chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea (intermittently) since the vaccine; just wait for the nausea to subside
Patient called on 12/1/21 to report she became very ill after receiving her first dose of Moderna on 9/30/21. She states she was very sick for several weeks with difficulty breathing and having to use her nebulizer more frequently. She then began to have chest pains in November and had to take nitroglycerin.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 07Feb2021 as dose 1, single (Lot number: em9810) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Experienced rash; This case was reported by a physician via sales rep and described the occurrence of rash in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th December 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows:  The patient experienced rash after 1st dose but she did not report it . On 5th February 2021 and on 5th March 2021, patient received 1st dose and 2nd dose of Covid Moderna prior to 2nd Shingrix vaccination. The reporter did not have information about dose, route of administration, site of injection, lot number or expiration date and information about the patient such as demographics or telephone number. The reporter consent to follow up. This case has been linked with US2021AMR093961, reported for the 2nd dose of same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR093961:Same reporter.
Information has been received from a medical assistant concerning a 15 year old male with no pertinent medical history and no known allergies, who on 16-OCT-2009 was inadvertently vaccinated with a 0.5ml dose of PNEUMOVAX 23 (lot # 662842/1296X) IM in the right arm, staff error. The patient was in for a sport physical. Suspect therapy included MENACTRA (unspecified) in the left arm. The patient's mother called the doctor office stating child got ill several hours post vaccination on 16-OCT-2009, Friday night. Mom reported that child had high fever, nausea, some vomiting, right arm red, hot, and tender to touch. Same evening child was taken to ER, and seen for a cough. The patient had 101F fever, mild sore throat, and nausea. Nasal test was performed for type A and type B flu. The result was positive for influenza type A. Child was treated with TAMIFLU, ZOFRAN 4 mg, and TYLENOL. The patient was not admitted to hospital, was discharged. The mother stated the patient was "a little better". Follow up information has been received from a medical assistant concerning a 15 year old male with no illness at time of vaccination who on 16-OCT-2009 in the PM was vaccinated with a dose of PNEUMOVAX 23 (lot # 662842/1296X) IM in the right arm deltoid, instead of MENACTRA. The patient also concomitantly received a dose of MENACTRA (lot # 4306IEA) IM in the left arm deltoid in the PM on 16-OCT-2009. The mother stated that the patient became ill with fever and body aches several hours after immunization was given. It was noted that the patient's father had just been diagnosed with influenza type A. The patient required ER room or doctor visit. At time of report, the patient recovered. Follow up information has been received from a medical assistant concerning a 15 year old male with influenza A at time of vaccination, who on 16-OCT-2009 was vaccinated with a dose of PNEUMOVAX 23 (lot # 662842/1296X) IM. On 16-OCT-2009 at pm, the patient had fever and red swelling at site of immunization. Lab test was performed, the patient had influenza A. The patient did not seek medical attention. The outcome was not reported. No further information is available.
1 month after second Pfizer mRNA vaccine for Covid-19, patient developed severe diffuse lymphadenopathy involving cervical, supraclavicular and axillary chains, so severe that she has developed some cutaneous bruising in axillary area and symptoms suggesting brachial plexus compression. Lymphadenopathy is bilateral
headaches; migraine; My endurance has also been greatly impacted and I have not been be able to exert myself for any extended period of time. Ten minutes of light activity is about all I manage.; My endurance has also been greatly impacted and I have not been be able to exert myself for any extended period of time. Ten minutes of light activity is about all I manage.; This is spontaneous report from a contactable consumer (patient). A 36-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in the left arm, at age 36 years, on 08Apr2021 13:30 (Batch/Lot Number: ER8729) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient had not had other vaccines in four weeks prior to the COVID vaccine. Patient had no other medications in two weeks. The patient historically took the first dose of BNT162B2 (Batch/lot number: ER2613) on 17Mar2021 at 02:00 PM on the left arm COVID-19 immunization. Adverse event start date and time was 09Apr2021 at 06:00AM. Patient reported having continuing and persistent headaches since his vaccine. After his second vaccine, he experienced his first ever migraine and it was very intense. Maximum intensity lasted for about 6-8 hours. His endurance has also been greatly impacted and has not been be able to exert himself for any extended period of time. Ten minutes of light activity is about all that he could manage. At the time of report, patient was still experiencing headaches more frequently than ever before. No treatment was received for the events. The adverse events resulted in disability or permanent damage. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.     Information on Lot/Batch number has been obtained.
A report was received from a health care professional on 25 November 2003, concerning a 11 month old male vaccinee who inadvertently received Fluvirin on 14 November 2003. On 14 November 2003 the vaccinee inadvertently received 0.25 ml of Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 1, 11 March 2004: Further information received from a health care professional indicated that the vaccinee did not experience any adverse reaction at the time of the report. No follow up pending, all information received. See Ref: PJP200301183, PJP200400053, PJP200400052, PJP200400051, PJP200400050, PJP200400049, PJP200400048, PJP200400047, PJP200400046, PJP200400044, PJP200400043, PJP200400042, PJP200400041, PJP200400040, PJP200400039, PJP200400038, PJP200400037, PJP200400036.
COVID Disease 6 months after first booster; Hives all over the body 2 weeks after first booster/Urticaria all over the body 2 weeks after first booster; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (Hives all over the body 2 weeks after first booster/Urticaria all over the body 2 weeks after first booster) and COVID-19 (COVID Disease 6 months after first booster) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939909, 009C21A and 006C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, the patient experienced URTICARIA (Hives all over the body 2 weeks after first booster/Urticaria all over the body 2 weeks after first booster). In May 2022, the patient experienced COVID-19 (COVID Disease 6 months after first booster). The patient was treated with CETIRIZINE for Urticaria, at a dose of 10 milligram (2 Cetirizine 10 mg in the Morning); FAMOTIDINE (PEPCID [FAMOTIDINE]) for Urticaria, at a dose of 20 milligram once a day and MONTELUKAST SODIUM (SINGULAIR) for Hives, at a dose of 10 milligram once a day. In May 2022, URTICARIA (Hives all over the body 2 weeks after first booster/Urticaria all over the body 2 weeks after first booster) had resolved. At the time of the report, COVID-19 (COVID Disease 6 months after first booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-1 test: (Positive) Positive PCR Test.         No concomitant medication was reported. It was reported that the Hives did not stop until MA-2022 when she had a positive PCR test. She stopped the allergy medications after she had COVID disease in MAY-2022..   This case was linked to MOD-2022-660888 (Patient Link).
Chill (overnight);  fatigue(2 1/2 days); temp. (only 1 brief time); diarrhea (about 24 hrs)
Abdominal pain, Abdominal distention, severe acid reflux, awake until 4 am with severe abdominal pain,
After 1st dose of Flu High Dose, large area of redness and swelling on her upper arm, causing itchiness and soreness. Advised BENADRYL and MD visit.
Inflamed area at site. 3 cm wheal, lightheadedness, fever, headache.
Hospitalization for acute hypoxic respiratory failure secondary to COVID PNA with concern for superimposed bacterial community-acquired pneumonia on dates 8/29/2023- 9/1/2023. Treated with dexamethasone, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
myocarditis admission to the hospital.  tropoinin I peak at 8.9 Normal LVEF and normal coronary CTA admission 5/16-5/18/2021
on 10/8 - I gave pt these immunizations:  influenza in L arm, and pneumonia in R arm.  Adverse effect was noted in R arm. 10/09/09 pm:  I evaluated his arm - no erythema or edema noted at this time, but advised pt to f/u if s/sx of cellulitis appeared.  He did c/o limited mobility and pain in R arm.  10/10/09 am:  Pt went to PMD due to s/sx of cellulitis.  Given ABX (Keflex)
Lightheadedness, dizziness, blurred vision, elevated BP with normal respiration and pulse, nausea, vomiting, chills, drop in body temp to 96F. Onset 10 mins post injection, increasing over the subsequent hour, subsiding x 1 hr then peaking 5 hrs later, resolved after 12 hours.
