chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received PNEUMOVAX in right arm & influenza in left arm. Developed peripheral edema, erythema, tenderness, pain in rt. arm same day. Had been applying ice and taking ibuprofen q 6-8 hours - sent to urgent care on 12/6/12 when she came to clinic.
Patient has developed spots on her legs that are bothering her , itching and red and not clearing up since she has recieved the Gardasil shots , she is also a heart patient with Truncusaterious Aterious type 1 1/2 with complications & also in remission for Antiphospholipid syndrom.. i dont know if any of these mixed with the Gardasil has made it possible for her to have a reaction but i would appricatiate if you could look into this matter , she does not have the spots anywhere but on her legs and they are getting worse , her doctor as listed above does not seem to be able to find solution to this
Redness, swelling, significant pain, Diagnosis- Cellulitis at injection site , with recovering.
Had COVID test/positive test result/Tested positive for COVID-19 after getting the initial dose of the vaccine; I am sick with COVID 19; This is a spontaneous report from a contactable other HCP. A 40-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration in left deltoid/left arm on 05Jan2021 at a single dose  for covid-19 immunization. Medical history included ongoing high blood pressure diagnosed about 7 years ago and ongoing GERD that he had his entire life. There were no concomitant medications. The patient got the first vaccine on 05Jan2021, then tested positive for COVID-19. The patient added that he experienced fever of 103, body aches, headache, cough, fatigue, nausea and vomiting and diarrhea times one week.Had COVID test Friday, 08Jan2021 and positive test result received on Saturday, 09Jan2021. The outcome of the event was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.
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 were reported.  This is one of eleven reports from the same reporter.; Sender's Comments:  US-009507513-1904USA013210: US-009507513-1904USA013268: US-009507513-1904USA013276: US-009507513-1904USA013272: US-009507513-1904USA013270: US-009507513-1904USA013275: US-009507513-1904USA013265: US-009507513-1904USA013269: US-009507513-1904USA000191: US-009507513-1904USA013278:
This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 39 year-old female patient. On 21-Sep-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2106). The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
Slight fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Slight fever) and MYALGIA (Body aches) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 042K21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced PYREXIA (Slight fever) and MYALGIA (Body aches). At the time of the report, PYREXIA (Slight fever) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: positive (Positive) positive.         Patient stated that they had hybrid immunity because in November 2020 patient was not feeling well and tested positive for COVID 19.   No concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-409884, MOD-2021-409904 (Patient Link).
have had the flu twice in all them years But it wasn't as bad as it would of been with the shot; Initial information received on 26-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves a patient of unknown demographics who have had the flu twice in all them years but it wasn't as bad as it would of been with the shot after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a unknown dose of suspect  INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date, strength, formulation, route, administration site were unknown) for prophylactic vaccination(Immunisation). Information regarding batch number details has been requested.  On an unknown date the patient have had the flu twice in all them years but it wasn't as bad as it would of been with the shot (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if there were lab data/results available  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (have had the flu twice in all them years But it wasn't as bad as it would of been with the shot).  Outcome: Unknown
Headache, Fever, Fatigue Narrative:  Missed one day of work following second dose due to flu-like symptoms.
Swelling on arm of injection, with pain. Swelling is the size of a half avocado, and has pain all around the swelling.
unilateral rt jaw pain w/dec fever & pain w/mastication; no evidence of orchitis, CN deficits, or encephalitis; pos ear pain;
3-4 hrs p/shots brok out in hives all over the body; no mucous memb involved; no difficulty breathing; no shock; EPi cleared it up in 3-4 hrs later another Epi given & DPH; pt recovered;
A non-serious spontaneous report of inadvertently given expired FLUMIST was received from a health professional concerning a six-year-old male. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 29-Dec-2010. The patient received the expired FLUMIST on 06-Jan-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
After Moderna dose 2 March 27,  2021.  Painful headache, chills but no fever.  Extremely painful legs especially the shins, calves, and ankles.  Difficult to walk as my ankles were so sore my feet didn?t want to move let alone the legs were as painful.  My left hand (dominate) and fingers were in terrible pain.  I could barely bend my fingers.  The right hand was extremely sore but not like my left.  I was unable to eat, no appetite. Nausea-  I could not keep water or tea down.   Slowly sipped ginger ale but vomited 3 times.  Day 7-15. Aching left palm very sore right leg calf which is very tender.  Sugar products do not taste the same.  This is Purgatory!!
Elevated temperature, vomiting, dizziness, diarrhea, lasted one week, hospitalized for 2 days (10/6-10/7/2010) due to weakness and above symptoms.
Patient received a dose of Pfizer vaccine.  It was noted that the vaccine 5 day expiration date/time was 5/12/2021 @ 930 am.  Vaccine was administered to patient at 10:12 am on 5/12/2021.  No adverse reactions noted during observation period.  MD and management team aware.
