chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by an other health care professional and describes the occurrence of DIARRHOEA (Diarrhea), CHEST DISCOMFORT (chest pressure), DYSPNOEA (Difficulty in breathing), AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 from 13-Jan-2021 to 30-Jan-2021. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), CHEST DISCOMFORT (chest pressure), DYSPNOEA (Difficulty in breathing), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), ILLNESS (Sickness), COUGH (chest pressure cough), FATIGUE (exhausted), VOMITING (vomiting), HEADACHE (Headaches), MYALGIA (Body ache), CHILLS (Chills) and NAUSEA (Nausea). The patient was treated with ALBUTEROL [SALBUTAMOL] from 10-Feb-2021 to 20-Feb-2021 for COVID-19, at a dose of 1 dosage form four times per day. At the time of the report, DIARRHOEA (Diarrhea), CHEST DISCOMFORT (chest pressure), DYSPNOEA (Difficulty in breathing), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), ILLNESS (Sickness), COUGH (chest pressure cough), PYREXIA (Fever), FATIGUE (exhausted), VOMITING (vomiting), HEADACHE (Headaches), MYALGIA (Body ache), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Chest X-ray: (normal) no infiltrate or pleural effusion, no acute disease. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were reported. This case was linked to MOD-2021-024986 (Patient Link).
HOSPITALIZED INPATIENT FOR COVID 11/11/23-11/14/23
Allergic reaction included hives, redness and swelling, with a rash as well. Rash is still present
Day 1 following shot - slept all day Day 2 headache, chills, low grade fever 99.7, sharp pain on side of head every 20 seconds Day 3 headache, chills, sharp pain on side of head every 20 seconds; Significant upper lip swelling started at noon.  Still swollen  at same level at 7pm.  No additional swelling .
48 hrs after vaccine admin - reaction at (LD) admin. site swollen rash & painful 2" x 3" - fevers up to 102- (+) flu like symptoms-pt believes worst is over now (12/11) but is not 100% well yet - using ibuprofen.
Muscles were aching on the opposite shoulder/Neck and back and shoulders, arms; I do get achy muscles; Rash like dry skin on cheeks and like nose; it's red, kind of burns but it's not hot; Rash like dry skin on cheeks and like nose; it's red, kind of burns but it's not hot; Not feeling well/not feeling really good; Rash like dry skin on cheeks and like nose; it's red, kind of burns but it's not hot; Muscles were aching on the opposite shoulder/Neck and back and shoulders, arms; I do get achy muscles; Muscles were aching on the opposite shoulder/Neck and back and shoulders, arms; I do get achy muscles; Muscles were aching on the opposite shoulder/Neck and back and shoulders, arms; I do get achy muscles; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration (right arm) on Jan2021, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had the shot on Friday and patient believes patient is having reactions to this, patient is not sure because it was not really listed. First of all, they mentioned like muscle aches on where you got the shot but patient's muscles were aching on the opposite shoulder. Patient got the shot in the right arm and patient's muscles were aching on the other side. That's one minor thing because it's like in patient's neck and back and patient's shoulders, like patient's arms. Patient do get achy muscles now and then. Paitent noticed that, the first thing, patient doesn't know if it's possible that it could be on the other of the side of that. It could be one of them but that's not what is really concerning patient. Actually, the one thing it said on the thing that it's a possibility you might get a puffy face. Patient has a rash, like dry, dry skin on patient's cheeks and like patient's nose and it's red that's one thing. Patient was sure that's from the shot. But patient's real concern, patient's main concern is, patient was in home service. Patient helps out people that are either handicapped or whatever and patient want to get this done. Does this mean patient should not have the second shot because patient was having like the red face, it kind of burns but it's not hot.Patient was not feeling really good because of the shot. This was the only number that patient was given when patient got the shot and patient would like to know what your purpose is. Patient was so angry for this (call issue). The outcome of the events was unknown.  Information on the Lot/Batch has been requested.
