chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first Bexsero, gave Trumenba instead of second dose; This case was reported by a consumer via call center representative and described the occurrence of interchange of vaccine products in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   Concomitant products included MENINGOCOCCAL B VACCINE (BEXSERO).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 21st June 2022, the patient received TRUMENBA. On 21st June 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products 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: 23-JUN-2022 Reporter's Comment: The patient's mother reported this case. The nurse mistakenly gave Trumenba instead of a second dose of Bexsero to the patient. The reporter had nothing else to report. The reporter consented to follow-up. Might follow up with prescriber. Additional supportive information: The patient mistakenly received Trumenba instead of a second dose of Bexsero, which led to Interchange of vaccine products.
Pt received DTaP & Hep A. That evening, vomited 6 times then had 2 episodes where he had a "blank stare" & looked glassy eyed for 3-4 seconds. He then jerked both arms "two times".
Immunization given 9/27 afternoon. Awoke 9/28 AM with T = 104 and red, sore (L) deltoid. Tylenol. Fever resolved 9/28 and saw her 9/29 afternoon - arm red and painful, but not hot or tender. No evidence infection.
Patient came to the vaccine clinic today and inadvertently received a 22 mcg dose of the Pfizer COVID-19 vaccine. I spoke to dad who said he completed the observation period without any unusual symptoms. I counseled dad to monitor his symptoms over the next 7 days and to report any concerns to his pediatrician or if more serious to go to the ED. I called back the next day and spoke to mom - he is doing well and no symptoms.
Menstrual cycle disruption- early period, heavy bleeding and cramping. Persistent severe headache lasting several days after shot. Significant increase in autoimmune symptoms within a week of recieving shot.
This spontaneous case, was received from other health professional (nurse) on 18-Oct-2017, concerns a 37-year-old, adult, male patient. On 18-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (as reported), batch number: 195230, expiry date: 31-May-2018, route of administration; intramuscular: anatomical location: left deltoid muscle). The patient received partial dose of the vaccine (explicitly considered as under dose). It was reported that, needle was not secured to the syringe and some of the dose leaked out as it was administered to the patient (explicitly considered as syringe issue). The patient had not experienced any adverse effects after receiving the vaccine. The outcome of the event was not reported. The reporter assessed the events as non-serious. Follow-up received on 26-Oct-2017: The additional event (no adverse effect) was added. It was reported that, the patient had not experienced any adverse effects after receiving the vaccine. The narrative was amended accordingly. Significant case correction received 18-OCT-2017: The LLT of the event 'the needle was not secured to the syringe and some of the dose leaked out as it was administered' was changed and listedness was corrected.
FEVER OF 101.5, HEART RATE OF 110 BPM (PATIENT NORMAL HEART RATE 80-85 BPM)- DEVELOPED 48 HOURS AFTER VACCINE ADMINISTRATION, SWELLING/RASH WHERE PATIENT RECEIVED VACCINE, ITCHING WHERE PATIENT RECEIVED VACCINE - DEVELOPED SAME DAY OF VACCINE ADMINISTRATION - NO TREATMENT FOR ADVERSE EVENTS HAVE BEEN ADMINISTERED AS OF THIS TIME
Couldn't breathe ended in hospital and port was removed. Staph infection and trouble breathing and swelling in stomach, Disease Control called.
Vasovagal episode-dizzy, brief (<5 seconds)seizure like activity, dilated pupils, sweaty, clammy, pale, and c/o being tired. First responders contacted, VS obtained, water given. Able to answer questions. Reports not eating anything today.  From time of vaccine given til patient left=30 minutes.  Pulse 58reg, BP 100/70, SaO2 99% Mother refused ER visit/exam. Child laughing and joking with brother as they left appointment.
Patient describes right arm pain that started after injection and continues for several months.  Patient is following up with his PCP.
I am feeling like I have the flu; Having lots of troubles with my throat; Runny nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: Unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization.The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "I am feeling like I have the flu"; OROPHARYNGEAL DISCOMFORT (non-serious), outcome "unknown", described as "Having lots of troubles with my throat"; RHINORRHOEA (non-serious), outcome "unknown", described as "Runny nose".  Additional Context: Reporter seriousness for all adverse events was Unspecified. It was reported that Consumer stated, "I do have some questions regarding the possible side effects after I got the Covid vaccine. I got my second dose like 14 days ago and I am feeling like I have the flu and I have been having lots of troubles with my throat and like runny nose. So, I don't know if this is normal, should I look for medical assistance? Is this is going to go way or should I wait for few more days or weeks?"  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
So the immediate thing that happened was getting a fever within a hour or two after the vaccine and then became delirious and I was unable to stand and had respiratory symptoms that were prevalent which is why I had to go to the doctor. This lasted for 2 or 3 days. As time progressed and it was a common thing for me that I had bronchitis and the doctor gave me more medication due to the coughing and bronchial issues. I was diagnosed with acute bronchitis, I still have a shade of it.
