chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a Registered Nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients' were vaccinated with an improperly stored dose of PROQUAD (anatomical route of vaccination, lot number and expiration date were not provided). The patients' concomitant medications were not reported. The registered nurse reported, that PROQUAD was stored under a temperature of -14.4 C for 54 minutes. Data logger was involved. The vaccine was not exposed to a previous temperature excursion. Additionally, no adverse events was reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Joint pain in left arm 1 hour after injection. Became slightly light headed. Ate and had large coffee and it resolved. After almost a day, a 2 inch circle around injection site became painful, red, swollen/hard & very warm. Took 400 mg Motrin every 6 hrs & 25 mg Benadryl every 12 hrs. Sx lasted 48 hours before improving slowly. After 4 days, lump & redness is mostly resolved.
Knee swelling; Hand swelling/ swelling looks like half a baseball on hand; Swelling/ fingers get larger and toes get larger like sausages; Painful feet/ feet had been feeling like marbles on bottom; Pain/ pain occurs after extended periods of use/ random pain; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Knee swelling), PERIPHERAL SWELLING (Hand swelling/ swelling looks like half a baseball on hand), PAIN (Pain/ pain occurs after extended periods of use/ random pain), SWELLING (Swelling/ fingers get larger and toes get larger like sausages) and PAIN IN EXTREMITY (Painful feet/ feet had been feeling like marbles on bottom) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Oct-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PAIN (Pain/ pain occurs after extended periods of use/ random pain) and PAIN IN EXTREMITY (Painful feet/ feet had been feeling like marbles on bottom). On 17-Dec-2021, the patient experienced JOINT SWELLING (Knee swelling), PERIPHERAL SWELLING (Hand swelling/ swelling looks like half a baseball on hand) and SWELLING (Swelling/ fingers get larger and toes get larger like sausages). At the time of the report, JOINT SWELLING (Knee swelling) and SWELLING (Swelling/ fingers get larger and toes get larger like sausages) had not resolved and PERIPHERAL SWELLING (Hand swelling/ swelling looks like half a baseball on hand), PAIN (Pain/ pain occurs after extended periods of use/ random pain) and PAIN IN EXTREMITY (Painful feet/ feet had been feeling like marbles on bottom) outcome was unknown.      Concomitant medication was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No information regarding treatment medication was provided.
Approximately seven hours after receiving my vaccine, I began to experience a slight headache and slight nausea that turned into a migraine.  I then rested, attempted to sleep, and used a cold wash cloth to alleviate symptomatic pain. The migraine eventually went away after about 14 hours.
range of motion restricted left arm; swelling size of softball, hot; rash on left arm; lymph node swelling left arm; knot on left arm; fatigue; headache; redness left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE MASS (knot on left arm), HYPOKINESIA (range of motion restricted left arm), FATIGUE (fatigue), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (redness left arm) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE MASS (knot on left arm), FATIGUE (fatigue), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (redness left arm). On 07-Apr-2021, the patient experienced VACCINATION SITE SWELLING (swelling size of softball, hot), VACCINATION SITE RASH (rash on left arm) and LYMPHADENOPATHY (lymph node swelling left arm). On 08-Apr-2021, the patient experienced HYPOKINESIA (range of motion restricted left arm). At the time of the report, VACCINATION SITE MASS (knot on left arm), HYPOKINESIA (range of motion restricted left arm), FATIGUE (fatigue), HEADACHE (headache), VACCINATION SITE ERYTHEMA (redness left arm), VACCINATION SITE SWELLING (swelling size of softball, hot), VACCINATION SITE RASH (rash on left arm) and LYMPHADENOPATHY (lymph node swelling left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concurrent medication reported. Treatment included antibiotic and steroid
Patient only received the Hib portion of the Pentacel vaccine reconstituted with a sterile diluent/No AE; Initial information was received on 14-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a four months old female patient who on 11-Sep-2020 received 0.5 mL second dose of only hib portion of the vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ217ACA and expiry date 25-Apr-2021) via intramuscular route in the left thigh for prophylactic vaccination which was reconstituted with a sterile diluent (product preparation issue)  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Immunisation.  It was an actual medication error case due to inappropriate reconstitution technique (latency: on same day).  It was unknown whether the patient had any adverse reactions.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient presented to pharmacy on 6/9/2014 with erythematous wheal, 3 cm induration, warm to touch, itchy and slightly tender. Denies shortness of breath, throat tightening, dizziness, spread of reaction. Patient advised to try OTC Benadryl for 1-2 days, if not improved or condition worsened to see PCP or visit local ED. Patient seen in MD office this afternoon, prescriber recommended oral Benadryl and monitoring for improvement.
