chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Apr2022 as dose 4 (booster), single (Lot number: Ew0150) at the age of 47 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Chronic pain" (unspecified if ongoing). Concomitant medication(s) included: Venlafaxine; Gabapentin; Tramadol. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID-19 Treatment. Therapeutic measures were taken as a result of drug ineffective, Covid-19. No follow-up attempts are possible. No further information is expected.
One half hour post injection I began feeling a tingling in my throat. It progressed to swelling, which made it more difficult to breathe. My lips swelled a bit and a white line formed on them. I took two 25 mg tablets of Benadryl. I began feeling better about an hour later. I also started my period the morning of the shot. The next morning, my period stopped.
Tongue, gums and throat numb for 45 minutes, waves of of tingling numbness from my knees to my throat every 10 minutes for about 45 minutes.
Covid-19; Covid-19; interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Nov2021 as dose 3 (booster), single (Lot number: 32030BD) at the age of 49 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Jan2021 as dose 1, single (Lot number: 025J20A), on 04Feb2021 as dose 2, single (Lot number: 016M20A) and on 22Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "GERD" (unspecified if ongoing); "insomnia" (unspecified if ongoing). Concomitant medication(s) included: VENLAFAXINE; SUVOREXANT; VITAMIN D3; RYBELSUS; VITAMIN B12 [CYANOCOBALAMIN]. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Nov2021, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient received other medication in two weeks. Patient received anti viral treatment for COVID 19 with Paxlovid from 19Sep2022 till 24Sep2022. Patient taken multivitamin as concomitant. There were no known allergies.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Body aches, shakiness, dizziness, headache, weakness, shivering, teeth chattering, 101.5 temperature for 32 hours, plus sore arm at injection site for 3 days.
expiry date was March 2022; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA468A, expiry date March 2022) for prophylaxis.   On 2nd June 2022, the patient received Menveo. On 2nd June 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 06-JUN-2022 Reporter's comment: Medical Assistant reported a dose of Menveo was administered to a patient on and it had expired. The vaccine administration facility was same as primary reporter. The reporter consented to follow up. Additional supportive information: The patient received Menveo which was already expired in 31st March 2022, which led to expired vaccine used.
Fever, chest cough, freezing then hot. Not just body aches like a flu but painful to move any part of my body, bad headache, very weak.
I was at work and all of a sudden my lower abdomen started bloating and it was very painful. Within seconds I started feeling nauseous and my mouth filled with saliva. I started to feel faint. I left work 30 minutes early. I had to take my pants off and put on pajama pants because that is the only thing that would fit me. The pain from my abdomen was around my female organs. I laid down and my quads started to ache and I developed a fever. I did take some Tylenol which helped with the pain. I took Tylenol all week. My abdomen was still swollen come Friday and I developed brain fog. I was really having trouble recalling my normal daily routines and people I work with. This lingered on for 3 weeks. My head feels clear now, but I am still having trouble remembering normal daily activities and recall.
This spontaneous report as received from a pharmacist refers to a 76 years old female patient. The patient was vaccinated with 0.65 ml ZOSTAVAX (lot number 0564AE, expired date 21-MAR-2013) subcutaneous on 15-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. Within 24 hours of getting the shot, on approximately 15-AUG-2012 the patient developed redness, swelling, pain and warmth at the injection site and the reaction was about 3" in diameter. Treatments TYLENOL and ice were given for adverse events. There was no laboratory diagnostics study performed. The outcome was unknown at the time of report. The patient had sought unspecified medical attention. This is one of several reports received from the same source. Additional information is not expected.
Janssen COVID-19 EUA.  feeling weakness & dizziness, chills. cough and muscle ache in arm, shoulder and neck. congestion and runny nose with nausea for 10 days now.
I got COVID in February, but the vaccine was in September. On Sunday, I went to a museum, on Monday night I started to get symptoms, sore throat, cough, head & chest congestion, mild nausea. I was with my family, my daughter was visiting that weekend, we went to the museum, my daughter had 4-5 times COVID-19 (she works in a school) but she tested negative. My wife suggested for me to test for COVID-19, and I tested Positive twice, I wasn't terrible sick, this was the first time I got COVID-19. On Wed or Thursday of that week, I contacted my doctor (tele visit), he said to my age I should take a drug to prevent getting sicker, I took it for 5 days. I got better and I am fine..
