chrisvoncsefalvay/vaers-outcomes huggingface dataset:
6 days after - high fever fever continues, low grade for additional 9 days pneumonia diagnosed 9-27-2006
Pt called to report a reaction to the second Pfizer vaccine.  She reports that day 2 she had itching in both arms, and day 4 had a full body rash.  She took 1/2 a benadryl with some relief.  Then, day 10 after this shot, she experienced low energy, emotional lability and muscle aches and pains.  Last night  she experienced severe muscle aches that woke her up, they are better this am.  She cannot take ibuprofen as she has had a nephrectomy.  She was not referred to allergy, but was encouraged to contact her PCP re any other meds that she could take for pain.  She is using topical methods like heat and massage with some relief.
This spontaneous report as received from a health care worker refers to a patient of unknown demographics. On 17-OCT-2013, the patient was vaccinated with unsupported dose of MMR II (lot number J002934 and expiry date 01-MAR-2014). No concomitant therapy was administered. No adverse effects reported. This report is one of the four patients reported from same source. This case is linked to 1311USA008915, 1311USA008916 and 1311USA008914 (same reporter link). Additional information has been requested.
Shingrix vaccine on Tuesday morning, on Wednesday he felt tired; Shingrix vaccine on Tuesday morning, on Wednesday he felt / achey the next day; sweating in sleep last night; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st June 2021, the patient received the 1st dose of Shingrix. On 2nd June 2021, 1 days after receiving Shingrix, the patient experienced tiredness, pain and night sweat. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the tiredness, pain and night sweat were recovered/resolved.   It was unknown if the reporter considered the tiredness, pain and night sweat to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The age at vaccination was not reported. On the morning of 1st June 2021, the patient got the first Shingrix vaccine.  The patient felt tired and achey the next day of vaccination and had sweating in sleep on the night before the reporting date.  The patient took some advil and felt better.  The reporter did not consent to follow-up.
Information has been received from an investigator concerning a 10 month old female child who received Prevnar on 12/22/00 and the next day, the child was taken to a clinic for urticaria and angioedema. The child has since recovered. Angioedema was considered a "Medically Important Event". Both the investigator and the medical monitor agree this event was 'possibly' related to vaccine administration. Follow up information received on 03/09/2001 clarified that the patient did not experience angioedema as previously reported. The patient experienced urticaria only. Therefore, the report has been downgraded to non-serious.
Chron´s disease; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Chron´s disease) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939901, 007M20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Penicillin), Drug allergy (Cipro), Drug allergy (Keflex), Asthma and Arthritis. Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 09-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In October 2021, the patient experienced CROHN'S DISEASE (Chron´s disease) (seriousness criteria hospitalization and medically significant). The patient was treated with BUDESONIDE ongoing since an unknown date for Crohn's disease, at a dose of 9 milligram. At the time of the report, CROHN'S DISEASE (Chron´s disease) had not resolved.            Patient never had COVID positive test or diagnosis. It was unknown whether patient experienced a similar event in the past.  Company Comment: This case concerns a 64-year-old female patient with relevant medical history of Autoimmune conditions (specifically asthma and arthritis), who experienced the unexpected serious event of Crohn's disease (seriousness criteria hospitalization and medically significant) on an unknown date in October 2021 while the third dose of mRNA-1273 vaccine administered on 09-Sep-2021. The patient was treated with Budesonide. Patients medical history of Autoimmune conditions could be confounding. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 64-year-old female patient with relevant medical history of Autoimmune conditions (specifically asthma and arthritis), who experienced the unexpected serious event of Crohn's disease (seriousness criteria hospitalization and medically significant) on an unknown date in October 2021 while the third dose of mRNA-1273 vaccine administered on 09-Sep-2021. The patient was treated with Budesonide. Patients medical history of Autoimmune conditions could be confounding. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This case was reported by a pharmacist via call center representative and described the occurrence of sore throat in a 46-year-old male patient who received FLULAVAL QUADRIVALENT. Concomitant products included LIPITOR and NORVASC. On 12th September 2017, the patient received FLULAVAL QUADRIVALENT (intramuscular) .5 ml. In September 2017, 4 days after receiving FLULAVAL QUADRIVALENT, the patient experienced sore throat and swollen glands. The patient was treated with Z-PAK. On an unknown date, the outcome of the sore throat and swollen glands were recovering/resolving. The reporter considered the sore throat and swollen glands to be possibly related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The patient was the pharmacist. At 11:00 hours, the patient received a FLULAVAL injection in the left deltoid. About 4 days after receiving the vaccine, the patient developed a sore throat and swollen glands. The patient happened to had routine blood work done while this was happening and everything came back to normal. He had not been to his doctor for these symptoms, but he did have a Z-PAK prescription called in, but that did not help the symptoms. At the time of this report, the patient was experiencing the symptoms, but they were slightly better.
