chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a sudden "explosion" of pain/level 10 severity/a new type of pain or perhaps a huge exacerbation of existing systemic pain of some kind; fever of 100.8 at one point; nausea; I was literally moaning and crying; I was literally moaning and crying; This is a spontaneous case received from a contactable consumer (patient). A 68-year-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6199) via an unspecified route of administration in left arm on 05Mar2021 13:30 (age at vaccination 68-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient was not pregnant at time of vaccination. The patient medical history included myalgic encephalomyelitis (ME/CFS), fibromyalgia, gastroesophageal reflux disease (GERD), hiatal hernia, mild depression, limited migraine headaches, hypothyroidism, high blood pressure, high cholesterol, degenerative disc disease (DDD) and other musculoskeletal issues, irritable bowel syndrome (IBS), lichen sclerosis and systemic pain. The patient had known allergies to cipro and sensitive to milk, citrus and nuts. Concomitant medication was not reported. The patient did not take other vaccine in four weeks. The patient took other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Mar2021 18:30, the patient experienced a sudden "explosion" of pain, level 10 severity lasted for hours, a new type of pain or perhaps a huge exacerbation of existing systemic pain of some kind, fever of 100.8 at one point and nausea, the patient stated that she was moaning and crying. It was the worst pain of her life, relentless with no let-ups, despite my taking a necessary opiate 2-3 times close together. Patient was literally moaning and crying, anything to help with the pain once back at home. The patient underwent lab test and procedures which included body temperature: 100.8 and pain assessment: level 10 severity on 07Mar2021. Otherwise, a visit to the ER of her local hospital should have been done. I wished the next day I had gone there but I doubted my pain would be understood. I also feared going to a hospital in this COVID environment. Her pain was intractable and unbearable. She had a fever of 100.8 at one point and nausea, preceded byusual short-term symptoms expected to go with the first COVID shot. She was seriously considering not getting the 2nd shot, wonder whether she can tolerate this or even worsened pain, not knowing the reason for this to have occurred. Therapeutic measures were taken as a result of the events which included treatment with opiates, hot/cold packs and Tylenol. The outcome of the events was unknown.  No follow-up attempts are possible. No further information was expected.
Rash on and around injection site, slightly raised and itchy. Took benadryl, went away in 7 days.
Given moderna booster too early. booster too early; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Given moderna booster too early. booster too early) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Given moderna booster too early. booster too early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Given moderna booster too early. booster too early) had resolved.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.   Reporter did not allow further contact
The pt came in for her first dose of moderna vaccine.  I accidentally gave her a booster dose (0.25ml).  I needed to give her the rest (another 0.25ml)  During that time she was a little light-headed and needed to rest for a while.  She did tell me that it was probably all in her head, but I kept checking in with her anyways.  I gave her the rest of her dose and everything was fine.  There were no rashes, hives, itching, SOB, or other issues.  Water was given and rest.
This spontaneous report as received from a registered pharmacist refers to a patient (male or female) of unknown age. The pharmacist reported that she administered a dose of ZOSTAVAX, subcutaneous (dose and lot number not reported) to a patient on an unspecified date in October 2014 (reported as last week) and administered ZOSTAVAX to his wife on 21-OCT-2014 (reported as yesterday). The reporter stated that either the husband or the wife called pharmacy on 22-OCT-2014, stating that one of them (she could not specify which patient it was as she did not speak to them) experienced a rash around the injection site (unknown date in October 2014). At the time of the report the outcome of rash around the injection site was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
On 10/28/19, patient stopped by pharmacy to inquire about a potential reaction to the Shingrix vaccine. She stated the right side of her scalp had small diffuse red bumps that itched and her skin around her right eye was visibly swollen and pink. Her eye appeared normal minus the swelling around it. She got her second Shingrix vaccine on 10/24 (Thursday), and on Friday she reported development of this itching and puffiness. She does not have any swelling of her face, tongue, throat, and no impeding of her breathing. She has taken 2 doses of Benadryl since the swelling started.  I advised her to continue Benadryl, and I also called her PCP to report these symptoms. Her PCP  advised the patient to go see an ophthalmologist due to eye involvement. I called patient advising her to see one as soon as possible and to update me/call with any questions. She stopped back in the store after visiting the eye doctor who reports her eye appears fine with no shingles involvement. She is following up with her PCP today  to check on the swelling and is going to take another Benadryl. I will follow up with her tomorrow, 10/29.
Headache, fatigue, body ache, cold sweats, large painful lump in neck
Pain and weakness LUE that started 3 hours after injection. It has persisted and she is unable to lift at work. No swelling or redness now.
