chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable Nurse. This Nurse reported for a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, on an unspecified date as single dose  for COVID-19 immunisation. Medical history included COVID-19 from Mar2020 to an unknown date. The patient concomitant medications were not reported. Reporter was concerned because some of her co-workers, about 5 of them, had previous COVID diagnosis last March also received the vaccine were fine and experienced only intense headaches and tired for a couple of days on an unspecified date. It was reported that one person, until now had headaches and took tylenol for it. The outcome of the event intense headaches was reported as not recovered and for tiredness it was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
One week before getting the second Moderna shot, both husband and wife got covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (One week before getting the second Moderna shot, both husband and wife got covid) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jul-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 COVID-19 (One week before getting the second Moderna shot, both husband and wife got covid). At the time of the report, COVID-19 (One week before getting the second Moderna shot, both husband and wife got covid) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing was delayed on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The treatment information was unknown. Company comment: This is a spontaneous case concerning a 56-year-old, female patient who experienced unexpected AESI of COVID-19. The events occurred after unknown days after the first dose of mRNA 1273 vaccine. The second dose was delayed due to reported event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-435460 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 56-year-old, female patient who experienced unexpected AESI of COVID-19. The events occurred after unknown days after the first dose of mRNA 1273 vaccine. The second dose was delayed due to reported event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Patient received the 0.5 ml Moderna covide vaccine for the booster when it should be 0.25ml. Patient was called by provider to inform the event and patient stated mild fever on 2/23 and feel fine today on 2/24 denies any more fever.
C/O sensation of throat swelling, flushing face, ears, ears warm, fine erythematous rash on back, and pt felt warm. All resolved after Epinephrine 1:1000, IM 0.3ml Zyrucloms and Benadryl 50mg IM. Also given 40mg Prednisone.
Woke up next day after booster feeling a bit woozy.  When I got up, suddenly found myself on bathroom floor, feeling like no muscle in my body was working.  Managed to crawl to next room and pull myself up by a chair.  Sat for quite a while until I felt able to move properly, then went back to bed.  By noon, I was feeling better but not good.   Luckily, my sister had thrown up all the next day after her booster and urged me to sleep downstairs and avoid stairs.  Good advice.
Shingles; This is a spontaneous report from a contactable consumer or other non-HCP (patient's daughter). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's daughter stated her mom received the Pfizer vaccine in Feb2021 at a different location and she never reported back about symptoms, but she got shingles after her second dose on an unspecified date 2021. The outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
testing positive for COVID; Fever for 3 hours after the vaccine/ High temperature; Joint pain; Severe upper back pain; Headache; A spontaneous report was received from a nurse concerning a 44-year-old female patient who experienced fever for 3 hours after vaccination, headache, joint pain, and severe upper back pain.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included dulaglutide, metformin, empagliflozin, losartan, amlodipine, levothyroxine, simvastatin, allopurinol, estrogen, colchicine, calcium, zinc, multivitamin and vitamin C.  On 05 Jan 2021, the patient received mRNA-1273 (Lot number 026L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 05 Jan 2021, patient experienced fever for 3 hours after vaccination.  The patient also experienced headache, joint pain, and  severe upper back pain. The patient stated her temperature was high from 05 Jan 2021 until 09 Jan 2021 when it went down.  Treatment information was not provided.  Follow-up received on 21 Feb 2021, from the patient's husband, included that the patient tested positive for Covid-19 on 09 Jan 2021 and was hospitalized on 11 Jan 2021.  The patient never recovered from her symptoms and the patient died on 02 Feb 2021.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events Coronavirus test positive was fatal and for headache, joint pain, severe upper back pain and temperature were unknown.  The cause of death was reported as Coronavirus test positive and autopsy details was unknown.; Reporter's Comments: This case concerns a 44-year-old female who was hospitalized with a serious unexpected event of COVID-19 with fatal outcome along with NS unexpected back pain and NS expected fever, headache, arthralgia. Event onset was 5 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes fatal. Autopsy results unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Testing positive for COVID
Approximately 8-10 hours after vaccination, I noticed a rash (roughly quarter-sized) on the right side of my face. I am reporting this 3 days after vaccination and the rash is still present. It provides discomfort and a slight itch. I also had arm pain at the vaccination administration sight. I have not experienced any other symptoms since vaccination.
