chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received a FLUVARIN and PNEUMOVAX injection in the same (L) arm on 10/14/08, symptoms started on 10/15/08 per patient. Daughter called and notified me of problem on 10/17/08. Area on upper left arm was hard, bright red and hot to touch. Patient is not aware of which injection is inflamed.
Narrative: UriticariaPruritus & localized redness/swelling Treatment:
Patient received 2nd dose of Moderna vaccine on 3/5/21 to his left deltoid. On 3/14/21, he began to develop tender, swollen, and erythematous area of lymphadenopathy to his left axillary region. He presented to clinic on 3/16/21 with concerns for infection and was noted to have area of induration with surrounding erythema and swelling. Was treated for possible underlying cellulitis.
Patient had severe pain the evening of the injection, and the next day he was unable to move his arm for several days. He went to the doctor's and told them that he received his injection high on the arm. He is now able to move his arm and has much less pain. The shot was administered on 12/2/17 and we were notified on 12/30/17.
pt had first Pfizer covid vaccine on 5/10/21, then a second Pfizer  covid vaccine on 6/1/21  and gradually developed left leg swelling over the course of the summer/fall, which gradually got worse and caused severe left leg swelling, it took several weeks if not longer for him to be correctly diagnosed with left lower and upper leg DVT after he went to the ER on  11/23/21  for which he is now being treated with anticoagulants, his leg swelling and pain is still persistent. His DVT appears to be unprovoked, however the hematologist believes that the covid vaccines could have contributed to patients large DVT, which, if left untreated, could have caused death.
TOOK UNREFRIGERATED DOSES; This spontaneous case report (PVX2019-1963) was received from a consumer on 30-Jul-2019. It described a male consumer who "took unrefrigerated doses" (PT: Product storage error), while being on Vivotif for an unknown indication.  Case report: The consumer left Vivotif doses at room temperature for 3 to 4 days and then took 2 doses. Later, he refrigerated it and took remaining 2 doses. He was not sure of the exact dates of the doses taken, but it had occurred a couple of weeks ago.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.
Severe Headaches and Excessive Tiredness with first dose.  Tinnitus, headaches and stuffy nose after the 2nd dose.
pt recv vax 14aug95. devel lump at inject site which progressed to inflammation.  19mar96 inflammatory process draining. additional info recv 23apr96 pt had excisional biopsy in outpatient surgery 15apr96.
Patient reported 5/10/21 that one week after vaccine, around May 1st, he developed a pain in his left shoulder. He reported no pain immediately after vaccine given. The pain starts at his shoulder to his elbow, and to his fingers. He states it feels like nerve pain. He says the pain does not go away.  I referred him to follow-up with his doctor. He understood.
felt dizzy/ Dizziness; Aches across his shoulders; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "recovered", described as "felt dizzy/ Dizziness"; ARTHRALGIA (non-serious), outcome "recovered", described as "Aches across his shoulders".  Additional Information: Reason for no lot number of Covid-19 Vaccine was Caller unwilling to complete the report. Caller said that about 2 hours after his dose, he felt dizzy and had aches across his shoulders. He said that the dizziness lasted about 15 minutes or less, and the aches were for a hour or 2. He had no reaction to the second dose or the booster.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Breakthrough case admission after 3 vaccines Unknown type 3/19/21 Lot# 046A21A;  Moderna 4/16/21 Lot# 043B21A;  Moderna 2/8/22 LOt# 016J21-2A
Patient requested to have the Pfizer Adult Bivalent vaccine as she has never had the vaccine, CMA accidentally drew up the Age 5-11 year old vaccine-Bivalent instead of an Adult one, she also did not dilute the 5-11 year old vial of vaccine as she thought it was the adult vial.  She administered 0.3 ml of undiluted 5-11 yo Pfizer vaccine to pt in left arm IM. Office caught this error when doing inventory of Covid vaccines on 7/27/23 at 0800.  0836 am-this nurse (clinic manager) spoke with a inpatient pharmacist in our hospital pharmacy who gave me feedback on what to discuss with the patient about the vaccine error.   Clinic Manager (myself) called patient on 7/27/23 when the error had been determined by clinic staff and verified with CMA who gave the vaccine.  The only thing the patient reported when this nurse spoke with the patient was that her injection site was really sore, no swelling or redness noted at site per patient report.  Otherwise patient feels fine at the time that this nurse spoke with her by phone.  Informed patient to contact our office if any further questions or concerns.  Patient was very understanding by phone.
