chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose December 28 2021, Unknown if 2nd dose was administered; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 28th December 2021, which batch number 3BD9E and expiry date 6th April 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 23-Aug-2022 Reporter's comment: The reporter reported that the patient was administered Shingrix 1st dose on 28th December 2021 and was back to received 2nd dose.  It was unknown if 2nd dose was administered on date of call to Medical Information The reporter consented to follow up. Additional supportive information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
15dec89 pt vax hepta B. that evening devel. flu like sx - chills,nausea,body aches,h/a itchy rash loc around waist and arms.  flu sx resolved w/in 4hrs but rash continued off and on for 1 month.
Pt state still have pain after 12 days and pt has a huge bruise that is approximately 3 by 5 inches.
Patient developed surrounding erythema with localized wheal around his injection site within 24 hours of vaccine administration. He had no other constitutional symptoms, ie no fever, no nausea/ vomiting, no fatigue or weakness. Erythema had improved notably by the time of follow-up assessment.
My heart feels like it pinches when it beats. The upper part of my heart hurts. I fell sick. My throat has been full of mucus and is scratchy. More importantly my heart hurts. I am a healthy person who is fit with a low resting heartrate.
Miscarriages at 5/6 weeks   Started  cramping night of first dose. Started bleeding the day after first dose.  Numbers started dropping. Miscarriage completed a week after first dose.
Loss of taste, 48 hrs after regained matalic taste, body aches, site pain.
A report was received from a health care professional on 7OCT2003 concerning a two year old female vaccinee who inadvertantly administered Fluvirin 0.25ml vaccine IM on 7OCT2003. On 7OCT2003, one does of Fluvirin 0.25ml was administered IM to a two year ld vaccine. No adverse event was noted or reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. No follow up pending.
Low back pain onset same day as immunizations.   No h/o injuries or trauma. Has improved over last 2 days somewhat.  No fever, no other arthralgias or myalgias, no weakness or numbness.  Patient has had h/o of similar episodes of low back pain x 2 in her life.  Immunizations given include Td right deltoid and influenza vaccine left deltoid.
He became very confused about time, went into the bathroom to brush his teeth 2 days after his 1st Pfizer shot and would not stop brushing his teeth for 30 hours. His parents tried to get him to stop several times. He only stopped because his parents finally called 911 to have someone help remove him from the bathroom. His gums were bleeding and he was limping a bit from standing at the sink brushing his teeth for so long. He was taken to the ER, his vitals looked good overall but he was dehydrated. Hospital could not explain why he did that, what was happening inside his brain. He could also not explain why he did that when asked. Very upsetting for his parents and siblings who felt they had no control over stopping him. It was mentioned he might need a neurological specialist. He improved once home. Seems he got very confused about time, did not understand how long he had been brushing his teeth and could not be reasoned with. He mentioned in the car on the way home from the ER with his dad that he still needed to brush his teeth once home. This scared his dad and his dad took him to go eat a meal outside of the home and that seemed to break up the time loop in patient's head. When they returned home patient no longer tried to brush his teeth for a long period of time.
The patient presents with his partner today to discuss ongoing unexplained symptoms of anemia, lymphadenopathy, gastric varices, and diarrhea which began shortly after his first series of COVID vaccination.  He explains 1.5 years ago he moved with his partner and later discovered the home may have had mold in it. The home also had a rat infestation. He has since been seen by ID who has done reported work up and did not feel potential mold exposure is related to current symptoms. They lived in the home for 1 year and during that time he received his COVID vaccines. He received the COVID Moderna vaccine first dose in May of 2021 followed by second dose in June of 2021.  Following the first dose he had no adverse reactions or unusual symptoms. Three days following the second dose he developed "left hand locked like a claw" which lasted for several days. Two weeks thereafter his "lymph nodes exploded" with associated chest pain.  He was seen by his primary who provided reassurance.  He later developed loose stools that resulted in an anal fissure and hemorrhoids. He was seen in the ER in August of 2021 due to "feeling horrific, dizzy, extreme fatigue, ongoing diarrhea" where he was found to have anemia.  He has since been diagnosed with hemolytic anemia and has undergone 40 blood transfusions by report. He was referred to the hospital heme/onc. He was seen by ENT for LAD.  He has been seen by rheumatology with all evaluation thus far being reassuring by report. He has been seen by GI for gastric varices, chronic diarrhea, and transaminitis with reassuring EGD, colonoscopy but abnormalities on HIDA scan.    He denies any adverse reaction within 24 hours of vaccine administration including hives, swelling, shortness of breath, wheezing, vomiting or diarrhea. First symptom was locked hand 3 days post second dose administration.  He has no previous history of adverse vaccine reactions.
