chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a patient received a dose of MMR II following a potential temperature excursion.; no adverse event; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 20-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis, subcutaneously, lot # R035701 and expiration date 09-DEC-2020 following a potential temperature excursion (product storage error). The temperature and time frame were unknown by reporter. No previous temperature excursion was reported. No adverse effects were reported in the patient. The outcome of the event product storage error was not reported.
Swelling and redness at injection site. (4" x 4") approximate. Hot to touch.
Patient was unaware of pregnancy and presented to clinic for back to school immunizations on 8/4/2023. Screening questionnaire completed by patient's father and no was marked to the question regarding any concern or risk for pregnancy now or within the next month. Patient returned to the clinic 6 days later on 8/10/2023 requesting pregnancy test and it was confirmed patient is indeed pregnant and is estimated to be 8 1/2 weeks gestation, which indicates she was pregnant at time of administration of MenQuadfi and Gardasil vaccines on 8/4/2023 visit.  Patient states she hasn't had any reactions to vaccines and is just concerned about receiving them since she is pregnant.
Initial unsolicited literature report received from a physician on 16 June 2015. This case is linked to 2015SA092506, 2015SA092507, 2015SA092508, 2015SA092509, 2015SA092511, 2015SA092512, 2015SA089479, 2015SA092722, 2015SA092723, 2015SA092724, 2015SA092725 (same vaccine). Abstracts: OBJECTIVE: To evaluate pregnancy outcomes of women who received Tdap vaccination at or after 32 weeks of gestation. Outcomes from consecutive pregnancies during which the mother received Tdap were also analyzed. METHODS: In a retrospective cohort study at a single institution, we compared pregnancy outcomes between those who accepted or declined Tdap at 32 weeks of gestation. Additionally, women who received Tdap vaccination in this and a prior pregnancy in the past 5 years were compared with multiparous women who only received Tdap in this pregnancy. RESULTS: Since 2013, 7,378 women who were offered the Tdap vaccine antenatally delivered at our institution: 7,152 accepted (97 percentage). There was no difference in stillbirths, major malformations, chorioamnionitis, 5-minute Apgar score, or cord blood pH. Neonatal complications including ventilation requirement, sepsis, intraventricular hemorrhage, and neonatal death were also similar. However, preterm birth rates at 36 weeks of gestation or less (6 percentage compared with 12 percentage, P less than 0.001), incidence of small for gestational age (10 percentage compared with 15 percentage, P equal to 03), and length of neonatal hospitalization (3.9 compared with 4.7 days, P less than 0.001) were all significantly increased in the unvaccinated cohort. No difference in neonatal outcomes was noted between women who were administered at least two Tdap vaccines in the past 5 years (n equal to 1,229) and those who received only a single dose (n equal to 4,159). CONCLUSION: No adverse pregnancy outcomes were identified in association with antepartum Tdap vaccination. This remained true in women receiving more than one Tdap vaccine in a 5-year timeframe. This may be the result of a type II error. A 7,378 number of female patients out of which 7,152 (97 percentage) patients received Tdap vaccine and 226 (3 percentage) patients declined Tdap vaccine. A 7,152 number of female patients, whose medical history and concomitant medication were not reported had received a dose of Tdap (batch number, expiration date, dose, dose number, route and site of administration were not reported) during pregnancy on an unspecified date. 84 (1 percentage) neonate patients had develop major malformation as they were exposed to Tdap vaccine in utero. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. Documents held by sender: none.
Pt recvd vax on 15JUL92 & 7 hrs following vax devel a severe h/a, nausea, vomiting & diarrhea; sx persisted through the noc & into next day; dx w/flu;
pt recv vax 19MAY97 & exp arthritis/arthralgia of the lt arm & lt hand;sx resolved;
a nurse called from health food fair and reported that the patient was having a reaction in the left arm in which he received pneumovax and fluarix.  red sore swollen and warm.....
abnormally enlarged bilateral (left greater than right) painful axillary lymph nodes; abnormally enlarged bilateral (left greater than right) painful axillary lymph nodes; This is a spontaneous report from a contactable physician (patient). A 42-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number EL3246) via an unspecified route of administration on left arm on 08Jan2021 07:30 at a single dose for covid-19 immunization. The patient got allergies to fluoroquinolones and dairy (milk protein allergy). Prior to vaccination, the patient did not diagnose with COVID 19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included famotidine and cetirizine hydrochloride (ZYRTEC). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number EH9899) on left arm on 19Dec2020 01:30 PM for covid-19 immunization. The patient experienced abnormally enlarged bilateral (left greater than right) painful axillary lymph nodes on 10Jan2021 16:00. It began about 48hrs after 2nd shot and still persisted to 5 days later. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID 19. The patient received Ibuprofen to treat the events. The outcome of the events was not recovered.
