chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccines were stored after beyond use date and expiry date; Vaccine administered to past 30-day use by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to past 30-day use by date.) and PRODUCT STORAGE ERROR (Vaccines were stored after beyond use date and expiry date) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to past 30-day use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored after beyond use date and expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to past 30-day use by date.) and PRODUCT STORAGE ERROR (Vaccines were stored after beyond use date and expiry date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   The date was reported as 02-APR-2022.   The vial was stored in standard freezer for the lot 068H21A with 2 degrees F high and -1 degrees F low on 04-JAN-2022.  No treatment medication were reported.  This case contains information for the twenty ninth of 45 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-571126 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-571126:Master case
Awful; Growing pain in left ear; Excessive pressure in ear; Excessive pressure behind eye (particularly left eye); Little eye pain; Dry eyes; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 15:15 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, nerve damage from child birth, C-section, reactive hypoglycemia, gluten intolerance and migraine with aura. The patient had allergy to pineapple, some adhesives and some more (unspecified). The patient received other unspecified medication within two weeks of vaccination. The patient previously took rofecoxib (VIOXX), phenazopyridine hydrochloride (PYRIDIUM), diphenhydramine hydrochloride (BENADRYL) all on an unknown date for unknown indication and experienced drug allergy. The patient previously took influenza vaccine (flu shot) (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and experienced allergy to vaccine. Prior to the 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 vaccination. On 31Mar2021 at 20:00, the patient experienced growing pain in left ear, excessive pressure in ear and also behind the eye particularly the left eye. The patient felt like there was expanding cotton or something in left ear which was trying to burst forth from head. At the same time, the patient also experienced dry eyes and little eye pain. It got steadily worsened all day until around 13:30 on 01Apr2021, the pain and other symptoms were just blossomed (as reported). The patient felt like the ear drum would explode or something and felt awful. The events resulted in doctor or other healthcare professional office/clinic visit. The doctor had advised the patient to report the events. The patient was advised to take ibuprofen (ADVIL) and loratadine; pseudoephedrine sulfate (CLARITIN D) for the events and to wait. The clinical outcome of the events little eye pain, dry eyes, awful, growing pain in left ear, excessive pressure in ear and excessive pressure behind eye (particularly left eye) were not recovered at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
In 1999, the vaccinee received his 1st dose of Lymerix. The day of the vaccination, he had injection arm soreness which lasted a few days and then resolved. In about May, 1999, the vaccinee received his 2nd dose of Lymerix and he had bilateral knuckle swelling which resolved after 1 month. On 5/11/00, the pt received his 3rd dose of Lymerix and he had redness at the injection site, about 6" in diameter and the injection site was hot to touch. These symptoms resolved on 5/16/00. The pt's symptoms were treated with ice packs to the site. The most recent information, received on 5/16/00 reports the condition of the vaccinee as resolved. THe pt was not sure if he had a fever as he did not take his temperature. The vaccinee's symptoms were treated with ice packs to the site. The most recent info, received on 8/20/00 reports that the events resolved. Please note that the event of "knuckle swelling" does not meet serious criteria, but is being sumbitted expeditiously for informational purposes.
Rash was big/ It started small and gradually became bigger/she noticed a lump or a red rash next to the site of injection; Lump or red rash next to the site of injection/the rash was big/rash still there; Redness at the injection site/ It started small and gradually became bigger/growing anymore and getting better; Weakness; Back pain; Chills; Fatigue; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), BACK PAIN (Back pain), VACCINATION SITE MASS (Rash was big/ It started small and gradually became bigger/she noticed a lump or a red rash next to the site of injection), CHILLS (Chills) and FATIGUE (Fatigue) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced ASTHENIA (Weakness), BACK PAIN (Back pain), FATIGUE (Fatigue) and MYALGIA (Body aches). 15-Oct-2021, the patient experienced CHILLS (Chills). On 16-Oct-2021, the patient experienced VACCINATION SITE MASS (Rash was big/ It started small and gradually became bigger/she noticed a lump or a red rash next to the site of injection). 16-Oct-2021, the patient experienced VACCINATION SITE RASH (Lump or red rash next to the site of injection/the rash was big/rash still there) and VACCINATION SITE ERYTHEMA (Redness at the injection site/ It started small and gradually became bigger/growing anymore and getting better). On 15-Oct-2021, ASTHENIA (Weakness), BACK PAIN (Back pain), CHILLS (Chills), FATIGUE (Fatigue) and MYALGIA (Body aches) had resolved. At the time of the report, VACCINATION SITE MASS (Rash was big/ It started small and gradually became bigger/she noticed a lump or a red rash next to the site of injection), VACCINATION SITE RASH (Lump or red rash next to the site of injection/the rash was big/rash still there) and VACCINATION SITE ERYTHEMA (Redness at the injection site/ It started small and gradually became bigger/growing anymore and getting better) was resolving.            No concomitant and treatment information provided.   This case was linked to MOD-2021-355758.
