chrisvoncsefalvay/vaers-outcomes huggingface dataset:
May not get the second dose on time (may be greater than 36 days) for second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (May not get the second dose on time (may be greater than 36 days) for second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event (No reported medical history).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (May not get the second dose on time (may be greater than 36 days) for second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (May not get the second dose on time (may be greater than 36 days) for second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided Treatment medications were unknown   This case was linked to MOD21-066487, MOD21-066488 (Patient Link).; Sender's Comments: This report refers to a case of Inappropriate schedule of Product administration, for mRNA-1273, lot # unknown,  with no associated AEs.
Pelvic floor muscles contracting with force causing pain to patient, started about 3 to 5 minutes after injection, gave patient 25mg benadryl and effects subsided after around 10 minutes
No adverse reaction - first dose given was the age appropriate Pfizer BIVALENT instead of age appropriate MONOVALENT
Pt recv vax on 11/20/98; on 11/23/98 pt exp local rxn at vax site
Sudden onset body aches, headache, nausea, fever of 102, light sensitivity.
Unconsolable crying for more than 3 hours. Tylenol did not help. Kept on crying in her sleep
Systemic: Abdominal Pain-Medium, Systemic: Diarrhea-Medium, Systemic: Exhaustion / Lethargy-Medium
24 hours after shot, l/arm was swollen from the site to arm pit.  Red inflamed area the size of silver dollar.  Pain and terderness was great.  Loss of sleep for two days. 5 days post vax developed a bruise and hardened knot at site.
I felt dizzy as soon as I got the vaccine. My heart rate increased but nothing to worry about. It took me at least 30 min to feel myself. That afternoon I felt L hip pinching pains and joints pain. A week later I had sudden vertigo , unable to walk normally with no tinnitus or loss of hearing . I took meclizine 50 mg and it helped. It?s already day 5 , vertigo has subsided , I still don?t feel myself but I am able to go around, drive and move. I only feel dizzy at times and feel vertigo when laying down
Idiopathic thrombocytopenic purpura-symptoms started 4 days after vaccination with nosebleeds, gingival bleeding. Two days later , on 11/6 , admitted to the hospital requiring IVIG and steroids. Symptoms resolved after treatment.   Uncertain if associated, though given onset of symptoms with vaccination, report generated.
LAB went into the room to draw blood and the patient said she was very tired and she had just had a shot.  The patient started slurring her words, became sweaty, lethargic, and stated her chest was heavy, and her throat was tight. Provider Dr. was brought to the room to evaluate the patient and he ordered 50 mg of injectable Benadryl, IM which was administered.  Dr. also called a rapid response through our hospital system and that team came as well.  The rapid response team decided to also administer an epi pen 0.3mg IM. After this medication the patient said her throat and chest felt less tight and she started to feel better and the team decided she did not need another dose of epi.The patient was observed for 1 hour in the clinic per rapid response team and left on her own after that.
Pt was given incorrect formulation of the Moderna covid vaccine.  Pt was given Moderna 6m-5y (Blue cap) covid vaccine but should have received Moderna 12+ (Red cap) covid vaccine.
Patient informed nurse on 06/21/2017 that she experienced some tingling bilaterally in hands after receiving Rabies vaccine on 06/14/17. Stated tingling was first noted on 06/15/17.
Noted eight hours after immunization - s/s of chills, headache, soreness at site of injection.  Dizziness this AM.  No erythema or swelling at site.
mom reported to medical examiner that pt had fever (unk amt) the day a/immun & on the evening of 2JUN94 pt was found not breathing the morning of 3JUN; pt looked like had chicken pox;
Sore Left Shoulder; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration in the left arm on 27Mar2021 at 13:00 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. The patient reported unspecified medical history. The patient had experienced unspecified allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medications within 2 weeks of vaccination. On 27Mar2021, the patient experienced Sore Left Shoulder. The patient applied diclofenac sodium(VOTAREN) cream for the treatment of the event. Since the vaccination, the patient not been tested for COVID-19. The clinical outcome of the event sore left shoulder was unknown at the time of this report.   No follow-up attempts are possible; information about lot number cannot be obtained.
TWITCHING; MUSCLE SPASMS; PRESSURE IN BACK; PAIN THRU BACK INTO CHEST; NEUROLOGICAL ISSUES; NAUSEA; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 28Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: MUSCLE TWITCHING (non-serious) with onset 22Jul2021, outcome "not recovered", described as "TWITCHING"; MUSCLE SPASMS (non-serious) with onset 22Jul2021, outcome "not recovered", described as "MUSCLE SPASMS"; BACK DISORDER (non-serious) with onset 22Jul2021, outcome "not recovered", described as "PRESSURE IN BACK"; CHEST PAIN (non-serious) with onset 22Jul2021, outcome "not recovered", described as "PAIN THRU BACK INTO CHEST"; NERVOUS SYSTEM DISORDER (non-serious) with onset 22Jul2021, outcome "not recovered", described as "NEUROLOGICAL ISSUES"; NAUSEA (non-serious) with onset 22Jul2021, outcome "not recovered", described as "NAUSEA".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Noted area at left upper arm measjring 4 1/2 in length 3 1/2 inches width with redness, warmth, swelling.
