chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cold chills; sweating; joint pain; dehydration; headache; vomiting; tight chest; light sensitivity; shaking; muscle pain; This is a spontaneous report from a non-contactable consumer. A 19-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE)(Batch/ Lot Number: Unknown), 2nd dose, via an unspecified route of administration in the left arm on 15Mar2021 at 10:00 AM for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's past drug history included BNT162B2 (Lot/batch no: Unknown), 1st dose, via an unspecified route of administration on an unknown date for COVID-19 immunization. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to vaccination. On an unknown date in Mar2021, the patient experienced shaking, sweating, cold chills, vomiting, headache, muscle pain, joint pain, dehydration, tight chest and light sensitivity. The patient did not received any therapeutic measures for the adverse events. The clinical outcome of the events shaking, sweating, cold chills, vomiting, headache, muscle pain, joint pain, dehydration, tight chest and light sensitivity were recovering at the time of reporting. No follow up attempts are possible,  information about batch number cannot be  obtained. No further information is expected.
Called to assess pt in post vaccine waiting area due to c/o swollen tongue at 10 Am.  Pt reports tongue swelling after her first dose, worse now  after 2nd dose with sensation of swelling in her throat/back of tongue. No c/o itching, no visible urticaria.  No shortness of breath/wheezing. Radial pulse in 70's. Pt reports tongue looks swollen to her in when she looks in mirror in the car. Med/allergy info in hand - multiple drug allergies noted. Did not meet criteria to receive epi pen, wamc EMS contacted to transfer pt to ED for further eval.  Spouse headed to ED from fairgrounds site. Foglia MD
Warm to the touch on injection site / warmer than touching other parts of body; Itching like a mosquito bite; Swelling on injection site; Red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch on injection site / warmer than touching other parts of body), VACCINATION SITE PRURITUS (Itching like a mosquito bite), VACCINATION SITE SWELLING (Swelling on injection site) and VACCINATION SITE ERYTHEMA (Red) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066DLA) for COVID-19 vaccination.     The patient's past medical history included Anxiety and Depression. Concomitant products included OMEPRAZOLE for Product used for unknown indication.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Warm to the touch on injection site / warmer than touching other parts of body), VACCINATION SITE PRURITUS (Itching like a mosquito bite), VACCINATION SITE SWELLING (Swelling on injection site) and VACCINATION SITE ERYTHEMA (Red). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch on injection site / warmer than touching other parts of body), VACCINATION SITE PRURITUS (Itching like a mosquito bite), VACCINATION SITE SWELLING (Swelling on injection site) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Severe headache, body aches, chills, joint pain, fatigue, weakness, dizziness, dry mouth, no appetite, nausea, fever, sore arm, hurting teeth, pain in chest and unable to stay warm.
pt. received a flu shot at the school flu clinic with written permission by mother.  When I went to enter it in the database it showed the pt. had received one 2 days earlier at PCP.  I talked with both parents today via interpreter.  They stated pt. had no adverse effects and is healthy.  This reported to pts. PMD.
moderate to severe muscle aches and joint pain chills and stomach pain for 4 days. Shoulder pain and weakness continuing thru today(17 days after shot)
Pt received Pfizer vaccine on 3/4/21 and 3/25/21. Pt presented to the ED with complaints of SOB requiring increased levels of oxygenation. Pt's SPO2 found to be at 77%. Pt was tested for COVID-19 and was found to be positive. Pt diagnosed with COVID-19 viral pneumonia.
pt recv vax & devel a small dime size rash on back;pt devel a fever & was seen by MD who dx ear infect & upper resp infect;devel pin head blisters;felt was ringworm;dx herpes shingles;
Asymptomatic until June 2, 2021. Developed symptoms of dysautonomia, dizziness, facial vasomotor symptoms, and near syncope. Full lab and cardiac work-up was negative, except for relative  bradycardia at rest and during hard exercise. Fast-forward 5+ weeks, developed sudden onset of lower extremity proximal muscle weakness, and wasting.  Diagnosis is AIDP/Guillain-Barre. Scheduled for IVIG therapy this week
HIVES; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to seashells. The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, Laboratory data included: Allergy test (NR: not provided) Allergic to tomatoes, peanuts, pecans, and grass. On 03-MAY-2021, the subject experienced hives. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hives was not reported. This report was non-serious.