Woke up with a one-sided facial rash (right side); one-sided facial rash (right side) redness; one-sided facial rash (right side) warmth; one-sided facial rash (right side) was blotchy; Left eye was red near the water line; My left eye had mild swelling.; Red bumps that were itchy on right arm; Red bumps that were itchy on my right arm.; This is a spontaneous report from a contactable nurse, the patient. A 24-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 09Apr2021 at 09:45 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included increased skin sensitivity, hives (frequently got hives, do not know source) and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. It was unknown if patient was pregnant at the time of vaccination. Concomitant medications included amphetamine sulfate (MANUFACTURER UNKNOWN), escitalopram oxalate (LEXAPRO) and buspirone (MANUFACTURER UNKNOWN); all taken for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. On 11Apr2021 at 09:45, the patient woke up with a one-sided facial rash (right side), redness, warmth, and was blotchy. Her left eye was red near the water line and had mild swelling. The patient also had red bumps that were itchy on her right arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events one-sided facial rash (right side), redness, warmth, was blotchy, the left eye was red near the water line and had mild swelling and red bumps that were itchy on right arm was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
The symptoms was chills, body aches, very tired and no fever.(estimated date of delivery 5/17/2021)
3 days post vax pt began to arch head, neck & spine & legs backwards;locking into position;mult times subsided 3days & began again;
(at injection site) little lump the size of a tangerine; (at injection site) warm to touch; swollen arm; (at injection site) itchiness; (at injection site) soreness; (at injection site) redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS ((at injection site) little lump the size of a tangerine), INFUSION SITE WARMTH ((at injection site) warm to touch), PERIPHERAL SWELLING (swollen arm), VACCINATION SITE PRURITUS ((at injection site) itchiness) and VACCINATION SITE PAIN ((at injection site) soreness) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS ((at injection site) little lump the size of a tangerine), INFUSION SITE WARMTH ((at injection site) warm to touch), PERIPHERAL SWELLING (swollen arm), VACCINATION SITE PRURITUS ((at injection site) itchiness), VACCINATION SITE PAIN ((at injection site) soreness) and VACCINATION SITE ERYTHEMA ((at injection site) redness). The patient was treated with Manual therapy (iceand alcohol rubbing) for Vaccination site mass; Manual therapy (Ice and alcohol rubbing) for Infusion site warmth; Manual therapy (Ice and alcohol rubbing) for Peripheral swelling; Manual therapy (Ice and alcohol rubbing) for Vaccination site pruritus; Manual therapy (Ice and alcohol rubbing) for Vaccination site pain and Manual therapy (Ice and alcohol rubbing) for Vaccination site erythema. At the time of the report, VACCINATION SITE MASS ((at injection site) little lump the size of a tangerine), INFUSION SITE WARMTH ((at injection site) warm to touch), PERIPHERAL SWELLING (swollen arm), VACCINATION SITE PRURITUS ((at injection site) itchiness), VACCINATION SITE PAIN ((at injection site) soreness) and VACCINATION SITE ERYTHEMA ((at injection site) redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient has been applying ice and rubbing alcohol at site.  Treatment information was not provided.   This case was linked to MOD-2021-131421 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Additional information received on 14-May-2021 was updated with additional event of swollen arm and rechallenge information was updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
circular rash; red rash; bruised arm; arm pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Mar-2021 and was forwarded to Moderna on 23-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH (circular rash), PAIN IN EXTREMITY (arm pain), CONTUSION (bruised arm) and RASH ERYTHEMATOUS (red rash) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Diabetes (has discontinued diabetes medication within the past month.). Concurrent medical conditions included Breast cancer and Weight loss.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain). On 16-Mar-2021, the patient experienced CONTUSION (bruised arm). On 23-Mar-2021, the patient experienced RASH (circular rash) and RASH ERYTHEMATOUS (red rash). At the time of the report, RASH (circular rash), PAIN IN EXTREMITY (arm pain), CONTUSION (bruised arm) and RASH ERYTHEMATOUS (red rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Chemo pill. No treatment information was provided.
