chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharamcist refers to a 66 year old patient. Historical drugs included PREVNAR 13 on 17-NOV-2014. On 02-JUN-2015, the patient was vaccainted with PNEUMOVAX23 lot # K010522, 0.5 ml, once, intramuscualr (indication reported as Pneumococcal). Four hours after injection the patient experienced redness below the injection site, the patient's arm became swollen to elbow, tender to touch and the patietn was barely able to move the arm. The patinet experienced these event for three days and then contacted the pharmacist. No treatment was given to the patient and no laboratories were performed. The pharmacist stated that the patients was feeling better on 04-JUN-2015 with less swelling, more mobility in arm and still some redness. Additional information has been requested.
Received the vaccine at 12 on April 10th. Went to sleep around 11pm that night feeling pretty normal and after taking one dose of acetaminophen, just in case as I've been told may people were experiencing high fevers after the 2nd dose.  Woke up at 2am with high fever (sorry, never actually took my body temp), chills, uncontrollable body shakes, body aches and extreme nausea. Went back to sleep around 5am. Woke up around 10am on April 11th with 99.9 body temp. Took more acetaminophen and ibuprofen to control the body aches and fever. Spent the day in bed on April 11th, with very little appetite and flu like symptoms. Gotten progressively better throughout the day but never felt quite right. On April 12th, was still feeling tired and had some muscle aches but was overall feeling much better. Noticed the lymph nodes under my left armpit (I received the vaccine in the left arm) were quite tender to the touch. Was able to resume normal activities but didn't feel like I was quite ready to go to the gym. On April 13th, feeling normal, finally, aside from the tenderness of the lymph nodes (left armpit).
The patient had an observed seizure. Patient was asleep when convulsions were observed by roommate; hospital staff alerted and seizure activity observed by nursing staff and medical students. Tonic clonic movements lasted approximately one minute, spontaneously resolved, then patient entered post-ictal state, and recovered approximately 5 minutes later.  Vital signs were taken (WNL) and patient observed until return to being stable.  Patient did have a history of seizure occurrence and was on anti-epileptic medication, which he was compliant with.   Patient was stable and seizure free for at least the previous six months per hospital records. Medications reviewed and levetiracetam dose was increased to 1,000mg PO
Feb 27th vacinne 1;  On March 14th developed upper right abdominal pain; Saw dr and she ordered chest xray and ab us; Both tests showed normal;   Pain continues to today at varying degrees - zero to a 6 on pain scale;  referred to gastro;  2nd moderna vaccine received on March 29th; saw gastro on March 31st.  She said she thought it was NASH;  ordered CT as I had breast cancer 10 years ago;  CT showed enlarged liver and spleen;  no treatment plan provided;  referred to a new gastro at my request.  Waiting for appt.   Pain is less over weekend.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: 2 days after negative antigen test - I tested positive again; (2022) Positive, notes: 2 days after negative antigen test - I tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Fever of 105 by 6PM 26AUG91 & by 1130PM vomiting & epistaxis, pain & inc warmth @ inject site; c/o h/a & sore throat; pale;
Approx. 15 vesicles on trunk and upper arms. Temperature 101.2F. Obesity. Treat with Acetasol, 1 drop QID and fruits and veggies and cereal.
blank stare, body trembling, clenched mouth lasted 20min 28FEB96 evening;
Following Dose #4 on 5/19/2022, I developed chest pains within 36 hours of receiving this vaccine.  There was significant fluttering and flushness.  My blood pressure went from normal range to a high of 146/100 with a pulse rate of 120 BPM at 11:20pm.  The following morning, May 21 at 8:39am, my blood pressure fell to 134/87 with a pulse rate of 91 BPM.  The following morning, May 22 at 7:41am, my blood pressure returned to normal at 115/78 with a pulse rate of 88.   I was made aware of this potential following a different episode following Dose #3 on 9/25/2021.  For several weeks, I was experiencing shortness of breath.  I went through a battery of tests to eliminate all possible risks, including pulmonary test, allergy evaluations and other exams.  At the time, my cardiologist did raise the possibility of myocarditis related to the vaccine.  Though, at the time he indicated that this was typically prevalent in younger vaccine recipients.  However, following the episode with Dose #4, my cardiologist advised against taking further doses of the vaccine until there are more data to demonstrate the risks associated with the vaccine and myocarditis.
This spontaneous report as received from a mother patient refers to female patient of unknown age. On an unknown date the patient was vaccinated with the first and second dose of GARDASIL (dose, route and lot # not reported). The patient's mother stated that the patient received two of the three doses in the series of GARDASIL. On an unknown date the second dose was administered with "five month passed the expiration date". Additional information is not expected.
fatigue moderate; muscle and joint pain; Joint pain; This is a spontaneous report from a contactable consumer. A 63-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an intramuscular route of administration on 27Apr2021 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history and allergies to medications, food or other products were reported as unknown. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient received any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an intramuscular route of administration on 06Apr2021 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. On 28Apr2021, the patient experienced fatigue moderate, muscle and joint pain, all lasted about 24 hours. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue moderate, muscle and joint pain was recovered on 29Apr2021.  No follow-up attempts are needed. No further information is expected.
