chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started having Low grade fever with chills the night after receiving 2nd dose of vaccine , having the symptoms for 2 days, took 250 mg of tylenol every 4 hrs.
Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient stated, right after getting the first dose of Shingrix he experienced pain at the injection site which lasted for several days. The reporter did not consented to follow up.  No further details were provided.
2 weeks after immunization, pt. came into office with parental complaint of blood in pt's stool.  MD suspects protein allergy to milk.
This spontaneous report as received from a healthcare worker refers to a female patient. She reports that the patient was vaccinated with the first dose 0.5 ml GARDASIL on 27-FEB-2007 and received her second dose 0.5 ml GARDASIL (lot # 0475AE and exp unspecified) 25-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
No adverse event; Inadvertently administered dose of the monovalent vaccines expiration date 13Jul2022 Date of administration of vaccine was -26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered dose of the monovalent vaccines expiration date 13Jul2022 Date of administration of vaccine was -26Jul2022) and NO ADVERSE EVENT (No adverse event) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 069H21A, 030L20A and 025L20A) for COVID-19 prophylaxis.     It was if patient was diagnosed or tested positive with COVID-19. It was unknown if patient had any acute illness at the time of vaccination and up to one month before. It was unknown if patient had any chronic or long standing health conditions.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 26-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered dose of the monovalent vaccines expiration date 13Jul2022 Date of administration of vaccine was -26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered dose of the monovalent vaccines expiration date 13Jul2022 Date of administration of vaccine was -26Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Inadvertently administered dose of the monovalent vaccines expiration date 13Jul2022 Date of administration of vaccine was -26Jul2022).    No concomitant product reported by reporter. It was reported that they inadvertently administered 51 doses of the monovalent vaccines of Lot number 004M21A, expiration date as 13-Jul-2022 and was administered on 26-Jul-2022 (40 doses), 04-Aug-2022 (1 dose), 19-Aug-2022 (1 dose), 30-Sep-2022 (1 dose). No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2023: Follow up contains significant information: Route and site of administration for suspect product added. Medical history details updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:(Master case)
Heart rate dropped to 26.  Below 40 all night.  Recovered the next morning, but the next evening dropped again to 33.  Went to ER on Day 2
While administering vaccine patient moved his arm and the needle came out of his arm. Less than half of the dose went into his arm due to him moving.  Per CDC Appendix C patient returned for a repeat dose the next day 7/6. Occurred without incident.
Inappropriate schedule of vaccine administered; Tiredness; Body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), MYALGIA (Body aches), PYREXIA (Fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029h21b) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (1st dose) on 03-May-2021 and Pfizer (2nd dose) on 24-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concomitant products included VITAMINS NOS for an unknown indication.    On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced FATIGUE (Tiredness), MYALGIA (Body aches) and PYREXIA (Fever). On 23-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 23-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, FATIGUE (Tiredness), MYALGIA (Body aches) and PYREXIA (Fever) had not resolved.            No medical history was provided by the reporter.  The patient reported following vaccination with the booster dose, the patient started to experience tiredness, body aches, fever and stated that the symptoms were ongoing.  No treatment information was provided.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 28-JAN-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J008433 and expiry date: 11-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Throat tightness, shortness of breath, urticaria. Treatment: Albuterol nebulizer treatment, Benadryl, Epinephrine.
I believe it was my left arm that I received the shot. I waited at the community center for 30 minutes after the second vaccine. I was okay and felt slighty itchy but nothing serious. On my way home around 10:55 am I really started feeling itchy, on my head, then torso and legs. I felt like bugs were crawling on me for about two days. I took benadryl to help and was fine about 48 hours later. I've had a reaction in the past to a certain medication and it felt exactly the same. I figured there was something in the vaccine with the same property.
Vaccine administered by myself in AM (09/23/02) when child awoke from nap about 15:00 that day, entire left thigh was swollen, red and baby crying inconsolable. Red/swelling noted within 24 hours but not progressive. Left sided weakness arm and leg within 2-4 weeks. Currently: Left hemiplegic cerebral palsy. Follow up: PCP states neurologist believes vaccine led to infant's encephalopathy, brain atrophy and stroke. The child's head is flattened on one side as a result of the atrophy. Hib was te only vaccine received on 9/23/02.  Nurse follow up on 10/20/04 states: "Case is complete."
Pt came another pharmacy store on 4/10/2021 and got his first dose of the moderna vaccine and visited pharmacy store today 5/10/21 for his second moderna vaccine. Immunizing technician administered Pfizer vaccine instead of moderna for the second dose.