She was feeling light headed/dizzy; The patient was nauseous; Hives; It was an allergic reaction to the flu shot; Injected arm started swelling; This is a spontaneous case, reported by other non health professional via agency (reference number: SEQ19-06611) on 13-Nov-2019, concerning a 19- year-old, female patient.  The patient's medical history included removal of tonsils and surgical removal of swallowed quarters. The patient was not taking any concomitant medication.  On 08-Nov-2019, the patient was administered Flucelvax Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular (IM), anatomical location: deltoid, batch number and expiry date: not reported] for influenza prophylaxis.  On the same day, within 5 minutes after vaccination, the patient's injected arm started swelling.  On 09-Nov-2019, one day after vaccination, the patient developed hives.  On an unspecified date, the patient used Benadryl (diphenhydramine hydrochloride) and prednisone, but it did not help. The patient went to emergency room (ER) and this event was confirmed to be an allergic reaction to the flu shot.  On 13-Nov-2019, five days after vaccination, the patient was feeling light-headed/dizzy and she was also nauseous.  On 27-Nov-2019, the patient recovered from all events.  This case was assessed as non-serious.  The reporter did not provide the causality assessment to Flucelvax Quadrivalent.  Follow up received from other non health professional (consumer) on 12-Dec-2019: It was confirmed that injected arm was swollen. The outcomes and stop dates for all events were provided. Narrative amended accordingly.  Company comment: The patient experienced peripheral swelling five minutes after administration of suspect product, Flucelvax Quadrivalent. The patient also developed urticaria one day post vaccination. Allergy to vaccine was confirmed. The patient developed nausea and dizziness, five days after vaccination. Chronology is plausible and causal role of the suspect product is assessed as possible.; Sender's Comments: The patient experienced peripheral swelling five minutes after administration of suspect product, Flucelvax Quadrivalent. The patient also developed urticaria one day post vaccination. Allergy to vaccine was confirmed. The patient developed nausea and dizziness, five days after vaccination. Chronology is plausible and causal role of the suspect product is assessed as possible.
Patient received Pfizer Covid19 Vaccine (booster) given by intern. When pharmacist (me) signed the form, we realized that we had not mixed any vaccine that day and she had been given a shot that had been pulled the day prior. We discussed with the patient and determined we needed to revaccinate so we gave he another Pfizer Covid 19 vaccine in her right deltoid (other was in left.) She understood what happened and was glad to be redosed.  She waited for 30 minutes and then left. I asked the patient to call us if she had any reaction other than what she had seen with the first two.
Initial literature report received on 01 Nov 2010: This patient participated in a prospective cohort study to evaluate T cell responses as correlates of protection against influenza following vaccination in older adults. The patients were vaccinated with Influenza virus vaccine 2007/2008 (seasonal influenza vaccine, manufacturer unknown, batch number: unknown) during the fall of 2007. The influenza surveillance was initiated at two study sites at the start of the influenza season in Jan 2008. The mean age of the study subjects was 74 years (range 60-92). Patients started reporting influenza-like illness (ILI) symptoms. When reported symptoms met the ILI criteria and were within 5 days of onset, a nasal swab for detection of influenza virus was obtained during a home visit or a clinic visit. A laboratory diagnosis of influenza illness was confirmed by the detection of influenza virus in a polymerase chain reaction (PCR) assay of the nasal swabs or a 4-fold or greater rise in the antibody titer after the illness. Subjects that met both clinical and at least one of the laboratory criteria were identified as laboratory-confirmed influenza (LCI). This patient had an antibody titer value of 40, 160, 80, and 160 after 0 weeks, 4 weeks, 10 weeks and 20 weeks of vaccination respectively. The patient had more than 4 fold increase in titer value and also tested negative for seroconversion of B strain but tested positive for PCR of B strain. Therefore this patient was considered as a LCI case of Influenza B. The outcome was not reported.
