chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This would be dose #3; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (2 dose received in 2019).   On 8th September 2021, the patient received the 3rd dose of Shingrix (intramuscular). On 8th September 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were reported as follows: A pharmacist stated she gave the patient Shingrix on the day of reporting and patient states this was dose number 2nd, dose number 1st given in 2019.  The patient's daughter reported that the patient had already received his 2 doses of Shingrix in 2019, and this would be dose number 3 which led to extra dose administered.  They could not find information or paperwork on vaccines to verify dates.  The pharmacist asked for more information on patient who receive three doses of shingrix.  Consent to follow up was granted.
Information has been received from a physician concerning a 7 year old male who on 23-FEB-2000 was vaccinated with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot # "1460J09'). On approximately 04-NOV-2006 the patient started to develop lesions and presented to the physician's office on 06-NOV-2006 with over one hundred lesions. No further information was available. There was no product quality complaint involved. Additional information has been requested. 02/11/2010 Follow up information received froma licensed practical nurse indicated that on 06-NOV-2006 the patient was diagnosed with chickenpox on his back, head, buttocks and groin. It was reported that the patient had greater than 100 lesions on his back. There were no lab tests performed. The patient was treated with (ATARAX) 2 teaspoons orally pm ever 8 hours for 10 days. On 16-NOV-2006 the patient recoverd. Additional information is not expected.
11/17 symptoms began 48 hours after the vaccination. Patient's arm was sore (left). Patient felt nauseous and did vomit for one week.  Patient also has severe itching on her arm and upper chest specifically her nipple. Her nipples (both) are itchy and she has put lotion on her chest area but has not helped.  Pt. has taken vitamin E capsules and cut them in half and placed on her nipples for relief for dryness.  No trouble breathing, no chest pain.    She has not yet seen a doctor yet but is going to see her PCP.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 40-year-old male patient received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: EN5318), in right arm, on 24Feb2021 as dose 2, single (Lot number: EN5318), in right arm and on 05Nov2021 as dose 3 (booster), single (Lot number: 301358A) at the age of 39 years, in right arm, all intramuscular for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jul2022, outcome "recovering" and all described as "COVID Infection diagnosed via rapid test on 03Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jul2022) Positive, notes: COVID test type post vaccination=Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, Covid-19.
Acute  left sensorineural hearing loss with tinnitus.  Significant hearing impairment noted on audiometric evaluation.  Symptoms began a day after receiving the second dose of the moderna vacccine.
Fever, chills, body aches, headache, redness, swelling and hot to touch at injection site. Ibuprofen after vaccine given.  No problem until following day, late morning.  Ibuprofen and tylenol alternating.  Swelling and redness at injection site have increased daily.
Extremely sore arm within hours, by 10 began to fever, woke up around 3:30 a.m with a fever of 102.5, felt overwhelmingly nauseated and fainted in my bathroom, husband described my speech as extremely incoherent, clammy and sweaty, needed assistance getting back to bed, claimed I hadn?t hit my head (I actually think I did lightly- my arm seems to have taken the brunt of it evidenced by a giant bruise, no bruising on head), drank two bottles of Gatorade and continued drinking water, continued to run fever until 3/15 sometime extremely early in morning, fever was accompanied by chills, joint and muscle aches, and headache. Fever always maintained predominantly above 102, dropped to 101 before it broke and went down.
Pt recv vax on 9/30/98; post vax pt exp shoulder pain at vax site; pain when shoulder rotation; joint pain in legs
PATIENT STATED HER THE INJECTION SITE SWOLLEN UP, AND SHE RAN A TEMPERATURE.
I82.409 ACUTE DVT, UNSPECIFIED VEIN 4/13/2022 PNEUMONIA J96.00 ACUTE RESPIRATORY FAILURE 4/24/2022 PNEUMONIA R09.02 HYPOXIA 4/29/2022 PNEUMONIA I82.409 ACUTE DVT, UNSPECIFIED VEIN 4/13/2022 ACUTE DVT OF RIGHT ARM J96.00 ACUTE RESPIRATORY FAILURE 4/24/2022 ACUTE DVT OF RIGHT ARM R09.02 HYPOXIA 4/29/2022 ACUTE DVT OF RIGHT ARM
Myalgia, Fever, Severe headache Started around 6 :00 PM and lasted all night until next day/evening. Resolved with multiple doses of Tylenol and Ibuprofen.
