chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; zoster-related conditions; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On or about 2017, the patient was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to Plaintiff's zoster vaccine live(ZOSTAVAX) inoculation, Plaintiff was treated by a physician, for shingles, and other zoster-related conditions. As a direct and proximate result of Plaintiff's use of the zoster vaccine live(ZOSTAVAX) vaccine, Plaintiff has and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was reported as not recovered. The lawyer considered shingles, and other zoster-related conditions to be related to zoster vaccine live(ZOSTAVAX).   .
Pt developed significant swelling at injection site on right upper arm. Pt was seen by PCP and cephalexin was prescribed on 12/8/14. (500 mg 1 qid x 10 days)
The night of receiving the vaccine, I got achy, my arm felt sore and was red. I had a fever for about an hour, a rash at the injection site and I had severe stomach pain. It continued for about 5 days: the first few days were the worst and then it gradually got better. I spoke to the doctor over the phone and he said to monitor it. He advised that if it got worse that I should go to the ER.
Severe arm pain that prevented sleeping on both left or right side, difficulty getting dressed and undressed the next day. Arm pain resolved  after 40 hrs. Extreme fatigue beginning hours after injection and continuing through present. Routine long walks now result in  need to rest for the remainder of the day. Fatigue examples: too tired to walk the dog, too tired to do daily chores, too tired to cook.
Elevated resting heart rate 140 bpm & elevated blood pressure.  Numbness and tingling in the face  2nd shot- March 31st  Loss of feel in left side extremities 13 days post vaccine.
The day after vaccine on 9/5/09 her arm felt heavy and she had a pins and needles sensation in arm. These symptoms lasted through 9/25/09. Symptoms have cleared up for the present.
Information has been received from a certified medical assistant (CMA) regarding a patient of an unknown age and gender who on 16-SEP-2013 and 30-NOV-2013 was vaccinated with an improperly stored dose of GARDASIL exposed to 20F and 30 F. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Tired during the day, about 14 hours later suddenly very nauseous, light headed, and faint. Developed a fever, and had shortness of breath. The next morning, arm was very sore, still a little light headed, developed a sore throat, and exhausted. Day three only feeling arm soreness and throat still sore.
Sore Arm; Achiness; chills; sore arm; Achiness; "Felt like flu"; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Mar-2021 and was forwarded to Moderna on 25-Mar-2021.    This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), the first episode of PAIN (Achiness), INFLUENZA LIKE ILLNESS ("Felt like flu"), PAIN IN EXTREMITY (Sore Arm) and the second episode of PAIN (Achiness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), the first episode of PAIN (Achiness) and INFLUENZA LIKE ILLNESS ("Felt like flu"). On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm), the second episode of PAIN (Achiness) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS ("Felt like flu"), PAIN IN EXTREMITY (Sore Arm), the last episode of PAIN (Achiness) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Ice.  Concomitant medication included Acid Reflux Medication.
2ND DOSE DOES NOT MEET MINIMUM INTERVAL FROM LAST DOSE (DOSE #1 HAVRIX ON 05/11/2023 LOT 77LYT) ADMINISTERED IN ERROR PATIENT REPORTS NO ADVERSE EFFECTS
low grade fever; This case was reported by a consumer via call center representative and described the occurrence of low grade fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st October 2020, the patient received Shingrix. On 2nd October 2020, 1 days after receiving Shingrix, the patient experienced low grade fever. On an unknown date, the outcome of the low grade fever was unknown.   It was unknown if the reporter considered the low grade fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient got a Shingrix shot and had a low grade fever at the time of reporting.
Irritation to rotator cuff, right shoulder. Went to physical therapy for 6 weeks.
