chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received PNEUMOVAX 23 at a lesser dose of 0.5 mL at 1:30. At 3pm that day was generally not feeling well. On 10/5/10 at 0500 had diarrhea & at 2pm had a rash on her back. Went to E.R. was diagnosed with inflamed bowel. Given medication for diarrhea and BENADRYL for rash. Sent home.
swelling of her right arm from the injection site, up her shoulder, into her neck and tongue; swelling of her right arm from the injection site, up her shoulder, into her neck and tongue; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer.  This case involves female patient of an unknown age who experienced swelling of her right arm from the injection site, up her shoulder, into her neck and tongue (swelling) and (vaccination site swelling), while she received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  In 2014, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot UI196AA and expiry date: not reported) via an unknown route in the right arm for prophylactic vaccination.  In Oct-2014, the patient developed a non-serious swelling of her right arm from the injection site, up her shoulder, into her neck and tongue (swelling) and (vaccination site swelling), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  It was also reported that her allergist wants her to obtain the ingredients to compare it to the coronavirus disease (Covid) vaccine ingredients  Details of laboratory data not reported.   The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at the emergecy room (ER).  At the time of reporting, the outcome of event was reported as unknown.
Arm sore 1st day.  2nd day arm sore, headache, achy body, ear pain.
Felt like a gerbil on a wheel that goes round and round and round and round and wouldn't stop; Funny taste in my mouth; No appetite; Body aches; This is like the flu.; Raging awful headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt like a gerbil on a wheel that goes round and round and round and round and wouldn't stop), TASTE DISORDER (Funny taste in my mouth), DECREASED APPETITE (No appetite), PAIN (Body aches) and INFLUENZA LIKE ILLNESS (This is like the flu.) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced DIZZINESS (Felt like a gerbil on a wheel that goes round and round and round and round and wouldn't stop), TASTE DISORDER (Funny taste in my mouth), DECREASED APPETITE (No appetite), PAIN (Body aches), INFLUENZA LIKE ILLNESS (This is like the flu.) and HEADACHE (Raging awful headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Felt like a gerbil on a wheel that goes round and round and round and round and wouldn't stop), TASTE DISORDER (Funny taste in my mouth), DECREASED APPETITE (No appetite), PAIN (Body aches), INFLUENZA LIKE ILLNESS (This is like the flu.) and HEADACHE (Raging awful headache) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Patient is reporting that she started to experience nerve pain from elbow down starting two days after receiving Adacel vaccine.
My arm was hurting but I figured that was normal. I was a little nauseated for a couple hours. That evening I had fatigue and a stuffy nose. That next morning I had a runny nose. I started running a fever. Since then, I've had sinus congestion, runny nose, and a sore throat. I am going back to my doctor today. I did have a little bit of a mild headache off and on. My ears are now also filled with fluid. I went out of town the day after my vaccine so I called my doctor and he prescribed me some antibiotics. Today I am actually going to see him in person.
Chills; Headache; Slight nausea; Sore left arm, where shot was administered; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 09Apr2021 at 14:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Concomitant medications included tamsulosin (MANUFACTURER UNKNOWN) 0.4 mg daily. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 19Marr2021 at 02:30 as a single dose for COVID-19 immunisation. 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 vaccine. On 10Apr2021 at 04:00 the patient experienced chills, headache, slight nausea and sore left arm (where shot was administered). 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 reported events. The clinical outcome of the events chills, headache, slight nausea and sore left arm were recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Injection site red swollen warm red rash pain, Fever, leg and body spasms
Information has been received from a physician concerning his 33 year old pregnant wife. (LMP 01/24/00) who had chickenpox as a child, and whose son was vaccinated with one dose of varicella vaccine. Subsequently, the pt's son  developed shingles, and approximately 3.5 weeks afterwards in 07/2000 the pregnant wife developed shingles as well. The wife's shingles were noted to be on the right side of her nose.
