chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 31Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 01Oct2021 as dose 3 (booster), single (Lot number: FF2588) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 22Apr2022 as dose 4 (booster), single (Lot number: 005M21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing); "reflux" (unspecified if ongoing), notes: Other medical history: reflux. Concomitant medication(s) included: EZETIMIBE; FAMOTIDINE; REPATHA; BABY ASPIRIN; PRILOSEC [OMEPRAZOLE]; ROSUVASTATIN; FLONASE [FLUTICASONE PROPIONATE]; TYLENOL; VITAMIN C [ASCORBIC ACID]; VIT D [COLECALCIFEROL]; ZINC. Past drug history included: Benzodiazepine, reaction(s): "Known allergies: Paradoxical reaction to benzodiazepine", notes: Known allergies: Paradoxical reaction to benzodiazepine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jun2022) so faint it was almost invisible, notes: By Friday my BinaxNow test was so faint it was almost invisible, and I was mostly symptom free; (12Jun2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. COVID 19 Treatment with Plaxlovid from 03Jun2022 to 08Jun2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Administration Error: ?         Pfizer Covid-19 Orange Top vials (Pediatric age 5-11) were diluted and administered following the Pfizer COVID-19 Purple Top vial (Adolescent age 12 and older) preparation and administration instructions. ?         1.8 ml was used to dilute the 1.3 ML vial instead of 1.3 ml. ?         This would change the concentration to 130 mcg/3.1 ml = 41.9 mcg/ml. ?         The dose given out of this vial was 0.3 ml. ?         The children (age 5-11) received 0.3ml x 41.9 mcg/ml = 12.6 mcg.  Pfizer Case #: ID
Pt recvd vax 25FEB92 & 4MAR92 pt devel ache in arm; 6MAR92 fever 101 through 9MAR92 lymph glands in neck swollen, cold, body aches pain, infect @ vax site;
Beginning 11-11-09 right arm tingling and numbness along with right foot/leg and right side of face and neck tingling/numbness/and coldness.  Symptoms are continuing have not resolved. 0 treatment.
general severe inflamation for 5 days. Could not climb stairs, could not walk more than 4 steps without wheezing,  asthmatic cough, migraine, physical exhaustion, Extended asthmatic episode for 3 weeks so far, is being treated.  NOTE: My mother was one of two people in 1959 who had Gulliane Barre after a flu vaccine. The other person who had it died. My mother was hospitalized for several months but survived. Dr. at CDC has details of case.
Sandifer's Syndrome caused by sudden onset of severe acid reflux. Patient had no history of reflux or symptoms of reflux prior to vaccination. Attacks occurred several times per day with patient twisting body and tensing in pain, momentarily losing consciousness, and eyes rolling back into head.
A few hours after vaccination, soreness in the arm, tingling all the way down to the hand. By next morning, body aches, tingling,  headache, chills. Took Advil every four hours, felt somewhat better with the advil. Third day feel a bit better, body aches not so intense, soreness in the arm still there.
Information has been received on 08/07/2001 from a consumer. On 09/09/1997, the 44 year old male pt received an injection of TD vaccine following a cut to her right hand. On 10/27/1997, the pt experienced a "stabbing pain in the middle of her back that radiated up the right side of her shoulder blade and neck with muscle spasms." Since that time, the pt has experienced hair loss, blurred vision, enlarged lymph nodes, flu-like symptoms, shortness of breath, cough, and nasal bleeding.
Headache, HEADACHE, INJECTION SITE PAIN, BODYACHES, CHILLS Narrative:
Vertigo, severe headache, exhaustion, sinus pressure, ear pressure, heart palpitations, racing heart, diarrhea, constipation, enlarged thyroid, high blood pressure
EXPOSURE IN UTERO; This spontaneous pregnancy report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient's parent received covid-19 vaccine ad26.cov2.s (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 exposure in utero. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of exposure in utero was not reported. This report was non-serious. This parent/child case is linked to 20210427241 (Parent).
Father reported the adverse reaction. son experienced limited mobility on the injected arm the second day after vaccination. On the third day, he was experiencing  swelling  and redness below the injection site on the right arm. There was also a big round bump below the elbow, it looked like an insect bite. The redness and swelling slowly went away on the fifth day.
