chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 6/24/13 pt given Td injection (L) deltoid-next day noticed swelling at site along w/neck pain-onto back/shoulder. Pt seen here on 7/3/13 and still has warm to touch, tender swollen area at injection site.
Information has been received from a published article, title as stated above. This literature case was initially reported to foreign health regulatory agency on 29-MAR-2010. This case concerned 32 patient's (8 male and 24 female) aged between one to 57 years (mean age of patients was 29 years). The patients received a RECOMBIVAX HB, manufacturer, batch number, route and site not reported, on unreported dates. On an unreported date between 1982 and 2009, one to fifteen days post vaccination, the patient experienced uveitis (mean time to onset of three days). The uveitis was reported to occur after the first vaccination in 15 patients, after the second vaccination in three patients and after the third vaccination in three patients. The duration of the uveitis was not reported for nine patients. One patient had recurrent uveitis after the first and second doses of vaccine. One patient had recurrent uveitis after both the second and third doses. Patient outcome had not been reported. The authors stated the RECOMBIVAX HB may have a possible association with the development of uveitis in some patients. Immune complex deposition and adjuvant effects are potential pathogenic mechanisms. Uveitis was considered to be an other important medical event. Other business partner numbers include E2010-02312. Additional information has been requested.
Received COVID vaccine 1/4/2021.  On 1/15/2021 developed chills, headache, loss of taste/smell, rhinorrhea, pharyngitis.  Tested positive for COVID.
Covid Arm. Rash started to develop 2 days after second dose. It was swollen and hot and itchy and got bigger and spread. Not just to spot that vaccine was injected but all upper arm was very sensitive to touch and hurt. I searched the symptoms and applied ice and got antihistamine. Today is day 3 it?s getting better but the whole area it spread  is still sensitive the touch and it feels like burning.
an adult patient was inadvertently administered PROQUAD; No additional adverse event; This spontaneous report has been received from a medical assistant and refers to an adult patient of unknown age.      On an unknown date, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S003864 and expiration date 08-AUG-2020 (dose and route of administration were not provided) for prophylaxis. No adverse event was reported.
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: pt is complaining of right arm numbness and not being able to move the arm since getting the first vaccine. symptoms started right after administration of first moderna dose. (numbness in right elbow to fingertips except for pinky, can move it, has motor function, but describes it as tv static when falling asleep)
PFIZER COVID Booster (#3) given 10/4/21, lot # FF2587; pt admitted to hosp 1/15/22 with SOB; found to be positive for COVID and have COVID pneumonia; family wanted comfort care; pt admitted to GIP hospice for end of life care; pt passed away in the hospital; DC and med records sent to vaers
Patient noticed moderate (R) axillary swelling/lymphadenopathy with a tendor, palpable lump. Skin is warm to touch; patient is afebrile.
Day after vaccine (10/14/21), extreme lethargy and severe muscle/joint aches throughout body.  Approximately 2 weeks after vaccine, headache, extreme lethargy, muscle/joint aches.
Having  episodes for loss of consciousness, back pain, hand and feet numbness, leg weakness, severe fatigue- has seen several doctors. Plan on EMG on all 4 extremities and EEG done on brain. Did take a round of heavy duty anti-histamines.
Pain at the injection site; Her arm felt feverish after both vaccines; This is a spontaneous report from a contactable consumer (patient), from a Pfizer Sponsored Program. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on Jun2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date of 2021 (It was the end of Apr or the Middle of May 2021) as dose 1, single for covid-19 immunization and experienced flu symptoms for a week after the first vaccine, sore arm, her arm felt feverish after both vaccines. It was reported that, for the second dose she pain at the injection site. Her arm felt feverish after both vaccines. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101119257 same reporter/SD/AE,different patient
Information has been received from a physician concerning an 80 year old female who was vaccinated with a dose of Zostavax (Oka/Merck).  Approximately 6 months after receiving the vaccine the patient experienced shingles.  Unspecified medical attention was sought.  No product quality complaint.  Outcome of patient was unknown.  No further information is available.
