chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very painful; shingles; very ill; Rash appeared at the injection site; Hypersensitivity reaction; itching; redness; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction), PAIN (Very painful), HERPES ZOSTER (shingles), PRURITUS (itching) and ERYTHEMA (redness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Wasp sting (sting 15 times, whole body rash, itching lasted forever a week) in 2019, Asthma, Hay fever, Urticaria and Hives.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction), PRURITUS (itching), ERYTHEMA (redness) and INJECTION SITE RASH (Rash appeared at the injection site). On an unknown date, the patient experienced PAIN (Very painful), HERPES ZOSTER (shingles) and ILLNESS (very ill). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 06-Mar-2021 to 20-Mar-2021 at an unspecified dose and frequency. On 21-Mar-2021, HYPERSENSITIVITY (Hypersensitivity reaction), PRURITUS (itching), ERYTHEMA (redness) and INJECTION SITE RASH (Rash appeared at the injection site) had resolved. At the time of the report, PAIN (Very painful) outcome was unknown and HERPES ZOSTER (shingles) and ILLNESS (very ill) had resolved.            Treatment information was not provided. Concomitant product use was not provided.   This case was linked to MOD-2021-042758, MOD-2021-042758 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow-up report received on 29-Jul-2021 and added new event information.
p/vax pt devel chickenpox w/ a rash on face, shoulder, trunk & inside mouth w/a fever;pt had about 40 water filled blisters that took about 6 to 7 days to crust over;
I had a really bad headache and body aches and extreme fatigue and generally I took a home COVID-19 test because my husband was sick over the weekend and tested positive. I called my doctor and was prescribed Paxlovid that I started immediately. I have finished my course of the Paxlovid and feeling much better.
shivers, upset stomach, generally feeling punky 11 hours after the shot. Shot was at 9 am, 8 pm I was shivering for a good 1/2 hour under the covers, felt bad throughout the night, kind of upset stomach, just didn't feel good. Shoulder was sore but that was expected and didn't really bother me, just listing it in order to list everything. But shivering dang, didn't see that coming.
Vaccinee completed an initial series of 3 Engerix-B vax according to 0, 1, 6 months schedule & did not seroconvert p/receiving the 3rd dose; No tx was given;
Patient has pain in arm and unable to fully lift arm. PAC believes shot administered too high in arm thru the tendon and joint per patient.
Horribly, not sure how long it took for me to decided to go, because weeks before I was having, Bells palsy signs then thoat with white spots swelling, ears, infected, heart, hurting so bad, and lungs felt like my body was swelled so bad that I was getting where I was having a hard time moving hurt inside. First was given Indocin and shot of pencicillin, and Augmentin to take, was not getting better went back on  October 30, inflammation was so bad, and I was so sick and hurting I went back to the clinic, they then gave me preidsone an Zpak, the N.P. called me the next morning to check on me, I could not believe after taking the prescription he gave me I felt my body relieve. Felt like person came out of me.
Called back to closed POD site because patient had become pale, clammy and irregular pulse 9:00;  BP 128/82  P- 88 bounding; able to talk and explain she felt poorly, was sipping on water.  Sat with client for 30 mins, color clearly improved, BP 156/88 P 84  (BP reported as more normal)   Blood sugar check at beginning 151  and again about 9:25 as 151.   Was now feeling very tired and wanted to go home.   Had patient call her provider for guidance and a ride to home.  Provider requested that she take the rest of the week off. Patient went home to rest.  Thursday still very tired and headache,  today better but still has a headache
SORE ARM; UNEXPECTED BENEFICIAL THERAPEUTIC RESPONSE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included left shoulder injury- a "spider fracture" of the "proximal humerus", and muscular pain.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, 1 total, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced sore arm. On 16-MAR-2021, the subject experienced unexpected beneficial therapeutic response.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, and the outcome of unexpected beneficial therapeutic response was not reported. This report was non-serious.
For the first two doses I had a sore arm, which I expected; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Jul2021 08:45 (Lot number: FA1027) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "other medical history: IBS" (unspecified if ongoing), notes: other medical history: IBS; "Birth control" (unspecified if ongoing), notes: other medications in two weeks: Yes (Birth control). Concomitant medication(s) included: LAMOTRIGINE; FLUOXETINE. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "For the first two doses I had a sore arm, which I expected". No follow-up attempts are possible. No further information is expected.
Vaccine arm achey: day 2-3 days 'under the weather' feeling: day 4 neck, bilateral shoulder, bilateral chest -muscle tightness and pain. Could hardly lift arms up: day 5 vomiting AM, started to feel better noon time day 5.
administered DAPTACEL 5 days after the expiration date with no reported adverse event; Initial information received on 03-Mar-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 19-month-old male patient to whom administered DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] 5 days after the expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Prophylactic vaccination.  On 03-Mar-2023, the patient received dose 4 at 0.5ml total of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection (strength: standard) (lot number: C5816AA, expiry date: 26-Feb-2023) via intramuscular route in the left thigh for Immunization and on the same day to the patient administered daptacel 5 days after the expiration date with no reported adverse event (expired product administered).  It was reported, Caller requesting information on DAPTACEL. Wanting to know if the dose needs to be repeated.   Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) was not applicable.  At time of reporting, the outcome was Unknown.  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 the guidelines. 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.
