chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Engerix-B was given in the 3 dose/second dose administered on 20210102; Pediatric (0.5 ml)dose / to a 33 year old / patient / All doses / in / series was pediatric dose; Pediatric (0.5 ml)dose / to a 33 year old / patient; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 33-year-old female patient who received HBV (Engerix B pediatric) (batch number 4CL44, expiry date 24th January 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B pediatric with an associated reaction of product administered to patient of inappropriate age (received 1st dose on 22nd December 2020, batch number-4CL44, expiry date-24th January 2022, refer case US2021AMR132394).   On 2nd January 2021, the patient received the 2nd dose of Engerix B pediatric .5 ml and Engerix B Pre-Filled Syringe Device. On 2nd January 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the underdose, adult use of a child product and drug dose administration interval too short were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were received as follows: The 33 year old patient received 0.5ml pediatric dose of Engerix B in the 3 dose series, which led to underdose and adult use of a child product. This case was for the 2nd dose of Engerix B pediatric. The patient received second dose of Engerix B in less than 1 month which led to drug dose administration interval too short. All doses given in the series was pediatric dose. The reporter enquired to draw a titer or revaccination. The reporter consented to follow up. As per sales data sheet reported batch number was changed from 4co44 to 4CL44. For tolerance to 3rd dose, refer case US2021131430.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021131430:Same reporter. US-GLAXOSMITHKLINE-US2021AMR132394:Same reporter.
She experienced fever of 100 degrees Fahrenheit and chills the entire night after the SHINGRIX shot. She took TYLENOL and the symptoms resolved the next day. She felt much better after the symptoms stopped and she is doing fine now.
Patient received Pediarix, Hib #2, PCV7#2, Rotateq #2 or 9/10/2007. On 9/12/2007, 2 days later, mom stated that patient woke up from 2.5 hour nap and did not seem herself. She was "glassy-eye" and lethargic and her hands and feet were bluish. Seemed to get better and then developed these symptoms again on 9/13/2007. Exam on 9/13/07 ---> hypotonia and mental status change went to Children's ER 4p possibility had HHE. 12/10/07-records received  9/14/07-Assessment: hypotonia. Possible seizure activity. C/O vomiting then unresponsive but not unconscious. Hands and feet turned dusky color. Sleepy period, pinpoint pupils. Glassy eyed episodes.
Patient has had muscle ache pain in his right arm since the PNEUMOVAX vaccine given on 11/14/13. He has had pain in his arm for 6 weeks. He reported his symptoms to his doctor. He also got a flu shot that day in the left arm, which did not have pain.
No additional AE reported; improperly stored product administered; This spontaneous report was received from a physician  and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 17-NOV-2020,  the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD) Lot # T010651, expiration date 22-SEP-2021, 0.5 milliliter for prophylaxis (route of administration not reported).     The improperly stored dose of the suspect vaccine experienced a temperature excursion of 22.8 degree fahrenheit (°F) for 13 hours and 25 minutes with a previous temperature excursion of 17.4 °F for 31 minutes and 30 seconds.  The call was made due to a digital data logger. No adverse symptoms were reported.
Patient developed a rash on his back after receiving a ZOSTAVAX shot on 02-10-15. Patient called seeking relief for itching from rash on 2-17-15 and picked up the recommended Aveeno Bath, lotion and BENADRYL. Patent was also advised to seek medical care. Follow up call was given that night 02-18-15. Pt said he will seek medical care if no improvement when he can at end of the week.
red, itchy spots on back PT SELF MEDICATED CHEWABLE BENADRYL X 2 P 83 R 24 BP 149/88 92%
I got the flu shot I got the flu; Initial information received on 19-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced i got the flu shot i got the flu after receiving  influenza 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 influenza vaccine produced by unknown manufacturer lot number not reported (formulation, expiry date, strength was unknown) via unknown route in unknown administration site for influenza vaccination.  On an unknown date the patient developed flu (influenza) (unknown latency).  It was reported that "we are assuming the consumer is referring to the Sanofi flu vaccine. Author/Reporter Comment: 3 weeks after I got the flu shot I got the flu, if you're going to get sick you're going to get sick."  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (I got the flu shot I got the flu).  At time of reporting, the outcome was Unknown for the event i got the flu shot i got the flu.
