chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5 Patients received an expired dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 Patients received an expired dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 Patients received an expired dose). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (5 Patients received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. The vial was initially stored in the refrigerator on 15-sep-2021 and the vial did not undergo any temperature excursions.
This spontaneous report was received from a nurse (also reporter as medical assistant) refers to a 4 year old male patient. The patient has no pertinent medical history and concomitant medications. On 13-JUN-2016, a vaccination attempt was made to administer M-M-R II, subcutaneous in the arm. During the administration of a dose the patient moved his arm, the needle came out of the patient's arm, and a portion of the dose squirted on the patient's skin in an unspecified location. The reporter stated that the patient's mother mentioned that the patient developed a knot on his arm at an unspecified time following the vaccination attempt. The outcome of "knot on his arm" was reported as recovered. The reporter did not provide the relatedness of the event with M-M-R II. Additional information has been requested.
afraid of getting her second dose; Severe joint pain; Nausea; Pain in back and shoulder balde; Dizziness; Felt of fainting; Tingling in the back and shoulderblades; Tightness in the back and shoulderblades; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PRESYNCOPE (Felt of fainting), PARAESTHESIA (Tingling in the back and shoulderblades), MUSCLE TIGHTNESS (Tightness in the back and shoulderblades) and FEAR OF INJECTION (afraid of getting her second dose) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history was provided by the reporter.     On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced DIZZINESS (Dizziness), PRESYNCOPE (Felt of fainting), PARAESTHESIA (Tingling in the back and shoulderblades), MUSCLE TIGHTNESS (Tightness in the back and shoulderblades), NAUSEA (Nausea) and MYALGIA (Pain in back and shoulder balde). On 14-Apr-2021, the patient experienced ARTHRALGIA (Severe joint pain). On an unknown date, the patient experienced FEAR OF INJECTION (afraid of getting her second dose). On 15-Apr-2021, DIZZINESS (Dizziness), PRESYNCOPE (Felt of fainting) and NAUSEA (Nausea) had resolved. On 20-Apr-2021, PARAESTHESIA (Tingling in the back and shoulderblades), MUSCLE TIGHTNESS (Tightness in the back and shoulderblades) and MYALGIA (Pain in back and shoulder balde) had resolved. At the time of the report, FEAR OF INJECTION (afraid of getting her second dose) and ARTHRALGIA (Severe joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
1hr p/vax given pt devel fever; temp ranged from 103 to over 105 for 24 hr; pt also cried for 1 hr cont
headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No concomitant medications reported.  The patient's past medical history included COVID-19.    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (headaches) outcome was unknown. Not Provided          No concomitant drugs reported. She was experiencing headaches after 10 days. Symptoms are ongoing.
A non-serious report of administration of expired FLUMIST has been received from a nurse concerning a ten-year old female. Neither medical history nor concomitant medications were provided. The patient received FLUMIST on 13-Mar-2008. The FLUMIST had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FLUMIST from the program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. The patient had no adverse events at the time of the report was received, neither as of 18-Apr-2008 when the office was contacted for follow-up information. The event has resolved. It was not reported whether or not FLUMIST was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-000668; MEDI-0006669; MEDI-00066670; MEDI-00066671; MEDI-00006672; MEDI-00006673; MEDI-0006674; MEDI-0006659; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684
Moderna COVID-19 Vaccine EUA I developed the sudden onset of tinnitus (high-pitched constant ringing in both ears) about 30 hrs after receiving the vaccine.  I have had associated feeling of fullness/popping in my ears as well. This has continued for 10 days without relief.
Patient admitted to Hospital  secondary to COVID-19 pneumonia. He was intubated. His hospital course was complicated by renal failure. Patient was eventually extubated, but was noted to have significant weakness and functional decline. For this reason, it was determined that admission to Rehab was necessary to allow for safe discharge back to home. Hospital admission within 6 weeks of receiving the COVID vaccine.
10pm Thursday chills, shivering. Uncontrollable shivering in bed for the next 3-4 hours Friday am: nausea, body aches, headache, weird taste in mouth, site of shot is sore Saturday am: pain in the armpit area of the arm that received vaccine, tired Sunday am: pain in the armpit area of the arm that received vaccine, tired
Itchy behind ear, then rash spread across face. Same thing happened after a progesterone shot. Entire side of faced swelled by the end of the week.  Same thing will happen for this.
