chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of therapeutic response decreased in a adult male patient who received TWINRIX. On an unknown date, the patient received TWINRIX at an unknown dose. On an unknown date, unknown after receiving TWINRIX, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decrease was unknown. It was unknown if the reporter considered the therapeutic response decreased to be related to TWINRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received TWINRIX series and reported low titers of Hepatitis (low seroconversion to hepatitis B vaccine).
I got a rash on my torso that looked very much like a sunburn. It started on my chest on Sunday, by Tuesday, it had spread to my stomach. Today is Thursday, I still have a small patch on my side.
Woke up the next morning and had my period. I have an IUD and have not had a full on period in about two years. Am now on day 2 of noticeable bleeding. Also had some menstrual symptoms return that I have not had since the IUD was inserted (cramps, bloating).
I didn't have any adverse effects from the vaccine but on January 3, 2022 I woke up with a fever, body aches, and coughing. On January 5, 2022, I tested positive for COVID. I got the monoclonal antibodies that same day on January 5th. I had the fever, cough, and body aches for about 5 to 7 days from January 3rd. I was also tired and had memory issues.
developed a rash; patient who got Prevnar 13 1 year ago at another pharmacy, then received another Prevnar 13 at her pharmacy, instead of a Pneumovax 23; patient who got Prevnar 13 1 year ago at another pharmacy, then received another Prevnar 13 at her pharmacy, instead of a Pneumovax 23/accidentally given a second dose of Prevnar13; This is a spontaneous report from a contactable Pharmacist.  A 68-years-old female patient received the second dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13 lot #AL3605), via an unspecified route of administration on 11Oct2019 at 0.5 ml, single for immunisation instead of pneumococcal vaccine polysacch 23v (PNEUMOVAX 23). The patient medical history and concomitant medications were not reported. The patient previously received the first dose of pneumococcal 13-val conj vac (dipht crm197 protein) 1 year ago at another pharmacy. The patient developed a rash on 13Oct2019, and stated she normally develops a rash after most immunizations.
I have no idea if this is related to the vaccine.  My daughter has a TBI in the left frontotemporal area sustained on January 4,1997 when she was 14.  She has never had a seizure.  On June 25, 2021 she had the sudden onset of facial contortions. Suddenly the right side of her mouth was pulled down.  It only lasted a few seconds.  I didn't panic at that time.  The next day it happened again but this time the right side of her face was pulled up.  Again, this only lasted a few seconds.  I took her to the ER where had 4 or 5 episodes.  She was given Ativan which stopped the episodes for a while but they started happening again.  Actually they looked more like absence seizures and these episodes lasted 2 to 5 minutes.  She was taken to Hospital for a 24 hour EEG with video where she had several more episodes, some lasting more than 5 minutes.  She wasn't responsive during the episodes and never seemed to be postictal.  The EEG did not detect any true seizures but it indicated some "irritability" in the area of her injury. She was started on Keppra and has not had any more episodes.  Her potassium was slightly low but all other lab work was normal.
pt admitted 9/20 with sob  found to be hypoxic pt made comfort care and expired on 9/24  pt had of  GI cancer,
Pt said, her arm swelled up from shoulder to elbow.  She took ibuprofen and iced it the night of shot and swelling went down, advised take Benadryl too in case allergic reaction when she called me on 12/30/15.
1. Soreness-severe, extremely difficult to lift arm for 2 days 2. Redness/hot to the touch-large area (approx. 6 in. Rough diameter) on arm, lasted 3 days 3. Fatigue-extreme, lasted 3 days
Patient states there was a dull pain that never fully went away. Patient became ill in February and the injection site became swollen and hot. At the time of reporting 7/11/18 the patient presents with a swollen area approximately the size of a quarter and states it feels like someone is pinching her when she tries to raise her arm. We instructed her to have it checked by a Doctor.
OFF LABEL DOSING FREQUENCY; FIBRO FLARE; CHILLS; HEADACHE; FATIGUE; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient was previously received with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total, administered on unspecified date for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s. (Dose number series 1). The patient was previously received with covid-19 vaccine ad26.cov2.s (Dose number series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total, administered on unspecified date for covid-19 prophylaxis. Patient didn't flare for the second injection (Dose number in series 2). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total, administered on 15-DEC-2022 for covid-19 prophylaxis which was off label dosing frequency (Dose number in series 3). The drug was associated with Off label use. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On DEC-2022, the patient was sick with chills, headache, fatigue and fibro flare (Dose number in series 3). It was reported as "Johnson and Johnson I had the last booster on Thursday. I'm sick with headache and chills, fatigue. I'm fibro flaring brought on by booster. I didn't flare for the second injection." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fibro flare, and the outcome of headache, chills, fatigue and off label dosing frequency was not reported. This report was non-serious.