I developed a new rash on my torso and have had three bouts of diarrhea.
Patient stated no immediate reactions  after receiving the Moderna vaccine on 04/08/2021. The following morning 04/09/2021 patient stated she felt like she was sunburned on her legs and arms and sometimes on her trunk with no redness, warmth or pain and no fever. 04/26/2021 is the first day she has noticed a decrease in her symptoms. Patient reported to Urgent Care at the direction of her Primary Care Doctor.
Patient never received her 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient never received her 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-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 PRODUCT DOSE OMISSION ISSUE (Patient never received her 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient never received her 2nd dose) had resolved.            No concomitant medications were reported.  Treatment information was not provided.   Reporter did not allow further contact
Elevated temperature of 105 started early am hours of 1/20/21, during the night, and did not decrease to 102 until 6pm. Also had loud ringing in ears. I?m still having ringing in ears.
3 days of severe fatigue, dizzy w/ change of position, feeling of her head spinning when getting out of bed or up from a chair & sometimes when sitting. "feeling confused, trouble concentrating, very tired". Hands feeling cold, not tingling.
Patient c/o dry mouth and some shortness of breath with in 10 min of getting vaccinated. However states she can breath fine. EMT in attendance and evaluated. O2 sat 98% on room air. BP - 130/86; HR strong/regular at 88.  EMT recommended ambulance and patient declined transport. Patient drove self and ambulated to personal vehicle. . No SOB noted.
pain has gone down has been away;  no neck pain/ no issues with my collar bone my shoulder; my shoulder I can move my arm up and down and everything; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "neuropathy" (unspecified if ongoing); "my shoulder I broke my collar bone" (unspecified if ongoing); "neck pain" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 05Mar2021, for Covid-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "pain has gone down has been away;  no neck pain/ no issues with my collar bone my shoulder; my shoulder I can move my arm up and down and everything".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021381420 Same reporter, drug, and event; different patient
This spontaneous report has been received from a physician referring to two to three patients of unknown age or gender. The patients had not medical history, concurrent conditions, drug reactions/allergies or concomitant medications. On unknown dates, the patients were vaccinated with the first, the second and the third doses of ROTATEQ (strength, dose, route, lot # and expiration date were not reported) by oral route as rotavirus vaccination. Approximately in 2017 (reported as over last couple of months), the patients were diagnosed with rotavirus, after the patients had completed the 3 dose series of ROTATEQ. Stool samples were sent on an unspecified date to an unspecified laboratory, for confirmation of rotavirus and the results from the laboratory were positive for rotavirus. The patients were treated and subsequently, on unknown dates in 2017, they recovered from the event. No additional information was provided. The causal relationship between the event and the suspect therapy was not provided. Upon internal review the gastroenteritis rotavirus was considered as a medically significant event. Follow up information has been received from the same physician on 04-MAY-2017, regarding a 3 year old patient of unknown gender. On 06-AUG-2015, the patient was vaccinated with third dose of ROTATEQ (lot number # L008034, expiry date not reported). On 09-APR-2015 and 08-JUN-2015, the patient received the first (lot# K016311) and second (lot# K023157) vaccine doses. This is one of the three reports received from the same reporter. Additional information is not expected. Patient's age, age at vaccination, start date of the suspect therapy and narrative were updated.; Sender's Comments: US-009507513-1704USA008747: US-009507513-1705USA004199:
LARGE AREA OF ERYTHEMA (>120 MM) W/ SWELLING AND PAIN EXTENDING FROM L. SHOULDER TO L. ELBOW.
Case number PHEH2044US019679 is an initial spontaneous report received from a healthcare professional (physician assistant) on 30 SEP 2014 with a follow up report received from the physician assistant on 27 OCT 2014. This report refers to a 64 year old male patient. His current conditions included hypertension, hyperlipidemia, allergic rhinitis and peripheral vascular disease. His concomitant medications were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 1412501) intramuscularly at a dose of 2.5 mg (o.5 mg x 5) (whole vial) on 30 SEP 2014 (overdose). He was monitored for 01 hour in the office and was told to take Benadryl. On 30 SEP 2014, the patient had fatigue, malaise, runny nose and cough. The patient completely recovered from the events four days after the onset on 07 OCT 2014. The seriousness and causality of the events were not reported.   Follow up report was received from the physician assistant on 27 OCT 2014: Updated current conditions and dose of vaccination. New events (fatigue, malaise, runny nose and cough) were added.
