chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The day she got her shot the had lots of pain in the site of the shot, and got a red rash that same afternoon. This past week it looks like a bruise on the left side of her neck all the way across to the right side. It also is going down the back of her neck looks dark in color.
Shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer unknown), administration date: 2021, for Covid-19 Immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset Dec2021, outcome "recovering", described as "Shingles". Therapeutic measures were taken as a result of herpes zoster.  Additional information: Caller received her second dose of the Pfizer covid vaccine about 6 months ago and was a due for her booster tomorrow. Caller developed shingles 2 weeks ago and was treated with Valtrex; states the rash has pretty much dried up. Asking if there were any contraindications to getting her booster tomorrow while recovering from shingles. Caller stated that her doctor wasn't sure, because Shingles is a virus, and her doctor was unsure how that would interact with a Covid vaccine  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Reported receipt of FLUSHIELD Lot #4998274 in 1999 to her left deltoid. The next day she noted fine pruritic red spots to bilateral cheeks progressing into and about her ears with a sense of throat itching and tightness. She denied shortness of breath, chest pain, difficulty swallowing, facial/oral swelling or rash elsewhere else. She went to the ER at work where she reports being given IV medication and released on a 7 day taper prednisone and BENADRYL. Her throat tightness resolved but the rash persisted another 2 days before resolving w/o reoccurrence. She has not received any vaccinations since. She reported the above reaction was similar to past/current food reactions which she describes as nasal/oral and skin itching, tight throat w/ sensation of closing off, runny nose, congestion, and redness to face with eating fresh apples, cherries, Jack fruit, and pomegranates. She has no problems eating eggs or cooked apples (apple sauce). She develops palmar dermatitis with carrots. She has had a similar fine red pruritic face/neck/ears rash December 2008 after using new make-up (where make-up was applied). She self-treated with CLARINEX/BENADRYL and removed/stop use of make-up with resolution w/in 3 days. She also reported total body pruritic hive-like rash within 24 hours after first dose of Hep B vaccine in summer 1989. She did not receive 2nd or 3rd vaccinations. Memory of events was unclear. She did not remember what vaccinations she received from birth to age 25. She denied any other vaccine adverse events. She has seasonal "pollen" allergies spring and fall (worse in spring) with watery eyes. Powdered gloved cause itchy hands/rash and sneezing. She is tolerant of Nitrile gloves. She has not had an Allergy evaluation. The pt has not received a flu or any other vaccination since 1999.
Broke out in hives all over her body around 7:45pm the day of the shot given..about 4 hours after...took patient to ER around 9:15 pm due to being all red in color and having hives all over.  She was very uncomfortable.  At the ER they gave her an IV and then some drugs to counteract the reaction.
Patient reports that just after leaving the pharmacy she experienced a sharp pain across her entire upper abdomen. She did not alert pharmacy staff at that time.  She states that the pain continued into the night and became slightly more localized around the gallbladder. She also experienced persistent belching. She came in to the pharmacy on day 2 to report the symptoms and states that she currently continues to be tender to the touch in the upper abdomen and also has some pain when leaning forward. She has not consulted with her doctor as of today and will continue to report to the pharmacy.
See SS8 from ACC 1/15/03. Redness of face, neck, trunk, ears and ???
Pt presented to office on 2/28/09 with red, swollen area on thigh where DTAP was administered.  Shot was given on 2/26/09.  Family noticed reddened area around injection site on 2/27/09 @ 1700 with swelling at 1800 on 2/27/09 MD was notified.  Pt using ice on leg.  On 2/28/09 redness and swelling measured 6 cm X 8 cm with 2.5 cm bruised area in center.  Pt. prescribed BENADRYL and CEPHALEXIN.
Patient was seen here in this office on the morning of 8/12/19 and had the Menactra and Trumenba vaccines. Later that evening she went to urgent care due to developing symptoms of headache, back pain, fever and fatigue. The patient was not seen here in this office for these symptoms.
Soon felt tingly and out of it, unsteady, worsening brain fog. Got worse after leaving observation area and returning to apartment. Trouble walking in straight line, walking into doorways, kept falling over and collapsing (skewing towards left and somewhat back, which is the side of me that is tightened and twisted in while the right is twisted out) but catching myself on the counter, even a slight sneeze started to knock me over, pulling on left, near-absolute brain fog (trouble making easy bagel lunch), started laughing at myself (like slightly tipsy), recognized I was useless and went to bed for rest of day. Was still a little loopy the next morning. See continuation page for the rest.
