chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant medications were reported.   No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow-up information included patient's age group updated.
Erythema, slight edema, warmth, slight pain around injection site. Grew to 14 x 9.5 cms. No LOM.
24 hours after shot, bright red about 4 inch spot, raised about 1/4 inch, a little sore but felt hot; lasted 4-5 days then to a bruise for a week, then gone.  Had about 3 weeks of flu-like symptoms a month after vaccine. Due to the circumstances of vaccination that generated this VAERS report, the vaccine manufacturer, the lot number, the injection site and the providers name and phone number were not available to us.
HYPOTENSION 2/1/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Patient started vomiting 7 minutes after receiving the vaccine. Patient vital signs taken by Nurse Practitioner on site . Vital signs stable. Client given ice pack and was given water. Client observed for additional 30 minutes and was able to leave without any further reactions. Advised to of side effects and to go to ER  for  SOB
This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke 4 months after Moderna) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke 4 months after Moderna) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke 4 months after Moderna) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medication information was reported. No treatment medication information was reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company comment: This spontaneous case concerns a 72yearold patient (unknown gender), with no medical history reported, who received a dose of mRNA-1273 vaccine and experienced the serious medically significant unexpected AESI of cerebrovascular accident. Although vaccination date and onset date of the event were not provided, the report mentioned the event occurred four months after vaccination. No further information has been provided for medical reviewing. Patient's age could be risk factor for the event. The benefitrisk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2022-623719 (E2B Linked Report). Sender's Comments: This spontaneous case concerns a 72yearold patient (unknown gender), with no medical history reported, who received a dose of mRNA-1273 vaccine and experienced the serious medically significant unexpected AESI of cerebrovascular accident. Although vaccination date and onset date of the event were not provided, the report mentioned the event occurred four months after vaccination. No further information has been provided for medical reviewing. Patient's age could be risk factor for the event. The benefitrisk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-623719:(same reporter).
An MA reported that a 10 month old male received an injection of Prevnar on 12/4/00. The next day, the infant developed a fever of 102.5F and a large area of induration at the injection site. On 12/6/00, he was seen in an ER and treated with Cefzil (cefprozil), Motrin (ibuprofen) and Tylenol (acetaminophen). The next day, the infant was seen by the physician. On 12/8/00, he was again seen by the physician. At that time, the injection site induration was improving but his fever was reportedly 104.5F. He was referred to an ER where a CBC was performed. His white blood cell count was 4.5, differential was 21%, band neutrophils were 16% and lymphocytes were 43%. A blood culture and a chest x-ray were negative. An unspecified urine test was negative. The ER physician felt that the child had an "acute viral syndrome"; however, the pediatrician felt the symptoms were a "vaccine reaction". On 12/9/00, the infant was seen by the physician. The next day, he developed "whole-body rash". On 12/11/00, he was seen again by the physician who changed the infant's treatment to Zithromax (azithromycin) and Atarax (hydroxyzine). He recovered.
Site is still red, spreading; Site with intermittent sharp pain; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd May 2022, the patient received Shingrix. In May 2022, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-MAY-2022. Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient received Shingrix vaccine on last Tuesday from day of reporting.  The patient said the site was still red with intermittent sharp pain and redness seems to be spreading. The patient asked as how could treat it.
also developed a minor runny nose/occasional nasal congestion that has persisted for at least 3 days (this might also be due to extreme cold weather in my area currently); also developed a minor runny nose/occasional nasal congestion that has persisted for at least 3 days (this might also be due to extreme cold weather in my area currently); mild pain/soreness at the site of injection evening and following day post vaccination; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration (at the age of 53-years-old) on 27Jan2021 11:30 at a single dose in left arm for COVID-19 immunization. Medical history type 2 diabetes. Concomitant medication included metformin (METFORMIN), colecalciferol (VITAMIN D), omega-3 fatty acids (OMEGA-3 FATTY ACIDS), multivitamins with minerals [umbrella term] (CENTRUM) and ''tumeric". The patient previously took azithromycin and experienced drug allergies. The patient experienced mild pain/soreness at the site of injection evening and following day post vaccination, on 27Jan2021 23:00, also developed a minor runny nose/occasional nasal congestion that has persisted for at least 3 days (this might also be due to extreme cold weather in my area currently) on 28Jan2021. No treatment received for the adverse events. The outcome of the events was recovered. The events were assessed as non-serious. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was at Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
On 03-27 Developed Fever, chills, muscle cramps and fatigue. 03-28 Fever and fatigue continued. 03-29 Fatigue and intermittent fever. 03-30 Fatigue and drowsiness.
