chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This retrospective pregnancy case was reported by a healthcare professional (nurse) and described the occurrence of missed abortion in a 16-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline), GARDASIL (non-gsk) and VARIVAX (non-gsk) during pregnancy. Concurrent medical conditions included postural orthostatic tachycardia syndrome. On 1 December 2011 the subject received 2nd dose of HAVRIX (720 elisa unit, unknown, left deltoid), 2nd dose of GARDASIL (unknown), 2nd dose of VARIVAX (Non-GSK) (unknown) and experienced and vaccine exposure during the first trimester of pregnancy. The subject was "one or two weeks pregnant" at the time of the vaccination, but did not know she was pregnant. Date of last menstrual period and estimated delivery date were not provided. On 26 January 2012, 56 days after vaccination with GARDASIL, HAVRIX and VARIVAX (Non-GSK), the subject experienced missed abortion. "No heartbeat was detected on a routine OB/GYN (Obstetrics and gynecology) exam on 26 January 2012". On 27 January 2012, the subject experienced d & c (dilatation and curettage) on an out-patient procedure basis. The healthcare professional reported that it was unknown if the events were related to the administration of the vaccines. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. The healthcare professional reported that she also contacted Merck.
receiving only the AS01B adjuvant; receiving only the AS01B adjuvant; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 3N3GH, expiry date 28th January 2023) for prophylaxis.   On 21st June 2022, the patient received Shingrix. On 21st June 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 21-JUN-2022 Reporter's comment: The patient was administrated only the AS01B adjuvant of Shingrix. It was administered prior to reconstitution. The reporter was consented to follow up. Additional Supportive Information: The patient received only the AS01B adjuvant of Shingrix. It was administered prior to reconstitution, which led to inappropriate preparation of medication and Inappropriate dose of vaccine administered.
I contracted Covid-19 approx 1 week after getting the vaccine. I do not believe that the vaccine gave me Covid. But, I believe that it made me more susceptible. The week of receiving the vaccine my daily schedule was approx  80-90% covid patients. I do Physical Therapy in a hospital with them and spend approx 30 min or more with each patient.  If I or my facility would have been given a warning  my schedule could have been different.  Our therapy team might have been allowed to change the individual patient load depending on when each person recvd the vaccine. I am older and have a few underlying conditions so I was concerned about contracting it.  Luckily I was able to stay home.  *main take-away is that health care facilities should have been given more information and guidance on how to change schedules to best protect the employees if the vaccine causes a reduction in immunity right after.    I asked the question in a Facebook group for therapists and many of them did get covid right away.  Coincidentally?  Could be. But for sure something to keep track of.
Signs and symptoms/reaction to the moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Signs and symptoms/reaction to the moderna shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION COMPLICATION (Signs and symptoms/reaction to the moderna shot). At the time of the report, VACCINATION COMPLICATION (Signs and symptoms/reaction to the moderna shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
My arm started hurting about 2 hours after my shot and that lasted from Saturday evening and had subsided by Tuesday.  Then, the following Saturday, (7 days after  the shot) my arm started to hurt again.  It's now Tuesday and it still hurts and feels stiff.
got the flu; Initial information received on 23-Dec-2022 regarding an unsolicited valid Social Media non-serious case received via consumer.  This case involves an unknown age and unknown gender patient who got the flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation, route, administration site, strength, lot number, expiry date: not reported) for prophylactic vaccination.  On an unknown date the patient had a non-serious event of got the flu (influenza) (unknown latency) following the administration of influenza vaccine.  It was reported: Got my flu shot. Also got the flu  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event got the flu.
18MAY94 mom presented w/pt for 15mo shots; mom stated pt was adm 2SEP93 w/t105 & sz following 1SEP93 immun; hosp called 10JUN94 to request ER record & hosp states pt adm 14SEP94 for OM;
Mild Flu like symptoms; This spontaneous case was reported by a pharmacist and describes the occurrence of INFLUENZA LIKE ILLNESS (Mild Flu like symptoms) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029l20a) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Mild Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Mild Flu like symptoms) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter.   This case was linked to MOD-2021-023022 (Patient Link).
The vaccine is metabolized through CYP450 same as the topiramate. On day 7 after the second vaccination, my migraines returned. They have been under complete control for over 5 years. I have had to increase the dose of topiramate in order the stop the migraines somewhat. My main concern is that topiramate is also used for seizures. If a person taking this for seizures has the same reaction as I did, they may have seizures shortly after their second dose of the MRNa vaccination (either Pfizer or Moderna).
