chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 15Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "epilepsy" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "sinusitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovered" (01Oct2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Positive, notes: Treatment of COVID-19; (01Oct2023) Negative, notes: Tested negative seven days later, on 01Oct; (07Oct2023) Positive, notes: Tested positive from Covid home test on 07Oct. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 24Sep2023 to 28Sep2023. Clinical course: Initial symptoms were fever, body ache, burning sensation in chest, and fatigue. Symptoms improved after treatment.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300320813 same patient, different drug/event;
Itchy hands and feet. Red dots on hands and feet. Feels almost like blisters on toes. Hands feels like recovering from being ?burned? like on a stove.  - minor red spots, not fully covered - about 6 on my hands - about 4 on my feet   - unsure if vaccine caused this but wanted to report anyways  - happened  10/11 days after vaccine
This case was reported by a other health professional via call center representative and described the occurrence of vertigo in a 12-year-female patient who received MENVEO (batch number M16096, expiry date 31st March 2018). On 3rd May 2017, the patient received MENVEO (intramuscular). On 7th May 2017, 4 days after receiving MENVEO, the patient experienced vertigo. In May 2017, the patient experienced headache. On an unknown date, the outcome of the vertigo and headache were unknown. The reporter considered the vertigo to be possibility related to MENVEO. It was unknown if the reporter considered the headache to be related to MENVEO. Additional details were provided as follows: At 1:00 hours, the patient received a dose of MENVEO on left deltoid. In May 2017, less than a month, after receiving MENVEO, the patient experienced headaches.
Headache 8/17 -> 8/19 worsened; 8/20 -> 8/22 subsided but still present. Rash on upper (R) arm spreading, warm to the touch, swollen.
Headache, nausea, vomiting after 3rd dose of oral typhoid, near syncope 2 days after 4th dose.
Vaccination site rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Vaccination site rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    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 VACCINATION SITE RASH (Vaccination site rash). At the time of the report, VACCINATION SITE RASH (Vaccination site rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medication was not provided. Treatment information not provided   Reporter did not allow further contact
Patient developed full body hives day after receipt of 3rd booster shot.; This is a spontaneous report from a contactable reporter (physician).   A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 11Feb2022 (Lot number: unknown) at the age of 34 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hemorrhoids" (unspecified if ongoing). There were no concomitant medications (it was reported that the patient denied). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: Unknown, Route of administration: Unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: Unknown, Route of administration: Unspecified), for COVID-19 immunisation.  The following information was reported: URTICARIA (non-serious) with onset 12Feb2022, outcome "recovering", described as "Patient developed full body hives day after receipt of 3rd booster shot". Therapeutic measures were taken as a result of urticaria. The event "Patient developed full body hives day after receipt of 3rd booster shot." was evaluated at the physician office visit.   Additional information: The patient's known allergies were reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. It was reported that the patient denied any other new medications, foods, soaps nor other vaccines. The patient received Prednisone and BENADRYL as treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
After receiving the pneumovax23, it was a very sharp pain. The pain got worse. Came back saw her doctor, had xrays which showed a lot of inflammation. Had a lot of pain especially at night. Was given steroids for 2 weeks. The steroids decreased the pain but had a lot of side effects. Can not sleep on right side.
low grade fever, rigors and chills, headaches, muscle weakness in left arm (site of injection), pain in small  joints (fingers, toes), profound fatigue, unable to concentrate, sore throat, dry cough
On July 4, I was feeling run down and had a sore throat. I had a hoarse voice but I thought it was because I just had a baby. It felt like my immune system was dropping and I was getting sick. The next day, I had cold symptoms like a cough, congestion, headache, very thick mucus. We took the COVID-19 tests and it was positive. It did get worse and was basically like a severe cold. Upper respiratory tract. I had a mild loss of taste and smell. It was basically like a pretty bad head cold with mucus and I've never had mucus that thick before. My voice was gone too. The only thing I could really do was take Mucinex because of my breast feeding. I couldn't take cough medicine or anything so I couldn?t do anything for it. I tested again on July 10 and it was still positive. I?m still having symptoms now, so I haven?t recovered. But I am getting better.  I did have gestational diabetes during this pregnancy which I did not have in the past. Birth weight of baby was 10 lbs. 1 oz.
Pt vaccinated with DTP developed a temp of 104 on 21SEP which lasted 3 days. Seen in ER where blood/urine test run told by ER possible rx to DTP vaccine. Developed a rash on 23SEP which resolved in 24 hrs. Now asymptomatic.
SHINGLES-lesions developed on the left side of my forehead w/ nerve pain to my head and ear. Itchiness to my scalp with left top pf head very warm to touch. Flush feeling to entire face. Woke up with this the Saturday morning after the injection and lacey rash over entire body w/ rash gone Sunday morning with lesions to my left forehead still visible. Lesions began to weep on Monday morning.
