chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On going since 1/13/2013. Both lower legs and feet numb. Shocking sensation in toes. Both forearms hurt, feel like they are on fire. Cramping in both calf muscles. tingling in both hands. Sensations in lower arms and legs like pins / needles, cold hands, shooting pains. Getting worse by the week.
1st dose on 10Feb2022, 2nd dose on 10May2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 26-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 10th February 2022).   On 10th May 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 10th May 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long 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 Information: GSK Receipt Date: 13-SEP-2022 Reporter's Comment: The reporter stated that at the time of reporting patient did not administer 3rd dose of vaccine. The reporter stated that the first two doses were given at a different facility so reporter did not have the lot number and expiration date information. The reporter did consent to follow up. Additional Supportive Information: The patient received 2nd dose of Twinrix vaccine later than recommended time frame, which led to lengthening of vaccination schedule.
Today was the latest and the worst.; Have been lightheaded to the point of almost passing out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Jan2022 (Batch/Lot number: unknown) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Zpak for Known allergies: zpak, notes: Known allergies: zpak. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), for COVID-19 immunization, reaction(s): "Covid test result=Positive", "Covid test result=Positive"; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), for COVID-19 immunization, reaction(s): "Covid test result=Positive", "Covid test result=Positive". The following information was reported: DIZZINESS (non-serious) with onset 24Jan2022, outcome "unknown", described as "Have been lightheaded to the point of almost passing out"; CONDITION AGGRAVATED (non-serious) with onset 17Feb2022, outcome "unknown", described as "Today was the latest and the worst.". Therapeutic measures were not taken as a result of dizziness, condition aggravated.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient has been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
4-6hr p/vax t105 ax spike off & on when seen in ER;t102.5 R 16JUL96 afternoon);pt had been given APAP q 4hr;erythema on lt thigh when seen in ER looked well was running around;
Patient woke up with a dull headache and later in the day (about 3:00 PM) had a 101 degree temperature and experienced chills, nausea, and swelling and pain at injection site. Pain and swelling remainded for 5 days. Patient still has a small knot at the injection site.
Janssen COVID-19 Vaccine EUA. Patient called on 3/04/2022 to inform us after receiving  Janssen vaccine on 11/15/2021 his shoulder area was sore and it has continued to hurt since with worsening of severity. States has pain and some numbness in his right arm and thumb. States this has made working difficult. He has not used any over the counter medications or comfort measures such as cold compress or heat for this pain since vaccinated and has not received any medical care for this pain.
Patient stood up to get a drink of water after receiving his vaccine and seemed a little unsteady. The pharmacy team asked him to remain seated for at least 15 minutes and brought patient water. He experienced syncope a few minutes later. Emergency services were contacted and evaluated patient.
Immediately after receiving vaccine, patient began complaining about her forehead and injection site itching.  Patient was given Oral Benadryl (25mg) and Orapred (38mg).  About 20 minutes later, patient continued to complain of right arm, left ankle and face itching.  Patient was given an additional 25mg of oral Benadryl . Two hours following the injection, the patient stated the itching had improved.  The patient did still have redness on forehead but she was able to be discharged home with instructions to follow up with an allergist before receiving second dose.
Pt first called on 4/13 to report throat and tongue tightness 3 hrs post first Pfizer vaccine.  She tried Allegra with no response.  She then called today to report symptoms that are continuing that she related to the first Pfizer vaccine.  She started to experience lip swelling and tinglings as of 4/16.  Her PCP instructed her to take Benadryl, and she has had good relief with that. Her throat and tongue tightness have improved since 4/13.
Pt developed a rash and local swelling after receipt of vaccines. Generalized patchy erythema developed with some areas of swelling. Bluish color of lisc noted. Alternate swelling of feet noted. No respiratory distress or GI symptoms prescribed Epinephrine 1:1000-0.05ml SC administered approximately 7pm-immediate response. O2-41/min-offered-unable to stop crying. Rescue squad arrives-no significant O2 received.  FOLLOW UP:  No site reaction.
