chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rheumatoid arthritis flare up/patient's toes were bothering; had stiffness in toes and feet; just tired due first covid shot.; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4142785-00 (AbbVie).  A 42 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 28Oct2021 (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovered", described as "Rheumatoid arthritis flare up/patient's toes were bothering"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "had stiffness in toes and feet"; FATIGUE (non-serious), outcome "unknown", described as "just tired due first covid shot.". The action taken for upadacitinib was unknown. The patient's toes were bothering, thoughts might be having rheumatoid arthritis flare and had stiffness in toes and feet. He also experienced achy due to second Covid shot and just tired due first Covid shot. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of Rheumatoid Arthritis Flare due to Covid-19 vaccination with Rinvoq (UPADACITINIB) was a reasonable possibility. The reporter's causality for the event(s) of Rheumatoid Arthritis Flare due to Covid-19 vaccination with bnt162b2 (BNT162B2) was reported as possible.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and the suspect drug BNT162B2 .The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
injection site itching; injection site red; vaccination site awrmth; kidney infection; Low grade temperature; Arm sore; A spontaneous report was received from Physician regarding a 39 year old female who received first dose of Moderna Covid-19 vaccine and have experienced delayed skin reaction, sore arm, fever and kidney infection.  The patient's medical history included botulinum toxin injection. Her concomitant medications were not provided. No information on allergies.   On 29-DEC-2020, prior to the onset of events, the patient received first of two planned doses of Covid-19 vaccine intramuscularly on Left arm for the prophylaxis of Covid-19 infection (Lot number 011L20A). On 07-JAN-2021, 9 days after vaccination, patient had visited health care professional and says that her arm was sore for about 5 to 6 days after vaccination and then she felt fine. Today, she woke up with injection site itching, red (half dollar size), and hot. She has been on antibiotics for her kidney infection for the past three days. She also had low grade temperature for last three days. She was diagnosed with delayed skin reaction and report was sent to regulatory authority. She was given instructions to check temperature, axillary lymph node swelling and apply cool pack to the area and take Ibuprofen/Tylenol as directed and as needed. Patient states that she heard about these reactions in people who use Botox in the past and she had used it in the past.  Action taken with the 2nd dose of vaccine in unknown.  The outcome of the event sore arm was resolved on 03 Jan 2021. Other events delayed skin reaction, kidney infection and fever are not recovered at the time of report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Case number PHEH2015US025690, is an initial spontaneous report received from a consumer via pharmaceutical company on 02 Dec 2015. This report refers to a patient of an unknown age and gender. Medical history was not reported. Concomitant medication was not reported. The patient received influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date, the patient experienced flu. Final outcome, seriousness and causality were not reported.
Stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for an unknown indication.     The patient's past medical history included Thrombectomy.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization, medically significant and life threatening). The patient was treated with Rehabilitation therapy for Cerebrovascular accident. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Company Comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.  Per SD date of administration of the first dose of vaccine is either 22-feb-2021 or 28-feb-2021. To be checked on query response.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.  Per SD date of administration of the first dose of vaccine is either 22-feb-2021 or 28-feb-2021. To be checked on query response.
The Gray cap Pfizer Covid 19 vaccine for ages 12 and up was diluted with 1.3ml of 0.9% saline and then drawn up 0.3ml and administered  in error to patient under 12 years old.  Spoke to DPH vaccine unit and they told me to contact the DPH  public health nurse, which I did and she told me to contact Pfizer to find out what they have to say about wrong vaccine given to patient. I spoke to RN and RN at Pfizer and they reviewed the Covid vaccines the gray cap 12 and older and the orange cap 5-11 years and it was determined that the dose the pt received was larger than the recommended dose and parents were notified.  Pfizer said not repeat the dose and to monitor for side effects and if they do not develop any significant side effects then they can receive their second dose 21 days later.
In November I notice bumps on my chest. I ignored them until I had my Shingles Shot in December and then I had many bumps on my scalp as well.  I went to the dermatologist and had a biopsy on one of the bumps on my scalp and it came back benign. My doctor said it was more than likely, because of the series of vaccinations I had within a month. COVID 19, Shingles and the flu were the shots I had.
Very sore arm, limited movement in arm, redness and swollen, VERY tired, no appetite, unable to do anything, fever (38C). Started getting better after 1.5 days.
Patient reports swelling of injection site all the way down to elbow and also bruising in that arm. Also reports swelling in other parts of the body.
Information has been received from a physician concerning an 8 week old patient who in January 2010, was orally vaccinated with the first dose of ROTATEQ. In January 2010, the physician suspected the patient may have had intussusception. The patient was seen on 21-Jan-2010 and was fine. Upon internal review, intussusception was considered to be an other important medical event. Additional information has been requested.
