chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle soreness; tiredness; lack of sleep; Some buzzing in ears, and increased tinnitus (pre-existing) off and on; Soreness in arm, typical of other vaccinations ie., some soreness in arm at/around injection site; typical of other vaccinations (minimized bruising and soreness by rubbing arm during 15 min wait time to disperse serum and reduce bruising/soreness) and increasing overnight; typical of other vaccinations (minimized bruising and soreness by rubbing arm during 15 min wait time to disperse serum and reduce bruising/soreness) and increasing overnight; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 62-years-old non pregnant adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 13Mar2021 14:15 PM (Batch/Lot Number: en6199) as dose 1, single for covid-19 immunisation (at the age of 62-year-old). Medical history included fibromyalgia, arthritis, slightly high blood pressure, tinnitus, vertigo, gall stones, neuropathy, plantar fasciitis, heel spurs from an unknown date and unknown if ongoing. The concomitant medications were not reported. the patient had known allergies for food such as some herbs and spices, other allergies to cats, wool, soap, dust etc. and no known allergies to drugs other than intolerance of Sudafed. The patient did not received any other vaccines within 4 weeks prior to the Covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient received medications in two weeks of vaccination. On 13Mar2021 16:15 PM, 2-4 hours post dose the patient experienced tiredness (may have been unrelated and due to lack of sleep and activity that day); 4 hours post dose to 36 hours post: Soreness in arm, typical of other vaccinations i.e. some soreness in arm at/around injection site, typical of other vaccinations (minimized bruising and soreness by rubbing arm during 15 min wait time to disperse serum and reduce bruising/ soreness) and increasing overnight -feels much like exercise muscle soreness, still a bit tender to touch at site. The patient not received treatment. The outcome of the events was recovering.  No follow-up attempts are possible; no further information expected.
Sneezing within 15 minutes of vaccines.  Left health center and patient starting coughing and face, neck & ears broke out in hives, then hives belly & back & started wheezing within 1/2 hour of vaccines Went to PMD.  Pediapred topo, Benadryl prn, Epinephrine 0.15ml IM at MD.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 1:34 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021 at 1:34 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medications on use were not provided.  Patients were given doses from vials that were stored in an ultracold freezer which is colder than they should have been. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion. The vials moved from freezer to refrigerator on 16 Nov 2021. The maximum and minimum reached temperatures was negative 82 degrees Fahrenheit. The vials were returned to the freezer or refrigerator or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursion issues had happened.  No treatment information was provided.   This case was linked to MOD-2021-402935 (Patient Link).
0.3 ml of undiluted vaccine administered; treatment - none; outcome - observed during more than 15 min; post vaccination symptoms reported by patient as "none"; left clinic in stable condition.
Received vaccine on the 29th. That night I had a fever, body aches, and headache. On the 30th I woke up to my left arm being swollen underneath. It was painful and very large, fluid filled. I was told it was lymphedema by Dr. who was in my department, the OR, at the time. It last about two weeks and has finally subsided. Nobody knew exactly why this happened after my vaccine.
I developed severe headache for two to three days after getting the 2nd dose of the Covid-19  vaccine starting approx. 3 hours after the vaccine. I took Celebrex as the head aches were quite severe(7-8/10) with difficulties in focusing due to the pain.  I received my first Covid-19 vaccination shot on 12/16/2020 and did not have any significant side effects besides mild pain in my left arm at the injection site the next day and it resolved with no intervention.   Then on 01/14/2021 I developed floaters in my right eye that was very sudden around early afternoon that progressed to large black spots obscuring my vision. It was associated with headache and deep eye itching and pain. I was unable to look at the computer and that is when I called my eye doctor and was told to come to see her right away. She then diagnosed me with Posterior Vitreous Detachment and referred me right away to see Dr. retinal specialist.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored dosed of GARDASIL 9 lot # L006547, expiration date 04-MAR-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt developed headache after first dose. Pt has a known hx of migraines. Vitals and assessment checked by ems. Pt treated for her headache. No transport needed.