Patient returned to pharmacy on 9/17/23 at approximately 2pm to show a quarter-sized, yellowish-brown bruise, She complained that she had pain and some tingling / numbness all week. She was going to give it another week before seeking treatment. She just wanted us to know that this was from the vaccine and she was demanding names. I assured her that I was required to report her reaction and that she should also report it and seek treatment.
pt recv ax 15NOV96 & 1hr p/vax exp h/a which remitted w/APAP;24hr p/vax pt exp dizziness, dysequilibrium, vertigo & ataxia;ER or MD visit was required;
leg swollen & red /p DTP X 72 hrs, had fine red rash face, neck, arms, trunk.
Injection site started out tender after injection. Around 9 pm a small red area surrounded injection site and continued to grow over the next 2-2 1/2 weeks. Area was apple size but elongated. Red, swollen area gradually went away but has continue to be sore and tender to touch. Is not aggravated by activity. Patient also complained of a splitting headache and nausea that first 24-48 hours. No treatment was used for pain, nausea or swelling.
Patient with Hx of Ovarian cancer on chemotherapy, recurrent atrial flutter, , HTN, COPD, recent Covid PNA presented to with weakness and fatigue, with a recent hospitalization for COVID PNA.  In ED patient afebrile, hemodynamically stable, soft BP, elevated Cr, mild hyponatremia, mild hyperkalemia, mild leukocytosis, troponin negative, BNP elevated, normal lactate.  CXR no significant interval change in bibasilar opacities and probable small left pleural effusion.  Patient was admitted for orthostatic hypotension/AKI. CXR later revealed moderate bilateral pleural effusions with overlying bibasilar airspace disease, atelectasis/PNA.  Cardiomegaly and pulmonary vascular congestion consistent with CHF.  Patient was treated with Cefepime and pulmonary toilet, desaturation requiring oxygen support.  Patient expired on 02/24/2022.
Fever 2 days after vaccine with diffuse arthralgias. 3/7/08-records received for DOS 2/24-2/26/08-Seen in ED with tonic-clonic seizure, fever to 102.4 the night before. Eyes deviated left and upwards, right hand twitching, right arm and right leg. Unresponsive. In ED right side flaccid and left side still twitching.  3/24/08-DC Summary received-DOS 2/24-2/2708-DC DX: Complex febrile seizure.
Information has been received regarding a case in litigation concerning a child who had vaccinations containing the toxic mercury-based preservative thimerosal that included hep B vaccine. Concomitant therapy included MMR vaccine, Tri-Immunol, Hib-TITER, Acel-Immune and Hep B vaccines. The periods of stated exposure were from March 1993 through September 1994 and August 1997 through December 1998. The alleged result of these vaccinations is that the pt suffers from and in the future will continue to suffer the toxic neurological effects of mercury poisoning. Upon internal review, mercury poisoning and neurological disorder were considered to be an other important medical event. No further info is available.
Hot to touch, swollen, no itchy, no fever. Width 12 cm, long 14 cm. Treatment: Benadryl for itching swollen if pain continues give Tylenol.
First HPV caused induration that lasted 2-3 weeks,  second HPV induration, blue color and pain persisting 4 months later.
Information has been received from a licensed practical nurse concerning a 66 years old female patient with no drug reaction/allergies and no pertinent medical history, who on 20-AUG-2012 was vaccinated with a dose of ZOSTAVAX (dose and route not reported) (lot # 0423AE, Exp: 02-APR-2012 - in validation process). No other co-suspects were reported. Concomitant medications included montelukast sodium, ZESTRIL, multivitamin, CALTRATE and mometasone furoate. On 22-AUG-2012 the patient developed a rash on the opposite arm of where ZOSTAVAX was administered. The nurse described the area of the rash as "erythema, circular lesions". No treatment was given. The outcome of the events was reported as not recovered. No laboratory diagnostic studies were performed. The patient sought medical attention via office visit. The relatedness for ZOSTAVAX was unknown. Additional information has been requested.
