chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vials that was put in the fridge and after that refrozen and thawed again for adult male patient; No adverse event; Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, 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-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient).    This case is for 62th  patient out of 100 patient's case. Concomitant product use was not provided by the reporter. Patient received additional booster dose. 100 male patients were received bivalent booster dose. Moderna COVID19 vaccine bivalent, dosage given was in ml but it was unknown to the healthcare practitioner. Also, lot number was unknown to the healthcare practitioner. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Patient experienced 4 large welts on arm where she received PNEUMOVAX 23 vaccine.
On 10-11-13 I had a routine physical and a flu shot. The shot was extremely painful the moment it was given. My arm continued to hurt for 6 months. I got no relief from physical therapy. In May 2014 I had a shoulder manipulation under sedation, and finally got relief. The ortho. dr. said the trauma from the shot resulted in a frozen shoulder.
Pt was nearing the end of his observation period, s/p injection of his first dose of the Pfizer vaccine. Patient was noted by observation team to be extremely diaphoretic, pale, and resting his head in his companion's lap. On-site EMTs and this RN evaluated the patient. Pt reported nausea and "not feeling well." Pt noted to be profusely sweating with an irregular pulse on palpation. Pt skin cool and clammy to touch. Vital signs recorded as follows: BP 95/68, HR 67, O2 sat on room air 96%. No irregular or labored breathing noted. Patient denied dizziness, lightheadedness and chest pain/pressure. Cool compresses applied to pressure points, patient given orange juice to drink. After about 10 minutes, patient stated, "I actually feel much better." Patient denied offer to call 911 for transport to hospital and sat with us for another 5-10 minutes. Pt then left the event with his two companions.
Patient called pharmacy to repeat fever, chills, migraine for two days, body aches, and injection site pain.  Patient was advised to contact her health care provider, telemedicine, or urgent  care.
Pt. phoned stating that her right arm at the site of flu shot was reddened and sore. No fever.
Elevated temp 105.0 for three day: heavy feeling in head stiffness at base of neck. Has an appt. with MD on 9/23/02. F/U on MD appt; blood work doneon ABT +2. Dx with sinus infection.
Fever (99.6); Arm soreness; Headache; Fatigue; This is a spontaneous report from a contactable physician (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EH9899), intramuscularly in the left arm, on 21Dec2020 at 07:15 (at the age of 28-years-old) at a single dose for COVID-19 immunization. Medical history included migraines and allergies to mango. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included magnesium (MANUFACTURER UNKNOWN) taken as supplement. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced fever (99.6), arm soreness, headache, and fatigue on 21Dec2020 at 20:00. The events were reported as non-serious. The patient underwent lab tests and procedures, which included body temperature: 99.6 on 21Dec2020. No therapeutic measures were taken as a result of the events. The clinical outcome of fever (99.6), arm soreness, headache, and fatigue was recovered in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
further down the left arm, she had a red spot like a bug-bite; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (further down the left arm, she had a red spot like a bug-bite) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No history reported by the reporter.  Concomitant products included ALPRAZOLAM (XANAX), METHIMAZOLE, HCTZ and METOPROLOL for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced RASH MACULAR (further down the left arm, she had a red spot like a bug-bite). At the time of the report, RASH MACULAR (further down the left arm, she had a red spot like a bug-bite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's Concomitant medications also include, statin and allergy.  Treatment information provided as, Antibiotics.   This case was linked to MOD-2021-056080 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: Consumer doesn't have email or fax number
aching; headache; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (aching) and HEADACHE (headache) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M2017) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced MYALGIA (aching) and HEADACHE (headache). At the time of the report, MYALGIA (aching) had resolved and HEADACHE (headache) had not resolved. Not Provided          No relevant concomitant medications were reported.  Treatment information was not provided.
Adverse effect of other vaccines and biological substances, initial encounter on 2022-01-15.
ACUTE DVT OF LEFT POPLITEAL VEIN ACUTE PULMONARY EMBOLISM 3/2/2022 &  3/10/2022  --  RECURRENCE OF SAME SYMPTOMS
CELLULITIS TO THE LEFT THIGH/NOT AT THE INJECTION SITE, HOWEVER THE LEFT THIGH WAS REDDENED BUT NOT SWOLLEN.  NO DISCHARGE ETC AT THE INJECTION SITE.
5JUN92 sl fever 6JUN t102; 7JUN t104.6 @ 11PM; 8JUN91 t105 12noon;
For the first 24-48 hrs I was fatigued, had a very sore arm and experiences a metallic taste, smell. After two days I got a canker sore. 7 days later my resting heart rate is 158-163. prior to the shot my resting heart rate was 168.