Pain all over her body; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: PAIN (non-serious), outcome "recovered", described as "Pain all over her body".  Additional information: The reporter stated that he was looking for apartments and the sellers broker mentioned she experienced pain all over her body following the second dose of her Pfizer vaccine and it lasted about a day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This patient was brought in by her mother, to receive vaccines that were due, one of the vaccines being the Tdap. The Tdap vaccine had an expiration date of 02/07/2021 and was given on 02/09/2021; vaccine not noted to be expired till after given and being documented into patient's chart. Patient had already left office with her mother, covering provider, APRN, whom was in the office was notified immediately/directly and PCP,  MD was notified directly the next day when returning to the office. NH state vaccine personnel notified of error as well. Personnel stated that the patient will need to be revaccinated with the Tdap Boostrix due to the expired vaccine that was given had lost its efficiency, which decreases over time. Due to the Tdap Boostrix vaccine not being a live vaccine, the patient can be revaccinated at any time. Patient's mother, notified as well and verbalized understanding that the patient will need to receive the vaccine again and notify the PCP if any reaction's occur. Mother stated that the patient is currently having a sore arm that is reddened to her left side where the Menactra was given, this being the first dose of the Menactra series. Patient was scheduled to come back into the doctors office in April of 2021 for another dose of Tdap/Boostrix.
Patient Presents to the ED with c/o SOB onset Monday and became worse today. Patient test positive Monday for Covid-19 and has received both vaccines and booster. HX: diabetes, HTN, AFib, bilateral leg swelling with discoloration. Denies fever, chills, chest pain. Patient was 61% on RA on arrival to ED, tachyonic, diaphoretic. Acute respiratory failure with hypoxia secondary to COVID-19 infection/atrial fibrillation. CONTINUE on pulmonary support included high-flow of oxygen steroid breathing treatment, rate control with telemetry with cardiology and Disease consult. Atrial fibrillation with RVR.  CONTINUE BB/CC / telemetry bed, anticoagulation with Cardiology consult. On decatron to 10 days and baricitinib.
pt stated she got nauseated the night of the vax and when she woke up this she was dizzy and felt like the room had turned upside down.  She is now feeling like she is trying to get a migraine headache.  She called her PCP and has an appt scheduled for tomorrow 1/28/2021.
I woke up and my arm was in pain, very heavy and stiff. It was hard to move and was swollen at the injection site. Later that day, my nose started burning. Then, I could not smell anything. These lasted for about 3 days. I just felt weird.
I had flu like symptoms with dizziness, fever, body aches. I did feel nerve pain like the 1st dose which was reported but not as bad as before. I felt lack of control of my movements. I felt progressively very weak in my muscles that has never went away. I have a lack of coordination. I have a lot of joint pain with brain fog. This has gotten progressively worse throughout the year. My doctor has done a series of blood work with no indication. I have been put on nerve medication which I could not tolerate and had to end taking the medication. I am weak with lack of energy. I use to walk and do yoga and now I am not able to do this. If I do walk, it feels like my muscles are shutting down and I get wobbly and lose coordination.
developed within 24 hrs of vaccine given nausea. within 5 days, developed  redness, swelling and itching to the injection site measuring 10x 10 cm.
Day 1 104 degree temperature, nausea, vomiting, diarrhea, chills, muscle aches, loss of taste and smell. Day 2-Day 9 severe muscle pain in back when standing or walking.  Fatigue, nausea. Day 10-14 Fatigue, tremors, nausea ( Day 12 - severe headache, diarrhea).
Pfizer batch/lot #FJ6369 with temperature excursion. Reported to Pfizer and they ok'd for use. Instructed by Pfizer staff to report each dose given in this system.
