chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse concerning a 1 month old patient who on 15-AUG-2012, was vaccinated with a 0.5 ml dose of RECOMBIVAX HB (lot number 666026/1455Y) (route not reported) that was expired. The vaccine expired on 03-AUG-2012. No adverse effects had been demonstrated by the patient. Additional information has been requested.
This spontaneous report received from a patient concerned a 58 year old female. The patient's height and weight were not reported. The patient's past medical history included: blood clot. Patient had blood clot previously. The patient received Covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808609 and expiry: 07-SEP-2021) dose was not reported, 1 total, administered on 04-APR-2021 for prophylactic vaccination. The patient didn't have any problem with the primary vaccine. She woke up at 4 AM with night sweats when treated with Covid-19 vaccine ad26.cov2.s (Dose number in series was 1). The patient received Covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211D21A and expiry: 11-APR-2022) dose was not reported, 1 total, administered on 29-JAN-2022 on left arm for prophylactic vaccination. No concomitant medications were reported. On 29-JAN-2022, the patient had her blood pressure elevated and had flu like symptoms (felt nauseated, bone aches, shaking, incontrollable freezing then body felt hot and headache). Her heart rate was unstable, her body felt like it did when she had a blood clot previously. The patient felt like throat was starting to close, the back of her neck hurt and eye felt like they were going to burst from eye pain and were red and watery. Her fingers since were swollen and having a hard time moving them. On 30-JAN-2022, the patient went to emergency room (urgent care) and did tests at the urgent care. In JAN-2022, the patient had bruising, veins looked budging green and painful. The patient went to urgent care (Dose number in series was 2). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure on JAN-2022, was recovering from heart rate was unstable, felt like throat was starting to close, and back of neck hurt, had not recovered from watery eye, swollen fingers, bruising, veins looking budging green, eye feels like they were going to burst from eye pain and were red, and painful veins, and the outcome of flu like symptoms was not reported. This report was non-serious. This case, involving the same patient is linked to 20220208604 (Dose number in series 1 case).
Arm where injection was given stayed swollen for 7 days, to the point where I could not use my hand.  They swelling continued into chest and neck which resulted in a trip to the ER.  I was given steroids and told to alternate Vistaril, Pepcid, and Allegra every two hours.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    There was no reported medical history.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.  No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-624687 (Patient Link).
her knees feel wobbly, feet are dragging aroudn the house; fever 100.4; chills; feeling terrible; Soreness in the left arm at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (fever 100.4) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension (Controlled) since an unknown date and GERD since an unknown date. Concurrent medical conditions included Seasonal allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, TELMISARTAN (MICARDIS) for Hypertension, FAMOTIDINE (PEPCID AC), MULTIVITAMIN [VITAMINS NOS] and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 22-Dec-2020 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021 at 1:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Dec-2020, the patient experienced PYREXIA (fever 100.4). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 400 mg. On 27-Dec-2020, PYREXIA (fever 100.4) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 98.8 98.8.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: The patient information, patient's medical history, additional event and event outcome, vaccine information (dose 2) and treatment drug were provided.; Sender's Comments: This case concerns a 59-year-old, female patient,  who experienced non-serious expected events of injection site pain, chills and  non-serious unexpected events of feeling abnormal and asthenia .The event of injection site pain occurred 1 day (same day) after the first dose of mRNA-1273, COVID -19 Vaccine. The events of chills and feeling abnormal occurred 5 days after the first dose of mRNA-1273, COVID -19 Vaccine. The event of asthenia  occurred 6 days after the first dose of mRNA-1273, COVID -19 Vaccine. Based on the current available information and temporal association between the use of the product and onset of the events, a causal relationship cannot be excluded.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients (age and gender of the patients were not reported). The patient's concurrent conditions, medical history and concomitant medications were not reported. Starting on 08-JUN-2015, an unspecified number of improperly stored doses of GARDASIL (Lot number K006960 and expiry date 19-FEB-2017, Lot number K006191 and expiry date 02-FEB-2017) were inadvertently administered to an unspecified number of patients (strength, dose and frequency were not reported). No adverse experiences have been reported. No further information was provided. Additional information has been requested.