2nd dose - In addition to the flu like symptoms routinely reported I had also had anaphylaxis approx. 24 hours after the shot. It happened between 6-11 pm on 4/12 (the day after receiving the vaccine at 6 pm on 4/11). It did not impact my breathing, but I had itchy welts and hives over most of my trunk and arms and upper legs. I took a Claritin and it helped relieve the symptoms.   After the 1st dose on 3/20/2021 I also experienced mild rash like symptoms and hives for several weeks following the vaccine.
This spontaneous report was received from a pharmacist technician via company representative, refers to an about 70 year old female patient. Medical history was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX vial, 1 host, strength, route, dosage and lot number were not reported. Concomitant therapy was not reported. The reporter informed that other pharmacist has a patient who received ZOSTAVAX while she held her infant grandchild and the infant developed chicken pox the company representative said that the contact between patient and the infant may have occurred the same day as the ZOSTAVAX vaccination. The patient sought medical attention by a pharmacy visit. The outcome of the event was unknown. Additional information has been requested.
Fever, Chills, Body Aches, Shortness of Breath, Elevated Heart Rate, and Fatigue for the first 3 days. Treated with rest and over the counter medication. Petechiae marks on the body for up to a month afterwards. Indicating low blood platelet counts. Treatment not given. Petechiae marks continue to appear on patients legs, torso, and arms.
delayed reaction; experiencing lip swelling; hives from head to toe; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (delayed reaction), LIP SWELLING (experiencing lip swelling) and URTICARIA (hives from head to toe) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (delayed reaction), LIP SWELLING (experiencing lip swelling) and URTICARIA (hives from head to toe). In June 2021, LIP SWELLING (experiencing lip swelling) had resolved. At the time of the report, IMMUNISATION REACTION (delayed reaction) and URTICARIA (hives from head to toe) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. The patient was experiencing lip swelling then a few days later started getting hives. Her allergist didn't think it was possible that this was a reaction to the vaccine but then she reported getting hives from head to toe and lip swelling after her second dose that lasted until Jun-2021. She had not had any symptoms since Jun-2021. Treatment information 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.
Muscle pain; Fever; This case was reported by a physician via call center representative and described the occurrence of muscle pain in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain and fever. On an unknown date, the outcome of the muscle pain and fever were unknown.   It was unknown if the reporter considered the muscle pain and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. The patients experienced usual muscle pain and fever. Physician did not have any additional information regarding the events or the patients (demographics).  Declined follow up. This case has been linked with US2021057184 and US2021AMR057595 by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR057595:Same reporter. Patient #2. US-GLAXOSMITHKLINE-US2021057184:Same reporter. Patient #1. US-GLAXOSMITHKLINE-US2021AMR057595:
Patient has 1st dose of Pfizer vaccine documented on 8/4/2021. Per hospital notes, pateint recevied dose and has been short of breath since.
01Sept95 pt recv 1 dose vax. 09Dec97 pt devel chickenpox. Additional info has been requested
administered the DTAP-IPV liquid separately from the HIB component, HIB Component was reconstituted with Merck live virus sterile water, then administered to the patient with no AE; Initial information was received on 20-Oct-2021 regarding an unsolicited valid non-serious case received from pharmacist and physician via the Medical Information  under reference number- 00821046.   This case involves a patient of (unknown demographics) who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] that was reconstituted with dtap-ipv liquid separately from the hib component, hib component was reconstituted with merck live virus sterile water (Product preparation issue).   The patient's medical history, past medical treatment(s), vaccination(s), concomitant therapy(s) and family history were not provided.  Concomitant medications included WATER FOR INJECTION (STERILE WATER).  On 19-Oct-2021, the patient received a 0.5ml {total} dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number UJ425AAA and expiry date 21-May-2022 was reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to wrong solution used in drug reconstitution (latency was on same day).   At the time of report, no adverse event reported.   Outcome of event 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 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.
Severe muscle pain inability to move arm has continued for 4 days and still going  Swelling at injection site Lethargy
SIRVA- severe shoulder pain. The most telltale symptom of SIRVA is severe pain in the shoulder that begins within 48 hours of injection...  Decreased ROM.  If you hae a shoulder injury from a vaccine, you will likely lose mobility in your injured arm...  arm pain.