Reaction of rash on both arms; This is a spontaneous report from a contactable Other HCP. A 30-year-old consumer (patient) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on an unspecified date (at the age of 30 years old) as SINGLE DOSE for covid-19 immunization. The patient medical history was none. Prior Vaccinations (within 4 weeks) was none. The concomitant medications were not reported. The patient experienced reaction of rash on both arms. The onset of event was about 24 hours after patient was administered first dose. The patient did not have to be hospitalized. The patient experienced no other symptoms. The event did not require a visit to emergency room or physician office. The outcome was recovered. The relatedness from reporter of event reaction of rash on both arms was related to Pfizer-BioNTech Covid-19 Vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
PATIENT HAS A REACTION TO THE VACCINE A DAY AFTER SHE RECEIVED MODERNA BIVALENT BOOSTER. SHE HAD A RASH  ON THE LEFT ARM BELOW THE VACCINATION SITE. IT WAS ABOUT 4 CM IN DIAMETER AND WAS ITCHING. SHE WAS RECOMMENDED TO TAKE BENADRYL TABLETS AND APPLY BENADRYL CREAM AND KEEP AN EYE ON SEVERE ALLERGIC REACTION SYMPTOMS. IF THISE HAPPEN SHE WAS ADVISED TO GO TO ER.
Started having fast heartrate; Took COVID-19 test and was positive; Called doctor and was prescribed a ZPAK and told to use nebulizer as needed.
Pt started feeling hot and tingly after getting your first series COVID-19 vaccine. lately started having hot flashes and tingly scratchy throat.  Pt was administered 04 Epi pens (0.30 mg IM) and 01 Diphenhydramine (50MG IM L Deltoid).  Pt was transported to Hospital via ambulance.
swelling, erythema & 4cm induration @ inj site;inc warmth & tenderness;
The covid vaccine vial was reconstituted with normal saline not with the diluent coming with the covid vaccine the one with pink top. This was not the right one. So the manufacturer stated that this is not valid and pt should do another dose in 6 months. Pt was receiving covid booster vaccine at that time.
3. 52 y/o female with no past medical hx c/o "feel like heart is beating fast" 15 mins after receiving the second dose of the Moderna vaccine. She reported that she only had a sore arm and getting the first dose. She was assessed and monitored by NP, EMT and paramedic. She was anxious, cried at times. Initial BP 179/95, 166/103, HR - 79, RR - 16, 02 sat 99% on RA. She was taken outside for fresh air, allowed to remove her mask, instructed on relaxation measures and kept at site until she reported that she was calm, felt better and had no complaints. Repeated BP -138/88. She was given the Vaccination information sheet, reinforced instructions on ADRs/ SEs to call 911and go to the ED, follow up with her PCP and register with V-safe. She verbalized understanding and willingness to comply. She left site in no acute distress, awake, alert, oriented to person, place time, and situation.
Tired for couple of days with 1st dose Moderna COVID-19 Vaccine; Achy for couple of days with 1st dose Moderna COVID-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired for couple of days with 1st dose Moderna COVID-19 Vaccine) and MYALGIA (Achy for couple of days with 1st dose Moderna COVID-19 Vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 FATIGUE (Tired for couple of days with 1st dose Moderna COVID-19 Vaccine) and MYALGIA (Achy for couple of days with 1st dose Moderna COVID-19 Vaccine). At the time of the report, FATIGUE (Tired for couple of days with 1st dose Moderna COVID-19 Vaccine) and MYALGIA (Achy for couple of days with 1st dose Moderna COVID-19 Vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information provided.
On 4/6/01, call from mom stating child had a fever of 106F (axillary) this AM. Notified nurse to return call. Tylenol and Motrin were given with good outcome. Temperature was down to 99F. During the day child was "tired". Fever went up again during the night to 103F Took child to ER on 4/7/01. Dx'd with bilateral otitis media. On different medication now and is doing well without temperature.
Symptoms: Pain in back of neck, right side facial paralysis,  swelling,  right eye not closing,  un even smile. Went to ER.  Diagnosis was Bell's Palsy.  Treatment included a course of prednisone and Valtrex and lubricating eye drops as needed.
Patient received vaccine on 02-Apr-2022, post expiry date of 01-Apr-2022.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 02-Apr-2022, post expiry date of 01-Apr-2022.) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 02-Apr-2022, post expiry date of 01-Apr-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 02-Apr-2022, post expiry date of 01-Apr-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter.  The vial was initially stored in the refrigerator on 04-Apr-2022. The vial did not undergo any temperature excursions. It was reported that pharmacist thought that the vaccine expired in Jun-2022, however it was expired on 01-Apr-2022.  Treatment information was not provided.
Pt c/o rash/hives/pain at site given on day prior to c/o's.
Information regarding PREVNAR was received from a pediatrician regarding a 6-month-old patient who experienced diarrhea.  At 6 months of age, the patient received a dose on an unspecified date.  The patient experienced diarrhea.  No additional information was available at the time of this report.
Pain in the injection site shortly after the injection. Initial health care professional report received on 09 Feb 2010: This patient was vaccinated with FLUVIRIN, (batch no unknown), 0.5 ml intramuscular in left deltoid on 20 Jan 2010 (possibly). On 20 Jan 2010, the patient experienced pain at the injection site after the vaccination. The outcome of the event was reported as condition unchanged.
rt arm w/ 13x10cm area of edema, pain, dec ROM, flu like sx, T >100;tx w/APAP;
Woke with a scratchy throat on 12/20.  By 12/23 I had very bad nasal congestion.     Tested positive on an At Home COVID-19 test, spoke to doctor who proscribed Paxlovid.  Symptoms got much better after 2 days on Paxlovid.  Primary symptom and complaint was congestion, which cleared after 2 days on Paxlovid.  By 10 days after starting Paxlovid, all symptoms cleared up.