Patient was admitted to Hospital on 11/19/2021 for COVID related symptoms after receiving the COVID19 Vaccine. This is considered a breakthrough case.
tested positive for SARS-CoV-2 infection on a home antigen test; tested positive for SARS-CoV-2 infection on a home antigen test; This is a literature report for the following literature source(s): (Withheld)  A 64-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for 1 day, as dose 2, single (Batch/Lot number: unknown) for 1 day and as dose 3 (booster), single (Batch/Lot number: unknown) for 1 day for covid-19 immunisation. The patient's relevant medical history included: "asthma", start date: Feb2022 (unspecified if ongoing); "chronic lymphocytic leukemia", start date: Feb2022 (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Venetoclax, start date: Jan2022, for chronic lymphocytic leukemia; Obintutuzumab, start date: Jan2022, for chronic lymphocytic leukemia. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant, life threatening), COVID-19 (hospitalization, medically significant, life threatening), outcome "recovered" and all described as "tested positive for SARS-CoV-2 infection on a home antigen test". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 38.8 Centigrade, notes: Fever; non-SARS-CoV-2 viruses: (unspecified date) Negative; Mycobacterium test: (unspecified date) Negative; SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Negative; (unspecified date) Negative; (unspecified date) Negative; (Feb2022) Positive; (14Mar2022) Positive, notes: Repeat SARS-CoV-2 PCR; (22Mar2022) Positive, notes: Despite the COVID-19-directed therapy; (Apr2022) Positive; (01May2022) Positive, notes: repeated PCR at a cycle threshold of 22, possibly consistent with a high SARS-CoV-2 load. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: In early Feb2022, a 64-year old man with asthma and CLL who previously received 3 doses of the Pfizer COVID-19 mRNA vaccine developed cough and dyspnea and tested positive for sars-cov-2 infection on a home antigen test. CLL was followed expectantly until Jan2022, when he started venetoclax and obintutuzumab (humanized anti-CD20 monoclonal antibody) for progression of disease.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and covid-19 and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Pt. c/o of feeling flushed and lightheaded. Pt reports being "very nervous" before the vaccine and that she has had anxiety attacks in the past. Pt. waited an additional 30 minutes and stated she was feeling better. Pt dc' d home.
I developed chills/shivering in the evening of the vaccination (2/19/21) but was not alarmed, just tried to stay warm.  I ate normally.   I awakened in the night with extreme chills and was shaking most of the night, unable to get warm.  I felt feverish and had body aches as well as nausea.  I threw up what I could to alleviate the feeling of nausea, about 2 a.m.   I slept restlessly until 9:00 am, then tried to take a hot shower.  Though the chills were gone, I felt weak and listless and went back to bed shortly after showering.  I slept for about 4 hours.  I had little/no appetite for most of the day after the vaccine.  By the second day I still had a headache but felt better, albeit weak.   I took Ibuprofen for the body/headaches with minimal success.
Baseball sized red circular rash appeared at the site of injection 2 days after 2nd vaccine.  The area is reddish, a little swollen and warm to the touch.  The shot was given to the right arm.     The same type of rash appeared at the site of injection a week after the 1st vaccine dose.  (Moderna Lot 029L20A) It took about 6 days for the rash to disappear after the first vaccine dose.  The first vaccine was also given in the right  arm.
Based on information received on 06-April-2015 the case is now medically confirmed. Initial unsolicited report received from Consumer on 16 December 2014. A 61-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE HD (Batch number, expiry date, route, site of vaccination and dose number was not reported) in morning on 22 October 2014. On 22 October 2014, the patient had experienced swelling under tongue, fever and chills in afternoon. Laboratory investigations and corrective treatment were not reported. On 23 October 2014 the swelling under tongue, fever and chills was resolved. At the time of this report, the outcome of the event was resolved. List of documents held by sender: none. Follow-up information received from a physician on 6 April 2015. No additional information to provide. Documents held by sender: None.
As the day went on I got more of the symptoms. Fatigue and headache first, then body aches. Then i went home around 230, took a nap and woke up with fever and chills. I've been taking ibuprofen but I rarely take that so ive only been doing 1 pill.
tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (tested positive for COVID-19). At the time of the report, COVID-19 (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, SARS-CoV-2 test: negative (Negative) nasopharyngeal RT-PCR test negative. On 25-May-2021, SARS-CoV-2 test: positive (Positive) nasopharyngeal RT-PCR test positive. On 01-Jun-2021, Blood pressure measurement: 115/75 (normal) 115/75.         Concomitant information was not reported. Treatment information was not reported. The action taken with mRNA-1273 with the event was considered as not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up information received on 12-jun-2021 contains significant information. patient details was added. Both dose information provided, event start date provided. On 04-Jul-2021: Follow up information received on 04-jul-2021 contains significant information. Patient lab data updated.
Within 1 month, post vax, our son withdrew both physically and socially. He lost the few words he had, had absolutely no eye contact and was dx'd with autism. He had severe language delay and also delays in gross fine motor skills with sensory issues. He does not communicate and he has rolling back of his eyes. All within a 30 day period following vaccines. Per doc 207942, in any residual symptom: Autism. The annual follow-up states pt "isolated, withdrawn, non-verbal."
