chrisvoncsefalvay/vaers-outcomes huggingface dataset:
did nt feel like eating; she is still feeling tired now; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (did nt feel like eating) and FATIGUE (she is still feeling tired now) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (did nt feel like eating) and FATIGUE (she is still feeling tired now). At the time of the report, DECREASED APPETITE (did nt feel like eating) and FATIGUE (she is still feeling tired now) outcome was unknown.
Hypersensitiveness for 16 days at the COVID-arm; Muscle spasms; A bump that is growing; Redness; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (Hypersensitiveness for 16 days at the COVID-arm), MUSCLE SPASMS (Muscle spasms), INJECTION SITE NODULE (A bump that is growing) and INJECTION SITE ERYTHEMA (Redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced SENSITIVE SKIN (Hypersensitiveness for 16 days at the COVID-arm), MUSCLE SPASMS (Muscle spasms), INJECTION SITE NODULE (A bump that is growing) and INJECTION SITE ERYTHEMA (Redness). At the time of the report, SENSITIVE SKIN (Hypersensitiveness for 16 days at the COVID-arm), MUSCLE SPASMS (Muscle spasms), INJECTION SITE NODULE (A bump that is growing) and INJECTION SITE ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt. described sore arm lasting greater than 2 months. Deltoid muscle sore. No trouble with movement.
Site redness, warmth, 3 lumps at injection site Narrative:  Other Relevant History:
with in 12 hours of the vaccine in the right deltoid, Herpes Zoster (shingles) outbreak t-1/T-2 right dermatome. rash blistering  upper anterior chest wall and posterior aspect of  upper right back down the right arm (posterior)  patient notes he has never gotten his Shingrix vaccine
Feeling ill by 10 pm of vax date (6/8/2021).  Experienced fever, chills, nausea, fatigue.  Administered alternating Tylenol/Advil for next 24 hours.  Too ill for school on 6/9/2021.  Symptoms lasted more than 24 hours; less than 30 hours.
Pt is 13 years-old and should have received Pfizer COVID-19 vaccine. Pt received 0.25 mL Moderna as booster. No noted or observed adverse reaction.
Post vax, the infant was irritable and crying for 3 hours with pallor, limpness, and unresponsiveness. She was blue around the lips. She was admitted to the hospital to rule out apnea.
Patient suddenly fainted hitting his head.  at evaluation patient presented low saturation of 87 and low blood pressure 106/52.
The patient was actually given FLUAD and not FLUZONE HIGH DOSE QIV with no reported event; The patient below the age of 65 was actually given FLUAD and not FLUZONE HIGH DOSE QIV with no reported adverse event; Initial information received on 22-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an adult patient of unknown age who was below the age of 65 and was actually given fluad and not fluzone high dose qiv with no reported event while receiving vaccine INFLUENZA 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 unknown dose of suspect  INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date, strength, formulation, route was unknown) in unknown administration site for prophylactic vaccination(immunization). Information regarding batch number details has been requested.  On an unknown date the patient had non-serious events of the patient was actually given fluad and not fluzone high dose qiv with no reported event (wrong product administered) and the patient below the age of 65 was actually given fluad and not fluzone high dose qiv with no reported adverse event(product administered to patient of inappropriate age) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Caller initially reporting a patient under the age of 65 was accidentally administered a dose of FLUZONE HIGH DOSE QIV. RA gathered patient data and caller realized the patient was actually given FLUAD and not FLUZONE HIGH DOSE QIV. "  Action taken: not applicable.  Outcome was Unknown for both the events.   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.
After a week at a conference, on December 12, 2022, in the middle of the night, I woke up with a scratchy sore throat.  It felt like I had been talking too much.  The next morning it was worse, and a cough began to develop.  I went to the pharmacy for a PCR, and it was positive COVID-19 test but I didn't have the results until December 12th.  I had a low-grade fever, 100.5 and I took Advil.  My blood oxygen level was never lower than 96%.   I was fatigued with congestion.  December 13th I still had my fever, and my home test was positive.  I contacted telehealth service.  Due to my health, I was prescribed Paxlovid.  I switched to Tylenol, Mucinex, Zinc, Vitamin C and Vitamin D1.   My fever began to lower.  I still had a cough and was hoarse I had a runny nose, and my headache came and went over time.  The last Paxlovid dose was Sunday morning.  Today is my first day without a fever but I still have my cough and congestion and feeling lethargic.
PATIENT REPORTS THAT UPON RETURNING HOME AFTER HER THIRD DOSE OF THE PFIZER COVID VACCINE, SHE BEGAN EXPERIENCING A BURNING SENSATION/NEUROPATHY IN HER RIGHT GLUTEUS MAXIMUS. PATIENT REPORTS THAT THE SENSATION HAS BEEN CONSISTENT SINCE THEN AND HASN'T BECOME CONSIDERABLY WORSE OR BETTER.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 30-OCT-2012 14:32, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
only have one dose, Dec 30th 2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 30th December 2020, batch number 52B24).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that, the patient received 2 doses of Shingrix but the Pharmacy records they only have one dose documented. So they were asking for information on a possible 3rd dose and late dose as well. The reporter consented to follow up.