After my first vaccine on 12/17/2020 I had swollen clavicle glands on the left side (same side as my vaccine) and never seen a physician concerning the swelling After my second vaccine on 01/09/2021 received vaccine in opposite arm (Right Arm) and again my clavicle gland swelled  on the side that I received the vaccine On 07/03/2021 I became sick with what I thought was a head cold on 07/06/2021 I tested positive for COVID-19
Information has been received from a  health professional concerning a patient in kindergarten or first grade who was vaccinated with a dose of Varivax. On 02-MAR-2006 the patient experienced chickenpox. Additional information has been requested.
Started experiencing extreme chest pains (stabbing feeling) between my lower right breast and upper rib cage on Saturday afternoon, especially when trying to take a big inhale. I went to the emergency room the next day after pain meds (ibprofen) did not help, and they did an EKG and X-Ray and they said it was a muscle strain. I went home and alternated between 3000 MGs of Tylenol every 24 hours, 2400 MGs of Ibuprofen, 8 hours of 4% lidocaine patch and then off for 8 hours + and a heating pad when the patch was off. The pain in my chest got worse and worse on Mon and Tue (started having spasms in the chest that caused extreme sharp shooting pain down my back up into my head) so went back into the ER Tues night. They
Quite sick; she had a fever; Stay in bed for 2 days; Did not eat or drink for 2 days; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (Quite sick), BEDRIDDEN (Stay in bed for 2 days), HYPOPHAGIA (Did not eat or drink for 2 days) and PYREXIA (she had a fever) in a 90-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.    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 ILLNESS (Quite sick), BEDRIDDEN (Stay in bed for 2 days), HYPOPHAGIA (Did not eat or drink for 2 days) and PYREXIA (she had a fever). At the time of the report, ILLNESS (Quite sick) and PYREXIA (she had a fever) outcome was unknown and BEDRIDDEN (Stay in bed for 2 days) and HYPOPHAGIA (Did not eat or drink for 2 days) had resolved.            No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Potential 2nd dose given outside recommendation range; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Potential 2nd dose given outside recommendation range) 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 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Potential 2nd dose given outside recommendation range). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Potential 2nd dose given outside recommendation range) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment medications were not provided.  It was reported that the second vaccine was scheduled for June 15. Because patient had a procedure involving back on June 15, the physician who did the procedure said needed to wait two weeks after the procedure to receive the second dose. That would make the date of the second test June 29. Questioned if that too late to receive a second dose.
brownish blood spot in his underwear, it looked like mixed blood to the urethra; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reported for self. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got first dose of covid-19 vaccine on 21Jan2021 and on an unspecified date he noticed brownish blood spot in his underwear, it looked like mixed blood to the urethra. He took Plavix and Tamsulosin. His provider does not think it is from those medications. The event outcome was unknown.   Information about lot/batch number has been requested.
no adverse event; PROQUAD was administered to a 16 year old patient; the patient received a dose of MMR in 2019; This spontaneous report was received from a nurse and refers to a 16-year-old male patient.  The patient's medical history and concurrent conditions were not reported. Hisconcomitant therapies included varicella virus vaccine live (oka/merck) (VARIVAX).  On an unknown date in 2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dosage regimen, lot #, expiry date, anatomical location, and route of administration were not provided), as prophylaxis (Inappropriate age at vaccine administration).  On 03-AUG-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumina (rHA) (PROQUAD) 1 time dose, lot #W012729, expiration date: 16-OCT-2023, (strength, dosage regimen, anatomical location, and route of administration were not provided) as prophylaxis(Inappropriate age at vaccine administration). No adverse event was reported.
Information has been received from a registered nurse concerning a 13 year old female patient who on an unspecified date was vaccinated with a dose of PROQUAD (Merck) (Lot # not provided), "back to school dose required by the state", instead of VARIVAX (Merck0. It was reported that the patient had not experienced any known symptoms. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Patient complained of a swollen arm in arm injection was given, and a rash in that arm. She was instructed to apply a cold compress and take Benadryl. Patient stated that she had been taking Benadryl.