When receiving the 2nd dose today, the patient commented that the Shingles vaccine she received within a week of her first dose of the COVID19 Pfizer vaccine was more painful.  Patient had not disclosed she had received a vaccine within 14 days of her 1st dose.
Widespread itching started approximately 5 hours after the vaccine. No rash or hives noted at the time of this appointment. No difficulty breathing, wheezing, nausea, or vomiting.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter  It was mentioned that the vial was initially refrigerated on 18-Nov-2021, the vial did not undergo any temperature excursion and patient did not experienced any adverse events.  No treatment medication was provided by the reporter.
Painful sore left upperarm musculature extending below injection site into bicep followed by redness and swelling. Next day flu like achiness across back and upper body; followed by fever the night of 09/13/2014.  09/14/2014 fever and achiness gone but swelling, soreness in bicep remains today with skin redness in the same area but slowly diminishing.
Irregular shaped red rash surrounding site of injection above and below.  Hourglass shaped.  Mild itching.
This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 31-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot# L016427; expiration date: 13-APR-2017) (dose and route of administration were not provided). Concomitant therapies were not reported. No adverse effects reported. The pharmacist explained that the RECOMBIVAX HB doses were not involved in a previous temperature excursion and this time the temperature and time frame were: 1.4C for 22 hours 52 minutes and 8.6C for 112 hours and 5 minutes. This is one of several reports received from the same source (original report 1602USA004808). Additional information has been requested.
On the day of the 2nd vaccine, I experienced pronounced ringing in my ears.  It subsided for the most part within a few hours, but at times I notice a lingering effect.  Prior to this, I did not have tinnitus.
On 11/12/2021, my right ear began to ache, and it would continue to ache for the next 3 or 4 days. I went to my PCP, on 11/17/2021, and he thought I possibly had a cold. On 11/19/2021, a rough area about the size of a quarter appeared in front of my right ear. I took a picture of it and sent it to my PCP. I then got a prompt response from him telling me that I had Shingles. On 11/22/2021, I saw another doctor in doctor practice, as the doctor was out of town. I was prescribed Gabapentin for the pain and an antiviral. They weren't effective, so I had to ride out the Shingles. In January 2022, I went to my annual dermatologist's appointment, and she observed that I had residual Shingles activity on my right ear lobe and the right side of my scalp. At the time of this writing, the symptoms have mostly vanished, though I still occasionally experience a tingling sensation.
Information has been received from a physician concerning a 19-year-old male who on 13-AUG-2007 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) or mumps virus vaccine live (Wistar RA 27/3 strain) (MSD). On 15-AUG-2007, the patient developed swelling of the parotid gland a couple of days after vaccination. IgM was also elevated on 21-AUG-2007. The "physician believes these were from the immunization." The patient sought unspecified medical attention. At the time of the report the patient's status was recovering and it was reported the "patient is doing much better now." A product quality complaint was not involved. Follow-up information was received on 07-NOV-2007 via a phone call from a physician. He stated that the patient received the vaccination while still living in another country. It is not known which vaccine was administered as the vaccination did not occur at the doctor's office. The doctor saw the patient for treatment after the symptoms had developed. Additional information has been requested.