Friend got the flu shot last week & has the flu this week vaccines are trash; Initial information received on 15-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case is linked to case 2020SA292385 (original case).  This case involves patient (unspecified gender and age) reported friend got the flu shot last week and had the flu this week vaccines were trash (influenza), while he/she received vaccine INFLUENZA VACCINE .  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (batch number and expiration date unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient reported that friend got the flu shot last week and had the flu this week vaccines were trash (influenza), (unknown latency, non-serious event).  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
possible Rheumatoid Arthritis; cannot hardly walk on my legs; pain in her muscles and her bones; pain in her muscles and her bones; cannot pick up her left arm over her head without pain; burning in her skull, then felt it going through her knees, under her knee caps and traveling; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date Sep2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset Sep2021, outcome "not recovered", described as "possible Rheumatoid Arthritis"; GAIT DISTURBANCE (non-serious) with onset Sep2021, outcome "not recovered", described as "cannot hardly walk on my legs"; BONE PAIN (non-serious), MYALGIA (non-serious) all with onset Sep2021, outcome "not recovered" and all described as "pain in her muscles and her bones"; PAIN IN EXTREMITY (non-serious) with onset Sep2021, outcome "not recovered", described as "cannot pick up her left arm over her head without pain"; BURNING SENSATION (non-serious) with onset Sep2021, outcome "not recovered", described as "burning in her skull, then felt it going through her knees, under her knee caps and traveling". Clinical course details: Caller states that her pharmacist gave her Pfizer's number to call and report her adverse event following the vaccination of Pfizer COVID-19 Vaccine. Patient reported she received the product 5 months ago. Patient stated she think she had it in the month of Sep2021 when her sister-in-law died as she had it right after, that's around 5 months. Ever since she has taken the vaccine, patient cannot hardly walk on her legs. She stated pain in her muscles and her bones. She thinks that her symptoms were a reaction to the shot and went in two times and finally told the pharmacist that she waited all these months, and it was getting worse. She stated it did something to the muscles in her legs. She cannot pick up her left arm over her head without pain. She thinks that the vaccination may have triggered something. She questions possible Rheumatoid Arthritis.  The 1st time she received the product she notes that she had burning in her skull, then felt it going through her knees, under her kneecaps and traveling. She reported this to the pharmacist and was not sure it was supposed to happen or not and they advised it was as the shot goes through her body she said.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Administered vaccine on 06-Apr-2022 which had an expiration date of 18-Mar-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine on 06-Apr-2022 which had an expiration date of 18-Mar-2022) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine on 06-Apr-2022 which had an expiration date of 18-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered vaccine on 06-Apr-2022 which had an expiration date of 18-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. There was no acute illness at the time of vaccination and up to one month before.  Patient had never diagnosed or tested positive for COVID-19. The patient reported no adverse events from the vaccine on 06-Apr-2022. The vial didn't undergo any temperature excursions.  The treatment information was not reported.
pt brought to ED with SOB; positive test in ED for COVID; AHRF secondary to COVID; admitted to hospital; treated with dexamethasone and remdesivir; pt in renal failure; O2 supplementation; developed A Fib; pt's condition worsened; pt transitioned to comfort care measures and passed away in the hospital
Starting to have memory issue . Day to day simple example signing in to work computer . Can?t remember if I fed the dogs . Go blank can?t think of common words . Thought process seems interrupted . My son is noticing the same issue we got our shots same day .
patient in the office last week received only the liquid DTaP-IPV portion of PENTACEL and did not receive the lyophilized Hib powder portion with no ae; Initial information received on 28-Sep-2021 regarding an unsolicited valid non-serious case received from an other health professional.   This case involves a 4-month-old and unknown gender patient who was in the office last week received only the liquid dtap-ipv portion of pentacel and did not receive the lyophilized hib powder portion with while receiving DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (product preparation issue).   The patient medical history, medical treatment(s), vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to product preparation issue [latency: on the same day].  It was reported "Pediatrician states that a patient in the office last week received only the liquid DTaP-IPV portion of PENTACEL and did not receive the lyophilized Hib powder portion. Caller asked if the patient required an additional injection of PENTACEL or if they could receive stand alone ACTHIB to account for the missing portion of PENTACEL".  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  There will be no information available on the batch number for this case.
Nausea/Mild nausea; Severe headache; Dry mouth; General Malaise; fatigue; Nighttime sweats.; Likely a low-grade fever; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3248, vaccine location=Left arm), via an unspecified route of administration on 04Feb2021 08:15 AM at single dose for covid-19 immunisation. Patient was known allergies to penicillin. The patient's concomitant medications were not reported. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL3248, vaccine location= Left arm), on 15Jan2021 08:00 AM for covid-19 immunisation and experienced nausea, injection site bruising and pain. Patient was not pregnant. The patient experienced injection site pain, severe headache, dry mouth, mild nausea, general malaise, fatigue, nighttime sweats and likely a low-grade fever all at 05Feb2021 04:00AM. No other vaccine in four weeks. No covid tested post vaccination. Events resulted in none of the above. No treatment received for adverse events. The patient was recovering; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021162107 same reporter, same patient, same product (different dose), different events.