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with pediatric doses of (lot number K012457 and expiration date 04-JUN-2017; lot number reported as K014696 and expiration date 11-NOV-2015; lot number L001627 and expiration date 11-NOV-2015) dose, frequency and route of administration were not provided, which, on an unknown date, underwent a temperature excursion. It was also reported that some patients received pediatric dose and some received adult dose of VAQTA. No adverse effects were experienced by any of the patients. This is one of several reports received from the same reporter. Additional information has been requested.
today, pt has 1" long x 1/2" wide hardened area inside lt deltoid area where DTP was given; non-tender; skin over area darkened w/dimpling; mom states the area no larger; has been rubbing it w/alcohol;
Pain at injection; 3 inches of redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection) and VACCINATION SITE ERYTHEMA (3 inches of redness at injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer.    On 12-Feb-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 VACCINATION SITE PAIN (Pain at injection) and VACCINATION SITE ERYTHEMA (3 inches of redness at injection site). At the time of the report, VACCINATION SITE PAIN (Pain at injection) and VACCINATION SITE ERYTHEMA (3 inches of redness at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
redness in the injected arm; swelling in the injected arm; redness, swelling and itching in the injected arm; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number HB2B2, expiry date unknown) for prophylaxis.   On 22nd April 2019, the patient received the 1st dose of Shingrix. On 23rd April 2019, 1 days after receiving Shingrix, the patient experienced erythema of extremities, swelling arm and itchy upper limbs. On an unknown date, the outcome of the erythema of extremities, swelling arm and itchy upper limbs were unknown.   It was unknown if the reporter considered the erythema of extremities, swelling arm and itchy upper limbs to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient developed redness, swelling, and itching in the injected arm (left arm) the day after vaccination. The pharmacist informed the patient that the patient might experience redness and swelling but she was concerned about the itching.  The pharmacist inquired if there were any incidences reported for itching and should the patient receive the 2nd dose.
Period stopped - have not had a cycle since June. My cycle has been normal every month until I had gotten vaccinated (Moderna)
This spontaneous report as received from a nurse practitioner refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 24-SEP-2014, the patient was vaccinated with first dose of GARDASIL (lot number, dose, frequency and route unspecified). Concomitant medications were not reported. On 03-MAR-2015, the patient was vaccinated with second dose of GARDASIL (lot number, dose, frequency and route unspecified) which was outside the vaccination recommendations. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with suspect product was not reported. Product quality issue was not involved. Additional information has been requested.
Passing kidney stones which hasn?t happend in 8 months Heart arithmia, rapid heart beat when doing anything, extreme lightheadedness
First symptom- gum bleeding Second symptoms-  long menstrual 15 days 22 pads a day Third symptoms- nose bleed for 4 hours Bleeding underneath skin on chest and neck
I had a routine COVID test at work about 2 pm on Friday, This test came back with positive results; This is a spontaneous report from a contactable consumer. A 23-years-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8727), dose 2 via an unspecified route of administration, administered in right arm on 25Mar2021 at 02:45 as second dose, single for covid-19 immunisation. Medical history included drug hypersensitivity. Allergies to medications, food, or other products included Zythromax. Concomitant medication included estrogens conjugated (estrin [estrogens conjugated]) birth control.  On 04Mar2021 at 03:45 pm, the patient received first dose of bnt162b2 (Batch/Lot Number: FN6205) administered in right arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 06Mar2021 friday, she had a routine COVID test at work about 2 pm. This test came back with positive results which was very strange considering she had not changed her routine or the people she interacted with for the last month and everyone she had interacted with also tested negative on the same day. She had no reason to test positive between this and the fact that she strictly went from home to work and back daily. For the second dose: About 2 am on 26Mar2021, she woke up with a fever of 100.9. She called out of work and spent entire next day in bed with horrific chills and an off and on fever eventually peaking at 102.8 around 5pm. Sometime after that, she fell asleep and slept until around 7 the next morning and by then her fever had broken. The whole day that she was feverish she had such bad body aches it hurt to walk across her apartment to the bathroom even and she spent the day off and on sleeping. The event assessed as non-serious with outcome of recovered.  No follow up attempts needed; information about batch/lot no. cannot be obtained. No further information is expected.
Case number PHEH2016US031774, is an initial spontaneous report received from a healthcare professional (physician assistant) on 02 Dec 2016. This report refers to a 60 years old female patient. Prior vaccination history included vaccination with influenza vaccine (unknown whether seasonal or pandemic, other manufacturer, batch number: not reported) with no side effects (well tolerated). Past medical history and concomitant medication were not reported. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: 185286 and expiry date: Apr 2017) at a dose of 0.5 ml, Intramuscularly on 02 Dec 2016 at 01:15 pm. It was reported that, first time temperature excursion occurred and vaccine reached 47 Fahrenheit for less than 24 hours, vaccine administered to patient on 02 Dec 2016 at 01:15 pm. It was reported that the temperature variation was discovered after the administration of vaccine. No adverse event was reported following this medication error (incorrect product storage). The case was assessed as non serious by the physician assistant. Follow up report received from a health care professional (physician assistant) on 09 Jan 2017: Updated reporter details (phone number), added prior vaccination history, updated suspect product information (time of administration) and updated reporter comment.