I have experienced pain and redness at the injection site for over a month. The redness has subsided but it is still painful to the touch. I received the intradermal flu shot.
severe chills and shaking which started suddenly about 11pm and lasted about 3 hours. slight fever of 99.3 to 100.2.  i don't know the exact name of the flu shot i got.  it just said Senior-dose flu shot.  i guessed on the exact type
The vial was initially stored in the refrigerator on 08-Mar-2022 and administered on 01-Jun-2022; Vaccine was administered after the 30 days beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the 30 days beyond use date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Mar-2022 and administered on 01-Jun-2022) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 prophylaxis.     The patient had never been diagnosed with or tested positive for COVID-19.  Acute illnesses at the time of vaccination and up to one month before were none.  It was unknown whether the patient had any chronic or long-standing health conditions.  Concurrent medical conditions included Hypertension, Diabetes and Hypercholesteraemia. Concomitant products included INSULIN GLARGINE (LANTUS) and INSULIN LISPRO (HUMALOG) from 01-May-2022 to an unknown date for Diabetes, ATORVASTATIN from 01-May-2020 to an unknown date for Hypercholesteraemia, AMLODIPIN [AMLODIPINE] and LOSARTAN from 01-May-2020 to an unknown date for Hypertension.    On 01-Jun-2022 at 1:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2022 at 1:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the 30 days beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Mar-2022 and administered on 01-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the 30 days beyond use date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Mar-2022 and administered on 01-Jun-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication Lantus was started on 01-May unknown year.  Number of doses/vials were 6 vials. The vial was initially stored in the refrigerator on 08-Mar-2022. The vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to MOD-2022-583062 (Patient Link).
She just got her 2nd dose of Moderna COVID vaccine and she's taking Valtrex/ Caller stated 1/4 of population have Herpes; This spontaneous case was reported by a consumer and describes the occurrence of HERPES VIRUS INFECTION (She just got her 2nd dose of Moderna COVID vaccine and she's taking Valtrex/ Caller stated 1/4 of population have Herpes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES VIRUS INFECTION (She just got her 2nd dose of Moderna COVID vaccine and she's taking Valtrex/ Caller stated 1/4 of population have Herpes). At the time of the report, HERPES VIRUS INFECTION (She just got her 2nd dose of Moderna COVID vaccine and she's taking Valtrex/ Caller stated 1/4 of population have Herpes) outcome was unknown.            No treatment information provided.
no adverse events observed by the RN however the patient was kept for observation. RN took vitals and patient had high BP. on call doctor was called and stated that the CDC had given higher doses to patients and that no further treatment  is recommended for now.
I had a disc protrusion injury in remission for 2 years with consistent PT and had not had any issues with it for well Over a year.  After the first shot my neck got very stiff and I could tell it was my old disc injury but after a week things calmed down and I was fine. After my second shot, however, things continued to escalate with the inflammation from the shot and I ended up in the ER I was in so much pain. They did an MRI an my herniation had gone all the way to more than 4 mm herniated. It took over 3 months to recover with PT and 2 rounds of spinal cortisone injections under anesthesia.
I started experiencing right side body swelling on Sunday through Monday.  I was not concerned, but knew to expect this.  At about 3pm on Tuesday, I started experiencing lip swelling.  As the evening progressed I started noticing odd sensations on my tongue.  It was swelling.  I had not eaten anything since lunch so I thought that odd.  I started noticing this around maybe 7:00 pm.  When it got to the level of concern, I started trying to connect to online doctors, which was taking too much time.  I opted to head to Urgent Care.  I arrived 9:31pm.  I had taken 50mg of Benadryl prior to arriving.
Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 19-JAN-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Patient reported a strange sensation in his chest about 20 minutes after the vaccine, so at approximately 2:40pm on 7/10/21.  I spoke to him today 7/11/21 at 9:50am and he reported it was a sensation going from his stomach to his chest and that it lasted approximately 5-10minutes and he is not having this effect today.
Sore arm; This is a spontaneous report from a contactable consumer. This consumer  reported for a 12 year old female patient (reporter daughter). A 12-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration, on an unknown date (at age of 12-year-old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. On an unknown date, the reporter stated her 12-year-old got the vaccination and she was fine except a sore arm. Now the patient is due for second one next week. Hoping she doesn't have same reaction as her sister. All four of them in the family had sore arm. Everybody said that was to be expected. Reporter's youngest goes to have the second one next week and if she has something happen caller will calls back. The Outcome of the event was reported as unknown.  The report is cross referenced to report ID: 8W2QO95A  Information about batch/ lot number has been requested.