That night, tingling on side of face where used to have Bells Palsy. Lasted a few days. Did not recur with second dose.
pt recv vax;w/in min,arm felt like stone;next am arm felt like it could not be moved & tingling & swelling set in;severe n,severe abd cramps & d;nasal drainage & throat irritation;HA following wk,also backache & general malaise;to MD;
Lightheaded, dizziness, weakness, low grain headaches (applies to both of us husband and wife)
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. The patient's medical history, drug reactions/allergies and concomitant medication were not reported. In 2012, the patient began the series of GARDASIL, (dose, frequency and route of administration not provided). On an unknown date in January 2013, the patient was vaccinated with dose two of GARDASIL, (dose, frequency and route of administration not provided). On 04-AUG-2015, the patient would be vaccinated with dose three of GARDASIL. No adverse effects reported. No further information provided. No product quality complaint (PQC) was involved. Additional information has been requested.
Client received H1N1 injection on 12-17-09 at school. One week after on Christmas Eve client started having seizures. Mother stated she took her son to the medical center for treatment. Diagnostic test done, MRI and CAT scan normal. EEG was abnormal. Client was placed on seizure meds. No history of known seizures. Mother states neurologist is adjusting meds for therapeutic level.
tore some chest and back muscles from severe coughing; Cough; weak; Very exhausted; did not know if it was RSV not diagnosed as such; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Nov2022 as dose 5 (booster), single (Lot number: EL8916) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Stomach acid" (unspecified if ongoing); "Type 2 diabetes" (unspecified if ongoing); "hearing loss" (unspecified if ongoing). Concomitant medication(s) included: ENALAPRIL oral taken for hypertension, start date: 2003 (ongoing); IMIPRAMINE oral taken for depression, start date: 2003 (ongoing); PANTOPRAZOL [PANTOPRAZOLE] oral taken for dyspepsia (ongoing); METFORMIN oral taken for type 2 diabetes mellitus, start date: 2021, stop date: Mar2023. Vaccination history included: BNT162b2 (dose 1, administered intramuscularly in the left arm, Lot number: ER8727), administration date: 23Mar2021, when the patient was 71-year-old, for Covid-19 immunization; BNT162b2 (dose 2, administered intramuscularly in the arm, Lot number: ER8731), administration date: 13Apr2021, when the patient was 71-year-old, for Covid-19 immunization; BNT162b2 (dose 3 (booster), administered intramuscularly in the arm, Lot number: FG3527), administration date: 22Nov2021, when the patient was 72-year-old, for Covid-19 immunization; BNT162b2 (dose 4, administered intramuscularly in the arm, Lot number: FK9894), administration date: 25Apr2022, when the patient was 72-year-old, for Covid-19 immunization, reaction(s): "tore some chest and back muscles from severe coughing", "Very exhausted", "weak", "did not know if it was RSV not diagnosed as such". The following information was reported: MUSCLE RUPTURE (medically significant), outcome "unknown", described as "tore some chest and back muscles from severe coughing"; COUGH (non-serious), outcome "recovered"; ASTHENIA (non-serious), outcome "unknown", described as "weak"; FATIGUE (non-serious), outcome "unknown", described as "Very exhausted"; RESPIRATORY SYNCYTIAL VIRUS INFECTION (non-serious), outcome "unknown", described as "did not know if it was RSV not diagnosed as such". Clinical course: Patient developed a serious cough in mid-Oct2022 so severe she tore some chest + back muscles from severe coughing. She had 2 years-no pneumonia. Very exhausted + weak from this. She did not know if it was RSV not diagnosed as such. She talked to friends+relatives (illegible) who described identical cough, relentless. She had 5 Pfizer vaccinations/boosters. On 01Jan2023, she got COVID+ was prescribed Paxlovid, and after 3 days on, the cough she had for 2.5 months was gone. The COVID was light, mostly fatigue for several weeks.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300039609 same patient, different vaccine dose/event;
Patient stated that they started to lose their hair in chunks about 2 weeks after vaccination. Patient had to shave their head because of the amount of hair loss.
severally heavy to the point I could not leave my house; changes to my menstruation/became irregular; some bleeding in the middle of my cycle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "severally heavy to the point I could not leave my house"; MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "changes to my menstruation/became irregular "; INTERMENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "some bleeding in the middle of my cycle".  Additional information: After each of her vaccination with the Pfizer round, patient had big changes to her menstruation. The month due after the injection it was severally heavy to the point that she could not leave her house. It also became irregular and had some bleeding in the middle of her cycle. Patient's booster was Moderna, this time as suggested the same thing happened again. It has not be normal since her first vaccines. Patient alternatively looked at her hormones, all were fine so far.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No medical history, concurrent conditions or concomitant therapies were reported. On an unknown dates, the patient was vaccinated with three separate doses of M-M-R II (lot #, expiration dates, doses, route of administration and anatomical location were not reported). On an unknown date, the patient experienced negative titers. The outcome of the event was unknown. The relatedness between the event and M-M-R II was not reported. Additional information has been requested.
