chrisvoncsefalvay/vaers-outcomes huggingface dataset:
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided.   This case was linked to MOD-2021-395985 (Patient Link).
the patient called and said she woke up this morning and her lip was swollen and the only thing different was the vaccines she had the day before. She said she was going to take benadryl and I suggested she needed to contact her physician. she said she was going to call her md.
Arm swelling, pain along veins, violent cramps, nausea, liquid diarrhea, exhaustion, confusion
Bleeding from nose /headache, clot in nostrils, dizziness. Proceeded with nausea, vomiting.
Diplopia; Sore shoulder; This case was reported by a consumer via call center representative and described the occurrence of shoulder soreness in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ivth nerve paralysis (4th cranial nerve palsy).   On 13th August 2021, the patient received the 1st dose of Shingrix (intramuscular). On 13th August 2021, less than a day after receiving Shingrix, the patient experienced shoulder soreness. On 13th September 2021, the patient experienced diplopia. On an unknown date, the outcome of the shoulder soreness was recovered/resolved and the outcome of the diplopia was recovering/resolving.   It was unknown if the reporter considered the shoulder soreness and diplopia to be related to Shingrix.  Additional details provided were as follows: The reporter is the patient himself. The patient received a dose of Shingrix vaccine in left deltoid intramuscularly and at the night of vaccination had a sore shoulder and lasted for 2-3 days. The patient also stated that he also started experiencing diplopia and that he went to the emergency room for treatment with follow up with ophthalmologist. He stated that his diplopia was improving. The patient inquired if Shingrix can cause diplopia. The reporter consented to follow-up.
Patient fainted after receiving  vaccines and fell to the ground. Patient appeared pale and faint. Patient was given crackers, juice, and vitals were monitored. Parents were given information on when to return to clinic or seek care. Patient was up and talking upon leaving.
64 yo F calling to report possible reaction to vaccines.  Traveling abroad, yellow fever area. On 1/16 received 5 vaccines.  Tdap, Flu, HepA, HepB and Yellow Fever.  On Thursday 1/22 she noticed a raised red area about the size of 50cent piece, itchy, left sub-Q area.  That resolved by 1/25 and she now has red/blue discolored area.  Not warm or hot to the touch. Denies any fever.  Sob, resp problem, dizziness.  On Sunday 1/25 she became nauseated with no appetite and achy.  No fever.  Today she has rash, small raised, over chest, stomach, legs and arms.  No itching, still denies fever, states she feels better today.  Is at work.  On further questioning she tells me she finished her Oral Typhoid vaccine on Thursday, 1/22. I advised her to call her MD, for evaluation and tx, I will fill out the Vaers form.  I further advised her if sx worsen, she needs to seek medical attention immediately.
pt recv vax 2MAR96 & 12MAR96 pt exp a swollen neck, fever of 104 & pain;fever was present for 2wk & the swelling was present for 20 to 22 days;
This spontaneous report as received from a Nurse Practitioner refers to a patient of unknown age. On 03-JUN-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot #, dose and route not reported). The patient inadvertently received a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck). No symptoms reported. Additional information has been requested.
First shot in December I woke up with ear completely full feeling. Then an engine tinnitus sound came later, all in the left ear. This has continued on and off and now is worse after getting the booster shot.
Vertigo began 14 days after the first vaccine. Dizziness, tinnitus, vomiting,  some days requiring me to stay in bed, continued intensely for about 3 weeks. I experienced ongoing dizziness (but not vertigo) over the following two months, gradually lessening in intensity and frequency during that time. I felt pressure in the center of my head (my brain), but not in my ears during the first few weeks.  I went to my PCP about a week after the onset of symptoms. She diagnosed BPPV in my right ear - the side of my injection - and referred me to a physical therapist. I visit the PT 3 times for Eppley maneuvers. Because of the tinnitus, she recommended I see an ENT. He recommended no further treatment and suggested symptoms would resolve in a few more days. They did not.  Until day 95 or so after receiving the vaccine, symptoms appeared intermittently. Now, about 3 months after the onset of symptoms, I am finally feeling normal.  15 days after the first vaccine, (while in bed with vertigo) I also began to have twitching that only occured on the right side of my body - the same side as the injection. It began in the palm of my right hand for a few days, just below my thumb, shifted to the front my shin for a few days, then has been most common and long-lasting in my right buttocks, intermittently appearing during the past 3 months. This continues to this day and has never happened to me before in my life.