Left arm was sore the day after receiving vaccine.  Upper left arm is still sore on Oct. 4, 2021.  Right arm for the second dose with no soreness.
Information has been received from a pharmacist and an approx. 53 year old female consumer who in 3/01 was hospitalized with bacterial pneumonia and bacteremia. While in the hospital, in 3/01, she was vaccinated with 1 dose of pneumococcal vaccine 23 polyvalent. On an unspecified date, the pt developed an injection site with a red mark, 4cm X 5cm and swollen glands. The pt inquired if pneumococcal vaccine 23 polyvalent can cause these problems long-term. The pt sought medical attention and reported her symptoms to the physician. According to the pt, the physician felt that the symptoms "could be due to (vaccination with pneumococcal vaccine 23 polyvalent)". It was reported that her physician is ruling out lymphoma. A biopsy was taken, on an unspecified date, with results pending. The pt was also seen by a dermatologist. At the time of the report, the pt's symptoms persisted. Upon internal review, "rule out lymphoma" was determined to be an "Other Important Medical Event". Additional information has been requested.
nausea, vomiting, chills, rapid heartbeat, fever- 18 hour to current (4 days out)
Box of Dtap placed with Tdap. Pt. given Dtap instead of Tdap. No adverse reaction
10 x 6cm area swelling, mild erythema over (L) ant thigh, non-tender, not warm walking normally - RTC if increased erythema or swelling pain. Ice packs TYLENOL or MOTRIN.
They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.).    No concomitant medications details were reported.  Patient received vaccine at Pharmacy.  Beyond use date of the vaccine was 21-May-2021.  No treatment medications details were reported.   number was reported as 80777-273-10.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow-up received wherein patient and vaccination details added. Case narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
I had a shingles vaccine on 5/4/13 in the afternoon. On 5/6/2013 at 4 AM, I awoke with vertigo which I had never had in my life. It required a trip to the ER where blood work, urinalysis, and head CT revealed no problems. This has required me to miss 3 days of work in addition to the hospital expenses. The vertigo has eased and now it is more dizziness at times. I really feel that this was related to the vaccine and would like to know if anyone else has reported this reaction. If it is part of the posted side effects, I possibly would not have incurred all of the ER expenses and stress.
Discharge Provider: MD Primary Care Provider: DO Admission Date: 11/15/2022 Discharge Date: Nov 18, 2022 COVID Date: 11/15/2022 PRESENTING PROBLEM: Shock [R57.9] Acute respiratory disease due to COVID-19 virus [U07.1, J06.9] resolved Septic shock  COVID Pneumonia  History of pseudomonas colonization  COPD Prior stroke with resultant apraxia Chronic dysphagia on tube feed   HOSPITAL COURSE:   The patient is a 57 year old with history of multiple CVA's 10 years ago, COPD, dysphagia, esophageal strictures with chronic feeding tube who presented to ED 11/15 with fever. He had been seen by his PCP 11/14 and prescribed doxycycline for a presumed CAP but his fever persisted so his wife brought him to ED.  In ED, he was febrile to 38.9, hypoxic requiring 2 L NC and hypotensive with SBP's in the 80's(baseline 90). He was given 2.5 L IVF, zosyn and started on norepi. He had a CXR with bilateral infiltrates and tested positive for COVID so he was given decadron. He was transferred to ICU for further management of his shock. He was given additional IVF, remdesivir and vanc/zosyn/azithro. His O2 was weaned off so remdesivir and decadron were discontinued. His cortisol was 5, stress dose steroids discontinued 11/17 given resolution of hypotension. Septic shock was attributed to COVID-19 pneumonia with possible secondary bacterial infection. He has known history of pseudomonas colonization Prior sputum culture in 2021 grew Pseudomonas intermediate to Cipro and Zosyn.  It was felt that pseudomonas infection is less likely and was transitioned to Augmentin to complete 3 more days course.   For COVID-19 pneumonia, he was initially placed on remdesivir and Decadron.  These medications were stopped after resolution of hypoxemia and hypertension.   After further goal of care discussion, patient wishes to continue aggressive therapy but do not wish to be resuscitated nor does he want to be intubated.  He was made do not resuscitate.   For dysphagia, he was status post PEG placement and will continue enteral feeding.   Patient was evaluated by PT/OT who recommended home with assistance. Patient was discharge in stable condition.