After waiting 30 minutes after my injection, I left the hospital and was driving home when I began to feel my face tingling and swelling. This was close to 45 minutes after the injection. I was not sure what I was feeling, but had a similar reaction to the first Shingles shot so I was monitoring what I felt. I went to a walk in clinic about 2 hours after this feeling began. The swelling was on the right side of my face from a midline of my top lip to my right cheek. The doctor I saw told me to take Benadryl and gave me scripts for a Medrol Dosepak and epi pens. I took the Benadryl and got through the evening. I took Benadryl on Saturday and stopped it on Sunday. My face was still puffy, but no worse. Sunday night, my face felt worse and I took the Benadryl again. Monday morning, my face was slightly more swollen. I decided to start the Medrol Dosepak. My face was not feeling good and my throat felt like I was swallowing a boulder when I ate making me think  that my throat might be closing up a bit. I decided to use the epi pen, gave myself the shot, got the shakes from the shot, and went to the emergency room as instructed on the pen. My blood pressure was very high arriving at the hospital which was from the epi pen. I was watched at the hospital, the epi pen had done it's work, and I went home 4 1/2 hours later. I have had continued puffiness in my face. I have been given Famotidine to add to the Benadryl as I had with the shingles vaccine reaction. This Wednesday after getting the shot on the previous Friday.
No adverse events occurred. The patient was administered a Pfizer Pediatric Covid vaccine that was stored in the refrigerator for 12 days beyond what is approved by the manufactuer.
I had two: First I had swollen glands in the left armpit.  Second:  My Atrial Fibrillation became very active.  Although i have had 3 ablations, I had several episodes of Afib spanning the last few months since my injection of the Covid vaccine.
Between 10 and 15 minutes after receiving the vaccine, I felt like someone had thumped me in the chest over my left breast. I tried to breathe deeply, and I started to feel light headed. I didn't tell anyone, I was let go after 15 minutes. I sat in my car about 5 minutes and then decided I was worse. I was weak and shaky and light headed, my top lip was fuzzy feeling. I didn't feel like there was a blockage in my airway but I felt like I was having trouble getting my rib cage to expand so I could breathe. I went back in and was sat down, I was evaluated. Paramedics were called, by time they came I was lightheaded and I was foggy brained. I couldn't respond easily. My BP was 165/99 and my heart rate was 98. my O2 was fine but by that time I felt like I had to work hard to get a deep breath. I was feeling worse quickly. I was taken to the ER in a wheelchair. I was put in a bed and hooked me up to monitors. I was left alone for a while. When the dr came in he checked me out and listen to my lungs. I had a hard time getting my lungs to expand. Doctor ordered a blood sugar test and it was below 100. Chest x-ray, EKG and blood work. He told me later that everything was normal. I was there for 2 hours before I felt like I could go home. I didn't receive any medication. I was able to breathe easier by time I left the hospital. I was thinking more clearly as well. The next day I was still feeling shaky and weak. I went to my PCP on friday and I was feeling normal by then.
patient received a Pfizer COVID-19 vaccine instead of a Moderna COVID-19 vaccine to complete their second dose of their series.
Woke up with every bone in the body aching; Felt like she went through the "ringer."; Severe reaction to the vaccine; Could not hardly walk,; Ankles were so tender and painful; Severe headaches/"Worst headache I've ever had"; Body aches; Low grade fever of 99.9 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Woke up with every bone in the body aching), FEELING ABNORMAL (Felt like she went through the "ringer."), VACCINATION COMPLICATION (Severe reaction to the vaccine), GAIT DISTURBANCE (Could not hardly walk,) and ARTHRALGIA (Ankles were so tender and painful) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A, 026620A and 032120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BONE PAIN (Woke up with every bone in the body aching), FEELING ABNORMAL (Felt like she went through the "ringer."), VACCINATION COMPLICATION (Severe reaction to the vaccine), GAIT DISTURBANCE (Could not hardly walk,), ARTHRALGIA (Ankles were so tender and painful), HEADACHE (Severe headaches/"Worst headache I've ever had"), MYALGIA (Body aches) and PYREXIA (Low grade fever of 99.9 degrees Fahrenheit). At the time of the report, BONE PAIN (Woke up with every bone in the body aching), FEELING ABNORMAL (Felt like she went through the "ringer."), VACCINATION COMPLICATION (Severe reaction to the vaccine), GAIT DISTURBANCE (Could not hardly walk,), ARTHRALGIA (Ankles were so tender and painful), HEADACHE (Severe headaches/"Worst headache I've ever had"), MYALGIA (Body aches) and PYREXIA (Low grade fever of 99.9 degrees Fahrenheit) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.9 degrees fahrenheit (High) low grade fever of 99.9 degrees Fahrenheit.     Treatment medication include Tylenol to Advil. No concomitant medications were provided by the reporter. Patient felt like she went through the "ringer."
