart attack". The action taken for upadacitinib was unknown.  Clinical course: Patient stated he had a heart attack and cardiologist had him to stop taking Rinvoq and he had now been added Rinvoq per physician.  Causality for RINVOQ (UPADACITINIB): The reporter's causality for the event(s) of heart attack with RINVOQ (UPADACITINIB) was no reasonable possibility. Agency's opinion is that the event of heart attack is not assessable.   The reporter considered "heart attack" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As per the available information there can be possible causality of the event myocardial infarction and suspect Bnt162B2. It will be reassessed after more information available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Agency, Ethics committees, and Investigators, as appropriate.
Information has been received from a physician concerning an 18 year old female who in June 2008, was vaccinated with the first dose of GARDASIL 0.5 ml I.M. route, in June 2008 was vaccinated with the second dose of GARDASIL 0.5 ml I.M. route and in December 2008 was vaccinated with the third dose of GARDASIL 0.5 ml I.M. route. On 26-JUN-2009, the patient was tested Positive for HPV, the PAP smear the same date was normal. At the time of the report the patient was not recovered. The patient sought unspecified medical attention in the office. No further information is available.
This spontaneous report was received from a Licensed Practical Nurse regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored PNEUMOVAX23 single dose (dose strength, route and lot number was unknown). No concomitant medication was reported. No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of several reports received form the same reporter. Additional information has been requested.
I had a miscarriage at 6 weeks. I went to my clinic where my doctor is. They did confirm that I had a miscarriage. The lab work.