chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with improperly stored doses of  VARIVAX 0.5 ml, once, lot # N017399, expiration date 07-JUN-2019, for prophylaxis (strength, route and frequency were not reported) reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). The temperature excursion was of 15 Fahrenheit degrees (°F) to 46°F (33.8°F) during 7 hours 15 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1803USA000994:
Case number PHEH2014US024303 is an initial spontaneous report from a nurse received on 02DEC2014 and with a follow-up from a nurse received on 21JAN2015. This report refers to a 45 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN 2014/2015 (seasonal influenza vaccine, batch number: 14511P, expiry date: MAR2015) into left deltoid intramuscularly at a dose of 0.5 ml on 05NOV2014. The nurse reported that FLUVIRIN 2014/2015 was stored at 49F for one hour and 15 minutes before administration to the patient. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided. Follow up from a nurse received on 21JAN2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
Patient reported that she had a severe reaction to the second dose of Moderna when presenting for Moderna Booster on 12/18/21. She says she had hives. Her doctor recommended the booster with benadryl premedication.  No reaction to booster noted in medical record.
Acute transverse myelitis; This is a spontaneous report from a contactable Physician.  A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (at the age of 39-year-old) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced acute transverse myelitis on an unspecified date with outcome of unknown.   The lot number for the vaccine bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the Myelitis transverse cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
Today is Friday, 02/26/2021. I Received 2nd Moderna vaccine on Sunday, 02/21/2021, at 12:15 PM; for the next 96 hours, sore arm, ran fever,  off and on, between 101 and 100, body aches, continued headache, taking Tylenol. 5th day, fever subsided, body aches improved, but headaches continue. I have a compromised lung issue due to recurrent pneumonias in the past, last episode 3 years ago.  However, whenever I get a cold, or sinus infection, my lungs are affected, and I need to check in with my doctor how to prevent the pneumonia. Treatment is usually antibiotics and /or inhaler.  After the flu like symptoms described above, I feel a burning in my lungs that indicate a possible problem. I have put in a call to Dr. office regarding this issue. The severe headaches continue today, the 5th day after Covid Vaccine Moderna #2. I continue taking Tylenol for the headaches.
This spontaneous report as received from a 44 year old female patient regarding herself. The patient's medical history included queasiness from some unspecified medications (manufacturers unspecified). On an unknown date 20 years ago approximately in October 2003, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was unknown. This is 1 of 3 reports from the same reporter/patient. Additional information has been requested.
Information has been received from a certified medical assistant (CMA) regarding a patient of an unknown age and gender who on 26-SEP-2013 was vaccinated with an improperly stored dose of GARDASIL exposed to 20F and 30 F. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
getting the chills; itchy all over; started to get hives from the scratching; reaction from the vaccine; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (getting the chills), PRURITUS (itchy all over), URTICARIA (started to get hives from the scratching) and VACCINATION SITE REACTION (reaction from the vaccine) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LISDEXAMFETAMINE DIMESYLATE for ADHD, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 29-Apr-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 CHILLS (getting the chills), PRURITUS (itchy all over), URTICARIA (started to get hives from the scratching) and VACCINATION SITE REACTION (reaction from the vaccine). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) ongoing since an unknown date at a dose of 40 milligram. At the time of the report, CHILLS (getting the chills), PRURITUS (itchy all over), URTICARIA (started to get hives from the scratching) and VACCINATION SITE REACTION (reaction from the vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant drugs includes Birth control pill, Vyvanse, Allegra.  Treatment includes H2-Blocker, Anti- Histamine, Pepcid 40 mg, Benadryl, Allegra.
This spontaneous report was received from a Certified Nurse Practitioner and refers to a 20 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant)(manufacturer unknown), (strength, dose, dose number, route, anatomical location, lot number and expiration date were not reported), for prophylaxis. No other suspect or concomitant therapies were reported. On 14-JAN-2017, a blood titer's test was performed to the patient and the patient "failed to seroconvert" (hepatitis b surface antibody negative).  No adverse events were reported. Product quality complain was not involved. At the time of reporting, the outcome of hepatitis b surface antibody negative was unknown. and, the reporter did not assess the causal relationship between hepatitis b surface antibody negative and the therapy with Hepatitis B Vaccine (Recombinant)(manufacturer unknown). This is one of several reports from the same patient. Additional information has been requested.; Sender's Comments: US-009507513-1702USA005672: US-009507513-1701USA013594:
I wasn't feeling well after the injection and on the 2nd day, I went to my Dr.  I had not urinated in about 18 hours.  I had total renal failure.  I was sent to the ER in our small town and was then sent by ambulance to a hospital.  I was in ICU for 2 or 3 days and then in a regular room for the next 5 0r 6 days.
No adverse evnts; patient received expired dose of VAQTA; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On 13-DEC-2019, the patient was vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) (strength, dose, route of administration and anatomical location were unknown) with lot # R025518 and expiration date 15-NOV-2019 for prophylaxis (expired product administered). There were no known adverse events. There was no product quality complaint associated with the case.
Received Flu vaccine 9/22/11. Seen at clinic 10/11/11 for cough and persistent bronchitis last 8 days - muscle aches, insomnia, sore throat placed on Z-PAK, LEVAQUIN 750mg, TUSSIONEX, AND MEDROL dose pack 3 days prior to GB onset. To ED with sinusitis 10/13/11. To ED with numbness in legs & weak arms. Admitted & ICU with Guillain-Barre Syndrome 10/14/11.
goofy; sleepy; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL BEHAVIOUR (goofy) and SOMNOLENCE (sleepy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-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 ABNORMAL BEHAVIOUR (goofy) and SOMNOLENCE (sleepy). At the time of the report, ABNORMAL BEHAVIOUR (goofy) and SOMNOLENCE (sleepy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was reported Treatment information was not provided
Serious post marketed study vase from a Nurse of chest pain considered medically important.  The reporter causality is possible top Flu Mist.  This is a case involving a 12-year-old female patient with unknown medical history who received Flu Mist VACCINATION ON 03oCT06.  Ten minutes after receiving Flu Mist, this patient returned to the clinic complaining of "not feeling right".  According to the nurse who was present at the clinic, the patient exhibited "diaphoresis" and "rapid respiration".  Patient's pulse rate was "over 150" (sitting) and patient began to complain of having "chest pain" (supine).  There were no complaints of shortness of breath, radiation of pain, nausea or vomiting, dizziness, anxiety, or loss of consciousness.  Paramedics were called and the patient's blood pressure ("160/80", no baseline BP available) was taken.  As the patient was waiting for an ambulance, she complained that he "throat felt funny".  After clearing her throat,the patient indicated that the throat symptom had completed dissipated.  The paramedics and the patient's father arrived at the scene five minutes later and the patient was taken to the emergency room.  The reporter denies that the patient was on any medications, including aspririn-containing therapy, prior to Flu Mist vaccination.  The patient's father denies this patient having any allergies or hypersensitivity to eggs or egg products.  According to the reporter, however, there is a history of patient hospitalization "about a year ago for stomach problems".  The patient was "told by the hospital not to eat eggs, corns and wheat".  The outcome of the events is unknown at this time.  A request was made to the reporter to forward all relevant follow up medical documentation's obtained on this patient to Product Safety.  The investigator causality is possible to Flu Mist. (OMIC) Per information from annual follow up: Subject recommende to receive regular counseling therapy-No additional information expected from the reporter. 07-Mar-2008
pt recvd vax;uncontrollable crying,started approx 3 hrs p/ vax;T 101 Ax;apap given q 4 hrs; did not seek med care
The evening of my vaccine I had severe chills. The next day I had a headache, body aches and fatigue. The second day just didn't feel well, lethargic. My arm where vaccine was given was tender for several days.
Pain under her left arm; Lump under her arm, which she believes is a swollen lymph node; Felt like she was getting a cold; Ears hurt; Tired; Arm hurt at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Arm hurt at the injection site), FATIGUE (Tired), PAIN IN EXTREMITY (Pain under her left arm), LYMPHADENOPATHY (Lump under her arm, which she believes is a swollen lymph node) and CHILLS (Felt like she was getting a cold) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history found).    On 09-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm hurt at the injection site). On 10-Jan-2021, the patient experienced FATIGUE (Tired). On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain under her left arm), LYMPHADENOPATHY (Lump under her arm, which she believes is a swollen lymph node), CHILLS (Felt like she was getting a cold) and EAR PAIN (Ears hurt). On 11-Jan-2021, VACCINATION SITE PAIN (Arm hurt at the injection site) had resolved. At the time of the report, FATIGUE (Tired), PAIN IN EXTREMITY (Pain under her left arm), LYMPHADENOPATHY (Lump under her arm, which she believes is a swollen lymph node), CHILLS (Felt like she was getting a cold) and EAR PAIN (Ears hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medication and treatment provided; Sender's Comments: 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.
partial deafness, rt ear, subsequent ringing 9-10NOV, weak, fever 98-101; 11-16NOV whipsaw fever, 103-6, single sided h/a, lt median & frontal lobes; cramps in esophagus; could not eat solid food for several weeks; weight loss, burning eye;
big bump on the injection site; scalp area has tingling sensation; white blood cells and neutrophils are low/white blood cells was low; white blood cells and neutrophils are low/absolute neutrophils was low; big knot at injection site and sore to touch; This is a spontaneous report from a contactable other hcp (patient). A 60-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6207), via intramuscular, administered in Arm Left on 14Mar2021 16:00 (at the age of 60-year-old) as dose 2, single for covid-19 immunisation. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6203), via intramuscular, administered in Arm Left on 21Feb2021 around 17:00 (at the age of 60-year-old) as dose 2, single for covid-19 immunisation. Medical history included uterine leiomyosarcoma from Jun2020 and ongoing, ongoing seasonal allergy, ongoing food allergy diagnosed within past 5 years with seed allergies like soy and sesame, chemotherapy from Jul2020 to Oct2020 From Jul to Oct 2020, she had a different round of chemo. She finished that chemo in October. Concomitant medications included adriamycin [doxorubicin] taken for an unspecified indication from 26Feb2021 and ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient had flu shot back in Nov2020, she did not had a problem with it and never had a problem with the flu shot. On 18Mar2021, the patient experienced big bump on the injection site, scalp area has tingling sensation. On an unspecified date in Mar2021, patient experienced white blood cells and neutrophils are low, big knot at injection site and sore to touch. The patient underwent lab tests and procedures which included blood test: low on 16Mar2021 her was white blood cells was low and her  absolute neutrophils was low, basically not there, blood test: improved on 17Mar2021 improved, going in the right direction. The events did not result in emergency room/physician office visit. The outcome of the events white blood cells and neutrophils are low were recovering while the outcome of other events were unknown.  No follow-up attempts are needed. No further information is expected.