Fever - 103, staring episode, constant crying, sleepy, jerky motions in sleep.
Teeth hurt; Could not get warm; Could not drink anything because water warm hit bad; This spontaneous case was reported by a consumer and describes the occurrence of DENTAL DISCOMFORT (Teeth hurt), FEELING COLD (Could not get warm) and HYPOPHAGIA (Could not drink anything because water warm hit bad) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 015M20A) for COVID-19 vaccination.     No relevant medical history was reported.  Concomitant products included LOSARTAN, OMEPRAZOLE, ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN 81), CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN, VITAMIN B COMPLEX, ARMODAFINIL, VITAMIN C [ASCORBIC ACID], PROBIOTICS NOS and VITAMIN D NOS for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced DENTAL DISCOMFORT (Teeth hurt), FEELING COLD (Could not get warm) and HYPOPHAGIA (Could not drink anything because water warm hit bad). The patient was treated with IBUPROFEN at a dose of UNK, q4h and PARACETAMOL (TYLENOL) 14-Mar-2021 at an unspecified dose and frequency. On 14-Mar-2021, DENTAL DISCOMFORT (Teeth hurt), FEELING COLD (Could not get warm) and HYPOPHAGIA (Could not drink anything because water warm hit bad) had resolved.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with ZOSTAVAX by a physician to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). In 2014, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient had and would continue suffered ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. Causality assessment was related.
Patient states within a couple of hours of receiveing vaccine, the site became tender, red. Over the course of 7 days, the rash continued to grow into what appears to be cellulitis.
Sunday, December 6- Onset of cold sweats and hypothermia. Monday, December 7- Despite intake of hot liquids, dressing warmly indoors, hypothermia remained- my body temperature went below 93degrees F.  At 7:30pm felt shortness of breath and immediately went to the local hospital emergency room. Symptoms on admission were: diarrhea, chest pain, hypothermia, hyponatremia   Tuesday, December 8- At ~3:45am, I was transferred to cardiology unit of the hospital where I spent the next four days; returned home Friday, December 11 at 11am.
(side effect); This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION COMPLICATION (side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effect). At the time of the report, VACCINATION COMPLICATION (side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter  Treatment information was not provided
GUM SORES; MOUTH SORES; SEVERAL DAYS OF BAD HEADACHES; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced gum sores, mouth sores, and several days of bad headaches. The action taken with covid-19 vaccine was not applicable. The outcome of the several days of bad headaches, gum sores and mouth sores was not reported. This report was non-serious.
My arm became sore about 6pm on 1/16/21  Shortly I noticed my sense of smell was diminished. On 1/17/20 I noticed  my taste gone also so I scheduled a test.  I feel completely fine aside from a slightly stuffy nose and lack of smell and taste.  On 1/18/21 I received the positive results.  I still feel completely fine.  I have not been out or know of anyone with Covid.
diagnosed with covid; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (diagnosed with covid) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (diagnosed with covid). At the time of the report, COVID-19 (diagnosed with covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
large local rxn developing 24hr p/vax erythema measuring 5 1/2 x 11cm @ inj site;inc temp 102 & sore arm;
Woke up several hours after vaccine, with severe shakes, cold sweats, back and head pain and presyncope.  Back to sleep, woke up again with same feeling of fainting. "Almost went to the ED."
I started to develop a headache and became a little nauseous right after. After two days, my fingers started swelling and hurting. I couldn't make a fist. It caused my immune system to go crazy. That lasted about 5 days. After taking Aleve and Tylenol, it helped reduce the pain. My kidney doctor told me to stop taking Aleve because it was interacting with my BP meds. The doctor from Northwest Arthritis prescribed Tramadol to help with pain. I still have pain, but it's tolerable.
No adverse reactions reported, expired vaccine given. Manufacturer stability data supports use of product through 10/19/2022 and we gave the dose on 10/01/2022 but the original manufacturer expiration date was 9/30/2022.
Starting 11/3/17 (one day after vaccine administration), patient had significant swelling on her vaccinated arm from shoulder down to the wrist. All symptoms have recovered as of 11/5/17.
Significant fatigue (couldn't remain sitting), malaise, and chills that progressed to diaphoresis after taking acetaminophen which helped the symptoms resolve on 12/31/2020.  The symptoms returned the evening of 01/01/2021 after eating and resolved with the same treatment.  They lasted about 1.5 hours. On 01/04/2021 had an episode of significant fatigue in the evening that resolved on 01/05/2021 after waking up.
Low-grade fevers for 2 days, arm pain at site of injection (right deltoid) for 4 days; seen in outpatient clinic on day 4 and assessed as right upper extremity cellulitis (tender area of erythema, induration 8 x 7.5 cm overlying right deltoid, no fluctuance or crepitus, but with moderate right-sided tender supraclavicular lymphadenopathy), treated with a 5-day course of AUGMENTIN and plans to f/u in 3 days for recheck; area demarcated in perm ink.