sore right arm; fever but 1/10 of Dose 2 reactions; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore right arm) and PYREXIA (fever but 1/10 of Dose 2 reactions) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore right arm) and PYREXIA (fever but 1/10 of Dose 2 reactions). On 10-Mar-2021, PAIN IN EXTREMITY (sore right arm) and PYREXIA (fever but 1/10 of Dose 2 reactions) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications provided by the reporter.     This case was linked to MOD-2021-162205 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up document received, contains: Updated patient demographics were updated dose and Updated Second dose information; Updated concomitant medication.
Right after my daughter received her injection she became dizzy, lethargic and then passed out/lost consciousness. When she came too she vomitted. The paramedics were called out of precaution. Vitals suggested an unsafe drop in blood pressure. Shocked her system. Strong adverse reaction.
01/03/2022 First PCR test was incoclusive.  The week before I had sinus infection and your husband tested positive the day before so you went to Urgent Care in town. That was a negative rapid test. I did another PCR test 5 days after he tested positive and was negative. Then I did another test 01/04/2022 PCR and that came inclonclusive Then on the 5th I did at home test that came back positive.  My symptoms were more severe than my husband and sons. I had sinus/chest congestion, GI diahhrea, fever that broke within 2 days. I did not need doctors care. I did do a tele-doc the week of the 17th because it turned into a sinus infection.  They prescribed Augmentin and it cleared up within week
Pain, swelling, hot to touch. Very low grade fever (98.4, normal ~97.3)
Patient received 3rd Moderna Covid booster vaccine at approximately 1723. At approximately 1735 patient reported to the counseling window of the pharmacy stating that she was having an anaphylactic reaction and needed an epinephrine pen administered. The patient verbalized that she was experiencing itching, had a swollen tongue, and difficulty breathing. Pharmacist had the patient walked to the immunization booth, instructed her to sit down, and suggested staff call 911. The patient instructed us not to do this, stating she did not want to go the Emergency room and just needed an epinephrine pen administered to her. While observing the patient her respirations were relaxed and regular at 16 breaths per minute. Use of accessory muscles for breathing was negative, and the patient was negative for audible wheezes. The patient was alert and oriented times 4 (person, place, situation, and time). Visual skin assessment of the patient was negative for the development of hives. The patient's tongue was visible, unswollen, and the patient's verbalizations were clear and audible. Based on these physical assessments it was the decision of the pharmacist not to administer Epinephrine at this time. Assistant store manager arrived at approximately 1745 and remained by the immunization booth to observe the patient. While the patient was under observation the patient's husband brought an epinephrine pen in from outside and administered it to the patient. Pharmacist  stayed with the patient in the immunization booth during the administration of the Epinephrine and continued to observe her. While the Epinephrine pen was administered pharmacist instructed the patient that they should consider going to the Emergency Room. The patient once again declined. Following administration of the Epinephrine assistant store manager and pharmacist observed the patient for approximately 10 minutes. The patient reported that she felt better after the 10 minutes and that the Epinephrine worked. I provided the patient with water and manager offered the patient an electric scooter to leave the store with. The patient politely declined and ambulated independently out of the store with her husband.   Pharmacist called the patient today at approximately 1130. A voicemail was left to follow up as the patient did not answer the phone. At approximately 1200 pharmacist called the patient's primary care physician  to inform the office of the perceived adverse event the previous evening. Pharmacist provided a brief verbalization of the events that occurred with a nurse representing Dr. The nurse stated they would update the physician regarding the events and follow up with the patient additionally.
Rash, fussiness and fever up to 104.1 Rectal. Treating with Tylenol for fever.
After receiving the Johnson & Johnson vaccination at approx 0855 the patient told the vaccinating nurse that he was "feeling dizzy." Pt then fainted and was lowered to the floor and positioned on his side; he was pale and diaphoretic initially but resolved before he was sat up. He then opened his eyes and stated that he was "feeling ok." Patient then confirmed that he has fainted twice before while receiving bloodwork or vaccines. Pt refused emergency services. Pt advised to call 911 or seek medical attention for any concerns after leaving facility. Pt verbalized understanding. Pt vital signs are as follows BP 136/58, R 18, P 84, O2 sats 98% on room air. Pt alert and denies any pain or discomfort. Denies any further concerns. Pt  left facility at 0900.