I was try to lay down certain way you moved that pain was hit horrible; I was so nauseous; I had vomit; A sharp pain in my right side of the lower back and like part of my body; I couldn't even move; I felt that whole night mostly on my feet because I couldn't sit, couldn't lay down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administration date 22Apr2021 10:00 (Lot number: EW0153, Expiration Date: 21Apr2022) at the age of 77 years 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: BACK PAIN (non-serious) with onset 22Apr2021 15:00, outcome "unknown", described as "A sharp pain in my right side of the lower back and like part of my body; I couldn't even move; I felt that whole night mostly on my feet because I couldn't sit, couldn't lay down"; NAUSEA (non-serious) with onset 23Apr2021, outcome "recovered" (2021), described as "I was so nauseous"; VOMITING (non-serious) with onset 23Apr2021, outcome "unknown", described as "I had vomit"; PAIN (non-serious), outcome "unknown", described as "I was try to lay down certain way you moved that pain was hit horrible".  Additional Context: The patient had a second shot Pfizer vaccine at Pharmacy, 22Apr2021 and appointment was at 9:45 the shot was given at sharp exactly 10am and came home at 3 O' Clock at the afternoon a sharp pain in right side of the lower back and like part of my body, couldn't even move, felt that whole night mostly on feet because couldn't sit, couldn't lay down. By Friday was so nauseous, fall as long as could by afternoon had vomit , was try to lay down certain way you moved that pain was hit horrible, daughter wanted to go emergency room, no, you go to emergency room you sit for 12 hrs. then couldn't sit so yesterday Saturday when got up off the couch, it wasn't quite bad, that was the third day. She wasn't nauseous anymore, so drunk some warm soda today the nauseous all gone, the pain is just certain way move, it is gladly, but it's nothing like when its 1st hit that was horrible. The patient just saw should report this in case it affect somebody else, they all know this, and that part of the after affect the shot may be. The patient came home right after the shot and at 3 pm in the afternoon same day that's when the pain grabbed, that mean grabbed couldn't move and so for that whole night you couldn't sit, you couldn't lay down, it was horrible really just horrible. Right now it's only just a certain way you move every now and then what I can live that comparative and the nauseous that's all gone. It was Thursday, Friday, Saturday today is the 4th day and guess mean today, the nauseous is definitely gone I was able to eat breakfast this morning.  No follow-up attempts are possible. No further information is expected.
: years later she completed 2 dose series with Gardasil 9 successfully; after the first dose of Gardasil in 2015. Years later she completed 2 dose series with Gardasil 9 successfully.; Email received inbox on 19APR2023 at 2013 ET with an adverse event report for GARDASIL and GARDASIL 9. Report verbatim: "A HCP  reported she developed hashimoto after the first dose of Gardasil in 2015. Years later she; Information has been received from a female patient of unknown age, referring on herself. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date in 2015, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), 0.05 milliliter (lot number, expiration date and anatomical location were not reported).  On an unspecified date in 2015, she developed Hashimoto (autoimmune thyroiditis) after the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL).   On an unknown date (reported as "years later"), she completed the two dose series with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(lot number, expiration date and anatomical location were not reported), successfully (interchange of vaccine products, inappropriate schedule of product administration).  The outcome of autoimmune thyroiditis and the causality assessment between the vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) and the event were unknown.     Upon internal review, the autoimmune thyroiditis was considered as medically significant event.
Dose given 1804, band aide placed, patient states feels a little light headed 1806, as laying flat LOC for 2 seconds, BP 90/50, pale, patient states small amount of nausea, left flat, talking throughout, A/Ox4, 1815 BP 90/56, patient states feels fine, skin color pink/dry, sat up slowly, sat for another 5 minutes then ambulated to chair, states feels well, waited another 15 minutes for observation, patient states after, previous blood draw, passed out
Patient experienced redness and swelling at injection site following vaccination with PCV20.; Patient experienced redness and swelling at injection site following vaccination with PCV20.; Patient was fine after pain/swelling subsided after a couple of days.; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", VACCINATION SITE SWELLING (non-serious), outcome "recovering" and all described as "Patient experienced redness and swelling at injection site following vaccination with PCV20."; PAIN (non-serious), outcome "recovering", described as "Patient was fine after pain/swelling subsided after a couple of days.".  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
3" L x 1" W red area noted. Pt reports on day before (4/28/15) it was "hot and itchy". Today it is not itching or warm to touch. Pt. denies discomfort and feels site is improving. No treatment was done. Provider updated.
