chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness on her left arm; hardness on her arm; like a flu; dry throat; it hurts(on arm); fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness on her left arm), INDURATION (hardness on her arm), INFLUENZA LIKE ILLNESS (like a flu), DRY THROAT (dry throat) and MYALGIA (it hurts(on arm)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.    On 06-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jul-2021, the patient experienced ERYTHEMA (redness on her left arm), INDURATION (hardness on her arm), INFLUENZA LIKE ILLNESS (like a flu), DRY THROAT (dry throat), MYALGIA (it hurts(on arm)), PYREXIA (fever) and CHILLS (chills). At the time of the report, ERYTHEMA (redness on her left arm), INDURATION (hardness on her arm), INFLUENZA LIKE ILLNESS (like a flu), DRY THROAT (dry throat), MYALGIA (it hurts(on arm)), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            Concomitant medications not provided. Treatment medications not provided.   This case was linked to MOD-2021-250592 (Patient Link).
Began c/o headache (severe) in the afternoon after receiving vaccine that morning. Photophobia, dizziness, nausea went to ER and admitted overnight.
Janssen COVID-19 Vaccine EUA: patient reports severe muscle pain during clinic visit for underlying medical condition 22 days after vaccination.  Pain is at injection site and through entire arm into hand and neck. The patient reports they are limited in activities of daily living, especially when they need to raise their arm. Patient denies numbness and weakness and is following up with a physical rehabilitation provider.
Patient went to doctor on 01/22/16 and said she has itching and pain at the site of vaccine administration even after 12 days.
Pt became faint, sweaty, and "I cannot see". Immediately seated pt with head down - water and crax and peanut butter given as she felt better. BP 78/50. P60. Had pt recline. BP 80/50. P-52. Pt had very little breakfast.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 15-APR-2014, the patient was vaccinated with a dose of PROQUAD subcutaneously, batch# J011124, expiration date 05-SEP-2015. On 03-OCT-2016, the patient was vaccinated with a dose of PROQUAD subcutaneously, lot# L033698, expiration date 28-FEB-2017.  On 24-JAN-2017, the patient was vaccinated with a dose of PROQUAD subcutaneously, lot # L033698, expiration date 28-FEB-2017. Additional information has been requested.
1 WEEK AFTER VACCINATION- EXPERIENCED HEAD ACHES , SORE THROAT AND EAR ACHES. AROUND 2 WEEKS- PATIENT. FELT DIZZY AND PASSED OUT. STILL HAS SOME BRUISING IN THE ARM NEAR BICEPS.
Patient received her first dose of Moderna, and after about 15 minutes she felt nauseous and began to throw up. After taking the patient's blood pressure, SBP was 220.
Janssen COVID-19 Vaccine EUA; patient reports intermittent blurry vision and fatigue after vaccination. Presents to infusion center for chemotherapy, experienced blurred vision, found to be hypotensive and bradycardic, and transferred immediately to emergency department (ED). In the ED diagnosed with acute left lower lobe segmental pulmonary embolism and thrombocytopenia. Admitting to hospital for further management.
