chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Throat was swollen, started having anaphylaxis; Throat was swollen, started having anaphylaxis; Blood pressure got totally out of control, it just spiked; had like a fever; Injection site turned red, swollen, angry, itching; Injection site turned red, swollen, angry, itching; Injection site turned red, swollen, angry, itching; got a very bad headache; nausea; chills; Brain fog; fatigue; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EW0162 and expiration date not provided), via an unspecified route of administration, in left arm, on 26Apr2021 09:30 (at the age of 65-year-old), at single dose, for COVID-19 immunization. Medical history included blood pressure, patient had anaphylaxis to other drugs in the past, the medication was an ace inhibitor caller took years ago when trying to help blood pressure. Family Medical History provided as "no". Concomitant medications included losartan for blood pressure (patient had been on this medication for years); and progesterone (began taking this medication probably last summer). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0153 and expiration date not provided), via an unspecified route of administration, in left arm, on 05Apr2021 13:30 (at the age of 65-year-old), at single dose, for COVID-19 immunization. No additional vaccines administered on same date. The patient got a very bad headache from 26Apr2021 (about an hour after received second vaccine); nausea from 26Apr2021; chills from 26Apr2021; brain fog from 26Apr2021; fatigue from 26Apr2021; throat was swollen, started having anaphylaxis from 28Apr2021 (in the evening) to 02May2021 (it had eased up enough and patient could swallow); blood pressure got totally out of control, it just spiked from 28Apr2021, patient was still having trouble getting it back down. Patient had to double up on blood pressure medication. Patient stated it was persisting a little bit. Patient's blood pressure was going way higher than what it would normally. Patient only took 25mg of losartan. Patient's blood pressure usually never went over 125. Injection site turned red, swollen, "angry", itching and had like a fever from 28Apr2021. On 26Apr2021, patient got a very bad headache, nausea, chills and fatigue. Patient was expecting all of this. Patient was sick on 26Apr2021 and 27Apr2021 and had to stay in bed, clarified she was sick with headache, chills and fatigue. On 28Apr2021 (Wednesday), patient's throat was swollen, started having anaphylaxis. The outcome of the events "headache, nausea, chills, brain fog" was recovered on 27Apr2021; of "fatigue" was recovering; of "throat was swollen, started having anaphylaxis" was recovered on 02May2021; of "blood pressure got totally out of control, it just spiked" was not recovered; of "injection site turned red, swollen, angry, itching and had like a fever" was recovered on 03May2021.
TIA with expressive aphasia; TIA with expressive aphasia; Blood pressure has been all over the place, getting as high as 160/90; Extreme light sensitivity and even closing her eyes in a dark room felt like a spot light was on her; Trouble sleeping; A Spontaneous report was received from a Consumer concerning for herself, a female patient of an unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced transient ischemic attack (TIA) with expressive aphasia/Transient ischaemic attack, transient ischemic attack (TIA) with expressive aphasia/Transient ischaemic attack/aphasia, blood pressure has been all over the place, getting as high as 160/90/blood pressure increased, extreme light sensitivity and even closing her eyes in a dark room felt like a spotlight was on her/ Photophobia and trouble sleeping/Insomnia.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 27Jan2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown) via Intramuscular route for COVID-19 infection prophylaxis. On 24Feb2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (batch number: unknown) via Intramuscular route for COVID-19 infection prophylaxis.  On 24Feb2021, 30 minutes after receiving the vaccine, patient started speaking and gibberish came out. The patient stated that she could not form words. The patient's physician diagnosed it as transient ischemic attack (TIA) with expressive aphasia. The patient had extreme light sensitivity and even closing her eyes in dark room felt like a spotlight was on her therefore, she had trouble sleeping. The patient also stated that her blood pressure had been all over the place, getting up to 160/ 90. The patient was treated with Excedrin (aspirin/paracetamol/caffeine).  The seriousness criteria for the event transient ischemic attack (TIA) with expressive aphasia was medically significant.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events, transient ischemic attack (TIA) with expressive aphasia, blood pressure has been all over the place, getting as high as 160/90, extreme light sensitivity and even closing her eyes in a dark room felt like a spotlight was on her and trouble sleeping were unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further details regarding the subject's medical history, investigations and treatment is necessary for assessment. Further information has been requested.