Sudden onset severe migraines. Stiff neck, vision problems, dizziness and jump in blood pressure. Went to  ER  on  Sept 13, 16, 17, and 22nd. Given various meds to stop nausea and pain.
9 days after injection approx. 4in triangle of rash. Slight pain with almost constant itch. 4days after symptoms rash still present.
PT STATES FELT DIZZY THEN HAD SEIZURE LASTING 3-4 MINUTES LONG NOTED CODE CALLED TRANSFERRED TO ER AT   THIS TIME AWAKE AND ALERT , COLOR PALE COOL AND WET.
she was found unresponsive by family and taken to the ER on 4/1 where she was found to have a massive subdural hematoma.  she was placed on comfort measures and passed away at the hospital.  she had had a fall out of bed in the week before her ER admission.
Body aches, fatigue, migraine, mild cough, nausea and vomiting.
pt devel pain in rt arm, 2 days later painful vesicles on all fingers, except for the thumbs, felt to be herpes zoster (shingles) in c7-c8 dermatome.
Patient became disoriented 10 minutes after vaccine was administered and he had a difficult time focusing with his eyes and fell asleep the car. Slurred speech and slow response when asked questions. Then he began to feel sick that night. Woke up and could not walk due to pain and nausea which continued throughout day and night. Face rash. pale skin. feels like he ingested gluten.
Pain and weakness  in upper arm at site of shot. Restricted range of motion due to pain when arm is extended past certain range. This has been ongoing since first shot
" Moderna COVID-19  Injection site soreness, fatigue, body aches, and chills
6/29/2022 Patient came in for immunizations only appointment. Patient was given 2 vaccines which were DTaP on left thigh and Polio on right thigh. 7/01/2022 Patient was assisted via tele for allergic reaction on right thigh where polio vaccine was given. Patient was diagnosed with cellulitis of the right leg. Medication was sent for patient we sent clindamycin (75mg/5 ml) 12 mL TID for 7 days, Hydrocortisone 2.5% Cream and Benadryl 7.5 mL
One week after vaccination?heavy fatigue and frequent vomiting. Fatigue seemed to subsist after the day ended, about 12 hours. Vomiting ceased. No other symptoms present.
The pt developed 11 x 13cm area of induration, redness and mild swelling on right thigh around vaccination site. Treated symptematically with Tylenol, Benadryl, and cool compresses.
Patient was administered a Pfizer Covid-19 vaccine that was exposed to a temperature excursion. (Vaccine was between 8-14.5 degrees C for 7hrs and 48 minutes). Pfizer was contacted and advised the clinic to consider the dose as invalid and to revaccinate. PAtient was revaccinated on 03/19/21 and has since received dose 2 on 04/09/21.
They had their first two doses of Gardasil 9 vaccine whilst in October and December 2015. he third dose was due in April 2016 but this has not yet been administered.; This spontaneous reporter was received from a consumer and refers to a currently 13-year-old female patient. The patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications were not reported.  On 19-OCT-2015, the patient was vaccinated with her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, route of administration, anatomical location, lot number and expiration date were not reported).  On 22-DEC-2015, the patient received her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, route of administration, anatomical location, lot number and expiration date were not reported). On April 2016, the patient was scheduled to receive her third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) however it was not administered at the time of this report (inappropriate schedule of product administration).  This is one of two reports from the same source.; Sender's Comments:  US-009507513-2001USA006201:GB20200100404/ GB20-00550
Day of shot 1/22, shaking, flu like symptoms, accelerated heart rate, high blood pressure, body aches and headache.
2 wks after receiving vaccine, pt developed a (R) facial rash spread from cheek to above eye/forehead stinging/itchy. Also ha, malaise.
Pt reported complaint of dry throat, dizziness, headache and muscle pain after receiving 2nd Hep-A vaccine. Pt complained "feels like my throat is closing". Pt given O2 2L NC, placed on C/A monitor-NSR, Benadryl given IM at injection site. Solu-Cortef IV X 1 and EKG. Transferred to ER.
Started having urinary frequency and pain, nausea, and lower back pain 2 days later. Went to urgent care got antibiotics finished the course with no improvement. Went to urgent care again, got another antibiotic. Finished that course. No improvement, all symptoms worsening, terrible lower back pain. Went to emergency department, got another antibiotic finished that course and still no change in symptoms. Went to urgent care again per primary doctor since I couldn?t get in to see them for another 2 months.
