chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The tech originally administered the vaccine in my left arm. I could feel the vaccine going into me, and then it started shooting out the back of the needle. The tech stated the needle was defective. I think this was both tech error and the needle defective. She proceeded with readministering a new vaccine  (as stated above) in my right arm.      That evening I had severe pain in both arms. (I continue to this day  have intermittent pain in both arms) By Monday, I did not feel well, I was very tired, did not sleep well, and was very exhausted. (this continues to be an issue as well) I have had spotting , bleeding  and premenstrual symptoms, even though I went thru menopause 1 1/2 years ago. I went to a cardiologist as I was having pain in my arms, back and chest, and have been diagnosed with RBBB.    I think the two doses of the covid booster have really effected me. The fatigue has been terrible and it has effected mu quality of life.
Sever pain in the lower abdomen. Unable to drive due to pain/ missed  two days of work
Received full dose as the first booster/received the first booster of Moderna COVID-19 vaccine, but they gave her more than the approved dose, (Full dose).; 2nd Primary shot: On MAR2021, First Booster dose on Aug2021; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Received full dose as the first booster/received the first booster of Moderna COVID-19 vaccine, but they gave her more than the approved dose, (Full dose).) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Primary shot: On MAR2021, First Booster dose on Aug2021) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In August 2021, the patient experienced ACCIDENTAL OVERDOSE (Received full dose as the first booster/received the first booster of Moderna COVID-19 vaccine, but they gave her more than the approved dose, (Full dose).) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Primary shot: On MAR2021, First Booster dose on Aug2021). At the time of the report, ACCIDENTAL OVERDOSE (Received full dose as the first booster/received the first booster of Moderna COVID-19 vaccine, but they gave her more than the approved dose, (Full dose).) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Primary shot: On MAR2021, First Booster dose on Aug2021) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Seen 5/19/06. Skin upper third of left arm swollen and warm to touch, not firm, macular.
I was tired when I got home after the shot, so I took a nap. When I woke up my teeth were chattering from a fever of 100, I was throwing up and had spasms, back pain, body pain, and I was shaking. It lasted all night, at least 5-6 hours. The next day was similar. I called my doctor a week later because I was hoping the symptoms would go away. My tongue was swollen which made it hard to talk. The doctor advised me to take Tylenol. I feel like I have had the flu everyday since April 10.
Administer expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Total number of doses administered with lot number 048C21A were 168. The vial did not undergo any temperature excursions. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains updated reporter details.
full body rash that was on her chest and knees; joints were hot; joints were large and enflamed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of JOINT SWELLING (joints were large and enflamed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Drug allergy (Polyethylene glycols (PEG)).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced JOINT SWELLING (joints were large and enflamed). The patient was treated with EPINEPHRINE (EPIPEN) for Rash, at an unspecified dose and frequency; PREDNISONE for Joint swelling, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (joints were large and enflamed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   no concomitant medication information provided; Reporter'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. Further information is requested.
I tested positive for COVID-19 on May 31, approximately 45 days after the vaccination.  Symptoms were mild, and included hoarseness, loss of voice, and just not feeling quite right.  My Primary Care Physician prescribed Paxlovid, and I tested negative about one week later.
left arm soreness a little; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscularly on 22Dec2020 16:30 at single dose at left arm for COVID-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced left arm soreness a little on 22Dec2020 16:30. There was no any treatment received for the adverse event. The case safety report was non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the event was recovering.
Patient has a red mark on arm around the area of vaccine. Not painful, not itching but its noticable and it is rectangular in shape approzimately 3 inches in height and 5 inches in width going from outter arm diagnoally to inner arm.
pain in her grain started at least 3 days after the fever and chills; She still doesn't feel too great; Low grade fever; chills; lymph nodes in her groin area; pain on her right side of her abdomen; This is a spontaneous report from a Pfizer-sponsored program from a Support (NCSP: 159558, 002191) from a contactable 71-year-old non-pregnant female consumer (patient) reported for herself. A 71-year-old female patient received first dose of bnt16b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: ER8734, Expiry date: unknown), via an unspecified route in the left arm on 02Apr2021 (age at Time of Vaccination: 71-year-old) around 11:00-11:30, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not taken any additional vaccines on same date of the Pfizer vaccine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Apr2021, patient experienced pain on her right side of her abdomen and on 05Apr2021 (age at time of onset of reaction: 71-year-old), low grade fever that goes up to 99 degrees Fahrenheit/ low grade fever on and off since vaccination and chills/ only had two episodes of chill. Sometimes, her fever goes down and up. She did have some pain and thought it might be appendicitis. Now she thinks it is just the lymph nodes in the groin area (05Apr2021). The pain in her groin started at least 3 days after the fever and chills. The chills were one or two days. They didn't last long it is just the low-grade fever most of time. She is making gradual improvement. She just wonders when these symptoms will go away. She wants to know if this is normal. She is scheduled for the second dose on 23Apr2021. She just wants to know what to expect for the next shot. She still doesn't feel too great. The patient underwent lab test and procedure which included experienced low-grade fever that goes up to 99 degrees Fahrenheit on 05Apr2021. The clinical outcome of pain on her right side of her abdomen has subsided right now and almost gone, chills was recovered on an unspecified date; lymph nodes in the groin area, pain in her grain, low grade fever was recovering and still doesn't feel too great was unknown.   No follow-up attempts are possible. No further information is expected.