patient sitting in waiting area and fainted and fell out of chair and hit her head on the floor. lost consciousness for approximately 30 seconds
Body aches; Minor Fever; Feels really tired; Headache; Throwing up; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN (Body aches), PYREXIA (Minor Fever), FATIGUE (Feels really tired), HEADACHE (Headache) and VOMITING (Throwing up) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (COVID-19 in July 2020).    On 25-Mar-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches), PYREXIA (Minor Fever), FATIGUE (Feels really tired), HEADACHE (Headache) and VOMITING (Throwing up). At the time of the report, PAIN (Body aches), PYREXIA (Minor Fever), FATIGUE (Feels really tired), HEADACHE (Headache) and VOMITING (Throwing up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was taken to the ER twice: firsts for the body aches and they gave her morphine and second time liquid tylenol to control the fever the second time and was throwing up.  Concomitant medication was for thyroid was provided by the reported.
5/11/2018 Fevers of 103 x 4 days, 5/11/2018 severe sweating during sleep x2 weeks, 5/13/2018 difficulty swallowing  and poor appetite, diagnosed with tonsillitis, 5/14/2018 rash and swelling, difficulty swallowing, 5/16/2018 severe rash and swelling.
This was a Moderna booster. After vaccine was given, I took 25mg Benadryl, another 25mg at bedtime. The next day I had a full rash on both forearms. Benadryl was required every 6 hours x 2 days. Rash was gone by day 3. This happened after dose 1 and 2 of Moderna. However, the rash lasted 1 day and was only on the arm that received the vaccine.
Mom called on 08/23 in the morning to say her child's leg was swollen to the size of a baseball on the right upper thigh area where she'd gotten 2 injections on 08/21/01. The site per mom's description was large, red, hot to touch and the size of a baseball. The child was complaining it itched and it hurt today.
Information has been received from a physician concerning a 65 female with asthma who on 13-APR-2007 was vaccinated subcutaneously with a 0.5 ml dose of Pneumovax 23 (lot #654977/0888F).  Concomitant therapy included an unspecified therapy and hydrochlorothiazide (manufacturer unknown).  On approximately 14-APR-2007 the patient developed a rash with redness, warmth, induration and pain in the arm in which she was vaccinated.  The rash was approximately 8 cm in diameter.  On 20-APR-2007, the patient called the physician's office and reported that she still had pain and developed chills and vomiting.  Medical attention was sought and the physician prescribed prednisone and a cortisone cream.  There were no laboratory or diagnostic tests performed.  At the time of the report, the patient had not recovered.  The reporting physician requested a lot check  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released by the regulatory agency.  Additional information is not expected.
Covid19 breakthrough infection.  1st vaccine 01/27/2021.  Pt presents with multiple falls and increasing generalized weakness over the past 3 days from SNF.
Shooting pain whenever I lifted my left arm. Severe for about 6 weeks. For the past 2 weeks it has been more minor pain with movement.
he has been feeling fatigued/ tired; Hot and cold flashes; diarrhea; nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, when the patient was 59 years old, for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "he has been feeling fatigued/ tired"; HOT FLUSH (non-serious), outcome "unknown", described as "Hot and cold flashes"; NAUSEA (non-serious) with onset 27Apr2021, outcome "not recovered", described as "nausea"; DIARRHOEA (non-serious), outcome "not recovered", described as "diarrhea".  Additional information: Caller stated he received the second dose of Pfizer's COVID vaccine on Sunday and ever since he has been feeling fatigued. Caller stated, "Yesterday, I tried to go to work and I experienced hot and cold flashes and nausea and diarrhea. I still have the nausea and diarrhea today, 27Apr2021. Is that normal Or should I go to the ER But I feel fine. I've been so tired it seems like I can't just stay up."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
she did get dizzy with the first shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabetic" (unspecified if ongoing); "Crohn's disease" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "she did get dizzy with the first shot".  Additional information: The first shot she got was fine, she had no pain, nothing. The patient clarified that she did get dizzy with the first shot and it passed in one or two hours and was not concerned about that part. She was diabetic and had Crohn's disease and she was not sure if that has anything to do with it. She got the shots through her doctor and that has been her doctor for seven years. She declined to complete report. She just wants her question answered. If it was normal then stated that Pfizer need add to the sheet as a side effect if it was normal.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient was given 3 vaccines during a scheduled flu clinic. She received flu (left upper deltoid), shingles (right deltoid), and tdap (right upper deltoid) vaccines. Later that evening she developed a widespread rash covering most part of her body. She made an appointment with her MD who treated her accordingly.
