chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; Headache; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Mar-2021. The most recent information was received on 25-Jun-2021 and was forwarded to Moderna on 25-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 28L20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Thyroid disorder. Concomitant products included PREDNISONE for Arthritis, LISINOPRIL, AMLODIPINE, PRAVASTATIN, SERTRALINE HYDROCHLORIDE (ZOLOFT), VITAMIN D NOS, LORATADINE and OMEGA-3 [OMEGA-3 NOS] for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). On 04-Mar-2021, PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Heart rate: increased (Inconclusive) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-236840.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: follow up received on  25-JUN-2021 ,Medical history updated.
This spontaneous report was received from a medical assistant and refers to a male patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 02-MAR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N020353 with expiration date on 18-APR-2020 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion, at or above, the range between 32°F to 35°F for 3 hours and 15 minutes as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved.
positive Covid test; positive Covid test; arm soreness; This is a spontaneous report from a contactable physician (patient). This report was received via a Pfizer sales representative. This is one of three reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced positive covid test and arm soreness on an unspecified date after the use of the vaccine. The physician reported that first dose caused no side effects other than arm soreness, second dose happened within weeks of having positive Covid test. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the reported information , a causal relationship between the events Drug ineffective and Covid-19 and suspected drug cannot be excluded.,Linked Report(s) : US-PFIZER_INC-202101425759 Same reporter and patient, different dose, different AE;US-PFIZER_INC-202101425760 Same reporter and patient, different dose, different AE
Flu vaccine given 9-13-11, client noting itching and beginning hives 9-14-11 AM. Sx's continued for two days. PMD seen 9-16-11 prescribed prednisone 10 mg qd x 5 days, BENADRYL and calamine lotion, as stated by the client. Sx's resolved in two days. Client reports she had not made any changes in foods, no medications. Clothing or other that may have affected her adversely. Client did report that about 1 wk. Later she noting itching and a rash which she thought due to foam pillows.
BEGAN 2 HOURS AFTER VACCINATION, CHILD BEGAN PROJECTILE VOMITING, SHIVERING AND HAD RASH ON ON LEFT LEG. TAKEN TO LOCAL ER.
I lost hearing in my left ear and have to have a hearing aid. I went through steroid treatments to bring the hearing back but it wasn't successful.
Chronic urticaria, onset about 4 weeks post-vaccination.  Random hives all over body.  Worse in evenings.   Random in timing and placement of appearance.   Still unresolved as of this date.
severe pain at the injection site; he went from "totally okay to hurting and terrible."; headache; vomited 5 times last night (22-Feb-2021); muscle soreness; fatigue; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient exposed to Men B NVS (Meningococcal B vaccine) in utero. The mother received the product for prophylaxis.   On an unknown date, the mother received Meningococcal B vaccine. The mother's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient was exposed to Meningococcal B vaccine at an unknown time during the pregnancy. The patient was diagnosed with vomiting, muscle soreness and fatigue. On an unknown date, the patient experienced injection site pain, feels awful and headache. On an unknown date, the outcome of the injection site pain, feels awful, headache, vomiting, muscle soreness and fatigue were unknown.   It was unknown if the reporter considered the injection site pain, feels awful, headache, vomiting, muscle soreness and fatigue to be related to Meningococcal B vaccine.  Additional details were provided as follows: The reporter was the mother of patient.  The age at vaccination was not reported. The reporter stated that the patient was having an adverse reaction to the meningitis B shot. She did not know the brand name to confirm if it was Bexsero (or Trumenba or other). The patient had severe pain at the injection site and also has experienced fatigue, muscle soreness and he vomited 5 times the night before reporting day. The patient also had a headache. The reporter stated that the patient went from totally okay to hurting and terrible. No further information was collected because reporter was going to check with patient's doctor to obtain the name of the vaccination that was administered.