Morning after I received the shot, behind my ears down to Base of back of neck had severe pain/ache. As the day progressed this pain spread to my shoulders, then full arms. My hips down my legs eventually had the same pain/aches.  It is now 11 days after the injection and the pain/aches in my legs have yet to stop. I am also experiencing periodic numbness and tingling in my limbs.    Lastly, I have had hot itchy hives in my armpits, groin, Intergluteal cleft, and behind my knees
Patient was administered third dose on 19Sep2021; Patient was administered third dose on 19Sep2021; Vomiting; Fever; Chills; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 70-year-old male patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448), via an unspecified route of administration in the left arm on 19Sep2021 at 11:00 (at the age of 70-years-old), as a single dose for COVID-19 immunisation. Medical history included advanced chronic obstructive pulmonary disease (COPD). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of COVID-19 VACCINE (MANUFACTURER UNKNOWN; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and also second dose of COVID-19 VACCINE (MANUFACTURER UNKNOWN; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date; both as a single dose for COVID-19 immunisation. On an unknown date in Sep2021, the patient experienced vomiting, fever, chills and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events vomiting, fever, chills and headache was resolving at the time of this report.
very ill; tingles; very high blood pressure; Shaking; shivering; chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very ill), PARAESTHESIA (tingles), HYPERTENSION (very high blood pressure), TREMOR (Shaking) and CHILLS (shivering) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced ILLNESS (very ill), PARAESTHESIA (tingles), HYPERTENSION (very high blood pressure), TREMOR (Shaking), CHILLS (shivering) and CHILLS (chills). At the time of the report, ILLNESS (very ill), PARAESTHESIA (tingles), HYPERTENSION (very high blood pressure), TREMOR (Shaking), CHILLS (shivering) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications. Treatment information includes Metoprolol 50mg. Patient did not remember all the medications  given to him.   This case was linked to MOD21-076620 (E2B Linked Report).; Sender's Comments:  MOD21-076620:MOD-2021-078045 -2nd dose of vaccine
Client verbalized feeling dizzy after receiving the vaccine.  She was evaluated by onsite nurse practitioner. Client was advised to seek additional evaluation.  Client declined to be transported to the hospital for elevated blood pressure.  Client was released out at 3:51 pm accompanied by co-worker.
the shot "felt warm" when injected; metallic taste in her mouth; itchiness in her nose, ears, and throat; rash at the injection site; severe headache; hands and feet swelled; she doesn't feel comfortable; inflammation; I had delayed allergic reaction; I have chronic issue with inflammation and respiratory to begin with; I'm a little bit nervous; This is a spontaneous report from a contactable consumer. A 64-years-old female patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Strength: unknown, Batch/Lot Number: unknown), dose 1 in the left arm on 04Mar2021 as Dose 1 SINGLE for covid-19 immunization (Age at vaccination was 65-Years-old). The patient medical history included she had sinuses and inflammation. On an unspecified date the patient had Injection site warmth, metallic taste in her mouth, itchiness in her nose, ears, and throat, rash at the injection site, severe headache, hands and feet swelled, discomfort, inflammation, allergic reaction. The reporter reported that she talked to her doctor's office this morning, so she had this first injection of Pfizer one almost 3 weeks ago and she was scheduled to have the second one on Thursday. she had delayed allergic reaction about 5 hours later. It had been what she considered she had allergies on her life and primarily medication (Captured as Unspecified medication) but she was considered moderate. she didn't have breathing issues, but she had the nose and the itchy eyes, ears and throat then she got the mouth reaction like on the warm parts on her arm you know like. So they didn't affect her breathing. Then the next day she had swelling in my left side in my arm, the whole way end to her back, even her hands were swollen for 2 days. The patient reported that for 3 days she had got inflammation. She worked for agency. she was responders. So she had lot more sensitivities from work you know at a site (Intent: History). So she had chronic issue with inflammation and respiratory to begin with. So she called her doctor today to see if maybe she should do some Benadryl or something before, she went. she was nervous about taking the second shot because she had such a moderate reaction to the first shot (Further not confirmed hence captured as unspecified shot). The outcome of the events was unknown.  Follow-up attempts are completed; information about lot/batch number cannot be obtained.
This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. Medical history and current conditions were not reported. On 23-JAN-2015 the patient was vaccinated with a dose of VARIVAX (Merck) (dose number, lot number and expiration date were not reproted), 0.5 ml, subcutaneous, that underwent a temperature excursion. No adverse effect reported. Additional information has been requested. Thiss is one (1) of two (2) reports from the same source.
Patient was given the incorrect Pfizer vaccine/dose - Patient given Pedi-Pfizer formulation (0.2mL)
chills; joint pain; feel hot; feel hungry; nausea; foggy feeling; off balanced leaning to right; redness on face; This case was reported by a nurse via call center representative and described the occurrence of red face in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included disorder equilibrium.   On 4th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 4th February 2020, less than a day after receiving Shingrix, the patient experienced red face. On 5th February 2020, the patient experienced chills, joint pain, feeling hot, hunger, nausea, foggy feeling in head and balance disorder. On an unknown date, the outcome of the red face, chills, joint pain, feeling hot, hunger, nausea, foggy feeling in head and balance disorder were not recovered/not resolved.   It was unknown if the reporter considered the red face, chills, joint pain, feeling hot, hunger, nausea, foggy feeling in head and balance disorder to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left deltoid. The patient planned to follow up with his physician on an unknown date. The outcome of all the events were reported as not recovered/resolved in the database however in source document, it was mentioned as recovering/resolving. The reporter consented to follow up.
