chrisvoncsefalvay/vaers-outcomes huggingface dataset:
warm to touch of her upper arm where the shot was received; She experienced pain/Pain in upper arm; She experienced swelling/swelling of upper arm; She experienced redness/redness at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-AUG-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). On 17-AUG-2023, less than a day after receiving Shingrix, the patient experienced injection site warmth (Verbatim: warm to touch of her upper arm where the shot was received), injection site pain (Verbatim: She experienced pain/Pain in upper arm), injection site swelling (Verbatim: She experienced swelling/swelling of upper arm) and injection site erythema (Verbatim: She experienced redness/redness at injection site).  The outcome of the injection site warmth, injection site pain, injection site swelling and injection site erythema were unknown.   It was unknown if the reporter considered the injection site warmth, injection site pain, injection site swelling and injection site erythema to be related to Shingrix.     It was unknown if the company considered the injection site warmth, injection site pain, injection site swelling and injection site erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-OCT-2023 The patient reported that she received first dose of Shingrix injection and experienced pain, redness, swelling and warm to touch of her upper arm where the shot was received.  Two physicians advised her not to receive the 2nd shot due to this experience. They provided the telephone number to provide to the physicians. The reporter did not consent to follow up. The patient did not want her doctor to feel singled out.
8 days later, after receiving vaccine, developed warm reddened, slightly raised 45X55mm area at injection site. Not painful. Slightly itchy.  Will monitor to see how long it lasts or change in status.
Vaccination failure; Rebound COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown), on 01May2021 as dose 2, single (Batch/Lot number: unknown) and on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(medication in 2 weeks) included: ALLEGRA, start date: 01Jan2018; ZOLOFT, start date: 02Jun2019; DEXILANT, start date: 06Jan2020. The following information was reported: COVID-19 (medically significant) with onset 22May2022, outcome "recovering", described as "Rebound COVID"; VACCINATION FAILURE (medically significant) with onset 22May2022, outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: Received antiviral medication for covid-19 treatment from 15May2022 to 19May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Two weeks later he tested positive for covid infection.; Two weeks later he tested positive for covid infection.; This is a spontaneous report from a contactable pharmacist (parent) via Pfizer-sponsored program.  A 34-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient received the first dose of suspect vaccine; two weeks later, he tested positive for covid infection. The patient received REGENCOV antibodies. On unknown date, the patient resulted positive to sars-cov2 test. The outcome of the events was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events drug ineffective and covid-19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This 61 year old white female received the covid-19 vaccine on 4/21/21 and died on 5/5/21.
Patient received Menquadfi subcutaneousversus IM with no reported adverse event; Initial information received on 28-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who had received meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] subcutaneous versus IM with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (lot number, strength, dosage, expiry date- not reported) via subcutaneous route in unknown administration site for prophylactic vaccination (Immunisation). Information on the batch number was requested.  On an unknown date the patient received meningococcal A-C-Y-W135 (T CONJ) vaccine subcutaneous versus IM (intramuscular) with no reported adverse event (incorrect route of product administration) (latency- same day). Caller was asking do they need to be revaccinated?   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the 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.
Vaccine was kept at 9 degree Celsius for approx 30 minutes, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00617255) and transmitted to Sanofi on 26-May-2021.  This case involves a two-month-old female patient who received 0.5 mL dose of IPV (VERO) [IPOL] (lot R1F801M and expiry date: not reported) via an intramuscular route in the left thigh for prophylactic vaccination on 15-Mar-2021 which was kept at 9 degree Celsius for approx. 30 minutes on 09-Mar-2021 (product storage error).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE), DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL), MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) and DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID (TENIVAC) for prophylactic vaccination.  A clinic calling to report that Ipol was given post a temperature excursion that made the vaccine not useable. The caller reported that the excursion occurred on 09-Mar-2021, that the excursion was spotted during an audit of temperatures from a data logger and three consumers received the vaccine. With further verifying dates and times of vaccine administration only two consumers received the vaccine.   This was a case of actual medication error due to incorrect product storage (latency unknown).  At the time of reporting, no adverse event was reported.  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 the 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.