3 booster doses given from an expired vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 booster doses given from an expired vial) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 booster doses given from an expired vial). On 22-Jan-2022, EXPIRED PRODUCT ADMINISTERED (3 booster doses given from an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-459566, MOD-2022-458939 (Patient Link).
This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 50-year-old female patient who received SHINGRIX (batch number L7F7E, expiry date 22nd November 2020) for prophylaxis. On 11th July 2018, the patient received SHINGRIX .5 ml. On 11th July 2018, unknown after receiving SHINGRIX, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional details were provided as follows: The age at vaccination was not reported. The registered nurse reported that one of the other nurses did not mix the adjuvant with the powder, and only gave the patient the adjuvant, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter called back to provide the initials and birthdate for the patient as well as the date the vaccine was given. Follow up information received from other health care professional on 3rd October 2018: The nurse did not mix adjuvant with powder only adjuvant was given to the patient. The reporter spoke to the patient approximately 1 week ago and patient reported localized discomfort and injection site along with diarrhea and fatigue for 1 or 2 days after vaccine, which resolved on its own. The patient was uncertain if she would restart series at the time of reporting. The VAERS details were updated.
I started noticing I was having a low-grade fever in the evening, and this has been off and on since November. I also had a UTI and sinus infection and upper respiratory system issues, fatigue and low energy, blood sugar has been all over the place.
Large lump appeared in left armpit 3 days after Vaccine It is very sore to touch and hurts most of the day. Went to Dr. Told me to keep taking Tylenol and using a pain rub (Hemp Vana) on it. Said it should die down in 4 to 6 weeks.
This case was reported in a literature article and described the occurrence of gastroenteritis in a 2-month-old female subject who received Rotavirus vaccine. On an unknown date, 5 days after receiving Rotavirus vaccine, the subject developed gastroenteritis. Serious criteria included hospitalization. Additional event(s) included Escherichia urinary tract infection with serious criteria of hospitalization and GSK medically significant. The outcome of gastroenteritis was recovered/resolved. The outcome(s) of the additional event(s) included Escherichia urinary tract infection (recovered/resolved). The investigator considered that there was a reasonable possibility that the gastroenteritis and Escherichia urinary tract infection may have been caused by Rotavirus vaccine. Additional information was provided: This case was reported in a literature article and it described the concurrence of gastroenteritis and urinary infection in a 2-month-old female who had received ROTARIX (GlaxoSmithKline). The patient was deemed to be a healthy infant by the authors and had received the vaccine as part of a clinical study with the following exclusion criteria: significant history of gastrointestinal disease or other serious medical conditions, history of immunodeficiency, known sensitivity to any vaccine components, previous receipt of a rotavirus vaccine, acute illness at the time of or in the previous 48 hours before vaccine administration (axillary temperature higher than 100.2 deg F, more than 3 looser-than normal stools or any episodes of vomiting), participation in another study involving an experimental agent, birth before 37 weeks of gestation, receipt of blood and/or blood products (including immunoglobulin) within 4 weeks before vaccine administration or receipt of any live vaccine within the previous 30 days or an inactivated vaccine within the previous 14 days. No further information on the patient's concurrent medical conditions, medical and family history or concomitant medication was provided. On an unspecified date between March 2011 and September 2013, the patient received a dose of ROTARIX. Dosage unknown; administration route and site unspecified; batch number was not provided. On an unspecified date, 5 days after the vaccination, the patient was admitted to hospital with gastroenteritis. She was also diagnosed with Escherichia coli urinary tract infection. Patient was discharged home after 48 hours. This was a serious case as the patient required hospitalisation. Treatment was unknown. Outcome of the gastroenteritis was recovery without sequelae according to the authors. Outcome of the urinary tract infection was unspecified at the time of reporting. The authors commented that her admission was believed to be associated with the vaccine. The authors concluded that "mixed rotavirus vaccine schedules are safe and non-inferior in immune responses when compared with those in which a single formulation of licensed rotavirus vaccines is administered alone."
