chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme pain at injection site; Extreme pain spreading up through neck; Extreme pain spreading down to fingertips on same arm; fever (101); Alternating periods of overheating extreme cold; fatigue; severe headache; severe body pain; Shoulder pain and joint pain.; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 09Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines. The patient was allergic to penicillin and sulfa. Concomitant medications included ibuprofen (MOTRIN). The patient previously received  the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 19Mar2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient also previously received clindamycin (MANUFACTURER UNKNOWN) and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021, less than 24 hours after injection, the patient experienced extreme pain at injection site spreading up through neck and down to fingertips on same arm, fever, alternating periods of overheating and extreme cold, fatigue, severe headache, severe body and joint pain. Then four days post injection, arm and should pain, stabbing pains through neck and finger tips, persistent headache and fatigue were ongoing. On the same day, the patient underwent body temperature measurement and result was 101 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of reported events which included treatment with MOTRIN and ice packs. The patient took rest, liquids, applied ice packs for overheating and extra layers when very cold. The clinical outcomes of the events extreme pain at injection site spreading up through neck and down to fingertips on same arm, shoulder pain, fever, alternating periods of overheating and extreme cold, fatigue, severe headache, severe body and joint pain were resolving.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL injection (dose, lot #, expiry date, anatomical location and route of administration were not reported). No adverse reactions were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccine was adminstered to the patient which was expired on 29-Apr-2022; Dose 1 on 27-JUL-2021 and dose 2 on 20-OCT-2021, time period between 1st and 2nd dose was more than 25 to 35 days.; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 27-JUL-2021 and dose 2 on 20-OCT-2021, time period between 1st and 2nd dose was more than 25 to 35 days.) and EXPIRED PRODUCT ADMINISTERED (Vaccine was adminstered to the patient which was expired on 29-Apr-2022) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042j21a, 011F21A and 023d1A) for COVID-19 vaccination.     It was unknown if the patient was diagnosed or tested positive for COVID-19. It was unknown if patient had acute illness at the time of vaccination and or up to one month before. It was unknown if patient was having chronic or long standing health condition.    On 27-Jul-2021 at 3:12 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Oct-2021 at 12:34 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 06-May-2022 at 11:17 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 20-Oct-2021 at 12:34 PM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 27-JUL-2021 and dose 2 on 20-OCT-2021, time period between 1st and 2nd dose was more than 25 to 35 days.). On 06-May-2022 at 11:17 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was adminstered to the patient which was expired on 29-Apr-2022). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 27-JUL-2021 and dose 2 on 20-OCT-2021, time period between 1st and 2nd dose was more than 25 to 35 days.) and EXPIRED PRODUCT ADMINISTERED (Vaccine was adminstered to the patient which was expired on 29-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was unknown  when the vial was initially stored in the refrigerator. Vial did not undergo any temperature excursions.  No treatment information were reported.   This case was linked to MOD-2022-573908 (Patient Link).
Influenza virus vaccine (FLUVIRIN) 2008-2009 formula expiration date 6/30/2009 given instead of 2009-2010 formula.  Vaccinated with influenza virus vaccine (FLUZONE) 2009-2010 formula after error discovered.
This is a spontaneous report from a contactable consumer. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on 26Feb2016 at single dose. The patient medical history and concomitant medications were not reported. The patient experienced unusual sinus congestion and cough on an unspecified date with outcome of unknown. Follow-up (27APR2016): Follow-up attempts are completed. No further information is expected.
Redness, swelling, itching, watery eyes, localized fever. From day of injection, symptoms got progressively worse until after treatment w/anti-histamines.
The pt was infected with HIV and was Hep-B surface antigen positive. He did not received any concomitant vaccines. Concurrent medications were not specified; however, the physician stated that "nothing had changed with his medication regimen". In approx. 8/01, the pt received his 1st injection of Engerix-B without adverse event. On 3/15/02, the pt received his 2nd injection of Engerix-B. On 3/19/01, he complained of fever and muscle aches. Liver function tests performed on 3/19/01, revealed AST 571 U/L and ALT 667 U/L. Prior to this, the pt's AST and ALT concentrations were normal. The results of serologic testing for other causes of viral hepatitis were not reported. He did not receive any treatment for the events. He returned to the physician on 3/27/02. At that time, the fever had subsided and the muscle aches had improved. Liver function tests revealed AST 100 U/L and ALT 217 U/L. This report of increased AST and ALT concentrations, is considered "Medically Serious". The follow up states the pt received hep A vaccine (Havrix). It was originally reported that the vaccinee received hep B vaccine (Engerix B); on follow up the vaccine administered was identified as Havrix. He smoked one-half pack of cigarettes daily; he "rarely" used alcohol. Concurrent medications included azithromycin 1200mg weekly beginning 3/27/02, Pentamidine 300mg daily beginning 11/3/00, Fluconazole; Paroxatine hydrochloride; Amprenavir; Ritonavir; menivudine.  The physician stated that "nothing" had changed with his medication regimen; however, the physician reported that fluconazole therapy was added on 2/26/02 and discontinued on 3/13/00. On 7/5/01, the vaccinee received his first injection of Havrix without adverse event. On 3/18/01, three days post immunization, he complained of fever, anorexia, and muscle adches. Liver function tests performed on 3/18/01. He returned to the physician on 3/22/02. The fever, anorexia, and muscle aches had resovled. The physician considered the reported events to be possibly related to Havrix administration and possibly related to HIV infection or hep B exposure. No further injections of Havrix will be administered.
