chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; monovalent Moderna COVID-19 vaccine was administered after the published expiration date on 6MAR2023.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (monovalent Moderna COVID-19 vaccine was administered after the published expiration date on 6MAR2023.) and NO ADVERSE EVENT (No adverse event) in a 24-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE JANSSEN on 10-Apr-2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE JANSSEN.    On 06-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 06-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (monovalent Moderna COVID-19 vaccine was administered after the published expiration date on 6MAR2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (monovalent Moderna COVID-19 vaccine was administered after the published expiration date on 6MAR2023.) had not resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (monovalent Moderna COVID-19 vaccine was administered after the published expiration date on 6MAR2023.).    No concomitant medications were reported. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient did not reported any symptoms. No treatment information was provided.
pt had imm. at clinic and a few hours later called to report: tremendous arm pain where injection was given, a little bit of sob, very shaky, very clammy, feeling a little warmer to the site than normal, bicept very painful
Pt vaccinated with DTP/OPV developed temp of 105.0, screaming more than 3 hrs, local rx.
1) swelling at injection site 6 cm wide x 9 cm long L posterior arm, slightly itchy, mild erythema.  2) rash at injection site at 4 x 6 cm superimposed over swelling, varicella-like.  Follow up: Information has been received from a physician concerning a 64 year old female consumer with no known allergies, hypothyroidism, mitral valve prolapse, osteoporosis and a history of chickenpox as a child who on 26-APR-2009 was vaccinated SQ in the left arm with a 0.65ml of ZOSTAVAX (Merck) (lot# 659760/0159X). Concomitant therapy included SYNTHROID, MOBIC, alendronate sodium and TOPROL XL tablets. Subsequently, the evening of the vaccination the patient developed swelling at injection site. The next morning on 27-APR-2008 the patient noticed a rash at the injection site. A neighbor who in a nurse said the rash was a sun blister type and looked like varicella rash around the injection site of the left arm. The area was not painful unless the patient pressed against it. There was mild itching to the area. Medical attention was sought by a phone call. There was no lab studies performed. At the time of the report the patient had not recovered. It was noted that the physician was on her way to the office to see the patient. There was no product quality complaint involved.  Follow-up infromation from the physician indicated that she examined the patient. No further infromation was provided.  Follow-up information has been received from a physician concerning this 64 year old female with hypothyroidism, mitral valve prolapse and osteoporosis who on 26-APR-2008 at 9:00 a.m. was vaccinated S.Q. in the left posterios arm with ZOSTAVAX (Merck) (lot# 659760/0159X). There was no illness at the time of vaccination or any other vaccination within 4 weeks prior to this vaccination. Concomitant therapy included SYNTHROID, MOBIC, FOSAMAX and TOPROL XL tablets. Subsequently, on 27-APR-2008 at 8:00 a.m. the patient developed swelling at the injection site that was 6 cm wide and 9 cm long on the left posterior arm. The are was slightly itchy with mild erythema. The patient also developed a rash at the injection site approximately 4X6 cm superimposed over the swelling it was varicella-like. There were no laboratory tests performed. At the time of the report, the patient was recovering (previously reported as recovered approximately five days later on 01-MAY-2008).  Additional infromation is not expected.
Thursday night the 19th, I was a little bit tired and went to bed early. Friday morning, my wife thought I was running a slight fever. It was 99.3. We had a COVID-19 test at home and it showed positive. We called the clinic and we got there within the hour. They did some vital tests and my temperature was back to normal. She asked if I would like Paxlovid and I said yes so that was prescribed. I took it easy the rest of the day. The next day I was tired for part of the day but felt better by the afternoon. By day 5, I was able to walk on the beach and the next day I went for a 3 mile walk. I felt pretty good and by day 10 I was back to normal. I was not experiencing any kind of symptoms at that point. Tuesday and Wednesday prior to being tired from the first day, I did think I had hay fever because of a sore throat and runny nose. There was also a lot of pollen around this time so I thought it may be seasonal allergies as well. I did take one Loratadine OTC. I did have a very tiring day the first day so I didn't think much of the symptoms at first. I had very minimal symptoms after Paxlovid. My regular temperature is also around 97 so my temperature at 99 was the alert.