Began with hives, moved to joint and muscular soreness with a 36 hour time of lethargy, low grade fever and chills
Bells palsy in face; This spontaneous case was reported by a patient and describes the occurrence of BELL'S PALSY (Bells palsy in face) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Bells palsy in face) (seriousness criterion medically significant). The patient was treated with METHYLPREDNISOLONE at an unspecified dose and frequency and VALACYCLOVIR [VALACICLOVIR] at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (Bells palsy in face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided. Company comment; Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded
Left leg swelling and erythema - thigh to knee. BENADRYL and ice.
On evening after shot 9-30-22 developed chills without fever  SOB, chest tightness, tachycardia 107-127 BPM and non productive cough . symptoms continued til CT Pul angio  done 10-12-22 showed segmental acute pulmonary emboli  all five lobes. with RLL pulm infarct 3cm. No right heart strain.  Seen in local hospital ER on 10-12-22. US doppler legs neg. Treated with eliquist and discharged. SOB, cough and chest pain continued for 10 days.
Pt arrived for second dose of Moderna. Moderna and Johnson and Johnson were stored in close proximity and J&J was administered instead of Moderna. Pt was made aware of error and vaccination card was changed to reflect administration. Other changes implemented to prevent this error in the future include but are not limited to: separate coolers for different manufacturers, color-coded bins for syringes stored at opposite sides of the room, individually-labeled syringes with BUD, and additional training for all vaccinators (in process). Attempted to reach out to the patient 6/1 for follow-up, left voicemail.
After receiving vaccine, we were told to sit and wait 10 minutes before leaving.  About 7 minutes into waiting, my son said he was thirsty and not feeling that good.  we started to walk to get a water and he totally blacked out and exhibited mild like seizure activity.  After he "came too", he complained of blurry vision and still didn't feel good as we waited for ambulance.  Once ambulance came he was feeling a little better.  Vitals all checked out good and were declined going to hospital.  He doesn't remember anything that happened in Pharmacy, except that he thought he was going to die.
Lower back discomfort (mainly central, lower back) began within a couple hours of my receiving the vaccine. The discomfort slowly intensified throughout the day. By evening there was stiffness and at times along with the steady discomfort, there would be sharp, stabbing pains experienced upon certain movements. Awoke in the middle of the night with severe stiffness, pain and discomfort. That morning (day after the vaccine), I made a doctor's appointment. My regular physician was booked for the day so I took an appointment with my wife's physician. Dr. gave me Skelaxin 800mg to take as needed along with ibuprofen and use of a heating pad. She told me to contact my physician if symptoms do not get better after a few days. Sometimes it would appear the medication(s) and/or heating pad helped somewhat but only for a very short time, maybe an hour or two at the most. I have since tried various over-the-counter pain relievers such as Tylenol, Advil and Aleve with little success. Nights and mornings are the most difficult with this ongoing condition, even with the heating pad. Last evening (3/39/2010) however, without taking any medications, I was elated to be experiencing much reduced pain, stiffness and general discomfort between the hours of 5:00 PM and 8:00 PM. So much so that I was confident I was entering the final stages of whatever was ailing me. Sadly, this was short-lived, as it all steadily came back through the remainder of the evening. I awoke last night once again in fairly severe pain and stiffness. I got some relief by using a reclining chair with a rolled blanket for lumbar support. I slept a little more like this but when I awoke, I was again in pain and stiffness. I have made a second appointment with a doctor for this evening. Please respond to this writing via email so that I may send updates to you.
