chrisvoncsefalvay/vaers-outcomes huggingface dataset:
doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Date the vial was initially stored in the refrigerator was 01-Mar-2022. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.
Patients husband states patient had a DVT and went to hospital.   Patient's husband was told for us to report this to VAERs due to her having recent covid vaccine.  I do not have specific information regarding length of stay, etc.  Pt has recovered.
I've got the 1st dose of vaccine and then unfortunately, in the interim, I started feeling sick and tested positive for Covid.; I've got the 1st dose of vaccine and then unfortunately, in the interim, I started feeling sick and tested positive for Covid.; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A male patient of an unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported he got the 1st dose of the vaccine and then unfortunately, in the interim, he started feeling sick and tested positive for Covid. The patient underwent Covid test and resulted positive on an unknown date. Outcome of the event was unknown.  No follow-up activities are needed. No further information is expected.
Only the liquid component (C, Y, W) was administered. The powdered component (A) was not administered. The nurse administering the vaccine has never given a meningococcal vaccine before and was unaware that there is a powdered component that must be reconstituted with the liquid component before administration.
Within one hour patient began to feel fever, chills, body aches, dizziness. Later that evening developed abdominal pain and swelling in right eye.
Woke am after injection with chills, malaise, warm, red urea at site. Woke next am with pruritic rash on legs.
Pt received vaccination and stated felt dizzy, wanted to lay down; reclined on exam table and became diaphoretic, eyes rolled back, gray/ ashen color, did not respond to name or brisk shaking for approx 15-20 secs; weak/ th ready pulse 70s, BP 84/40s, RR=12, Pulse ox= 99%; 911 called immediately; 0.3 mg SQ epi administered while awaiting ambulance; Pt responding by time ambulance arrived in approximately 5 minutes; BP 100s/70s, then 140s/70s, responsive, A&OX3; taken to ER via ambulance by Fire Dept.
No unusual or prolonged local or systemic reactions within first 1-2 weeks post-vaccine receipt. Around June 2005, Started having muscle pain and also developed paresthesias. Pt description of ongoing symptoms: elbows lock up...have decreased muscle mass...weak...can't do push-ups and can't walk for any length of time...have severe spasms and a lot of pain...unable to use hands because (he) can't hold onto things...Hands get "stuck in position"...knees are weak...gained about 40-50 lbs because of medication and he cannot exercise...neck and back pain, UE pain (L>R), paresthesias of UEs, right shoulder pain, obstructive sleep apnea, Knee pain. Also reports chronic skin lesions since 2006 which have not been documented in medical records. ATTACHED: Summary of Medical evaluation of symptoms per medical records review (records reviewed dated between June 2005 and April 2008).
Diagnosed with autoimmune disease Birdshot Chorioretinopathy also called Birdshot Uveitis.  Vision changes began soon after the vaccine and 13 days after the vaccine the symptoms were pronounced enough to see my eye doctor.  Vision deteriorated continuously until I finally received an accurate diagnosis in November 2021. Treatment thus far has been oral prednisone and Ozurdex intravitreal steroid implants.  The long term treatment will be determined by a rheumatologist on 1/6/2022.
Tinnitus comes on goes. Sometimes is very low sometimes is unbearable with a headache.
I've just been living with servere hives got blexten from doctor But it made them worse now I'm getting help from natropath 100 times worse after vaccines.
Patient reports having an "achy" arm from her shoulder to fingertips, throbbing and "cold" sensation, radiating up to her nect, ribs.  No redness or swelling at injection site.  She also reports "heartburn" that wouldn't go away. Denies chest pain.  Sx started to improve after 1 1/2 days but lasted 3 days.  Sx were reported on her left side (where the injection was given).  She has a hx of "heartburn" but this time it lasted.  She said that ibuprofen 600 mg did not relieve the discomfort.  Pain was severe enough to disrupt her sleep.  She spoke with her family physician but he did not seem concerned or advise any medical follow-up.  Symptoms have completely resolved.  She says that she typically experiences severe pain after a flu shot but not as extensive as this time.