2:00 PM stomach started shaking, then rash under the skin on my arms, hands and face.  Given RX Prednisone 20 mg for 5 days
Information has been received from a registered nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-OCT-2016, the patient was vaccinated with a dose of PNEUMOVAX23 (strength, dose, lot number, expiration date, anatomical location and route were not reported) for prophylaxis. Later, on 15-DEC-2016, the patient was vaccinated with a second dose of PNEUMOVAX23 (strength, dose, lot number, expiration date, anatomical location and route were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved.       Additional information has been requested.
Patient already received complete vaccination of COVID Pfizer vaccines. 2nd dose of Pfizer received on 04/14/2021 from a Pharmacy
sore on his lower back kidney area; tendon pain; shooting pain in his left arm; Muscle and tendon pain in different areas of body; Musculoskeletal pain; very ill; felt awful; Joint Pain; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very ill), MALAISE (felt awful), BACK PAIN (sore on his lower back kidney area), TENDON PAIN (tendon pain) and MUSCULOSKELETAL PAIN (Musculoskeletal pain) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced ILLNESS (very ill), MALAISE (felt awful) and ARTHRALGIA (Joint Pain). On 09-May-2021, the patient experienced MUSCULOSKELETAL PAIN (Musculoskeletal pain). On an unknown date, the patient experienced BACK PAIN (sore on his lower back kidney area), TENDON PAIN (tendon pain), PAIN IN EXTREMITY (shooting pain in his left arm) and MYALGIA (Muscle and tendon pain in different areas of body). On 07-Apr-2021, ILLNESS (very ill), MALAISE (felt awful) and ARTHRALGIA (Joint Pain) had resolved. At the time of the report, BACK PAIN (sore on his lower back kidney area), TENDON PAIN (tendon pain), MUSCULOSKELETAL PAIN (Musculoskeletal pain), PAIN IN EXTREMITY (shooting pain in his left arm) and MYALGIA (Muscle and tendon pain in different areas of body) outcome was unknown. Not Provided          No concomitant medications were reported. Treatment medication includes: 2 Tylenols Patient reported to experienced a right ankle shooting pain up to his left knee, it was unbearable and occurred at different times.  Patient went to the Chiropractor but everything was normal. On 09-MAY-2021, Patient reported there was a shooting pain in his arm, and mid finger was tender and a sharp pain in his arm as he was unable to move his arm.  Action taken with mRNA-1273 in response to the events was not Applicable.
Working out and I had an episode of severe pain in my left hip - no matter if I'm standing or sitting etc I had pain  - I had a limp. I had to stop working out. I had a problem with a sharp pain if squatting or bending down with straight leg. I had an x-ray - hip sublocations - with my condition of  hip dysplasia is what I have (my ball joints move around a lot and because I'm hyper mobile - it moves around even more)  - possibly caused some soft tissue damage in my hip and  had some Inflammation. My hip wanted to come out - leg bone wanted to come out of hip joint. They put me on Physical therapy  - it's twice a week - and gave me Meloxicam. That has been helping. I am also being scheduled to get an MRI to look to see if there are any tears in the joint or cartilage - labral tear - we don't know if this has happened. It is likely to happen due to my condition. I am not in constant pain but it's still an issue.
4 hours after my injection, I started feeling dizzy.  This dizziness lasted 3 days.  I have had flu shots for over 25 years and never had a reaction like what occurred to me.  I received the Fluzone High Dose Quad 2020-21.  I am 67 years old and apparently this dose is too high to give seniors.
Within a couple minutes I had a metallic taste. Within about 15 minutes of vaccine my lips started feeling tingly and numb, after 20 minutes it spread to my mouth, nose area and eventually my whole face. My face felt numb. My eyelids felt like they were turning in. I was advised to take a Benadryl. I took one and within 20mins symptoms improved. After about 40mins the numbess started to come back. I then realized my Benadryl had expired in July 2020. I went back to vaccine site and they gave me pepcid & advised to take more Benadryl. I took pepicid & went to pharmacy & got new Benadryl.  Within about 20 mins my symptoms improved. I was advised to take another pecid and did so that evening. I stayed with the metallic taste for another day.  Symptoms have not returned.
Patient presented with round, reddened, somewhat raised area of upper left arm the morning after injection.  Area is about 4 inches in diameter.  Reported  10/31/23 by nurse   I recommended treatment with cool compress and continue to monitor.  The nurse will escalate  care if condition worsens.