pain in the arm; rashes on her both leg and chest area; This is a spontaneous report from a contactable consumer.   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: not provided) via an unspecified route of administration; administered on 09Mar2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. On an unspecified date, it was reported that her mother could take the 2nd dose as her mother experienced pain in the arm and rashes on her both leg and chest area on her first dose. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Right arm pulling; bump in arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Right arm pulling) and NODULE (bump in arm) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced LIMB DISCOMFORT (Right arm pulling) and NODULE (bump in arm). At the time of the report, LIMB DISCOMFORT (Right arm pulling) and NODULE (bump in arm) outcome was unknown. Not Provided          Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Diarrhea, feeling stomach sick like i was going to vomit; Diarrhea, feeling stomach sick like i was going to vomit; very tired; usual sore arm at the site; This is a spontaneous report from a contactable consumer (patient herself). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6200), via intramuscular route on 04Mar2021 09:15 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6200), via intramuscular route on 11Feb2021 09:30 as DOSE 1, SINGLE for covid-19 immunisation. On an unknown date, the patient experienced diarrhea, feeling stomach sick like she was going to vomit, very tired and usual sore arm at the site. The patient took 1 ammodium went to bed morning till noon started to feel better and was very tired for 3-4 days. Nothing but the usual sore arm at the site that night and next one then nothing. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Abdominal pains with nausea and vomiting (1 episode) Abdominal pain x 48 hours. SX began 2 hours after 2nd dose of oral typhoid.
Injection was entered in Bicep  Swelling , Edema ,Itching rash pain
Red, warm to touch with swelling 10mm x 10mm. No resp distress, local reaction.
No adverse event; Received a Toddler dose for 2nd booster/Not sure if received the toddler dose from a Bivalent vial for 2nd booster/Not sure if received the toddler dose from a Monovalent Toddler vial for 2nd booster; This spontaneous case was reported by a patient and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received a Toddler dose for 2nd booster/Not sure if received the toddler dose from a Bivalent vial for 2nd booster/Not sure if received the toddler dose from a Monovalent Toddler vial for 2nd booster) and NO ADVERSE EVENT (No adverse event) in a 30-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccine (Patient received 2 primary Pfizer COVID-19 vaccines.). Past adverse reactions to the above products included No adverse reaction with Pfizer COVID-19 vaccine.    On 13-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Sep-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Received a Toddler dose for 2nd booster/Not sure if received the toddler dose from a Bivalent vial for 2nd booster/Not sure if received the toddler dose from a Monovalent Toddler vial for 2nd booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Received a Toddler dose for 2nd booster/Not sure if received the toddler dose from a Bivalent vial for 2nd booster/Not sure if received the toddler dose from a Monovalent Toddler vial for 2nd booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant product use was not provided by the reporter.  On 15-Dec-2021, the patient received third dose of First Moderna Booster(unknown route) 1 dosage form with the lot no.020F21A.  On 13-Sep-2022, the patient received second Moderna booster dose.  Treatment information was not provided.
5/27/2000 pt became very dizzy, tired, achy. Her temp was 102.0F, she took some ASA. Her fever increased to 104.0F. Doctor office recommended Tylenol. Temperature dropped to 102.0F but the aches continued. Sunday she had sore throat. Pt recovered fully by Monday.
Received GARDASIL #1 6-14-11. 6-15-11 broke out in generalized hives (< 24 hours after vaccine). Tx'd with BENADRYL. Still experiencing (6-16-11).
Patient presented sweating, flushed, and shaking an hour after administration. Appeared to be in a panic attack
Patient presented with a cardiac event. Patient had decreases O2 and congestion, cough. Patient has beeen vaccinated and resulted positive for COVID.