I believe the shot was administered too high on the arm, close to shoulder and it affected me strongly. I could not raise my arm or undress and was in pain. I even had a quarter size black and blue mark. My arm was swollen twice the size. I've had shots before and was never affected. My doctor recommended applying ice only.
EYES SENSITIVE TO LIGHT, HEADACHE, WEAKNESS IN EXTREMITIES, ACHY JOINTS, RASH OR ITCHY ON  ARMS, SHORTNESS OF BREATH.   LOW GRADE TEMPERATURE.  FATIGUE.  TOOK TYLENOL .
Severe headache; fever; chills; fatigue; This is a spontaneous report from a contactable nurse, the patient. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly on 23Dec2020 at 18:15 (at the age of 40-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included multiple sclerosis and hypothyroidism. The patient had no known allergies. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included duloxetine hydrochloride (CYMBALTA), gabapentin, cefixime (FLEXERIL), tolterodine, levothyroxine, liothyronine; all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient experienced severe headache, fever, chills, and fatigue on 23Dec2020 at 18:30. No treatment was received for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the severe headache, fever, chills, and fatigue were recovering.   Information on the lot/batch number has been requested.
Near syncope and vomiting.  Very pale coloring.  Unable to sit up for more than a minute
Skin rashes (itchy) and breathing shallow and arm sore. I got prednisone, benadryl, tylenol, clotimazole/hydrocortisone cream, albuterol breathing treatments. Getting better after day 3.
Patient vaccinated with 2nd dose of Pfizer.  6 days later patient began having dizziness, blurred vision, headache, neck pain, ptosis, and difficulty eating, swallowing and speaking.  CT head 1/23 negative.  CTA head/neck 1/23 negative.  MRI 2/5 negative. Lumbar puncture  found to contain protein in CSF.  Was originally worked up for AIDP and started on IVIG.  After 3 infusions, no improvement.  Patient then on 2/5 began worsening and was unable to swallow at all and unable to protect his airway.  He was intubated in Neuro Critical Care Unit.  Now being worked up for Guillian Barre Syndrome due to increased bulbar weakness.  4 more doses of IVIG will be infused.
Red patch of bumps high on left leg. Mom considered bug bites, but twin sister has same rash. Had shots 6 days ago.
Patient developed warmth, swelling and redness to injection site. Evaluated on 8/8/2014 and administered clindamycin HCl 300mg TID x 7 days.