Information has been received from a RN concerning a 65 yr old male with diabetes, heart disease and reaction to tuberculin test who on 29Nov05 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (0.5ml) (lot650648/0957P), IM in the deltoid. On 30Nov05 the pt experienced a severe local reaction with redness, severe pain and massive swelling from the elbow to shoulder in arm where pneumococcal 23v polysaccharide vaccine was given. At the time of the report, the pt was considered to be not recovered. Unspecified medical attention was sought. The reporter would like a lot investigation for lot 650648/0967P. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. In addition, a review of the quality control system revealed that there were no open quarantines registered against this lot/fill. It was also reported that another pt had a similar reaction (WAES0512USA00204). Additional information has been requested.
I received my second Pfizer booster for COVID-19 on 4/1/2022. On 7/1/2022, I underwent double bypass surgery on my heart. I stayed in the hospital until about 7/7/2022. On that day, I was transferred to a skilled nursing facility. Then about a week later, I was transferred to a rehabilitation center on 7/14/2022. When I arrived at the rehab center, I was tested for COVID-19, and the result was positive. I was then isolated and retested on the morning of 7/15/2022, and I again got a positive result. Thankfully, I remained asymptomatic during the whole time I was infected with COVID-19. I was isolated in the rehab center for 5 days and closely monitored. Since I was asymptomatic, I was not given any treatment for the COVID-19. I ended up staying at the rehab center until about 7/27/2022; during my stay at the facility, I underwent occupational therapy and physical therapy, which aided in my recovery from the bypass.
My face broke out in hives; My face broke out in hives/were itchy and hot/ itching; My face broke out in hives/were itchy and hot; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247; expiry date: unknown) via an unspecified route of administration in the left arm, on 25Jan2021 at 09:00, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 04Jan2021 for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On Friday, 30Jan2021 at 11:00, the patient's face broke out in hives. They were itchy and hot, and it was sudden, over the course of 15 to 30 minutes after the itching, they appeared. The patient took cetirizine hydrochloride before bed and applied cooling balm. The hives were gone this morning. The events were considered non-serious. Outcome of the events was recovered. The patient has not been tested for COVID-19 since vaccination.
A nurse reported that a pt received an injection of Flu Shield '00-'01 on 12/4/00 and the next day, the pt developed an injection site reaction characterized by redness, soreness, swelling and itching. The reaction was managed with an unspecified antibiotic.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. During 2011, the patient was inoculated (by an unspecified person) with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) at a pharmacy for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, she was treated (by an unspecified healthcare professional) at a healthcare facility for a blistering vesicular outbreak which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Fever Headache Vomiting Nausea Fatigue Soreness of injection site
Excessive vomiting, chills, fever. Achey and painful, face, sinuses, jaw.
p/vax pt cranky, wouldn't smile until 12hr p/vax;next AM while mom was holding baby eyes rolled back, began shaking x1min then slept p/event;mom brought to office nl exam;will hold pertussis in vaccine;
Rash on chest , neck and  face. 30  min after injection, next day  lymphadenopathy.
This spontaneous report was received from a Licensed Practical Nurse concerning to a female patient of unknown age. A nurse told that the patient was administered ZOSTAVAX (dose, route and lot not reported) and an unspecified pertussis vaccine (unspecified) (manufacturer unspecified) at the same arm. No concomitant medications were reported. The patient developed itching at the injection sites. The outcome of the event was unknown. The relatedness for the event was unknown for ZOSTAVAX. Additional information is not expected.
sore throat; congested; tired; not feeling great; chills; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (not feeling great), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (congested), CHILLS (chills) and FATIGUE (tired) 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 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced CHILLS (chills). On 19-Apr-2021, the patient experienced MALAISE (not feeling great). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (congested) and FATIGUE (tired). At the time of the report, MALAISE (not feeling great), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (congested), CHILLS (chills) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment medications included cold and flu medication.
5 minutes after administration of the patients 2nd Pfizer Covid 19 vaccine the patient was in and out of consciousness, non-verbal and tremors.911 was called and the patient was transported to a medical treatment facility.
admitted to the MICU from the Emergency Department at an outside hospital for hyponatremia (Na 108) in the setting of diarrhea for the past week, COVID positive as of 11/23 and with pulmonary infiltrates although without respiratory symptoms.
Patient had redness and hives the size of (2) 25 cent pieces at the injection site within 5 minutes of receiving the injection. Patient was given BENADRYL (qtsp) and observed in our office for 30 minutes without any difficulties.
States was hospitalized for was very sick after getting a flu shot in the mid 70's had not gotten 1 since writer suggested he discuss with his PMD. He declined & stated he just wanted to get one & that he thought it would be safe. 8 hours after receiving the vaccine he states his sinuses became full, he felt feverish & throat closed up about 1/2 way." Took antihistamine 5 hours later he was getting better. 12 hours later symptoms were totally resolved. States considered ER but TYLENOL sinus med started to open up sinuses & airway.
pt recv vax & devel an inj site rxn;the inj site had a red wheal w/a white dot in the center;
Arm was sore and hard to move. 2 weeks later, with some pain and numbness.