Subject, a 29 year old female, with history of 5 previous Anthrax vaccines developed pain and swelling at the injection site on 01Jun00 following a vaccination with Anthrax vaccine. lot number FAV047 on 31May00. There were no concomitant medications or vaccines administered. The pt had a 10cm x 10cm area of induration and edema. The area continued to be tender 48 hours post vaccine. She was seen by a physician. Treatment was not indicated and outcome is unk.
Presented to the ED complaining of a cough; reports seeing PCP and prescribed abx for infection; cough did not improve prompting ED visit. Pt dx w/COVID-19 pna; tx w/ remdesivir, O2, and steroids.
Redness, itching, heat began in left arm with injection progressed across upper chest and into upper right arm, histamine reaction resolved with 150 mg Ranitadine and Prilosec.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Consumer reported in response to Non-HCP follow-up letter sent in cross reference case.   A 28 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 11:40 (Lot number: EW0161) at the age of 28 years as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxicillin for Allergies: hives, notes: Allergies: Amoxicillin, hives. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 15Apr2021, outcome "unknown", described as "sore arm".  No follow-up attempts are possible. No further information is expected.
Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding an 8-year-old male patient who experienced sneezing and congestion. At 8 years of age, the patient received a dose of 01-Oct-2003. Medical history: The patient has no relevant medical history. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 01-Oct-2003. Dose regimen was 0.5 mL (intranasal). Concomitant therapy: The patient was not receiving concomitant medications. Event details: the patient developed sneezing and congestion on 04-Oct-2003. As of 06-Oct-2003, the symptoms persisted. The patient's brother experienced sneezing and congestion following receipt of Flumist on 01-Oct-2003 at 11 years of age (see MCN HQWYE094909OCT03). No additional information was available at the date of this report.
VAXELIS administered since temperature excursion above 8.5° (10 mins)/Previous temperature excursion on 12-APR-22 above 8° (10 mins); This non-serious spontaneous report was received by partner (reference number 02197725) on 05-JUL-2022 and forwarded on 06-JUL-2022 from a consumer.    The causal relationship between Vaxelis and the reported event "multiple doses of VAXELIS administered since temperature excursion" was assessed as not applicable due to the nature of the event.    Further information is expected.  FOLLOW-UP INFORMATION was received by a partner on 01-AUG-2022 and forwarded on 03-AUG-2022, from a HCP. The case is maintained as non-serious.  The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient.  Due to the nature of the event, the causality between the event "VAXELIS administered since temperature excursion above 8.5° (10 mins)/Previous temperature excursion on 12-APR-22 above 8°C (10 mins)" and Vaxelis remained not applicable.  For reference purposes this case is linked to MCM-003725, MCM-003724, MCM-003729, MCM-003734, MCM-003735, MCM-003737, MCM-003738, MCM-003739, MCM-003740, MCM-003741, MCM-003742, MCM-003743, MCM-003744, MCM-003747, MCM-003749, MCM-003751, MCM-003752, MCM-003753, MCM-003757, MCM-003759, MCM-003760, MCM-003761, MCM-003763, MCM-003766, MCM-003767, MCM-003769, MCM-003770, and MCM-003772, due to same reporter.  No further information is expected.
A couple days after the vaccine, Hands were sore and burning; felt like needles pricking on top of my hands. No swelling and were not red. I had that for about a week. No treatment.
This case was reported by a pharmacist via call center representative and described the occurrence of numbness of upper extremities in a 61 years old female patient who received SHINGRIX for an unknown indication. In April 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). In April 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced numbness of upper extremities, pain in arm and nerve pain. On an unknown date, the outcome of the numbness of upper extremities, pain in arm, nerve pain and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the numbness of upper extremities, pain in arm and nerve pain to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the retired health care professional who reported for her wife. The patient was administered SHINGRIX in the left deltoid subcutaneously instead of intramuscularly, which led to incorrect route of administration. Since the vaccination (less than a 6 months after vaccination), the patient had been experiencing intermittent pain going from her left deltoid down to her left hand. Sometimes this pain was accompanied by numbness. Since then, for the past few months, the patient continued to have intermittent nerve pain, extending down to her hand with numbness. The reporter wanted to know was this normal, or were there any side effects such as this when the vaccine was administered. There appears to be some confusion as to whether or not a booster was required and when and the reporter needed advice from GlaxoSmithKline.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Diarrhea-Medium, Systemic: Weakness-Medium, Additional Details: Pt also reported shortness of breath, wheezing and muscle cramps
Fever of 102, fast heat beat, shivering, sweating, pain at the injection sight
Patient was accidentally given a COVID-19 Pfizer shot instead of the Influenza Afluria Quad shot (P100367897)
Vaccine was out of range (70 degrees Fahrenheit) due to maintenance issue with refrigerator. The dose was administered before the pharmacist discovered that the flu vaccine was in the refrigerator in spite of note being placed on the frig not to use. This is the only patient that received a dose.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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 (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case contains information for the 77 out of 190 adult patients described by the reporter. No concomitant information was reported. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Minor soreness in left shoulder around site of injection. Began today approximately 18 hours after injection.