Started itching all over my body shortly after the shot was given.  I kept itching worse and worse until I itched from my head to the soles of my feet badly. Also my chest hurt inside.  Slightly hard to breathe.  Took Allergra and then called my doctor (talked on the phones, it was Saturday morning) for a prescription for Prednisone.  In addition to ADvair which I take daily, I used a nebulizer to help the breathing situation.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: BURNING IN ARM-Medium, Additional Details: Pt complained for burning at injection site on 1s then none til the 9th day. she can feel lumps inside her harm and it is still tender to the elbow. pt went to urgent care and received an antibiotic for skin infection and norco. pt still has pain and being treated with voltaren gel and gabapentin as of 5/7/21
Patient due for 4th dose(booster) and received the full dose (0.5 m), instead of the half (0.25 ml) dose on 1/31/22
10/19/2007 Vet calls with report of flu sxs, cough, sore throat, chills, fever since this  am. She says, she received a flu shot on 10/16/2007at MC.  Follow up call done on 10/22/07 with symptoms decreasing to afebrile, chest congestion and cough.  Pt states that 10/20 was worst day, but feels progressively better.
This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown gender and age. Information regarding the patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, these patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # L020015, expiry date: 16-AUG-2017). Medical assistant reported that the vaccines went to 31.8 F for 7 hours and 45 minutes. They were logged by a data logger and there were no prior excursions. The vaccines were back in range. No adverse effects were reported. This is one of five reports received from the same reporter. Additional information has been requested.
pt recvd vax & devel fever 103-4 7-10 days later;
Fatigue, general malaise, chills-onset within 2 hours of getting the vaccine. Lasting at least two days. Treatment: rest and Tylenol
last night she was feeling a small wheeze in her chest; heart beating fast; loud thump when it beats in her chest; This is a spontaneous report received from contactable consumers (one was patient). A 48 year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: FF2588), via an unspecified route of administration on 16Sep2021 as DOSE 1, SINGLE on right arm for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 21Sep2021 she began to experience her heart beating fast and she could hear a loud thump when it beats in her chest. She was treated in the Emergency room. Patient states she has a question, as a secondary side effect, was the heart beating fast or louder thumps, is this a side effect of the vaccine. Patient clarifies that she experienced this after her dose of the vaccine. Patient stated last night she was feeling a small wheeze in her chest, states it was just staying the same. Patient states she did go to the emergency room. The outcome of heartbeats increased was not recovered while outcome for other events was unknown.  Follow-Up (19Oct2021): Follow-up attempts are completed. No further information is expected.
Mom reported that she has had syncopal events with shots before and the student and mom thought that she had grown out of it.  Student was holding her breath while given the shot.  Eyes started to roll back.  RN giving the shot told her to cough and RN was tapping her her back to try to get her to cough.  Ice, juice, water were given to the student.  Student vomited x 1,  Student rested on the cot until she felt better in about 10 minutes.
Tiredness, dizziness, body aches, joint pain, headache, nasal/ear congestion, hoarse throat, shivering, digestive cramping, excessive sweating during night, soreness at injection site. I had several episodes of shivering during the day. All other symptoms mentioned above, with the exception of the excessive sweating, lasted for most of the day. I slept for approximately 6 extra hours during daytime and missed work. My first SHINGRIX injection (in early April) was symptom free, except for some soreness around the injection site.
Pt REPORTS tachycardia, lightheadedness within 15 minutes of her vaccine. A few hours later, at home she reported chest pain, difficulty breathing, throat pain and throat swelling. She did NOT seek medical attention. She took her kid's EpiPen and benadryl. She followed up with PCP 2 days later, symptoms were already resolved.