233 Patients given expired doses; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (233 Patients given expired doses) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021 at 1:36 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (233 Patients given expired doses). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (233 Patients given expired doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was not immunocompromised.  No concomitant medications were reported.  Vials were stored in a vaccine freezer set to -20 C. On 12 Nov 2021, vial was placed on counter at room temperature for 30 minutes to thaw and vaccine was drawn up and then placed in vaccine in fridge for the duration of the clinic, and was taken out when patient was ready to receive. Temperature readings of fridge were at 3.8 C . No temperature excursions were noted during the administration of the vaccine.  No treatment medications were reported.
suppose to receive the 2nd dose on 17May2021 but did not; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (suppose to receive the 2nd dose on 17May2021 but did not) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (suppose to receive the 2nd dose on 17May2021 but did not). At the time of the report, PRODUCT DOSE OMISSION ISSUE (suppose to receive the 2nd dose on 17May2021 but did not) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The reporter stated that patient takes daily medications but the caller does not know the names of the medications.  No treatment information was provided.
extreme fever; chills; shortness of breath; This is a spontaneous report from a contactable physician (patient). A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunization. Medical history included hospitalization due to COVID-19 (severe case several months prior but less than 90 days). The patient's concomitant medications were not reported. The patient experienced extreme fever, chills, and shortness of breath on an unspecified date. The clinical outcome of extreme fever, chills, and shortness of breath was recovered on an unspecified date.   The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
09/24- Developed wheezing, chest tightness, coughing  approximately 20-35 mins. after vaccination.  Took Zyrtec 10 mg, NAC 600 mg, Glutathione 500 mg. Pulse ox-92%-taken with Apple watch. Felt slightly better.  Couple to few hours after-felt extreme fatigue, neck pain, upper back pain, left arm and hand pain, drowsiness. Took Aspirin,Turmeric capsule. During the night- irritable, woke up few times-felt dehydrated/lips and mouth very dry, stiff neck, shoulder pain, arm pain, malaise, headache L sided. 9/25-unusual falling asleep while talking, eating, slight headache, backpain-stabbing but on and off, mild chest pain, abdominal pain on and off, upper back pain, left arm feeling weak, still with extreme fatigue,  felt slightly better after taking Glutathione but other symptoms continued.  8 p.m. upper and lower eyelids sl. red and swollen-took Zyrtec.  09/27-A.M. chest pain on and off-relieved by Aspirin, chest tightness continued, on and off wheezing relieved by Zyrtec and inhaler; fatigue, left arm malaise, upper back pain throughout the day 09/28--A.M. some symptoms are better except wheezing, fatigue, malaise to left arm, and left scapula. P.M- slight headache, slight chest pain, left arm pain, malaise persistent, on and off chest pain 09/29- A.M -still with fatigue, slight wheezing, left arm still with malaise and weak but able to lift light objects. Called Dr. office at 9:24 a.m. Office RN returned call at 10:10 a.m. and was informed about reactions.
Post vax, the pt developed red, burning sensation to skin from waist upward. Flushed skin coloration.
96yr old female presents via ambulance for complaints of neurological changes. Patient lives with so., Son reports patient has had "decrease alertness last couple of hours and" not feeling good for couple of days" Patient heard of hearing, does not answer nurses questions, opens eyes to sternum rub.  Urinary tract infection with hematuria, site unspecified  cefdinir (OMNICEF) 300 mg capsule    cefdinir (OMNICEF) 300 mg capsule 2. COVID-19 virus infection    3. Pleural effusion on right    4. Weakness    5. Hypoxemia    6. Hypokalemia    Neurological Changes
This spontaneous report was received from a teacher of children with autism and refers to an unspecified number of children. The patients' pertinent medical history, drug reactions, allergies and concomitant therapies were not reported. The teacher reported that on an unknown date, the patients were vaccinated with M-M-R II injection (dose, route of administration, lot number and expiration date were not reported) for prophylaxis. She stated that she had seen children "before and after getting M-M-R II" and some of these children have developed autism on an unspecified dates. The primary reporter did not clarify if she was referring to some of her individual students or if she was referring to cases she has heard about or read about. The outcome of the event was not reported. Causality assessment was not provided. Upon internal review, the event of autism was considered to be medically significant.