Sedation, Myalgia, Arthralgia, NauseaVomiting,  chills and fatigue. pain at the injection site. Narrative:  Other Relevant History:
The patient received a dose from a vial more than 30 days on the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Significant Follow up- HCP confirmed number of patients
About 2 hours after MENACTRA and ADACEL, pt did not feel well. About 6 hours after shots, T 104 degrees x 24-48 hours with chills and arthralgias. Soreness at shot sites. Diarrhea the next day x 1-2 days. Patient was fine by the time mom reported episode to me.
Pharmacist gave Moderna vaccine to Patient in error due to looking over her age (16 years old) at the time of reviewing her consent form.  Patient provided us with an official letter from director stating that she works in education at child Center and "therefore currently qualifies for COVID-19 vaccine."  I overlooked her age because I saw the work letter and assumed she was 18 years old or older, which I should not have assumed.  Every other aspect of her consent form (allergy questions, etc) was reviewed by me except the birthdate at the top of the form. I assumed that our company's appointment scheduler for this vaccine would failsafe against allowing anyone under 18 sign up for the vaccine.  I had to get an age override to complete the paperwork processing  from our Third Party Help Desk for this error.I am also completing an incident report within my company. I contacted the patient and spoke with her mother who has no concerns about this error, said she appreciated the call, and I informed her that Patient can still get her second dose with us as advised by Third Party Help Desk.
experiencing a rash after receiving yf-vax; Initial information received on 28-Sep-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 49 years old female patient who experiencing a rash after receiving yellow fever vaccine - [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Sep-2023, the patient received a dose 0.5 ml of suspect Yellow Fever Vaccine - Solution for injection lot UJ8308C expiry date: 31-Jul-2024 via unknown route in unknown administration site for immunization.  On an unknown date the patient developed experiencing a rash after receiving yf-vax (rash) (unknown latency) following the administration of Yellow Fever Vaccine.  Reportedly, Pharmacist called in to report that one of their patients has been experiencing a rash after receiving YF-VAX. They wanted to understand the potential causes and incidence of rashes during clinical trials. They mentioned that the patient had contacted them on the night of September 27, 2023, stating that they were still experiencing the rash. She mentioned they are unsure if the patient is taking any medication for the rash.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event experiencing a rash after receiving yf-vax.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event experiencing a rash after receiving yf-vax.
Patient reported feeling itchy after the vaccination. According her, this happened with the first two doses as well. This was not disclosed to us before she received the vaccine. She was instructed to take Benadryl, which she purchased and told to take right away.
She felt like she was passing out; Dizziness; Felt tingling of her tongue; Blood pressure was rising; She had tongue itching; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. This 73-year-old female consumer reported that she received 1st dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine; lot number FL1284) on 10Jan2021 1:00pm at left arm for COVID-19 immunization. Medical history included allergic to latex. Concomitant drugs included Atenolol for Blood pressure high from 2011, Furosemide from 2011 as Diuretic, Alprazolam from 2011 for Sleeping and anxiety, Simvastatin from 2011, all were ongoing. The patient experienced a reaction after the first dose on 10Jan2021 that she became dizzy and felt tingling of her tongue. Every 15 minutes they checked her blood pressure for an hour. Her blood pressure was going up slightly. She was monitored by fire rescue and her blood pressure was rising but not dangerously high.  The fire rescue also checked her blood sugar (normal result) and other lab values and decided she did not need emergency room care and instructed her to take Benadryl when she got home. They felt she had a mild reaction.  The patient stated the dizziness came in waves and she felt as if she was going to faint. The dizziness went in waves where she felt like she was passing out. The tingling on her tongue felt similar to the allergic reactions she has had in the past to latex but without swelling. She did not have tongue swelling. She had tongue itching. It was like having a reaction to the latex gloves when you go to the dentist. Her symptoms only lasted for two hours. After a total of 2.5 hours she had no symptoms. Dizziness, tingling, and elevated blood pressure initially that went away after taking Benadryl. She was scheduled to receive second dose on 31Jan2021. The events was resolved on 10Jan2021.
SHOULDER AND ARM HURT GOING TO THE BACK TOWARD LEFTSIDE NECK CAN'T LAY DOWN ON IT .
administering DAPTACEL to a patient after its expiration date with no reported adverse event.; Initial information received on 10-May-2022 regarding an unsolicited valid non-serious case received from healthcare professional.  This case involves a 1 years old female patient who was administered with Daptacel after its expiration date with no reported adverse event while receiving vaccine Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine Conj 13v (Crm197) (Prevnar 13); Hib Vaccine Conj (Pedvaxhib); and Hepatitis A Vaccine Inact (Vaqta).  On 10-May-2022, the patient received 0.5 ml 4th dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] (lot C573A22 and expiry date 24-Apr-2022 via intramuscular route in the right vastus lateralis) (strength, formulation: unknown) for immunization.  On 10-May-2022 the patient developed a non-serious event administering daptacel to a patient after its expiration date with no reported adverse event (expired product administered) following the administration of Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  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.
Pain and swelling lips, and several areas of the face (swelling and pain in lips, pain only in face) both sites, only  where she has had filler (filler name unavailable Restylene or Juvaderm??).