EYTHERMA, WARMTH AND TENDERNESS SURROUNDING INJECTION SITE, STARTING DATE OF VACCINATION.
Dizzy, lightheaded, nausea, vomiting, tired, sleeplessness
Severe pain in left and right hip joints; Severe soreness in left and right thigh muscles that extended down to back of knees; Severe soreness in left and right thigh muscles that extended down to back of knees; Wrong vaccine administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 at 16:15 as dose 1 (bivalent), single (Lot number: GJ6739) at the age of 80 years, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "slow urine flow" (unspecified if ongoing); "sluggish stool" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESYLATE. Past drug history included: Known allergies: statin medications, reaction(s): "known allergies: Statin medications". The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 06Oct2022, outcome "unknown", described as "Wrong vaccine administered"; ARTHRALGIA (non-serious) with onset 11Oct2022, outcome "not recovered", described as "Severe pain in left and right hip joints"; MYALGIA (non-serious), PAIN (non-serious) all with onset 11Oct2022, outcome "not recovered" and all described as "Severe soreness in left and right thigh muscles that extended down to back of knees". Therapeutic measures were taken as a result of arthralgia, myalgia, pain.  Additional information: The patient did not receive any other vaccine within four weeks. The patient did not have Covid prior to vaccination and the patient was not tested with Covid post vaccination. AE treatment: Extra Strength Pain Reliever Acetaminophen 500 mg.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
he received the 2nd dose on day 35 after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (he received the 2nd dose on day 35 after the 1st dose) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (he received the 2nd dose on day 35 after the 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (he received the 2nd dose on day 35 after the 1st dose) had resolved. Not Provided          Concomitant medications were not provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Event verbatim updated
Patient stated he didn't feel well after receiving vaccine. Patient stated his throat felt funny, BP 186/94, HR: 117, o2 99%. Patient went to ED for further evaluation.
4 hours after immunization mom stated patient tongue turned blue and face. This responded to tactile stimulation. A second episode occurred where the face and tongue were blue. Mom thought patient was choking on tongue. Neither events were witnessed except by mom.
Left thigh noted to be reddened, swollen and warm to the touch, with harddened ecchymatic area in center. SP DTaP on 05/17/05. Advised to give Motrin and apply cold compresses to area.
Vaccine administered approx. 2 inches (back of arm) below deltoid in adipose tissues. Edema-swelling, heat, pain - 3 inch x 6 inch size - extended to elbow. Lasted 5-6 days. Took ALLEGRA antihistamine 1 tab ea day.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with GARDASIL (lot, dose and route not reported), as a young girl. Concomitant medication was not reported. On an unknown date after receiving GARDASIL, the patient had an abnormal PAP smear. Therapy with GARDASIL continued. The outcome of the event was not reported. Additional information has been requested.
Itchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (Itchy). The patient was treated with COLECALCIFEROL (D3 5000) for Adverse event, at a dose of 5000 IU once a day; ASCORBIC ACID (VIT C) for Adverse event, at a dose of 1000 mg once a day; ASCORBIC ACID, QUERCETIN (QUERCITIN) for Adverse event, at an unspecified dose and frequency; ZINC for Adverse event, at an unspecified dose and frequency; RUPATADINE for Adverse event, at an unspecified dose and frequency; LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Adverse event, at an unspecified dose and frequency; METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) for Adverse event, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Itching, at a dose of 10 mg twice a day. At the time of the report, PRURITUS (Itchy) had not resolved.            No concomitant information was reported.  Reporter reports the case from the Chronic Spontaneous Urticaria After COVID-19 Vaccine Support Group from Social Media.  Patient stated that he tried low histamine diet, cut alcohol and intermittent fasting and was taking lots of supplements but nothing worked like Zyrtec. He said that the maximum days without taking Zyrtec was 4 but even then, he was taking steroids. So maximum days without taking antihistamines was 3 days. Patient reported that his condition started on 01-Nov-2021, 10 days after receiving his Moderna Booster and he has visited an allergist on 02 Nov, and since then he has tried all the antihistamines, Rupatadine, Xyzal, Zyrtec and 12 days of Medrol (same as Prednisone).   He stated that he keeps a healthy lifestyle and exercises regularly, no prior allergies (only to Penicillin, but it was very common). He said that his condition was getting better than in the first weeks, but now he was being very careful with his food, he does not eat sugar, bread, no alcohol and no junk food. He said that he tried not to take any meds (no Ibuprofen or other NSAID drugs) and was trying not to be stressed. Unfortunately, he needed Zyrtec 2 times per week when the itching was back.   Patient stated that he had an appointment with an allergist, and she told him that it was not a good idea to take medication only when needed and thus she doubled his Zyrtec dose (10 mg in the morning and 10 mg in the evening) for 1 month and asked him to visit again after one month. She told him that it was an immune reaction, and the body needs antihistamines to regulate itself. Otherwise, this condition may become chronic.   This case was linked to MOD-2022-437335 (Patient Link).