4/31 erythema, swelling left arm, fever 104.5 deg F Motrin. 5/2 increased erythema swelling left arm, cont. Motrin and ice packs to arm. Temp 103.5 deg F. Visit to doctor no infection of ears or throat noted. Possible asthma, wheezing in lungs. Fever, swelling of arm, lasted 7 days. 5/13 returned to doctor prescribed Albuterol. Doctor referred child to pediatrician. Mother states 5 days post vaccines child became aggressive hitting, bitting, scratching others, broke mother's ribs. Sleeps 2-3 hrs per night. NO daytime naps. Rubs head on wall repetitively.
Patient had syncopal episode within 15 minutes of vaccination.  Patient had not eaten that morning.  Felt better after resting and was released to home.
Pt experienced symptoms, sweats, chills, nausea, vomiting, joint aches, fatigue, Shortness of Breath, dental problems, urinary difficulties, sinus congestion, ear congestion.
Within 24 hours had ear pain in right ear.  Pain lasted several weeks and saw my physician who said it was allergies and take Claritin, pain did not clear up so saw an ENT.  ENT said it was an atypical migraine,  Pain continued and got a second opinion,  they said it was Eustachian tube disorder and to take Flonase,   Pain persists for months and slowly decreased.  Pain fiannky went away after 6 months.
Pfizer vaccine was administered outside of hospital - reported by patient I95.9 HYPOTENSION 7/2/2022 GI HEMORRHAGE I95.9 HYPOTENSION 7/2/2022 DYSPNEA
4PM day of vax pt felt fatigued & aching beginning in limbs;1AUG96 pt reports t102, generalized ache in all limbs, extreme tiredness & nausea;2AUG96 t99.1, appetite good, sl ache to limbs;two 2cm circles of erythema to lt deltoid tender
arm pain; very fatigued; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) and FATIGUE (very fatigued) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) for COVID-19 vaccination.     Concurrent medical conditions included Generalized anxiety disorder and Depression.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain) and FATIGUE (very fatigued). The patient was treated with PARACETAMOL (TYLENOL) for Prophylaxis, at an unspecified dose and frequency. On 21-Mar-2021, PAIN IN EXTREMITY (arm pain) had resolved. At the time of the report, FATIGUE (very fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information included Tylenol.
Myalgias, Diarrhea, Weakness Acute kidney injury, Hyponatremia
pain in left arm; hands went numb; tingling in arm/"feels like a tingle"; Both hands are hard to open; very stiff; body aches/pain in muscle; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in left arm), HYPOAESTHESIA (hands went numb), PARAESTHESIA (tingling in arm/"feels like a tingle"), HAND DEFORMITY (Both hands are hard to open) and MUSCULOSKELETAL STIFFNESS (very stiff) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in left arm), HYPOAESTHESIA (hands went numb), PARAESTHESIA (tingling in arm/"feels like a tingle"), HAND DEFORMITY (Both hands are hard to open), MUSCULOSKELETAL STIFFNESS (very stiff) and MYALGIA (body aches/pain in muscle). At the time of the report, PAIN IN EXTREMITY (pain in left arm), HYPOAESTHESIA (hands went numb), PARAESTHESIA (tingling in arm/"feels like a tingle"), HAND DEFORMITY (Both hands are hard to open), MUSCULOSKELETAL STIFFNESS (very stiff) and MYALGIA (body aches/pain in muscle) outcome was unknown. Not Provided          No concomitant or treatment information was reported.   This case was linked to MOD-2021-047811 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: AE Contact Information Updated
This spontaneous report as received from a pharmacist refers to a 64 years old male patient who is a physician without drug reactions or allergies. The patient had no pertinent medical history. The patient was vaccinated with the first dose of PNEUMOVAX23 (lot number, injection site and route were not known) (0.5 ml) 15 years ago, in 1997. No other co-suspects were reported. There was no concomitant medication. On 11-OCT-2012 the patient experienced developed severe throbbing and inability to raise his right arm after administration of his second dose of PNEUMOVAX23 (lot number reported as H009826 expired date 11-FEB-2014) (0.5 ml, intramuscular, right arm) on 11-OCT-2012. The patient called the pharmacy for medical attention within 3 hours of administration of the PNEUMOVAX23 to report the symptoms. There was no treatment given for adverse event and no laboratory diagnostics studies performed. The patient was reported as not recovered at the time of report. The reporter considered that patient unable to lift his right arm to be significant disability or incapacity. Additional information has been requested.