pt recv vax 16SEP96 & w/in 24hr devel rash over entire body w/the x/of head & face, also devel edema bilat feet & ankles sx persisted for approx 7 days;denied any resp distress;
Zostavax given 11/2/2007 Patient developed shingles (physician diagnosed) on 11/4/2007
My hand brushed across throat on the afternoon of May 23 and noticed large, hard swollen circular area about 2 in diameter at base/right side of throat. Was painful when I touched it but not really otherwise. Seemed slightly less swollen on 5/24 but as I had an MRI last fall for a back issue that noted a growth on my left thyroid, I was a bit worried. I had an ultrasound of my thyroid on 2/28 and radiologist's impression was "TI-RADS 2 nodule in the right thyroid lobe measuring up to 3.8 cm" and no followup or biopsy required. NP said the thyroid is higher up than where the swelling was. I also noted I'd had a BCC removed from the other side of my neck up under my ear lobe and at jaw line on the same day as the vaccine. NP thinks the swollen spot is lymph nodes reacting to the vaccine (or possibly the Moh's procedure, or a combo of the two).   If it persists beyond a few wks, she's scheduled another neck/parathyroid/thyroid ultrasound scheduled for me but couldn't get appt unitl 8/8.
Cellulitis by that evening. In office next day for treatment. Rocephin 1gm IM given. Patient started on Keflex 500 mg every day for 10 days. Went to acute care 11/28 received another shot of Rocephin.
Sore arm, fever, body chills, aches, inability to sleep, and fatigue.
Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer: Unknown), for COVID-19 immunization, reaction(s): "fever"; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer: Unknown), for COVID-19 immunization, reaction(s): "fever"; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer: Unknown), for COVID-19 immunization, reaction(s): "fever". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever".  Additional information: Patient received COVID-19 vaccines and boosters when available (24 hour fever after each).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
felt kind of confused; arm soreness but it was no issue; left ventricle of her heart become enlarged; had palpitations ever since; This spontaneous case was reported by a consumer and describes the occurrence of LEFT VENTRICULAR HYPERTROPHY (left ventricle of her heart become enlarged) and PALPITATIONS (had palpitations ever since) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MONTELUKAST SODIUM (SINGULAIR), CEFALEXIN (CEFALIN [CEFALEXIN]), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), SALBUTAMOL SULFATE (VENTOLIN ACCUHALER), LOSARTAN, VENLAFAXINE, PANTOPRAZOLE, HYDROCODONE, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), IRON (IRON ORAL) and PRAVASTATIN for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm soreness but it was no issue). On 19-Mar-2021, the patient experienced CONFUSIONAL STATE (felt kind of confused). In 2021, the patient experienced LEFT VENTRICULAR HYPERTROPHY (left ventricle of her heart become enlarged) (seriousness criterion medically significant) and PALPITATIONS (had palpitations ever since) (seriousness criterion medically significant). At the time of the report, LEFT VENTRICULAR HYPERTROPHY (left ventricle of her heart become enlarged), PALPITATIONS (had palpitations ever since), CONFUSIONAL STATE (felt kind of confused) and VACCINATION SITE PAIN (arm soreness but it was no issue) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient stated about medical history that several years ago had a heart stress test done but she can't remember anything about it. Laboratory investigations included EKG and stress tests done but results were not mentioned. Treatment information was not provided.   This case was linked to MOD-2021-371800, MOD-2021-371801 (Patient Link).; Sender's Comments: This case concerns a 64-year-old, female patient with no relevant medical history, who experienced the unexpected event of Left Ventricular Hypertrophy. The event occurred approximately 1 month (exact date not specified) after the first dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.