I received the Moderna Bivalent COVID-19 booster on 10/17/2022. On 12/24/2022, I began to develop cold-like symptoms like runny nose and cough. The symptoms worsened throughout that night and made sleeping difficult, because I kept coughing. On 12/25/2022, I took a home antigen test and got a positive result. I then went to work shortly thereafter and was tested again at my workplace, and I got another positive result. I then went home and then self-isolated from my family. On 12/27/2022, I contacted my doctor and was prescribed molnupiravir, which I took for 5 days. He also recommended that I take acetaminophen for pain relief and MUCINEX (not MUCINEX DM) for cough and congestion relief. He also told me that I could take ROBITUSSIN cough medicine at night, so I could sleep better. I ended up taking it twice, and it helped. My symptoms gradually improved every day after I started the molnupiravir. The symptoms became more tolerable. The fatigue was the worst symptom; if I climbed the stairs to go to the bathroom, I would have to sit for a while afterwards to catch my breath. I normally sleep 7-8 hours at a time, but during my illness, I slept often during the day, sometimes for up to 10-12 hours. I frequently tested myself, and I continued to test positive until 1/6/2023, which was the first day that I finally tested negative. I then returned to work on 1/7/2023. At the time of this writing, I still have occasional mild symptoms, such as a mild cough, runny nose, and sinus drainage. I also get fatigued more easily than I did before the virus, and I have to stop and rest if I do too much. I am gradually regaining my old energy levels, though. I would say that I am 90% recovered.
Day 1 after 2nd dose - extremely ill with flu symptoms and chills Day 2 after 2nd dose - sharp, burning chest pain around heart  Entire 1st years after 2nd dose - Pain (Sharp, burning) around heart that worsened with deep breaths and exercising
After receiving Covid-19 product Moderna NDC 80777-0275-99 RX team and RPh were under the impression that this product was to be used for booster doses. After due diligence and checking it was found to be that this patient may have received 0.25ml of that product (rather than the recommended 0.5ml dose for boosters).  I will then contact the patients physician to see if they would like us to repeat the dose.
Shoulder feels separated, sore, pain; Very limited arm movement; Unable to bath, dress, get in-out of bed & chairs without help; This case was reported by a consumer via interactive digital media and described the occurrence of shoulder pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On 8th December 2021, the patient received the 1st dose of Shingles vaccine. In December 2021, less than a week after receiving Shingles vaccine, the patient experienced shoulder pain, mobility decreased and activities of daily living impaired. On an unknown date, the outcome of the shoulder pain was not recovered/not resolved and the outcome of the mobility decreased and activities of daily living impaired were unknown.   It was unknown if the reporter considered the shoulder pain, mobility decreased and activities of daily living impaired to be related to Shingles vaccine.  Additional details were provided are as follows: The patient self-reported the case. The age at vaccination was not reported. The patient received a dose of Shingles vaccine on Wednesday and he/she felt like his/her shoulder was been separated. The word sore did not begin to describe the pain. No outer swelling or bruise but he/she had very limited arm movement. The patient did not expect to be unable to bath, dress or get in and out of bed and chairs without help.  The patient hopes it did not last much longer.  The patient asked that pharmacist might be hit a nerve, and nothing takes away the pain. The patient was not sure for getting the 2nd shot and already had shingles so he/she knew what the pain was like. The follow-up could not be possible as no contact details were available.
Pfizer-BioNTech COVID-19 Vaccine EUA  41-year-old female with history of anaphylaxis to fish and cashews, asthma, aortic stenosis, eosinophilic esophagitis, and chronic idiopathic urticaria presenting to emergency department for chest tightness, dyspnea, nausea, vomiting, and throat discomfort following 1st dose COVID-19 vaccination (Pfizer).   Vital signs remained normal and stable during this ED visit.  On presentation, patient was in moderate distress.  Physical exam was notable for retching and tachypnea upon arrival. Patient's presentation consistent with anaphylaxis likely due to COVID-19 immunization (Pfizer). Epinephrine, famotidine, benadryl, solumedrol, zofran, and fluids administered with complete resolution of symptoms. Patient observed for 4 hours without worsening of symptoms.  Patient discharged home.
This spontaneous report as received from a nurse practitioner refers to a 4 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 12-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature exucrsion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Patient fainted within 30 seconds of administration of flu shot. Patient's father and brother were present and helped lay patient to the floor. He abruptly woke up after about 3 seconds, confused, but dad was able to calm him easily. Patient reports feeling dizzy. He sat for a few minutes, pulse of 50 bpm. Family reports he's a swimmer and generally has a low BP and pulse. Within 5 minutes of incident, patient reported feeling "fine" and ready to leave. I followed up with father about 90 minutes after episode and he reports patient is doing fine and playing his Xbox. Dad said he will keep an eye on patient overnight.