FluBlok vaccine intended for 18 yo and over was administered. No side effects or concerns
shortness of breath; wheezing in breast; fatigue; muscle aches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), WHEEZING (wheezing in breast), FATIGUE (fatigue) and MYALGIA (muscle aches) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, LOSARTAN and SIMVASTATIN for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced DYSPNOEA (shortness of breath), WHEEZING (wheezing in breast), FATIGUE (fatigue) and MYALGIA (muscle aches). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath), WHEEZING (wheezing in breast), FATIGUE (fatigue) and MYALGIA (muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the vaccines hepatitis a vaccine, inactivated(VAQTA) (lot # S019435 with expiration date 23-AUG-2020, lot # S026003 with expiration date 17-OCT-2020, and lot # S032056 with expiration date 09-NOV-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 dosage form at a dose of 0.5 ml (route not provided) for prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA004521: US-009507513-2005USA004522: US-009507513-2005USA004523: US-009507513-2005USA004524: US-009507513-2005USA004525: US-009507513-2005USA004526: US-009507513-2005USA004527: US-009507513-2005USA004528: US-009507513-2005USA004529: US-009507513-2005USA004530: US-009507513-2005USA004531: US-009507513-2005USA004532: US-009507513-2005USA004533: US-009507513-2005USA004534: US-009507513-2005USA004535: US-009507513-2005USA004536:
Palpitations, PAC, PVC, tachycardia, 2 hours and then extended off and on for 2 weeks
Vertigo; Dizziness; Weakness; Trembling in the leg; I still feel weak; Shakiness in my hand; I am not feeling too well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 09Feb2021 (Lot number: EL9269) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VERTIGO (non-serious) with onset 2021, outcome "not recovered", described as "Vertigo"; DIZZINESS (non-serious) with onset 2021, outcome "not recovered", described as "Dizziness"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "Weakness"; TREMOR (non-serious) with onset 2021, outcome "not recovered", described as "Trembling in the leg"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "I still feel weak"; TREMOR (non-serious) with onset 2021, outcome "not recovered", described as "Shakiness in my hand"; MALAISE (non-serious) with onset 2021, outcome "not recovered", described as "I am not feeling too well".  Additional Information: It was reported that NDC number and UPC number of Covid 19 vaccine was unknown. Patient did not have any reaction right away but patient think like sometime around the weekend patient started getting vertigo and dizziness, weakness, trembling in the leg and it has been stopped patient meant it comes and go, symptoms are coming and going and patient was looking at the papers and saw there was symptoms of dizziness, patient thought it might be something related, it didn't happened right away, it happened by weekend so now it's really almost a month and patient still feel weak and dizzy every now and then. Patient registered for second dose because patient was still weak and do not feel normal right now.  No follow-up attempts are possible. No further information is expected.
tired, hard to take a breath, nausea, sore arm, swollen lymph nodes for 2 weeks after, body aches, worst chills i have ever had in my life, fever for 24 hours exactly after shot given
Almost passed out 10 min after vaccine was given. Symptom onset approximately  2 hours after vaccine. Extreme fatigue, muscle aches, headache, nausea and vomiting associated with diarrhea, high fever, dizziness, periods of memory loss, and  involuntary muscle twitching and trembling ongoing since vaccine was administered.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 09-JUL-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Face and ears turn bright red. Total body flushing; "pens-and-needles" and then itching. Throat constricted but didn't have a problem with breathing. 8 days later still have "pens-and-needles" in face chest and arms some numbness in my face.
Moderna Covid-19 EUA.   This was reported to me by RN who tried to fax form to VAERS unsuccessfully.  Client was administered the vaccine on 2/24/21, 23 days after receiving the first dose.   No adverse events were reported.
28 days after first dose of the Moderna COVID vaccine, I started my period. I'm post-menopausal and I have not had a period in over 7 years. Other than starting my period (when I should not be having a period), I only had a sore arm for several days.
Blister at injection site of VARIVAX vaccine given 1 day prior.  No redness, no swelling, no pus.
pt recv vax FEB98 & 8-10days post vax pt exp a local inj site rash;the rash was a red raised wheal, non-tender;
bad headache; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration on 14Mar2021 09:45 (at the age of 61-years-old) , as first dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced bad headache on 14Mar2021. Patient would like to know if it is okay to take paracetamol (TYLENOL) to treat the headache. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Right arm pain radiating to axilla and breast. Pain described as burning, aching, tender to touch. Breast feels swollen. On exam a node was noted on fold of axilla, medial aspect. No redness, induration on  warmth noted.