This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Covid-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient used Paxlovid from 23Dec2022 to 27Dec2022 for COVID 19 Treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Myalgia, Fever, Diarrhea, fatigue, chills Narrative:
This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (pain around the injection site), nausea and myalgia (soreness) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 037B21A) for COVID-19 immunization. No medical history reported. On Jun 14, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 14, 2021, patient experienced vaccination site pain (pain around the injection site), nausea and myalgia (soreness). At the time of the report, vaccination site pain (pain around the injection site), nausea and myalgia (soreness) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant product use and treatment information not provided.
day p/vax pt exp fever, low grade, by evening temp went to 105f. sent to ER exam fine. pt tired appearing & ?grunting; fussiness also noted by mom;
headaches bodyaches, diagnosed with giant cell arteritis. put on prednizone on 06/06/2021
Rapid heartbeat; severe heart palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 13 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Jul2021 (Batch/Lot number: unknown) at the age of 13 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 26Jun2021, when the patient was 13 years old, for Covid-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset 11Aug2021, outcome "recovering", described as "Rapid heartbeat"; PALPITATIONS (non-serious) with onset 11Aug2021, outcome "recovering", described as "severe heart palpitations". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, palpitations.  Follow-up (30Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up activities closed. No further information is expected.
Severe headache; muscle aches and stiffness; dizziness; elevated BP (related???)
Patient received the vaccine around 11:00am, and was at home later that afternoon, and around 3:00 pm the patient started experiencing cold-like symptoms. He had a sore throat, runny nose, and some difficulty breathing. When he called this morning to report the adverse event, he was feeling better, but the symptoms were not completely resolved.
Complained of feeling "off and feeling like legs are falling asleep" and upset stomach.   at 14 35  BP 179/102,  Pulse 73, 98% on room air.  Rested for approximately 45 mins. Bp 171/95  at 1455.  Patient reported feeling better and agreed to follow up with primary MD or go to ER is symptoms worsened.
Patient complained of facial droop 10/29/16; given history of DVT and PE he was transferred to a Medical Center, evaluated for stroke and neurological deficits and diagnosed with Bell's Palsy.
Seizures occurred 3 days after receiving DTAP/IPV/Comvax.  Referral to seizure specialist.
vaccine in May 2021 / was diagnosed with bell's palsy in June 2021 / has not fully resolved; This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2021, the patient received the 1st dose of Shingrix. In June 2021, less than 2 months after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was not recovered/not resolved.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient himself. The age at vaccination was not reported however it could be 73 or 74 years. The Patient had received the first dose of shingrix in May 2021 and he was diagnosed with bell's palsy in June 2021. He was currently taking medication for the bell's palsy. The bell's palsy had not fully resolved. The reporter consented to follow up.
Just prior to 5P had left arm pain -that traveled to my hand. At 5PM driving and heart rate went 128 - most likely higher (registered on iwatch). This is abnormal for me as my heart rate is typically in high 40's (marathon runner).  Along with the rapid heart rate felt like throat was closing - like a reaction caused by an allergy.  The rate rate stayed like that for about a minute or two followed by severe chills (chills can be described like when a person comes out of the OR).  I felt like I was coming out of my skin and became dizzy. I became nervous and called 911.  In discussion with the 911 dispatch everything subsided and decided I would continue driving with an intent to going to Hospital.  About 10 minutes later, prior to getting onto I95 the same cycle with increased heart rate followed by chills occurred again for about the same timeframe.  I do not know how far apart the cycle was occurring other than I ended up calling 911 again and Ambulance was dispatched while I was on I95 and I had pulled over.  Approx arrival of ambulance was about 6P Once in the back of the ambulance, I showed no arrhythmia and heart rate was now in the 70's, however I was still having the chills.  Decided to drive home after waiting about 20 minutes in the back of ambulance with no further issues of the tachycardia. Once I was home I continued with chills and a high fever throughout the night.  The fever did not go away until about 48 hours. The chills went away by the following morning. Thursday and Friday have had chest tightness and the feeling of needing to take large breaths to expand chest.  Continue to have moderate headache.