Purpura/ecchymosis-sever of L ear, L cheek and trunk. Moderate on R side of face; ecchymosis mild/moderate L ear. Sx only on face. Pt alert as /// wnl. Mild erythema of OD. Mom instructed to give Tylenol and Motrin (is not given ASA). Hold Pcn Mist, Flutuss. No meds given. Recheck next wk.
3 x 4cm area of erythema and induration on her left upper arm at injection site.
Headache, Fever, fatigue Employee received 2nd vaccine and developed mild headache, low grade fever and fatigue. symptoms already improving
Fever of 100.3, chills, nausea/vomiting, fatigue
little tenderness; slight sore arm; This spontaneous case was reported by a physician and describes the occurrence of TENDERNESS (little tenderness) and MYALGIA (slight sore arm) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 001A21A) for COVID-19 vaccination.     Concomitant products included METOPROLOL, LEVODOPA and AMANTADINE for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, 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 TENDERNESS (little tenderness) and MYALGIA (slight sore arm). At the time of the report, TENDERNESS (little tenderness) and MYALGIA (slight sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.    No treatment details were added. Action taken with mRNA-1273 in response to the event was not applicable
He received his second dose of Pfizer vaccine 12 May 2021 and had expected symptoms of  fever, chills, and sweats. He woke up at 0530 the following morning to take Tylenol and lost consciousness while getting out of the bed. He was taken to the ER for eval, had labs performed and EKG completed, reports normal. Also given fluid boluses and observed for a few hours then discharged. He has not had any reoccurring episodes and has returned back to his baseline.
Symptoms began January 10, 2021, and included severe vertigo / dizziness with vomiting.  Symptoms have persisted, despite treatment with antivert, zofran, and phenergan.  I am unable to walk without assistance.  I am unable to drive and unable to work at this time.
feet starting having problems; Peroneus Brevis; wisted my ankle which actually got rid of the pain for a day; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on Apr2021 (at age of 50 years old, no pregnant, Lot Number: EW0176) as a singled dose for covid-19 immunization. There were no medical history and concomitant medications. No known allergies. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at left arm on Apr2021 (Batch/lot number: CVS16506 EW0176) as a singled dose for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient reported that 4 days after second dose on May2021, her feet starting having problems.  The patient did treatment RICE. Thought it was plantar fasciitis ruled that out because it switched feet. She was a marathon runner (so in good shape). She had not upped her activity level.  Hydrated. Nothing was working. Went to Dr, he thought it was Peroneus Brevis, did stretches etc, made it worse and twisted her ankle which actually got rid of the pain for a day and then was came back full force. The adverse event result in Doctor or other healthcare professional office/clinic visit. Received treatment included Stretching, RICE, Advil. Since the vaccination, the patient was not had been tested for COVID-19. The outcome of the events was not recovered.
My upper left arm has been itchy since the second or third day after receiving vaccine.  Grew progressively worse, and my scratching broke the skin.  It is almost healed, and itching has gone away.   The skin on my chest and neck and back has developed small bumps, a few of them "itchy".   I have rather sensitive skin, due to exposure when a late-teenager working as a lifeguard.   I do not stay in the sun for "tanning". I've heard the second shot is more problematic, so I'm afraid of a "body breakout" when I get the second shot.
Arm red and sore, temperature at 101, hard to breathe (used Symbicort), very tired, went  to bed 8:00.  Today is 01/18/2016 and arm still red and hurts.
EAR FEELS CLOGGED; RINGING IN EARS; This spontaneous report received from a consumer concerned a 42 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 12-APR-2021, the subject experienced ear feels clogged. On 12-APR-2021, the subject experienced ringing in ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ear feels clogged, and ringing in ears. This report was non-serious.
erythematous, induration rash 1 in. below injection site, size about 3x4 in. with mild tenderness and pruritus and still existing until now. No fever or any other systemic symptoms accompany.