Patient started with arm pain at 9 PM on 11/13/17. She had severe pain until 11/15/17. The pain has decreased each day since then, but she still has pain when she raises her arm on 11/20/17. She said this has never happened to her in the past with flu shots.
Narrative: Patient received 4th dose of moderna vaccine 5/13/22 and two days later presented to ED after a few days of increased muscle weakness, confusion and decreased vision which started within 24 hours of the vaccine. Patient was further determined to have right sided pneumonitis and was treated accordingly. Patient was discharged 5/19/22 after being treated for pneumonia.
Information has been received from a physician concerning her adult niece who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (Lot# not reported). It was reported that a few years ago, but at some time after the immunization she had a negative varicella titer. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Fever Chills, Loss of Appetite Narrative:  Fever 100.6 and chills, mild loss of appetite, Resolved by next day.
pt recvd vax; exp large inject site rxn; area hot to touch; to md; tx decadron im & dph po;
LVN ADMINISTERED MODERNA MONOVALENT FOR VACCINE BOOSTER #2 INSTEAD OF ADMINISTERING BIVALENT
Information has been received from a physician concerning a 70 year old white male elevated cholesterol levels, hypertension, atrial fibrillation and impaired fasting glucose who on 19-SEP-2007 was vaccinated subcutaneously with a first dose of ZOSTAVAX (Lot #658083/0885U). Concomitant therapy included NORVASC, LIPITOR, aspirin, COUMADIN,  atenolol and MAG-OX 400 TABLETS. On 02-OCT-2007 the patient developed itching at the injection site, which proceeded into diffuse, pruritic, papular rash over trunk and arms. The rash resolved with a course of oral steroids. The patient was considered recovered on 15 OCT 2007. There was no illness at the time of vaccination. No diagnostic studies were performed. The patient had no prior history of adverse events with previous vaccinations. Additional information is not expected.
Presented to ER 6-28-15 was transferred to medical center for ITP. Platelet count was low, had unusually easy bruising. Received vaccine 6-15-15.
No additional AE reported; he has not been able to go to his physician's office and receive the third dose/he was supposed to receive the third dose approximately 1 year ago but never received it; This spontaneous report was received from a consumer of unknown age referring to himself. The patient's concomitant medication, pertinent medical history and drug reactions and allergies were not reported.     On an unknown date, the patient was vaccinated with the first two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot# and expiration date were not reported) for prophylaxis according to the dosing schedule.         The patient stated he was supposed to receive the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in approximately 1 year ago, but was not able to go to his physician's office and receive the third dose due to Coronavirus disease (COVID-19) pandemic (inappropriate schedule of vaccine administration). The patient inquired about when to receive the third dose. No additional adverse event (AE) reported (no adverse event). No product quality complaint (PQC).
This spontaneous report was received from a vendor refers to unknown patients of unknown age and gender. The vendor reported that one of her customers had a temperature excursion for VARIVAX (Merck) (lot # not reported and ZOSTAVAX (lot # not reported) at unspecified temperatures for an unspecified amount of time. The vendor was unable to specify if any of the doses were administered to patients. Additional information has been requested.
Red ring around the injection site.  Warm to the touch and itchy.  Dizziness (not sure related as I'm having a stiff neck as well)
Parosmia or Phantosmia: smelling fumes or gasoline like smells. These phantom smells began a couple days after receiving the second dose. These symptoms lasted for almost 2 weeks and then went entirely away. Received 3rd dose in mid-August and just started smelling fumes again 2 days ago, almost an entire month after 3rd dose was administered.