Initial unsolicited report received from a pharmacist on 19-Sep-2017. This case involves a 79-year-old female patient who was vaccinated with a 0.5 ml single dose of FLUZONE HIGH-DOSE (batch number UI853AB) via intramuscular route on 18-Sep-2017. The patient had a medical history of allergy to codeine. It was reported that patient completed chemo Aug-2017 but reporter did not know what type of cancer. Concomitant medications were not reported. On 19-Sep-2017, one day following the vaccination, the patient woke up at 2AM in the morning with fever, chills and her blood pressure was 206/90. On an unknown date reported as today, patient had a temp of 97.8F; blood pressure is 143/61 and was feeling tired and has sneezing and congestion. The patient's corrective treatment was not reported. The patient's outcome reported as recovering. List of documents held by sender: none.
Patient reported upper arm pain and was treated in a urgent care clinic w/antibiotics and anti-inflammatory meds.
Aches; Low fever; Slept most of 3 days; No appetite; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (on an unknown date patient received the 1st dose and experienced aches, low fever, slept most of 3 days and no appetite.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain, low grade fever, sleepiness and appetite absent. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain, low grade fever, sleepiness and appetite absent were recovered/resolved.   It was unknown if the reporter considered the pain, low grade fever, sleepiness and appetite absent to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient experienced aches, low fever, slept most of 3 days and no appetite after that patient was fine. This case has been linked with cases US2018239609 and US2018AMR239999 reported by the same reporter.
No adverse event; Pneumovax 23 Syringe 01-OCT-2015  and 10-OCT-2019; This spontaneous report was received from an 66 year old female patient, concerning to herself from a case in litigation for zoster vaccine live (ZOSTAVAX) (1902USA008671). The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.  On  01-OCT-2015, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were not provided). It was reported that another doses of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was administered  ON 10-OCT-2019 (inappropriate schedule of product administration).  This is one of two reports received from the same patient. ; Sender's Comments:  US-009507513-1902USA008671:
Within a few minutes after administration of HPV vaccine patient felt dizzy (BP 84/44, Pulse 144), turned pale and then had a syncopal convulsion (per Dr.) that lasted about 5 seconds. Patient was laid down on the exam table, given a cool compress, orange juice and water and she was assessed by Dr. (pulse 60). Patient felt better after laying down, cool compress was applied, orange juice and water were given. BP 111/72 Pulse 70. Mother reported to Dr. that when patient was 5 years old she had a vasovagal episode where patient turned blue from pain after cutting her chin and she called the paramedics. Mother forgot to mention this prior to administration of the vaccine when asked if she has ever fainted, felt dizzy or did not feel well after vaccines or procedures. Patient was given a sucker prior to the vaccine. Patient was assessed again by Dr. and discharged home. Patient left the office with Mom. Mother aware to have patient eat prior to her future vaccines and to always tell the nurses and doctors about her past history of feeling faint and syncope with pain and vaccines.
p/vax pt lt arm swollen next morning by afternoon deltoid, upper arm lt side chest were red & swollen;seen by ARNP;instructed to observe;if s/s inc to ED/PMD;mom stated took pt to ED on 9/21/99 area looked worse;
I gave the patient a 3rd Pfizer shot as a booster by mistake. He is only 16 years old
COVID; COVID/Hard time breathing; Rheumatoid arthritis Spikes in flares; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4511720-00.  A 67-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "COVID"; COVID-19 (medically significant), outcome "unknown", described as "COVID/Hard time breathing"; RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis Spikes in flares". The patient underwent the following laboratory tests and procedures: COVID-19: Positive. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "covid", "covid/hard time breathing" and "rheumatoid arthritis spikes in flares" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "hard time breathing" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of  "covid" , "rheumatoid arthritis spikes in flares" and "drug ineffective".
Short of breathe, Muscle Spasms, Heart Palpitations. I had someone drop me off at Emergency room. They did testing and when I was not having a heart attack the doctor said that others have had the same symptoms after getting the second shot and sent me home.
Case number PHEH2013US006564, is an initial spontaneous report received from a medical assistant on 18 Mar 2013. This report refers to a patient of unknown age and gender. The patient was vaccinated with MENVEO (batch number: A 12024) intramuscularly and did not receive Men A lyophilized conjugate in Mar 2013. No adverse event was reported.