This spontaneous report as received from a healthcare worker, office manager, refers to an unknown number of patients of unknown age and gender. Concomitant medication and pertinent medical history were not provided. On unspecified dates the unknown number of patients were vaccinated with doses of PNEUMOVAX23 (injection, lot#, dose, route and frequency were not provided), which were improperly stored. These PNEUMOVAX23 included multi-dose vials that had been opened (or were "in-use"), single-dose and unopened multi-dose vials had been exposed to temperature excursions that were not supported. No adverse effect had been observed or reported. This is one of several reports received from the same source. Additional information has been requested.
Redness and swelling, hard know at injection site that did not go away after 3 days.
None - informed mother to look for localized swelling or redness, and to call back of symptoms continue or worsen
Patient reports she had fever blisters after receiving the flu vaccine, and she believes they were due to the vaccine.
Nausea, Light headed, Dizziness. MD office gave him another Tdap shot on 6/19 by mistake.
Headache, malaise, Fatigue, chills, flu like symptoms, prolong Fatigue , feeling unwell, chills.
On 5/2/03 (day 9 post-vax) developed low grade fever, pain and erythema surrounding vaccination site.  Symptoms peaked on day 11, with 8 cm erythema, lymphadenopathy, lymphangitis.  Resolved day 12-14 post vaccination.  No antibiotics given.
Fever of 101.3 the day after vaccines administered. Fever responded to Tylenol and decreased throughout the day. Pea-sized pink spot on right thigh at injection site.
Awoke am after vaccination with fever, extreme body aches and nausea.  Took tylenol/advil every 4-5 hours but fever kept climbing to 103.4 by 4 pm on 9/23/21.  Extreme nausea with dry heaves as unable to eat or drink at that point.  Dr. advised me to go to ER for treatment.  Spent 4+ hours in ER and was given IV fluids, toradol via IV, and Zofran via IV.  Today is 9/25 (3 days after injection) and still running a low grade fever of 99 (my normal body temp is 97.5) and feeling unwell.  Also have LARGE red, hot and very swollen area on arm where injection was given which has grown in size since yesterday.
Patient states that last night she began to feel body aches and a severe headache that radiates down the neck. Patient states feeling all hot inside but does not have fever.
Pt got shot on 8/28/13 in the morning, starting afternoon pt felt hot around area of shot (underneath the area) no fever, the area also swollen, pt put alcohol on it. When came on 8/30/13 11:45 am. Observe the area red but not hard swollenness is better. Pt inform also on new med warfarin. Check couple days later. Pt is ok. Swollen is gone.
I had leg pain in both legs, causing me to have paraplegia which resulted in me walking with drop foot. I went the local Urgent Care where they ran a blood panel that came back within the normal limits. They referred me to a Neurologist and to get an MRI, that came back just showing normal aging issues. The neurologist has not found anything that should be causing my issues. I am going for a second opinion in a week with another neurologist I can barely walk a few feet before getting tired, this in not me.
This spontaneous report as received from a pharmacist via a company representative refers to a 66 year old female patient. ON 03-NOV-2013 the patient was vaccinated with ZOSTAVAX. The dose number, lot number, expiry date, route of administration and anatomical location were not reported. Within four days following the administration, the patient developed a dime-sized rash on her face, described as painful and blistering. An appointment with a physician was made for medical attention. Treatment information was not reported. The outcome of dime-sized rash on her face is unknown. Additional information has been requested.
Went to movies after vaccine. During movie patient stated her arm was sore, red, swollen and had some itching. She continues to watch the movie and afterwards felt like she had swelling in her throat. Presented to the Emergency room at 8:42PM. Treatment in ED consisted of Benadryl, toradol, Pepcid & Solumedrol.
Information has been received from a physician concerning a 21 year old male pt who was vaccinated with a second dose of Hep B. Subsequently, "within hours of the second dose," the pt experienced vomiting, numbness in hands, headache, dizziness, and blurred vision. It was noted that the pt went to the ER and that "within two days all symptoms resolved." Additional information has been requested.