No adverse event; 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    No concomitant medications were reported. The vial was initially thawed on 10-Jun-2023.  Treatment medications were not reported.  This case is for 3rd patient out of 30 patients reported by reporter.    This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live follow-up significant information received: Drug start date was updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case (Patient 1)
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 06-OCT-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8  F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
First day achy bones, for 2 days.  Extreme pain starting in upper thigh, radiating around to buttocks, up to waist. Skin extremely sensitive to touch. No lesions. Some puffed up areas. This started 24-48 hours after immunization.   Dr. Visit 9/19/19 - Valtrex, gabapentin prescribed
Around 10pm same day as receiving the shot, client states she began not feeling well.  For "Several days" she could not walk more than 10 feet without being winded.  Had difficulty breathing.  H/A  Sweating, Weakness.   Hsd small red area size of dime at injection site. Did not call MD.  Was afraid they would send her to hospital.  She waited until now to report reaction because she wanted to cancel next vaccine appointment
Developed rash on arms, neck and abdomen - for 4 months. Occasionally experienced blurred vision and headaches for two months. Had to wear cool summer clothing for 4 months. Still have to use special body wash, so rash doesn't reoccur.
Father stated child that on July 10th the child had a red area on the left leg that he thought was a bug bite. On July 11th the area was red, swollen, hard, itchy, warm to touch and the size of a baseball. Advised to seek medical care. Parent took child to Urgent Care and was told child had an "infection in the muscle." Child received a prescription for Bactrim. On the 12th parent reported the area was no bigger.  On the 15th parents states child has fully recovered.
Patient has redness and swelling below the injection site, not on or around. Patient stated that he also experience chills and fever the night of the vaccine and continues to experience this. Suggested that the patient contact physician or immediate care facility if no physician. Can also take tylenol for the fever and use a cool compress for left arm.
4NOV97 lt leg unable to move, swollen, crying cont > than 3hr;no temp, leg swollen, sore for 24hr;
A literature review found one case of NHL (Non-Hodgkin's lymphoma) that developed shortly after Moderna COVID-19 vaccination; This spontaneous case was reported by a consumer and describes the occurrence of NON-HODGKIN'S LYMPHOMA (A literature review found one case of NHL (Non-Hodgkin's lymphoma) that developed shortly after Moderna COVID-19 vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced NON-HODGKIN'S LYMPHOMA (A literature review found one case of NHL (Non-Hodgkin's lymphoma) that developed shortly after Moderna COVID-19 vaccination) (seriousness criterion medically significant). At the time of the report, NON-HODGKIN'S LYMPHOMA (A literature review found one case of NHL (Non-Hodgkin's lymphoma) that developed shortly after Moderna COVID-19 vaccination) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.  ID was reported.  Company comment: This is a spontaneous case concerning a patient of nknown age and gender with no medical history reported, who experienced the unexpected serious (medically significant) event of Non-Hodgkin's lymphoma. The event occurred after a dose of mRNA-1273 vaccine. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    This case was linked to US-MODERNATX, INC.-MOD-2023-736010, US-MODERNATX, INC.-MOD-2023-735263 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2023: Follow-up information included no new information. On 03-Aug-2023: Follow-up information included no new information. On 03-Aug-2023: Follow-up information included no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-736010:same reporter US-MODERNATX, INC.-MOD-2023-735263:same reporter
The patient broke out with shingles on his left thigh where his chicken pox vaccination was given. The patient experienced blisters, pain and itching constantly. The blisters went away in 2 weeks but the pain never goes away.
From initial information received on 12/12/03 from the patient's father who is a physician regarding an adverse event occurring in the USA, it was reported that a 16 year old female patient received her first dose of FLUZONE, lot number U1076AA, administered IM in the left deltoid on 12/7/03. One day later, the patient developed joint swelling, difficulty ambulating, and a low grade fever. There was no nausea, vomiting, or diarrhea. No hematuria. At the time of vaccination, the patient also took contraceptives. Her pre-existing medical history includes allergies to horses, feathers, and cats. Otherwise, no medical conditions. The patient was treated with non-steroidal medications. Reportedly, the patient is feeling better, but is still sore.
Information has been received from a female with a history of shingles who was vaccinated with a dose of ZOSTAVAX.  On an unspecified date the patient developed shingles.  At the time of the report the patient's status was unknown.  A product quality complaint was not involved.  No further information is available.
pt states neck swelling lt side 2 dasy p/Hep B vax 26AUG93; no breathing problems or itching @ that time;
stomatch bug on 01/20/2022,  that lasted 24hrs. then she felt well for two days and she did a COVID swab since she was at work she was sent for testing and it was negative then on 01/23/2022 throut felt felt tight and she thought it was allergies and she took an allegy pill the later in early moring of 01/24/2022  could not swallow and through was inflammed and she did a home COVID tested  Avid was the brand of test and she received a positive test.  Other at work was covid positive and fluids and isolation and called doctor a few days later because she thought that she had stempt throught.  Another associate with COVID gave her zpac that she received and she took it and a few days later her throught felt better.  60% better and tested again at day 6 and still tested positive for COVID so she had to stay off work. Televisit and talk with Dr. at hospital that she works for, also gave directive of the zpac.