Vaccine given prior to individual turning 16. Individual turns 16 on 3/30/2021 and vaccine was given on 3/24/2021.
burning sensation in my torso area; hot sensations moving from my abdomen to my chest, from my neck, nose and lips and sometimes in my head; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation in my torso area) and FEELING HOT (hot sensations moving from my abdomen to my chest, from my neck, nose and lips and sometimes in my head) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 BURNING SENSATION (burning sensation in my torso area) and FEELING HOT (hot sensations moving from my abdomen to my chest, from my neck, nose and lips and sometimes in my head). At the time of the report, BURNING SENSATION (burning sensation in my torso area) and FEELING HOT (hot sensations moving from my abdomen to my chest, from my neck, nose and lips and sometimes in my head) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Lymph Node Swelling-Severe, Additional Details: patient complains of lymphnode swelling in left armpit. size of swelling = golfball
Patient received a flu vaccine at the County Health Dept 9-24-12. While with father and stepmother, she received another flu vaccine from Dr.'s office on 9-28-12.
Only the diluent portion was administered; Only the diluent portion was administered; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd March 2022, the patient received the 1st dose of Shingrix. On 23rd March 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. Health care professional (HCP) did not had any patient demographic or vaccine details (lot, expiry date) at the time of call. Clinical pharmacist practitioner stated that only the diluent portion of Shingrix was administered to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via email.
Tiredness; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Tiredness) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis and Crohn's disease.    No Medical History information was reported.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) was resolving.        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.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Following two Covid shots in January & February, 2021 (both were Pfizer) as well as a Booster on October 6, 2021 (also Pfizer), my PCP, recommended my 2nd Booster to be the Moderna shot.  10 hours after administration, I experienced the normal side effects (headache, slight fever, some aches ) but that very quickly morphed into severe convulsions (arms flailing around like propellors, thrust out in front of me., head & torso severe shaking, lasting for over three hours before subsiding.  Simultaneously, I experienced  a severe drop in my core temperature, requiring me to continuously drink hot water out of the tap which also lasted for over three hours before gradually subsiding around 3:30 AM.  I had never in my life experienced these severe convulsions.  Had I wanted to call emergency, I would have been unable to dial it on my phone, such was the severity of the convulsions.
Verterbal artery dissection that caused a stroke   Very sharp neck pain, tingling on left side, dizziness, nausea (this went on for about 20 minutes prior to getting to the hospital)
localized minor discomfort at the site of injection; chills; Extreme Fatigue; A spontaneous report was received from a nurse, a 54 year-old female patient who received Moderna's COVID-19 Vaccine and experienced chills, extreme fatigue, and localized minor discomfort at the site of injection.  The patient's medical history included Covid-19. No relevant concomitant medications were reported.   On 28 Dec 2020, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (batch 0261.20A) intramuscularly for COVID-19 infection prophylaxis.   On 28 Dec 2020, after receiving the vaccine, the patient experienced some side effects. She stated that these side effects included chills, extreme fatigue, and localized minor discomfort at the site of injection. Treatment for the events included paracetamol, 1000 mg and ibuprofen, 100 mg.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, chills, extreme fatigue, localized minor discomfort at the site of injection, was considered resolved on 29 Dec 2020.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Vaccine that had dark grey particulate matter present had been administered to the patient.; Vaccine that had dark grey particulate matter present had been administered to the patient; A spontaneous report was received from a healthcare professional concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) where a dark grey particulate presented inside the vial, but a dose had already been administered to the patient.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an unknown date, the patient received her first of two planned doses of mRNA-1273 (Lot number: 010M20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, patient received the vaccine which already contained dark grey particulate matter inside the vial.  Treatment information was not provided.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the event, a dose had already been administered to the patient and a dark grey particulate presented inside the vial, was resolved.; Reporter's Comments: This report refers to a case of Product  contamination physical and poor quality product administered for mRNA-1273, lot # 010M20A. There were no reported AEs associated with this case of Product contamination physical and poor quality product administered .