Very bad headache,  chills,  fever  and body aches  (all through the night)
Weakness; Dizziness; could hardly get up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 12Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset Oct2022, outcome "unknown"; ASTHENIA (non-serious) with onset Oct2022, outcome "unknown", described as "Weakness"; MOBILITY DECREASED (non-serious) with onset Oct2022, outcome "unknown", described as "could hardly get up".  Additional information: The patient was just concerned that they had side effects, weakness and dizziness. About three days, patient had the shot on Wednesday (12Oct2022) and when patient woke up in morning (unspecified date), patient could hardly get up. Patient never had that before.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dizziness and nausea 5 minutes after vaccine. Symptoms resolved after laying down and slow position changes for 15 minutes
Abdominal pain on right lower side for over 24 hours.  No appetite, constant, but pain level went up and down.  ER, thought it could be appendicitis,  or ovaries. Tests revealed nothing. But as pain still persisted, advised to go to OBGYN.
I received my second booster on 05/01/2022 and on 05/02/2022 I woke up with spots on my body. Over the next few days the rash became worse. I was embarrassed to go out anywhere because I felt like I looked like I had leprosy.  I visited a dermatologist clinic and seen an apn, she did look at one red spot that was on my arm and gave me samples of Dove laundry soap, told me to hydrate and change my soap. I still have the rash to this day but not as bad as they once were. I also had a breakthrough of COVID-19, I tested positive on 06/17/2022.  I woke up with a really bad sore throat, headache  and just overall felt bad.  I took a home test that was positive at that point I went to urgent care and received a prescription Paxlovid. Within 2-3days after starting medication I started feeling better. As of today I am still dealing with fatigue.
Varicella and Hep A given 3/18/08. Facial symptom 4/14/08. Seen 4/15/08 diagnosed with (L) Facial Bell's Palsy. Treated with steroids and Acyclovir.
Admitted for management of pulmonary abscess, klebsiella present in sputum and abscess. IV antibiotics given. Chest tube inserted for abscess. Discharged home when stable.
Red itchy rash about 1.5? below where the shot was  It?s about 2.5? long and 1? wide.
Dizzy Nausea Diaphoresis Monitored for 45 min resolved.
pt recv vax 5MAR97 & two days post vax pt devel chickenpox;It was reported that an additional pt (WAES #97030694) also devel a rash p/vax;
It has been 8 days and I still feel weak and my head feels heavy. This started the day after the vaccine. It feels like a mild headache where moving makes it worse,  or as if I had a hangover but I don't. I feel tension in my head. Lying down makes me feel better, as does any position where I'm resting my head. Yesterday I also had a weird feeling in my throat that came and went rhythmically.
I noticed a swollen lymph node under left arm  months after second dose of vaccine and I visited the doctor and she sent me for a mammogram. I was told that the mammogram looked fine. But the lymph node is still swollen.
Patient came in for her 2 y.o. physical on 4/27/04 11AM then received Hep A vaccine at 11:30AM then came back in at 1PM for 1:30PM appt with Dr. It was reaction to the Hep A vaccine received Benadryl liquid then rashes disappeared at 1:40 PM. According to pt's mother she stated that rashes reappeared last night and this morning again. Pt. on Benadryl will stay on for 4-5 days.
Case number PHEH2014US003695, is an initial spontaneous report from a pharmacist received on 21 FEB 2014 with a follow-up received on 26 MAR 2014. This report refers to a 12-uear-old male patient. Past medical history and concomitant medications were not reported. He was inadvertently vaccinated with FLUCELVAX 2013/2014 (batch number: 010031A, expiration date: JUNE 2014) at a dose of 0.5 ml intramuscularly in to the left arm on 24 NOV 2013 at 6:00 PM. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).  Follow-up received from the pharmacist on 26 MAR 2014: Updated site and time of application of FLUCELVAX.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 26 MAR 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "adult product administered to child".