Itchy; Noticed 3 or 4 faint red marks when he took a band aid off from injection site; Body ache; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Noticed 3 or 4 faint red marks when he took a band aid off from injection site), MYALGIA (Body ache) and HEADACHE (Headache) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M208) for COVID-19 vaccination.     Concomitant products included QUINAPRIL, ATORVASTATIN and TAMSULOSIN for an unknown indication.   On 03-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced MYALGIA (Body ache) and HEADACHE (Headache). On 05-Mar-2021, the patient experienced PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Noticed 3 or 4 faint red marks when he took a band aid off from injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 04-Mar-2021, MYALGIA (Body ache) and HEADACHE (Headache) had resolved. At the time of the report, PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Noticed 3 or 4 faint red marks when he took a band aid off from injection site) outcome was unknown.            Reporter did not allow further contact
Pt received second dose of COVID vaccine at hospital on 2/19 (date given by pt).  Pt had been more sedentary than usual due to winter season.  As weather warmed and pt became more active, she began to experience symptoms of left lower extremity DVT on 3/15.  Pt evaluated at urgent care on 3/19 and was sent to medical center for follow up.  Lower extremity dopplers were negative for DVT.  Pt presented to orthopedic surgeon for follow up because symptoms not resolved and was placed on Medrol Dosepak for possible issues related to remote hip replacement.  When symptoms progressed, pt presented to hospital on 3/24.  3/24 lower extremity dopplers revealed thrombus in left leg that extended into saphenofemoral junction.  Patient was then transferred to hospital for L iliac venous EKOS catheter placement for catheter-directed thrombolysis with alteplase on 3/25.  Pt underwent second procedure on 3/26 where Angiojet thrombectomy and venoplasty of left external iliac, common femoral and femoral vein was performed.
Swollen lymph node under his right armpit; Chills; Low grade fever; Aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Low grade fever), MYALGIA (Aches) and LYMPHADENOPATHY (Swollen lymph node under his right armpit) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced CHILLS (Chills), PYREXIA (Low grade fever) and MYALGIA (Aches). On 27-Jan-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph node under his right armpit). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), PYREXIA (Low grade fever), MYALGIA (Aches) and LYMPHADENOPATHY (Swollen lymph node under his right armpit) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication was provided.
After the 1st shot, my right great toe had sudden onset of chronic neuropathy with sensation as if a cord is tied tightly around it and that sensation has not gone away and has stayed constant; This is a spontaneous report from a contactable consumer. A 35-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10Apr2021 13:30 (Batch/Lot number was not reported) as 1st dose, single (at the age of 35 years) for covid-19 immunization. The patient's medical history included Lymes disease (prior TBI, Lymes disease at 12 yrs old and treated with amoxicillan and tested negative for Lymes in 2019) and ganglion cysts (since 2018 in hands). Concomitant medications included indomethacin; diphenhydramine hydrochloride (BENADRYL); and fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported. The patient previously took hydrocortisone  and had allergies (as an adolescent, had inflammatory response to hydrocortisone topical cream). The patient experienced after the 1st shot, her right great toe had sudden onset of chronic neuropathy with sensation as if a cord is tied tightly around it and that sensation has not gone away and has stayed constant on 01May2021 16:00. Patient was not treated for the event. It was reported that the event was mild and further reported as, after the 1st shot, her right great toe had sudden onset of chronic neuropathy with sensation as if a cord is tied tightly around it and that sensation has not gone away and has stayed constant. Shr never had this condition prior. After the second shot same evening, her left ankle was swollen without pain, which was not a normal condition for her and she did not recall any recent bumps or twists which would have caused it. Patient would seek treatment if conditions worsen and/or after the weekend. The patient diagnosed with COVID-19 prior to vaccination. Patient was tested for COVID-19 since the vaccination. The outcome of the event was not recovered.
The patient has covid symptoms on 09Sep2021; The patient has covid symptoms on 09Sep2021; 1st dose date: 25Apr2021, 2nd dose date: 16Jun2021; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 26-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date: unknown), via intramuscular administered in Arm Left on 16Jun2021 (at the age of 26-year-old) as single dose for COVID-19 immunisation. Medical history included birth control pills from May2020 and ongoing. Concomitant diseases and concomitant drugs were reported as none. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date: unknown) via intramuscular route of administration in left arm on 25Apr2021 (at the age of 26-year-old) as single dose for COVID-19 immunisation. Previous vaccination within 4 weeks and any additional vaccines were reported as none. The patient has covid symptoms on 09Sep2021 as running nose, cough, pain in whole body, dizziness. The patient stated that she has been lost her taste and smell. The outcome of event was reported as not resolved.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Patient developed rash on abdomen area and face.  She also reports sometimes developing rashes due to anxiety.