Information has been received from a health professional concerning an 8 year old female who on 11-JAN-1999, at 3:00 p.m., was vaccinated with a subcutaneous first dose Varivax (Lot# 628246/1655H). It was reported that the patient's mother called into the office to report chickenpox symptoms beginning on 20-NOV-2006. Additional information has been requested.
Swelling around eyes; Redness around eyes; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 15Mar2021 at 12:00 hours as a single dose for COVID-19 immunisation (age at vaccination 63-year-old). On an unknown date, the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: UNKNOWN), dose 1, single, via an unspecified route of administration and anatomical location for COVID-19 immunisation. Medical history included intermittent atrial fibrillation. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, and medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021 at 05:00, the patient experienced swelling and redness around eyes and the swelling shut when patient awoke in the same morning. The clinical outcome of swollen eyes and eye redness was recovering at the time of this report.   No follow up attempts are possible. No further information is expected; information about Lot number cannot be obtained.
SOB, fever, slight AMS.  COVID no hypoxemia. CKD. Gental hydration, trated for UTI . dc'd on keflex for UTI and guafenesin
could not get the second shot within 6 months due to Covid-19 vaccination; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date intramuscularly in the left deltoid).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: This case was reported by the patient himself. The age  at vaccination was not applicable for this report. The patient reported that he could not get the second shot within 6 months due to Covid-19 vaccination, which led to social problem. The medical disclaimer was given. The reporter was referred to Health care professional. Consented to follow up.
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The patient had rash on whole arm. The healthcare professional unable to provide patient demographics or lot or expiry number.
ADMINISTRATION OF VACCINE FROM AFFECTED VIALS DUE TO TEMPERATURE EXCURSION; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 23 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: 21-SEP-2021) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-JUN-2021, the patient experienced administration of vaccine from affected vials due to temperature excursion. On 23-JUN-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine from affected vials due to temperature excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915731, 20210915852, 20210916228, 20210916312, 20210916455, 20210916553, 20210915623, 20210915661, 20210915748, 20210916312, 20210916401, 20210916455, 20210916553, 20210916715, 20210916768, 20210916808, 20210916811, 20210916849, 20210916849, 20210913164, 20210916520, 20210916129, 20210916415, 20210916520, 20210916584, 20210916658, 20210916959, 20210916907 and 20210916910.
Pt had throat tightening as well with vaccine similar to her taking Sulfa. Gave Benadryl and she felt better with no problems swallowing vitals 143/98 O2 sat 98% HR89  with pt observed after IM benadryl. Felt better will not have her get second Pfizer vaccine
I was 52 and still had regular menstruation. My period stopped after the COVID-19 booster. It stopped immediately. While I think I was approaching menopause, it is not typically a sudden full stop.
HYPOTENSION 5/10/2022 SECONDARY HYPERPARATHYROIDISM. HYPOXIA 2/9/2021 SECONDARY HYPERPARATHYROIDISM. HYPOTENSION 5/10/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA HYPOXIA 2/9/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA
I had lip swelling, flushing and coughing the day of the vaccine. I had swelling and redness around the vaccine site. The next morning I had swelling of my hands, feet and legs.
an improperly stored dose of PEDVAX was administered to the patient on an unknown date; No adverse effects; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # N024570 and expiration date on 01-MAY-2020 (strength, route and anatomical location were not provided), for prophylaxis. The vaccine was exposed to a temperature below 36 degree fahrenheit (32.1F) during 8 hours. There was not previous temperature excursion. It was reported that digital data logger was involved. No adverse effects were reported.