EXTREME MALAISE; WEAKNESS; DIZZYNESS; Booster dose taken on 27Oct2021 at 14:30; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received third (BOOSTER) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: F63527) via an unspecified route of administration in the left arm on 27Oct2021 at 14:30 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), diastolic dysfunction, severe neuropathy bilateral lower extremities (BLE), depression, high blood pressure (B/P) and stroke minor. 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 vaccination. The patient received unspecified regular concomitant medications within two weeks of vaccination. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 30Mar2021 at 13:15 (at the age of 75-years-old) and first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 05Mar2021 at 14:00 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. The patient previously received simvastatin (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and experienced drug allergy. On 28Oct2021 at 07:00, the patient experienced extreme malaise, weakness and dizziness. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme malaise, weakness and dizziness were resolving at the time of this report.
pt recvd Rubella vax/Recombivax HB  on 18OCT91 & 10 days p/vax devel lymphadenopathy; pt later recovered; no further details were provided;
Approximately 10 minutes after the vaccines were given, pt stated she felt "hot" and like she was going to "faint". Pt then fainted which included loss of conciousness for several seconds but less than one minute.  Pt also experienced stiffening of her body during this episoed for several seconds but no "tonic/clonic" motions were noted. Pt was then placed on the floor with her knees elevated. Pt was then given an ammonia inhalant which was placed under her nostrils. Pt returned to conciousness immediately after ammonia inhalant was administered. She was then given fluids to drink and cool rags were placed to neck and forehead area.  BP=80/50 approx. 5 min after episode occured.  Pt rested approx. 10 min in exam room and was then escorted to vehicle for transport home. Pt stated she felt "weak" but was otherwise oriented to person, place and time upon departure.  Pt also evaluated by Dr. at clinic today (2/19/03).
The shot was given in my upper left arm but lower than normal. It was very sore for a week or more and I had a large  bruise that stayed for a week or more. I also received the 2nd dose in March 26, 2021. On 4/1/21 I went for a physical at my doctors office and they drew bloodwork. The results were abnormal for me. I have always been very healthy with no known issues except overweight. My bloodwork showed several issues. My red blood cell count was elevated and my hemoglobin. I have never had that problem! I asked if this could be due to the vaccine and my doctor said no, but do we really know for sure? I think the person that gave me the vaccine gave it too low and possibly in my blood vessel instead of the muscle.  The bruise was not a normal side effect of the vaccine and it lasted a long time.   My blood is still very thick. I had blood drawn this week on 9/24/21 and the technician had a hard time getting blood out of my finger. It would start to clot after a few minutes. This is scary and unusual for me. They have never had problems getting blood from me before I got the Moderna vaccine.
Nausea, vomiting, diarrhea, itching throughout body but no hives, slight headache, tenderness to the injection site.
Swelling of tongue and throat, red itchy area on Left collar bone. Dr prescribed Benadryl and Prednisone 60mg 1xday for 5 days.  Symptoms started around 9pm in the evening of same day as vaccine was given.
vaccine given elsewhere. 3 hours after vaccine pt developed fever 102, blisters in nose, congestion, vomiting, wheezing. the patient did not return calls after event for a follow up
Client reports and adverse reaction to SHINGRIX dose 1. "At 11:00 PM I was sitting on couch and had like an anxiety attack, client reports her heart rate increased and she felt dizzy and tried to move to the bedroom and nearly passed out on her way. She reports putting her head between her knees and prevented herself from passing out. Client reports her husband helped her into bed and she felt a rush of hotness like a fever for a minute of two and then felt really cold and was shivering. Client reports her husband took her temperature and it was 97.4 and they continued to try to get her warm with blankets, not pad etc which took over one hour. She took 2 advils and was able to sleep through the night. 03/28/2019 she woke up and took 3 more advil and states she feels very weak today and tingling in her arm. She states she has a very sore arm as she expected to have but just feel terrible today. Client denies and gastrointestinal adverse effects.
This spontaneous report was received from a physician refers to a 24 years old male patient with no pertinent medical history and no drug reactions or allergies, who on 12-DEC-2012, was vaccinated with the first dose of GARDASIL (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that on 19-DEC-2012, the patient developed groin swelling after receiving the first dose. No treatment was given for the experience. NO lab diagnostics studies were performed. At the time of the report, the patient had not recovered. The patient sought medical attention by calling the physician. The relatedness for patient developed groin swelling was unknown for GARDASIL. Additional information has been requested.
First day: vaccinated on Monday at noon Arm hurt Tired 12 hours later - Tuesday - fever, chills Fever all day Tuesday and body aches   Went to bed Tuesday night with a 101.7 fever Broke fever at about 36 hours Wednesday - Woke up feeling pretty normal but had really sensitive teeth  As the day persisted my lungs started hurting.  It felt like I smoked 2 packs of cigarettes or was on the verge of an asthma attack. Thursday - teeth less sensitive, lungs hurt but nothing as bad as Wednesday At 8:00pm found a golf ball size swollen lymph node on my left side where I got the vaccine.  Also have a few swollen lymph nodes in my throat Friday (today) - swollen lymph node still present and large, Still having difficulty breathing.