Info has been received from a physician concerning a white female with a history of recurrent ear infections who on 11/7/05, was vaccinated, SC, with the 1st 0.5 mL dose of varicella virus vaccine live (lot 650223/0426R). Concomitant vaccinations given on that same day included the 4th, IM, dose of Prevnar (lot A98341H) and the 1st, IM, dose of influenza virus whole virion 3v vaccine inactivated (Fluzone) (lot U1743KA). The pt developed a red, bumpy (raised lesions) rash at the injection site that did not appear to be classic chickenpox. Unspecified medical attention was bought and the physician was trying to determine if the pt should be isolated. No lab/diagnostic tests were performed. Subsequently, the pt's rash resolved. Additional info is not expected.
I have a mark from the vaccine i got as a child.  I think its a smallpox which i received at birth in 1981.  Only around and on that prior vaccination site is a little swollen and very red.  It itches a lot.  It is raised and red.  My vaccination was 2-4 cm cephalad to the mark.   I was ok until Monday morning a week later woke up with it.  Felt fatigued and achy all day following the next day.  Today, 1/12/21, it is still red with a ring around the prior vaccination and fatigue to follow.
This spontaneous report as received via company representative, from a registered nurse refers to a female patient of unknown age. The patient's medical history included multiple sclerosis. On 04-MAR-2014 the patient was vaccinated with ZOSTAVAX (dose unknown) lot # J011548 dose 1 in the right arm. No other suspect therapy or concomitant medication was reported. On an unspecified date in March 2014 the patient experienced an injection site reaction that was warm, but not raised and about 2 inches in diameter after receiving ZOSTAVAX. And needed to have varicella titers or receive the chickenpox vaccine before starting GILENYA (manufacturer unspecified) not ZOSTAVAX. The reporter specified that the vaccine was not given in the recommended deltoid region of the arm, but underneath the upper right arm. The reporter also stated that the patient was diagnosed with Multiple Sclerosis and was instructed by the physician that she had to be vaccinated before receiving GILENYA (manufacturer unspecified) however when the Field Representative reviewed the product information it stated the patient needed to have varicella titers or receive the chickenpox vaccine before starting GILENYA (manufacturer unspecified) not ZOSTAVAX (off label use). The physician instructed the patient to follow up with the office in 4 weeks. The reporter also reported that the patient stated she's been having reactions to a lot of different things recently (unspecified). The outcome of injection site reaction that was warm is unknown. The reporters relatedness of an injection site reaction that was warm to ZOSTAVAX is unknown. Additional information has been requested.
About 45 seconds to 1 minute after vaccination, the patient passed out.  He was unconscious for about 30 seconds and had no recollection of what happened.
Late evening after vaccine administration, baby's face, neck became swollen. No other apparent distress, such a respiratory difficulty, reported. Dr made home visit to child's home. No medical intervention reportedly needed.
The afternoon after getting the vaccine she noticed a red lump under skin at the site of injection that was around the size of a walnut. She reported it as red and hot feeling. The swelling slowly grew to half an orange sized, the redness area is tennis ball sized. As of the morning of 10/11 the swelling and redness had decreased slightly.  No other symptoms reported.
Up to 23 patients received 2nd doses 30 days beyond the use by date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Up to 23 patients received 2nd doses 30 days beyond the use by date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Up to 23 patients received 2nd doses 30 days beyond the use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Up to 23 patients received 2nd doses 30 days beyond the use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Treatment information was not provided.  The reporter was a clinic supervisor. His clinic administered up to 23 injections, all 2nd doses beyond the 30 day refrigeration window. The doses came from 2 vials, both with same lot number and expiration date. The vials did not undergo a prior temperature excursion. He did not have the date when they were placed in the freezer.  The vials came from McKesson frozen and were removed from freezer and placed in the refrigerator on 12-Apr-2021 where they were stored from 40F to 41F until administered.  None of the doses were kept at room temperature. They were removed from the refrigerator and immediately given to patients. Ten 2nd doses were administered on 26-May-2021 and 11 or more 2nd doses were administered on 23-Jun-2021. All patients received the shots via the same route of administration. The vials were currently stored in the refrigerator awaiting destruction. Upon visual inspection, the vials looked normal.
I received my 1 dose on 3/1/2021 LOT Number 022M20A, and on day 3 03/03/2021, I woke up and having a pre-exciting condition tinnitus with worsen symptoms. I went to see a specialist an audiology at the end of March 2021, he did a general hearing test on me and discovered a significant loss of hearing at a frequency between 3-4000 in my right ear. After Dr. ran the test, he said I wanted you to go see an ENT. On April 16, 2021, I went to see the ENT and I saw the physician assistant she ran another hearing test on me, and it came back with the same results a significant loss of hearing at a frequency between 3-4000.  And on July 29, 2021, they will repeat this test and order an MRI for my right ear. April 28th, 2021 I was given a trail hearing aid for my tinnitus masker by the doctor for two months and after the two months I gave it back because it was not helping.