Patient was seated and in 15 minute observation period (approx 10 mins in) and when questioned if he was ok, replied that he was light headed. His pallor was very pale and he was sweating. When the pharmacist approached him to help, he was slumping over in the chair and in and out of coherence. He answered questions about his breathing and confirmed that he only felt light headed and breathing was not labored.  After removing his sweatshirt and mask to cool him off and allow better breathing and giving him some water, his skin color returned to normal and he was again speaking coherently.  His pulse and heart rate were a bit slow throughout. Ambulance was called and the patient refused to go to the hospital claiming he felt fine.
pt recvd 2 doses of varicella 24JUN95 & 28JUL95;on 3AUG95 pt exp 8 episodes of vertigo;MRI & CAT scans revealed no cranial bleeding;vertigo cont in an irregular fashion;No further details were provided;
Pain at injection site; Headache; Muscle aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 11th April 2019, refer case US2019177136).   On 5th September 2019, the patient received the 2nd dose of Shingrix. On 5th September 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, headache and muscle pain. Rechallenge with Shingrix was positive. In September 2019, the outcome of the injection site pain, headache and muscle pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain, headache and muscle pain to be related to Shingrix.  Additional case details were reported as follows: The reporter was patient's husband The patient received vaccine in left arm. The patient experienced the symptoms on the same day when she received the 2nd dose of vaccine. The injection site pain was lasted 3 to 4 days. The muscle aches and headache resolved within 2 days. The phone number or address was not available. The reporter consented to follow up.
I felt a feeling of discomfort across my chest, as if someone was tightening a band on my upper chest. Two episodes occurred, one on 11/10/2022 and the second occurrence on 11/15/2022. It was difficult to breathe in almost to the point of it being painful, but it was more uncomfortable than painful. Both times I had to breathe very slowly and shallowly before I could take a normal breath in. The doctor did an EKG and said that it was perfectly normal. She listened to my heart and lungs, and talked about my asthma. We wondered if it was in relation to the asthma acting up, but we are unsure if it's in relation to the vaccine. We talked about things and she urged me to come back if anything worsened or if it happened again.
Pt experienced extreme irritability, high pitched cry, lethargy for 4-5 days after vax.
his wife died from the vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A female patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for covid-19 immunization. The following information was reported: DEATH (death), outcome "fatal", described as "his wife died from the vaccination". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Additional information: The reporter mentioned that he doesn't believe in the Covid-19 vaccination because his wife died from the vaccination, and it has been proven that the vaccine doesn't really cure Covid-19. Reporter also mentioned that his wife died after taking her second vaccination.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: his wife died from the vaccination
Information has been received from a nurse concerning a 14 (age unit not specified) patient who on 10-JAN-2008 was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (Lot # 659209/1504U). On 10-JAN-2008,, the patient developed a red welt at injection site. On 12-JAN-2008, the patient recovered from the red welt at injection site. Additional information has been requested.
PUI's symptoms started from 9/2/2021. She was hospitalized for a day at hospital due to dehydration. PUI's son thinks PUI got COVID from the emergency center of hospital as she had visited the hospital due to an UTI.
Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old unknown gender patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the upper right arm on 23Mar2021 at 14:45 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history reported as "do not do that" and had known allergies to opiates. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications taken for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the upper left arm on an unknown date as a single dose for COVID-19 immunisation. On 23Sep2021 at 14:30, the patient experienced tinnitus. The event resulted in doctor or other healthcare professional office/clinic visit. On an unknown date in Sep2021, the patient underwent hearing test and the result was unknown. Therapeutic measures were taken as a result of the event which included treatment with hearing test and would get hearing aid. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tinnitus was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Extreme fatigue - extreme body weakness- metal taste - vertigo - lack of appetite - nausea - diarreaha  - 11 days plus duration
I experienced severe arm pain to the point of not moving my arm and holding it to my chest all day. For two consecutive days I experienced extreme fatigue, dizziness and a small temperature. This lasted about three hours mid day.
L arm with injection site redness and swelling beginning 1/26/2021. Area mildly tender.
This spontaneous report was received from a licensed practitioner nurse referring to a 15 month-old child of unknown gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on 17-JUL-2015, the patient was administered an improperly stored dose of LIQUID PEDVAXHIB injection (lot # K026533, with expiration date: 07-AUG-2017; dose, frequency and route were not reported). No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
On 05/07/209, Patient presented to Primary Care and received vaccination for shingles with Shingrix. The next day the Patient reported to the ED with complaints of fever of 100.8 at home, myalgia of the shoulder, and joint pain. No treatment was administered and CXR was negative for acute concerns.