May have Guillain-Barre Syndrome; Could not walk for 2 weeks; Could not turn over in bed/ bend over; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th July 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 mg/ml. On 19th July 2022, less than a day after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant), unable to walk and mobility decreased. On 2nd August 2022, the outcome of the mobility decreased was recovered/resolved. On 16th September 2022, the outcome of the unable to walk was recovered/resolved. On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome, unable to walk and mobility decreased to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-SEP-2022 Reporter's Comment: The reporter was the patient and reports she received her first Shingrix vaccine in right arm. The patient could not walk for 2 weeks after receiving the Shingrix vaccine.  The patient could not even turn over in bed for 2 weeks.  The reporter reports about 2 weeks after receiving the Shingrix she could begin to walk with a cane and walker. The reporter reports she still could not bend over to picked something off the floor. The reporter reported that on 6th Sep 2022 patient was able to walked with out the walker or cane. The reporter felt she may had guillain-barre syndrome.   The patient would to saw her HCP tomorrow.  The reporter consent to follow up.
Paralysis of the right side of my face, altered tastes  Bells Palsy Prescriptions  Prednisone 14 days Doxycycline 14 days Valtrex 7 days Paralysis  was gone by  4 weeks
Pt reports approximately 12 hours after the injection, suffered 2 hours of dry-heaves and diarrhea, then quite exhausted for the next day.
About 44 hours after my booster shot, I started breaking out in hives all over my body. The hives are itchy, and raised. At times, my eyes itch as  well.
A patient received a dose from a vial that was transported outside of the recommended policy; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (A patient received a dose from a vial that was transported outside of the recommended policy) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2022, the patient experienced PRODUCT STORAGE ERROR (A patient received a dose from a vial that was transported outside of the recommended policy). On 29-Jan-2022, PRODUCT STORAGE ERROR (A patient received a dose from a vial that was transported outside of the recommended policy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that the patient received a dose from a vial that was transported outside of the recommended policy. The vial was removed from the cooler (unpunctured), placed in a glove with two ice cubes and transported for 15 minutes to a different location. Upon new site, vaccine was then punctured, and dose was administered.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Follow up received contains no new information.
11/11/2022 after getting up that morning, I was watering a plant and was unable to stand. I fell, vomited and had dry heaving. I did a 2 channel EKG to check for AFIB. I was in AFIB. I spent two hours in bed. I went to the emergency room and stayed in the hospital emergency room overnight in an observation room. The doctor said I was severely dehydrated and wanted to change my heart medications to bisoprolol dropping out the diuretic part. I was on an IV for dehydration which was part of the reason for the fainting spell. The next day I was able to stand up and did not feel dizzy at all. Since then I have had follow up with the Cardiologist, he changed my bisoprolol to half dose.
She has a terrible case of shingles on her face; Her eye is all swollen shut. It looks like a big red strawberry!; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles and eye swelling. On an unknown date, the outcome of the shingles and eye swelling were not recovered/not resolved.   It was unknown if the reporter considered the shingles and eye swelling to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-MAR-2022 Reporter's Comment: This case was reported by a consumer via Interactive digital media. The case was reported by the patient's friend. The patient never had shingles and was told by her doctor that because of her age she needed the vaccine. A week later, she had a terrible case of shingles all over her face and her eye was all swollen shut.  It looked like a big red strawberry. The reporter said that all vaccines were not good. Additional Supportive Information: Follow up would not possible as no contact details were available.
When I woke It felt like a inner tube was inflated around my waist really tight and locked up where my back is fractured and the upper earlier surgery hurt and itched from nerve I am assuming. It settled in to all my weak spots. Today I have no pain like that in my back but right leg function and reflexes are nonfunctioning with spasms.
Henoch-Schonlein purpura. 03/2017: BL ankle edema. No cardiomegaly per CXR. Normal UA. Labs normal. Ended up being early HSP - rash started next day.  recommended bi-weekly f/u for BP and UA. Nl UA and BP 3.27. VAERS to be done given association in time with vaccines.
I had the regular side effects for a couple of days. I started getting a bad headache and bad foot and leg pain. I took Tylenol every 4 hours. A few days later the headache started to go away but then I started getting these big bumps all over my body, but mostly my leg. They were hard bumps that itch. I had them on my back, thighs, joints, feet, legs. It hurts to walk because of the swelling from the bump around my ankles. On the second of September, I went to Urgent Care. A few days later I went to the ER, but they couldn't help me. I saw a dermatologist and diagnosed me with Erythema nodosum. He said it's possible that the vaccine triggered an immune response and could be due to pregnancy. My due date is March 6, 2022.
within days of #1 of 2 Pfizer Covid-19 vaccine, the patient developed intermittent modest vertigo that persisted for several weeks before improving/resolving