After falling asleep for the night, I awoke 8 hours after the vaccine and was chilling and achy. I needed to void and went a very large amount (I had peed and emptied fully before going to bed). I awoke for 2 more significant voids during the night and by the 3:30am bathroom trip I was trembling and light headed with blurry vision. After voiding, I walked toward the bedroom door and the next thing I remember is my legs buckling and I then woke up to find myself sitting on the bathroom floor, fortunately uninjured. My guess is that I fainted (and I have never fainted before).  I got back to bed and slept till 8am but until 11 am had light headedness/ blurry vision and tremors in my hands (also a symptom I have never experienced).
Chills started about 13 hours after vaccine was given. Swollen, itchy, rash, 4 x 4 inches at injection sight appeared on 5/16/18.
No adverse effects reported; one dose of an improperly stored vaccine was administered to one patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patients' concurrent conditions or medical histories provided.    On 07-MAY-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, subcutaneously, lot # R034391 with expiration date on 27-NOV-2020 (frequency was not reported)  for prophylaxis. Concomitant therapies included sterile diluent (Merck Sharp & Dohme). The vaccine underwent  temperature excursion of 12.7 degrees Fahrenheit for 50 minutes. There was previous temperature excursion of 6.8 degrees Fahrenheit for 20 minutes on 01-MAY-2019. The digital data logger was involved in recording excursion details. Sterile diluent was stored in the correct temperature storage range. No adverse effects were reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA010267: US-009507513-1905USA010266:
first dose was administered on 03Jan2021 and second dose was administered on 15Jan2021; pain at injection site; Muscle pain; joint pain; nausea; This is a spontaneous report from a non-contactable other health professional. A 45-year-old female patient received second dose oBNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (batch/lot number and expiry not available), via an unspecified route of administration, in the left arm, on 15Jan2021 13:00 at a SINGLE DOSE for COVID-19 immunization.  The patient's medical history was not reported.  Patient was not pregnant during vaccination. Historical vaccine included BNT162B2 on 03Jan2021 at 02:00 PM, in the Left arm (1st dose) for COVID-19 immunization. Concomitant medications included Birth control (unspecified) and sertraline hydrochloride (ZOLOFT). The first dose was administered on 03Jan2021 and second dose was administered on 15Jan2021. On 15Jan2021, the patient experienced muscle pain, joint pain, nausea and pain at injection site. The patient underwent lab tests and procedures which included covid test via nasal swab post vaccination (on 15Jan2021) with unknown result. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number cannot be obtained.
15 to 20 minutes after receiving MENACTRA while still laying down developed urticarial rash face, arms, abdomen, back, legs - no difficulty breathing, no swelling of lips, or face, no vomiting - given BENADRYL 50 mg oral, observation for another 30 minutes - no new hives - ok home phone call 4 hrs after no more hives, or any problems.
I did not have a reaction to the vaccine. On 08/25/2022I started not feeling well with a runny nose, sneezing, sore throat and dry cough. I went to an urgent care center and tested for COVID-19 with a rapid test, but it was negative.  The PCR test was positive for COVID-19.  I contacted my primary care doctor and was given the prescription for Paxlovid.
DOSE 1: MILD FATIGUE 72 HRS. SWELLING/SORENESS/REDNESS INJECTION SITE 72-96 HRS  DOSE 2: MILD FLU SYMPTOMS--MUSCLE STIFFNESS/ACHE FATIGUE 99.3 FEVER LASTED 48 HOURS AFTER VACCINATION. SWELLING/REDNESS INJECTION SITE SAME AS DOSE 1 CONTINUES. BUT NOW ALSO SWELLING IN LARGE AREA LEFT ARM PIT INTO PECTORALS NOW GOING ON 96 HRS (5 DAYS AFTER VACCINATION).  PHARMACIST ADVISED COLD COMPRESS ON SWOLLEN AREA WHICH HELPS REDUCE SWELLING.
Headache; had a lot of chills; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a 63-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced headache (Verbatim: Headache) and chills (Verbatim: had a lot of chills). The outcome of the headache and chills were not reported.   It was unknown if the reporter considered the headache and chills to be related to Shingles vaccine.     It was unknown if the company considered the headache and chills to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 11-JUN-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received the shingles vaccine and experienced lot of chills and Headache. The patient states that he/she felt like a beaten dog but it is better to get vaccinated because the problems are worse and imagine your whole body full of little bumps and then you get an unbearable Itch when they Burst. Follow up was not possible, as no contact details were available.