Fever 101.2 Chills  Body aches  Headache  Losses of  appetite
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown demographics. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On unknown dates, between January, 2016 and March, 2017, these patients were vaccinated with improperly stored doses of M-M-R II for prophylaxis (strength, dosing details, anatomical location, lot# and expiration date were unknown). The nurse could not provide the lot and expiration date for the properly stored STERILE WATER DILUENT used to reconstitute the doses of M-M-R II. No adverse effects were reported. Time frame of temperature excursion was from January, 2016 until March, 2017 (exact hours not provided). There were no previous temperature excursions. A data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1704USA000068: US-009507513-1704USA000111: US-009507513-1704USA000112.
Sore arm; A spontaneous report was received from a consumer concerning a 89-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a sore arm.  The patient's medical history and concomitant product use were not provided.  In 28 Dec 2020, two days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 29 Dec 2020, the patient developed a sore arm which was treated with a heat pad. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event sore arm was unknown.; Reporter's Comments: This case concerns an 89-year-old female who experienced a NS unexpected event of pain in extremity.  Event onset occurred on Day 2 after the first dose of mRNA-1273 Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Symptom onset ~12 hours after vaccine administration: severe chills, rigors, body aches: lasted ~10-12 hours followed by moderate headache and mild nausea, malaise, muscle soreness all resolving by 36 hours after administration. Afebrile. Injection site tenderness from time of administration still persisting.
Extreme congestion and headache onset 12 hours after vaccine, resolved within 48 hours
Felt heart palpitations which doctor then defined as premature atrial complex (PAC). This hasn't happened to me before and started the day after getting the vaccine.; Felt heart palpitations which doctor then defined as premature atrial complex (PAC). This hasn't happened to me before and started the day after getting the vaccine.; This is a spontaneous report from a contactable consumer or other non hcp. A 27-years-old non-pregnant female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in arm right on 27Feb2021 13:00 (age at vaccination: 27-years-old) as dose 1, single for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing and food allergy from an unknown date and unknown if ongoing Known allergies: I think I'm allergic to eggs, but not confirmed. Patient did not received other vaccines within 4weeks prior to vaccination. The patient concomitant medications were not reported patient was not tested to post vaccination. On 28Feb2021, the patient experienced felt heart palpitations which doctor then defined as premature atrial complex (Pac). This had not happened to me before and started the day after getting the vaccine. Patient had physician office visit for the events and patient did not had any treatment for the events. The outcome of the events palpitations and supraventricular extra systoles was recovering.  No follow-up attempts are possible. No further information is expected.
Guillain-Barre, numbness started hands and feet 10-20-08. Seen 10-27-08 for same progressed with ascending numbness and weakness and back pain. Hospitalized in ICU for one week. Mostly better now.  12/11/08 Received hospital records of 11/06/11/13/2008 FINAL DX: ascending polyneuropathy secondary to GBS Records reveal patient experienced numbness of both feet 6 days s/p vaccine which progressed to her hands,  feet heaviness & balance difficulties.  Symptoms did not improve & admitted.  Neuro consult done.  Tx w/IVIG x 5 days.  Improved & d/c to home for outpatient PT & neuro f/u.  2/11/09 Received hospital Neuro consult & hospital labs. Neuro consult indicates pt had begun outpatient w/u w/neurosurg which was WNL.  Had been referred to neuro but fell in MD office several times & was admitted to hosp w/o EMG/NCS being done.  Neuro exam in hosp revealed decreased reflexes & decreased sensation.  LP done but no EMG/NCS while in hospital due to equipment difficulty.  Tx w/IVIG.  EMG/NCS scheduled as outpatient & has been requested.  2/17/09 Received Neuro consult, EMG/NCS & CSF studies. FINAL DX: polyneuropathy Records indicate patient experienced numbness & tingling of hands/feet, unsteady gait.  Fell several times in MD office & admitted to hospital.  Exam revealed decreased reflexes of LEs.