Initial information received on 25-Feb-2019 regarding an unsolicited valid serious case received from a physician. This case involves a 18 years old male patient who experienced vision blackening, passed out for about 45 seconds and awoke, weak and shaking and trembling, while he received vaccine MENACTRA and TRUMENBA. The patient's past medical history included Syncope related to heat and dehydration. Medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and TRUMENBA (lot number not reported) in the left arm. On an unknown date, the patient developed a serious passed out for about 45 seconds and awoke (loss of consciousness) and non-serious vision blackening (vision blurred) and weak (asthenia) and shaking and trembling (tremor) (Unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. Patient denied feeling lightheaded. He felt week, tried to get him to stand to get blood pressure, started shaking and trembling again, so laid him back down for about 20 or 30 minutes. This case was assessed as serious due to loss of consciousness. (Other relevant tests included No lab data.) Final diagnosis was shaking and trembling, weak, passed out for about 45 seconds and awoke and vision blackening. It was not reported if the patient received a corrective treatment. The patient was recovering from all the events. It was also reported some water(about 4 glasses) was given to patient. Was able to stand. Called mom about an hour they left and reported he was feeling better. List of document held by sender: none.; Sender's Comments: This case involves a 18 year old male patient who experienced loss of consciousness for 45 minutes, after vaccination with MENACTRA. He concomitantly received TRUMENBA. Time to onset is unknown. However the event is expected with the role of vaccine. The patient also had history of syncope with heat and dehydration. However, additional information regarding patient's condition at the time of vaccination, history of similar episode with past vaccinations and lab tests ruling out alternate etiologies are required for complete assessment of the case. Based on reported information the role of individual vaccine cannot be assessed.
Started to have cold symptoms, and possibly fever a couple days before receiving the COVID-19 vaccine on 3/26/2021.  He had worsening symptoms a couple days later was seen and discharged from an urgent care on 3/28, and was admitted to on 4/4. He developed severe cytokine storm and we theorize that receiving the vaccine which primes the immune system exacerbated his severe storm. He received Remdesivir and decadron. He was on high flow oxygen until 4/21, intubated on 4/21 and transferred to hospital. Unfortunately, he requires ECMO now.
patient received three pfizer vaccines as per system  4/19/2021 5/10/2021 7/31/2021 no reactions reported
This spontaneous report was received from a physician assistant, via a company representative, concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (strength, dose, route of administration, lot # and expiry date were unknown). Then, on an unknown date (reported as "9 months after the first dose), the patient was vaccinated with the second dose of GARDASIL (strength, dose, route of administration, lot # and expiry date were unknown). No adverse effects were reported and no product quality complaint was involved. Additional information is not expected, no permission for further contact was provided.
lump in left arm, redness over injection site, intensely itchy, swelling in arm (now improved), insomnia (resolved), achiness (resolved), fatigue (resolved)
I had some mild arm soreness. I was feeling a little hot around that time. The next morning when I woke up is when I felt extreme fatigue and severe arm soreness. The following day, mild soreness  but could do my normal activities.   My estimated date of delivery is July 19, 2021.
Received vaccine on Friday morning. Mild arm soreness that evening. On waking on Saturday morning, had moderate neck stiffness/soreness bilaterally. Took ibuprofen with some relief, but still had pain with neck movement. Neck soreness continues from ear to shoulder.
No additional AE; HCP called to report inadvertent administration of GARDASIL 9 to a 6-year-old male patient on 10/13/2023. Limited patient demographics provided. No additional AE/PQC.; This spontaneous report was received from a medical assistant and refers to a 6-year-old male patient. No information on patient's medical history current conditions and concomitant medications was provided.  On 13-OCT-2023 the patient was vaccinated at inappropriate age with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # X005044 and expiration date 02-JAN-2025 for prophylaxis (exact dose, dose number, route and site of administration were not provided) (product administered to patient of inappropriate age and no adverse event).
Mother came into health center to report child had seziure and was taken to the emergency room by ambulance for treatment and observation.
symptoms began with a fever in the early mornings hours, followed by coughing, hot/cold flashes, dizzyness, hoarseness of voice. Symptoms led me to leave work early, see my primary care doctor who told me to take flu medication and return to the hospital if my symptoms became worse.  I will return to my doctors office as soon as they are open again as my symptoms are not improving.