NO SYMPTOMS AT THIS TIME- VACCINE WAS GIVEN SOONER THAN THE RECOMMENDED WINDOW
2 day after receiving vaccine pt had redness and tenderness at injection site. Pt went to clinic and was diagnosed w/cellulitis infection.
Rapid heart rate (over 100 BPM) experienced for approximately two hours before sleep. I had not been exercising or consuming carbohydrates for three hours before the symptoms started. For reference, my resting heart rate is approximately 42 BPM. When I woke the following morning, there were no symptoms.
Child became inconsolable for 3 hours starting at 04:00pm. Child developed fever of 101 degrees Fahrenheit at 05:00 PM despite fever reducing medications being given at 04:00 PM. Child continued to have inconsolable episodes and remained feverish despite medications. Child's leg became swollen, hard and hot to the touch as well.
A 16 year old male patient was vaccinated with the Moderna vaccine by this reporter, RN, while working wit Health Center's street medicine team during efforts to vaccinate people experiencing homelessness in encampments in city.  The patient was located in an encampment near the clinic.  He screened negative for allergies and other contraindications to the vaccine prior to administration.  This reporter realized after vaccinating the patient that he was 16 years old and below the eligibility age for the Moderna vaccine (18 years old).  The patient was monitored post-administration, and no adverse reactions to the vaccine were noted.  No treatment was necessary.
Headache, achy joints. Injection site: significant swelling, heat, tissue hardening, lumpiness to muscle still present after a week.
possibly frozen product was administered on accident with no adverse event; Initial information was received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via Agency under reference number - 00815014).  This case is linked to case 2021SA345065(CLUSTER).  This case involves 87-years-old male patient who was accidently vaccinated with possibly frozen suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no reported adverse event (product storage error).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On 27-Sep-2021, the patient received a 0.7ml {total} once dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number UJ716AA expiry date 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was reported "the doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen; that the packages underneath were frozen; that the entire rest of the shipment was frozen and likely all the product was frozen at some time; that 2- FLUZONE QUADRIVALENT doses and 13- FLUZONE HIGH-DOSE doses were administered from the frozen shipment."  It was case of an actual medication error due to product storage error temperature too low (latency was on same day)  At the time of report, no adverse event was reported.  Event outcome was 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 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.
Employee came to Health clinic right arm with swelling after vaccinated 12/1/2021, returned today with redness swelling and tenderness appears worse ice applied
Arm became sore immediately.  About 1 week later client began to wake up at approx. 3AM with numbness in right arm from deltoid area to finger tips.  Continues to do so nightly and pain continues.
Patient in to receive immunizations for international travel. About 10 minutes past receipt patient c/o nausea, sweating, feeling bad. Patient drank a little coke without relief of s/s. V/O 60/ weak radial pulse - ammonia under patient's nose; started IV of N?S in right arm.  911 called.  Patient more alert and walked to ambulance stretcher.  Patient using phone; transported to Medical Center.  Pateint d/c from ER on 4/6 when checked on him at 4:30 p.m.  Spoke with patient 4/12/2012.  States completely recovered.  States ER gave him Rx for nausea (Phenergan) although he has not taken in a few days.  Still plans to travel in June.  Will visit private provider for f/u and Rx for Maleria medication.
Monovalent covid vaccine was ordered and given instead of bivalent. RN discovered event when reviewing inventory. No side effects reported in chart.
