chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Administered second bivalent Moderna COVID-19 vaccine at 1:30 reporting day after a previous dose of the Moderna Bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (Administered second bivalent Moderna COVID-19 vaccine at 1:30 reporting day after a previous dose of the Moderna Bivalent vaccine) 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)) (batch no. 045H22A) for COVID-19 prophylaxis.     The patient did not received any other vaccines prior to COVID-19 Vaccine.  Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE and BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5). Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE and BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5).    On 11-Apr-2023 at 1:30 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Apr-2023, the patient experienced EXTRA DOSE ADMINISTERED (Administered second bivalent Moderna COVID-19 vaccine at 1:30 reporting day after a previous dose of the Moderna Bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Administered second bivalent Moderna COVID-19 vaccine at 1:30 reporting day after a previous dose of the Moderna Bivalent vaccine) 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 EXTRA DOSE ADMINISTERED (Administered second bivalent Moderna COVID-19 vaccine at 1:30 reporting day after a previous dose of the Moderna Bivalent vaccine).    No concomitant information was reported. It was reported that no other symptoms were there and no additional doses medications or treatments administered in response. This case contains information for the 1st patient out of 2 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-719304 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719304:2nd patient case
~3-4 days following vaccination c/o severe abdominal cramping and bloating. Went to ER d/t suspecting appendicitis.
I'm not sure which series of shots caused but at 7 months we finally brought our son in due to sleep apnea which started somewhere after he was 6 months after his vaccinations. He started having vomiting; Congestion; And sleep apnea.
I exp fatigue, arm soreness, body ache and flare of Psoriasis lasting 48 hours,
This spontaneous report was received from a physician refers to 4 patients of unknown age and gender. On 01-APR-2013 the patients were vaccinated with GARDASIL (lot# H021608, expiration date 13-AUG-2015, route not reported). The physician noted that GARDASIL was shipped on 27-MAR-2013 and did not arrive at the office until 01-APR-2013 and the GARDASIL was in the shipper the entire time. The physician's office could not determine the exact temperature the GARDASIL was exposed to while in the shipment from 27-MAr-2013 to 01-APR-2013. No patient contact details available. No further information was available. Additional information has been requested.
Patient received her COVID-19 booster (Pfizer/BioNTech) at the Health Department on 12/20/2021 at 1:15 pm per father.  She started to have flu-like symptoms that evening at 11:00 pm- fever, achy and sore arm.  She took Ibuprofen 600mg at 11:00 pm and went to bed.  She awoke on 12/21/2021 feeling the same symptoms and took Tylenol 500mg at 8:00 am.  She attended Gymnastics practice from 9:00 am  to 1:00pm and continued with feverish feeling, achiness and sore arm.  She took Ibuprofen 600mg at 1:00 pm.  She started with sharp Right Lower Quadrant abdominal pain at 5:00pm that evening and they continued to rotate Tylenol and ibuprofen for pain/symptom control through the night and next day.  They contacted the pcp via test and office (PA-C) at 8:42 am and 9:21 am on 12/22/2021 with list of symptoms and asked for recommendations - at that point pain was moderate (5 out of 10)  but not worsened with movement, low grade temperature 100-101 believed to be due to recent vaccine.  Pain and fever improved some with over the counter pain relievers (Tylenol at 10:00 am).  Denied nausea, vomiting, diarrhea.  Had normal appetite and BM.  Parents concerned maybe just gas pain.  PCP voiced concern for possible appendicitis and what to watch for and when to go to ED.  Checked in via text at 4:51 pl and no change.  Stable and resting but increased pain now with pressing in RLQ (8 out of 10), afebrile.  PCP recommends ER evaluation.  Patient is taken to ER by father and CT of abdomen and pelvis revealed mildly dilated appendix and fluid-filled measuring up to 9mm, also with some diffuse enhancement of the mucosa minimal infiltrative changes seen around the appendix which could represent appendicitis.   labs were normal including normal white count.  Surgical consult recommended IV dose of cefotetan, rx for Augmentin and discharge home with plan to surgically remove appendix tomorrow since she was stable.  Appendectomy occurred on 12/23/2021 at 4:30pm.  Patient did well with procedure and is recovering as expected.
Redness, swelling, localized fever to injection sight. Redness continued to spread and cellulitis set in. Sight became sore and itched, but no rash appeared. Redness and area of swelling continued to spread. Currently, the area is approximately 6cm around with a raised hot red center.