Persistent swollen lymph nodes exerting serious pain in both armpits since the administration of the booster shot.
Severe pain in chest.  Headache.  Dry cough.  Pain seems to he worsening tonight.   Very fatigued tonight.  Was very fatigued all day Thursday, but pain has been bad since afternoon, worsening tonight.
This is a  19 Years old  Female  presenting with chest pain for yesterday night. Pain started gradually. It is described as tight and pressure, radiating into nowhere. Pain is described as mild upon onset and is currently mild. Patient states the pain occurs when she is laying down and when she is walking. She also endorses fatigue and palpitations. Patient received her second dose of the Moderna vaccine on Wednesday. She states that she has also has an area of redness and swelling to the left upper extremity at the site the vaccine was given. She states that the swelling and redness has decreased since yesterday but is still present.
Received a monovalent dose after FDA  released statement that monovalent was no longer to be used.  We have now administered a Bivalent Dose on 5/12/2023 per Interim Clinical Considerations for use of COVID 19 Vaccines.
Sleepier than normal. Sleeping greater than 5 hours and would not latch or feed. 1 wet diaper in 12 hours. Odd cry for approximately 10 minutes.
Fever initiated approximately 4 hours after injection.  I took 2 regular dose Tylenol 5 hours after injection.  Fever continued to increase.  I experienced involuntary shivers for about 30 minutes.  I also experienced aches throughout my entire body, from my head to the tips of fingers and to the soles of my feet.  My fever was 100.3 (3 degrees over my normal temperature of 97 or below)  approximately 14 hours after injection.  After a dose of 1 regular Tylenol at that time, fever started to reduce.  I was without fever approximately 24-28 hours after fever started.
I contracted COVID-19 on 05/29/2022 with symptoms of sore throat, fever of 102 that lasted for 3 days, body aches, nausea, headache, fatigue, brain fog, abdominal pain, diarrhea, and cough. I went to the Clinic as was prescribed Paxlovid on 06/03/2022. I was ill for 5 days before my symptoms began to resolve. I became ill after a trip. I am fully recovered now with no lingering symptoms.
This case was reported by a consumer via call center representative and described the occurrence of pain in a 62-year-old female patient who received SHINGRIX (batch number 102778 ?, expiry date unknown, GSK note: the reported lot number did not match with any GSK lot number) for prophylaxis. On 25th June 2018, the patient received the 1st dose of SHINGRIX 1 ml. On an unknown date, several days after receiving SHINGRIX, the patient experienced pain, shingles, fever and overdose. On an unknown date, the outcome of the pain, fever and overdose were unknown and the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the pain, shingles and fever to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX, the patient developed aches, low grade fever and shingles on her feet going up towards her head and internally. Also the patient received 1.0 ml dose of SHINGRIX, instead of 0.5 ml, which led to overdose. The lot number reported was double checked. She said that was the number the pharmacy gave her when she called them for it. Her doctor did not prescribe it, she just went to the pharmacy to get it and has not followed up with a doctor to get a physician documented shingles diagnosis. She was unsure if the pharmacist had reported her reactions already but could not find the pharmacist's name that would have reported it. Her husband also had similar adverse events to her so this was report one of two. This case has been linked with case US2018151971 (husband's case), reported by same reporter.
root canal that caused an infection; facial swelling; This spontaneous case was reported by a non-health professional and describes the occurrence of ROOT CANAL INFECTION ( root canal that caused an infection) and SWELLING FACE (facial swelling) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 13-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to Dose 1. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 02-Mar-2021, the patient experienced ROOT CANAL INFECTION ( root canal that caused an infection) and SWELLING FACE (facial swelling). At the time of the report, ROOT CANAL INFECTION ( root canal that caused an infection) and SWELLING FACE (facial swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient was treated with prednisone and antibiotics.
Developed fever, chills, body aches within 4 hours. Developed intermittent right sided chest pain with associated shortness of breath x 18 hours.
I immediately felt dizzy.  Within a few hours, I became very tired and lightheaded.  Within 12 hours, I had severe muscle aches, chills, headache, and a fever of 102 degrees.  The fever and chills lasted 24 hours.  The fatigue and light-headedness have continued for 7 days without stopping.
I had fever and  headache the day after reviving the 2nd shot. The fever last about 2 days. Started to experience sore throat since the 3rd day after the 2nd shot. And I am still experiencing the sore throat after 45 days. I even took the Covid test and it came back negative.
Post the Second Dose Following symptoms started to show-up - Tiredness, Confused state of mind, Loss of appetite - Lack of Sleep  - Fluid accumulation and swelling in legs, face/eyes - Increased Creatinine, Reduced Hemoglobin, Vitamin and Iron Deficiency