Rash noted on cheeks and arms (flushing in appearance) went away in 2 minutes. Gave Benadryl and Tylenol and observed pt for 30 mins still had normal exam No rash 4/5/07
red hive like reaction (rash) some labored breathing treatment was watched in office x 30 mins;
Syncopal episode 1 day after receiving COVID vaccine #2. Labwork in ER afterwards normal. Suspect vasovagal syncope.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose03/27/21 2nd dose04/19/21 Diagnosed covid positive:08/12/21 Symptom onset:08/10/21 Exposure:travel Symptoms:fever, cough,loss of smell/taste, chills, HA
Breast cancer; Sore arm with all 4; After dose 2 exacerbation of psoriatic arthritis symptoms; This spontaneous case was reported by a non-health professional and describes the occurrence of PSORIATIC ARTHROPATHY (After dose 2 exacerbation of psoriatic arthritis symptoms) and BREAST CANCER (Breast cancer) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21A, 012L20A and 039K20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy (Sulfa allergy), Drug allergy (Zofran allergy) and Psoriatic arthritis (psoriatic arthritis symptoms).   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced PSORIATIC ARTHROPATHY (After dose 2 exacerbation of psoriatic arthritis symptoms) (seriousness criterion medically significant). On an unknown date, the patient experienced BREAST CANCER (Breast cancer) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Sore arm with all 4). At the time of the report, PSORIATIC ARTHROPATHY (After dose 2 exacerbation of psoriatic arthritis symptoms) had resolved with sequelae and BREAST CANCER (Breast cancer) and PAIN IN EXTREMITY (Sore arm with all 4) outcome was unknown.            Concomitant medication information was not reported.  Patient had received increased dose of autoimmune medication.  Patient had received Covid-19 treatment from 14-Aug-2023 to18-Aug-2023.  Company Comment This spontaneous case concerns a patient of unknown age and gender, with medical history of Drug allergies and Psoriatic arthritis who experienced the seriousness medically significant unexpected events of psoriatic arthropathy, breast cancer and the unexpected non-serious event of pain in extremity in the context of 3rd. dose of  mRNA-1273 vaccine. After 2nd. dose the patient referred exacerbation of psoriatic arthritis symptoms; approximately one month after 3rd. dose, the informed that the patient was diagnosticated breast cancer. As per data available to date, there is no evidence that mRNA-1273 vaccine can cause cancer or relapses and vaccine does not modify DNA. On the other hand, COVID-19 mRNA vaccines are recommended in cancer patients as protection from a possible SARS-COV-2 infection. The medical history of Psoriatic arthritis is a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2023-739305 (Patient Link).
Bell's Palsy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Bell's Palsy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history provided).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced FACIAL PARALYSIS (Bell's Palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Bell's Palsy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
within 24 hours; near syncope, brain fog, fatigue/weakness, exac of underlying anxiety secondary to symptoms; these have been episodic.  Brought to ER The Four Paramedics that came to take her to the ER stated they were overwhelmed with calls for post covid vaccine problems and that ALL of their vehicles were out on calls many due to this.  Agressive workup including CT, EKG, Cardiac monitoring, CTA neck and Brain, Carotid and peripheral dopplers and vascualar surgeon consultation revealed nothing. Told it temporally had to be assoc with the vaccine??  I am reporting so that this can be evaluated for confirmation.
This vaccine really exacerbated my tinnitus in my left ear. I actually noticed an increase post the second vaccine, however post this third vaccination it has become very bothersome. It has been a week and it has NOT improved any. I was also very very light headed and had mild fever, body aches for 2 days post vaccine. I still have some light headedness post 1 week.
Redness, warmth and swelling. Warmth remained, swelling and redness increased to aprox 4"diameter between shoulder and elbow.
1st dose in 2018, is late for 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (the patient received the 1st dose of Shingrix on unknown date in 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 Information: GSK Receipt Date: 21-APR-2022 Reporter's Comment: The reporter did not have the exact date of administration or the lot/expiry in their records. The reporter consented to follow up.  Additional Supportive Information: The patient did not receive the second dose of Shingrix till the time of reporting, which led to incomplete course of vaccination.
Cellulitis in their arm; Injection site became hot; Injection site became itchy; Injection site became hard; Injection site became red; Injection site became swollen; A spontaneous report was received from a consumer concerning a 60-years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events cellulitis in their arm/cellulitis, injection site became hot/vaccination site warmth, injection site became itchy/vaccination site pruritus, injection site became hard/vaccination site induration, injection site became red/ Vaccination site erythema and injection site became swollen/ Vaccination site swelling.   The patient's medical history was not provided. No relevant concomitant product use was reported.  On 09 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 022M20A) in the left arm for prophylaxis of COVID-19 infection. The route of administration was unknown.    On 09 Mar 2021, the patient reported that the injection site was itchy, red, hot, swollen, and hard. On 19 Mar 2021, the patient consulted her doctor, who determined that the patient's arm was infected, and she has developed cellulitis in her arm.  The event cellulitis was considered as medically significant event.  The doctor prescribed a course of antibiotics.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event of the injection site was itchy, red, hot, swollen, hard, and cellulitis was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
PATIENT RECIEVED VACCINE AT AROUND 3:20pm 9/28/06. At around 7pm had itching and hives on arms and a few on chest. Patient's wife called pharmacy ask what they should do. Advised to take benadryl and contact MD if symptoms got worse and to phone their doctor in the morning. Talk to wife following day patient doing fine.
started out on 4/3/2021 in the morning with a rash down my right leg and right hip
Just finished administering the Moderna vaccine and whilst still having a conversation with the patient I was about to start the clock  on the timer to monitor the patient when his eyes rolled over, the patient slumped in his chair and fell to the floor.  He jerked twice then his eyes opened and he looked very confused trying to figure out where he was. I let him stay  on the floor for about two minutes and then I helped him get up and sit back into his seat.  I monitored him for 30 minutes. There was no difficulty in breathing, shortness of breath or tightening of the airways. No swelling of the face or other sites of the body where observed.  The patient was able to carry out a normal conversation.  Once the 30 minutes where I released the patient and advised him to get in touch with his primary care physician, Dr.