Patient felt fine after vaccination and ambulated to observation room accompanied by his mother.  After 5 minutes in the observation room he had a syncopal episode.
Fever, chill, nausea, vomiting x 2 days. Diarrhea x 1 week. Really weak. SOB resolved with TYELENOL and MOTRIN. As per patient she did not go to ER.
Maternal exposure during breast feeding; had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (had a sore arm) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced PAIN IN EXTREMITY (had a sore arm). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). At the time of the report, PAIN IN EXTREMITY (had a sore arm) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by reporter.  Treatment information was not provided by reporter.  Patient's weight was 200 COMPANY COMMENT: This case concerns a 25 year old breastfeeding female with no reported history who experienced the non-serious, unlisted AESI of Maternal exposure during breastfeeding and the event Pain in extremity the day of dose 1 of mRNA-1273. Re-challenge is positive for pain in extremity as it recurred with dose 2. Benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-355915 (Parent-Child Link). This case was linked to MOD-2021-356130 (Patient Link).   See case MOD-2021-355915 for details regarding the child case.; Sender's Comments: This case concerns a 25 year old breastfeeding female with no reported history who experienced the non-serious, unlisted AESI of Maternal exposure during breastfeeding and the event Pain in extremity the day of dose 1 of mRNA-1273. Re-challenge is positive for pain in extremity as it recurred with dose 2. Benefit-risk relationship of mRNA-1273 is not affected by this report.
Information has been received from a physician concerning a 6-month-old female born prematurely at 34 weeks gestation and with a history of gastroesophageal reflux disease (GERD) who, at four months of age, was vaccinated with the second dose of ROTATEQ (lot number not reported) (first dose administered at 2-months-old). Concomitant vaccinations on that same day at four months of age included a dose in the left leg of PEDIARIX, a dose in the right leg of PREVNAR (Lot #B26510A), a dose in the right leg of ACTHIB (Lot #UE958AA)(manufacturer unknown). There were no illness at the time of vaccination. Other concomitant therapy given on that same day included SYNAGIS. The physician reported that, nine days after receiving the second dose of ROTATEQ, the patient developed diarrhea and vomiting. At that time, medical attention was not sought. No other symptoms were reported. The patient was seen by the physician at six months of age. At the time of this report, the outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/3/2007.  Information has been received from a physician concerning a 18-week-old female born prematurely at 34 weeks gestation and with a history of gastroesophageal reflux disease (GERD) who on 27-AUG-2007 was vaccinated PO with the second dose of ROTATEQ vaccine (Lot #656378/0028U). The physician reported that on 05-SEP-2007, the patient developed diarrhea and vomiting. The patient's mother thought it was rotavirus infection. The patient subsequently recovered. Additional information has been requested.
I have an upset  stomach  with constant Diarra; I have an upset  stomach  with constant Diarra; off label use/ the patient received 3rd dose of vaccine; the patient received 3rd dose of vaccine; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: FC3182) via an unspecified route of administration on 01Sep2021 at 15:00 (at the age of 48-years-old) in right arm as a single dose for covid-19 immunization. Medical history included known allergies to Penicillin, Sulfa, Morphine and Vicodin all from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. The patient's concomitant medications received in two weeks included other unspecified vaccine. The patient received third dose of Pfizer vaccine on 01Sep2021 at 15:00 (coded to off label use and immunisation). The patient experienced upset stomach with constant diarrhoea on 03Sep2021 at 12:00. Treatment was reported as unknown. The outcome of the events off label use and immunisation was unknown and for all other events was not resolved.  Follow-up attempts are completed. No further information is expected.