I had a fever, vomiting, SEVERE Migraine, aches, diarrhea - With both shots.  I got COVID 8/31/2020, hospitalized from 10/9/2020 - 10/16/2020 with double pneumonia.  Very dehydrated, fever was uncontrolled, vomiting, diarrhea.
Fever 102.6, chills, body aches, extreme fatigue, headache and nausea. Started 2.5 hrs after vaccination and has continued. Following up with PCP for further actions to return to work
On Friday, January 14, it was in the evening after he came home from school. About 6PM. I heard him cough a couple times. He will usually have a cough here and there. He told me he wasn't sure and maybe something went down the wrong pipe. It was strange none the less. The next morning, around 4-5AM on Saturday the 15th, he woke up complaining of a sore throat. When he woke up at 8am he still complained about the sore throat. Gave him some hot chocolate and it felt better and it was gone. He didn't have it again until around 5pm the same day. He complained about the throat being sore again. I gave him an at-home test which came back negative. He didn't complain anymore then went to bed. He woke up at 10pm and complained again and he seemed to have a fever. He had a popsicle, and he just couldn't sleep and that his throat was sore. I offered to take him to emergent care, and he said no. he was struggling to sleep well and gave him fever reducing medication. At around 6-7am, he was still complaining, and he said he didn't feel good. And still had a fever. Took him to urgent care. They did a strep test culture and rapid, and the COVID PCR test. The COVID PCR came back positive. On Sunday, the fever was still occurring, he was lethargic. Throat was hurting. Didn't want to drink or eat. His fever broke about 10-11pm on Sunday. He had this fever for about 24 hours. He woke up on Monday and bounced back to being normal. He didn't complain about a sore throat anymore and viewed himself as normal. So, by Wednesday or Thursday, a cough appeared. He did on Sunday have a cough like a fake cough. 2-3 days after when he felt better was when the cough came. The cough was deeper and he never had phlegm and didn't have anything come up. Sounded like an adult deep cough. He had that for 2-2 1/2 weeks. The cough subsided and I would hear him clear this throat constantly. Towards the end of February, I brought him to the pediatrician and she said his nasal passages were swollen, possibly allergies. She recommended putting him on CLARITIN ever since. He doesn't have the throat clearing like he used to, but if I miss a day, he starts to feel weird. Not sure if it's an allergy thing or because of COVID. He was sick a couple weeks ago as well. This last time I took him to the office and they did a rapid test and it came back negative. His symptoms were nearing what COVID was. He had a fever, cough appeared later. He didn't have a confirmed COVID test, but I'm concerned he had it again. There have also been some nose bleeds that may be due to the swollen nasal passages.
Pt woke up while on vacation with blurred vision. Sought out treatment from optometry who referred her to neurology. Pt was diagnosed with anterior ischemic optic neuropathy. While this is not uncommon with MS, pt reports that neurologist felt like this was not related to her MS and given the proximity of the incident to her vaccine, was suspicious this could have contributed to this.
This spontaneous prospective pregnancy report was received from a physician concerning to a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) (lot # and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. It was reported that the patient was pregnant when she received the dose of VARIVAX (Merck) (date unknown). The last menstrual period and estimated delivery date were not known. The reporter stated that the vaccine was administered by another physician. No symptoms were reported. Additional information has been requested.
Headache; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (two weeks ago) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced headache and diarrhea last night. The outcome of the events was unknown.  The lot number for the vaccine was not provided and will be requested during follow up.
First dose received 09/07/2022 and received 2nd dose 09/30/2022 (too early). No adverse events noted.
This was a difficult give-she felt tight but it was the fully accessible correct site. She was due for her routine 10 year Td booster. She tolerated injection well though she said it hurt like "the dickens" Good comfort measures. Spoke with EE about other issues 02/28 and 03/01 she made no mention on 03/03 she came in c/o severe pain and unable to move arm well. No visible irritation to site-Referred for medical follow up. In Process?
Tingling tongue; Itchy neck and chest; This spontaneous case reported was received on 22-Sep-2020 from other health professional (nurse) to Agency (reference number: SEQW20-02108) with additional document received on 23-Sep-2020 (being processed together) and concerned a 32-year-old, female patient.  The patient's concurrent conditions included thyroid disease. The patient's concomitant medications included levothyroxine for an unreported indication.  On 21-Sep-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: deltoid and route of administration: intramuscular) for influenza prophylaxis. The batch number reported was 283848 and expiry date was 30-Jun-2021.  On the same day, after receiving Flucelvax Quadrivalent vaccine, the patient experienced tingling tongue and itchy neck and chest.  On the same day, the patient recovered from the events.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  This case is linked with cases 202004667, 202004665, 202004666, 202004663 and 202004664 (the same reporter).  Company comment: The events of 'tingling tongue' and 'localized itching' are assessed as related to Flucelvax Quadrivalent vaccine.; Sender's Comments: The events of 'tingling tongue' and 'localized itching' are assessed as related to Flucelvax Quadrivalent vaccine.