On July 19 my left forearm where I got vaccine was very red/hard and swollen. Was told by Dr. that I can't ever have this vaccine.
pt states about 24 hours after the vaccine her arm started itching and then the entire right side of her body was itching.  She noticed she had red circles on her arms, chest, legs and under her arm pit.  She took Benadryl which did not help.  She went to her PCP and was given a steroid shot.  The rash had then spread to the right side of her body from her kneecaps up to her scalp.  It was a red raised circular rash that pretty much covered the top part of her body including her buttocks.   She then given a prescription steroid ointment to apply.  She still has the rash but it has improved.
Broke out in hives/rash. Went to Emergency Department. Followed up at PCP 02/23/2015. Presented with Erythema Minor. Treatment consists of 5 days oral steroid, ranitidine and hydroxyzine until rash is gone plus 3 days.
high fever w/twitching of muscles @ 2AM on 11AUg92; fever dec to 100.9 in waking hras; 11AUG92; fever gone by 11AUG92 PM;
Red, spotted rash that started as small blisters that popped and leaked clear fluid if touched. Started on Left arm, then spread to chest, abdomen, and Rt anterior shoulder. Spots are painful to touch, i.e. by a T-shirt. Sometimes itches.
STARTED LIKE SEVERE ALLERGIES,SNEEZING,NASAL CONGESTION,THEN PROCEEDED TO WORSEN TO SORE THROAT HEADACHE,COUGHING,LARGE AMOUNT OF PHLEGM AND MUCOUS DISCHARGE
I started feeling an adverse reaction early the following morning  on 11/5 starting with a 99.1 degree fever, chills and body aches. They lasted through the next day and fully subsided 11/7. I am back to normal health on 11/8.  My PA, directed me to treat symptoms with Advil and Tylenol which helped.  I contracted covid August 1st 2021 and fully recovered without complications after three weeks.
I have been experiencing Chills, fever, aches, fatigue, headache 15 hours following the vaccine up until now 28 hours the vaccine. I have been taking Tylenol and Ibuprofen to relieve my symptoms
Information has been received from a healthcare worker referring to a patient of unknown age and gender. No concurrent condition or medical history was reported. The reporter noted, that one unspecified patient was administered with improperly stored ZOSTAVAX (dose, route of administration and indication were unknown; Lot # K008885, an expiration date 20-SEP-2015) on 06-MAY-2015. There was no adverse effect reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Bruise upon injection almost - no tx redness below injection site - mild vasculitis - patient will continue to watch area.
diagnosed with covid in June 2022 and had worse symptom; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (diagnosed with covid in June 2022 and had worse symptom) in a 51-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In June 2022, the patient experienced COVID-19 (diagnosed with covid in June 2022 and had worse symptom). At the time of the report, COVID-19 (diagnosed with covid in June 2022 and had worse symptom) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant products reported. It was reported that patient had worse symptom than her husband. Patient was not hospitalized.  No treatment products reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-680917 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-680917:Husbend case (Reporter case)
THE FIRST DAY OF VACCINE at nighttime  I HAD A NAUSEOUS FEELING AND SLIGHT HEADACHE. ON THE SECOND DAY AFTER VACCINE AREA BECAME VERY RED, ITCHY AND SWOLLEN  FOR 4 DAYS.  On the 5th day after vaccine i felt very flushed and headache and nauseous again with no fever
Caller reports there have been no additional adverse experiences reported.; an improperly stored vaccine was administered to a patient; This spontaneous report was received from a physician referring to patient of unknown age and gender, whose medical history, concurrent conditions, and previous adverse drug reaction/allergies were not provided.  On 12-JAN-2023, the patient vaccinated with 1 dose of an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered for prophylaxis (lot number: W021743, which was verified to be valid, with an expiration date: 10-JUL-2024; strength, dose, frequency, route of administration and anatomical injection site were not provided) (product storage error).  The vaccine underwent temperature excursion of 10 degrees Celcius for 1 hour 28 minutes. There was no previous temperature excursion.  No adverse event was reported (no adverse event).