No additional AE; Caller reported inadvertent administration of expired STERILE DILUENT that was used to reconstitute PROQUAD. No temperature excursion. No symptoms reported. STERILE DILUENT supported for 12 months post-expiry. Obtained consent to contact HCP. AEs Fil; Caller reported inadvertent administration of expired STERILE DILUENT that was used to reconstitute PROQUAD. No temperature excursion. No symptoms reported. STERILE DILUENT supported for 12 months post-expiry. Obtained consent to contact HCP. AEs Fil; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-JUN-2023, the patient was administered with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dosage form, administered for prophylaxis (strength, dose, lot number, expiry date, anatomical location and route of administration were not provided) which was reconstituted with expired sterile diluent solution for injection/infusion (1 dosage form, lot #T029529, expiration date: 16-APR-2023, administered for prophylaxis, strength, and route of administration were not provided) (Expired product administered; Product preparation issue). No temperature excursion. No symptoms reported. No additional adverse event (AE) (No adverse event). Sterile diluent supported for 12 months post-expiry.
Osteoporosis.; lower leg edema; anemia; arthritis of my left knee; This is a spontaneous report from a contactable consumer(patient). A 80-Year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 18Feb2021 as a single dose for COVID-19 immunisation. On an unspecified date, the patient experienced Osteoporosis, lower leg edema, anemia, arthritis of my left knee. On 09Mar She had a treatment for Osteoporosis. The treatment She had was an infusion called 'Reclast' which is zolodronic acid. On 11Mar, she had a second Pfizer Covid-19 vaccination. Within two days She began to have a serious negative reaction to the 'Reclast'. She had lower leg edema and then anemia. A hospital stays and tests indicated no other cause for the anemia. She also had the reversal of what had been an effective treatment for arthritis of my left knee. It was reported that Because of those negative reactions to the 'Reclast', I am wondering if the zolodronic acid could have injured the effectiveness of my vaccination shots. I have been wearing a mask when I go into stores or places where I do not know that the people have been vaccinated. I am very appreciative of all your company has done to help people in this country and the world get protected against Covid-19. I wonder whether or not my vaccination protection has been injured by the zolodronic acid. If you think it could have compromised my protection, should I have a booster or a repeat of the original series? I could only do that with specific permission from your company. I hope you will take my concern seriously and reply to my letter.The outcome of the events was unknown.  Information about lot/batch number has been requested
Patient was given Moderna Vaccine Series of 2 shots. 02/12/21 and 03/12/2021. Patient came in for 3rd dose of vaccine. It was confirmed by provider LPN that it had been 6 months since last vaccine . It was relayed to this nurse, LPN that they were due but I never confirmed in the chart that the patient had Pfizer. It was just assumed that the other 2 people mentioned had confirmed that the patient had received Pfizer.  Patient waited the full 15 minutes and had no side affects. Patient was informed of the error and verbalized understanding.
Within 3 minutes after vaccination, patient started to cough. Her throat felt itchy. There was redness and swelling of her face. She went to urgent care. The doctor's notes state she was given 3 doses of Zyrtec.
I have 101,7 fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (I have 101,7 fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (I have 101,7 fever). At the time of the report, PYREXIA (I have 101,7 fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.7 (High) fever-101.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were reported. No treatment was reported.