Discomfort in throat due to swollen lymph nodes. Additionally, swollen lymph nodes under left armpit.
Twitching or restless leg movements (muscles) starting at 10:30 PM-12:00 AM (midnight), feet cold, uneasy feeling due to quick onset. Rest, warm milk, camomil tea was given and child did not have any twitching in next AM, just the start of a cold.
April 8, 2021 (9 days after 1st dose of Moderna Covid-19 vaccine), I saw a large, red rash/discoloration at the site of my vaccine injections. Discoloration is oval in shape, longer vertically than horizontally, and around 3 inches by 2 inches. The rash/discoloration is hard to the touch, slightly painful, but does not itch or hurt in any signicant way.
About 8 days after the immunization, my right arm started itching a LOT and there was a blotchy rash about 3" by 4".  It has lasted, so far, about 4 -5 days.   I would be happy to send a photo, but there is no place here to do that.
patient was supposed to receive the new updated booster for covid (bivalent) but ended up receiving the monovalent
Father states Left arm reddened, swollen. Denies fever.  Further states slightly tender to touch.  Moving arm without difficulty.
neck pain, torticollis appearing x 3 days, lethargy x2 days, no fever
an expired dose of TENIVAC was inadvertently administered to a patient with no reported adverse event; Initial information received on 24-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 26 years old female patient whom an expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] was inadvertently administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-May-2022, the patient received an expired dose 0.5 ml of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (lot U6669AA; Expiry date: 15-May-2022) via intramuscular route in unknown administration site for Immunization inadvertently with no reported adverse event (expired product administered).  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event an expired dose of tenivac was inadvertently administered to a patient with no reported adverse 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 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.
admitted to local Medical Center on  1.20.2023 from alternate Memorial Hospital expired 1.23.2023
Narrative:  88 y/o male with a hx of metastatic lung adenocarcinoma to the bone died at home in home hospice on 12/7/2021. Pt had received covid vaccines 0n 1/14/21 & 2/11/21. This death is not related to covid vaccines.
Patient reports that she has been having localized tremors in the arm that she received the influenza vaccine. Patient also reported that she had marked decreased strength in the right arm, as well.  She reported today (12/29) that she has had some improvement from when both the tremors and weakness started.
35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment information was reported by reporter.
C/O palpitations 6.5 hours after flu shot. Was seen by MD, diagnosed with left chest muscle twitches.
pt eyes rolled back in head & shock all over x 2, lasting approx 20 sec;T99;pt taken to hosp;mom took pt home because felt wasn't taking care of appropriately;MD states poss infect or ?sz r/t DTAP;
The joint pain in my left wrist is the worst, to the points where I can't pick up a cup. All my joints ache as well. I believe the technician said that sore joints was one of the side effects. I've been taking Tylenol for the pain.
Inappropriate Schedule of Vaccine; Swelling; Blotchy Extremeties; Redness/redness occurred on face downward to neck/arm redness; Fever/feeling feverish; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 19th February 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 21st February 2019, 2 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced erythema and feeling hot. On 22nd February 2019, the patient experienced swelling and blotchy. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the erythema, feeling hot, swelling and blotchy were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the erythema, feeling hot, swelling and blotchy to be related to Shingrix.  Additional details were received as follows:  The patient received Shingrix in right arm . At physician's office and was debating whether or not to receive 2nd dose 2 to6 month window expired. This led to incomplete course of vaccination.  The reporter reported that, approximately 2 days following vaccination redness occurred on face downward to neck.  That evening caller reports feeling feverish, and after waking the next morning reports swelling along with redness on face that last a couple days. Lastly, caller reports extremities, mostly arms, were blotchy and red for several days. The reporter consented to follow up.
On 2/11/2021 Three days after getting the vaccine I started to have right arm pain similar to being punched. On this same day I began to feel as though my lips were very chapped, almost as I was dehydrated. As I drink 100 oz of water daily I knew this was not the case. I treated the lips with vaseline but did not see any outward appearance of a rash or redness. The arm pain lasted two days and the lip issue resolved approximately 5 days later. On 2/20/2021 after taking a shower, I noticed a red blotchy spot on my arm where the vaccine was given. It reminded me of a Polo Vaccine scar in approximately size, was red and raised in nature. I woke up on 2/21/2021 to about 3% of my upper right arm with a rash that was warm, swollen, and the outer edges of the rash we more red and raised versus the interior part of the rash. I went to my PCP on 2/22/2021 who was very concerned as he had not seen anything like this before. His best diagnosis was an adverse effect to the vaccine that had caused some form of Fungal Infection. I was given three medications in hopes of resolving the rash: Fluconazole 100mg, Prednisone 10mg, and Cephalexin 500mg. I was told to follow up with the office on Friday if the rash was still there or to make an appointment earlier if it got worse.