Soreness in her arm; This is a spontaneous report from a contactable consumer (patient).   A 73-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/lot number was not reported), via an unspecified route of administration on an unspecified date at 08:15 (at the age73-years-old) as dose 1, single for COVID-19 immunization.Patient medical history included hyperthyroidism and low vitamin D.Concomitant medication(s) included methimazole tablet, 10 mg, taken orally for hyperthyroidism and cholecalciferol (VITAMIN D [COLECALCIFEROL]) 2400 mg oral, taken daily (Taken about 3 years, 2000mg tablet 400mg is gelcap, takes 2 separate pills) for low vitamin D. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date, the patient developed little soreness in her arm. The adverse event does not result in visit to emergency room or physician office. she goes to an endocrinologist once a year for her blood work. On an unspecified date, the patient underwent lab tests which included blood work with unknown results. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Pt recvd a series of 3 doses of Engerix-B & p/completion of series was found to be a non-responder; recvd an additional dose & titer results still showed that pt was not protected;
Immediately while receiving my shot my mouth went dry, I have had continuing dry mouth since them, It made my blood sugar go up and I'm now a diabetic. Soreness for almost 2 week in my arm, blurred vision.  I was extremely exhausted, and had a headache. I ended up going to the ER
Pt vaccinated with DTP/OPV experienced excessive high pitched screaming for 3 1/2 hrs.
Severe Vascular Thrombosis (vomit, loss of balance, numbness in arms and legs, lost of speech, impaired vision) had to be hospitalized for 4 days, and had some brain damage from the thrombosis.
Symptoms of weakness, tired, mild fever and headache starting the day after COVID vaccine.  The following day woke up at 6am with chest pain, described as mild to moderate in severity with no radiation.  Patient experienced a loss in family member within last 3 months and was under significant stress.  Cardiology consult suggested stress may have caused elevated levels of adrenalin and COVID vaccine may have increased catecholamine levels which caused increase in troponins.
Blisters on tongue; Yeast infection symptoms; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 13:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes. The patient had allergy to sartans. Concomitant medication included insulin aspart (NOVOLOG) since an unknown date for unknown indication. The patient previously took rabies vaccine inact (chick embryo) (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and experienced allergy to vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 31Mar2021 at 21:00, the patient experienced blisters on tongue. About 8 to 9 hours after vaccination, the patient got yeast infection symptoms. The patient did not receive any treatment for the events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events blisters on tongue and yeast infection symptoms were unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
6 patients administered expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 patients administered expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 patients administered expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 patients administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
multifocal motor neuropathy; Bell's palsy; Information has been received from a lawyer referring to an elderly patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On or about 17-NOV-2009 (approximately 66 years old), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) by a physician for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a healthcare provider (reported as provider) for the following injuries resulting from zoster vaccine live (ZOSTAVAX): multifocal motor neuropathy and Bell's Palsy. The outcome of the events was unknown.   Upon internal review, multifocal motor neuropathy and Bell's Palsy were determined to be medically significant.
This spontaneous report as received from a pharmacy technician refers to a 3-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 19-MAR-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA001558:
pt recvd vax & w/in 1 day of vax exp acute diarrhea & hives;
This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Bad pain left shoulder) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRALGIA (Bad pain left shoulder). At the time of the report, ARTHRALGIA (Bad pain left shoulder) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No laboratory details were  provided. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021:
Patient called pharmacy on 7/27/2017 and stated she developed a rash on her neck and leg on 7/23/2017 (ZOSTAVAX given on 7/18/2017). She mentioned that she went to her medical provider (did not state date of visit), and now rash has resolved.
Patient hospitalized within 6 weeks of receiving COVID vaccination for stenosis of right carotid artery.
Information has been received from a Doctor of Pharmacy concerning a 72 year old male patient who on 09-NOV-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot #, expire date and route not reported) and then, on 15-NOV-2010 the patient was vaccinated with a dose of ZOSTAVAX (Merck) (lot # 664670/0151Z, expire date 28-AUG-2011, route not reported). There was no concomitant medication. On 15-NOV-2010, within 1 hour after receiving ZOSTAVAX, the patient developed diarrhea, also nausea and stomach pains that evening. Subsequently, the patient recovered from developed diarrhea, nausea and stomach pains on 16-NOV-2010. The patient sought medical attention by calling to the pharmacy. Follow up information has been received from the physician reporting that the patient experienced diarrhea one hour after vaccination with a dose of ZOSTAVAX (Merck). No further information is available.
1-2 days with "redness (R) thigh". Pt got MMR vaccine (R) thigh on 10/15/07. No fever pas per Mom "warm".