5/9/03 fever for 24 hours, no other symptoms, playful. 5/10/03 no fever, no symptoms.
Upper left arm only, around site of vaccination repeatedly breaking out in extremely red itchy patchy rash and bumps, extremely warm to touch and sore, seems to get bigger and bigger over time.
Patient received vaccine on 8/17/09. According to parent: pt started vomiting on 8/25/09 at school and sent home; developed rash on right side of body.
Severe hives over most of my body.  Started on opposite arm three days after vaccine shot, spread to entire body 48 hours after noticing first hive.   Treated with prednisone ,  Hydroxyzine HCL , Famotidine  Symptoms lasted about 5 days
1/5/22 - 1500hrs - General fatigue, slight chills, mild achiness. 1/6/22 - 0800hrs - Major Achiness, horrendous flu like symptoms, cold chills.  Upset Stomach, mild cough, minor itchyness, Injection site 4/10 pain. 1/6/22 - 1100hrs - Major fatigue, Confusion, and worse Flu like symptoms.  Unable to keep food down. injection site 4/10 pain. 1/6/22 - 1900hrs - Continued fatigue, mild confusion and flue like symptoms persist.  able to keep food down. Injection site 4/10 pain. 1/7/22 - 0800hrs - Minor Flu like symptoms, fatigue, injection site 3/10pain 1/7/22 - 1100hrs - Continued Minor Flu like symptoms, fatigue, injection site pain 3/10
Patient presented to ED on 5/23 with weakness and muscle pain/burning in shoulders and arms, bilaterally. Symptoms started on 5/20. Patient also reported that the weakness was progressive, was unable to lift arms, and had bilateral swelling of hands. Patient was transferred to Medical Center for neurosurgery evaluation.
the patient had flu like symptoms; Initial information regarding this unsolicited valid non-serious social media  case received from a consumer (patient) and transmitted to Sanofi on 15-Dec-2020.  This case involved a patient who experienced flu like symptoms, after receiving vaccine INFLUENZA VACCINE.  It was reported that 5 years ago the patient got Influenza vaccine shot and experienced Guillain-Barre syndrome.  Relevant medical history, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu like symptoms (influenza like illness), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was influenza like illness.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
Infanrix administered to an adult patient; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 53-year-old female patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st August 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 31st August 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's comment: A health care provider reported that an adult patient received an Infanrix dose. The reporter consented to follow-up. Additional Supportive Information: An adult patient received an Infanrix dose, which led to inappropriate age at vaccine administration.
ED on 01/14/2022 with acute shortness of breath, mild cough, generalized weakness, and orthostatic hypotension (BP 68/40 at home), superimposed on chronic dyspnea and cough since March 2020.  Initial laboratory studies were notable for positive SARS-CoV-2 PCR
pt recvd vax & 1/2 hrs p/vax pt exp urticarial rash;sx were treated w/DPH & resolved;
Discomfort at Injection Site; This case was reported by a physician via call center representative and described the occurrence of injection site discomfort in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site discomfort. On an unknown date, the outcome of the injection site discomfort was recovered/resolved.   It was unknown if the reporter considered the injection site discomfort to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient experienced mild-moderate discomfort at the injection site for about 3 days. No additional details were provided. For tolerance to the 2nd dose of Shingrix, refer case US2019075342.