Headache, Myalgia, fatigue, chills, swollen glands and arm pain Narrative:
clinical dx of mumps by MD; swelling of parotid gland on lt side w/onset on 4NOV93; still swollen on 22NOV93; also some earache;
not feeling right; soreness on her arm; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling right), PAIN IN EXTREMITY (soreness on her arm) and FATIGUE (tiredness) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (not feeling right), PAIN IN EXTREMITY (soreness on her arm) and FATIGUE (tiredness). At the time of the report, MALAISE (not feeling right), PAIN IN EXTREMITY (soreness on her arm) and FATIGUE (tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter No treatment medications provided by the reporter. .  Patient stated that after vaccination she experienced for 4-5 days not feeling right, soreness on her arm and tiredness   Reporter did not allow further contact
This spontaneous report was received from a certified medical assistant referring to unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # L049532, expiration date on 08-DEC-2017 (route, dose and anatomical location were not reported). Concomitant therapies were not provided. The vaccines were stored in a temperature of 10F for 84 hours; 18.2 F for 30 minutes and 7 F for 1 hour. Digital data logger was involved. No adverse events were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt states he has been experiencing a daily headache "severe, sharp pain starting from the neck, going up the head and wrapping around to the front of the head."  He is also experiencing dizziness, vertigo, and brain fog.  The vertigo occurs while seated as well as when up.  Of note, he did have COVID on 2/4/2021.  This was treated at home and was tolerated moderately well.   He received his FIRST Moderna vaccine on: 2/18/2021 and experienced severe sickness (nausea); fever, headaches, chills, sweating, and painful extremities, but this was reported to (vaccine provider) as was told these were normal side effects.
This spontaneous report as received from a licensed practical nurse practitioner refers to a 60 year old male patient with asthma and no known drug reactions or allergies. On 10-DEC-2014, the patient was vaccinated with a dose of ZOSTAVAX, lot # K012924 and expiry date on 29-NOV-2016, (route and dose were not provided). The patient has no any concomitant medications. It was reported that patient called to reporter's office on 12-JAN-2015 complaining of numbness in his face. The patient was sent to the emergency department of an unspecified hospital due to the symptoms. The patient was diagnosed with Bell's Palsy and was prescribed prednisone and acyclovir as treatment, then, patient was released from emergency room at the same date. Patient was seen in reporter's office on 29-JAN-2015 for follow up, and it was reported that his symptoms have improved substantially since starting treatment with prednisone and acyclovir but over the previous two days he began to experience tingling and heaviness on the right side of his face. At the time of the report, the patient was recovering from Bell's Palsy. The relatedness between the event and suspect therapy was not provided. Additional information has been requested.
BREAKTHROUGH COVID INFECTION.  RECEIVED REGEN BY IM TODAY.  HAS MILD-MODERATE SX.
Fever, chills, body ache (chest area), irritated throat, sinus congestion, and breathing difficulties
6/3 I couldn't swallow, throat felt on fire and I had a bad headache that continued on to 6/16. 6/4 At home Covid test is negative. This lasted for about 3 days, I gradually gained a cough and a fever. 6/7 I went to urgent care, where fever was 102.1. Urgent care did Strep throat, negative. Meloxicam and amoxicillin prescribed. 6/11 two at home Covid tests were positive.
very mild neuralgia around the rash on her temple, sensitivity around her scalp; very mild neuralgia around the rash on her temple, sensitivity around her scalp; Red and itchy rash; red and itchy rash; it could be shingles; bruise that seems to be a rash; Peeling; This is a spontaneous report from a contactable consumer or other non hcp. A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: 6/2015; Expiration Date: Jun2021), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 11:55 (at the age of 67-years old) as dose 1, single for COVID-19 immunisation. Patient medical history was reported as none. The patient concomitant medications was reported as none. No adverse events prior vaccination. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient was calling about the COVID 19 vaccine she received her dose on 19Mar2021 and about a week later or so she thinks she kind of bumped her head on a low ceiling and then she got this a bump and still has not healed which is kind of odd. Since having the vaccine, caller was wondering if getting a small bruise could develop or cause a reaction to a bruise because it is like a rash and it is peeling and healing up. Caller stated she is concerned about if this is any way a reaction to the vaccination. Patient stated she thinks she bumped her head but she does not keep track of something like that. Then, she gets this rash she clarifies its a rash more so than a bump. Bruise that seems to be a rash is like a normal bump on the head the way it's preceded. Patient stated it started about a week after injection which the vaccine was on 19Mar2021 so around 26Mar2021 or so but she did not pay attention since she thought she bumped her head. Caller stated it is going away and it seems to be healing, but it's not all gone. It seems like it is taking an inordinate amount of time to go away. Also, there is a very mild neuralgia around that spot, like sensitivity. She clarifies it's on her temple, so the sensitivity is around her scalp thinks this started a week ago since she noticed peeling and it is getting better but naturally she looked more closely and felt this kind of sensitivity around that area and still has it, but it is diminishing and improving. Also reported the red and itchy rash. The peeling started about a week ago. There's still a little bit of peeling and thinks it is getting better since it seems to be healing. Patient asked nurse if she should be concerned about a worse reaction when she went for 2nd dose. Nurse said it could be shingles, which patient believed it is (mild case). It travelled (under hair) towards the back of scalp. The adverse event does not resulted in Emergency Room or Physician Office. The outcome of the events contusion and skin exfoliation was recovering and for all other events unknown.  No follow-up attempts are possible. No further information is expected
Fever (highest noted 100.7) and generally feeling tired. Fever was gone by the evening and I was fine the next day.