Noted lethargy, patient reported 'throat feels like closing'. Pt given Epi 0.3 mg IM at start of reaction. IV placed and diphenhydramine 50 mg IV given 4minutes after Epi 0.3 mg IM dose given. Approximately 12 minutes after reaction onset patient reported continued feeling of throat swelling and nausea with retching . Pt given Epi 0.3mg IM to left deltoid. Pt transferred to ER via EMS. EMS response time approximately 11 minutes. Pt felt somewhat better after 2nd dose of Epi 0.3 mg IM.
Early menstruation, Heavy menstruation, longer menstruation.  Repeated for 3x cycles post vaccination, then returned to normal.
Upon onset of other typical effects (sore/swollen arm, fever, fatigue) experience instantaneous and intense panic attack, which included tightness in the chest, feeling of fear and danger, sobbing, and paranoia. I had no anxiety surrounding the receiving of the vaccine nor anxiety about potential side effects. I was standing still and upright at the time of the attack and it lasted appx 30-40 min, subsiding to feelings of heightened anxiety through the remainder of the night. While anxiety and panic attacks have occurred in the past, it is not on a regular basis, nor has either occurred in over 6 months.
Child immediately starting crying weakly and became limp in my arms within seconds of being vaccinated. His head started twitching to one side only as if he was severely dizzy and couldn't control it. We were at the health department for vaccines so I'm not sure of the attending doctor's name but she glanced at him and said he's just frustrated and exited the room. He stayed limp and continue to twitch his head for about a minute until it ended. He then started crying stronger again and trying to hold me. Within a half hour he had a low fever and unbearable pain to were you couldn't touch him. This lasted about 24 hours and we gave him TYLENOL every 6 hours.
May 13th 2021, left arm shaking with heart palpitations and nausea vomiting for 3-4 days September 13th 2021: Left arm shaking fluttering of heart with heart palpitations, also with nausea/vomiting for 9 days
sore arm after first dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm after first dose".  Additional information: The patient was querying on storage and stability of the covid-19 vaccination; stated when he was at the facility to receive the vaccine, he was watching the providers, questioning deep freeze, temperature gauge on a box and how long syringe was good for after the freezer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient had already received his influenza vaccine on 9/26/2023, another was accidentally given today.  Patient tolerated well with no side effects at this time
Vertigo; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) and VOMITING (Vomiting) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Dyslexia, Auditory disorder and Eyeglasses wearer.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo) and VOMITING (Vomiting). At the time of the report, VERTIGO (Vertigo) and VOMITING (Vomiting) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not reported. No treatment medication was taken for the events.    This case was linked to MOD-2021-163582 (Patient Link).; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Vaccine given to right thigh extensive swelling from upper right thigh to tibial taberosity, less than 24 hours after injection.  Orapred 15/5 1 1/2 teaspoon by mouth 4 times a day for 5 days, Dytan 1/2 teaspoon 2 times a day.
she had lost her baby; there was no more heart beat; This is a spontaneous report received from a contactable reporter (Pharmacist). The reporter is the parent.  A 32 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Oct2021 (Lot number: 320308D) at the age of 31 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: no medical history. The patient was 7 weeks pregnant at the event onset. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose no: 1, LOT of 1st dose: 301558A), administration date: 04Oct2021, when the patient was 31 years old, for COVID-19 Immunization. The following information was reported: ABORTION SPONTANEOUS (medically significant) with onset 03Dec2021, outcome "unknown", described as "she had lost her baby; there was no more heart beat". The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death. The patient underwent the following laboratory tests and procedures: physical examination: (03Dec2021) there was no more heart beat, notes: The doctor measured that the baby could be 7 weeks. The patient just had a physical check with the obstetrician but no lab work. The patient received a vaccine on her first trimester and upon checking with her doctor 3 days ago she has lost the child that she is carrying and she had a vaccine second dose on 22Oct2021 (the patient received the first dose 20 days before). The reporter stated that it makes a sense because the baby was still around and the patient just had a check with the doctor to ensure that she was pregnant and that was on 24Oct2021 when she made an announcement that she was pregnant, so the baby was still there. She checked again on 03Dec2021 and there was no more heart beat. The doctor measured that the baby could be 7 weeks. The patient just a physical check with the obstetrician but no lab work.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the reported events Abortion spontaneous and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101739119 baby case