I received the vaccine on 4/1/2021, and I had an adverse reaction within 5 minutes of receiving it. I had a full-body, mild itching from head to toe. I even had it on my scalp and on my lips and inside my mouth! I took a Zyrtec, and it got better, but it didn't completely get rid of the itch. I had pain at the injection site that was mild at first, but after a couple of hours, it became extremely painful and I wasn't even able to move my arm. Later, little by little, I began getting flu-like body aches. That night, I had a fever of about 99. I had had surgery on my left shoulder in 12/2019, and the pain from my injection site radiated to it. The whole left arm from the fingers was sore. I took one Tramadol and possibly 2 Advil, and the next day I woke up with severe nausea, and the body pain was still present. The body subsided after a 2-3 days, but the nausea persisted for 5 days. I intermittently took Tylenol and Advil to treat my symptoms at this time. I was also extremely fatigued and low in energy; I could hardly move around. On the 6th day after the vaccination, my symptoms were gone and I was back to normal.
day after 2nd shot, I woke up with severe neck and head pain in lower left side.  This continued to worsen every day. Sharp shooting pain up side of neck to above left ear, This later continued to other side of neck and head in same manner.  I went to my primary care Dr. who referred me to physical therapy which I did for 3 weeks, twice a week.
Arm was sore for the first two days.  On the 8th day I developed a knot the size of an orange and itching. No pain was present.
3 days after receiving Zostavax patient came to the pharmacy with 3 shingles at the injection site and 1 shingle on her belly.  Patient said they aren't painful they just itch. Gave her Benedryl for the itch.
Parents believe patient's new onset IDDM, diagnosed on 6/08/2006 is related to the Pediarix vaccine received on 5/12/2006. Has lifelong diagnosis of IDDM. Consultation Report: Chief complaint: lethargy and labored breathing. Impression: H&P and lab reports indicate patient is in diabetic ketoacidosis.  Transferred to Hospital -records received  for DOS 06/09-06/13/06 DC DX: New onset diabetes mellitus             Diabetic ketoacidosis HX Present illness: 20month old full term 35 week gestation ex twin (other twin lost early in pregnancy, mother had preeclampsia)who had approximately 1 week of upper respiratory infection with concurrent polyuria, polydipsia and decreased PO intake over 2 days prior to admission. Low grade tactile fever with an episode of emesis. On day of admission noted to have acute decrease in energy and found to have elevated serum glucose. Airlift transfer to this facility from another facility. Initial glucose at hospital 396, sodium 145. Treated with NS and insulin drip. PE: significant for an afebrile toddler female in no acute distress. Exam WNL. RX included IV hydration, and insulin drip and bean subcutaneous insulin glargine on her second day of admission with glucose ranges from 60-306.  DC home on insulin glargine dose 5 units. 01/1/2010 Patient has Type 1 IDDM. Parents originally were concerned that IDDM could be related to vaccine administration. They have since done research and undersand that vaccines are an unlikely cause of their diagnosis IDDM. 60 day Follow-up Information 29-SEP-2006: Parents are now less sure that pt's DM was caused by a vaccine.
pt recve vax & 4 days later exp numbness in feet & hands, aching & discomfort in shoulders & neck;
pt recvd vax & did not devel a titer p/8wks;MD reported approx 14 patients;pts assigned WAES95081597 & 95081815 through 95081827;
arm sore; Feeling sick; pain all over body; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore), MALAISE (Feeling sick), PAIN (pain all over body), PYREXIA (fever) and CHILLS (chills) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 01-Oct-2020.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm sore), MALAISE (Feeling sick), PAIN (pain all over body), PYREXIA (fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm sore) had not resolved and MALAISE (Feeling sick), PAIN (pain all over body), PYREXIA (fever) and CHILLS (chills) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # L020015, expiration date: 16-AUG-2017, route and dose were unknown). The vaccine was excursion to -3.8 degree centigrade for 113 hours. It was not excursion previously. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Arm around the area of the shot about the size of a baseball a week a 2 days later swelled, turned hot, a was painful.  This lasted for about five days.  I did go back to Walgreens and asked them what to do; they told me to take Benadryl, put ice on it and go to the CDC website.  As of today, there is still discoloration of that area where the shot was so you know something happened.