This study case was received from the investigator in a trial on 12 November 2012. A 33-year-old male subject received an injection of ACAM2000 (lot number not reported) on 14 June 2012. Medical history and laboratory data were not available. On 20 June 2012, the subject was diagnosed with unspecified disease of pericardium. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Increased silence around 5 minutes after shots were given. Arousable but goes back to sleep for 9 hours. Fussiness also present.
Patient received her 1st Moderna Covid vaccine and is due for the second dose on 4/12. She reported having a headache of 3 days after the 1st dose. She is now on oxygen full time and has f/u testing to assess the cause of her situation. She will ask Dr whether she is to hold Cosentyx or continue as normal.
Initial report received from a non-health care professional (consumer) on 9 January 2014. A 63-year-old male patient, received first dose of Swine Flu vaccine (Lot number unknown, route and site of vaccination was not reported) on an unspecified date in 1976. It was reported that the patient was not certain about the symptoms except it is the sickest he has ever been. The patient also had high fever. The patient was hospitalized on an unspecified date. Vaccination and Pre-existing physician diagnosed allergies and birth defect was unknown. Laboratory details and corrective treatment was not reported. At the time of this report the patient was recovered from adverse event. Documents held by sender: none.
The patient has rheumatoid arthritis but he has never been so bad. He went to the hospital and an orthopedist told him that he has arthritis; his arm also hurt/pain "went down" to his left leg and got worse; This is a spontaneous report from a contactable consumer (patient's wife) reported that a 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Feb2021 at a single dose for covid-19 immunization. Medical history included rheumatoid arthritis from an unknown date. The patient's concomitant medications were not reported. It was reported that on Sunday (28Feb2021), his arm also hurt. But as of Monday (01Mar2021), the pain went down to his left leg and got worse. The patient has rheumatoid arthritis but he has never been so bad. He went to the hospital and an orthopedist told him that he has arthritis, he prescribed Ibuprofen and "another pill" but it did not take away the pain. Now her husband cannot walk due to pain. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Intense shoulder/arm main where shot was administered.  Pain continues and has gotten worse since then.  It has now been one month and patient can hardly move arm without extreme pain.
Tiredness; Lump on arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) and MASS (Lump on arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 25A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tiredness) and MASS (Lump on arm). At the time of the report, FATIGUE (Tiredness) and MASS (Lump on arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication include Blood thinner.  No treatment medications was reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up document was add on 02-JUL-2021. Event outcome was changed to Recovered and Resolved.
covid 19 vaccinations and how sick it made me; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "covid 19 vaccinations and how sick it made me".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pain; feeling of heaviness in the arms.; This is a spontaneous report from a Pfizer sponsored program COVAX US support. A contactable consumer (patient) reported for himself that a male patient of an unspecified age received bnt162b2 (Pfizer Covid-19 Vaccine, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Lot number, Expiration date: unknown) as single dose for covid-19 immunisation. The patient received bnt162b2 (Pfizer Covid-19 Vaccine), dose 1 via an unspecified route of administration on an unspecified date (Lot number, Expiration date: unknown) for covid-19 immunisation. Concomitant medications were not reported. The patient experienced pain on an unspecified date, feeling of heaviness in the arms on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.