chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist concerning a 67 year old female with penicillin and quinolones allergies, who on 17-NOV-2008 was vaccinated with PNEUMOVAX (Lot # 658074/0916U). Concomitant therapy included influenza virus vaccine (unspecified). The pharmacist reported that the patient developed redness and swelling of her right arm at the injection site that extended down to her forearm after receiving the vaccine. This is the third time the patient has received the vaccine. The dates of the first two doses were unspecified. The pharmacist requested a lot check. At the time of the report, the patient was recovering. The patient sought medical attention at the physician's office. A standard lot check was performed on the Lot # 0961U All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center and was released. Additional information has been requested.
Lethargy and falling asleep (slept 16 hours), fever (100.1 F) for four hours
VACCINE WAS ADMINISTERED ON 3/3/23 AFTER EXPIRATION DATE (2/24/23).
Sudden loss of hearing in left ear.  I had lost hearing suddenly 6 days after the first shot, but hearing recovered completely the next week.  The hearing did not recover after the second shot.
ALREADY BEEN THROUGH MENOPAUSE AND STARTED BLEEDING AGAIN AFTER COVID VACCINE; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via a company representative concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: relapsing remitting multiple sclerosis, menopause, and allergy to regular painkillers. The patient received two doses of covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, first dose administered on MAR-2021, and second dose administered on an unspecified date in 2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The second dose of vaccine was associated with Off label use (off label dosing frequency). Age at time of vaccination 59 years old. Concomitant medications included amlodipine, botulinum toxin type a, hydromorphone hydrochloride, levothyroxine, methenamine hippurate, and propranolol.  On MAR-2021, Patient reported she got a vaccine and it took her out of menopause. She started bleeding constantly since her first covid vaccine shot. Patient reported she had already been through menopause and started bleeding again after her Covid vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the already been through menopause and started bleeding again after covid vaccine and off label dosing frequency was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20221262360- already been through menopause and started bleeding again after her Covid vaccine. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Hives - took BENADRYL (25mg) and used cortizone-10 cream for three days without relief - Hives on trunk, legs and arms and hands. Saw physician on 12/16/09. Prescribed cimetidine (400mg) and doxepin (10mg) hives gone in 3 days.
Red, knot, swollen, itchy, sore circle around injection site about 2 inches wide for the last 3 days
This spontaneous report as received from registered nurse refers to multiple unspecified patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was unknown. The nurse reported that multiple unspecified patients were administered VAQTA (dose, frequency and route unspecified) that were improperly stored. Concomitant medications were unknown. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with VAQTA was not reported. Product quality issue was not involved. This case is linked to #1409USa001487, #1409USA001774 and #1409USA001776 via same reporter link. Additional information has been requested.
-Fever off and on, chills, body aches treated with Tylenol, resolved within 48 hours -Sore lymph nodes in armpit and neck, still present -Fatigue gone within 48 hours -Difficulty breastfeeding (very slow or no letdown) for 24 hours, resolved now
October 19, 2013 I received the vaccine in my left arm had pain went back to hospital the following week was told it could hurt up to 28 days waited but pain increased so went to my doctor the letter from her is attached.
A nurse reported that an 18 month old male received an injection of Prevnar (pneumococcal 7-valent conjugate vaccine) in the leg on 10/25/02. Concomitant therapy included DTaP in the opposite leg. On 10/27/02, he developed a fever and injection site reactions characterized by redness, swelling, and tenderness at both sites on the legs. On that same day, the child was returned to the physician's office. On 10/28/02, the child developed a red rash and blotches the size of a small fingernail on the torso. He was examined by a physician and treated for his symptoms. On 10/29/02, the reporter indicated that the temperature was fine and the rash was worse. On 10/29/02, a diagnosis of erythema multiforme was made. The physician noted that the event was related to the herpes infection of the mouth and not related to the administration of the vaccines. The child was referred to a pediatrician. He recovered.
Rash located bilateral arms high bicep muscle. Red and itchy rash spreaded to upper back between shoulder blades. Bumps also contain fluid. Symptoms were first noticed 240 after vaccine was administered. Dx at age 17 w/shingles.
Lymph node swelling on the back of her neck on the left side. Rash from knees up to her face with itching. Night sweats, weakness, lightheadedness.
Blurry vision/hard time seeing; Hard time breathing; Brain fugue; pain on her body, the pain is like when she breaks a bone; Pain on arm of injection; Feels really sick; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Hard time breathing), DISSOCIATIVE AMNESIA (Brain fugue), VISION BLURRED (Blurry vision/hard time seeing), ILLNESS (Feels really sick) and MYALGIA (pain on her body, the pain is like when she breaks a bone) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylactic reaction.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced ILLNESS (Feels really sick). On 20-Mar-2021, the patient experienced DYSPNOEA (Hard time breathing), DISSOCIATIVE AMNESIA (Brain fugue), MYALGIA (pain on her body, the pain is like when she breaks a bone) and VACCINATION SITE PAIN (Pain on arm of injection). On 21-Mar-2021, the patient experienced VISION BLURRED (Blurry vision/hard time seeing). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Hard time breathing), DISSOCIATIVE AMNESIA (Brain fugue), VISION BLURRED (Blurry vision/hard time seeing) and ILLNESS (Feels really sick) outcome was unknown and MYALGIA (pain on her body, the pain is like when she breaks a bone) and VACCINATION SITE PAIN (Pain on arm of injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included vitamins.