Intense itching at the vaccine site and down entire upper arm, tingling at vaccine site and entire upper arm, phantom post-vaccine type pain in entire upper arm that has continued on and off since vaccination date (it is not October 2021.)
Vaccinated with Pfizer on 3/1/21 and 3/22/21.  Symptom onset 7/1/21 - cough, runny  nose, muscle aches, loss of smell and taste, sore throat, nasal congestion headache and fatigue.  Tested positive for Covid19 on 7/13/21.
Body aches, fever between 103 to 105.4 for almost 12 hrs. Dry heaving. Still have body aches and headache at the moment. Been taking Tylenol and ibuprofen with lots of water.
Vertigo for 3 hours intermittently, then nausea and mild dizziness from 7am- 5pm
redness, swell and itchiness around neck and top left corner of chest. started appearing on the day i got the second dose of the vaccine. It increased following day and the day after.
05/22/2021 9:00pm - muscle aches, fatigue 10:30pm - migraine, chills 11:00pm - fever (100.6) 05/23/2021 1:00am - fever (101.5) 11:00am - sustained fever, migraine, fatigue 8:00pm symptoms begin to subside
a big drop of liquid running down from the site of vaccination; Initial information received on 15-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 72-year old male patient who experienced a big drop of liquid running down from the site of vaccination (injection site extravasation), while he received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Sep-2020, the patient received 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number not reported via unknown route in the left deltoid for prophylactic vaccination.  On an unknown date in Sep-2020, the patient developed a non-serious a big drop of liquid running down from the site of vaccination (injection site extravasation) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Case Details: It was reported that, pharmacist did not notice anything wrong with the syringe and he knew he attached the needle securely but when the patient got home he noticed a big drop of liquid running down his arm which they think came out of the site.  No laboratory data was reported.  It was not reported if the patient received an corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
Patient experienced swelling, warmness, and redness in the left arm that has progressed and worsened the last several days since the vaccine was given 3 days ago. The warmness has gone down but the swelling and redness has increased below the injection site. The reaction stops at the elbow. She has also noticed neck stiffness/pain correlating with the arm reaction. We have recommended she reach out and seek medical attention if worsens. She is already in touch with her doctor.
SEVERE TINNITUS ATTACK OF RIGHT EAR; LOST 15-20 LBS IN TWO WEEKS; DID NOT SLEEP FOR THREE WEEKS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included tinnitus, and hearing loss.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-MAR-2021, the subject experienced severe tinnitus attack of right ear. On an unspecified date, the subject experienced lost 15-20 lbs in two weeks, and did not sleep for three weeks. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) Negative, and MRI (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost 15-20 lbs in two weeks, had not recovered from severe tinnitus attack of right ear, and the outcome of did not sleep for three weeks was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
I am breastfeeding my almost 4 month old son. Within 8 hours of receiving the vaccine, my breast milk supply had severely diminished. I have been an overproducer of milk and I could no longer produce enough to adequately feed my baby. While it has improved some in the last 2 days, it has not returned to anywhere near what my supply was prior to receiving the vaccine.
Pt had pain in left leg and stopped moving the leg around 6-8 hours after the vaccine shot in left leg. Now in clinic she is walking with a limp No h/o seizures, hives, shortness of breath. No neurological deficit on exam. Recommend - MOTRIN, TYLENOL.
patient was given vaccine at 10:34am. at 11:06am as patient was walking out she said her tongue feels itchy and lips feel tingly. she has EpiPen in car and husband took her to ER. I looked at her tongue, lips and face and they looked normal. she said she has no other symptoms ie breathing or heart. at 3:30pm, I follow up with patient and she said hospital kept her for 1 hour 15 min. she said she's better and dr prescribed prednisone and Benadryl to be taken only if rash or itching appears again.
Chest pressure and headache followed by generalized itchiness and hives. Progressed to facial swelling and airway swelling. Treated with EpiPen x1 IM, 50 mg diphenhydramine PO, 20 mg famotidine, and 10 mg dexamethasone. Immediate reaction improved. Itchiness and intermittent hives continued. The headache continued along with other common/expected side effects of vaccine.