Swelling arm/swollen  upper arm; I experienced  a mild out break of gout; pain is very severe for the first few days; It was a little warm; itchy; Redness; Hypersensitivity reactions; This spontaneous case was reported by a patient and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reactions), PERIPHERAL SWELLING (Swelling arm/swollen  upper arm), GOUT (I experienced  a mild out break of gout), PAIN (pain is very severe for the first few days) and FEELING HOT (It was a little warm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Shingles ( Shingrix on 12-Sep-2020; for an unreported indication: FLU. Past adverse reactions to the above products included Gout with Shingles ( Shingrix. Concurrent medical conditions included Hypersensitivity reaction, Diabetes since 01-Sep-2008, Chronic kidney disease stage 3 since 26-Feb-2009 and Blood pressure high since 20-Sep-2002. Concomitant products included ATENOLOL, CLONIDINE and LOSARTAN for Blood pressure, ATORVASTATIN for Cholesterol, INSULIN GLARGINE (TOUJEO) for Diabetes, ACETYLSALICYLIC ACID (BABY ASPIRIN) and COD-LIVER OIL (FISH OIL [COD-LIVER OIL]) for an unknown indication.   On 04-Mar-2012, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reactions). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling arm/swollen  upper arm), GOUT (I experienced  a mild out break of gout), PAIN (pain is very severe for the first few days), FEELING HOT (It was a little warm), PRURITUS (itchy) and ERYTHEMA (Redness). The patient was treated with COLCHICINE for Gout, at a dose of .6 mg twice a day. On 13-Feb-2021, HYPERSENSITIVITY (Hypersensitivity reactions) had resolved. At the time of the report, PERIPHERAL SWELLING (Swelling arm/swollen  upper arm) had resolved and GOUT (I experienced  a mild out break of gout), PAIN (pain is very severe for the first few days), FEELING HOT (It was a little warm), PRURITUS (itchy) and ERYTHEMA (Redness) outcome was unknown.            The patient had history of much stronger side effects to some described reaction as more intense side effects generally experienced. The patient historical medications include Blood pressure lowering. The patient historical vaccines condition include flu or pneumonia.   This case was linked to MOD-2021-031242 (Patient Link).
Patient received first Moderna dose at age 16. Pharmacist contacted Moderna to determine if it was safe to give the minor a second injection in 4 weeks, Moderna stated it was. Patient did not have an adverse reaction at the tent.
Lower back and neck pain; Lower back and neck pain; This is a spontaneous report from a non-contactable consumer, the patient. A 35-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 an unknown date as a single dose for COVID-19 immunisation. The patient had unspecified allergies. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 27Feb2021, the patient experienced lower back and neck pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of events lower back and neck pain was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
EXPIRED VACCINE TAKEN; This spontaneous report received from a patient concerned a male 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: 1822812 expiry: 13-OCT-2022) dose was not reported, administered on 09-NOV-2022 for covid-19 prophylaxis. The drug was associated with Drug taken beyond expiry date. No concomitant medications were reported. On 09-NOV-2022, the patient experienced expired vaccine taken. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine taken was not reported. This report was non-serious.
No adverse event; patient received improperly stored vaccine; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 15-NOV-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) prefilled syringe, intramuscular injection, 1 dose, lot number W023937, expiration date: 06-DEC-2023, administered for prophylaxis (exact dose, strength, and route of administration were not provided). Before the administration the vaccine underwent temperature excursion (temperature: 47.8 Fahrenheit (F), time frame: 14 minutes, previous temperature excursion: 48 F for 10 minutes) (product storage error). No additional adverse events were reported (no adverse event).
Developed increased weakness and was admitted to Hospital. Was treated with plasmapharesis and during treatment developed acute psychosis and paranoid delusions. Was transferred to the Geriatric Psychiatry Unit at Hospital in for further treatment. Around a week into that admission, she had a dramatic neurologic change and was found to have extensive dural vein thrombosis with ischemic and hemorrhagic events. She was started on heparin drip and sent to Unit for thrombectomy that was unsuccessful. She is currently intubated and comatose with plans for compassionate withdrawal of care soon. Family wanted this sequence of events to be related to the appropriate authorities to investigate if there is any link to the initial vaccination.
Patient developed left optic nerve neuritis June 29, 2008. Also, chronic headache. 8/12/08-records received  for DOS 7/3-7/8/08-DC DX: Optic neuritis versus pseudotumor. Presented to ED with 3 week history of blurred vision of left eye and headache. One week prior patient saw eye doctor who noted swelling of optic nerve unilaterally and referred for MRI which was normal.
~ 1 -2 second patient stated that he was feeling heat in his arm; face noted to flushed ~30 seconds continue to have burning ~ 1 min moved to Isolation; c/o metallic taste in mouth and feels nausea  ~ patient appears the same - allergic symptoms reviewed multiple times 1514 162/102 112; c/o tongue thickness  ~1516 stated he felt mild tightness to in throat ~ 1518 136/96  100; states he is feeling worse; EPI pen suggested patient declined ~1520 paten states his allergist had told him that he is not a candidate for the Moderna Vaccine  ~ 1524 EMT was called given  patients condition and the allergist suggested no vaccinations ~1524 patient continues to refuse EPI administration despite c/o throat tightness and enlarged tongue; able swallow and tongue visually appears normal  1528 131/81 100 99%; stated tightness is improving 1530 158/106 104 flushed able to swallow; lung sound are clear; no increased WOB 1533 EMT at bedside - care endorsed to EMT after rport given  As he was leaving with EMT patient stated he may have had COVID 19 ~ December 12 to 20 2019