Arm was really sore and heavy; Arm was really sore and heavy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Jan2021 13:30 (Lot number: EL0142) at the age of 76 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Flu shot, administration date: Sep2020, when the patient was 76 years old, reaction(s): "arm is really sore and heavy", "arm is really sore and heavy". The following information was reported: PAIN IN EXTREMITY (non-serious), LIMB DISCOMFORT (non-serious) all with onset 24Jan2021, outcome "recovered" (2021) and all described as "Arm was really sore and heavy".  Additional information: She initially described event as arm was really sore and heavy with Pfizer-BioNTech COVID-19 Vaccine as being sore the next day like a flu shot where arm is really sore and heavy-but during vaccine supplemental form she clarified that she has no history of adverse events or reactions to prior vaccinations and that she had her flu shot around Sep2020. Patient's Medical History (including any illness at time of vaccination) Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity reported as none. Family Medical History Relevant to AE and Relevant Tests reported as one. Additional Vaccines Administered on Same Date of the Pfizer Suspect reported as none. Prior Vaccinations (within 4 weeks) reported as none.   No follow-up attempts are possible. No further information is expected.
Blister  Left arm 6/3/2020,  Blister right arm 6/16/2020, Blister left arm 6/26 additionally general lack of energy, aches and pains more reactive to environment; sores, rash
I went to pharmacy late afternoon on the 22nd of November 2013 to get my flu shot. When he put the shot in my arm, I remarked it did not feel right--I could feel something running all the way down to my finger tips. It didn't hurt at the needle site as much as some other shots I have had in previous years, but he kept pushing in much longer than most do. It bothered me some that evening. I woke up in the night and put my arms up to yawn and I noticed the left arm (where I got the shot) did not come up, just the right. I thought I might be dreaming, so later I tried it again and lo and behold, it did not come up. I had to take my right arm and pull my left one up. It hurt to do that, also. I have been taking pain pills (xtra strength TYLENOL and 800 MG ibuprofen). I also put Absorbine Jr liniment to try to help the pain. I keep praying and waiting for this to go away, but it is still there. I called on Monday after I first got the shot and another pharmacist suggested he might have nicked a nerve. He advised me to keep moving it and it would soon go away. I don't even know how to describe the pain I have with it now. It almost makes me cry to try to get my hair pulled up in the morning. From my shoulder to my elbow is the most painful. I can't lift my arm with pain. I would like some suggestions on how to get this problem solved. I don't want to even get anymore flu shots after this bad experience. If you have any ideas on how to help with this, please let me know.
Fever 102.5, chills, severe headache, tachycardia, dizziness.
Advice to apply cool compress as directed and give ATARAX as directed. Return to f/u appt on 7/3.
Later the same day about 12 hours later I started getting chills and shivering. Also had a really bad headache.  It?s much better now but I still don?t feel great.
Received both doses of the Moderna Covid19 Vaccine while she was pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Received both doses of the Moderna Covid19 Vaccine while she was pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Received both doses of the Moderna Covid19 Vaccine while she was pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Received both doses of the Moderna Covid19 Vaccine while she was pregnant) had resolved.            Patient wanted to know if the child should be tested for antibodies once they give birth to it, and wanted to know any information related to pregnancy and the vaccine.  No Concomitant medication were reported. No treatment medication were reported.
one of their nurses accidently gave a 12 month old patient an MMR vaccine that expired by 6 days; no additional AE reported; This spontaneous report was received from a nurse via company employee and refers to a 12-month-old patient of unknown gender. No information regarding patient's medical history, concurrent conditions and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot#, expiration date, dose number, dose, route and site of administration were not provided) for prophylaxis. The vaccine was expired by 6 days (Expired product administered). No other adverse events were reported (no adverse event).
shingles; This initial spontaneous report was received 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 medications were not reported. In 2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided), as prescribed and/or administered by a healthcare provided for the long-term prevention of shingles and/or zoster-related conditions. Subsequently, the patient was treated by medical providers for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient suffered and would continue to 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 shingles was unknown. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).