chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dose given comprised of multiple vials; A spontaneous report was received from a healthcare professional concerning an unknown patient who received Moderna's COVID-19 vaccine (mRNA-1273) and stated that the dose given comprised of multiple vials  No patient details were provided.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On unknown date, prior to the onset of the events, the patient/patients received their first of two planned doses of mRNA-1273 (lot/batch: 031L20A) for prophylaxis of COVID-19 infection.  The reporter stated that 12FEB2021 1 patient would have received a dose from multiple vials and on 13FEB2021 2-3 patients may have received doses from multiple vials.  Laboratory details if provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event ( dose given comprised of multiple vials ) was recovered/resolved..; Reporter's Comments: This case concerns a patient of unknown age and gender who had a nonserious unexpected event of Product preparation issue with mRNA-1273 (lot # 031L20A) without associated adverse events.  Reporter stated a "pharmacy pre-filled syringes and combined the contents of multiple vials to make a single dose, and that multiple patients may have received doses from multiple vials". Very limited information regarding the events has been provided at this time.  Further information has been requested.
Increased inflammatory / arthritic joint pain after exertion, slowly subsided (hands, wrists, arms, knees)
pain in her bicep muscle; right arm pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm, on 25Feb2021 as a single dose for COVID-19 immunisation. Medical history Lyme disease from 2020 and knee pain. The patient's concomitant medications were not reported. The patient experienced right arm pain at the injection site on 25Feb2021 and pain in her bicep muscle in Mar2021. The events were reported as non-serious. The clinical course was reported as follows: The patient received the first dose on 25Feb2021, and she had right arm pain at the injection site. Then the week went on and she started feeling pain in her bicep muscle and three weeks later it was still bothering her. The patient stated she had taken ibuprofen (MANUFACTURER UNKNOWN) to help treat the pain. She also went to her physician and he thought it could be post Lyme disease symptoms, but her blood tests came back negative on an unspecified date. The patient stated she had been in physical therapy for knee pain and now they are giving her exercises for her arm pain. Therapeutic measures were taken as a result of the events as aforementioned. The clinical outcome of right arm pain at the injection site and pain in her bicep muscle was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Night sweats for next two nights (1/23 and 24) Sore neck, left arm ache, head ache that would come and go for the next five days 1/24 -) On the eight day, severe vertigo with nausea, throwing up multiple times, blood pressure rose to 171/94, no fever (1/30) Ninth day seemed to lessen but dizziness and headache was still there. 1/31 2/1 - very minor, left arm aches, head aches, call my primary to said to contact you.
I had a friend who's 6 MONTH OLD DIED from the TDAP shot; Initial information received on 11-Jun-2022 regarding an unsolicited valid social media serious case received via consumer/non-hcp.  This case involves a 6 months old female patient who experienced had a friend who's 6 month old died from the tdap shot while receiving vaccine Diphtheria, Tetanus And Acellular Pertussis Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect diphtheria, tetanus and acellular pertussis vaccine produced by unknown manufacturer (dose, route, lot number and administration site: unknown) for prophylactic vaccination.  On an unknown date reportedly had a friend who's 6 month old died from the tdap shot (death) (unknown latency) following the administration of Diphtheria And Tetanus And Acellular Pertussis Vaccine.   This event was assessed as medically significant and was leading to death.  Final diagnosis was (fatal) i had a friend who's 6 month old died from the tdap shot.  Action taken: not applicable.  Corrective treatment: not reported  Outcome: Fatal   It is unknown if an autopsy was done. The cause of death was reported as Death NOS.; Sender's Comments: Sanofi company comment dated 14-Jun-2022: This case, received from social media, concerns 6 months old female patient who, as reported, died from the shot Diphtheria, Tetanus And Acellular Pertussis Vaccine. The cause of death was unknown. Temporal relationship cannot be established due to lack of information on event onset date and vaccination date. Furthermore, information regarding condition at the time of vaccination, medical history, concomitants, lab data excluding other predisposing etiologies, corrective treatment/clinical measures, family history, and autopsy findings would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.; Reported Cause(s) of Death: not provided
Verbatim report from CMA: immediately starting c/o burning when it went in and then his lips started turning blue he lost all color in his face then started saying he didn't feel well. I asked him what was bothering him and he said his stomach was hurting like stomach pain and then he said he began to feel nauseous and felt like he was going to vomit. I asked him to lay down and asked mom to stay with him then I went and got another medical assistant to help me and she told me to go get him some juice so I did. After the patient starting drinking the juice he started feeling better mom had said also that he had nothing in his system yet today. I asked him to keep lying down and when I felt like his color came back and that he was feeling okay I let him leave. Mom said she was going to take him to get something to eat and come right back. I then spoke to the registered nurse and asked what she thought and she said she feels that he had a possible reaction to the vaccine. Then when Dr. came out of the room I told her what happened and asked if she wanted the patient to come back today or wait a couple days to come in and get the other two vaccines and she said wait and come back another day so mom was then informed when she walked back in the office to wait a couple days and then bring patient back in to get MCV4 and hep A. I kept patient laying down and in the room for 15 minutes after the incident happened.  Note: I (Dr.) called the mother later in the afternoon.  She reported that he was fully recovered after he ate.