(R) thigh is red 1 cm raised lesions with central pronounced not vesicular but ? at site varicella or flu vac.
Nausea, fever, chills, body aches, headache 12 hours after injection for about 24 hours. Headache currently.
EYE IRRITATION/SENSATION OF PRESSURE IN HER EYES; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced eye irritation/sensation of pressure in her eyes and had to go to the hospital for surgery. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of eye irritation/sensation of pressure in her eyes  was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210420255.; Sender's Comments: V0: 20210420006-Covid-19 vaccine ad26.cov2.s-eye irritation/sensation of pressure in her eyes. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Feeling shaky; fever at 102; chills; Headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (Feeling shaky), PYREXIA (fever at 102), CHILLS (chills), HEADACHE (Headache) and FATIGUE (fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Pancreatic cancer (Patient is taking other medication and she have  pancreatic cancer).   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced NERVOUSNESS (Feeling shaky), PYREXIA (fever at 102), CHILLS (chills), HEADACHE (Headache) and FATIGUE (fatigue). At the time of the report, NERVOUSNESS (Feeling shaky), PYREXIA (fever at 102), CHILLS (chills), HEADACHE (Headache) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 102 f High.         Concomitant Medications include unknown drug for pancreatic Cancer. Treatment Medications incudes Tylenol.
Appeciable joint symptoms after 5/08. Tingling in fingers, ankles and toes changing symptom/pain locations. Arthritic symptoms persist 5/2010-forcing retirement.
49 yo F who works as CNA with hx of "borderline" DM and heart murmur who was here for scheduled covid vaccination. She has history of reactions to influenza vaccine in the past. No current medications.   20 min after administration of covid vaccine in L arm, she began to have nausea and dry heaving. She was alert, oriented and said this was similar to prior vaccine reactions. No LOC, SOB. Escorted to wheel chair and exam room. Had some complaints of mid chest pain and L arm/hand stiffness.   VS: 99.4, 98, 158/103 98% on RA at initial assessment in waiting area Repeat VS 15 minutes later in exam room: 127/98, 85, 98% on RA Gen: tremulous, dry heaving CV: RRR wo MRG. Pulse fast and thready on initial assessment, then improved Pulm: CTAB Ext: No LE edema. Difficulty grasping with L hand and moving L arm. At deltoid, no erythema, swelling, or fluctuance. She was sensitive in the deltoid area to light touch. She had gross sensation to arm/hand in tact.   A/P: 49 yo F with prior history of reaction to vaccines with post-vaccination reaction including nausea, tremulousness. -pt given zofran in clinic -monitored closely VS, given water.  -EKG ordered and pending -Pt drove herself to clinic and will need to assess her safety for discharge Vitals sighs were taken three times while patient was in clinic. The initial vs were 158/103, HR: 97, T: 99. 5, RA pulse ox: 98%. Repeat BP: 127/98, 117/91. Patient's major complaint was stiffness to left hand and arm with inability to straighten fingers. Patient also complained of chest tightness, reports hx of heart murmer.    Patient denied ambulance to ED, stating she will be okay. Patient remained in clinic after feeling better and stating she was "okay and awake again." Patient walked out of clinic without assistance and was scheduled to follow up with PCP on Thursday morning.
tightness to hands, pain to elbows and wrists - all for 30 minutes after waking up - resolves after one hour of walking around but returns every morning fatigue
Information has been received from a licensed practical nurse concerning a 7 year old female with no pertinent medical history and no drug reactions/allergies, who on 05-OCT-2001 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot number: 637957/1882K). Concomitant therapy included measles-mumps-rubella vaccine (MSD) and "hemin". On 15-NOV-2007, the patient developed chickenpox after receiving the vaccination. The patient presented with itchy red rash all over the body. She has no fever, but had mild cold symptoms. The patient had been eating and drinking well. No further information was available. There was no lab diagnostic studies performed. Unspecified medical attention was sought. The patient had been by the physician. There was no product quality complaint. Additional information has been requested.
Information has been received from a consumer concerning her  daughter who in approximately may 2001, at a little over 1 year of age, was vaccinated with a dose of Mump virus vaccine live (Jeryl Lynn). A couple of hours post vaccination, the patient broke out in hives. The patients mother had called the physicians office at the time of the event, and the patient was treated with an unspecified medication. Subsequently, the patient recovered. Additional information is not expected.