Information has been received from a nurse referring to a patient of unknown age and gender. Information about concurrent conditions and medical history were not provided. On 03-MAR-2015 the patient was vaccinated with GARDASIL (lot # K006191, expiration date 02-FEB-2017, dose, dose# and route not provided) after it was improperly stored. No adverse effects reported. The outcome of the events was not provided. This is one of several reports received from the same source. Additional information has been requested.
Jan 26, 2021: 3:00 pm, mild fatigue 9:00 pm sound asleep (unusually early for me)  Jan 27, 2021 1:30 am  woke up  feeling hot and perspiring (really unusual for me, but I did not think much about it at the time) 3:00 pm - mild headache ( unusual for me, but I did not take anything for it) 5:00 pm felt mildly unwell and felt mildly chilled 5:30 pm, took temperature - 99.5 - and did not want anything to eat - no nausea, just not hungry. 8:30 pm, took temperature - 100.2, ate some mild cheese and fruit (pear) and coca-cola to settle my stomach a little
PNEUMOVAX 23 given to a 13 months old instead of PREVNAR 13; no reaction was noted in the child; This spontaneous report was received from a physician via company representative referring to a 13 months old female patient. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reaction or allergy were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, batch/lot# and expiration date were unknown, strength and route were not reported) for prophylaxis instead of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) (wrong vaccine administered). No reaction was noted. The outcome of the event was not reported.
I have always had low blood pressure and suddenly I have pretty consistently high blood pressure over the course of repeated doctor visits and monitoring at home (141/100 is my highest so far).
5-10 minutes after vaccination started to vomit for 5 minutes, vital signs assessed and monitored, complained of dizziness
She reports arm started hurting about an hour after vaccine given and then got progressively worse over the course of the night. Bruising started to appear around midnight and her sleep has been very poor due to discomfort. She did take IBU and put cool pack on and didn't really help much at all with pain. She has pain to the point of not being able to raise her arm overhead and it extends around "entire upper arm" and into armpit. There is also a red "ring" on outer portion of upper arm and extending to armpit but not redness centrally in ring. Denies numbness, tingling, weakness of R UE. No fevers or chills or feeling sick. Was slightly dizzy this am when she woke but ate breakfast and that feeling went away entirely, thinks it was because she didn't sleep well.  Denies nosebleeds in last 24 hours, no gum bleeding.  RICE recommended and po keflex prescribed at time of presentation 24 hours after vaccination with improvement noted subjectively and objectively 6/15/22.
Pt vaccinated with DTP/OPV developed high pitched cry onset on the afternoon of 12JUL90.
Pt developed hives two weeks after receiving MMR on May 2014. Also SOB. Pt reported hives on her (L) leg.
Information received from a nurse 2 months post hepatitis b series pt developed gastrointestinal problems such as abdominal cramping and intolerance. Was diagnosed with celiac disease. F/U no new info given.
blurring of vision/blurredness; 1st dose of the vaccine - 26Apr2021; 2nd dose - 04May2022; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (blurring of vision/blurredness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of the vaccine - 26Apr2021; 2nd dose - 04May2022) in a 25-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 056A22A and 018B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in April 2020.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-May-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of the vaccine - 26Apr2021; 2nd dose - 04May2022). On 05-May-2022, the patient experienced VISION BLURRED (blurring of vision/blurredness). At the time of the report, VISION BLURRED (blurring of vision/blurredness) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of the vaccine - 26Apr2021; 2nd dose - 04May2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2020, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication reported. Patient had an appointment on 10-may-2022 No treatment information was provided.
I got the shot yesterday and I almost thought I was going to died; This is a spontaneous report received from a non-contactable consumer or other non hcp (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient reported that I got the shot yesterday and I almost thought I was going to died. The clinical outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Patient received the vaccine on 7/14/21 in the evening. Patient said he woke up on 7/15/21 with a red dot rash on his body that did not itch. He said it lasted for 1 week and resolved on its own.
Hives on back of upper arm; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration on16Mar2021(at the age of 23-year-old), as a single dose for COVID-19 immunisation. The patients medical history and Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. On 17Mar2021, the patient experienced hives on back of upper arm. The clinical outcome of the event hives on back of upper arm was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
bad pain around injection site, Chills that lasted 15 hours and soreness in lower back
Client received AstraZeneca COVID vaccine, no reaction. AstraZeneca vaccine unavailable, Janssen given as an alternative on 09/15/21.