A report was received from a healthcare professional on 5 November 2003 concerning a 50 year old female vaccinee who experienced a 3-4 inch red area which was itchy, painful and hot on the same day as receiving Fluvirin on a 4 November 2003. On 4 November 2003 the vaccinee experienced a 3-4 inch red area which was itchy, painful and hot.  The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
found to have extensive lower extremity compartment syndrome and extensive bilateral lower extremity and left subclavian arterial thrombus and intracardiac thrombus
pt received 1st dose of Shingrix on Sept 8, 2019, developed shingle (one spot near shoulder on her back) on Sept. 9, 2019. also low grade fever, fatigue, red dots around injection site. Currently taking Valtrex for the singles. Pt had a shingle episode in July 2019, recovered, dr. sent her to get shingle shot.
No additional AE reported; Patient was administered expired MMRII; Expired / Administered Vaccine Detail Summary is located within following space.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 04-MAY-2022, the patient was vaccinated with expired dose (expired product administered) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (recombinant Human albumin) lot #: T007231, expiration date: 27-FEB-2022 (exact dose, strength, site and route of administration were not provided) for prophylaxis. There was no temperature excursion reported for affected product as confirmed by reporter. There was no additional adverse event reported.
first dose of Shingrix on 8/18/2018 / had not yet received the second dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on 18th August 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No further events were reported. The health care professional agreed to be contacted for follow up. The reporter did not consent to follow-up.
3-4 INCHES OF REDNESS, LOCALIZED PAIN, FEELING SICK (GENERAL) FOR AT MINIMUM 3 DAYS FOLLOWING INJECTION; NO ANAPHYLACTIC SIGNS; NO TREATMENT REQUIRED.
Intense headache-Days 2-5 Nausea-Day 3-4 Fever (100.1)-Days 2-4 Joint pain-Day 2-3 Lethargy- Days 2-4 Sneezing-Day 4 Diarrhea-Day 4
Information has been received from a licensed practical nurse concerning her female daughter who on an unspecified date was vaccinated with GARDASIL (route and lot # unknown). Concomitant therapy included VARIVAX, MENACTRA and hepatitis B virus vaccine (unspecified). The patient complained that her both arms were swollen and red. At the time of this report the patient had recovered. This is one of several reports from the same source. Additional information has been requested.
patient had heat induration and erythema to right deltoid area and low grade 99.4 oral temp.  Complained of pain in upper right arm restricting movement.  Given oral antibiotic Levofloxacin 500 mg daily for 7 days with resolution when seen one week later.  (Levo chosen for compliance of daily only administration in this patient.)
This spontaneous report has been received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # N002922, expiration date 30-SEP-2018 and lot # L042846, expiration date 15-SEP-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47.5 degrees Fahrenheit for 1 hour 30 minutes. Digital data logger was involved. There were no previous excursions reported. No product quality complaint has been filled. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007678: US-009507513-1709USA007679: US-009507513-1709USA004665.
Day of shot pt cried all day; 12AUG pt was pale, shaking, limp, taken to ER admitted w/resp distress & vomiting; Mom states pt was pale, limp, shaking & seems to go into deep sleep; Had low 02 level; was bagged for short period of time;
Post vax has hives on extremities and trunk. Mom denies any other signs & symptoms. Encouraged Benadryl for children. Went to ER later because rash was not better.
My primary care physician informed me on the use of GARDASIL and how it prevents cervical cancer.  After reading a small pamphlet on the drug I agreed to be administered my first dose sometime in October 2008.  One month after the first initial injection I got a golf ball size knot on my left shoulder exactly where the injection was given.  I had such terrible deep within the muscle so I opted not to have another injection, but I wonder to this day what would have happened if I had, since my arm has never been the same.  I still have some muscle weakness in that arm at the times along with pain where the injection was given.  As well as less of strength in that arm.  Now I told my MD my thoughts and concerns and he just said that maybe it was a good idea I didn't have another.  But like I said what if I had.  I am concerned with this drug.  After my incident I have researched and found that I am not alone, GARDASIL has also been reported to cause moderate to severe migraines.  I really think that more studies should be done on this drug.  And until those studies have been done neither of my daughters will ever have that vaccine!