Pain in elbows and fingers that is worse at night - both arms; Pain in elbows and fingers that is worse at night - both arms; Pain in elbows and fingers that is worse at night - both arms.; Felt like tennis elbow and arthritis; Felt like tennis elbow and arthritis; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported, expiry date: not reported, Age at vaccination: 56-year-old) via an unspecified route of administration in right arm on 12Mar2021 03:30 PM as DOSE 1, SINGLE for COVID-19 immunization. Medical history included asthma, allergy, severe food allergies to nuts, rice, potatoes, onion, nightshades, Legumes, several antibiotics. Concomitant medications included Benadryl, Excedrin, Hydrochlorothiazide, Ibuprofen. On 14Mar2021 07:00 PM, patient experienced pain in elbows and fingers that is worse at night - both arms (pain in elbow, pain in fingers, pain in arm), felt like tennis elbow and arthritis (tennis elbow and arthritis). No treatment received for adverse event. Facility type vaccine was hospital. No other vaccine in four weeks. No covid present prior vaccination. Covid was not tested post vaccination. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Administered ZOSTAVAX 6/6/16 - Returned to office  6/7/16 with c/o fever, chills, body aches, ear pain, nausea.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 03-MAY-2016, the patient was vaccinated with an improperly stored dose of M-M-R II injection, 0.5 ml lot # L026553, expiration date 16-JUL-2017 (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). Digital data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Swelling and rash on arm at site of injection after 7 days. Initial pain at site of injection subsided in 24 hours.
Started out as a small hard, warm lump that progressed to a small softball size. Today I measured and it is 3 1/2 in long, still warm and hard. It?s itching and hurts.
At 14.48pm,  after given the vaccine patient came back complaining of tingling of  both arms, redness and swelling. Hives to forehead, no itching nor fever. Vitals taken at this time, BP was 128/72.   Patient was given 0.5ml of Benadryl left deltoid site.  At 15.02pm second vitals taken, BP was 130/84, no redness, no swellings on both arms and no hives at this time. Patient was asked to sit back for 15 mins for further observation. At  3.15pm, patient was stabilized and asked to leave.
Headache, Arthralgia, Fever, ErythemaMultiform, NauseaVomiting, fatigue, chills, injection arm pain, tongue tingling
patient received Bexsero, but was supposed to receive Menquadfi; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received Men B NVS (Bexsero) (batch number 5P2P7, expiry date 31-JAN-2026) for prophylaxis.   On 28-AUG-2023, the patient received Bexsero. On 28-AUG-2023, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: patient received Bexsero, but was supposed to receive Menquadfi).  The outcome of the wrong vaccine administered 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: 29-AUG-2023 The reporter was a medical assistant. The reporter reported that the patient received Bexsero but was supposed to received Menquadfi, which led to wrong vaccine administered. The reporter reported that Bexsero was given accidentally. The reporter consented to follow up via email.
Elevated temp to max 100 F; rash on chest, neck ears; 2 white bumps on R cheek.
1wk p/vax pt devel redness, swelling & warmth @ the site of vax;tx w/DPH & an ATB & recovered;this is 1 of 2 pt from this site to devel an inj site rxn p/vax;
Pt reported a drop in systolic blood pressure by 10 points.  This was not verified by a health care provider and was reported to us after the patient was at his home.
completely unable to use hand; redness on hand; redness on arm; hives on arm; "silver dollar coin" rash on arm; blisters on hand wrist and fingers; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE ERYTHEMA (redness on arm), URTICARIA (hives on arm), RASH ("silver dollar coin" rash on arm), BLISTER (blisters on hand wrist and fingers) and HYPOKINESIA (completely unable to use hand) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (redness on arm), URTICARIA (hives on arm), RASH ("silver dollar coin" rash on arm), BLISTER (blisters on hand wrist and fingers) and ERYTHEMA (redness on hand). On 22-Feb-2021, the patient experienced HYPOKINESIA (completely unable to use hand). At the time of the report, INJECTION SITE ERYTHEMA (redness on arm), URTICARIA (hives on arm), RASH ("silver dollar coin" rash on arm), BLISTER (blisters on hand wrist and fingers), HYPOKINESIA (completely unable to use hand) and ERYTHEMA (redness on hand) had not resolved.        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.