I started feeling a little weird a few hours after taking the Pfizer booster.  By the evening I had a slight runny nose and itchy in my upper arms.  By Tuesday morning, runny nose, itchy throat and stuffy nose.  I sort felt a little better on Wednesday morning, only to have an unstoppable runny nose, itchy throat, arms, legs, stomach and face and a dry cough.   I had a really rough weekend due to unable to breathe normally through my nose, dry cough, unable to sleep.  It feels like an Asthma attack.  Right now, I have patches all over my face, my lips are swollen and have black patches on them.  Still coughing, still itching all over and dealing a runny nose.
Soreness of arm; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm) and FATIGUE (Tired) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness of arm) and FATIGUE (Tired). At the time of the report, PAIN IN EXTREMITY (Soreness of arm) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information in response to events was not provided.
First episode 2/21 [26 hours after 2nd shot].  Dull Chest pain.  Took 2 Tylenol and it went away.  Eleven days later,  chest pain returns but pain radiates up back into neck and head.  Took 2 Tylenol and went to bed.   Pain subsides.  Next 3 days pain repeats from chest to  head.  Fourth day I start to shiver internally.  This lasted about 75 minutes before going away..  Next day went to ER.  All ER tests were negative and was released.  Went to cardiologist and had a stress test and several other tests that were all normal.   A week later, I thought I was having a heart attack and went back to ER.  All tests were negative again.  Still wake up with neck pain  alleviated with Tylenol..
This spontaneous report was received from a nurse referring to a 4 month old patient of unknown gender. It was reported that the baby was healthy and had no prior reflux or vomiting issues. Patient's concomitant medications were not reported. The baby received a prior dose of ROTATEQ at age 2 months in approximately October 2016. In 2016, on an unspecified date, the patient was vaccinated with the second dose of ROTATEQ (orally, Lot # M022373, expiration date: 20-FEB-2018; dose not reported) for prophylaxis. In December 2016, reported as within the last week, the patient experienced projectile vomiting after took the complete dose of ROTATEQ. The baby did not receive another dose of ROTATEQ. There was no treatment given for this adverse event. A product quality complaint was filed because the ROTATEQ seemed more viscous. To be sure that the ROTATEQ was not a bad batch, the physician put a few drops of the ROTATEQ on his fingers and then tasted the vaccine. He reported that this vaccine was fine and he did not experience an adverse effect. The outcome of vomiting projectile was reported as recovered/resolved. The causality between this event and the therapy with ROTATEQ was unknown. This is one of the several reports received by the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA010099: US-009507513-1612USA010136: US-009507513-1701USA004136.
pt had 8-10 cm hot very tender area over inject site also tender nodes - axillae.
Axillary lymphadenopathy with swelling extending to left breast.  Left Scilla lymph node size of golf ball
Muscle ache; Tiredness; Chills; Fever; Headache; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 34-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0172), via an unspecified route of administration in left arm on 26May2021 at 09:00 as a single dose for COVID-19 immunization at pharmacy. The patient's medical history was not reported. Concomitant medication included ongoing naproxen sodium (ALEVE ARTHRITIS) at 220 mg, twice a day for minor headaches. The patient did not receive any additional vaccines administered on same day. The patient did not receive any vaccinations with 4 weeks prior to the fist dose administration. The patient did not experience any adverse events prior vaccination. It was reported that she experienced chills, fever, headache, muscle aches, tiredness. patient stated she woke up last night at 10:30 with chills, literally shivering until she realized possibly what was going on, says she then knew it was a fever on 01Jun2021. patient stated she took Tylenol to help see if it would subside some. She started to develop a headache on 01Jun2021, slept on and off throughout the night on. patient says this morning when she woke up and felt ok, her head hurt kind of hurt a little bit, and she was really tired on 02Jun2021. patient stated she began developing chills and was just kind of sleeping off and on all day, says she has a slight headache and has not taken any medicine since 5am, says she wanted to see what's going to happen. The chills have gotten a little better. Today, she just started to develop muscle aches also on 02Jun2021 08:00. Fever began around 10:30 and she doesn't feel she has a fever anymore. Headache began around midnight and it's better, it's tolerable. Last night, her headache was to the point, she had to force herself to sleep just because she knew she needed the sleep. Muscle aches began around 8am when she got up this morning. She confirms the aches are better, it feels fine to get up and walk, but they are still noticeably there. Tiredness was kind of off and on, says she wakes up from sleeping, then dozes back off. patient states she slept from 5am until 8am really good, and then by 9am she was ready to doze. She took a nap between 10 to 11am and has been up since. The tiredness comes in waves. The patient was not hospitalized. The patient did not underwent any laboratory test. The outcome of the event fever was unknown, fatigue was not resolved and all other events was resolving.  No follow-up attempts are possible. No further information is expected.