bloating; bleeding; Spotting between period; Extended period circle from 3 days to 7 days; My cycle have changed with increased pain/Excruciating pain and cramps; This is a spontaneous report from a contactable other health care professional (patient). A 38-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0176), via an unspecified route of administration in right arm on 21May2021 at 17:30 (at the age of 38-year-old) as dose 2, single for COVID-19 immunisation at pharmacy or drug store. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0162), via an unspecified route of administration in left arm on 04Apr2021 at 17:30 (at the age of 38-year-old) as dose 1, single for COVID-19 immunisation and experienced menstrual disorder. The patient had no known allergies. No covid prior vaccination and no covid tested post vaccination. 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. It was reported that her cycle has changed with increased pain, bloating and bleeding on 21Jun2021 at 09:00. She has had 2 cycles within her first dose and last dose of the vaccine. On an unknown date in May2021, spotting between periods, extended period circle from 3 days to 7 days, excruciating pain, and cramps. The events were reported as non-serious. The patient did not receive any treatment for the events. The outcome of the events was reported as not resolved.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: PATIENT CAME INTO THE PHARMACY AFTER SYMPTOMS HAD RESOLVED.  HE CLAIMS HIS ARM SWELLED FROM THE ELBOW TO THE SHOULDER SO BADLY THAT HIS SKIN WAS STRETCHED.  IT WAS VERY TENDER, RED AND PAINFUL.  WHEN I ASKED HIM IF HE SOUGHT MEDICAL ATTENTION HE SAID NO.  HE FIGURED IT WOULD JUST GO AWAY  BY ITSELF . (WHICH IT DID)
Pain at injection site; Myalgia; Swelling of armpit; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number ZP3P9, expiry date 10th September 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain, myalgia and local swelling. On an unknown date, the outcome of the injection site pain, myalgia and local swelling were unknown.   It was unknown if the reporter considered the injection site pain, myalgia and local swelling to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that after administration of Shingrix vaccine, the patient returned and complained of myalgia, pain at injection site and swelling in armpit for 4 days.
A lump like a bubble under her left/right knee cap; Swelling in her knees; tingling in her left heel; Left eye swollen; Left eye red; Left eye irritating her contact eye glass; This spontaneous case was reported by a physician assistant and describes the occurrence of JOINT SWELLING (Swelling in her knees), PARAESTHESIA (tingling in her left heel), MASS (A lump like a bubble under her left/right knee cap), EYE SWELLING (Left eye swollen) and OCULAR HYPERAEMIA (Left eye red) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included METOPROLOL SUCCINATE and LEVOTHYROXINE for Hypertension.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced PARAESTHESIA (tingling in her left heel), EYE SWELLING (Left eye swollen), OCULAR HYPERAEMIA (Left eye red) and EYE IRRITATION (Left eye irritating her contact eye glass). On 13-Jan-2021, the patient experienced JOINT SWELLING (Swelling in her knees) and MASS (A lump like a bubble under her left/right knee cap). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (Swelling in her knees), PARAESTHESIA (tingling in her left heel), MASS (A lump like a bubble under her left/right knee cap), EYE SWELLING (Left eye swollen), OCULAR HYPERAEMIA (Left eye red) and EYE IRRITATION (Left eye irritating her contact eye glass) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medications Metoprolol succinate, levothyroxine.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
HYPOTENSION 1/22/2022 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION ACUTE RESPIRATORY FAILURE 1/23/2022 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION HYPOXIA 2/5/2022 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION
A spontaneous report was received from a consumer concerning a female patient (height: 69.0 inches; weight: 165.0 pounds). The patient received nasal FLUMIST (intranasal) in 2011 and 2012, nasal FLUMIST QUADRIVALENT (intranasal) in 2013, 2014 and 2015 so patient would not get the flu. The dose was unknown. Patient stated that since taking the FLUMIST, she would get a cold once a year instead of 3 times a year prior to starting the FLUMIST, also stated that after the FLUMIST was administered, sniffing would occur because otherwise the vaccine would run out of from the nose after administration. The outcome of cold and would sniff after administration of FLUMIST or the vaccine would run out from the nose after administration (medication error) was unknown. The company physician assessed cold and would sniff after administration of FLUMIST or the vaccine would run out from the nose after administration (medication error) to be non serious. Corrected report on 08-Nov-2016: Suspect product FLUMIST QUADRIVALENT was added. Dosing regimen was corrected. Associated case ID was added. Narrative updated.
Extreme fatigue, chills, and muscle aches/weakness approximately 22-23 hours after shingles vaccination (this was my 2nd dosage - 1st dosage received approx. 3 months earlier from same pharmacy - only had extreme fatigue with 1st dosage).  Symptoms lasted for approximately 7 hours.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 07-JUL-2015, the patient was vaccinated with an improperly stored dose of M-M-R II lot # K016154 with exp. 24-SEP-2016, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt complained of dizziness and nausea. She looked pale, broke out in a sweat. Had a pulse and was still breathing. Pt was in and out of consciousness 3 X w/in 15 min. loss of consciousness lasted no longer than 1 minute. EMT responded and took vitals. All normal. Pt's father came to store to drive her home.