Information has been received from a nurse at a country health department concerning a 4 year old female patient with no previous medical history reported who on 13-APR-2009 was vaccinated with VARIVAX (Merck) SQ in the left arm and concomitantly at the same time with MMR (MSD), hepatitis B virus vaccine (unspecified) and diphtheria toxoid + pertussis acellular vaccine (unspecified) (+) poliovirus vaccine inactivated (unspecified) (+) tetanus toxoid. Subsequently, the patient came back, she experienced injection site reaction. The injection was red, itchy and hot (no rash reported). The patient sought unspecified medical attention. Information has been received from a Registered Nurse concerning a 4 year old white female patient who on 13-APR-2009 at 16:00 was vaccinated with the second dose of VARIVAX (Merck) (660334/1533X) subcutaneously into her left arm. Concomitant vaccines given on the same day at 16:00 included the second dose of MMR (Lot # 663162/1579X) subcutaneoulsy into her right arm, the fourth dose of ENGERIX-B (Lot # AHBVB582HA) intramuscularly into her right deltoid and the last dose of KINRIX (Lot # AC20B116AB) intramuscularly into her left deltoid. It was reported that on 13-APR-2009 in the afternoon the patient experienced arm red, itchy and warm to touch at the injection site. It was reported that approximately on 18-APR-2009 the patient had recovered. This is one of several cases from the same source. No further information is available.
Significant left deltoid soreness, inflammation and weakness persisting to present since approximately one week after administration of second vaccine dose.
Lightheaded, dizziness immediate upon insertion of needle.  Syncope-pt helped to floor, legs raised, B/P, pulse taken WNL.  Pt recovered quickly with no other problems.
Information has been received from a consumer, for GARDASIL, a Pregnancy Registry product, concerning her 15 year old daughter with no medical history and no drug reactions or allergies. On 12-AUG-2010 the patient was vaccinated with the first dose of GARDASIL (lot # not reported). Concomitant therapy included TDAP and meningococcal conj vaccine (MCV4). It was reported that "within the last few weeks" the patient was becoming pregnant after receiving the first dose of GARDASIL (LMP: approximately in May 2010, reported as "was about 5 months ago"). Therapy was reported as discontinued. No lab diagnostics studies were performed. The patient sought unspecified medical attention. Follow up information was received from a registered nurse who reported that the patient's LMP was on 15-MAY-2010 and estimated delivery date is on 10-FEB-2011. The registered nurse noted the LMP did not coincide with the estimated delivery date. There was no infection or illness during pregnancy. The patient had late prenatal care starting at 24 weeks. The patient had anemia and was treated with prenatal vitamins. On 25-OCT-2010 ultrasound was normal. The patient also had arrest of descent and had to have a C-section. On 17-FEB-2011 at 39 weeks from LMP the 15 year old female patient delivered a normal female infant (birth weight 8 pound 13 ounce, live length 21 inch, apgar score 7/9) with no congenital anomalies or other complications or abnormalities. Upon internal review, the patient had arrest of descent and had to have a C-section was considered to be an other important medical event. Additional information has been requested.
Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 24-years old male patient who experienced the vaccine squirts out the side and runs down their arm and when they attach the needle it feels loose or jiggly, while he received vaccine TYPHIM VI. The patients past medical history, concomitant medication and family history were not provided. On 10-Nov-2018, the patient received a 0.5ml dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE lot number: NIK911M expiry: 27-Oct-2019 via skin exposure in the left deltoid. On 10-NOV-2018, the patient developed a non-serious the vaccine squirts out the side and runs down their arm (exposure via skin contact) and when they attach the needle it feels loose or jiggly (needle issue) following the administration of TYPHOID VI POLYSACCHARIDE VACCINE. (Other relevant tests included no lab data.) Final diagnosis was the vaccine squirts out the side and runs down their arm and when they attach the needle it feels loose or jiggly. It was unknown whether patient experienced any adverse reaction. The patient outcome was reported as Not applicable for all the events. List of documents held by sender- none.
Pt received flu shot 10/15 and called pharmacy 11/11 complaining of a sore shoulder w/limited mobility. She has taken meloxicam w/no relief and will have MRI 11/16.
Rotavirus Vaccine administered on 21 August 2009, on 26 August 09, mother of baby reported blood in baby's stool, returned to clinic, occult blood positive, baby otherwise fine with no other complaints.  H&H 11&37,
Large red rash around the site of the Moderna Booster injection on the right arm. The patient had a similar rash after the 2nd Moderna dose.
pt recv vax & exp swelling of lymph nodes in neck & swelling of tonsils;
Shortly after the vaccine was administered the pt had difficulty breathing, she sat down and started to experience back pain. She used her inhaler, and waited until EMS arrived.