Arm sore; Fever of 102 for 2 days; Back aches; Diarrhea/upset stomach; Diarrhea/upset stomach; Headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the left arm on 15Sep2021 at 16:45 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included drospirenone/ ethinylestradiol betadex clathrate (YAZ) started from an unknown date taken daily for birth control. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 27Aug2021 at 15:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. On 16Sep2021 at 13:15, the patient experienced arm sore, fever of 102 for 2 days, back aches, diarrhea/upset stomach, headache and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 16Sep2021, the patient underwent lab test body temperature and the result was 102 (units unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm sore, back aches, diarrhea/upset stomach, headache and fatigue were resolved on an unknown date in Sep2021; while the event fever of 102 for 2 days was resolved on 18Sep2021, after the duration of 2 days.
Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 22 years, in right arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Known allergies: allergic to mushrooms" (unspecified if ongoing), notes: Known allergies allergic to mushrooms; "Known allergies: allergic to cats" (unspecified if ongoing), notes: Known allergies allergic to cats. Concomitant medication(s) included: SERTRALINE; BUPROPION; CLARITIN [LORATADINE]; also reported as other medication in 2 weeks. Past drug history included: Quinoa, reaction(s): "Known allergies: allergic to quinoa", notes: Known allergies: allergic to quinoa. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Apr2022, outcome "not recovered" and all described as "Tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Negative, notes: Began to test negative on day 6; (22Apr2022) Positive; (22May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started on 22Apr2022 (took for 5 days) and stopped on 27Apr2022 (Began to test negative on day 6). Symptoms reoccurred, patient experienced rebound symptoms on 19May2022 and tested positive again on 22May2022. No treatment received for symptoms and patient was not recovered from symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
sore arm; left arm pit lymph nodes swollen with pain; left arm pit lymph nodes swollen with pain; This is a spontaneous report from a contactable consumer, the patient. A 13-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm on 15May2021 at 10:00 (at the age of 13-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. Concomitant medication included multivitamins (MANUFACTURER UNKNOWN) from an unknown date and unknown if ongoing for an unknown indication. 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 vaccination. On 15May2021 at 10:15 the patient experienced sore arm. On an unknown date in May2021 the patient experienced left armpit lymph nodes swollen with pain. Therapeutic measures were not taken as a result of the events sore arm and left armpit lymph nodes swollen with pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events sore arm and left armpit lymph nodes swollen with pain was resolved on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.
Mom called on 3/23/01 and stated child has pimple-like fluid fill blisters over body and is itchy.
Patient had severe diarrhea, loss of appetite, vomiting status post ROTARIX.
Symptoms started 30 minutes after injection. Vomited at this time. No further vomiting but extremely nauseous til 2/23. Dizzy off and on. Voice became scratchy and hoarse. Neck glands swollen for one day. Slight headache(lasted less than one day). 2/19 hearing R ear seemed to be echoing for about two minutes. Ok after that. Decreased appetite. Loose stools started day vaccine and continued til 2/24/05.
Client began experiencing sharp pain radiating across right shoulder, behind the ear and back of neck during week of 12/25/2004. Client states pain is a constant pain and that is reduced to an aching pain after taking Aleve every 4-6 hours and using a heating pad.
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: The pt bled after injection and I wiped it with a paper towel and alcohol swab. after the 15min waiting period she had a pea sized hard bump at injection site and pink/red slightly swollen area a little bigger than a quarter around it.
several pts recvd 2 doses Engerix-B; 6AGU92 @ time of inject recvd pain on inject; resolved;
Body chills, aches and pains, congestion, and headache the night of second dose of vaccine. Symptoms lasted for several days. Tested positive for Covid four days after second vaccine.