Headache started 20-30 minutes after administration, off and on the last 24 hours. Sore left arm with pain in armpit/lymph node area. Tingling pain down to left elbow and hand. Sore back and shoulder. Chills throughout night sleeping and into next night
Patient woke up on 1/7/2021 (8 days after vaccination) with a large red dot at the injection site.  The area itches.
does were 1 year apart; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 54-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 1 year apart from 2nd dose ).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received 2nd dose of Shingrix later than the recommended time interval, which led to lengthening of vaccination schedule. The patient asked if his or her immunity fine.
After 5 doses of DTAP with significant erythema, warmth, and swelling at site.
Patient experienced extreme swelling and rash at the injection site. Referred to prescribed if persists beyond diphenhydramine use.
This spontaneous prospective pregnancy report as received from a other health professional refers to a 17 years old female patient of unknown age. On 12-MAR-2014 the patient was vaccinated with VARIVAX (Merck) (lot # was not reported) and M-M-R II (lot # was not reported). The patient became pregnant with LMP of 24-MAR-2014 and EDD of 29-DEC-2014 (also reported estimated date of confinement was 31-DEC-2014). It was 5 weeks Gestation when reported. The patient took a urine home pregnancy test and it was positive. Another urine pregnancy test was performed at the student wellness center and was indeed positive. The patient did not experienced any adverse events. No treatment was given. The pregnancy outcome was pending. Additional information has been requested.
pt. had LGF 2 hrs after HAV given (2nd HAV).  The next day woke with 101 F, started vomiting, and c/o back/stomach pain, and H/A. Went to ER that eve w/ fever 102.5.  Received 500cc IV fluids for dehydration.  lab work was NL. Unable to keep fluids down, was given Tylenol suppository.  Woke this AM with fever 103.5 and seen at our office.  Patient did not have any local reaction at injection site.  States no pain at site this AM. Taking fluids well, alert, active, walking. UA - WNL, mild dehydration.  Prescribed Tylenol suppositories 325mg q 4-6 hrs prn, pedialyte, clears, then BRAT diet.  Vomited x1 after office visit.
Headache, Myalgia, Rash, NauseaVomiting, fatigue Narrative:
On 10/16/2019 I gave patient pneumovax-23 & a flu shot in the left upper arm in deltoid region.  The patient wanted both shots in one arm, so I planned to give them in left upper arm, 1 inch apart.  Patient reported on 10/29/2019, that she had an adverse reaction to the pneumonia vaccination.  She was unable to lift her arm and had welts appear on her left upper arm.  The reaction lasted 3 days.  On 10/29/2019, I asked to see the arm in case there was any bruise.  The bruise that was still apparent.  To me appeared to be higher on the arm then where I would give a deltoid injection. I am not sure if I adminstered the vaccine too high.  It is possible I may have done this to make room for 2 shots in upper arm, 1 inch apart.  I thought I would report it, just in case.  After 3 days, the patient was able to lift her arm and the welts  had resolved. She did take zyrtec.
3 days p/vax pt found by husband to be lying unresponsive, very shallow breathing, eyes wide open & had to arouse by shaking;aroused okay;
This spontaneous report as received from a pharmacist via a field representative refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. Approximately on 05-OCT-2015 (6 weeks ago), the patient was vaccinated with ZOSTAVAX (unknown dose, route and strength). Concomitant medications were not reported. Approximately in 2015, after receiving ZOSTAVAX, the patient had an injection site reaction that was swollen and tender. The outcome of the events was unknown. Causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
contracted covid; contracted covid; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) received via COVID-19.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: 037A21B), in left arm, on 30Apr2021 as dose 2, single (Lot number: 006C21A), in left arm and on 10Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 32 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient received other vaccine in four weeks.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Jul2022, outcome "recovering" and all described as "contracted covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jul2022) Positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. It was unknown if patient had covid prior vaccination.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information
mom states pt woke fr nap about 3PM covered w/urticaria bright, redness on abd, both legs & face; pt taken to MD given DPH;
Spoke with Mom of child, child had seizures with unconsolable crying and elevated temp for 3 days following administration of second DTAP.