In my first 2 menstrual cycles following the 2nd dose of my COVID-19 vaccine (approximately 2 weeks later), menstruation phase was significantly heavier and longer than my normal menstruation phase. Normal (currently on an Mirena IUD) currently is 5-6 days of hormonal changes and very light. brown or dark colored spotting, with very little red blood, that peaks on day 2 or 3. After the vaccine, menstruation for the next two cycles lasted 8 full days of bright red discharge which was daily heavier than normal conditions and consistent across the days (did not get more or less for 8 days). However, it was never so heavy to be dangerous (e.g. still rarely used a tampon). The concerning or noticeable change was both the color and the length of time. Have only had 2 menstrual cycles so far.
death sepsis UTI J18.9 - Pneumonia D69.6 - Thrombocytopenia (CMS/HCC)
patient had immediate left eye vision blurring with hypertension. No known history of hypertension. The blurred vision resolved in about 40 minutes, the hypertension did not resolve
This case was reported by a other health professional via call center representative and described the occurrence of vasovagal reaction in a 61-year-old female patient who received SHINGRIX (batch number 27J4P, expiry date 12th April 2021) for prophylaxis. On 23rd October 2018 15:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd October 2018, less than a day after receiving SHINGRIX, the patient experienced vasovagal reaction, tiredness, dry mouth, throat tightness, disorientation and felt faint. On an unknown date, the outcome of the vasovagal reaction, tiredness, dry mouth, throat tightness, disorientation and felt faint were unknown. It was unknown if the reporter considered the vasovagal reaction, tiredness, dry mouth, throat tightness, disorientation and felt faint to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the day of reporting and she sat down and began to feel tired, disoriented and felt like passing out. The patient put her head down and her throat felt tight. The office called a paramedic. The patient was evaluated and it was determined that she was not having an anaphylactic response, but might have had a vasovagal response. The patient was not taken to the hospital.
Severe itching all over, anaphylactic, took two allergy pills and medical test on music related to the nostril shot of Flonase
After getting the second Pfizer vaccine. I was sick over a week. I lost my Ballance, and began shaking all over, including my stuttering. Then I was diagnosed with leukemia. I was doing very well, before the Pfizer vaccine. I have to take medication for the shaking. My ballance was perfectly fine before as well.
having soreness in her arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable other healthcare professional (patient) reported a 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EKF730 and expiration date unknown) via an unspecified route of administration at the arm on 22Dec2020 at a single dose for COVID-19 immunization. The patient has no medical history. There were no concomitant medications. The patient experienced soreness in the arm that the vaccine was given on an unspecified date in Dec2020. The outcome of the event was unknown. The patient was curious if she can take ibuprofen instead of Tylenol. The reporter stated that she does not think that the event soreness in the arm that the vaccine was given was because of the vaccine; not because of the vaccine necessarily and clarified that probably because of the needle being injected in.
History of schizoaffective disorder, otherwise well-controlled, developed worsening delusions and possible neuroepileptic malignant syndrome the day after his 1st vaccination and again after his 2nd vaccination. Had not had any manic or delusions in the 4 years prior. The day after his 1st vaccination he developed new delusions and hypomania that resolved after 2 weeks. After his second vaccination he was hospitalized the next day with mania, delusions, aggression, hypertension, tachycardia.  Required chemical sedation for mania.
pt recv vax & 3 months following vax devel elevated SGPT & SGOT values; values were still elevated 2 yr later (@ the time of this report); No further details were provided;
muscle pain; sore throat; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable 43-year-old female Nurse (patient) received the first dose of BNT162B2 (Covid-19 vaccine) on an unspecific date at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. Caller said she is scheduled for the 2nd dose of Covid-19 vaccine tomorrow. but she is a PUI and has to be on a covid test tomorrow. Caller wanted to know if she still had to take the 2nd dose of covid-19 vaccine, since she's still experiencing muscle pain and sore throat. Mentioned having headache also but gone now. Outcome of the event headache was recovered, for other events was not recovered.   Information on the Batch/Lot number has been requested.
1 hour after administration of Hep B vaccine employee reports feeling lightheaded, nauseous. Reports completely resolved after 2 hrs.