This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included COVID-19 VACCINE for prophylaxis. On an unknown date, the patient received Shingrix and COVID-19 VACCINE. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and immune system disorder. On an unknown date, the outcome of the vaccination failure, shingles and immune system disorder were unknown. The reporter considered the vaccination failure, shingles and immune system disorder to be related to Shingrix. Additional Information: GSK Receipt Date: 11-MAY-2022. Reporters comment: The patient self-reported the case via interactive digital media described the occurrence of suspected vaccination failure. The patient stated that, the Shingrix shot gave him/her shingles, 4 times. This combined with Covid shot had destroyed the patient's immune system. Additional supportive information: The reporter considered the shingles and immune system disorder to be related to Covid-19 vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting. No follow up would be possible as no contact details were provided.
Initial report received on 09 October 2013 from a health care professional. A patients whose gender, age, medical history and concomitant medications were not reported, received a dose of FLUZONE High-Dose (lot number, route and site of vaccination was not reported) on an unspecified date. It was reported that a patient have received the High-Dose Flu Vaccines. On an unknown date, reporter stated that a patient received two doses of the high-dose flu vaccine within 10 minutes. List of documents held by sender: none.
tingling and tremors; sweating profusely; tremors; warm to the touch; Very hard and warm to the touch; bad headache; itches in the injection site; Pain down chest (touhgt was a heart attack); extreme pain in the left jaw...then right jaw; Redness in the Injection site with the size of a half dollar coin; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Pain down chest (touhgt was a heart attack)) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness in the Injection site with the size of a half dollar coin). On 24-Jun-2021, the patient experienced CHEST PAIN (Pain down chest (touhgt was a heart attack)) (seriousness criterion medically significant) and PAIN IN JAW (extreme pain in the left jaw...then right jaw). On 02-Jul-2021, the patient experienced VACCINATION SITE PRURITUS (itches in the injection site). On an unknown date, the patient experienced PARAESTHESIA (tingling and tremors), HYPERHIDROSIS (sweating profusely), TREMOR (tremors), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE INDURATION (Very hard and warm to the touch) and HEADACHE (bad headache). At the time of the report, CHEST PAIN (Pain down chest (touhgt was a heart attack)), PAIN IN JAW (extreme pain in the left jaw..then right jaw), PARAESTHESIA (tingling and tremors), HYPERHIDROSIS (sweating profusely), TREMOR (tremors), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE INDURATION (Very hard and warm to the touch) and HEADACHE (bad headache) outcome was unknown and VACCINATION SITE ERYTHEMA (Redness in the Injection site with the size of a half dollar coin) and VACCINATION SITE PRURITUS (itches in the injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jun-2021, Electrocardiogram: normal (normal) Normal. On 24-Jun-2021, Troponin: normal (normal) Normal.         No treatment information was provided. No relevant concomitant medications were reported.  Action taken with mRNA-1273 was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Patient received Moderna COVID vaccine on 2/20/21, 3/38/21, 9/14/21, and 4/14/22. On 4/19/22, patient admitted to our inpatient facility with acute hypoxemic respiratory failure (AHRF), moderate COPD exacerbation, COVID-19 pneumonia (also positive status on admission), and volume overload secondary to ESRD. Patient was in med/surg unit from 4/19-4/22, then in CCU from 4/22-4/24, then back to med/surg unit on 4/24 and still admitted as of today (4/29).
This case was reported by a pharmacist and described the occurrence of injection site redness in an adult subject of unspecified gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 21 September 2012 the subject received dose of FLULAVAL (.5 ml, details unknown). On 21 September 2012, less than one day after vaccination with FLULAVAL, the subject experienced injection site redness, swelling injection site and injection site pain. On an unspecified date in September 2012, the subject experienced fever greater than 102 within 24 hours. At the time of reporting the outcome of the events was unspecified. The pharmacist also reported two other subjects experienced events after receiving FLULAVAL (see case ids A0996176A and A0996178A for more details).
48 hrs after administration of FLUMIST developed fever and had witnessed seizure like activity with c/o severe headache.
Received DTaP/IVP on 1/22/2002. Had low grade fever that night. Began head shaking 1/23/2002 and change in behavior since then. Less content, not smiling as much. Also received Hib on 1/15/2002.
2:00am - Chills 5:00am - Flushing, heat, sweating Muscle soreness, headache, excessive fatigue  Still having upper chest discomfort and pressure, consistent heartburn
Joint pain. Swollen lymph nodes. Pain in lymph nodes under right arm. I had some lymph nodes removed from under my right arm in 2010 as treatment for breast cancer. The remaining lymph nodes were extremely sore after the second Pfizer Covid-19 vaccine. I have not had trouble with these lymph nodes since some were removed. It hurt so much I couldn?t sleep. This lasted for about a week. The doctor prescribed pain medication, but I chose not to take it. Just took Tylenol instead.
Red saucer like erythema hot to touch 10 cm diameter medial mid thigh adjacent to injection site.
