chrisvoncsefalvay/vaers-outcomes huggingface dataset:
following the Moderna COVID-19 Vaccine EUA:  at around 6:00 PM I began experiencing a headache and some soreness in my left arm around the shot site and became very tired, then around 10:00 pm nearly half my joints began aching.  After waking, I still had a headache and body aches, but felt somewhat better.  by 1:00 pm, became very achy in my joints again and tired. I  had 2 times during that evening lasting about 5 to 10 minutes each  of difficulty breathing and a slight tightness in my chest.  This passed and I did sleep better the night of 3/5/21.
Chills; Feeling abnormal / It has been all day, all day has been terrible; Dizzy; I just feel sick; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 15Feb2021 (at the age of 70-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included diabetes mellitus (verbatim: Diabetes), anaemia (verbatim: Anemia), and blood cholesterol increased (verbatim: High cholesterol). The patient reported to have lot more (unspecified) medical conditions. The concomitant medications for patient were not reported. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown) on 23Jan2021 (at the age of 69-year-old) for COVID-19 immunization. The patient reported that she received both the vaccines. After the first one there was no problem but the second one, the patient really did, 'I really figured about that' (sentence not clear on call). On an unspecified date in 2021, the caller felt chills and touchy and a little dizzy and "I just feel sick", just sick, and "Feeling abnormal / It has been all day, all day has been terrible". The patient underwent lab tests and procedures which included blood cholesterol: high on an unspecified date. Unspecified laboratory test in "January": unknown result. The patient was reported to still experience events a little bit. The patient reported "It is little better, it has been all day, all day has been terrible, now it is a little better". The patient wanted to know, would it be okay to take some medicine like Tylenol or something like that. Consumer was informed about the role of Pfizer Drug Safety and also informed about Pfizer Medical Information department. The outcome of the events was resolving.  Follow-up attempts completed. No further information expected.
Complaints of sinus symptoms (post nasal drip, sore throat, nasal congestion) and body aches morning of 10/19/05. Late that evening was in bed with mom eating pizza when mom states had seizure. Then had another 20-30 seconds after first one. Went to ER.
Redness, swelling, itching, warm to touch. Treated prophylactically with Bactrim.
This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FG3527) via an unspecified route of administration in the left arm on 23Nov2021 at 00:00 (at the age of 78-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) and, known allergies to pineapple and thermasil. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration on 11Mar2021 at 13:15 (at the age of 77-year-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 01Apr2021 at 13:15 (at the age of 77-year-old); both as single dose for COVID-19 immunisation. On 23Nov2021 at 20:30, the patient experienced injection site pain, headache, chills, fever, diarrhea, arm pain, dehydration and intestinal cramps. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site pain, headache, chills, fever, diarrhea, arm pain, dehydration and intestinal cramps was resolving at the time of this report.
Rash (described as hives) to legs and back; dry mouth; reflux; tongue swelling;  Pt went to ED and treated.  Pt DX with "Generalized allergic reaction with skin rash secondary to drug."
Initial information received on 14-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four-months old male patient who experienced crying for a minute, while he received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR for Immunisation; HEPATITIS B VACCINE for Immunisation; ROTATEQ for Immunisation; and ENERGIX. On 13-Sep-2018, the patient received a 0.5 mL second dose of suspect DTAP IPV Lot: C5409AA and HIB Lot: C5552AA, expiry date: 10-Oct-2019) via intramuscular route in the left thigh. On an unknown date, the patient developed a non-serious crying for a minute (crying), following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. It was also a case of actual medication error due to inappropriate reconstitution technique. The patient was administered PENTACEL but due to an error in reconstitution they did not get the HIB part of the vaccine. It was also reported that nurse then reconstituted the HIB portion with the 0.4 percent NaCl saline solution as directed and gave the patient the HIB portion of the PENTACEL injection. All parts of the PENTACEL injection were given on the same day. Relevant tests were not reported. Final diagnosis was crying for a minute. It was not reported if the patient received a corrective treatment. On an unknown date, the patient was recovered from the event (duration reported as a minute). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by the sender: none.
Pt developed urticaria on arm where he received vaccination (L arm) about 3 hours after vaccination. Also with itching of whole body. No wheezing, shortness of breath, or other symptoms.
Running fever during the night 101; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Running fever during the night 101) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Running fever during the night 101). At the time of the report, PYREXIA (Running fever during the night 101) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) Running fever during the night 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was reported by reporter.   Reporter did not allow further contact
Sore arm; Red spot on arm; Warm; Itching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Red spot on arm), FEELING HOT (Warm) and PRURITUS (Itching) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Red spot on arm), FEELING HOT (Warm) and PRURITUS (Itching). At the time of the report, PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Red spot on arm), FEELING HOT (Warm) and PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; 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.