Patient woke from sleep and was in apparent pain, crying, and movement was stiff.  It appeared to be a stroke  (she has had one previously in 2015).  911 was called and she was taken to ER.  They did a UI test, sent her to CT for head scan.  Urine analysis was abnormal.  She was calmer in the ER but appeared to have lost function in her left arm and leg.   She was unable to hold her head up.  After several hours in ER she was sent for MRI Where she was sedated for procedure.  She was admitted (total of 8 hours after admission to ER).  Given antibiotic for UTI but not meds given for what was cerebral infarct as she had history of previous hemorrhage.  PT, Speech, Neuro consulted.  Sent home via ambulance and had home health, PT, OT, Speech for a month.  After stroke she required some adaptations to her wheelchair for head and trunk support.  Some function has returned to left arm, hand but not to left leg.  Swallow and oral eating have been compromised and patient no longer takes any food by mouth or can assist with physical transfers.
On day 8 after 1st dose got rash itchy red now 3 in by 3.5 in.  Rash at injection site.  Covid arm
LARGE RED RASH FROM SHOULDER TO ALMOST ELBOW. PAIN TO POINT OF PARTIAL IMMOBILITY OF LEFT ARM. NAUSIOUSNESS (DID NOT VOMIT) CHILLS SEVERE IRRITABILITY
shaking,  fever of 101.7, body felt like it had been beaten, very tired
Arrhythmias; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273), and who experienced arrhythmias.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  Prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   Patient had adverse heart reaction after receiving the vaccination. Patient has some arrhythmias and ended up in the ER two days later. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the events, adverse heart reaction and arrhythmias were not reported.; Reporter's Comments: This case concerns a female patient of unknown age with unknown medical history subject, who experienced a serious unexpected event of arrhythmia. The event occurred on unspecified time after the first dose of mRNA-1273 vaccine (but not later than 2 days after vaccination). Treatment information was reported; however, patient was sent to emergency room.  Outcome of reported arrhythmia is unknown. The event was assessed as possibly related, however additional information has been requested.
03/09/2021, I felt the vaccine go into my arm, down into my elbow.  Within 2 hours, I felt itching spreading into my arm, elbow, nose, face, mouth, flooding from my left arm, a strange allergic reaction, swelling and itching in throat and eyes.  I think it went into an artery and deposited into the tissue. My throat felt like it was closing, so I took 50 mg of Benadryl.  After 6 hours, the Benadryl would wear off and the itching would come back. I took the Benadryl for 3 days.
Inflamed skin and tissue at the injection site that began within a couple of hours after shot and is continuing more than 60 hours after injection. I have a hard lump and red skin around the injection. The area is about 6 inches in diameter and is very tender to the touch and hot.
This is in follow-up to report (s) previously submitted on 03/26/2008. After recieving the injection my arm started to burn at the injection site. and then started to spread across to my shoulder towards my clavicle midway, down my arm mid way towards my elbow. There are blotches of reddened areas that feel like burns. Sensitive to touch and feel warm. It hurts to extend my arm. Dr. has seen the area and has perscribed Keflex and has told me that it has developed into cellulitis. He told me to use ice to the site. Thru out each day it has gotten worse. The injection was given 4:30PM on Monday 3/24/08 and each day there is more red areas and an increase in pain. There is swelling of the arm also. Initial and follow-up information has been received from a healthcare worker concerning a 51 year old female registered nurse (employee nurse) with allergies to penicillin and BIAXIN, who on 24-MAR-2008 at 16:30 was vaccinated IM in the left arm with a first dose of PNEUMOVAX 23 (lot #659150/1384U). There were no illnesses at the time of the vaccination. On 24-MAR-2008 at 16:30 the patient experienced burning at the injection site that spread across the shoulder midway towards the clavicle and then down the arm midway towards the elbow. The patient developed blotches of reddened areas that were reported to feel like burns. The area was sensitive and warm to touch. The patient reported that it hurt to extend her arm. On 27-MAR-2008, the nurse presented to the office with shoulder pain and welts over her entire arm (treatment not specified). The doctor examined the area and said tht it had developed into cellulitis. The patient was prescribed KEFLEX and was advised to apply ice to the site. It was reported that each day the symptoms have gotton worse, there are more red areas, an increase in pain, and swelling of the arm. At the time of this report, the nurse was not recovered. A healthcare worker requested a lot check be performed. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satifactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This in one of 2 reports from the same source. No further information is available.
First dose was given 11/12/21, second dose was given 12/6/21 Pt was erroneously given Moderna even though he is under 18yo and should have received Pfizer Pt has not reported any side effects