pt recv vax 27DEC95 & 1MAY97 pt devel chickenpox;
Information has been received from a physician concern a 9 year old male who on 15-FEB-1997 was vaccinated with a single dose series of varicella virus vaccine live (Oka/Merck). On 10-OCT-2007 the patient came into the office and had a rash all over his body and had a fever. The physician performed a TZANCK test and the test came back positive. The physician reported that it was a break through of varicella. At the time of report the patient had recovered. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
Information has been received from a physician concerning an approximately 4 month old patient who on unspecified dates was vaccinated with two 0.5 ml doses of Proquad. Subsequently, the patient experienced swelling at the injection site after the second dose of Proquad. Unspecified medical attention was sought. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Joint pain in my shoulder and upper arm; Joint pain in my shoulder and upperarm; Joint pain in my shoulder and upperarm making it difficult to raise my armto put my arm in the sleeve of a t-shirt.Any movement out to the side ispainful.; Burning sensation when press along the deltoid muscle; This is a spontaneous report from a non-contactable consumer, the patient. A 64-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 30Mar2021 at 11:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 04Apr2021, the patient experienced joint pain in shoulder and upper arm making it difficult to raise arm to put the arm in the sleeve of a T-shirt. Any movement out to the side was painful. The patient experienced burning sensation when press along the deltoid muscle. 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. The clinical outcome of the events pain in joint involving the shoulder region, pain in arm, pain upon movement and muscle burning sensation were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
having pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 26Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 26Mar2021, outcome "unknown", described as "having pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
she received BCG vaccine she did not get the COVID; Information has been received from a pharmacist, regarding a female patient born in a different country from the country of incident (age not provided). The patient's concurrent conditions, drug reactions/allergies, medical history and concomitant medications were not provided.  It was reported that on unspecified date, the patient received a dose of BCG live (BCG vaccine) (dose, frequency, route, lot # and expiration date were not provided), for prophylaxis. The vaccine was administered in the patient's country of birth.   Subsequently, the patient was adopted for a family in the reporter's country. Her extended and nuclear family got infected with COVID, however, she did not get the COVID and was the only person in her family (besides her grandfather on hydroxychloroquine). According to that, the pharmacist considered the BCG vaccine could be beneficial against COVID (therapeutic response unexpected). The patient's outcome was uknown and the reporter considered the event to be related to suspect therapy.  The pharmacist was also aware of cases where people from other countries benefited from receiving BCG vaccine tested negative for COVID (non-valid case MARRS US-009507513-2008USA012450). combinationproductreport: Yes; brandname: BCG VACCINE USP PUNCTURE DEVICE (DEVICE); commondevicename: BCG live; productcode: LDH; devicetype: SYSTEM, DELIVERY, ALLERGEN AND VACCINE (LDH); manufacturername: Organon Teknika Corporation LLC; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2008USA012450:
both my doses of vaccine led to facial tightening, twitching, and slightly more paralysis; both my doses of vaccine led to facial tightening, twitching, and slightly more paralysis; both my doses of vaccine led to facial tightening, twitching, and slightly more paralysis; This is a spontaneous report from a contactable consumer (patient).  A 55-years-old female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE)), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 11:30 (Batch/Lot Number: EP7533) as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 11:30 (Batch/Lot Number: ER8729) as single dose for covid-19 immunisation .  Medical history included high blood pressure (HBP) from an unknown date and unknown if ongoing , supraventricular tachycardia (PAT) from an unknown date and unknown if ongoing, had Bell's palsy from 2001 to an unknown date. No known allergies. Concomitant medication(s) included amlodipine taken for an unspecified indication, start and stop date were not reported; enalapril taken for an unspecified indication, start and stop date were not reported.  The patient did not have any vaccines in four weeks and did not have covid prior to vaccination. In 2001, the patient had Bell s palsy (Medical history). Her left side paralysis never fully went away. Now, both of her doses of vaccine led to facial tightening, twitching, and slightly more paralysis on 23Mar2021 11:30 with outcome of unknown. She did not regret taking the vaccine and would do it again. Her mainly reason for reporting this was that she wanted to know if the vaccine was still effective. No treatment was received. No covid test post vaccination.
After getting Hep A vaccination on 12/20, went home and son took a nap, he woke up and would not walk.  After 48 hours of him not walking at all and then I noticed swelling in his left knee (same leg as vaccine) went back to Dr's office, Dr took blood work and x-rays.  Dr spoke to Ortho Nurse Practitioner and they advised to give Motrin thru the holiday weekend.  My son began to walk, with a bad limp on Fri 12/23.  On Tues 12/27, went to see the Ortho Nurse Practitioner (b/c Dr was on vac), she did more blood work.  On Wed received a call from my Ped. & she advised me to go to hospital.  They did more blood work, ultrasound, and x-rays.  Then drew fluid from knee.  After that test came back they admitted us due to a bacterial infection in the knee.  My son had surgery the next day to flush out the knee.  Son is doing much better, still walking with a limp.  They were unable to determine what kind of bacteria caused the problem.