Before the administration of Pfizer COVID vaccine it was diluted by one of the pharmacists on duty, however she did not dilute it with the correct amount of diluent. The proper dilution amount is 1.8 ml of diluent added to the vial, but it was discovered that the vial was only diluted with 0.8 ml. The error was discovered, after 3 doses had been administered. While determining the number of doses remaining in the vial it was discovered  that only 1 more dose remained instead of 3. This was caused by too little diluent being added resulting in each vaccine dose to be a higher concentration that what is recommended.
Sleeplessness, headache, whole body muscle pain, pain in right temple, fever, tinnitus.
Narrative:  The patient received two doses of Pfizer COVID 19 Vaccine in Feb/Mar 2021. The patient tested positive for COVID 19 on 7 February 2022. The patient presented to the ED with cognitive impairment, weakness, and malaise. The patient was admitted and diagnosed to the hospital with COVID 19 with hypoxia, sepsis, and acute kidney injury. The patient was treated with remdesivir and dexamethasone. The patient was discharged on 18 Feb 2022 in stable condition. Reported per EUA.
pt recvd MMR/DTP/OPV/PedvaxHIB & on 28JUL91 pt devel t102.8 to 103; 2 days later pt devel a measles-like pruritic rash & diarrhea; tx @ hosp as an outpatient;
HPI Pt. is a 21 year old female with pmhx of prematurity, IVH, post hemorrhagic hydrocephalus with VP shunt placement, Pt. presenting to the ed with seizure. Per patient and mother: pt saw neurosurgery today for normal office visit with no acute findings. Then was waiting at her pcp office to get a covid vaccine and had an witnessed seizure that lasted less than a minute. Pt did not have head trauma or fall. Mother laid her down on a bench. No bowel bladder incont or tongue biting. The last thing the pt remembers is standing up in the pcp office to walk to another waiting room. The next thing she remembers is the ems team taking her blood pressure. Pt states that currently she still feels confused and her vision feels a bit blurry. Has been in her normal health. Pt denies ha, f, c, n, v, d, abd pain, numbness, weakness, saddle anesthesia.    8/2016 had R VP shunt revision for shunt disconnection. Last shunt imaging was 3/2021 and was stable.  Recent scabies infection on 2/16/22         Review of Systems  Constitutional: Negative for chills and fever.  HENT: Negative for congestion, ear pain and nosebleeds.   Eyes: Positive for visual disturbance.  Respiratory: Negative for cough, shortness of breath and wheezing.   Cardiovascular: Negative for chest pain and palpitations.  Gastrointestinal: Negative for abdominal distention, diarrhea, nausea and vomiting.  Genitourinary: Negative for flank pain.  Musculoskeletal: Negative for back pain and neck pain.  Skin: Negative for wound.  Neurological: Positive for seizures. Negative for dizziness, weakness, light-headedness, numbness and headaches.  Psychiatric/Behavioral: Positive for confusion.
This patient died 11/14/00, from possible SIDS. He was taken to the ER 11/14/00, after being found in his crib cyanotic at 8:30 AM. Autopsy also states pulmonary congestion and edema. Final opinion of autopsy is the infant died because of sudden infant death syndrome.
Patient recieved the vaccine into her left deltoid. Within minutes, reported seeing black spots, feeling dizzy and hot/pale. She then lost consciousness and the pharmacist/bystander held her head to prevent her from collapsing onto the floor. She regained consciousness shortly after and was able to sit up in the chair. The pharmacist took her BP (100/61 mmHg) and she was given water/monitored. EMS were called and arrived within 5-10 minutes. Patient was then taken to ER with EMS.
- Fever x 2-3 days (102.0). - Alternate TYLENOL/MOTRIN. - Swelling to injection site. - Push fluids. -Headache x 2 days. - Vomiting x 1-2 days.
Rapid decline. Patient was reportedly vaccinated (unknown location / brand of vaccine) on 3/4/2021. On 3/5/2021, patient suffered fever of 104, nausea/vomiting, lethargy, loss of appetite, and patient expired unexpectedly.