seasonal allergies; Information has been received from a medical assistant via a company representative referring to a 17 years old male patient. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not reported.  On 12-AUG-2019, the patient was vaccinated with his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (Lot No. S008151, expiration date : 20-NOV-2021; strength and dose were not reported), intramuscularly for routine vaccination. On 25-AUG-2019, the patient went to a minute clinic and was diagnosed with sinusitis and was given antibiotics, after he came into see the physician and was given an azithromycin (ZPAK). Two days after the azithromycin (ZPAK), he ended up with sinusitis again, the physician felt there might have been mono involved. On 01-SEP-2019, the patient experienced hives. On 04-SEP-2019, the patient came back to the office and was given diphenhydramine (BENADRYL). Hives were still coming and going. The patient did have seasonal allergies. The patient received lab diagnostics of complete blood count (CBC), lipid panel, thyroid panel and Epstein-Barr virus (EBV). All results were not provided. The outcome of the event was unknown. The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was unknown.
Headache, Myalgia, Arthralgia, Fever, swollen glands, "nerve pain" for one week Narrative:  Other Relevant History:
Parent presented to ED describing 6 hours of decreased responsiveness, limpness, and ? pallor beginning at 1 pm (Comvax, IPV and PCV given at 10:30am). Stable vital signs at presentation, had returned to baseline. Observed x 3 hours in ED without recurrence and discharged.
Pt. Reported next day that after receiving the flu inj. (on 10/12/17 around 1105AM) that early (10/12) evening she developed shoulder, back legs, and hips aches. 1030 That evening had chills and a headache and some vomiting. Much better when reported 10/13/17 at 10:30A. Feeling good 10/13/17 at 4:45p. T98.3
Breakthrough infection of COVID-19. Tested positive 5/23/2022. Severe headache, sore throat, ear and sinus ache, fever to 104 F. finally broke below 100 on 5/26/2022. Fatigue and productive cough of phlegm. Blocked stuffed nose and sinuses.
I believe I had the Virus already a few days before I received the vaccine. I felt fatigue on Monday after receiving the vaccination. On Tuesday I woke up with sinus issues and felt fatigue all day. Wednesday evening, I lost sense of smell and taste.
6 HOURS AFTER I RECEIVED THE VACCINATION IN MY RIGHT ARM, I STARTED TO GET RED WELTS ON THE SIDE OF MY NECK. THEN IT WENT TO THE SIDE OF MY FACE AND THE BACK OF MY NECK. MY GLAND RIGHT UNDER MY EAR IS SWOLLEN. I HAVE SWOLLEN LUMPS ON THE BACK OF MY NECK AND SHOULDER. MY RIGHT SHOULDER IS IN A LOT OF PAIN. I WAS GIVEN A BENADRYL INJECTION. I HAVE BEEN TAKING THE PILL BENADRYL. THE DOCTOR SAYS THAT IT WILL TAKE MAYBE A WEEK TO GO DOWN. I AM GOING TO SEE ANOTHER DOCTOR . I THINK THE GLAND UNDER MY EAR MAY BE INFECTED FROM THE VACCINE.
lower arms were red and itching real bad; Heart palpitations after 1st dose; Lightheaded/ Dizzy; Shortness of breath; Lower arms red and itching real bad after 1st dose; Whole body covered in rash after 1st dose; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (lower arms were red and itching real bad), PALPITATIONS (Heart palpitations after 1st dose), DIZZINESS (Lightheaded/ Dizzy), DYSPNOEA (Shortness of breath ) and ERYTHEMA (Lower arms red and itching real bad after 1st dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure, Cholesterol and Mitral valve prolapse. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PRURITUS (lower arms were red and itching real bad), PALPITATIONS (Heart palpitations after 1st dose), DIZZINESS (Lightheaded/ Dizzy), DYSPNOEA (Shortness of breath ), ERYTHEMA (Lower arms red and itching real bad after 1st dose), RASH (Whole body covered in rash after 1st dose) and HEADACHE (Bad headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PRURITUS (lower arms were red and itching real bad), PALPITATIONS (Heart palpitations after 1st dose), DIZZINESS (Lightheaded/ Dizzy), DYSPNOEA (Shortness of breath ) and ERYTHEMA (Lower arms red and itching real bad after 1st dose) outcome was unknown, RASH (Whole body covered in rash after 1st dose) was resolving and HEADACHE (Bad headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: fluctuating Fluctuating.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported