chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feeling winded; out of breath; feeling a little weak; barely sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administration date 05Aug2021 (Batch/Lot number: unknown) 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: FLATULENCE (non-serious) with onset Aug2021, outcome "unknown", described as "feeling winded"; DYSPNOEA (non-serious) with onset Aug2021, outcome "unknown", described as "out of breath"; ASTHENIA (non-serious) with onset Aug2021, outcome "unknown", described as "feeling a little weak"; PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "unknown", described as "barely sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
blood clot in her leg/clots in upper thigh on inside of thigh which were very sore; more lumps in crease of leg/knee/lump red and raised/ones behind the knee in the crease are still there and hard as a rock; lump was red and raised; Patient reports it was really sore up toward groin; A spontaneous report was received  from a consumer concerning herself, who is 68-years old  female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced thrombosis, mass excision, groin pain, skin swelling, developed more clots in upper thigh on inside of thigh which were very sore.  No medical history was reported. No concomitant medications were reported.  On 04-Feb-2021, the patient received their first of first planned doses of mRNA-1273  (Lot number: 031120A)was administered intramuscularly with unknown site  for prophylaxis of COVID-19 infection.   On an unknown date, an unspecified amount of time, the patient developed a blood clot in her leg, her lump was red and raised. She went to the doctor and they told her to put a warm compress and keep her leg up. The lumps did not start to go down. She started to develop more lumps in crease of leg/knee. Patient went to vascular doctor who did an ultrasound and diagnosed superficial thrombophlebitis. Patient then went to get second Moderna vaccine on 10MAR2021(lot#036021A). She developed more clots in upper thigh on inside of thigh which were very sore. Patient reports it was really sore up toward groin. She went to doctor again and they put her on Xarelto, and Aleve as directed on box. Symptoms are ongoing. Original lumps were no longer sore to the touch, ones behind the knee in the crease are still  hard as a rock. New lumps after second dose are tender.   Action taken with mRNA-1273 in response to the events was not applicable .  The outcome of the events were not recovered.  The reporter did not provide an assessment for the events; Reporter'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.
diarrhea; COVID shot made the diarrhea worse.; This is a spontaneous report from a contactable consumer. A 78-Year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 27Jan2021 (Batch/Lot number: Unknown) as single dose for covid-19 immunisation, hyaluronic acid (GEL ONE), via an unspecified route of administration from 21Jan2021 (Batch/Lot number: Unknown) at 2 DF (he got two shots in his knees) for his bones.The patient medical history was not reported. Concomitant medication included paracetamol (TYLENOL) taken for an unspecified indication. In Jan2021 the patient experinced diarrhea and In Jan2021 the patient stated covid shot made the diarrhea worse. It was reported that he later added that he got two gel shots, clarified as, Gil 1, he got two shots in his knees on 21Jan2021. After he got these shots in his knees he a little diarrhea about 3-4 days after that. He got the shots in his knees for his bones. He then got the shot, the COVID shot on 27Jan2021 and he thinks the COVID shot made the diarrhea worse. He reinforced he does not go like 5-6 times a day. However, sometimes it is twice a day and it is loose. It is a lot worse than before, not normal. He stated he only took one Tylenol before the shot and now it's out saying should not take it before the COVID shot. He stated they have not taken any Tylenol since the COVID shot. The outcome of the event diarrhea was not recovered and outcome of the other event was unknown.  Information on the lot/batch number has been requested.
This is in follow up to report (s) previously submitted on 11/26/02. Information has been received from a physician concerning a 2 month old child who was vaccinated IM with the first dose of haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast). Subsequently, following the two month vaccination, the child developed a high fever which lasted over 48 hours. At the time of this report, the outcome of the event was unknown. No further information was provided. The patient sought unspecified medical attention. Additional information has been requested.  Follow up 02/04/04: "This is an amended report. The date received by manufacturer was changed from 11/07/02 to 11/07/01.  The report type listed as Follow-up (1) should have been a report type of Initial. The sentence, this line is in follow-up to report(s) previously submitted on 11/26/02 was entered in error.  This report is corrected as amended."
Pt had syncopal episode due to atrial fibrillation with rapid ventricular rate. Admitted to hospital 5 days after vaccination. Treated with IV amiodarone. Prior to this he had history of atrial fibrillation converted to sinus rhythm via pulmonary vein ablation in 2012 - was in sinus rhythm for 8 years.
GUILLAIN-BARRE SYNDROME; This spontaneous report received from a patient via pharmaceutical company  concerns a patient, sex, age, race, and ethnic origin not provided. The patient's height, weight, and medical history was not reported.   The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported.  The Company is unable to perform follow-up to request batch/lot numbers.   No concomitant medications were reported.  On an unspecified date, the patient experienced Guillain-Barre syndrome. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Guillain-Barre syndrome was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received from a patient via pharmaceutical company concerns a patient of unknown age who experienced Guillain-Barre syndrome (GBS) unspecified time after vaccination.  Patient past medical history , concomitant medications and concurrent medications were not reported. No other pertinent details reported. The information available precludes a complete and meaningful assessment . Information regarding other potential etiologies was insufficient, and the occurrence of GBS could represent background incidence of such events in the general population. Considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.
Extreme pain that traveled down left arm & left side of body. Lasting 3-4 days. Also noted muscle swelling, no redness. No other difficulties.
After a month my arm/shoulder became sore and painful with movement.  Painful enough to wake me up in my sleep..  Pain is not constant but there are more painful days than not,.
4 cm area of redness, swelling, heat, and tenderness consistent with cellulitis.
Hair started falling out in clumps; This case was reported by a pharmacist via call center representative and described the occurrence of hair loss in a 84-year-old female patient who received Herpes zoster (Shingrix) (batch number 53RF3, expiry date 17th October 2021) for prophylaxis.   On 18th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 19th July 2019, 1 days after receiving Shingrix, the patient experienced hair loss. On an unknown date, the outcome of the hair loss was unknown.   It was unknown if the reporter considered the hair loss to be related to Shingrix.  Additional details were provided as follows: On Friday, the patient received Shingrix in left deltoid and on Saturday, her hair started falling out in clumps. The reporter was unable to provide any additional details. The reporter consented to follow up. This case was found to be duplicate of the case US2019132804. Case US2019132804 would be deleted and all the future corresponding information to the present case would be submitted to US2019132802 (case of record).
Very itchy Hives that got bigger all over body including head, swollen lips, fever and several chills.
The day before I tested positive, I was having symptoms like I had a head cold. I tested positive on COVID-19 via the at home test. I then reached out to my doctor, and I was put on Paxlovid. I started recovering and within three days I was better.  I dealt with it for about a total of 4 days.  Day 7 I did test negative.
Anaphlactic allergy within minute or 2. I STILL feel awful and have problems with asthma.
Ringing in ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in ears) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (Ringing in ears). The patient was treated with PREDNISONE for Ringing in ears, at a dose of UNK 6 days. At the time of the report, TINNITUS (Ringing in ears) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.
Patient couldn't sleep; Body itching, Itching in arm pits, itching on torso, itching on hips; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Body itching, Itching in arm pits, itching on torso, itching on hips) and INSOMNIA (Patient couldn't sleep) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Minocycline allergy).    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced PRURITUS (Body itching, Itching in arm pits, itching on torso, itching on hips). On 04-May-2021, the patient experienced INSOMNIA (Patient couldn't sleep). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (Body itching, Itching in arm pits, itching on torso, itching on hips) and INSOMNIA (Patient couldn't sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provider by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Addition information received on 07 May 2021 had specification of event, areas where patient experienced itching.
your arm gets sore from the shot; I got this rash, it's a hot looking rash on my arm, I do not know my shoulder but it is top on my arm; Headache; it had a big lump on it for a while; I have had shingles before and it feels like it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 72-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing); "MGS" (unspecified if ongoing); "I take this for my 'eyes'" (unspecified if ongoing); "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for thyroid disorder; PREMARIN taken for eye disorder and a vitamin supplement.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "your arm gets sore from the shot"; RASH (non-serious), outcome "unknown", described as "I got this rash, it's a hot looking rash on my arm, I do not know my shoulder but it is top on my arm"; HEADACHE (non-serious), outcome "unknown"; LIMB MASS (non-serious), outcome "not recovered", described as "it had a big lump on it for a while"; HERPES ZOSTER (non-serious), outcome "recovered", described as "I have had shingles before and it feels like it". Therapeutic measures were taken as a result of pain in extremity, headache.  Additional Information: It was reported that the patient got a Prevnar, the Pneumonia vaccine(Later confirmed as Prevnar 20) and her arm got sore from the shot but few days ago she was little sore it was not as swollen and did had top of it, it had a big lump on it for a while, almost 3 weeks and now she got the rash, it's a hot looking rash on her arm, she do not know her shoulder but it is top on her arm. The patient was asking was there something she need to do about it. And she was still a little sore. The patient also reported that because it was rash and she had shingles before and it feels like it, shingles but it's not coming back, its been like this for a while. The patient reported that for treatment she just took Tylenol. She had headache and it was sore. She took Tylenol and put alcohol in her arm that was it.  Follow-up attempts are completed. No further information is expected.
Rash started 9 days after vaccines were given. No treatment other than Tylenol, ibuprofen and Benadryl if  needed.
30-60 minutes post vax, the pt developed chest tightness with wheezing. Albuterol was administered with relief.
Information has been received from a physician concerning a 9 month old patient who on an unspecified date was vaccinated with a dose of ROTATEQ (lot # not reported) and on an unknown date had intussusception. The physician stated that he had seen the patient one time. The physician stated the patient did not receive any vaccination in his office. The patient went to the hospital. The physician was not sure if the patient had received the ROTATEQ. Upon internal review intussusception was considered to be an other important medical event. Additional information has been requested.
Informatoin has been received from a physician assistant referring to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates between 25-OCT-2015 and 02-NOV-2015, the patients received doses of PNEUMOVAX23 lot # L008664, expiration date 03-NOV-2016, 1 dose, (route and dose were not reported) that were improperly stored. Concomitant drug was not reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Runny nose, fever of 101.7, on 06/08/2013 rash appeared, loss of appetite and fever spike of 102.9 Saturday evening. Currently (06/10/2013) has a full body rash, still maintains loss of appetite.
5cm local erythematous indurated pruritic lesion at site of varicella injection.
Initial and follow up information has been received from a medical assistant concerning a patient of unknown age and gender. On 14-APR-2015 the patient was vaccinated with GARDASIL lot # K006960 (expiration date, dose, route and site of administration were not reported) that was exposed to temperature outside of the recommended range for 12 hours. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information is not expected at follow ups requested to complete the case were received
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. Co-suspect drug included sterile diluent (manufacturer unknown). The nurse reported a patient was inadvertently administered ZOSTAVAX (lot: N025703, expiry date: 16-DEC-2018) reconstituted with a sterile diluent (manufacturer unknown) by the intramuscular route instead of subcutaneous on 22-MAR-2018. No adverse effects were reported.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication was provided. No treatment medication was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   This case was linked to MOD-2021-623784, MOD-2021-623786 (Patient Link).
expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 8 patients. This report is for 4th of 8 patient. A patient of unspecified age and gender received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient expired before receiving the second dose on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed.  Information about Lot/Batch number has been requested.; Sender's Comments: Current information is very limited for full assessment. The patient died following the vaccine use; further information such as patient demographics, complete medical history, concomitant medications, concurrent illness and event term details especially death cause and autopsy results are needed for meaningful evaluation.   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.,Linked Report(s) : US-PFIZER INC-2021034595 same  drug, reporter and event but different patient; Reported Cause(s) of Death: expired before receiving the second dose
I took Ibuprofen 800 Mg - taking every 8 hours  - I took this after I started having symptoms which was the next morning.  I noticed the next morning and it lasted 24 hours - headache; fever, chills and fatigue.
1st Dosage:  Same day, received headaches, tiredness, fatigue, weakness whole body, coldness in body, hot flashes.                              Next morning-have slept for around 12 hours.                              Following few days:  Same symptoms for the first 4 days, the 5th day finally feeling better                              Did not take any other medications over the counter or prescriptive medications.                              Naturally recovered from sickness side effects of the medications.  2nd Dosage:  Same as above.  3rd Dosage:  1st Day immediately, fatigue, tired, weakness.                               2nd Day:  could not drive at all.                               3rd Day:  could not drive at all.                               Did not drive for 5 days from 12/29/2021 Booster Shot Moderna Vaccine   Terrible feeling of fatgiue, tiredness, weakness and coldness at times. Muscular function could not allow me to do daily activities such as basic local driving or even any type of driving at all. I was basically bedridden every time I had these vaccines. I hope your future Covid-19 vaccines, especially Moderna will improve with time without adverse side effects at all.
pt recv vax & devel nausea, weakness, diarrhea, rapid heart rate, diff breathing, numbness in legs & unable to walk 6-7hr;
patient fainted after receiving first dose of moderna. we placed an ice pack on his neck. he was recovered fully within 15 minutes.
YEAST INFECTION; ALLERGIC REACTION - ITCHING ALL OVER THE BODY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced itching all over the body (mostly in hands and feet). On 09-MAR-2021, the subject experienced yeast infection. On 09-MAR-2021, the subject experienced allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the itching all over the body (mostly in hands and feet), yeast infection and allergic reaction was not reported. The batch number was not reported and has been requested. This report was non-serious.
Myalgia, CoughWheeze, CHILLS, EXTREME ACID REFLUX;  CONGESTION