Seizure; muscle spasm; weakness; hard to breathe at time; can't stay awake; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3346), via an unspecified route of administration at Left arm on 15Jan2021 08:00 at single dose for covid-19 immunization.  Medical history included seizure, asthma, known allergies to penicillins and NSAIDs. Concomitant medication included levetiracetam, escitalopram, phenytoin, lamotrigine. The patient previously took naproxen, azithromycin, clindamycin; all experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 at time of 08:30, the patient experienced seizure, muscle spasm and weakness, hard to breathe at time, can't stay awake. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the seizure and other reported events due to temporal relationship.   Of note, the patient has a medical history of seizure disorder.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Irregular breathing...patient was fine the first two day after he was born, no usual breathing. Right before we left the hospital they gave him the hepatitis vaccine with out consent and within a few hours I noticed he was breathing very funny. I took him to the doctor, they said he looked ok. Just to monitor his breathing. He had several issues with his nose being stuffed and they told me to get a humidifier to help with his breathing. Within a month or so his respiratory issues seemed to have cleared up. (he would breathe ok then suddenly breathe very heavy it went in intervals it continued for several weeks after he received the shot)
Pt says arm is sore and sensitive to touch at the injection site. Pt came in to be viewed by the pharmacist. Upon inspection, injection site is slightly more red than surrounding area and area of redness is slightly larger than size of quarter. Gave pt ice pack and recommended TYLENOL (pt unable to use NSAIDs). Told pt to continue to observe site and monitor pain. If any increase in site or pain, to call pharmacy again. Also, left note for pharmacy to call on Sunday 12/23 to follow up with patient.
Breakthrough case admission after 4 vaccines Pfizer 3/4/2 Lot# EN6205;  Pfizer 3/25/21 Lot# Er8733;  Pfizer 10/4/21 Lot# FF2588;  Pfizer 4/28/22 Lot# FJ9943
Pt. states 04/12/2021 vaccination day feeling nauseous shortly after but subsided through the night. 05/29/2021 stated itching in palms, headache, feet started itching.  Rash covering back, chest, arms, and legs. ER 06/02/2021 (steroid shot), 06/18/2021 visit with Allergist, Allergy test preformed (stated she was allergic to herself). Producing too much histamines/ histamine blockers prescribed.
On Sunday July 25th I noticed a little arm discomfort but I didn't pay much attention to it. On Tuesday July 27th started itching a little and I noticed that it was warm to the touch. On Wednesday July 28th contacted my doctor's office she suggested Tylenol and an ice pack on the location and if it's still the same to come see her on the following day.
The cases were received on 21 March 2014 at GPV. Initial misuse report received from a health care professional on 16 September 2013. This case was linked to case # 2014SA040017 (same vaccine same reporter). A 12-year old patient had received FLUZONE ID. It's an inappropriate age at vaccine administration. No adverse event was reported. List of documents held by sender: none
constant crying more than 72hr, irritability, T101 APAP relieved would not eat as of 7/30/99 child was being taken back to clinic;pt placed on phenobarb 7/26/99 & still irritable & not eating & phenobarbitol not helping according to grandma
pt recv vax 20OCT97 & 22OCT97 pt devel a local rxn @ the inj site which was described as redness approx 2inches in diameter w/some swelling & warmth;
Site of injection red, warm to the touch, swollen, and itchy. Pt started on Medrol Dosepak
Severe elbow pain/shoulder pain in right arm.  Unable to lift more than 1 in. Unable to fully extend right arm.  Fatigued and extremely tired - lump for two weeks with localized redness. Anthrax #2.