Sinus tachycardia, inability to turn neck/swollen neck muscles, headache, sore throat, muscle and body aches, sore/swollen arm of injection site, nausea, diarrhea, swollen knuckle joints, unilateral weakness/unequal grips and strengths.
like my whole immune system is affecting like you know my leg ,just a general malaise; I am having horrible pains in my back in my arm in my shoulder; I am having horrible pains in my back in my arm in my shoulder; I am having horrible pains in my back in my arm in my shoulder; there kind of thing in the leg it still there; feeling you know like specially round my knee and the front of my thigh / I don't think it's doing any thing/ I never had  any of this before; This is a spontaneous report from contactable consumer. A 72-year-old female (Patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8730) via an unspecified route of administration on 25Mar2021 (at 72-year-old), as dose 2 single for COVID-19 immunization. The medical history of the patient included dust allergy. The patient did not take any concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9263) via an unspecified route of administration on 25-Feb2021 (at 72-year-old) as dose 1, single for COVID-19 immunization and experienced bad leg pain like throbbing ,aching ,burning ,there were like twitching also, that lasted very badly until the end of the next day and then it sort of went away. On an unknown date the consumer stated that when she took the second dose there was this feeling you know like specially round her knee and the front of my thighs, you know just that what it was like. the second shot she did not had a bad reaction immediately and she could not remember when started but it seemed like, so hard to describe, it was like , she went to my doctor, it was kind of like fibro neuralgia symptoms a little bit like he does not know may be what rheumatism was. She never had any of this before by the way like her whole immune system was affected like you know her leg ,just a general malaise, then she never know, what was going to come next , for example starting 2 or 3 days ago she had horrible pains in her back, arm and shoulder, there was kind of thing in the leg it was still there ,and it seemed like it was oing through every system of her body. She was really concerned and wanted to know if was not alone in this feeling. She did not know what to do. She mentioned that she never had symptoms like other people do ,you know like they felt feverish, cold flu like it was all this kind of stuff. The patient received treatment for side effect, consumer stated her back was showing heavy and she took Tylenol and Advil and she does not think it was doing anything. Regarding the lab test, her doctor took lot of blood test, but she does not have the result ,anything that related to all this symptoms and doctor said to her that it was not in the vaccine and she said it was because she had I never had any of this before, it was just multi system like the back ache that she has, she can remember long time ago she had it that back ache very similar , it was like the virus was triggering her old responses.   PC filed  No follow-up attempts were needed. No further information was expected.
It was Saturday morning Jan.30th 7:00AM. I laid on my back and I felt a awkward feeling on my growing and it was a lymphoid. It was the size of a pickle.
The patient reported that she was starting to sweat and was concerned about having a reaction, as she had a previous reaction with the first vaccine.  The paramedics were called and she was monitored for about 20 minutes before the patient departed.
Red splotches around the injection site; Red dots over the rest of body, even as far as legs; Dose received 3, dose number: 3 of BNT162b2; Sometime between 36 and 48 hours after the vaccine developed a rash over most of body, concentrated on upper body; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.   A 48-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 28Nov2021 at 09:00 (Batch/Lot number: FH8028) at the age of 48 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: ER2613; Route of administration: Unspecified; Anatomical Location: Left arm), administration date: 17Mar2021, when the patient was 47 years old, single for COVID-19 immunisation and BNT162b2 (DOSE 2, SINGLE; Lot Number: ER8729; Route of administration: Unspecified; Anatomical Location: Left arm), administration date: 07Apr2021, when the patient was 47 years old, single for COVID-19 immunisation.  The following information was reported: RASH (non-serious) with onset Nov2021, outcome "not recovered", described as "sometime between 36 and 48 hours after the vaccine developed a rash over most of his body, concentrated on upper body"; VACCINATION SITE ERYTHEMA (non-serious) and RASH MACULAR (non-serious) both with onset 30Nov2021, outcome "not recovered", described as "red splotches around the injection site" and "red dots over the rest of body, even as far as legs". Therapeutic measures were not taken as a result of rash, vaccination site erythema and rash macular.  Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any medication within two weeks of vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
COUGH, Muscle or body aches ,sore throat,sinus ,stuffy nose    Pt recently received her COVID Vaccine #1 on 1/11/21