After second dose, extreme chills and shivering that lasted 2.5 hrs. Temperature of 100.1F; After second dose, extreme chills and shivering that lasted 2.5 hrs. Temperature of 100.1F; This is a spontaneous report from a contactable Consumer (patient). This 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EL3248/expiration date: unknown), via unknown route of administration, on 08Jan2021 at 07:15 AM (at the age of 39 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history was unknown. The patient had known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS). The patient previously received the first dose of BNT162B2 (lot number: Eks5730/expiration date: unknown) on 18Dec2020 at 02:45 PM (at the age of 39 years old) as a single dose in the left arm via unknown route of administration for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Jan2021 at 09:30 PM, after the second dose, the patient experienced extreme chills and shivering that lasted 2.5 hrs with temperature of 100.1F. The patient took ibuprofen and temp went down. Then give or take a few hours, the temperature was rising again. The patient stated that she is " self-medicating currently and hope it does not get worse". Treatment was received for the events extreme chills and shivering included ibuprofen. The outcome of the events extreme chills and shivering was not recovered. The patient was not pregnant at the time of vaccination. Since the vaccination, the patient had not been tested for COVID-19.
Information has been received from a 34 year old female who "three weeks ago", on 08-JAN-2007 was vaccinated with Varivax. On 08-JAN-2007 the patient experienced nausea. The patient reported that she was nauseous for about two weeks. The patient did not seek medical attention. Subsequently, the patient recovered from nausea. There was no product quality complaint. No further information is available.
Rash with swelling and heat; Mildly sore arm; Tennis ball sized itchy rash on left arm at injection site; Tennis ball sized itchy rash on left arm at injection site; This is a spontaneous report received from a contactable consumer, the patient. A, non-pregnant female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number- EN6200); via an unspecified route of administration in left arm on 17Feb2021 at 11:00 AM as a single dose for Covid-19 immunisation and second dose via an unspecified route of administration in the left arm 10Mar2021 at 10:00 AM (Lot Number- EN6206) as a single dose. Medical history includes allergy to Sulfa, Penicillin, Latex, Lactose and other food sensitives. Concomitant medication includes Rosuvastatin (MANUFACTURER UNKNOWN), D3 (MANUFACTURER UNKNOWN), RepHresh Pro-B (MANUFACTURER UNKNOWN), 7 others for an unknown indication and unknown date. Patient had no symptoms associated with COVID-19 and not had a COVID-19 test.                  On 10Mar2021 the patient experienced tennis ball sized itchy rash on left arm at injection site and mildly sore arm. On 16Mar2021 at 12:30 AM, the patient experienced rash with some swelling and heat to it. No treatment was received for tennis ball sized itchy rash on left arm at injection site, mildly sore arm, rash. The clinical outcome of swelling had subsided but redness and itching were not recovered. The clinical outcome of tennis ball sized itchy rash on left arm at injection site, mildly sore arm was unknown.                  No follow-up attempts are needed and no further information is expected.
sore arm after getting the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm after getting the vaccine".  Additional information: Reporter husband took both doses of the Pfizer Covid19 vaccine and doesn't have a reaction aside from a little sore arm.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My son is very lightheaded and dizzy. Can?t get out of bed for 3 days. Nauseas and feels week. This comes in waves. Went to ER 2x and they can?t find anything causing it
Administered only the adjuvant; Administered only the adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th October 2022, the patient received Shingrix. On 4th October 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 04-Oct-2022 Reporter's comment: The pharmacist reported an adverse event for Shingrix with limited information.  The pharmacist stated that a patient was given just the adjuvant of the Shingrix and it was not reconstituted with the antigen.  The pharmacist had not furthered information in regard to the patient demographics, event, or vaccine itself.  The reporter did not consent to follow up. Additional Supportive Information: The patient was given just adjuvant of the Shingrix and it was not reconstituted with the antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
On 06/25/2021 a couple of minutes after my vaccination.   I started having reflex up and the muscles in my face started going numb, The muscles around my neck started getting really tight. my face started going numb, mostly on my right side. It was predominantly on the right side of my face. I gave myself Benadryl and Tylenol it helped within a few hours and relaxed my body. Within a few days later, I started having tremors. At the movies my legs and feet started moving, I started having involuntarily moving and shaking on my legs and feet. In the same week I started having issues on my left shoulder. Like it started shaking and grabbing., a weird sensation. I am having problems with my wrist and nerve pain down my arms. I went to the ER on 07/16/2021, I went to Hospital. I was having pain from my left arm down to my wrist, a little on the right, but mostly on my left where I had my vaccine. They  did  x-rays and evaluated me. They did a CT scan of my head. I was evaluated in the ER for over 24 hours.  3 weeks afterwards, I went to see my doctor, he gave me cortisone shots to calm down the spasms on my back. I still have spasms on my back, shoulders and wrist.   I am still being monitored.