Initial report received on 17 January 2008 from a line listing as the result of a VAERS database search, VAERS# 271049.  The reported received date to VAERS was 24 January 2007.  A 72-year-old male patient had received injections of TYPHIM VI, lot number not reported; and IPOL, lot number not reported; on an unspecified date.  At an unspecified time post-vaccination, the patient experienced hallucinations and headache.  The event required intervention in order to prevent permanent impairment and damage.  The patient subsequently recovered.  Additional information was not provided.
Warm feeling to face and ears. Tingling or burning feeling to face.  Started 25 minutes after injection.  still with mild tingling. No breathing issues.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 21-NOV-2013, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # J004319 and expiry date: 17-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
83 yo M with PMH significant for asthma/COPD, DM2 and BPH who presents with a chief complaint of worsening shortness of breath in the setting of a positive covid test.   Patient seen in ED on 11/27 with similar symptoms; diagnosed with COPD exacerbation, discharged from ED on steroids and azithromycin at that time.  Followed up with PCP on 12/1 and found to be covid positive; sent home on prednisone and doxycycline.  Presents to ED today due to progressively worsening shortness of breath, fever (Tmax 100.7), productive cough, chills, fatigue and decreased appetite x ~1 week.  Previously followed with pulmonologist for COPD, recently scheduled with new provider.  Does not use oxygen at baseline.  Takes his prescribed Symbicort regularly, but states he does not ever use his home albuterol (seems unsure of its role).   Inpatient hospitalization 12/04/21 to 12/07/21.
"COVID arm" or "delayed cutaneous hypersensitivity": redness below the injection site (that has a yellow-ish diffuse bruise since a few days). The redness was noticed today (day 9), and wasn't there yesterday to the best of my knowledge. Pain at injection site initially, mostly resolved after 2 days.
it was tricking his immune system; had herpes pop out on his lip; This is a spontaneous report from a contactable consumer (patient).   A 63-year-old male patient received (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 14Apr2021 15:00 as single dose for covid-19 immunisation.  Medical history included herpes. Stated he had a situation in his world where he got herpes if he was in the sun or if he caught a cold and the herpes popped out on his lip. The herpes normally pops out and the Valtrex eliminated the pain because when the herpes pops out and it puts pressure on the lip it hurt a little bit and he has taken the Valtrex over the last year or so and when he has the herpes it happens a couple of times per year. There were no concomitant medications. There was no additional vaccines administered on same date. The patient received the 1st dose on 17Mar2021 10:00am and the 2nd dose was supposed to be administered on 06Apr2021 which was 21 days after the 1st dose, but the 2nd dose was administered on 14Apr2021. Both doses administered in left arm. He stated he was not out in the sun and he had the Pfizer COVID Vaccine 2nd dose and had herpes pop out on his lip and it began he thought on Saturday 17Apr2021 or 2-3 days after the 2nd dose of the shot and the herpes was ongoing and was getting better because he took generic of Valtrex. He took 1 pill per day of the generic Valtrex and it worked.  He had no further treatment for the reported event and stated it took time to heal and it pops out then goes away and he was not sick the next day after the Pfizer COVID Vaccine and did not feel anything in terms of sickness and then after the 2nd dose of the vaccine, the herpes popped up a couple of days later maybe it was his body feeling the illness and it was tricking his immune system. The event did not require a visit to ER or MD office.The outcome of had herpes pop out on his lip was resolving and for the event it was tricking his immune system was unknown.   No follow-up attempts are needed. No further information is expected.
Approximately 5 hours post vaccine severe chills occurred for the next four hours. Intense shaking to try to warm up body, I used three comforters in room set to 70F in order to achieve any warmth. Just prior to the immediate onset of chills I felt tired as if at the end of a busy day. After severe chills I had extreme body aches mostly in lower half ( butt and legs and lower back). About midnight through the next 24 hours I had severe fever (~ 102 when measured), 2 x 200 mg ibuprofen did not reduce however 2 x 500 mg of tylenol did help but effects wore off before next recommended dose. Spent 24 hours in bed with fever the day after the vaccination. In addition to the severe chills and severe fever and sever body aches, there were times of nausea. Appetite was ok, actually hungry during the fever. 36 hours post injection still no arm pain, lower back starting to feel better, but still have small fever. I typically walk 3-4 times a week 4-5 miles each time, no medications, no high blood pressure, no allergies. Had flu shot in Sept 2020, no effects.