Sore arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Hypercholesterolemia, Hypothyroidism and Drug allergy (Sulfa). Concomitant products included LISINOPRIL, ATORVASTATIN and LEVOTHYROXINE for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever) had resolved. It was reported that patient never been tested positive or diagnosed with COVID-19. No treatment information was reported.   This case was linked to MOD-2022-541588, MOD-2022-541581, MOD-2022-538599 (Patient Link).
fever w/seizure 24 hours post vaccines 101 degree F  otitis diagnosis at 24 hours as well
I was having a sore throat and started as a small tickle that got worse. I then started having a lot of phlegm in my throat mostly. I took a COVID-19 Home Test and that was positive. I called my doctor and they put me on Paxlovid and a Z-Pack which helped a ton, along with an albuterol inhaler in case I needed it. At that point I was having a head ache and bad fatigue which lasted about two weeks.
One of five pt (B/W JUL-AUG 1990) experienced an inject site rxn which included erythema & swelling. tx included ice packs @ site of inject & tylenol PRN. Pt afebrile.
On 9/26/00, the pt developed status epilepticus. He was taken to the ER after he developed approximately three seizures and admitted to the ICU. He developed additional seizures in the ER and in the ICU. He was treated with phenytoin, sedation, and ventilation. As of 9/28/00, the seizures were controlled with phenytoin. He was taken off the ventilation; however, he was unresponsive except for a gag reflex. The reporter noted that the child completed a course of antibiotic therapy for the treatment of an ear infection 8 days prior to IZ.
Case was given the wrong type of COVID vaccine.  Case was given Moderna instead of Pfizer booster.   No side effects were noted.
Syncopal episode with syncopal convulsions, monitored and BP checked, low BP, vomiting
I have been on the DEPO shot for 4 years and have had no menstral cycle or symptoms.  A month after I got the first vaccine and a week after, I started having light bleeding and cramps. It has been 4 years since I had experienced this. Now on today, May 15 - 2 months after my first dose of Moderna, I am having period symptoms again but with some stabbing pain in my uterus. I am very frustrated because these were NOT listed as side effects in the information given and I would not have gotten this vaccine had I known this would happen.
Patient reported to primary clinic 8/6/21 chief complaint of constipation. This has been going on for a week and a half. Tried Dulcolax with minimal relief; tried this twice per day for a couple days.  Last bowel movement 1 week ago.  Patient then reported to ED 8/25/21 with complaint of lower abdominal pain x1 month.  Pt also c/o associated nausea, vomiting, diarrhea, and decreased PO intake.  Pt notes that he has lost 35 lbs over the past 1 month.  His last episode of vomiting was this morning after drinking water and he had an episode of watery diarrhea.  Pt reports intermittent fevers for the past few days (Tmax 101.7 F).  He also notes recent onset of rash to bilateral elbows.
Pt became chilled, shaky, dry heaves, dizzy, weak 2 hours after hi dose flu shot - no fever - nauseous in bed all day Saturday 11/8. Sun 11/9 felt better. Took Zofran for nausea.
Information has been received from a physician concerning a 15 month old male who on an unspecified date was vaccinated with MMR (dose and date not specified). On an unspecified date, after vaccination, the pt developed a high fever, difficulty walking and partial paralysis. It was reported that the pt sought unspecified medical attention. At the time of this report, the pt had recovered from the events. Upon internal review, the partial paralysis was considered to be an other important medical event (OMIC). Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to an unspecified patient of unknown demographics. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unspecified date, the patient received an improperly stored dose GARDASIL 9 injection (lot # L040054 with expiration date at 26-DEC-2017; dose and route of administration were not reported) for prophylaxis. The administered dose of vaccine was exposed to a temperature of 32 Fahrenheit (F) degrees for 20 hours. There was no previous temperature excursion reported. Data logger was used to track the temperature. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA013776: US-009507513-1612USA013777.