Fever; Nauseousness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), NAUSEA (Nauseousness) and HEADACHE (Headache) 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 PYREXIA (Fever), NAUSEA (Nauseousness) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever), NAUSEA (Nauseousness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment history was reported.   Reporter did not allow further contact
Shingles; This is a spontaneous report from a contactable consumer reported for herself. A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number Batch/Lot number was not reported, via an unspecified route of administration on 24Jan2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and Concomitant medications was not reported. 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 not been tested for COVID-19. No allergies to medications, food, or other products. The patient experienced shingles (herpes zoster) on 26Jan2021. Outcome of the event was recovered. The reporter considered the events as non-serious.   Information on the lot/batch number has been requested.
Received 2 mo vaccines on 3/27/07. More fussy + sleepy that night but OK. Next day screamed all day and refused to eat. Admitted to hospital that night with irritability and dehydration. No fever, no other symptoms otherwise - normal exam. mom ill 3/31 - had diarrhea. Infant also devel. fever and foul stools. Normal exam 4/2/07.  4/24/07 Records received from hospital which reveal patient experienced initially lethargy then irritability & refusal to eat since vaccines.  Seen by PCP on 3/27 & sent home but returned to ER on 3/30 due to ongoing fussiness, being unable to console & decreased oral intake.  Given IVF & admitted 3/28/07-3/30/07 for observation.   FINAL DX: atypical reaction to immunizations.
Throwing up for 4 days cranky, running a fever, 10 days later infection to the injection site, swollen red and warm, Keflex was prescribed. 12 days later still red swollen and hot.
ON 1/1/2009 CHILD STARTED RUNNING A FEVER, 1O2.2 PARENTS WERE ADVISED TO TAKE TO ER.  2 DAYS PRIOR TO THIS CHILD WAS FUSSY AN GASSY. ER TREATED CHILD WITH ROSEPHIN VIA IV.  DX WITH OM WITH REPTURE OF TM. FEVER OF UNKNOWN ORGIN.  URINE AND BLOOD SAMPLES COLLECTED.  SEEN IN PCP OFFICE ON 01/02 GIVEN ROCEPHIN IM, SAT 01/03 & SUN 01/04 SEEN IN ER FOR ROCEPHIN VIA IV.  MONDAY 01/05-TODAY  GIVEN ROCEPHIN IM.
Right arm tender with 3" x 7" red area on morning after receiving immunization. Pt self-medicated with BENADRYL & reported improvement.
Post flu shot felt very hot & face flushed. BP 180/90 epinephrine administered 911 called & EMS transported to hospital. Hospital unknown.
APPROXIMATELY 20 MINUTES AFTER THE PATIENT RECEIVED THE VACCINE SHE DEVELOPED DYSPNEA, SUBJECTIVE DIFFICULTY SWALLOWING AND MENTIONED TONGUE SWELLING/PARESTHESIA OF THE LIPS.  SHE WAS RAPIDLY ATTENDED TO; AN EPIPEN WAS ADMINISTERED IN LEFT THIGH AND SYMPTOMS PERSISTED.  EMS WAS CALLED AT 5:20PM.  VITAL SIGNS WERE MONITORED AND RECORDED.  SHE LATER REPORTED CHEST PRESSURE; EMS ARRIVED AND SHE WAS TAKEN TO THE HOSPITAL.
This spontaneous report was received from a nurse practitioner via a field representative, referring to 2 unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with ZOSTAVAX vial (lot#, expiration date, concentration, dose, route and frequency were unknown) for prophylaxis. On unknown dates, the patients developed "upper arm pain that went from their shoulder to his elbow and lasted for 4 weeks". The outcome of event was unknown. The causality between event and ZOSTAVAX was not provided. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1708USA006513: