chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vial was initially stored in the refrigerator on 22-Aug-2022 and administered on 23-Sep-2022; Received expired  Monovalent vaccine after 30 day beyond use date; Received expired  Monovalent vaccine after 30 day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired  Monovalent vaccine after 30 day beyond use date), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 22-Aug-2022 and administered on 23-Sep-2022) and NO ADVERSE EVENT (Received expired  Monovalent vaccine after 30 day beyond use date) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 057A22A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Sep-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired  Monovalent vaccine after 30 day beyond use date). On 26-Sep-2022, the patient experienced NO ADVERSE EVENT (Received expired  Monovalent vaccine after 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 22-Aug-2022 and administered on 23-Sep-2022). On 27-Sep-2022, EXPIRED PRODUCT ADMINISTERED (Received expired  Monovalent vaccine after 30 day beyond use date) and NO ADVERSE EVENT (Received expired  Monovalent vaccine after 30 day beyond use date) outcome was unknown. At the time of the report, PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 22-Aug-2022 and administered on 23-Sep-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (Received expired  Monovalent vaccine after 30 day beyond use date) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received expired  Monovalent vaccine after 30 day beyond use date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 22-Aug-2022 and administered on 23-Sep-2022).    No relevant concomitant medications were reported.  The vial was initially stored in the refrigerator on 22-Aug-2022. Patient received expired Moderna COVID-19 vaccine after 30 day beyond use date 22-Sep-2022. There was unbroken cartons on vial. The vial size of adult was 5.5 ml. The vial did not undergo any temperature excursions. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2022: Live significant follow received contains narrative updated.
Patient lied on consent form and in person and said she'd never received a dose of a COVID-19 vaccine. Pfizer was administered and when logging it into System it was discovered that the patient had received Janssen already.
Doesn't feel like eating; Aches and pain in her leg; Fever; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Doesn't feel like eating), PAIN IN EXTREMITY (Aches and pain in her leg), PYREXIA (Fever) and VOMITING (Vomiting) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced DECREASED APPETITE (Doesn't feel like eating), PAIN IN EXTREMITY (Aches and pain in her leg), PYREXIA (Fever) and VOMITING (Vomiting). At the time of the report, DECREASED APPETITE (Doesn't feel like eating), PAIN IN EXTREMITY (Aches and pain in her leg), PYREXIA (Fever) and VOMITING (Vomiting) outcome was unknown.            No concomitant medications were reported. No treatment related information has been reported.  Based in current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD21-053012 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: No specific follow-up information recorded.; Sender's Comments: Based in current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. MOD21-053012:Cross link
Approximately 3 hours after receiving her 2mo vaccines, the patient developed what looked like diaphragmatic spasm that was occurring approximately every 0.5-3minutes as well as facial spasms that would last a few seconds and resolve resulting in her screaming, these episodes kept repeating every few minutes for approximately 5 hours. At around 5:50pm She received 2.5ml of benadryl and went to sleep and the episodes resolved.
Right leg femoral artery seizure. Patient was taken to emergency room, due to a fever that developed after PCV shot was given.
Pt had trouble sleeping on Monday night, she said it was because of a headache. She reported having a headache Monday afternoon when she came home from school. Pt didn?t have a headache on Tuesday, but could not sleep last night. She was tired, but said she just couldn?t fall asleep. She doesn?t normally have trouble sleeping. Only other symptom she reported was stomach hurting a little Monday evening. No stomach discomfort today. No fever, no chills, etc.
Pt came in on 10/11/2017. She said about 2 days after getting the shot, the pain moved from the immunization site in her arm to her joint. She said she does not have the same range of motion, and when she goes to move her arm in a certain way, it hurts. She is following up with her md tomorrow.
She suffers from depression but after the both doses of the Covid Vaccine, she has a lot of energy and generally happier; She suffers from depression but after the both doses of the Covid Vaccine, she has a lot of energy and generally happier; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRE-EXISTING CONDITION IMPROVED (non-serious), THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown" and all described as "She suffers from depression but after the both doses of the Covid Vaccine, she has a lot of energy and generally happier".  Additional information: She suffers from depression but after the both doses of the Covid Vaccine, she has a lot of energy and generally happier.   Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Shortness of breath; Experienced chest pain; This is a spontaneous report from a contactable consumer (parent) or other non hcp reported for patient (daughter). A 27-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 02Apr2021 as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient experienced shortness of breath, experienced chest pain on an unspecified date. The outcome of the events was reported as unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021393499 Same drug different patient and AE
Day p/immun 3 1/2 to 4hrs inconsolable crying episode; Including 3JUN91 excessive sleeping, near all the time x/crying when position changed or laid down; 12JUN91 pt much better;
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 03-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Symptomatic COVID-19 infection. Symptoms started on 12/11 with very slight non-productive cough, escalated to headache, cough, sneezing, congestion, and sore throat from post nasal drip on 12/13. Had to cancel doctors appointments due to quarantine until 12/22. Was unable to work or perform household chores from 12/13-12/15 due to illness. Symptoms almost completely resolved by 12/16 other than fatigue.
Around 4:45 I started getting a tension headache. Around 9:30 p.m. same night my upper chest and throat muscles tightened to the point breathing was painful and difficult. Took a muscle relaxer cyclobenzaprine 10 mg, and topical CBD. An hour later took CBD orally.  Approximately 2:00 am took more oral CBD as well as two ibuprofen. Throat muscle started to relax around 3:30 a.m. making breathing easier. Following morning took more CBD orally. Still have very tight back neck and shoulder muscles. Breathing was difficult from 9:30 p.m. until 3:30 the next morning.
I developed uncontrolled afib, the first instance was a few weeks after my second vaccine- chest tightness. short of breath, dizziness.  these episodes were occurring monthly, and lasting 2-4 hours. Did not seek care until the 3rd episode, was seen at PCP, ended up in ER  2 weeks later.  the arrhythmia has been extremely hard to control with 7 medication changes.  I am now on 5 medications, prior to this I was on none.
Patient had swelling of the lips 4 days after the vaccine. Called his Dr. Prescribed prednsione and to take OTC Benadryl. Swelling resolved
This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 10-APR-2017, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB which had the lot # reported as M046140, expiration date 27-SEP-2019, lot # N009802, expiration date 19-DEC-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 49°F for 68 hours. Data logger was not involved.  No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA007325: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766:
Patient presented to local ED on 2/11/22 with a PMH of RA on methotrexate, COPD on O2 at 2L, CAD, HTN, HLD, Hypothyroid, GERD, Fatty liver, and Pulm HTN for complaints of weakness, N/V, and SOB. Pt states that her symptoms started early in the morning. Patient was transferred to another ED for admission. Patient previously vaccinated with Pfizer on 6/8/21 and 6/29/21, however was not boosted.
Pain in left upper arm and shoulder, includes joint, increasing over several days.  I still have it and it has not decreased.  It hampers everything I do. This is not the normal pain from flu shot I've always had for a few days. This is severe and limits my ability to take care of myself and my home. I have trouble driving and I require help with some activities.
J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/4/2021 FECAL IMPACTION IN RECTUM J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/4/2021 ATHEROSCLEROSIS OF AORTA
C/O feeling flushed, chest heaviness, BP 158/100. Patient went to urgent care for medical evaluation.
first and second dose, developed shingles/Suspected vaccination failure; shingles; rash; pain; itching; bleeding lesions on his skin; bleeding lesions on his skin; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 8th April 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 29th January 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 2 years 10 months after receiving Shingrix and more than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash, pain, pruritus, skin lesion and skin bleeding. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, rash, pain, pruritus, skin lesion and skin bleeding were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash, pain, pruritus, skin lesion and skin bleeding to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was reported by the patient. The patient recently had developed the shingles rash with pain and itching (Lack of Effect).  The patient also reported that the rash was causing bleeding lesions on his skin.  This issue had developed 2 years and 10 months after receiving the 2 dose Shingrix series. No lot or expiration dates were known for either vaccine.  The patient wished to be contacted via email for any follow up. This case was considered as suspected vaccination failure as detail regarding laboratory test confirming shingles were unknown at the time of reporting.
1 day after vaccination I woke up to an unbearable headache that will not go away with any medication. Still have headache 3 days after shot that will not go away with any medication.
I received the Shingrex vaccination (2nd vaccination in the two-part series) on Friday (10/11/19), and had some feverish symptoms afterwards, which I also had with the first vaccination, but I noticed on 10/12/19 that my hearing seemed impaired (I already had some hearing loss in my right ear, but it was markedly worse now), on Monday, 10/14/19, I went to Urgent Care and received a prescription for Methylprednisolone tablets 4 mg dosepak + Acyclovir 800 mg, which I have been taking as prescribed, but my hearing isn't improving. I fear I have loss a significant amount of hearing in my right ear as a result of the vaccination on 10/11/19  I wish I had known that this could happen, I would have been more vigilant and would have received medical care sooner - which could have prevented what I am now afraid is permanent hearing loss.
I started to notice swelling the night of the 26th. The next morning it was red, itchy, swollen, and hot to the touch. I contacted a colleague (FNP) who advised ice, Benadryl, and drawing a circle around the red site to see if it increased. The following day it had more than doubled and my entire upper are was red, swollen and itchy. The evening of the 28th I went to my primary providers walk in hours to have it checked as my arm also began to throb.
Feeling tired; Feeling achy; This case was reported by a consumer and described the occurrence of tiredness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th March 2020, the patient received the 1st dose of Shingrix. On 21st March 2020, 1 days after receiving Shingrix, the patient experienced tiredness and pain. On an unknown date, the outcome of the tiredness and pain were unknown.   It was unknown if the reporter considered the tiredness and pain to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient's wife. The patient felt tired and achy after waking.  The reporter enquired how long do the side effects last normally.
Intense muscle pain, muscle hard and rigid, arm swollen, red and hot, rash approximately 6 inch in diameter around injection site.
At 1800 on 4/7/03, pt became very irritable and was unconsolable. He developed fever up to 104 deg F. He also developed a localized reaction (9.5cm x 8cm area of induration, tenderness) on left thigh site of injection.
The patient is a poor historian and history is obtained from him and his partner.  His symptoms have started yesterday after receiving the second dose of a Covid vaccine.  The couple went to eat a meal of Chinese food, and that evening the patient developed persistent nausea and vomiting.  He had multiple episodes of emesis.  According to his partner, he continued to have episodes of emesis this morning.  The emesis was nonbilious and nonbloody, described as watery.    The patient says he woke up this morning and may have felt some palpitations.  He thinks the palpitations may have been worse than usual.  He says he generally just felt unwell.  He could not get out of bed and move around very much due to the nausea and vomiting.  He says that for this reason, he activated EMS who brought him to the hospital.  Regarding his atrial fibrillation, he says he is mostly compliant with taking his medications, however he did not take any of his home medications today.In the ER, he was hypertensive to 141/111 and tachycardic to 141, tachypneic to 23.  His heart rate went up to the 170s and he was given multiple doses of IV metoprolol.  On labs, he had a leukocytosis with a white blood count of 12 and the D-dimer was elevated greater than 20.  CTA was obtained to rule out pulmonary embolism which was negative.  However, down in the scanner he developed an episode of unresponsiveness with questionable seizure symptoms.  He was treated with an LR bolus 500 cc but due to the findings of increased pulmonary vascular congestion, was diuresed with Lasix 80 mg IV x1.  Blood cultures x2 were obtained.