Death Narrative: Patient received his first COVID-19 vaccination 2/27/2021 and received his second COVID-19 vaccination 03/27/2021. Patient had not been tested for COVID per chart review and had no contraindications to receiving the vaccine. Patient did not experience any adverse events to the COVID-19 vaccine between time of vaccination and the time of death 12 days later. Of note, patient was receiving home hospice at the time of his death (04/08/2021) for his advanced acute myeloid leukemia.
p/vax pt felt a burning sensation later that noc noticed a reddened area on upper arm that was sore & warm to touch;
I had fever and chills 12 hours after the vaccine was administered. I felt fine after 36 hours of the vaccine's administration. But on May 25-26, I started developing a tightness in my chest and had difficulty breathing. My chest hurt and hurt even more when I took deep breaths. The breathign issue came with a pain in my upper back for which I once took ibuprofen and another time I took half a painkiller [Diclogem]. I felt extremely tired/fatigued and weak, had irregular sleeping patterns, felt dizziness and lightheadedness during the day and this continued until Saturday, May 29. Thereafter, the dizziness during the day subsided but I still felt too tired to do anything. Over the long weekend of May 29-31, I have started developing painful acne on my buttocks. The left buttock inparticular has multiple painful acne. I still have trouble breathing and my chest still hurts so much that I cannot wear a bra for more than a few hours a day as it feels very constrictive. The breathing issue and chest pain really worries me because I don't have the stamina to do errands or go outside for more than on hour or two on any single day. Today, June 2,  is the 10th day since I got my vaccine.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 49-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 at 04:00 as dose 1, single (Lot number: EN6208), in right arm, on 08Apr2021 at 04:00 as dose 2, single (Lot number: EP7533), in left arm and on 08Oct2021 at 03:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "food to shrimp" (unspecified if ongoing), notes: known allergies: food to shrimp. There were no concomitant medications. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 31May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: I resulted positive of COVID in a rapid test; (unspecified date) Positive, notes: I decided to do rapid tested and results positive again; (27May2022) Negative, notes: after 9 days of isolation I have two negative rapid test 27May & 28May; (28May2022) Negative, notes: after 9 days of isolation I have two negative rapid test 27May & 28May. Therapeutic measures were taken as a result of suspected covid-19, drug ineffective.  Clinical course: Adverse event: Rebound COVID.I resulted positive of COVID in a rapid test, I consulted with my Dr and she recommended to took 5 days treatment Paxlovid, starting may 19/22 then after 9 days of isolation I have two negative rapid test 27May & 28May, however I started with minor symptoms after 5 days, minor cold symptoms during 1 day, I decided to do rapid tested and results positive again so was necessary begin with isolation for 7 days more. No additional problems it was total asymptotic rest of time. The patient did not received any other medications prior to 2 weeks. No other medical history.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Shingles hit me, I had one shot/ horrible after effects; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-JAN-2023 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient reported that shingles were wicked, one of the worst thing to hit him/her and the patient had one shot, didn't quite make it to two doses. The patient was still in process of recovery with the horrible after effects. No follow up attempts possible as no contact information available.