This spontaneous report was received from a patient of unknown age or gender. Pertinent medical history or drug allergies/drug reactions were not reported. On 11-JUL-2015 (reported as 3 days ago), the patient was vaccinated with ZOSTAVAX (lot number, expiration date, dose, strength and route of administration were not reported). There was no concomitant medication reported. On an unspecified date in July 2015, after the vaccination, the patient experienced fatigue, headache, pruritus, swelling, erythema and influenza like illness. At the reporting time, the outcome of erythema, headache, influenza like illness, fatigue, pruritus and swelling was reported as not recovered/not resolved. Additional information has been requested.
Beginning 12/14/2021 I experienced mild itching and occasional hives on torso through 12/21/2021. I had a surgical procedure under sedation (not general anesthesia) on 12/21/2021. The surgeon administered steroids an hour prior to procedure because of my itching and hives. Itching returned evening of 12/22/2021 and I resumed the Benadryl I had been taking since 12/14/2021. 12/23/2021 I experienced a red, swollen, itchy left breast and applied cortisone cream. I took 25 mg Benadryl every 8 hours through 12/28/2021. I began to decrease my dose but had to increase to 6 hr. between doses due to itching, hives and another incident of red, swollen itchy left breast. Continued Benadryl 3X day until 1/1/2022. Gradually decreased Benadryl from 1/2/2022 through 1/10/2022. I have experienced intermittent and decreasing episodes of mild itching since that only required cream. I was unable to reach my doctor or advice nurse during this time.
Patient had typical delayed large reaction involving her hands, arms and trunk that have persisted until present though slowly abating  Delayed Large Local Reactions to mRNA-1273 Vaccine
fever of 103; dizziness; nausea; still was sick for 3 days; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient in her 60's received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PREMARIN; ESTRADIOL. Vaccination history included: Covid-19 vaccine (Dose 1; Manufactuerer Unknown), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "dizziness", "nausea", "fever of 103". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever of 103"; DIZZINESS (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; ILLNESS (non-serious), outcome "recovered", described as "still was sick for 3 days". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reported AE experienced from the Pfizer Covid19 vaccine, really uncomfortable reactions. With the second one patient had a fever of 103, dizziness, nausea, also with the booster, same reaction, but not as bad, she was still was sick for 3 days. Patient is a senior citizen, and is a wreck thinking of taking this booster." She states she's reported this experience to Pfizer before. Patient was asking about receiving the new booster dose of the Pfizer Covid19 vaccine, Bivalent, GRAY cap. She also wanted to know about reports of blood clots.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Today i just can´t get going; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On 25th May 2022, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 25-MAY-2022. Reporter's Comments: This case was reported by the patient via interactive digital media. Today (on the date of reporting) the patient could not get going. The patient asked could this be a possible side effect of the vaccine shot. Additional supportive information: The follow-up would not possible as no contact details were available.