Local swelling and pain lasting 3 weeks.  Fatigue lasting more than 3 weeks
ringing in ears/Ear ringing; face numbness/1/2 face numbness; This case was initially received via an unknown source, no reference has been entered for a health authority on 21-Apr-2021. The most recent information was received on 06-Aug-2021 and was forwarded to Moderna on 06-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (face numbness) and TINNITUS (Ear ringing) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No historical condition was reported by reporter.  Concomitant products included BUPROPION for Antidepressant therapy, LEVOTHYROXIN for Thyroid therapy.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced HYPOAESTHESIA (face numbness). On 24-Mar-2021, the patient experienced TINNITUS (Ear ringing). On 24-Mar-2021, HYPOAESTHESIA (face numbness) and TINNITUS (Ear ringing) had resolved with sequelae. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were provided.   This case was linked to US-MODERNATX, INC-MOD-2021-083167.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Significant follow-up receive on 06-AUG-2021 included concomitant drug information and update both events outcome. Causality was updated to related. Sender's Comments:  US-MODERNATX, INC-MOD-2021-083167: CROSS LINKED WITH DOSE 2.
Her mother has been having prolonged paralysis. She can't move her body. She stated that her mother has now become like a limp rag. She is not talking and she wasn't like this before she took the vaccine. Her throat closed and started having trouble swallowing and the food kept coming back up. She is now tube fed.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162B2, BNT162B2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for COVID-19 immunisation; bnt162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 22Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 24Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 25May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "Some plants cause skin allergies" (unspecified if ongoing). Concomitant medications included: GLYBURIDE/METFORMIN; LISINOPRIL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Sep2023) Positive, notes: First positive test. Therapeutic measures were taken as a result of vaccination failure, COVID-19 which included Paxlovid from 11Sep2023 to 15Sep2023.   The information on the batch/lot number for BNT162B2, BNT162B2 OMI BA.4-5, bnt162b2 has been requested and will be submitted if and when received.
gum/teeth are bothering her; gum/teeth are bothering her; gum/teeth are bothering her; This is a spontaneous report from a contactable consumer (patient's husband) from a Pfizer sponsored program. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 15Apr2021 (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient's medical history included her gum/teeth were bothering her. Concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unspecified date at 66 years old for covid-19 immunisation. The patient received the second dose of the Pfizer covid vaccine a week prior to the report and her gum/teeth were bothering her, the dentist prescribed antibiotic penicillin and caller wanted to know if it was ok to take it after the week of the vaccine. He was asking if this would be okay even if his wife received the second dose of the vaccine five days prior to the report, 15Apr2021. She had this problem before the vaccine also, same spot. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients. Information about the patients' pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD, lot # L047307 with expiration date 23-MAY-2017; lot # reported as L041267 with expiration date 20-APR-2017 and lot # L019997 with expiration date 02-DEC-2016, (route of administration was not provided). The vaccines were exposed to a temperature of -12F by a time frame of 3 hours. NO adverse effects were noted. Additional information has been requested.
Her oxygen level has been outrageous; This is a spontaneous report from a contactable consumer (patient mother). A 86-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection) via unspecified route of administration on 04Feb2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. patient previously took first dose of bnt162b2 on an unspecified date as COVID-19 immunisation. As per reported, reporters mom recently had her last COVID vaccine it's probably been 3 weeks as of yesterday or 3 weeks as of today, the whole time she had her second part of the vaccine, her oxygen level has been outrageous, she had the oxygen tank whole time since then and she just wanted to report that apparently that was the side effect because she has not had any oxygen problems in probably 10 years. The event took place on the same day, 04Feb2021. Reporter stated, Yes, when she had to go without her oxygen, yes it did get low. And as treatment patient received oxygen tank. Outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This is a spontaneous report by a contactable physician through a Pfizer Sales Representative. A 79 year old female patient received PREVNAR 13 unknown dose, at unknown anatomical site, at an unknown time on an unknown date. Relevant medical history and relevant concomitant medications were unknown. Vaccines given on the same day and vaccines taken within the last four weeks were unknown. On 20Aug2012 she experienced severe swelling in the arms, was severely sick and temperature was up to 102 degree F. It was unknown if she had any siblings. Relevant lab data was unknown. At the time of the report clinical outcome of the above mentioned events was unknown.
patient covid positive on 6/6/22, 3 days after 4th booster dose.