On 07/01/2003 @ 15:00 after receiving a Td#1 and HBV #1, patient walked out of clinic accompanied by her mother in no apparent distress.  Allergies, side effects and precautionary measures discussed prior to her injections.  Approximately 3-4 minutes later, mom came back into clinic stating her daughter had "passed out" upon entering her car.  PHN assessment revealed no injury or head blow.  Patient did not fall.  She was sitting in her car behind the steering wheel.  Color slightly pale, respirations/pulse WNL, responded to verbal stimuli.  She stated her hands felt numb.  Mother informed PHN that her daughter has a habitual history of fainting and feeling of weakness after experiencing any discomfort.  This information was not given to PHN prior to the injections.  911 called.  Ambulance arrived shortly after call.  Patient accompanied to EMT walked to the ambulance and climbed inside.  Physical assessment done by EMT.  Patient sat for several minutes inside ambulance.  EMT informed PHN no need to go to ER.  Patient was able to ambulate to her mother's car, and was driven home.  07/09/2003: Spoke with patient per telephone.  She stated she was doing fine and had fully recovered from incident that afternoon.
pt devel rash over entire body was seen in ER dx hives-instructed to give DPH;hives gone by 27SEP96 PM;
Overall body pain and stiffness increasing in intensity over first 2 hours and lasting for 30 hours. The 3 days following overall body pain had pounding headache and extreme fatigue.
My face is tingly and numb Started about 45 min after I and getting worse as day progresses It's been 5 hours now; My face is tingly and numb Started about 45 min after I Justin and getting worse as day progresses It's been 5 hours now; My face is tingly and numb Started about 45 min after I  and getting worse as day progresses It's been 5 hours now; This is a spontaneous report from a contactable other health care professional (Patient). A 52-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date not reported) via an unspecified route of administration in an unspecified anatomical location on 19Feb2021 09:45 (at the age of 52-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No COVID prior vaccination nor tested for COVID post vaccination. No known allergies reported. The patient did not receive any other vaccine within 4 weeks prior to vaccination. On 19Feb2021 10:15, the patient's face was tingly and numb started about 45 min after justin and getting worse as day progresses it's been 5 hours (at the time of reporting). No treatment received for events. The outcome of all events was reported as not resolved.  Follow-up (11MAY2021): Follow-up attempts completed. No further information expected.
Fever 103, myalgias, HA, insomnia, SOB, hallucinations, rigors.  Symptoms lasted longer than 24 hrs.
Information has been received concerning a 26 year old female nursing student who on 09-MAY-2007 vaccinated herself with Gardasil (LOT#654741/1208P) which was exposed to room temperatures for about 4 hours, subcutaneously in her left arm. Concomitant therapy included cough, cold, and flu therapies (unspecified). On 09-MAY-2007 the patient's left arm hurt. The patient's experience persisted. Additional information is not expected.
Patient is a 38 y.o. female presenting with nausea with middle taste sensation after immunization.  Presentation most consistent with vasovagal reaction versus allergic reaction.  No signs of severe allergic reaction or anaphylaxis, no signs of cardiopulmonary compromise.
I had the first dose on Friday afternoon and on Monday morning when I woke up it feels like my face has been sunburned. It is red and slightly puffy. No new skin products or foods. No difficulty breathing or other symptoms. I am also a nurse practitioner.
I have been having shoulder pain in both my shoulders for about a year and a half. Shortly after getting the vaccine I started having pain in both my knees, both shoulders, back, hands. I started having more pain that was more severe. It started getting worse and in more areas. I saw a couple orthopedics surgeons. They thought I needed surgery. I saw some rheumatologists and they said I had ankylosing spondylitis. My symptoms started before getting the vaccine but they got much worse after getting the vaccine. I had a ton of MRIs, x-rays, lab work.  I am still in pain and they are still trying to find a medication that would work. I had to stop my treatment because I was taking immunosuppressants and my whole family got COVID so they stopped my treatment. I have been having COVID symptoms for the past 2 weeks. I tested negative twice but my doctor is still treating me as I have it.
12 hours after injection headache, nausea, tightness in chest and abdominal area, dizzy, confused, body aches low grade fever
6 hours after - very short of breath - pounding heart - heavy chest - chills - slept 16 hours - thought about emergency room.
Diagnosed with shingles aprox three weeks after second vaccine given. Shingles like back pain in same dermatome 1-2 days after vaccine given. Resolved and rash appeared May 6 in same dermatome with reappearance of same pain.
Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 17-SEP-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, Lot #L024997, expiration date: 06-OCT-2016), which were improperly stored for 3 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Received vaccine in left arm and within 5 minutes went into vertigo, palpitations, and had a heavy pressure in the front of my head that lasted for the next 48 hours. it went away but continued to have several  "episodes" per month after. In May noticed that I started having vibrations/tremors on left side of upper body and head and right eye vision changes. In February of 2022 I began having the tremors on bilaterally from toes to head.
Patient within 15 complains of back spasm with nausea.  Patient affirms hx. of back-related problems.
Swollen armpit and neck, both locations are painful, along with a hard lymph node, which is painful to the touch.
Patient called today (11/30/21) to report that on the evening he received his pfizer booster vaccine (11/24) he started experiencing severe pains in his arm that radiated to his shoulder, neck, and across his chest.  He also reports on and off headaches in the days since he received his vaccine.  He reports only mild improvement from the initial symptoms.
This unconfirmed spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (dose reported as one vial, route of administration and lot # not provided). The field representative was told by the physician, who was told by a neighbor that a friend's daughter had a vagal response when she received GARDASIL, fell and bumped her head on the table and had to go to an Emergency Facility, where she received a couple of stitches in her head. The patient's outcome was not reported. The relatedness between events and GARDASIL was not reported. Additional information is not expected, because there is no consent for follow-up.
RASH; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash. This report was non-serious. This case, from the same reporter is linked to 20210724371.
A booster third dose was administered to  patient, but Moderna is not currently approved for third dose booster for patients.  It is listed Moderna that a third dose may be given if the patient is immunocompromised. The patient has COPD so is immunocompromised, so the third was given based off that information.  The patient was called on 9/24/21 at noon, and she reported that she felt fine and had no side effects. The doctor's office  was informed that the patient received the third dose and that the patient has not experienced any side effects
Mom states p/pt recvd 1st dose of DTP had high pitched cry 3 times for 20min ea; Also devel quivers ever since vax given;
This spontaneous report was received from a other health professional refers to an unspecified number of patients of unknown demographics. On an unknown date the patient was vaccinated with PEDVAXHIB, (lot #, expiry, dose, dose # and route unspecified). No concomitant medications were reported. On an unknown date, it was reported that patients received doses that were exposed to temperatures outside of the proper storage range. No adverse effect reported. The outcome of patients received doses that were exposed to temperatures outside of the proper storage range and no adverse effect reported is unknown. There was no product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
12MAR92 t104, seizure, seen @ ER, MD dx ear infect, put on Amoxicillin; seen by MD 13MAR92, no evidence of ear infect; hx of febrile seizure 1DEC91 in conjunction w/influenza t104;
Moderate rash appearing 3 days after vaccination consisting of elevated, small, circular, red bumps approximately 1 mm in diameter starting at the neck line and descending down to the groin. Symptoms are also present along the back in minor quantities. No fever after second day past vaccine administration. One week past vaccination and rash is still present. Healthcare providers are not concerned as the patient is otherwise healthy and not bothered by symptoms. Rubor has declined, but the elevated bumps are still present. There is no expected long term consequences according to healthcare provider.
Vaccinated pt admitted to inpatient facility and tested positive for covid. No access to vaccination information
This case was reported by a other health professional via call center representative and described the occurrence of blistery rash in a adult male patient who received SHINGRIX for prophylaxis. In 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 10 days after receiving SHINGRIX, the patient experienced blistery rash, pruritus and blister infected. The patient was treated with hydrocortisone. On an unknown date, the outcome of the blistery rash and pruritus were not recovered/not resolved and the outcome of the blister infected was unknown. It was unknown if the reporter considered the blistery rash, pruritus and blister infected to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient had no history of herpes simplex. The healthcare professional stated that the patient developed a blistering rash on the left side of mouth following SHINGRIX which was not completely resolved over the past 2 months and it was still ongoing. The event started out as being itchy. The patient thought it was just a pimple but then clear liquid and puss came from the blister area. The healthcare professional was unable to provide the lot number and expiry date of the product used at the time of reporting. The patient used Hydrocortisone cream on rash. The patient had improved, but not resolved fully. The reporter consented to follow up.
This spontaneous report was received from a Registered Nurse referring to unspecified patients of unknown age and gender. No pertinent medical history, concurrent conditions, drug reactions allergies or concomitant therapies  were provided. From 10-MAR-2017 to 09-JUN-2017, the patients were vaccinated with unspecified improperly stored doses of VAQTA for prophylaxis (lot # M033611 with an expiration date of 02-MAR-2018) (dose, route and anatomical location were not reported). The administered doses of the vaccine experienced a temperature excursion from 32 degrees Fahrenheit  to 35 degrees Fahrenheit for 72 hours, no data logger was involved and no previous temperature excursions were reported. There was no adverse reactions. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1707USA000421.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On unspecified dates, the unspecified patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L012835, expiration date 11-MAR-2018 and lot # K008879, expiration date 30-MAR-2017 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Pt recv vax on 2/1/99; 3 hr post vax pt exp fever (103.5-104) & 2 seizures
pt recv vax 10AM 15OCT98 about 1hr later the inj site was very hot & painful;states went to MD was given med;
After looking at the patient's vaccine card, which had a first dose of pediatric Pfizer on 3/12/2022, I assumed they would need a pediatric dose for their second, and administered a pediatric dose. I then went into the computer to document this and found out that the patient was actually 12 years old. I then reported this accident to my supervisor, we informed the family and I filled out an incident report for our site