palpable spherical subcutaneous facial mass, 7mm diameter, discolored no treatment
Patient complained of itching  at LAC site. She believed it may be from the blouse she is wearing.; Patient complained of redness at LAC site. She believed it may be from the blouse she is wearing.; Her blood pressure was slightly elevated. Heart rate, oxygen saturation, and temperature were normal. Patient reported improvement with clothing sensitivity. No medications given. Patient drank two8 fluid ounces of water.; This is a spontaneous report from a contactable healthcare professional, the pharmacist. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot Number: ER8733), via intramuscular route of administration in the left arm on 19April2021 (at the age of 64-year-old), as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient was known allergic to tetanus antitoxin. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot Number: ER8727), via intramuscular route of administration in the left arm on 29Mar2021 (at the age of 64-year-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 19April2021, the patient experienced itching and redness at LAC site and believed it may be from the blouse. Blood pressure was slightly elevated. Heart rate, oxygen saturation, and temperature were normal. The patient reported improvement with clothing sensitivity. Patient drank two 8 fluid ounces of water. No therapeutic measures were taken for the adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events itching and redness at LAC site and slightly elevated blood pressure was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
The patient presents with rash. These symptoms began 1 mo ago. He is not having fever. Other comments include: pt. c/o pain in left arm at vaccine site. Was here 1 month ago for PE and received MENACTRA in right arm and GARDASIL in left. Red initally, but last week reddness and swelling worsened, cont to worsen. + painful. Patient has a cellulitis of his arm start him on the antibiotics, as reviewed 3x/ d x 10d give w/ food or milk to prevent up set stomach encourage probiotics and binding foods to dec risk of diarrhea expect improvement in the next 2-3days can give pain meds if needed if not improving or if worsening, return visit.
Vaccines are kept frozen until they were ready for administration, in fridge about 1-3 days; Administered Moderna vaccines beyond the use date and/or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Moderna vaccines beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines are kept frozen until they were ready for administration, in fridge about 1-3 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Moderna vaccines beyond the use date and/or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines are kept frozen until they were ready for administration, in fridge about 1-3 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered Moderna vaccines beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines are kept frozen until they were ready for administration, in fridge about 1-3 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. Vaccines were kept frozen until they were ready for administration which meant they would be in the fridge about 1 to 3 days. They tend to store 1 to 3 bottles in the fridge to thaw out and was ready for the patients when needed. At worst case scenario they would have been in the fridge for about week if no one came in to be vaccinated. No treatment medication was provided by reporter.
Patient called and complained of swallowen arm, redness and hard as a rock. She said swelling is spreading and she feels warm inside her skin.
I didn't really experience any symptoms than extreme body fatigue and aches for some nights. I felt tired all of the time. I took an at-home COVID-19 test on 11/09/2022 because my husband had recently tested positive, and mine came back positive as well. I called my doctor who prescribed me PAXLOVID for treatment. Soon after, the body aches went away.
DATE OF NOTE: APR 10, 2013 at 16:04 Pt into clinic was seen by Dr on 4/8/13 and was given PNEUMOVAX. Pt comes into clinic with mild reaction of the vaccine. Pt noted to have some redness on the inner aspect of his bicep and warmth to the upper part of the left arm. Dr into see pt and advised pt to do the following: 1) BENADRYL OTC two caps Q 4-6 hours as needed 2) Ibuprofen 200mg OTC one to two prn as needed 4-6 hours 3) Contact clinic tom. if still having issue. BP:132/80 (04/10/2013 16:01) T:98.4 F [36.9 C] (04/10/2013 16:01) P:104 (04/10/2013 16:01) R:18 (04/10/2013 16:01) Pain: 0 (04/10/2013 16:01). Also added PNEUMOVAX to pt's list of allergies. 04/11/2013 ADDENDUM STATUS: COMPLETED TC from pt. Pt calling to report status of mild reaction. Pt reports arm is still red, but fading. States arm is no worse and seems to be improving.
First two weeks ongoing continuous extreme migraine. Second two weeks ongoing migraine. Ongoing continuous headaches thereafter.
Client given normal saline instead of Pfizer vaccine. Client re-vaccinated 4/19/2021 at 1410. Given Pfizer EW0162 IM in right deltoid.
mom states crying started around 9PM inconsolable, temp 1030PM 102, pt given APAP all noc;12noon in clinic T103 ear, very sick looking;no redness or knot noted in rt leg;lt leg small size knot w/redness tongue white patches
This spontaneous report as received from a medical assistant, refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients may have been vaccinated with GARDASIL (dose, route, and lot number were not reported), that were improperly stored (49.3 degrees F. for 2 hours). Concomitant medications were not reported. No adverse effect reported. This case is linked to cases 1404USA005406, 1404USA007013, 1404USA007014 and 1404UAS007014 via same reporter link. Additional information has been requested.