Pt stated that her arm swelled up down to elbow, was seen at urgent care and given steroids to relieve swelling. She also reported that she was unable to move the arm. She went to the urgent care the same day that the injection was given 8/28/18, and reported the issue to the pharmacy on 9/6/18, a little over 1 week, at this point the patient states that she still has some swelling down to the
Information has been received from a physician concerning a 12-month-old male with no medical history or allergies, who on 08-OCT-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot# 658297/1106U). There was no concomitant medication. On 18-OCT-2007, 10 days after vaccination, the patient experienced "full blow chickenpox (more than 50 lesions)". Unspecified medical attention was sought, no laboratory or diagnostic studies were performed. No outcome information was reported. No product quality complaint was involved. Additional information has been requested.
inconsolable crying 3 hours after immunizations. Mother did not make us aware until she returned for 4 month check up on 10/25/04.
Inflamed joints (hands, ankles, elbows, wrists, toes, feet)
moderate pain in left knee, left thigh, and left hip (the vaccine shot was in my left arm) and the pain continued for weeks and is still happening.  Doctor recommended Tylenol, Ibuprophen which did not help.  Orthopedist recommended Cortisone injection in 3 weeks from now.
Tdap (Adacel) was given instead of DTaP.  Nurse that administered vaccine was filling in at our office.
This was the booster for the shingles vaccine. Scalp was very sore - no lesions - pain moved around crown of head.
Within seconds both arms, hands, fingers went completely numb. After injection had achy severe pain with burning from her shoulder down to her fingers. She have been diagnosed with RSD due to this injury (vaccine) and take nuerontin for nueropathic pain, receive stelute gangalion nerve blocks and now is in physical therapy. Her treatment started early but no one knows it has now almost been 5 month since the vaccine.
Pfizer 4/25/21 and 5/16/21. Positive on 12/30/21
Moderna Covid-19 vaccination :  pain at injection site with swelling beginning 11 hours after injection. could not find treatment online. used Motrin 600 mg with lidocaine patch over injection site. Feeling of generalized tiredness after night of restless sleep. 3 brief incidents of dizziness within 2 hours of injection that resolved rapidly with no harmful affects.
Sudden onset of chills, high fevers up to 104.6 within 24 hours; shivering and profuse sweating over many nights and difficulty getting fever to reduce even when maxed on tylenol and ibuprofen and in a tepid bath. Fevers lasted 4 days and then 11 days after the shot I developed  shingles lesions on my right breast and had to start acyclovir. I also had IV vitamin C and IM Vitamin D to help recover my immune system.
Reaction is 1 week after I received the vaccine.  Large red circle on left arm where vaccine was adminstered.  Slightly swollen.
Pt report  fever of 100.6,  left shoulder blade pain and swelling of the left arm pit. Treatment include Tylenol will continue to monitor.
Consistent mild headache with no relief with otc Tylenol.  Vertigo, feeling dizzy with no relief
Patient indicated in the vaccination room that he would like his flu shot in addition to his Covid vaccine that he was scheduled for.  I verified his age and that he had not received his flu shot yet this season with him and administered the 65+ flu vaccine.  After administration we entered the vaccine into our pharmacy system and a data utilization review indicated that he had already receive one flu vaccine for 2022.
On November 8, 2000, at or about 2:30 PM, the patient received Hepatitis B vaccine. The patient complained of his legs being sore in the evening of November 8, 2000.  On November 9, 2000, he woke up with extreme soreness in his legs and pain with walking.  The mother describes son as "walking like an old man". The mother was advised by PHN to take the son to the MD for evaluation. The patient was seen by family MD, on 11/09/2000 who felt that the patient had a "mild" reaction to the Hepatitis B vaccine but still advised to continue with the series. The patient was ordered to rest with his legs elevated and use Tylenol if needed.
Information has been received from a pharmacist concerning a 64 year old female with no pertinent medical history and no known drug allergies who on 03-MAY-2011 was vaccinated subcutaneously with a 0.65ml dose of ZOSTAVAX (Merck) (lot#: 669865/0362AA) (Expiration: 09-Jun-2012). There was no concomitant medication. On 05-MAY-2011 the patient developed 3 inch wide injection site reaction, skin was not broken but the redness was hard and hot. There was no lab diagnostic performed. On an unspecified date, the patient called the pharmacist. No treatment was given. At the time of the report, the patient had not recovered. Additional information has been requested.