Patient experienced pain in left arm right away and had a hard time sleeping that evening because of the pain. Pt took 400mg ibuprofen for pain. Rash (mostly below injection site) appeared 2/25/11 afternoon. Pt. reports less pain 2/26/11 but rash still present. She will try BENADRYL.
Unarousable in the morning. Mom called 911. Lethargic. Taken to ED. Given IV fluids. arousable and back to normal self by 11 AM on 11/13. This was a Hyporesponsive episode likely due to DTaP.
Hair loss, insomnia, painful inflamed joints, fatigue, cognitive issues, nerve pain, muscle pain, depression, anxiety, heart palpitations
Developed hives 36 hours after imms. Started on arms bilaterally, then involved legs bilaterally with a few urticarial lesions behind ears as well. No lip or face swelling, no throat tightness, no light headedness, no nausea, no vomiting,  no diarrhea. Took benadryl which helped the hives improve somewhat. 3 days after the urticaria began at the time of clinic visit the the lesions were still present but improving, becoming lighter, with one arm entirely resolved. Initially had itching, but this resolved after 36 hours.  He had acute gastroenteritis like illness 3 days prior to receiving vaccines, so viral urticaria is possible as well.
Within 2.5 hours after taking the second injection I started coughing , wheezing and chest tightness. Within another 2 hours pressure in my neck and head with a bad headache as well.  By the next morning body aches, severe headache with  pain in my neck and chest like aching all over. By that evening chills, fever and body aches and a dull headache. The second day neck stiffness and mild body aches but overall feeling much better.    Treatment used:When the coughing and bronchial spasms  and wheezing started I used my inhaler twice in total, used menthol cough drops and peppermint to help with the shortness of breath and wheezing. I then took a Vistaril just in case it was  an allergic reaction. I have not had an asthma attack in several years since i started utilizing daily essential oils. So this is not normal for me. I used Ibuprofen 800 mg and Tylenol ,migraine combination in conjunction with essential oils and ice packs for the headaches, body aches and so forth.
Pt recvd 1 dose of Engerix-B 10JAN92 & 3 days later broke out w/blistery rash inside both arms; tx rhusvenera & valisone cream; rash resolved in 3 days;
From the first does I still had some soreness in my arm. After the second dose I woke up the next day with flu like symptoms- I was unable to get out of bed for the first 24 hours. I had severe dizziness for three weeks, my heart was racing. This happened 2-3 days after the vaccine. Its Pulsatile Tenuti's and started off super severe  and correlated with my hear racing fast. My Blood pressure has been going up and down since the second dose. Sometimes is normal and other times it's really high like when I had my child- I had preeclampsia. I went to see several Dr's  and saw an ENT who sent me to a Neurologist and Cardiologist. The Neurologist had me do an MRI, everything came back ok. Dr's didn't really find anything. The Cardiologist believe it could have been the vaccine, but he knew people that complained on dizziness after getting the vaccine.
Fever, arthralgia, chills, headache, fatigue, back ache,dry mouth
wheezing, itching, lips and tongue swelling, throat itching and burning, hoarseness
Bright red painful itchy sores on skin that come to a head. Appearing on arms, legs trunk and face,
the patient developed the first of many painful outbreaks of shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (Pt) of unknown age and gender. Pt's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not provided. On or around August 2014, the Pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, anatomical location not provided) as recommended for routine adult health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Subsequently, on an unspecified date in early 2015, the Pt developed the first of many painful outbreaks of shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the Pt's symptoms had resulted in physical limitations not presenting prior to the use of the vaccine. As a result, Pt sustained severe, serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the reporting time, the outcome of herpes zoster was considered as not recovered. The reporters considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).  The reporters considered the event of herpes zoster to be disabling.
I have a lump in my left armpit. The size is about a half-inch. There was nothing before vaccination. I had a little pain for 3 days, but now there is no pain.