This is a spontaneous report from a contactable consumer via Pfizer sales representative, who reported same event for the four patients . This is the second of four reports. A female patient (age range reported as 50-70) receive a single dose of PREVNAR 1 , on an unspecified date as vaccination. The patient medical history and concomitant medications were not reported.  On an unknown date, few days after vaccination, the patient complained of soreness between the elbow and shoulder. There was redness as well.The outcome of the events was unknown; Sender's Comments: Linked Report(s) : US-PFIZER INC-2016487623 same reporter/drug/event, different patient.
Flu shot caused symptoms of frozen shoulder. I was unable to move my arm up and the injection site was sore + painful. I went to PT and am currently working on gaining mobility back on my left side.
On Saturday, November 27, 2021 client came for vaccination POD accompanied by his Mother for his second Covid-19 Pfizer pediatric dose. During assessment questions, Mom stated to RN, patient received his first dose Covid-19 Pfizer pediatric dose (LOT #: FK5127) on 11/6/21 in his right arm and and a flu shot on his left arm. Two weeks later, Mom stated patient experienced a "pinching sensation" on left side of chest. Mom stated patient would experience this sensation once or two times a day intermittently. The last time it happened was on 11/25/21, Thanksgiving day. Mom stated they spoke with his MD who recommended a 30 minute wait after second vaccination. Patient has no chronic medical conditions and takes Loratadine every day due to allergies to cats and dust. Lead Nurse elevated to Vaccine Operations Lead who was on site, who consulted with County MD. Per County MD, Pfizer pediatric dose was approved and advised client to receive his second dose of Pfizer Covid-19 vaccine with 30 minute observation. Client was vaccinated with Covid-19 Pfizer vaccine (LOT #: FK5618) in his left arm at 2:07 PM. Client and client's Mother was educated by RN on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client's Mother was also encouraged to sign-up on v-safe. Client experienced no adverse reaction while waiting in Observation Area and left vaccination site with a steady gait at 2:45 pm.
inadvertently administered PNEUMOVAX23 instead of receiving PREVNAR 13; no adverse effects reported; This spontaneous report was received from a physician refers to patients aged between 2 and 4 months of age. No information was given regarding the patient's concurrent conditions, medical history or concomitant medications.   On an unknown date, the patient was inadvertently vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, route of administration, lot number and expiration date were not reported instead of pneumococcal 13v conj vaccine (crm197)(PREVNAR 13). However, no adverse effects were reported.
Received H1N1 vaccine on 10/27/09. Started bleeding on 10/29/09 and miscarried on 11/1/09. 11/17/09 Medical records received from date 11/6/09. DX: SAB, depression. F/u appt from SAB past weekend.(+) bleeding/cramping. OV 11/9 c/o pelvic pain, bleeding. DX: SAB.
Red and swollen for a week below injection site and now 2 months later my upper arm is painful to move or exercise it.
Metallic taste in mouth for over 24 hours from time of injection. unable to focus eyes for about an hour after injection
Immediately 10 minutes after receiving the vaccination, I started sweating really bad, I got a metal taste in my mouth. The next morning, I woke up with a huge migraine, couldn't concentrate, pain in my arm, and my whole body was just very hot. Over the next few months, I had developed swelling from my toes to my mid-calf, which went into my thigh the next week. It got to where I could no longer fit into my jeans. My whole body turned red. I went to the urgent care, which they immediately sent me to the ER. They did an ultrasound all over my body to test out blood clots, they took blood work. They ruled out having a heart attack and blood clots. They sent me home. A Few weeks later, I was at work and the pants I was wearing were cutting into my abdomen. I went to my PCP; I was so swollen head to toe. He put me on a steroid. PCP did blood work and everything is still going on and they still can't figure out why and having more symptoms on top of swelling. I have been on many different kinds of steroids. Had hallucinations, my PCP told me to go to the ER again. My breasts got super enlarged, the doctor I got at the ER still didn't figure anything out. They did a CT, Blood work, EKG, more ultrasounds. They then sent me to another ER, they did another CT, my brain was smaller than normal, my eyes were in the wrong place. To this day I am still experiencing all of these symptoms.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 03-DEC-2015 at time- 15:54, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L025738 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.4 and 3.1 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.