The pt went to the ER with a headache for 4 days and a stiff neck, elevated temp and nausea.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and drug reactions or allergies was reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Merck) VARIVAX, lot number L001325 and expiry date: 13-JAN-2017, (dose, route of administration and injection site were not provided). No concomitant medications were reported. No adverse effects were reported. There was no product quality issue reported. Follow up information has been received on 03-AUG-2015 informing that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received on 05-AUG-2015 from the reporting certified medical assistant via telephone call. The Certified Medical Assistant reported that she would have to research the request made for patient identifiers, lot number, expiration date and dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 12-month-old patient of unknown gender. On 20-JUN-2015, the patient was vaccinated with improperly stored dose of (Merck) VARIVAX lot number was confirmed as L001325 with an expiry date of 13-JAN-2017. This is one of the several reports received from the same reporter. Additional information has been requested. Patient's details, suspect details, event information and narrative were updated.
developed a bladder infection; some soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (some soreness in her arm) and CYSTITIS (developed a bladder infection) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included Bladder infection. Concomitant products included SULFAMETHAZINE, INSULIN LISPRO (HUMALOG), INSULIN GLARGINE (LANTUS), METFORMIN, LISINOPRIL and APIXABAN (ELIQUIS) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (some soreness in her arm). On an unknown date, the patient experienced CYSTITIS (developed a bladder infection). At the time of the report, PAIN IN EXTREMITY (some soreness in her arm) and CYSTITIS (developed a bladder infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was provided as antibiotic for bladder infection.
Blood pressure, it was 182/115, in her doctor's office, after second vaccine.; Pain from her injection site shooting down her arm in a single line for a day/ Severe pain in both of her forearms and then it went away; She had kidney pain, and dropped to her knees, causing her to throw up water and then it subsided, after second vaccine; She had kidney pain, and dropped to her knees, causing her to throw up water and then it subsided, after second vaccine; She had kidney pain, and dropped to her knees, causing her to throw up water and then it subsided, after second vaccine; Wheezing and coughing and then it stopped, after second vaccine.; Wheezing and coughing and then it stopped, after second vaccine.; She had intense pain in the left side of her abdomen, and by the next day it was gone.; pain from her injection site; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) (at the age of 64 year-old), via an unspecified route of administration on 26Sep2021 as Dose 2, Single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccination included the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on  on an unspecified date for covid-19 immunization. The patient reported, after taking second shot, she had been having side effects. The patient had pain from her injection site shooting down her arm in a single line for a day. She had kidney pain, and dropped to her knees, causing her to throw up water and then it subsided. She had wheezing and coughing and then it stopped. The patient had intense pain in the left side of her abdomen, and by the next morning it was gone. She had severe pain in both of her forearms and had to take two Tylenol, and the pain went away. The patient went to her doctor and when they took her blood pressure, it was 182/115. She has never had any previous problems and this is not normal. The patient underwent lab tests and procedures which included blood pressure measurement: 182/115 on an unspecified date. The outcome of events was resolved on an unspecified date while the outcome of the events  blood pressure, it was 182/115, in her doctor's office; kidney pain, and dropped to her knees, causing her to throw up water and then it subsided was unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Vaccine was incorrectly diluted with 0.8 ml of sodium chloride instead of the correct 1.8 ml amount.
Patient received GARDASIL vaccine at medical clinic on 8/10/09 has ongoing pain left shoulder x 6 weeks after injection. Arm strength weaker on left. No relief with ibuprofen or TYLENOL. 10/ 19/09 Received medical records from date 9/24/09. DX: injection site reaction, myofacial pain, pharyngitis. SX: pt presented to office with c/o left shoulder pain and weakness since last HPV vaccine 8/10/09. c/o right side neck gland tender, sore throat. Assessment: Normal ROM left arm, decreased strength left arm, tender over left deltoid, (-)redness, (-)swelling, (+)mild enlargement right pharyngeal tonsil.
Vertigo; given Meclizine to treat dizzy symptoms. Followed up with doctor March 3rd. Symptoms had improved; with minimal vertigo symptoms remaining.