Blood pressure is now reading 170/80 and dropped a little to 140/90; This is a spontaneous report received from a contactable consumer (patient). A 61-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ew0162), via an unspecified route of administration on 10Apr2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant mediation was not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ep7534), via an unspecified route of administration on 20Mar2021 as a single dose for COVID-19 immunization and had no problems. The patient reported that for 10 years she gets up, she works out and checks her B/P which was usually 110/70, 110/60. Since the vaccination, the patient blood pressure was now reading 170/80 and dropped a little to 140/90 and it had never been that high and stated that sorry the patient got the vaccine. The patient was beside physician because the patient's blood pressure had never been so high. The clinical outcome of the event was unknown.  No follow-up attempts are needed. No further information was expected.
12:35pm patient states her tongue and lips are tingling - patient evaluated by provider - 12:40pm 25mg benadryl given - patient observed 1 on 1 1:25pm patient states she can not swallow - epi pen administered per providers order 1:35pm patient states she is feeling better and symptoms are dissipating
Phantosmia: scent of stale cigarette smoke all the time. Can smell other scents normally. Stale cigarette smoke/burnt dust smell is in background all the time. At first attributed scent to unwashed clothes due to 36 hour fever/sweats caused by vaccine, but upon bathing/changing, noticed scent was in nose. No treatment. It's been nearly two weeks.
Generally mild and not unexpected, but worse than previous years. More soreness at site than usual. Malaise/Fatigue. Mild diaphoresis. Body temperature 100.0F.
Arm soreness at injection site; fatigue; slight muscle aches in neck/shoulders; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN 5318 and expiration date unknown), via an unspecified route of administration on left arm at the age of 54 years old on 26Jan2021 at 08:30 AM at a single dose for COVID-19 immunisation at the workplace clinic. Medical history included hypertension and pre-diabetic. Allergies to medications, food, or other products was none. Concomitant medications included metoprolol tartrate, atorvastatin and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient experienced arm soreness at injection site, fatigue, slight muscle aches in neck/shoulders on 26Jan2021 at 05:00 PM. The patient assessed the events as non-serious. No treatment was received in response to the events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient recovered from the events on an unspecified date in Jan2021.
Patient reports soon after injection she experienced swelling in the injected arm and lymph nodes. She woke up the next morning with facial swelling and palsy. She was instructed to seek medical attention.
This spontaneous report was received from an administrator referring to an unspecified patient (age and gender unknown). No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on an unspecified date, the patient was vaccinated with an improperly stored dose (incorrect product storage) of M-M-R II (lot# M029229 with albumin status of rHA (recombinant human albumin), but unknown expiration date) (strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. Reportedly, the reporter could not provide the lot number and expiration date for the properly stored sterile diluent to reconstitute M-M-R II. The vaccine dose was exposed to a temperature excursion of 48 Fahrenheit degrees for 30 minutes; no digital data logger was involved or previous temperature excursions. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA001661:US-009507513-1704USA001660.
Fever 4-10-03, red rash over left leg; extreme swelling in leg, painful to walk; rash is hot to touch.
Case number PHEH2014USO19177 is an initial spontaneous report received from a nurse on 19 SEP 2014. This report refers to a 43 year old male patient. His medical history and concomitant medication were not reported. On 18 SEP 2014, he was inadvertently vaccinated with FLUVIRIN 2014/2015 (batch number: 1412001) intramuscularly at a dose of 01 ml instead of the recommended 0.5 ml dose. No adverse event was reported following this medication error (overdose).
Immediate swelling/tenderness at inj. site no pruritus, erythema, SOB or other concerns noted.