He was supposed to get the second dose on 28Mar2021 but he missed; felt like a kid punched him in the arm; Temperature was 1 degree warmer than the rest of his body; felt a little burn as he was being injected (like putting out match with his fingertips); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Temperature was 1 degree warmer than the rest of his body), PRODUCT DOSE OMISSION ISSUE (He was supposed to get the second dose on 28Mar2021 but he missed), VACCINATION SITE PAIN (felt like a kid punched him in the arm) and VACCINATION SITE PAIN (felt a little burn as he was being injected (like putting out match with his fingertips)) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included Guillain Barre syndrome (Patient had this syndrome 15-20 years ago). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (felt a little burn as he was being injected (like putting out match with his fingertips)). On 27-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Temperature was 1 degree warmer than the rest of his body) and VACCINATION SITE PAIN (felt like a kid punched him in the arm). On 28-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (He was supposed to get the second dose on 28Mar2021 but he missed). On 28-Feb-2021, VACCINATION SITE WARMTH (Temperature was 1 degree warmer than the rest of his body), VACCINATION SITE PAIN (felt like a kid punched him in the arm) and VACCINATION SITE PAIN (felt a little burn as he was being injected (like putting out match with his fingertips)) had resolved. On 28-Mar-2021, PRODUCT DOSE OMISSION ISSUE (He was supposed to get the second dose on 28Mar2021 but he missed) had resolved.            No treatment medication was provided Patient is on Pacemaker and taking other medications also   This case was linked to MOD-2021-217835 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Medical history and concomitant medications were added; Sender's Comments: This report refers to a case of product dose omission issue for mRNA-1273, lot # 006M20A.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
resurgence of Covid-19 symptoms experienced the month prior; I still feel sick; congestion; sore throat; This is a spontaneous report from a contactable other HCP (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot #: EK9231) on 08Jan2021 17:00 at single dose in left arm for Covid 19.  The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included sleep, had Covid back in Dec, early Dec. Concomitant medication within 2 weeks of vaccination included zolpidem tartrate (AMBIEN) to sleep. The patient experienced resurgence of Covid-19 symptoms experienced the month prior on 11Jan2021 12:00 AM. She had her first dose on 08Jan2021 and all of her Covid symptoms return except this time little bit worse than the first. It says 13 days since her dose and she still feel sick on 11Jan2021 12:00 AM, congestion on 9Jan2021, sore throat on 9Jan2021. No treatment received for all the events. All the events result in Doctor or other healthcare professional office/clinic visit. The patient have Covid test (Nasal Swab covid test) on 15Jan2021 but have not received the result yet. The outcome was not recovered. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient stated, "Advil, probably 400 mg maybe like two times a day at most but it wasn't every day. I did not take it every day, I take it for couple of days."; Sender's Comments: The 41-year-old female patient had Covid in early Dec2020. On 08Jan2021, she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), and experienced resurgence of Covid-19 symptoms on 11Jan2021.  The patient have Covid test (Nasal Swab covid test) on 15Jan2021 but have not received the result yet.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the resurgence of Covid-19 symptoms most likely represents a pre-existing infection prior to vaccine use.  Further information is needed for full medical assessment.  The case will be reassessed should additional information become available.  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.
MODERNA VACCINE GIVEN TO A 15 YEAR OLD IN ERROR.  MODERNA APPROVED FOR 18 YEARS AND OLDER ONLY.
In the last Saturday of February, I had high speed internet installed. The gentleman wore an extremely flimsy face covering. I came down with a cold or flu that progressed to a sinus infection. I have then started having terrible mood swing, being very dizzy, my balance is off, swallowing sometimes feels like right at the base I am going to choke or suffocate. I have been have extreme headaches. My Neurologist diagnosed me with Dysautonomia Syndrome.
This spontaneous report as received from a physician via agency refers to a 11 year 9 month old male patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 21-FEB-2017 the patient was vaccinated with GARDASIL 9 dose 3, intramuscular from lot reported as "024261" for prophylaxis. On 23-FEB-2017, the patient experienced redness, fatigue, pyrexia, cough, pain and injection site swelling. The patient had no energy (asthenia) and sleeps often. The outcome of erythema, hypersomnia, fatigue, asthenia, pyrexia, cough, pain and injection site swelling was reported as recovered/resolved. Causality assessment was not provided. Lot number 024261 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast). Follow up information has been received on 04-DEC-2018 via telephone call from an unspecified reporter from the reporting physician's office. It was reported that the lot number of the GARDASIL 9 dose administered to the patient was M024261 (previously reported as " 024261") with an expiration date in 30-JUL-2018.