Pt recvd vax in OCT86 U on 13FEB92 pt hospitalized for H. flu epiglottitis; intubated; cultures were pos for H. flu type B; tx included IV ATB; pt d/c 18FEB92; doing well;
loss of vision; Postherpetic neuralgia (PHN); Shingles (herpes zoster); This spontaneous report was received on 15-NOV-2019, from a lawyer via a Plaintiff Fact Sheet regarding a case in litigation and refers to an approximately 62-year-old female patient (pt). Pt's concurrent conditions, concomitant medications and medical history were not reported. On 08-OCT-2014, pt was vaccinated with zoster vaccine live (ZOSTAVAX) (exact dose, frequency, site and route of administration, lot# and expiration date were not reported) for prophylaxis. Pt claimed that she suffered following physical injuries caused by zoster vaccine live (ZOSTAVAX): shingles (herpes zoster), post herpetic neuralgia (PHN) and loss of vision. On 01-JAN-2014, pt was diagnosed with loss of vision (conflicting information - onset date of that event was reported as prior to vaccination with zoster vaccine live (ZOSTAVAX)). On an unknown date in 2015, pt was diagnosed with shingles. On an unknown date, pt was diagnosed with PHN. Pt was treated by a physician in 2015. The outcome of the events was unknown. The relatedness between the event and zoster vaccine live (ZOSTAVAX) was reported as related.  Information was received on 15-NOV-2019, from medical records. Pt had no known allergic reaction to bakers yeast, diptheria toxoid, gelatin, latex or sensitivity to latex, neomycin, polymyxin B, streptomycin, tetanus toxoid and thimerlsol. On 08-OCT-2014, pt was vaccinated with zoster vaccine live (ZOSTAVAX) subcutaneously.  Upon internal review, the events of loss of vision was determined to be medically significant.  All available medical records will be provided upon request.
I had a low-grade fever with a headache and joint pain. Believe I may have rebound COVID-19 after taking PAXLOVID.
Patient received injection and was standing talking to staff several minutes afterwards. She fainted and stood right back up saying she was just looking for something and then fainted a second time. She was assessed by clinical team and released within 1/2 hour. Patient attributes it to "the needle" and was not concerned about situation. She had not indicated prior to injection that she had issues with needles.
Information has been received from a registered nurse concerning a 5 year old female patient with no pertinent medical history and no drug reactions or allergies who on 10-APR-2007 was vaccinated subcutaneously in the right thigh with the first dose of MMR II (Lot # not reported). There was no concomitant medication. The nurse reported that the patient received the second dose of MMR II (Lot # not reported) on 19-AUG-2010 and after the injection the patient developed a quarter sized redness on her right thigh at the injection site. The following day, on 20-AUG-2010, the patient developed a rash on her buttocks. The patient did not seek medical attention. Lab diagnostics studies were not performed. At the time of the report the patient had not recovered. No further information is available.
Menstrual cycle is abnormal, continued for 7 days instead of 3 days with blood clots / Does not appear to be stopping; This spontaneous case was reported by a consumer and describes the occurrence of MENORRHAGIA (Menstrual cycle is abnormal, continued for 7 days instead of 3 days with blood clots / Does not appear to be stopping) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced MENORRHAGIA (Menstrual cycle is abnormal, continued for 7 days instead of 3 days with blood clots / Does not appear to be stopping). At the time of the report, MENORRHAGIA (Menstrual cycle is abnormal, continued for 7 days instead of 3 days with blood clots / Does not appear to be stopping) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications or medical history provided.
Pain in arm/Soreness of arm; Pain in the chest; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm/Soreness of arm) and CHEST PAIN (Pain in the chest) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included IRBESARTAN, ATORVASTATIN, FEBUXOSTAT, CALCITRIOL and LEVOTHYROXINE for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (Pain in arm/Soreness of arm) and CHEST PAIN (Pain in the chest). At the time of the report, PAIN IN EXTREMITY (Pain in arm/Soreness of arm) and CHEST PAIN (Pain in the chest) outcome was unknown.            No treatment medications were reported.
lt arm has a red hot area measuring 7x9cm w/5mm induration @ 10AM Friday
Localized cellulitis after 7 days.  Induration, redness, heat and itch in area  It faded after 3 days. No meds used only ice.
3-26-03 Vaccine administered and client traveled for meetings.  When she arrived and removed her jacket, she noticed red, vesicle type eruptions on her lower left arm and hand.  These eventually spread to the entire left arm, left shoulder and across the upper back and some to the face.  The vesicles were itchy and red but she did not experience fever, illness or pain.  She presented to the Emergency Room where she was diagnosed with reactive resonse, possible SWEET syndrome.  She was given Rx's for Benadryl and Zyrtec.
Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received vaccine past its 30-days expiry date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days expiry date) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022 at 6:37 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022 at 6:37 AM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days expiry date) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   .oncomitant medications were not reported. Treatment information was not reported.
Infant received IZ at 10:45, and at about 18:00, the mother noted that the infants eyes were swollen shut and red. She called her MD and he told her it was invironmental allergies. She was instructed to apply cold packs to the eyes for 2 hours. Infant had no other symptoms.
Pt recvd vax on 30JUN92 & exp brief episode of lightheadedness & nausea; pt was seen by MD; exam was nl; pt recovered w/in a few hrs; No further details were provided;
8 days later large red welt at injection site.  Welt hot to touch, tender and itchy.  Shortly after chest and throat itchy/scratchy feeling.  Progressed to throat swelling and difficulty swallowing.
11 x 4 cm area erythema. Warmth tenderness. Antibiotic and follow up 11/10/14.
Male consumer received Pfizer's COVID vaccine on 18Jan2021 and caught COVID 19 a week ago; This is a spontaneous report from a contactable consumer (himself). A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 18Jan2021 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications was not reported. The patient underwent lab tests and procedures which included sars-cov-2 test: negative in 2021.  Male consumer received pfizer's covid vaccine on 18Jan2021 and caught covid 19 a week ago on Jan2021. The outcome of the event was recovered on an unspecified date 2021.
Flushing on face like sunburn; Ears fill full; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushing on face like sunburn) and EAR DISCOMFORT (Ears fill full) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 01-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 FLUSHING (Flushing on face like sunburn) and EAR DISCOMFORT (Ears fill full). At the time of the report, FLUSHING (Flushing on face like sunburn) and EAR DISCOMFORT (Ears fill full) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report as received from a licensed practical nurse (also reported as registered nurse), refers to a 45 year old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. On 08-OCT-2013, the patient was vaccinated with MMR II (lot number H016132; expiry date 31-AUG-2014; dose and route not provided). No co-suspect or concomitant therapies were reported. It was reported that the MMR II vaccine administered to the patient was exposed to temperatures above 8 degrees C (between 8.09 and approximately 22.36 degrees C), since 05-OCT-2013. No adverse effect had been reported. This is one of several reports from the same reporter. Additional information has been requested.
Initial vaccine was received on March 26, 2021.  Little or no reaction until the following Thursday (April 1) when the injection site seemed to be somewhat itchy.  The itchiness  was not present early in the next day (April 2), but in the early evening (7 PM - 8 PM) it came back.  The next morning (April 3) the injection site was red, warm to the touch and itchy.  Today is April 5 and the redness is still apparent, but the site is not warm to the touch and not as itchy.  After reading an article on "Covid Arm" I decided to wait a few days before seeking regular medical help.  No other symptoms have been observed.
Matches description of 'COVID Arm'.  Some tenderness reappeared around injection site 6 days after injection in evening with light red rash.  Visual red rash increased (about 4"x2"), deepened in color overnight and became swollen in same general area. Became itchy.
couldn't raise my left arm. It scared me.; vaccine is so painful, arm was sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the mobility decreased was unknown.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that the vaccine for shingle was so painful. The patient received dose of Shingles vaccine and experienced arm soreness for a week and he/she could not raise left arm. The patient scared. The follow-up would not possible as no contact details were available.
On 2/4/21 a 53y/o Male arrived to a school to recieve a CoVID Vaccine. PT recieved vaccine and after was placed in observation for 15min. After the 15minute pt began to have a c/c of dizziness. Pt was assessed by onsite paramedic with a determination for a pt to refuse transport. PT signed AMA after hospital cntact made. For further information on pt vitals, treatment, and status please refernce
A  half dose (0.25) was given for the second primary injection, rather than administering a full dose (0.5).
No adverse event. Mom upset that son received influenza vaccine when he was scheduled for MENACTRA and Tdap only. RN gave him MENACTRA and influenza by mistake. Notified mom at clinic and administered Tdap also. Mom states last time he received the influenza vaccine he "was sick for over a month".