Pt was given vaccine that was removed from refrigerator 48 hours prior to administration.  Contacted Pfizer who could not provide data showing efficacy of vaccine beyond 24 hours.  No adverse reaction
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A male patient received BNT162b2 (BNT162B2), 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's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Her brother was also boosted with his 4th booster and recently was diagnosed with Covid/ She stated they all have had the Pfizer Covid vaccine for their vaccinations". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Additional information: In addition, caller mentioned that she had her 4th Pfizer Covid vaccine booster and recently was diagnosed with Covid. Her brother was also boosted with his 4th booster and recently was diagnosed with Covid. And her son also has Covid but has not yet had a booster. She stated they all have had the Pfizer Covid vaccine for their vaccinations. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On Jan 7th 2016, was given a TDAP vaccine, shot made me very tired, went home had a drink of grape juice, layed down and slept for 2hrs. When I awoke my breathing was worse and my inhalers are not helping like they were before shot. Anxiety is worse medication not helping as before.
Runny nose and eyes, itch deep in left palm, stroke and loss of use in left hand
possible colitis; not feeling well, had no energy; not feeling well, being exhausted; abdominal problems like diarrhea; abdominal problems like discomfort in the stomach; Initial information regarding an unsolicited valid non-serious case was received from a consumer (patient) via Medical Information (Reference number- 00414814) and transmitted to Sanofi on 04-Jan-2021.  This case involves an 85-year-old female patient who was not feeling well, had no energy (asthenia) was being exhausted (fatigue), had abdominal problems like diarrhea (diarrhoea) and discomfort in the stomach (abdominal discomfort) and later was diagnosed with possible colitis (colitis), after she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past vaccination included influenza vaccine (first flu vaccine) and she experienced the injection site swelling to the size of a tennis ball and the arm stayed swollen for 4 days. She did not had a reaction since the first flu vaccine.  The patient's past medical treatment(s) and family history were not provided. The patient had no other vaccines.  At the time of the event, the patient had ongoing lactose intolerance and had to avoid rich cream sauces.  On 02-Oct-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) once via an intramuscular route in an unknown administration site for prophylactic vaccination. The patient first time received this product.  In Oct-2020, the patient was not feeling well had no energy (asthenia), was being exhausted (fatigue), had abdominal problems like diarrhea (diarrhoea) and discomfort in the stomach (abdominal discomfort) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  In Oct-2020, the patient was diagnosed with possible colitis (colitis), two weeks following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  The patient wanted to know possible side effects from getting Fluzone High-Dose Quadrivalent due to the adverse events she experienced. It was reported that this pharmacy gave people over 65-years of age the Fluzone High dose and did not tell them. The patient would have preferred the standard dose due to being sensitive to medications. The colitis may be due to other factors and the caller was just tracing her steps. She had recently moved into a new retirement community and was now getting served meals which consist of foods she had avoided in the past, the foods consist of fried foods that were usually not in her diet.  No laboratory data was provided.  Final diagnosis was possible colitis.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the patient recovered from asthenia and fatigue while not recovered from rest of the events.  There will be no information available on the batch number for this case.
Received her first dose of the COVID vaccine (Pfizer LOT#: EW0161 Exp: 7/2021) at 1057. Patient alerted EMT. Patient stated that she felt a tingly feeling on her right chest/ breast area. EMT alerted. Asked patient to stay 30 more minutes for further observation. Patient agreed. BP: 106/62, pulse: 67, 02: 99%. Patient stated that she has been diagnosed with anxiety. After 30 minutes of observation patient stated that she was feeling much better and that the tingly feeling went away. Patient left with her friend and walked out of vaccination site with a steady gait.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 51-year-old female patient who received SHINGRIX for prophylaxis. On 27th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm, general body pain, diarrhea, nausea, tremor, headache, fever and chills. On an unknown date, the outcome of the pain in arm, general body pain, diarrhea, nausea, tremor, headache, fever and chills were recovered/resolved. It was unknown if the reporter considered the pain in arm, general body pain, diarrhea, nausea, tremor, headache, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. But, it could be 50 or 51 years old. The patient experienced sore arm, fever, body ache, chills, nausea, shakes, headache and diarrhea. The patient recovered from all events about 3 days after the injection. The patient did not report any of this to her physician and that physician was likely unaware that patient received the SHINGRIX.