On 05/29/2022 I attended an event and we were cheering loudly. I did notice I had a sore throat on the way home and I'm not sure if it was sore from the screaming or the onset of COVID-19. On 06/01/2022 I felt like I had a minor cold. By the evening I was a little tired. 06/2/2022 my nose was a little stuffy. I decided to take a rapid test and it came back positive. The same day, I went to the pharmacy to do a PCR test which also came back positive. 06/03/2022 my wife had an appointment at urgent care so we both took a PCR test again and once again it came back positive. They prescribed PAXLOVID. I contacted my Primary Care Physician to advise of the positive tests. My symptoms were not very severe so I can't say the PAXLOVID was a big help, but my symptoms have not gotten worse.
The spotting started on July 5 2021. Irregular period since then. Had to take the progesterone pills for ten days because of amenorrhea. She took the pills in April 2022.. Now she is skipping her period again. The hair loss started in May 2022.
Patient with underlying bilateral SNHL, patient noted that ~ 3 weeks after second dose she noticed drop in hearing on the left. Audio from 3/31 with decreased hearing on the left compared to prior audios. Currently on oral steroids, antivirals and underwent first intertympanic injection.
Neuropathy "tingling, slight pins and needles feeling" in hands and feet Friday after vaccine administered.  Symptoms have not resolved.  Diagnosed by physician as ADR to flu vaccine.
Information has been received from a physician concerning a 13 year old female who in 2007 was vaccinated with her first dose of GARDASIL, 0.5 ml via injection. The patient did not experience any adverse event with her first dose. On approximately 04-JAN-2008 the patient received her second dose of GARDASIL, 0.5 ml via injection and fainted. On that same date, the patient recovered. The patient sought unspecified medical attention. Additional information has been requested.
This is not a critical reaction but want to report in order to help build up the information available to healthcare professionals going forward.   Morning after chills, neck stiffness, pain back of head left side. Applied heating pad to neck. By late morning I was nauseous , and weak as a kitten. Took a 500 mg Tylenol and slept for about 4 hours. Woke up in a sweat but chills gone and am now able to eat a little bit. Back of head and neck still very sore.   The injection site is sore but no rash; right arm seems to have "phantom pain" as well ( I experienced this with Shingles shot in December 2020 too).
The adverse event was a significant drop in my platelet count. On a follow up visit for a kidney stone that had been removed in January 2021, I was scheduled to have another procedure that required a blood test and pre screening. The blood tests revealed a platelet count of 108 compared to a blood test taken in hospital  in January 2021 that showed a platelet count over 130. I was instructed to have another blood test a week later to see if the platelet count continued to go down. On April 3rd, 2021 I had my blood test and the results showed a platelet count of 139. On September 1, 2021 I had my routine blood work which showed my platelets at 127.
From patient report: "I just wanted to let you know that I think I had a reaction to the Covid booster shot. I had it last Monday, and noticed that evening a quarter sized red circular rash next to the injection site. The next two days, it was very itchy and got much larger. It almost looked like what you see with cellulitis. It was gone by this past Saturday. I have also noticed some odd lower leg sensations, like electric current running through or something. I don?t know if those two things have any relation, or if the leg thing is just a coincidence".
Day following first injection, I had unbearable anxiety which induced suicidal ideology. so severe I couldn't see how i was going to make it to the next moment.  I would walk in circles and then sit on the ground and rock back and forth.  symptoms include restlessness, anxious with tight chest, tense muscles, labored breathing, increased heart rate (111bpm, 79 bpm resting), flushed, body temperature fluctuations (hot then cold etc),  Food tasted offal and i could barely eat, even if i was hungry.
Patient was given vaccines in office on 6/5/06. Also started on new formula today 6/6/06, Enfamil Lipil. Developed redness and swelling of trunk, ears and extremities 1/2 hour after
an expired dose of VAQTA was administered; No further AE; This spontaneous report was received from a medical assistan and refers to a patient of unknown age and gender. No information was given regarding the patient's concurrent conditions, concomitant medications or medical history.  In January 2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) lot # T008149 with expiration date on 06-JAN-2021 for prophylaxis (dose and route of administration was not reported). However, no adverse events were reported.
Redness and swelling to (L) outer aspect, noticed 24 hrs after vaccines. Tx BENADRYL & ice packs to site.