Headache; Nausea; Chills; Sore arm; Very distinct metallic taste in mouth.; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration on an unknown date in Apr2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and sleep apnea. The patient had a known allergy to sulfa based drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) and procaterol hydrochloride (PRO-AIR); both for unknown indications from unknown dates and unknown if ongoing. On 16Apr2021 at 19:00, the patient experienced headache, nausea and chills which only lasted for a few hours and a sore arm that lasted for about 48 hours. On an unknown date in Apr2021, about 24 hours post vaccination, the patient developed a very distinct metallic taste in mouth. It had been almost 72 hours after vaccination and the taste persisted. 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. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache, nausea and chills were resolved on an unknown date in Apr2021; whereas sore arm was resolved on 18Apr2021. The clinical outcome of the event very distinct metallic taste in mouth was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Client received 2nd dose Moderna with 23 day interval; 5 days earlier than recommended 28 day interval per Manufacture and FDA EUA.  Client did not accurately answer pre-vaccination screening checklist indicating the correct date of initial Moderna COVID-19 vaccination from another agency on 02 FEB 2021.  No adverse reactions reported post vaccination to program personnel.
headache; develop inflammation on her back; muscle cramps; feeling numbness in half of her body; she stayed on bed for 2 days because of this; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 19Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunization and experienced numbness in half of her body. It was reported that Patient received the second dose on 19Feb and she presented the same adverse reaction feeling numbness in half of her body, she stayed on bed for 2 days because of this. On an unspecified date in Feb2021, 5 days after receiving the second shot of the vaccine she started to have a headache and to develop inflammation on her back and muscle cramps. She has attended to her physicians office the whole week and has been unable to go to work. The events resulted in physician office visit. The outcome of the events was unknown.  No follow up attempts are possible; information on Lot/batch cannot be requested; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021215428 Pfizer
Pt woke up day after receiving the vaccine(received 9/27/2019) with swollen arm and redness. He had lower back pain that required ice. He felt weak and nauseated and just bad in general. As of 9/29/2019 he was feeling better and his arm was not so tender and this weakness had subsided.
12MAR91 4PM started vomiting,diarrhea & running low grade temp @ 730 PM on 13MAR91 took infant to ER- MD said it may be related to immun rec'd 14MAR91 9AM diarrhea persists;
Tinnitus began in right ear on 4/29/21 followed by sudden hearing loss in the same ear. Visited ENT on 5/11 and 5/13 and was diagnosed with sudden hearing loss and treated with steroids for 12 days. Hearing mostly (85%) recovered however tinnitus began in left ear on 5/17/21. Subsequently, further tingling and numbness in limbs has continued along with increased eye pressure.
Fever of 102-105 for 12+ hours; This is a spontaneous report from a contactable consumer or other non hcp.  A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection in pre-filled syringe, Batch/Lot number: Unknown), via an unspecified route of administration on 30Sep2021 15:00 PM (At the age of 41 years old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. Medical history was reported as none from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received multivitamin within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, patient has not been tested for COVID-19. On 01Oct2021 02:00 AM patient experienced fever of 102-105 for 12+ hours. The patient treated the event with Advil, patient didn't have relevant medical history and concurrent conditions, Relevant past drug history, No known allergies.  On 01Oct2021 patient underwent lab tests and procedures which included body temperature: 102-105. Therapeutic measures were taken because of fever of 102-105 for 12+ hours. The outcome of the event was recovered on 01Oct2021 (14.00).    Batch/lot number not available for [Vaccine BNT162B2], no further information is expected.
Mild fever 99-100 F; Coughing; Tested positive for covid; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Mild fever 99-100 F) and COUGH (Coughing) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 613L20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included ATORVASTATIN for Cholesterol.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PYREXIA (Mild fever 99-100 F) and COUGH (Coughing). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and OMEPRAZOLE for Reflexes abnormal, at an unspecified dose and frequency. At the time of the report, PYREXIA (Mild fever 99-100 F) and COUGH (Coughing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: NNI
Sore right arm immediately after vaccination. Couldn't lift arm. Still taking NSAIDS and physical therapy. Notified Employee Health re: above 4-1-08. Spoke with "patient" 4-18-08 to file report.