DIZZINESS POST 10 MIN FROM VAX. NO OTHER C/O. PT. STATE SYMPTOMS HAVE LESSENED SINCE INITIAL CARE STARTED. WAITED ADDITIONAL 15 MIN AND AFTER PATIENT STATES ALL SYMPTOMS RESOLVED. 127/88 97% HR 92 RR16
Developed hives within 10 minutes of HIB / PREVNAR administration.  BENEDRYL given in office.  Monitored X 20-30 min
Syncope event - pt felt light headed - clammy skin - rapid breathing - pt never experienced hives/redness/difficulty breathing/speaking/maintained an open airway - pt did experience rigidity and numbness in hands and fingers.
Rash on day # 5 after MMR Vaccine.  Reported rash was macular, urticarial in presentation. Fever on day 4 after MMR vaccine.
pt recvd vax & 2hrs post vax devel generalized central nervous system,irritability,inconsolable crying,& vomiting;there was no fever;pt improved in less than 24hrs;no diagnostic tests were performed;
pain at her back; fever; nausea; chills; body ache; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported a female patient of unspecified age received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 23Mar2021 at 10:00 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced some reactions which were chills, fever, body ache, headache, nausea, and pain at her back. The outcomes of chills, fever, body ache, headache, nausea, and pain at her back were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
TOOK ONLY ONE DOSE; This spontaneous case (PVX2019-1304) was received from a pharmacist on 22-May-2019. It describes a male consumer who "took only one dose". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif couple of weeks ago (almost 2 weeks). He did not take the remaining doses.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took only one dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took only one dose" was considered as not applicable.
About 15 minutes after vaccines were given, pt felt nauseous, felt clammy to the touch, had cold sweats and face felt numb. Symptoms improved slowly and totally resolved in 90 minutes.
This spontaneous report was received from a registered nurse refers to a unspecified patients of unknown age. On an unknown date, the patients were vaccinated with GARDASIL 9 which was outside the recommended administration intervals. No adverse effects were reported. Additional information has been requested.
pt had some redness @ site of inject immed p/vax;  then pt exp red blotches over trunk of body; @ MD office face was swollen, had difficulty breathing, welts w/blisters, screaming episode 10-12noon, t102, vomit, sz, choking, dehydrat, rash
Redness, erythema, induration two days after administration. Treated in ED. Given prescription for KEFLEX and doxycycline. Warm soak 2-3 times per day.
CLIENT WAS ADMINISTERED INCORRECT VACCINE PRODUCT FOR AGE. NO REPORTED ABNORMAL EFFECTS FOLLOWING VACCINATION.
Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 21-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterates that because facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec 2021, Jan 2022, and Feb 2022. They were filling out a temperature excursion assessment with the State at that time. It was reported that no adverse reactions were reported by any patients. No treatment medications were reported.
3/21 - Felt like a sinus infection/Ear infection.  Swollen lymph nodes.  No congestion. 3/27 - Went to urgent care.  Was given antibiotic/steroid to combat sinus/ear infection type symptoms.  Tested neg. for strep. 3/29 - Went to PCP for continues pain in head and starting to have pain in lower back and down both legs.  Some pain in arms too. 3/31 - Went to PCP for increased pain, weakness and numbness in legs and arms.  Took blood for tests.  COvid test 4/3 - Went to ER with intense pain/numbness/weakness/ restlessness in legs and some in arms/hands.  Head still hurts too.  More blood work, given Hydrocodone/Ibuprofin to help manage pain. 4/5 - Returned to PCP.  Was given Gabapentin to help with the pain.  Was referred to neurologist. 4/8 - Initial exam at neurologist.  Plan to complete MRI and Nerve Conduction studies. 4/9 - Had MRI completed of brain and upper spinal cord.