Patient called to report marked swelling in right bicep where she received vaccine. Arm was red, hot, swollen.
Vaccine admin around 9:30 AM. NKDA. 1st time to receive vaccine. No food allergies. Pt came to me around 11:30 AM with c/o itching all over. No hives. Noted on body. VS BP 102/76. HR 120 SPO2 98%. Also c/o sore throat, she did not have prior to vaccine. 1 Benadryl 25mg given orally (at 11:35). She started c/o not being able to swallow the Benadryl. Husband notified. At 11:45 pt c/o more difficulties swallowing. 911 notified. .3cc of epinephrine given subq. BP 104/76 99.2 temp, 97%  SPO2 HR 96. Ambulance arrived pt taken to ER.
Headache, Aleve , the Aleve helped some, resolved after 48 hours Body aches, Bolus (Dialadid) from pain pump 1 time, Aleve, duration 72 hrs, Dizziness, 72 hours, had to be very careful when I walked around or stood up  Triggered a Fibromyalgia flair up.  My pain level has gone up to 6 in some areas, started 48 hours after vaccination and is continuing though long-term pain is coming down. Increased the shakiness I have in my hands, 72 hours, it has gotten somewhat better
About an hour after receiving the vaccine I was lightheaded, nauseated and my tongue began to get itchy and swollen like the beginning of an anaphylactic reaction. I took some Benadryl and Pepcid like I would for an allergic reaction. Then I went to urgent care. While I was waiting to see the doctor at urgent care my throat began to spasm and tighten and I had trouble breathing, this was about two hours after I got my vaccine. I was given a steroid and a muscle relaxant. My throat was quite sore for a few days after, but besides that I felt much better after I was given the steroid and muscle relaxer
Redness, swelling, warm skin site of administration (left arm). Her doctor prescribe: Doxycycline 100 mg BID (one tab twice a day).
Swollen lymph nodes in groin area, rash at injection site 2" in diameter, then grew to 4" diameter within 24 hours. Rash, red spots covering legs, arms and scalp.
Injections were given around 10:40 am and within 20 minutes after leaving office, patient became violently ill. He began throwing up every 10 min, until he came back to office around 5pm.
pt recv vax & devel an inj site rxn characterized by erythema, swelling & pain;pt recovered;
Moderna COVID-19 Vaccine EUA About a week after receiving the shot the site became red and painful. The pain subsided after two days but the redness grew into a rash that is, at current, expanding.
Large red circle at the injection area and he had a rash on his armpit area; Large red circle at the injection area and he had a rash on his armpit area; This is a spontaneous report received from a contactable consumer (parent). A 13-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0173, Expiration Date: Unknown), via an unspecified route of administration on 15May2021 (at the age of 13-years) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient's parent reported that the patient weight is around 65-70 pounds and height is around 5 foot (might be a little under 5 foot). On an unspecified date in May2021, the patient experienced large red circle at the injection area, and he had a rash on his armpit area where he received the vaccination. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
APPROXIMATELTY 10 MINUTES AFTER RECEIVING MODERNA VACCINE, SHE REPORTED TO THE MONITORING PHYSICIAN THAT SHE FELT LIKE HER HEART RATE WAS HIGH A LITTLE BIT.  DENIED ANY OTHER ISSUES. PHYSICIAN CHECKED MANUAL PULSE=100BPM, THEN DECREASED TO 84 BPM THEN DOWN TO 76 BPM WITHIN A 3 MINUTE TIME SPAN.  PATIENT SAID SHE FELT BACK TO NORMAL AFTER THAT AND CONTINUE TO WAIT AN ADDITIONAL 15 MINUTES JUST TO BE SURE.  NO FURTHER ISSUES NOTED. PHYSICIAN REPORTING THIS INFORMATION WAS AT THE COUNTY HEALTH DEPARTMENT
Booster COVID given incorrectly, nurse gave 0.5 ml for booster instead of 0.25 to this resident