Pain on injection, increased heart rate, stiff neck/shoulders, pain in multiple joints, headache, tiredness, nausea
Patient with complaint of pruritis and rash present on neck, upper chest, and right axilla 35 minutes after vaccine dose. Patient denied shortness of breath. No blisters or drainage present with rash. Patient was ordered and administered Benadryl 50mg PO x 1. Within 45 minutes, patient reported feeling better, and that pruritis had subsided. Medical provider placed standing order for EpiPen. Patient requested EpiPen appx. 32 hours after vaccine administration due to return of itching and rash, which was administered by nursing staff. Medical provider reported verbally that dose was effective appx. 20 hours later.
Pt started to feel weak and said that he was about to pass out.  He got on the floor and felt weak. I asked if he had eaten anything and the wife said no.  I quickly gave him some water and told him to sip slowly on it.  After a few seconds, he passed out.  I asked the wife to move so I could give him an epi-pen and she said no.  Both her and her son shouted at him to wake up and slapped his face.  He finally came to after a few minutes.  I asked the son to go get him so peanut butter crackers.  He snacked on it slowly, while sipping on water.  He started feeling bad again and laid on his back and we elevated his feet.  After ~5-10  minutes, he started feeling better and sat up.  After about 30 minutes, he was able to stand and felt better.
This spontaneous report as received from a registered nurse refers to a child patient of unknown age and gender. At an unknown date, the patient was vaccinated with VARIVAX (Merck). Route, dose and frequency were not reported. No other co-suspects were reported. No concomitant medications were reported. Nurse reported that in the past she had a patient who received VARIVAX (Merck) and then developed varicella-like lesions at the injection site. The patient sought medical attention through office visit. No intervention was required to prevent serious criteria. No other details. NO treatment information was reported. The outcome of varicella-like lesions at the injection site was reported as recovered/resolved at an unknown date. The relatedness for varicella-like lesions at the injection site for VARIVAX (Merck) was not provided by the reporter. Additional information has been requested
On 09/22/2022 at about 01:15 pm, the Chief Nursing Officer (CNO) at Hospital illegally scanned her badge at the pharmacy door and gained access to the pharmacy to retrieve COVID-19 (Moderna Bivalent) vaccines. When the CNO was informed by the pharmacist that she (CNO) had illegally gained access to the pharmacy, then CNO replied that since she (CNO) was the boss of the pharmacist and supervised the pharmacist, she (CNO) could scan her badge to the pharmacy door to gain access to the pharmacy. The pharmacist then reported the matter to the State Board of Pharmacy. The CNO retrieved on e2.5 mL vial of COVID19 Moderna Bivalent vaccine and administered to patients. The following week, pharmacist requested for and reviewed the vaccine administration record. It shows that the CNO used the one 2.5 mL vial to administer to 8 patients. Since on 2.5 mL vial fo COVID-19 (Moderna Bivalent) vaccine can not be safely administered to 8 patients, the pharmacist then submitted a SQSS Risk Report, utilized by the hospital, and also sent an email to the CEO, and copied the Risk Assessment Nurse and the CNO. The pharmacist no longer works for Hospital and is concerned that the hospital administration and the CNO would not take appropriate steps to address the vaccine administration event, since the person in question is the CNO who is aldo a top administration member.
Shortness of breath. Rapid heart rate. BP 114/73 P. 85 T. 97.8 O2 Sat 99%. BENADRYL 2 - 25mg tabs given -> resolved.
The day after receiving vaccine the patient's arm and face started swelling. Arm/injection site was warm, red, and raised (size of a baseball) for several days. Also pt. had diarrhea x 4 days.
I woke up not feeling well before going to work so I tested before going to work as I did I have flu like symptoms. I consulted with my doctor which changed the course of my prenatal care.