Tension; This spontaneous case was reported by a consumer and describes the occurrence of TENSION (Tension) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.     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 TENSION (Tension). At the time of the report, TENSION (Tension) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
felt very ill; fever; migraine; This case was reported by a consumer  and described the occurrence of feeling unwell in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis, fibromyalgia, ehlers-danlos syndrome and crohn's disease.   In December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced feeling unwell, fever and migraine. On an unknown date, the outcome of the feeling unwell, fever and migraine were recovered/resolved.   The reporter considered the feeling unwell, fever and migraine to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, after vaccination with 1st dose of Shingrix, the patient felt very ill and had a fever and migraine, which were recovered. The reporter did not consent to follow up. This case was linked with case US2020AMR240559, reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR240559:same patient, 2nd dose
Initial and follow up information has been received from a certified medical assistant concerning a 68 year old retired black female with allergies to clarithromycin (Biaxin) and dicyclomine hydrochloride (Bentyl) who on 11/15/2004, at 10:40AM, was vaccinated intramuscularly in the right arm with a second dose of pneumococcal 23v polysaccharide vaccine (lot # 649694/0386P).  Concomitant therapies included alprazolam (Xanax), atorvastatin calcium (Lipitor), calcium carbonate (Caltrate), fexofenadine hydrochloride (Allegra), hydroxyzine hydrochloride (Atarax), hydrochlorothiazide and lactulose.  Subsequently, the patient developed a local site reaction of slightly raised area, painful, red, hot.  The patient sought unspecified medical attention.  Follow up information from the certified medical assistant indicated that on 11/15/2004 at 3:00PM, the patient developed swelling, pain, fever in arm and throbbing sensation.  The patient was seen in the doctor's office.  It was reported that the patient had a rash on her hands and writs at the time of vaccination.  The patient had one previous dose of pneumococcal 23v polysaccharide vaccine in 10/1998.  It was also reported that the patient recovered on an unspecified date.  It was also reported that 4 other female patients experienced these adverse events following administration of pneumococcal 23v polysaccharide vaccine within the last 2 months.  No product quality complaint was involved.  No additional information is expected.
patient received second booster too early. first booster on 1/14/22 so second booster should have been on or after 5/14/22.
Presented with incidental finding of thrombocytopenia (plts 7K) on 4/10/21.  No bleeding noted, no adenopathy.  Treated with IVIG x2 with platelets increased to 40,000.    Normal CBC several months earlier.
March 16, 2007-Mom called and stated child had been running fever since Wednesday 03-14-07 as high as 103.9. Instructed to contact MD and I would follow up with her on Monday March 19, 2007. March 19, 2007-Phoned mother back and she spoke with MD and he said it was o.k. to give future immunizations. Mother went on to report that child was still running fever since 03-14-07 ranging from 100.5-103.9. She was giving the child Tylenol & Ibuprofen. The child also has a loss of appetite. She also reported that she noted a red bump on the child's right buttock near anus the day she received immunizations but the child wasn't running fever then and today the bump was now formed into a boil and the child is unable to sit down. She was waiting for the MD's office to call her back with an appointment for the child. March 21, 2007-Spoke with mother and child is not on antibiotics by mouth and topical for boil on right buttock and MD said it is not related to immunizations.
No additional AE.; A patient received a PROQUAD on 15AUG2016 that their system is calling an "invalid dose". The HCP did not have an expiration date for the PROQUAD, and is not sure if the product was actually expired or not; This spontaneous report was received from a nurse referring to a 4-year-old male patient. Information regarding the patient's medical history, concurrent conditions and concomitant therapies was not provided.   On 15-AUG-2016, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (human serum albumin) (PROQUAD) 0.5 cubic centimeters (cc) administered subcutaneously in his left thigh, as prophylaxis (lot number L004004 has been verified to be valid, expiration date was not reported but upon internal verification was established as 05-AUG-2016) (expired product administered).  Additionally, it was stated that the reporter was asked by the school nurse to investigate the dose given, however, in the facility the reporter was told that the patient was not theirs. They did not give the dose and did not have the paper record to check the appointment date (conflicting information). No adverse event was reported.
Night of vaccination pt's arm slightly swollen, next day arm red, hot to touch and increased swelling. Pt was at the beach on this day also. 8/12/15 pt seen in clinic treated with clindamycin 300mg TID x 10 days.
Lt upper arm became very red, swollen half way down the arm very hot to touch; 3 days p/inject arm still same & hardly able to lift arm; Pt advised to got to ER to have MD check; 1 wk post still has lumb & feels fevered, but getting better
Approximately 10 minutes after receiving vaccination, patient became pale, faint, with slowed speech and responses. Patient was mildly sweating. Pulse was 80 and BP was 90/40 upon first checking. 911 was called and pt became more responsive (BP elevated to 115/60) while waiting for EMTs to arrive. Patient recovered by the time EMTs arrived, he was assessed by responders and denied going to hospital. Patient's significant other was present to provide transportation home.
Patient received the Moderna vaccine that is not approved by the FDA for vaccination under the age of 18.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a six-year-old male. Neither the patient's medical history nor the concomitant medications were reported. The product expired on 20-Nov-2011. On 20-Dec-2011, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
24 hours following administration, pt developed extreme pain that radiated down left arm. She also experienced numbness in ring and pinky fingers - left hand. Visit to MD on 2/23/17.
Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 30-Oct-2021; expired dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 30-Oct-2021) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 30-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 30-Oct-2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided. No treatment information was provided.  The patient received the booster dose of the vaccine. No adverse event was reported. The vial had not undergone any temperature excursion issue. The vial was initially placed in the refrigerator on 30-Oct-2021. Many doses were administered from expired lots due to confusion with the expiration date printed in the carton.