Moderna Bivalent vaccine was given to pt on 2/6/23, 3 days after the vaccine had reached its 30 days fridge expiration. Contact was made with Moderna and internal studies indicate that lot/dose given is just as effective as if given prior to 30 days refrigeration.
After the Covid shot, I was instructed to wait in my car for 15 minutes. Approx. 12 min after the shot, I got a burning sensation in my left arm that continued across my upper body, throat and into my bladder and felt like I was going to urinate. It lasted approx. 2 min and subsided. Then I felt like I was going to pass out, so I drank some water and reclined in my seat to rest. I never passed out but waited another 15 minutes to proceed home. As I was driving home approx. 6 minutes since I left the clinic, the same feeling came over me. I immediately pulled off the highway into a near by parking lot until it subsided which was again approx. 2 minutes. I waited 10 minutes then proceeded to drive home which was only. Additional information for Item 18: which was only 5 minutes away. Once home, I laid down because I was tired and uneasy about what had just happened. I had no other symptoms and that feeling never returned.  I thought I should call my family doctor and let him know what happened. I called Dr. office and left a message for him about what happened. His nurse called me back and she had relayed the message to Dr., and said I should not receive the 2nd Covid shot since I had this reaction to the first shot. I have not had any other issues except a little soreness in the arm where the shot went in.
CT scan showed positive for stroke and aneurysm; CT scan showed positive for stroke and aneurysm; left side drooping in face; slurred speech; left arm clumsy; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer representative. This consumer reported the same events under the same suspect product for three patients. This is the first of three reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 26Feb2021 (Batch/Lot Number: EN6263) as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received 2nd Pfizer Covid vaccine on 26Feb2021. Approximately 48 hours later patient experienced slurred speech, left side drooping in face, unable to text on phone, left arm clumsy, went to ER (emergency room) Monday morning, CT (computed tomography) scan showed positive for stroke and aneurysm. Patient admitted and hospital gave heparin and daily aspirin. MRI (on Magnetic resonance imaging) Tuesday - unknown results. Symptoms subsided a few days later. The outcome of events was recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021606116 Same reporter and drug, similar events, different patients;US-PFIZER INC-2021606117 Same reporter and drug, similar events, different patients
Headache. Body aches. Hot/cold/freezing. Boiling eyeballs. Not able to sleep. Perfuse sweating. Dizzy. Nausea. Like bad flu symptoms, like the worst flu I have ever felt.
Symptoms: Intense physical and mental fatigue, body aches, body itchiness, rash Timeline: Physical and mental fatigue started on 01/06/21. Patient noticed large rash on right arm on 01/16/21.  Treatment: Amoxicillin and Clavulanate Potassium Tablets as well as Triamcinolone Acetonide Cream Informal Treatment: Sleep, rest, reduced work hours Outcome: Continuing to treat bacterial cellulitis, still experiencing some fatigue   Other outcome: Patient tested positive for strep on 1/17/21
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Fever-Medium, Additional Details: developed redness around site that spread to under armpit and breast. urgent care said bacterial infection and put on 10 days antibiotic
Initial report was received from a consumer, who was also the patient, on 17 April 2012. A 60-year-old female patient had received a dose one intramuscular injection in the right arm of ADACEL, sanofi pasteur Ltd., lot number C4136AA on 03 March 2012. Within three hours of the vaccine, the patient's right arm was swollen and red lesions appeared at the injection site. On 04 March 2012, the patient had itching in her rectum, vagina, palms and bottom of feet. The patient also had "locked jaw" and went to the emergency room (ER) where they gave her BENADRYL. Since then, the patient had a persistent cough and pain in her jaw near both ears. The patient also had trouble talking. The patient had no illness at the time of vaccination, no known allergies and no medical conditions. The patient's outcome was not recovered. Documents held by sender: None.
Constipation, nausea, generalized weakness, poor appetite, abdominal bloating, abdominal pain, midsternal pain, weight loss and generalized body aches, imbalance.
I had the vaccination on 05/23/2022. On 07/23/2022 I started to cough more with my allergies. I didn't feel bad. I took the at home test on 07/24/2022 and I was COVID-19 positive. My doctor prescribed me PAXLOVID. I am not having any residual affects.
Upper Respiratory Infection; This case was reported by a pharmacist via call center representative and described the occurrence of upper respiratory tract infection in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th June 2019, the patient received Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced upper respiratory tract infection. The patient was treated with prednisone. On an unknown date, the outcome of the upper respiratory tract infection was unknown.   It was unknown if the reporter considered the upper respiratory tract infection to be related to Shingrix.  Additional details were provided as follows: The patient developed an upper respiratory infection after they received the dose of Shingrix. They were being treated with Prednisone, at the time of reporting.  No additional information was provided
Headache, Diarrhea Nausea Vomiting, painfulsubclavian node, swollen left side. runny nose
Blood Pressure spiked to 213/114 - I feel fine, but this is as high a reading as I have ever had. Recent range between 151/98 and 184/118. I am not taking medication for blood pressure. My doctor and I are trying dient and exercise, though obviously I do have a monitor.