Myalgia, Arthralgia, facial swellilng, fever, feels "flu-like" fatigue Narrative:
Fever, chills, achiness, loss of appetite, headache, cough, head congestion, insomnia all lasting 36 hours. Cough and head congestion persists into the second day.
loss of consciousness; tunnel vision; convulsing with arm and head; She felt like she lost control/ Loss of control; arm went numb; tingling from shoulder to wrist, across chest and head; felt nauseous; felt dizzy; headache; felt foggy; seeing bright lights; shaking, patient reported it to them as "seizure like"; felt tired; This case was reported by a other health professional via sales rep and described the occurrence of loss of consciousness in a 19-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA94AA, expiry date 28th February 2022) for prophylaxis.   Previously administered products included Bexsero (received 1st dose on unknown date).   On 22nd July 2020, the patient received the 2nd dose of Bexsero .5 ml. On 22nd July 2020, less than a day after receiving Bexsero, the patient experienced loss of consciousness (serious criteria GSK medically significant), tunnel vision (serious criteria GSK medically significant), convulsion (serious criteria GSK medically significant), coordination abnormal, numbness of upper extremities, tingling, nausea, dizziness, headache, foggy feeling in head, abnormal vision, tremor and tiredness. On an unknown date, the outcome of the loss of consciousness, tunnel vision, convulsion, coordination abnormal, numbness of upper extremities, tingling, nausea, dizziness, headache, foggy feeling in head, abnormal vision, tremor and tiredness were unknown.   It was unknown if the reporter considered the loss of consciousness, tunnel vision, convulsion, coordination abnormal, numbness of upper extremities, tingling, nausea, dizziness, headache, foggy feeling in head, abnormal vision, tremor and tiredness to be related to Bexsero.  Additional details were reported as follows: The patient got her second dose of Bexsero, she drove home, and then 2 hours post visit her arm went numb, tingling from shoulder to wrist, across chest and head. She developed tunnel vision, loss of consciousness, felt nauseous, dizzy, had a headache, felt foggy, was seeing bright lights, shaking, patient reported it to them as seizure like, she felt like she lost control. Her friend reported her convulsing with arm and head. The patient felt very tired afterwards. He brought her in later that night and she felt better.
Rashes on the left lateral aspect of the trunk and left leg approximately 3 weeks after 2nd dose of vaccination. Rashes have slightly faded but are persistent  Episode of left lower extremity thrombophlebitis in June 2021
I received FLUZONE HD PF 15-16 Inj on September 28, 2015. It was given in the left deltoid. It was administered correctly. Within an hour aching began. Swelling and redness was apparent within 2 hours. Aching, swelling, and redness persisted for 2 days. Muscle soreness with pain on movement involving the deltoid muscle lasted until the end of October, 2015. The pain was initially 3 on a scale of 1 to 10. I have not had this extended period of pain previously with this vaccine. Beginning November 22, 2015, I experienced onset of acute diverticulitis. I was seen by my primary care physician, 11-24-2015, and treated with a combination of levofloxacin and metronidazole. On November 25, 2015, the injection site of the influenza immunization once again became painful with slight swelling and no redness. The patient was again 3 on a scale of 1 to 10. The left deltoid pain is still present today, but now has decreased to 1 or 2 on the scale of 1 to 10. I have received the high dose influenza vaccine previously with only minimal soreness for 1 day. I believe that the recurrence coinciding with an acute infection is unusual, and could be connected to this particular vaccine type or lot. I am enclosing records of these immunizations and a summary of my medical history.
JYNNEOS vaccine given at 1pm on 8/30/2022. Started having intense liquid diarrhea 3 hours after the vaccine (different than previous food/IBS related diarrhea I've had in the past). Continued to have diarrhea 4 additional times for the next 12 hours even after taking pepto and immodium. Diarrhea subsided the next day after additional immodium was taken.  In addition, the injection site became itchy, red, and swollen on 8/31/2022 and became puffy even after taking an antihistamine. It's currently 9/1/2022 and injection site is inflamed, red, swollen, and itchy. Using wrapped ice pack and anti-itch cream.
Severe headaches and mild fatigue, turned into body cramps all over. Joint pain is keeping me from being able to work and take care of my children and house responsibilities. I am hurting and very angry, as I only took the vaccine for upcoming travel (in Oct. 2021) and now I'm in very bad shape.
Urticarial rash to bilateral upper extremities and trunk. Treated with 50mg of Benadryl IM and Medrol Dose pack.
Dizziness, weakness, injection site pain, tiredness, headache, chills, joint pain, nausea.
Breakthrough case admission after 2 vaccines: Pfizer 3/11/21 Lot# EN6207; Pfizer 4/1/21 Lot# ER8732.
Muscle aches and pain, including headache, lightheadedness, swelling at injection site, weakness, loss of appetite, and brief loss of awareness.
No additional AE/PQC; HCP called to report inadvertent administration of PROQUAD to a patient after a temperature excursion that occurred on 10/12/2023. Limited patient demographics provided. No additional AE/PQC.         ?    Names of vaccines involved (including lot/e; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On an unknown date in October 2023, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (rHA) injection (lot#: X007087, expiration date: 04-SEP-2024; strength, dose, and route of administration were not reported) for prophylaxis. The vaccine administered inadvertently experienced a temperature excursion on 12-OCT-2023 at -12.4C for 18 minutes without any other previous temperature excursion (product storage error). No additional adverse events (AE) were reported (no adverse event).