(L) leg swelling and red as recalled by mother on date of vaccine admin. (2/25/15).
Right arm upper area swelling pain check by doctor no meds needed, hot compressions needed only.
received the first shot of the series of Imovax rabies but did not follow up to get the second shot with no reported adverse event; Initial information received on 08-Feb-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to case 2023SA047985(CLUSTER).  This case involves a 11 years old and unknown gender patient who had received the first shot of the series of RABIES (HDC) VACCINE [IMOVAX RABIES] but did not follow up to get the second shot with no reported adverse event.  The patient's past medical history, medical treatment(s),concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect RABIES (HDC) VACCINE (Strength , formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious event of received the first shot of the series of imovax rabies but did not follow up to get the second shot with no reported adverse event (product dose omission issue) (latency: unknown) following the administration of RABIES (HDC) VACCINE. Patient got bit by a dog 2 weeks ago.  Action taken with RABIES VACCINE (IMOVAX RABIES) was not applicable.  Outcome: Unknown  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.
A 64-year-old female presents to the vaccination center for her booster dose. Patient refers that when administering her 2 previous doses of MODERNA'S vaccine, she has presented allergic reactions and that at the vaccination center they had to administer epinephrine. Doctor is consulted, who indicates that the recommendation for the administration of booster doses is to administer Janssen. The Janssen vaccine is administered to the patient, approximately 3 minutes after the administration, the patient reports feeling itching in the area of ??the face, neck and head. Consultation with Doctor is made, who orders 25mg of BENADRYL PO. The patient is reassessed, 15 minutes after the administration of BENADRYL, it refers to having improved the symptoms. Later, the patient leaves the vaccination center under his own feet.
Case number PHEH2014US018540, is an initial spontaneous report from a pharmacist received on 15 Sep 2014 and with a follow up information received from the pharmacist on 22 Oct 2014 and a follow up report from the physician received on 05 Nov 2014. This report refers to a 49 years old female patient. Past medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into arm on 31 Aug 2014. On 01 Sep 2014, one day after vaccination, she started experiencing pain and was unable lift her arm completely. Outcome of the events was reported as ongoing at the time of this report. Seriousness and causality of the events was not reported. Reporter stated that they do not administer FLUVIRIN at their office and only administer FLUZONE. Reporter also stated that they have a patient with same identifiers but not sure whether this was that patient report. The physician stated that the vaccine was not given in their clinic and due to limited information, it was unable to determine the patient. Follow up information received from the pharmacist on 22 Oct 2014: Updated reporter comment in the narrative. Follow up report from the physician received on 05 Nov 2014: Updated physician's comments regarding the patient in the case.
Major stroke and blood clot in neck that caused him to be completely paralyzed of the left side, had to be air lifted out and required serious surgery and long term recovery
Next morning woke up with chills, low fever, headache, achy, slightly upset stomach- lasted all day. Took 1 Tylenol. Next day woke up fine.
I believe the vaccine may have been expired. The vaccine was in the fridge when I pulled it out to withdraw the dose. After giving the dose I realized I had not pulled the top off myself, and that it may have been opened yesterday. After calling the manufacturer they recommended not revaccinating and having the patient receive a second dose in 28 days as normal.
Severe nausea; heaving; vomiting; coughing; fever of 101.2; feeling dizzy; achy; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's mother) reported that a female patient of an unspecified age received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot/batch number and expiration date were unknown), via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization. Relevant medical history included mild case of Covid in mid-Nov2020. The patient's concomitant medications were not reported. The patient works at a hospital delivering food to patients rooms. She received her first dose of the vaccine on 30Dec2020 and 12-14 hours later (unspecified date in Dec2020), she started feeling dizzy and achy. This was followed by heaving, vomiting, coughing, and a fever of 101.2 on 31Dec2020. At the time of the report, it was her third day with fever. When receiving her first dose, she was asked if she had a mild case of Covid, or if she was hospitalized and needed an IV drip, and she stated she had a mild case. The reporter wanted to know if the patient should have been given the first dose of the vaccine to begin with. The patient also experienced severe nausea on an unspecified date. The patient underwent further lab tests and procedures, which included a positive corona virus disease (CoVid) test in mid-Nov2020. The outcome of all the events was unknown.  Information on the lot/batch number has been requested.
1. Flu vaccine 10/2/06. Developed fever 10/10/06, rash 10/12/06. C/O blurred vision, spots, halo effect 10/22/06. To ER with eye complaint 12/2/06.
only put 0.8 mL of the diluent instead of the required 1.8 mL. Pt received only half diluted dose.
zoster p/varivax;no fever;vesicles on erythematous base;
About 15 minutes after vaccine administration patient experienced chest tightness and midback and epigastric pain.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2008, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a health department, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.