Moderna shot got him sick; within 24 hours everything is fuzzy, and 2 years later he is still brainfogged.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Moderna shot got him sick) and FEELING ABNORMAL (within 24 hours everything is fuzzy, and 2 years later he is still brainfogged.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 ILLNESS (Moderna shot got him sick) and FEELING ABNORMAL (within 24 hours everything is fuzzy, and 2 years later he is still brainfogged.). At the time of the report, ILLNESS (Moderna shot got him sick) outcome was unknown and FEELING ABNORMAL (within 24 hours everything is fuzzy, and 2 years later he is still brainfogged.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications details were reported. It was reported that, patient took the vaccine 2 years ago. No treatment medications details were reported.
pt recvd vax; 19aug94 mom noticed fever; tenderness at lt leg; on 22aug94 pt could not move lt leg; was swelling; was hospitalized per MD; tx w/ atb; swelling site was incised, drained; as per mom, poss vax site infect;
Patient was given these immunizations as a duplicate. He was also given these immunizations on 3/9/2021
Administered flu shot and Pfizer in the same left arm and they are separated by 1/2 in ch Vs 1 in on the same arm little pain felt but nothing happened
Influenza vaccination was given at 1745 on 10/13/10.  Around 2300, patient noticed her right arm feeling very sore and heavy.  On the morning of 10/14/10, her arm became stiff.  Upon waking around 1500, her neck on the right side was stiff and it was painful from her to turn her head.  The pain and stiffness went down her back and around her right shoulder.  This pain and stiffness lasted for 6 days.
The patient had hives on her torso; This is a spontaneous case, reported by other health professional (nurse) to Agency (case ID: SEQ19-04530) and initially received on 11-Oct-2019, concernig a 69-years-old female patient.  The patient had no relevant medical history and concomitant medications were not provided.  On 08-Oct-2019, the patient was administered Afluria Quadrivalent [Influenza vaccine, dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscular, batch number: P100123035 expiration date: 30-Jun-2020] for influenza prophylaxis.   On 09-Oct-2019, one day after vaccination, the patient developed hives on her torso. It went away during the night and reappeared the following day. The patient was treated with Benadryl (diphenhydramine hydrochloride).  On 11-Oct-2019, the event of hives was resolved.  The reporter assessed the case as non-serious and did not provide causality criteria.  Non-significant follow-up reported by Agency [reference number: SEQ19-05425] on 23-Oct-2019: Additional Agency reference number added. No changes in narrative.  Follow up received from nurse via Agency (reference number: SEQ19-05425) on 14-Nov-2019: Stop date for the event of hives was updated. The narrative was amended accordingly.  Company comment: Event was assessed as related to Afluria Quadrivalent.; Sender's Comments: Event was assessed as related to Afluria Quadrivalent.
mom reports that pt became limp & devel difficulty breathing, then stopped breathing for a few seconds on 26MAY93; pt was immediately taken to hosp ER dx w/head injury; pt fussy; pt had closed head trauma;
Profuse diarrhea lasting 36 hours with accompanying emesis to a lesser degree making it impossible to keep even clear fluids down, producing marked dehydration.  Near-syncopal events related to dehydration; while the patient did not ultimately require hospitalization it was a near miss.  Fever >102F and occasional rigors.  Myalgias.
Patient received the  vaccine, and after 5 minutes, she started to have seizure. Seizure lasted for 3 minutes. patient went unconscious  afterwards, patient was then moved to rescue position, and 9-1-1 was called. Patient was not alert and oriented upon arrival of EMS, and was sent to the nearest hospital.
soon after vaccination patient broke out in full body rash, with itching and burning sensation. not sure if that night or next morning.
About 10 minutes after receiving the vaccination he said he had tightness in his chest and felt clammy. No breathing problems, no heart racing or palpitations. He turned down any medical treatment to be called. I had him sit in the pharmacy area for about 10-15 minutes-after which he said he felt better. No more symptoms. I suggested him to continue sitting for a few minutes longer, but he insisted he was feeling fine and left.