10/26/01-Prescription for Amoxicillin for ear infection; 10/31/01-1 year old vaccinations; 11/6/01 to 11/10/01-Rash from Amoxicillin (?); 11-14-01-Seen by doctor, losing weight, not eating, prescribed Polycose and sent home, vomiting and said it was flu. On 11/17/01, dx'd with diabetes by ER staff. Follow up information received 10/18/02 stated, "She has Type 1 diabetes." Annual follow up received on 08/20/2003: "Vaccine recipient did not recover from the adverse event that was reported for this vaccination.  COMMENT: Type I Diabetes."
This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 71-year-old male patient who received SHINGRIX for prophylaxis. On 10th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm, tiredness, sweating, influenza-like symptoms, neuralgia, shivering and diarrhea. On an unknown date, the outcome of the pain in arm, tiredness, sweating, influenza-like symptoms, neuralgia, shivering and diarrhea were recovered/resolved. It was unknown if the reporter considered the pain in arm, tiredness, sweating, influenza-like symptoms, neuralgia, shivering and diarrhea to be related to SHINGRIX. Additional details were provided as follows: This case was reported by other health professional for himself. The patient received 1st dose of SHINGRIX in the right arm. After receiving SHINGRIX, the patient experienced sore arm, diarrhea, tiredness, sweats, chills, neuralgia and flu like symptoms which lasted for total of 4 days. This case has been linked with case US2018163104, reported by same reporter.
Diarrhea (6 times per day); Weakness; Muscle ache; Headache; Chills; Nausea; Vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhea (6 times per day)), ASTHENIA (Weakness), MYALGIA (Muscle ache), HEADACHE (Headache) and CHILLS (Chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]), ATENOLOL and HYDROCHLOROTHIAZIDE for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced DIARRHOEA (Diarrhea (6 times per day)), ASTHENIA (Weakness), MYALGIA (Muscle ache), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, DIARRHOEA (Diarrhea (6 times per day)) had resolved and ASTHENIA (Weakness), MYALGIA (Muscle ache), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication were not reported
A spontaneous report had been received from a Health Professional concerning an adult female patient. The patient had received nasal FLUMIST (intranasal), 0.2 millilitres, unknown for influenza on 19-Oct-2015. Nurse reported that FLUMIST was inadvertently given on 19-Oct-2015 as one full dose up one nostril to an adult female. The outcome of the event of full dose up one nostril was unknown. The company physician assessed the reported event to be non-serious.
This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 62-year-old female patient who received SHINGRIX (batch number 32PE4, expiry date 23rd January 2021) and (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. On 10th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, neck swelling, labored breathing and swelling of elbows. On an unknown date, the outcome of the extensive swelling of vaccinated limb, neck swelling and labored breathing were recovered/resolved and the outcome of the swelling of elbows was unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, neck swelling, labored breathing and swelling of elbows to be related to SHINGRIX. Additional details reported as follows: The patient received SHINGRIX on left deltoid. The patient experienced swelling the size of a baseball, in the arm where the vaccine was given. The swelling went down to the elbow and up to the neck. The patient experienced labored breathing. The swelling took 3 weeks to resolve and the labored breathing lasted one evening.  The healthcare professional did not know how soon after the dose of SHINGRIX that the events started. The patient did no go to the emergency room.
Sweats, nausea, muscle spasms in the injected arm for 24 hours.  Spasms went away and came back a couple of days later and have continued off and on.   On 3/3/21 a mild fever and on 3/4/21 "covid arm" at the injection site.  It is red, very itchy and hard and swollen.
Patient describes developing painful case of shingles one week after second Pfizer vaccination.  Pain and rash broke out in peri-orbital area with pain in the temples, sinuses, and above the eye.  The pain and rash lasted for 2 to 3 weeks.  She had no prior history of shingles. It healed completely and left the patient with no long term symptoms.
Itching - rash - swelling (lip, arm) -  trouble breathing - started with itching and progressed to trouble breathing.
This spontaneous report as received from a healthcare worker refers to a 12 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 16-MAR-2016, during the same vaccination session, the patient received PROQUAD (Merck) lot # L045676, expiry date 09-MAY-2017 (dose, route and site of administration were not reported) and VARIVAX (Merck) lot # L037561, expiry date 29-SEP-2017 (dose, route and site of administration were not reported). The patient was accidentally vaccinated with PROQUAD (Merck) instead of M-M-R II which was the intended vaccine. The reporter said, who was also the person who administered the vaccines, that she confused these two vaccines, as she did not know PROQUAD existed. No adverse effects were reported. Additional information has been requested.