Vaccine given at 12:00 on 12/6/21. pt woke today with body aches, recurrence of vertigo and changes in depth perception along with fatigue and some disorientation
Initial report received on 21 May 2008 from a physician.  A 61-year-old male patient who is a traveling lawyer, and who has a history of coronary artery disease, and no known allergies, had received prophylaxis post-exposure rabies vaccine consisting of a dose of "RIG" (trade name, manufacturer name, lot number, route and site of administration "unknown") on an unknown date, and five doses of IMOVAX RABIES vaccine on unknown dates.  Approximately four weeks prior to 21 May 2008, the patient received the fifth and last dose of IMOVAX RABIES vaccine (Lot number A0259-2 (route and site of administration not reported).  Approximately three to five days post-vaccination with the fifth dose of IMOVAX RABIES vaccine, the patient complained of persistent malaise, joint pain, myalgias, and muscle discomfort.  Lymphadenopathy was described, but it is not clear if this was localized or generalized lymphadenopathy.  Diagnostic laboratory data revealed a Complete Blood Count, C-Reactive Protein, and Sed Rate tests that were within normal limits.  The patient was placed on low dose steroids for an unknown period of time to help control symptoms.  At present the reporter, who is also the treating physician, plans to recommend symptomatic prescriptions with NSAIDS and if symptoms persist, he will contact the rabies branch at the Centers for Disease Control and Prevention.  At the time of this report, the patient had not recovered.  A corrective version was created on 03 June 2008, using the receipt date from the previous version, in order to amend the coding of RIG in the product screen.  No medically significant new information was added to the case.
Per mother "My MS was caused by son's Varicella vaccine triggering a reaction to the pox already in my system." "His vaccine triggered my MS via pox or shingles/silent"
On March 13, my arm began to itch near the injection site. By evening it was swollen, red, and itchy
This case was reported by a physician via call center representative and described the occurrence of back pain in a 64-year-old female patient who received Shingrix (batch number 524S7, expiry date 31st August 2021) for prophylaxis. Previously administered products included Zostavax (received in 2014) and Shingrix with an associated reaction of pyrexia (1st dose received on 8th June 2018, for tolerance refer case US2018174928). Concurrent medical conditions included atrial fibrillation. Concomitant products included Cardizem, flecainide, Lipitor and Xarelto. On 7th September 2018, the patient received the 2nd dose of Shingrix. On 7th September 2018, immediately after receiving Shingrix, the patient experienced back pain, burning sensation, musculoskeletal discomfort and scapula pain. In September 2018, the patient experienced fever. The patient was treated with Tylenol. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the back pain, burning sensation and musculoskeletal discomfort were unchanged and the outcome of the fever was recovered/resolved and the outcome of the scapula pain was unknown. It was unknown if the reporter considered the back pain, burning sensation, musculoskeletal discomfort, fever and scapula pain to be related to Shingrix. Additional details were provided as follows: The patient experienced pain in same area across top of back as pain after 1st dose, musculoskeletal discomfort, pain across the lateral upper back (across scapula), burning sensation across top of back, all of these events began immediately after receiving dose continued at the time of reporting. The patient tried Tylenol without relief. The fever had resolved without sequelae.
Mom states redness and swelling started Tuesday 8/07/07 in the evening.  On Wednesday 8/8/07 it got worse.  Mom states it kept getting worse and it was at the worst on the 11th of Aug.  Redness and swelling started subsiding during the day of the 11th and then flaired up again on the evening of the 11th of August.  Went away completley on the 13th of August.  Mom states Benadryl was given the entire time.  On 8/17/03 RN examined shot site. Site was without redness or swelling. kr
Covid was before her daughter's 1st dose but got sick after the 1st dose of the Moderna covid-19 vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (Covid was before her daughter's 1st dose but got sick after the 1st dose of the Moderna covid-19 vaccine) in an 18-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Covid was before 1st dose).   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Covid was before her daughter's 1st dose but got sick after the 1st dose of the Moderna covid-19 vaccine). At the time of the report, ILLNESS (Covid was before her daughter's 1st dose but got sick after the 1st dose of the Moderna covid-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive - Before the 1st dose of Moderna vaccine.  mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.  Concomitant medications details were not reported by the reporter.  The patient had COVID and waited the recommended amount of time before she got the 1st dose of the Moderna vaccine. Covid was before her 1st dose but got sick after the 1st dose of the Moderna covid-19 vaccine. The patient also received the 2nd dose of the Moderna covid-19 vaccine, but was unable to provide any dates, lot numbers or expiration dates.  The patient had positive COVID test before the 1st dose of Moderna vaccine.  Treatment details was not reported by the reporter.
Stiffness at injected arm, shoulder, arm and hand; This case was reported by a pharmacist via call center representative and described the occurrence of limbs stiffness in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number F49L5, expiry date 1st December 2021) for prophylaxis.   On 12th December 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced limbs stiffness. On an unknown date, the outcome of the limbs stiffness was not recovered/not resolved.   It was unknown if the reporter considered the limbs stiffness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on an unknown arm. After receiving Shingrix, the patient experienced stiffness at the injected arm, it started on the shoulder and went down the arm and hand.