Headache; This is a spontaneous report from a contactable consumer via a sales representative. A male patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), via an unspecified route of administration from an unspecified date at a single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 for Covid-19 immunization. On an unspecified date, the patient experienced just a headache, occurred after the patient received the second injection in the series. Outcome of the event was unknown.
Flu like symptoms; Pain under arm of same injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and VACCINATION SITE PAIN (Pain under arm of same injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and VACCINATION SITE PAIN (Pain under arm of same injection site). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and VACCINATION SITE PAIN (Pain under arm of same injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported No treatment information was provided
Swelling to lymph nodes on right side; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling to lymph nodes on right side) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 15-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced LYMPHADENOPATHY (Swelling to lymph nodes on right side). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (Swelling to lymph nodes on right side) outcome was unknown.             No concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable. Concomitant drug was not reported.
Admitted with progressive SOA/Cough/congestion//weakness. Clear/white sputum only. Weak. No change in taste/smell/appetite.
This spontaneous report as received from a physician via agency refers to her 71 year old mother with high blood pressure and heart burn. She had no relevant medical history. On 19-SEP-2013 the patient was vaccinated with ZOSTAVAX (lot # unknown), 0.65 ml, subcutaneous. Concomitant therapies included hydrochlorothiazide, triamterene, aspirin (low dose) and vitamins (unspecified). On 20-SEP-2013 24 hours after vaccinated with ZOSTAVAX, the patient experienced fullness in the right ear with some tinnitus. On 21-SEP-2013, the patient experienced lightheadedness, mild hearing loss, vomiting, nausea and loss of balance. There is no relevant lab data. The reporter suspects that her mother may be developing shingles. As of 21-SEP-2013, it was unknown if she would continue ZOSTAVAX and she was still experiencing fullness in the ear, mild hearing loss, loss of balance, and lightheadedness. The tinnitus was worsening. The out come of nausea and vomiting was unknown. The reporter would taking her mother to the emergency room. Upon internal review, mild hearing loss was considered to be medically significant. Additional information has been requested.
Severe pain in shoulder at vaccination site, mild pain in joints, Fever; required 2000mg of Tylenol daily.
This spontaneous report as received from a licensed practical nurse concerning a 47 years old male patient who on 01-SEP-2012 was vaccinated with a dose of ZOSTAVAX (Lot# reported as "0242AE", EXP. 01-APR-2012) (SQ, .65ml) in place of prescribed VARIVAX. The patient did not experience any adverse effect. Additional information has been requested.
Started feeling extremely hot-warm or burning inside of her body and light headed sensation 5 minutes after FluMist administration.
Area of redness and tenderness left upper arm. Returned arm develop knot under skin size of nickel. 12/15 lump resolved.
Fever of 103 F for 5 days. Negative for covid. Cellulitis of lower extremities worsened. Infection occurred prior to vaccine.
expired dose of Menveo was inadvertently administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA677A, expiry date 30-APR-2023) for prophylaxis.   On 16-MAY-2023, the patient received Menveo. On 16-MAY-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: expired dose of Menveo was inadvertently administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 22-MAY-2023 The reporter was a medical assistant. The reporter did not consent to follow-up. The reporter informed that an expired dose of Menveo was inadvertently administered to a patient, which led to expired vaccine used.
local rxn, red & swollen, unusual crying lasting about 2hr;no appetite, diarrhea, sweating @ time;
Vaccination was given on 6/8/21. Pt reported to pharmacy on 6/11 a rash that started on 6/10 on left (injected) arm, shoulder and neck spreading to right arm. Pharmacy encouraged her to contact PCP or go to Urgent Care and that we may be contacting her for more information.
104.5 fever, severe headache, left leg and left arm pain and numbness, body aches, chills
received monovalent booster ( spikevax) in error instead of bivalent booster
received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR201274:same reporter
About 5-7 minutes after I received my booster vaccine, I started first to feel my stomach bloating, then I felt a heat travel upwards inside my body along pathways, through my arms, my legs, in my neck and then through my brain. I then started to shake. I was provided fluids and my blood pressure, oxygen and heart rate were monitored. I also felt a sharp shooting pain intermittently for 2 hours in the right side of my head about an inch above my ear. I felt a small about a pencil tip size tingling in my lower lip. The next day. I had mild arm pain where the injection was given and I had a dull headache that lasted a week. I was too scared to take anything for it after what happened to me.
unusual sleepiness on 1/21, extremely fussy 1/22 through 1/24
pt recvd vax 26MAR93 same eveing, mom noted that pt had a sz; required/ER MD visit; no hospitalization; pt recoverd;
Pt stated she was shaky, heart was racing and she had dry mouth. Vitals were taken at 15 min intervals after pt was placed in a supine position with feet elevated. She was given a bottle of water for hydration. I noticed a fruity odor to her breath and her hands were cool/clammy. She stated she only had 1 sm. yogurt and a rice cake for breakfast, and was hungry. She was seen by staff doctor and released after symptoms subsided and she said she felt better. Pt fully recovered.