Petechia, red and swollen, raw which lasted days and really itched and burned.  Treated with ice packs.
At the injection site there is a knot 1" circ and a rash that has spread 3" from sight. Hot to touch. Treatment Zyrtec, Benadryl, cool compresses, Hydrocortisone cream and Ibuprofen TID. for 3 days if fever >101 needs to bee seen.
Hair falling out on two days of receiving the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Sep2021 11:30 (Lot number: Ff2568) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy to Penicillin" (unspecified if ongoing), notes: Past drug event and known allergies: Penicillin; "Allergy to Cecile" (unspecified if ongoing), notes: Past drug event and known allergies: Cecile; "Allergy to Sulfonamide" (unspecified if ongoing), notes: Past drug event and known allergies: sulfa drugs. The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "drug allergy", notes: Past drug event and known allergies: Codeine. The following information was reported: Alopecia(non-serious) with onset 20Sep2021 08:00, outcome "not recovered", described as "Hair falling out on two days of receiving the shot". The event "hair falling out on two days of receiving the shot" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of alopecia.  Follow-Up (29Sep2021): Follow-up attempts are completed. No further information is expected.  Follow-up (08Oct2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported in response to Non-HCP letter sent   Additional Information:My hair started falling out less than 48 hrs after receiving my 1st shot. It is still falling out. While it is not life threatening it is serious reaction and one that should have been told to me. I don't feel it is in my best interest to take the 2nd dose.  No follow-up attempts are possible. No further information is expected.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case contains information for the 143 of 190 patients described by the reporter.  No concomitant medications were reported.  It was unknown patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Patient complains of shoulder pain in the shoulder the vaccination was delivered. He says he as visited the doctor about the pain and his lack of mobility in the arm.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On approximately an unknown date in 2012 (reported as one year after patient received), the patient was vaccinated with ZOSTAVAX. Approximately on an unknown date in October 2013 (reported as 10 days to 2 weeks) the patient experienced shingles. The outcome of shingles is unknown. Additional information is not expected.
Tested positive for COVID-19 with symptoms; Tested positive for COVID-19 with symptoms; This is a spontaneous report from a contactable consumer or other non hcp. A 75-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as dose number unknown, single (Age at vaccination was 75 Years) for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. The patient medical history was not reported. The patient's concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient underwent Nasal Swab test on 27Jul2021 which result was positive. Symptoms include diarrhea, nasal congestion, labored cough and fatigue. AE results in Emergency room/department or urgent care. The patient was recovering from the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
itching on her face; itching on her lips; itching on her ears; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching on her face), LIP PRURITUS (itching on her lips) and EAR PRURITUS (itching on her ears) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Patient was allergic to flagyl, Vicodin, arthromycin and Bactrim.), Seasonal allergy since 1985 and Depression since 1987. Concomitant products included LORATADINE from 2005 to an unknown date for Allergy, SERTRALINE HYDROCHLORIDE (ZOLOFT) from 1993 to an unknown date for Depression, LANSOPRAZOLE (PREVACID) from 2018 to an unknown date for Heartburn, AMITRIPTYLINE HYDROCHLORIDE (ELAVIL [AMITRIPTYLINE HYDROCHLORIDE]) for Nerve pain, MAGNESIUM for an unknown indication.    On 08-Apr-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PRURITUS (itching on her face), LIP PRURITUS (itching on her lips) and EAR PRURITUS (itching on her ears). On 09-Apr-2021, PRURITUS (itching on her face), LIP PRURITUS (itching on her lips) and EAR PRURITUS (itching on her ears) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Patient reported getting acupuncture same day of vaccine administration.        Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10-MAY-2021 contains Added patient's demographics, concomitant drugs. Updated medical history and event outcome to recovered.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (dose not reported, orally, lot # L000571 with expiration date: 26-JUL-2017, lot # L008578 with expiration date: 14-DEC-2016). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Slight rash and faded blotchiness (no redness) became noticeable at approximately 9 pm (9+ hours after injection) on both left and right lower arms (forearm), more prominent in right arm. Slight itch. Started off thinking I had a flea bite. Itch faded quickly, within 30 minutes. Called advice nurse with Kaiser and was suggested that I take an allergy medication. Only had Claritin, and took one dose at approx 10pm. Went to bed. Still have slight bumpy skin and slight blotchiness on arms, no itch and no other issues beyond a sore right arm. Up to now, have never had any allergic reactions to foods or medication. But had eaten fresh strawberries for dessert at about 8:30 am. It would be the first time in my life to react to a food. But thought it worth mentioning.