No adverse symptoms. Last years Influenza vaccine given (R) deltoid in error. 9/16/14 3:15pm.
COVID Arm after first vaccine; Hot Left arm Injection Site after first vaccine; Red Left arm Injection Site after first vaccine; Pain Injection Site Left Arm  after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID Arm after first vaccine), VACCINATION SITE WARMTH (Hot Left arm Injection Site after first vaccine), VACCINATION SITE ERYTHEMA (Red Left arm Injection Site after first vaccine) and VACCINATION SITE PAIN (Pain Injection Site Left Arm  after first vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jul-2021, the patient experienced VACCINATION COMPLICATION (COVID Arm after first vaccine), VACCINATION SITE WARMTH (Hot Left arm Injection Site after first vaccine), VACCINATION SITE ERYTHEMA (Red Left arm Injection Site after first vaccine) and VACCINATION SITE PAIN (Pain Injection Site Left Arm  after first vaccine). On 22-Jul-2021, VACCINATION COMPLICATION (COVID Arm after first vaccine), VACCINATION SITE WARMTH (Hot Left arm Injection Site after first vaccine) and VACCINATION SITE ERYTHEMA (Red Left arm Injection Site after first vaccine) had resolved. On 24-Jul-2021, VACCINATION SITE PAIN (Pain Injection Site Left Arm  after first vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-294351 (Patient Link).
My period would have begun week of 4/12, but it never came.  I'm on birth control only to keep my period regular.   I took a pregnancy test to make sure, and it was negative.
Patient reported red, swollen/painful deltoid which happened within 1-3 hours from having vaccination in clinic.  Urgent care sent her to ER  who then treated her with PO antibiotics and steroids.  Patient reports no further symptoms.
Received dose 2 of COVID vaccine (Pfizer) on 1/25/2021.   On 3/24/2021 developed body aches and cough.  Tested positive for COVID.
patient was 16 years of age when the vaccine was given; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient was 16 years of age when the vaccine was given) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 003B2A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 26-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient was 16 years of age when the vaccine was given). On 26-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient was 16 years of age when the vaccine was given) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by the reporter.  No treatment medications provided by the reporter.
Pt recvd vax 12APR91 & following day devel a red patch (size of 50 cent) below the inject site which subsequently got better; later that weekend had fever 104 & was dx w/sinusitis;
miserable flu-like side effects after 2nd shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced influenza-like symptoms (Verbatim: miserable flu-like side effects after 2nd shot). The outcome of the influenza-like symptoms was not resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine.     It was unknown if the company considered the influenza-like symptoms to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-JUN-2023 This case was reported by a patient via interactive digital media. The patient stated that currently going on day 3 of miserable flu-like side effects after 2nd dose.
w/in 1 hrs of vax pt began crying w/unconsolable crying; also had vomiting-crying lasted over 3 hrs-until pt exhaused;
A non-serious spontaneous report of administration of expired product was received from a health professional concerning a 31-year-old male patient after receiving FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 30-Jan-2011. The patient received the expired FLUMIST on 20-Feb-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
The patient requested to be administered influenza and covid-19 vaccine, but on separate days. The patient had requested to be administered their Covid-19 booster on 10/06/2023 and the flu vaccine on 10/10/2023, but the patient completed the consent for the flu vaccine on 10/06/2023. Therefore, the patient received their 2023-2024 dose of the flu vaccine on 10/06/2023.  The patient was scheduled to return to clinic on 10/10.2023 for their covid-19 booster. The patient suffers from memory impairment and upon checking in on 10/10/2023, thought they they had already received the Covid-19 booster on 10/06/2023 and was to be given the flu vaccine. Additionally, there was an error in the transmission between the EMR and immunization registry causing the 10/06/2023 flu shot to not transfer to the registry. This prevented our RN to verify whether a previous dose was given. This caused an accidental administration of an additional flu shot on 10/10/2023. The patient has been monitored and has not had any adverse event. The respective RN has been spoken to and has been assigned required additional training.