Narrative:  Patient receiving the vaccine around 0900 and the diarrhea started around 2pm. He reports eating 2 peanut butter sandwiches to stop it.Lasted a couple of hours. Did not seek medical attention.
1/13/10 Pt was up during the night, 4-5 x crying, difficulty sleeping. Woke up this AM with red bumps on arms and red blotches all over body. Red from ears to knees. No other sx.
Myoclonic jerks first reported 4-6 hours after injection and persisting. One episode associated with eyes rolling back.
2 days after taking the second dose on my left arm I got a lump  under my arm pit; administration_date=21/May/2021; dose_number=1/other_vaccine_same_date_vaccine_d; This is a spontaneous report from a contactable consumer. A 38-year-old male patient reported for himself.  This patient reported for himself that a 38-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine, Formulation: Solution for injection, Batch/Lot number: 59267-1000-1/EW0217), via an unspecified route of administration, administered in Left arm on 21May2021 (38-year-old at the time of vaccination) as dose 2, single and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine, Formulation: Solution for injection, Batch/Lot number: 59267-1000-1/EW0183), via unspecified route in right arm on 21May2021 13:30 (38-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The COVID-19 vaccine was administered at hospital facility. Patient had no medical history. Patient had no known allergies. Concomitant medication(s) included zolpidem (ZOLPIDEM) 10mg. The patient was not diagnosed with COVID-19 prior to vaccination. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. On 21May2021, the patient received 2 doses of vaccine on 21May2021 (same date). On 16Jun2021 19:00, after taking the second dose on left arm he got a lump under my arm pit. Patient was not received treatment for events. Since the vaccination, patient has been not tested for COVID-19. The clinical outcome of event 2 days after taking the second dose on her left arm she got a lump under her arm pit was not recovered and other event was unknown.  No follow-up attempts are possible. No further information is expected.
injection site is swollen and sore; injection site is swollen and sore; Initial information received on 01-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a patient with unknown demographics who experienced injection site is swollen and sore and injection site is swollen and sore 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  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a non-serious injection site is swollen and sore (injection site swelling) (injection site pain) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (injection site is swollen and sore, injection site is swollen and sore).  At time of reporting, the outcome was Unknown for the event injection site is swollen and sore and was Unknown for the event injection site is swollen and sore.
Superficial blood clot in right upper thigh; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 14Mar2021 12:00 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization at the Pharmacy or Drug Store. Medical history included ongoing birth control.  Concomitant medications included unspecified birth control pills and vitamins.  The patient was not pregnant (including the time of vaccination). On 15Mar2021 12:00, the patient experienced superficial blood clot in right upper thigh. The patient had no COVID-19 prior vaccination and not tested for COVID-19 post vaccination. The patient was treated with apixaban (ELIQUIS) 10 mg. The patient was recovering from the event.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt. received flu vaccine in (L) deltoid and had massive swelling, erythema and warmth greater than 20 cm that has persisted for greater than 72 hours.
Missed  2 consecutive menstrual cycles followed by 3 regular cycles then one heavy, lengthy cycle lasting 26 days
First 2 days after vaccine, arm soreness at site of vaccine, resolved. Starting on 01-05-21 (8 days post vaccination) developed headache, runny nose and sore throat.  On 01-06-21 reports small amounts of coughing.  Will go for COVID testing tomorrow 01-07-21.
Large amt swelling next AM redness, hot to touch.  Went to ER.  Swelling continued then getting larger.  Seen @ office, continued thru afternoon.  Went to ER again for 2nd time.
First sign of adverse symptoms was 13 days after receiving 3rd dose of Covid-19 Moderna Booster shot.  Symptoms include Welts, Itchy Skin, Hives in chest, back, arms, leg, butt, groin.    Symptoms also appear to be overproduction of histamine.  When scratched the skin swells up, becomes red and itchy.    Adverse symptoms still persist.