erythema, induration approx 2 inches in diameter & heat @ site of inject; inc prurutis @ site of inject;
24SEP exp local rxn/swelling & vesicles;25SEP pt exp fever, chills, fatigue, pustular lesions & pruritus;
She got her vaccine, she had no reaction, did not hurt and was told to put a face cloth in the bag and freeze it.  Around 12 hours later she started to get cold, could not get warm.  She put blankets around her feet and then kept getting colder.  She laid on the bed and then she started to shake from what felt like the inside the body.  Her knees started shaking and could not stop shaking and freezing.  Then she got scared as she has never had anything that felt like that.  She rolled out of her bed and became weak as she was not able to push herself up, her wrist gave out.  She tried to get up after that and her whole body started shaking, her arms and had no control over her body.  This went on for about 20 minutes.  Then she sat down on the bed and her husband said that she was shaking the whole bed.  The entire event lasted for about 2 hours.  She was thinking what she might have, epilepsy, Parkinson's disease.  She was ready to go tot he hospital.  She laid back down at home, still shaking and her husband was looking up stuff and she was not able to stop the shaking, her arms, legs, shoulder, the core of her body was shaking inside.  Then finally she started to get hot around an hour or two later.  She did not sleep all night as she was afraid that if she closed her eyes she would not open them again.  She then began sweating profusely, she got up and was weak, and went back to bed.  She stayed that way the entire night.  The next morning she still felt weak, went around with a cape on her shoulders and gradually it went away.    The next week she got the flu shot and reported that she did have a reaction to the COVID shot.  She had no reaction to the flu shot other than it hurt more in the arm than the other one, but otherwise no reaction.
When I caught COVID I had really mild cold symptoms. I had a lot of sneezing and a very stuffy head. I had no fever. My cold symptoms lasted about 5 days. 2 weeks after that I had heart palpitations that lasted about 5 days. When I walk my heart would get up to a certain number of beats. When I would do cardio exercises I would get heart palpitations. I didn't have any coughing or lung involvement issues. My primary care doctor said I should get the monoclonal antibody infusion but I ended up not getting one because it was too much of a hassle. Some people were saying that it wasn't necessary to get. On 1/5/2022 I had a consultation with my PCP.
Muscle pain in arm of injection about an hour after injection (~2pm); about 3 hours after injection, coughing (~4pm); about 3.5 hours after injection, wheezing and swelling of throat-- I could not swallow. This was shortly after I had called my doctor's office. (~4:30pm). Ambulance called at ~4:45 and emergency treatment received.
Pain during injection, dizziness, nausea, and tinnitus for about 5 minutes after vaccination
On 5/23/2021 I experienced a seizure, and again on 5/9/2021.
Brain fog; headache; tired; nausea; extremely hot feeling; itchy all over; face tightness; This is a spontaneous report from a contactable other HCP (patient reported herself). A 46-year-old non-pregnant female patient received first dose of BNT162B2 (COVID 19, PFIZER, Solution for injection) via an unspecified route of administration, administered to her left arm on 05Mar2021 02:30 PM (Lot number: EL9267) as single dose for Covid-19 immunisation. The patient's medical history included high blood pressure (BP), chronic obstructive pulmonary disease (COPD) and post-traumatic stress disorder (PTSD). Known allergies: any caine medicine. Facility type vaccine: Public Health Clinic/Veterans Administration facility. Concomitant medications included lisinopril and tramadol (other medications in two weeks). On 05Mar2021 05:30 PM, the patient experienced brain fog, headache, tired, nausea, extremely hot feeling, itchy all over and face tightness. No COVID tested prior or post vaccination. The patient did not receive any treatment in response to the events. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
PATIENT EXPERIENCING DECREASED APPETITE AND FUSSINESS OFF/ON X 2 DAYS, THEN UP TO 12 LOOSE SMELLY STOOLS IN 24 HOURS. NO VOMITING SOME CRAMPING NO FEVER
sore painful arm for close to a month; This is a spontaneous report from contactable Physician via Pfizer Sales Representative. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced sore painful arm for close to a month after receiving vaccine administered in the arm on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Palpitations in my heart after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations in my heart after second dose) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 491B21A and 019D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Palpitations in my heart after second dose). The patient was treated with PREDNISONE for Adverse event, at a dose of 1 dosage form. At the time of the report, PALPITATIONS (Palpitations in my heart after second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-396037, MOD-2021-396143 (Patient Link).
pt was hospitalized w/in the last 6 months for kidney disease recvd flu vax on 30OCT92; 6 wks after the pt was found to have antibodies to Hep C & elevated liver enzymes;
On 1/6/22 patient was diagnosed with Acute deep vein thrombosis of femeral vein of lower extremity. Patient has had groin pain for 10 days prior.