This spontaneous report was received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent condition and concomitant medication was provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot # L000877, expiration date 22-JUN-2017; lot # L033343, expiration date 13-SEP-2017, (dose and route of administration were not reported). No adverse effects were reported. Data logger was involved. The vaccine lots were exposed to a temperature of 32.7 degrees fahrenheit (F), time frame of excursion was reported as 4 hours and 54 minutes total cumulative time. There was no previous excursions. No product complaint (PQC) was reported. This is one of the several reports from the same reporter. Additional information has been requested.
vaccine bin not being placed back in the refrigerator after use with no reported adverse event; Initial information received on 26-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of unknown demographics who reported vaccine bin of vaccine IPV (VERO) [IPOL] not being placed back in the refrigerator after use with no reported adverse event.   This case is linked to case 01078080(Companion Case for general 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 IPV (VERO) (lot T1D481M, expiry:25-JUL-2022)  (formulation, strength, dose, lot number, expiration date, route of administration and administration site: unknown) as prophylactic vaccination (immunization).   On an unknown onset and latency, reportedly vaccine bin not being placed back in the refrigerator after use with no reported adverse event (product storage error). Max/low temperature reached: High of 72.0 F, Duration out of labelled range: 10 hours. The 1 punctured MDV IPOL was not suitable for use under the extended stability data.   Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a registered pharmacist concerning a 73 yr old female who was hospitalized for dehydration who on 18Aug05 was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine. On approx 18Aug05, the pt developed a localized skin reaction, fever, and cellulitis and was treated with ice packs. The pt was not treated with antibiotics for the cellulitis. Subsequently, the pt recovered. The pharmacist did not believe that the adverse events prolonged the pt's hospitalization and she did not feel this was an other important event (OMIC). A product quality complaint was not involved. No further information was available.
Client c/o tingling and numbness of L arm.  Client seen by EMT (no v/s taken).  Client observed to be stable, no distress noted at the moment.  Client cleared to go home by EMT.
This spontaneous report was received from a nurse refers to an unspecified patients of unknown age and gender. On 05-FEB-2015, the patients were vaccinated with MMR II INJ (strength, dose and route were not reported) (lot # K0054431 and expiration date 15-APR-2016) which were exposed to an unsupported temperature excursion. No adverse effect was reported. No product Quality Complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested.
Pt started heavy uterine/vaginal bleeding in the evening of the 3rd dose, when prior she was not bleeding
mom stated pt temp was 103-104 & did not respond to APAP; crying w/a high pitch; unable to console pt; to MD next day;
Information has been received from a health professional concerning a 42 year old female with a history of four previous normal pregnancies and live births who on Aug 24 2005 ( 4 weeks after the LMP) was vaccinated subcutaneously in the left arm with a 0.5 ml dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 648671/1070P). It was reported that the patient was pregnant. Medical attention was not sought. There was no product quality complaint involved. Follow up information from the health professional indicated that she had limited information about the patient as she was seen at an immunization clinic. Follow up information received from a medical assistant indicated that the patients pregnancy was confirmed on Sept 2 2005 by a positive home pregnancy test. Her LMP was Jul 24 2005 and the EDD was April 30 2006. The patient had her first trimester ultrasound on Sept 27 2005 (9 weeks from her LMP). The results of the test were reported as follows single intrauterine pregnancy. Crown rump length of 4mm. Corresponds with 6 week gestational age. Minimal chorioamniotic separation, too early to determine viability. It was reported that the patient had a spontaneous abortion at 9-10 weeks. The patient did not take any prescriptions drugs during her pregnancy, but did take pre natal vitamins. Upon internal review spontaneous abortion was considered to be an other important medical event (OMIC). Additional information has been requested.
20 min after receiving vaccine, R upper extremity from elbow to hand developed numbness. Nasal rash was noted by co-worker 50 minutes after receiving vaccine, was initially dart red and slowly fading in color but remains red today. At 2:30 pm yesterday, he developed lightheadedness, was clammy and looked pale. He drank a bottle of water and rested x 1 hour. Lightheadedness, clamminess and numbness of right upper extremity slowly improved and resolved when patient woke up this morning at 0530. Nasal rash persists but much less red. No meds taken.
Patient described a sensation of throat tightness 30 mins following vaccine. O2, pulse, BP normal, lungs clear. Administered 50mg oral benadryl and observed for 45 minutes prior to release back home.
Administration of an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amva380a, expiry date 31st August 2021) for prophylaxis.   On 26th January 2022, the patient received the 1st dose of Menveo. On 26th January 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient was inadvertently administrated an expired dose of Menveo, which was already expired in 31st August 2021, which led to expired vaccine used. No further events were reported. The reporter consented to follow up.
No adverse event; Bivalent doses administered after the BUD to patients 12 and up; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Oct-2022, 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 11-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up).    Patient ID. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medication were reported.  No treatment information was provided by the reporter.