Patient reported before the vaccine was administered that she had a history of fainting upon receiving vaccines in the past. As predicted, she fainted within seconds of administering the Janssen vaccine. While unconscious, patient had a few mild head/neck twitches which then progressed to 2-3 full body twitches/spasms before regaining consciousness. Total time unconscious with less than 1 minute. Once fully awake and alert, patient informed me that she had a history of a seizure once before. We gently laid her on the floor and I took her vitals. Vitals were low with BP 90/49, HR 49, and O2 90%. She continued to lay on the floor for approximately 10 minutes before checking her vitals again. At that time, vitals were better with HR 60 and O2 99; I was unable to retake her BP at that time, but patient claimed that it usually was on the low side. She called her mother who agreed to come stay with her to keep watch for more events at her home. A family friend was also called to come pick her up and drive her home. Before leaving, I strongly advised patient to see a doctor to check everything out. Patient just moved here and claims to not have a primary at either location.
This spontaneous report as received from a physician refers to 2 female patients of unknown age. On an unknown date the 2 patients were vaccinated with GARDASIL (dose, route and lot# unknown) in the arm. No other co-suspects were reported. No concomitant medications were reported. The physician reported the 2 patients (anonymous) missed the third dose GARDASIL because they experienced dizziness that lasted a few weeks after they received the second dose of GARDASIL (onset date not reported). It was unknown if they had sought medical attention. The outcome was reported as recovered/resolved on an unknown date. Action taken was not provided. Additional information has been requested.
Patient received Pfizer vaccine at 11 years old. Vaccine not approved for children as of 9/2021.
Tonic clonic Sz activity with high fever to 102.4 degrees.  Spontaneous resolution with post-ictal state x7 20 mins.  Seen in ER, given Tylenol.  Was normal upon exam.  Normal in follow up exam.
fever (not sure hog high, but warm), stiffness & pain in rt leg, sl crankiness, tired;
pt came in with redness/swelling/numbness in left arm where vaccine was administered, pt also reports left sided facial numbness and temperature 101.3 last night , pt also developed a cough
Narrative:  90 y/o M received Moderna covid-19 booster dose on 10/28/2021. About 3 days after dose, developed a pruritic body rash. Denied fevers, chills. He previously had similar rash exacerbations after first and 2nd Moderna shots (1st dose 1/13/21, 2nd dose 2/10/21), but not as severe. He also had intertrigo and was treated with antifungals. He was referred to dermatology who dx xerosis 4/6, 7/7 and 10/14. Current rash thought possibly exacerbated by the booster dose. Treated with hydroxyzine and prednisone.
Horrible pain in arm and entire body.; Horrible pain in arm and entire body.; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Unknown), via an unspecified route of administration in the right arm on 25Mar2021 at 12:00 (at the age of 22-years-old), as a single dose for COVID-19 immunisation. Medical history included P.O.T.S (Postural orthostatic tachycardia syndrome) and fibromyalgia. Concomitant medication included beta blocker (MANUFACTURER UNKNOWN) from an unknown date for unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 22:00, the patient had experienced horrible pain in arm and entire body and reported that she had so much pain that she could not even use a blanket or had anything touching her. It was unknown if the patient had received any treatment for the reported events. Adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events horrible pain in arm and entire body was resolving at the time of report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Shingles; This spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 67-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2016 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated for shingles resulting from her use zoster vaccine live(ZOSTAVAX). At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live(ZOSTAVAX).
Felt severe chills for about 2 hours; became very warm, then fell asleep; Initial information received on 01-Oct-2020 regarding an unsolicited valid non-serious case received from a non health care professional .This case involves a male patient (age not reported) who experienced severe chills for about 2 hours (chills) and became very warm, then fell asleep (body temperature increased), while he received vaccine INFLUENZA VACCINE.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date at 2:30 p.m., the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date at about 10:30 p.m., the patient developed non-serious severe chills for about 2 hours (chills) and became very warm (body temperature increased) (Unknown latency) following the administration of INFLUENZA VACCINE.  Case Detail: Patient started feeling chills at about 10:30 pm. He took his temperature but did not have a fever then he felt severe chills for about 2 hours, then became very warm, then fell asleep  Relevant laboratory test results included: Body temperature - On an unknown date: 100.1 [100.1] and COVID-19 - On an unknown date: Negative.  It was not reported if the patient received any corrective treatment.  On an unknown date, patient had recovered from both the events (Woke up in the morning and felt fine).  There will be no information available on batch number for this case.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced crankiness and neck pain. It was reported that the pt developed a rash at the injection site. The pt presented with a rash on right external ear, the right cheek which is fading and a fever. The physician reported the pt had possible shingles.