-immediate headache 5 min post vaccination -dizziness 10 min post -fogginess and confusion 45 min post -increased mucus 1 hour post -flu-like symptoms in evening  (lasted 48 hours) -throat/trachea inflammation 10:00pm with wheezing, felt like throat closing and asthma attack (relieved w essential oil to open airways).   (lasted 48 hours) -woke up with swollen lips  & eyes and inflammation in tonsils & trachea, coughing, coughing up black mucus, felt like asthma attack and migraine, can?t take deep breath  (lasted 48 hours) -9:00am took 2 Advil -coughing & flu like symptoms continued -swollen tonsils & closing trachea as if having an asthma attack -enlarged lymph nodes (and above left clavicle) one week post vaccine (lasted almost 2 weeks)
Severe headaches began 3/19/21; Urgent Care treated with meds and did CT Scan; sent to ER on 3/25/21. Admitted to hospital. MRI and CT scans done; Lumbar Puncture done--no bacteria; diagnosed as Cerebral Vascular Sinus Thrombosis; treated with Lovonox for 5 days then switched to Pradaxa when released from hospital; given oxycodon, dilaudid, and tylenol for pain. Starting 4/1/21, numbness in right arm down to fingers. Sent to ER again on 4/8/21 as headaches and numbness worsened.  MRI and CT done. Clot dissolving but pain continued at 10/10 level. Released and continues on Oxycodon, Tylenol, Elavil, without relief as of today, 4/13/21. Still incapacitated by pain and unable to walk at length, work, or any normal activities.
This case was reported by a physician and described the occurrence of tonic-clonic activity in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date in 2013 the subject received a dose of FLULAVAL (unknown details). In 2013, within months of vaccination with FLULAVAL, the subject experienced tonic-clonic activity and syncope. No further details were reported. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events were unspecified. The physician reported another case with FLULAVAL. See case A1045820A for details on the other case.
Patient received the Covid-19 vaccine. She reports symptoms of Other: feeling dizzy. I have observed: Approx 10 min post vaccination pt became diaphoretic and c/o feeling faint. She was transported to the observation area via wheelchair. Treatment/intervention Pt was given water and crackers and VS obtained: 1033: BP 93/78 HR 78 O2 sat 100% RA 1038: BP 92/52 HR 92 O2 sat 97% RA 1046: BP 97/53 HR 88 o2 sat 99% RA Pt finished water and crackers and stated she was feeling much better, no c/o of dizziness or feeling faint. She was oriented to person, place, and time and aware of the events that occurred. Her speech was clear and coherent. She was observed until 11am at which time she was observed during ambulation and outside for fresh air. The patient was steady on her feet with normal coordination and reports feeling at baseline. Pt is approx. 28 wks pregnant. She stated that the two weeks prior she has been having episode of dizziness and was approved by her provider to drink electrolye enhanced water.  She also did not have much to eat prior to coming so after drinking water and eating some crackers was feeling much better.
Metallic taste, dizziness, nausea, chills, elevated BP 158/108, HR 85 all within 5 minutes.
High fever (102.5 - 103), chills, and body aches starting 5 hours post vaccination and lasting ~12 hours.
On June 25, 2022 I began to have a head cold with a sore throat. I never had a fever. I did a home test on the 26th and it was negative. On June 30th since I was not getting better I went in to have a PCR and it was positive. I began taking Claritin and the inhaler prescribed and symptoms began to decrease. On July 7th I had a home test and it was negative.   On July 24th I had another PCR test and it was negative. As of today, the only symptoms I have are stuffy feeling in my head and nasal drip with a slight cough. I also have a hoarse voice.
fibromyalgia pain; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received second dose of COMIRNATY (Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on unspecified date as SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of COMIRNATY (Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on unknown date as SINGLE DOSE for COVID-19 immunisation. On unspecified date the patient experienced, Fibromyalgia pain came back once after her 2nd covid shot (Pfizer). She just had one episode. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Reported by patient:  body aches started on 5/25/10 @ 0500. Throughout the day, body aches continued, fever (tympanic of 101.0), started to have shortness of breath and felt constriction ("didn't last long"), swelling to injection site (right deltoid).  Took ibuprofen and that helped with symptoms.  On 5/26/10 continued to have body aches, chills, felt like arthritis all over body, injection site swelling appears to be getting bigger, fever (tympanic 101.0). Continues to take ibuprofen which is helping symptoms.
TOOK PART OF A BROKEN CAPSULE; This spontaneous case report (PVX2019-1665, PTC-000066) was received from a pharmacist on 26-Jun-2019. It describes a male consumer who "took part of a broken capsule". She was receiving Vivotif capsule (lot number: 3003272 and expiry date: Apr 2020) for an unknown indication.  Case report: The consumer reported that there was a broken capsule in the box and he took the part of that broken capsule.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took part of a broken capsule" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "took part of a broken capsule" was considered as not applicable.
Fatigue and Nausea. Vomiting two times. Rash on bilateral hands two to three hours post. Rash subsided within 4 hours of onset.
This case was reported by a other health professional via sales rep and described the occurrence of adverse reaction in a 29-year-old female patient who received Seasonal Influenza vaccine. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The age at vaccination was not provided. The details of the reaction was not reported. For tolerability after FLUARIX QUADRIVALENT, please see case US2016164682.
pt recvd vax & 5DEC93 devel a fever of 99.2, vertigo & nausea; No further details were provided
Tightness in throat. Trouble taking deep breaths. Flu like symptoms. Headache.
This spontaneous report was received from a registered nurse concerning an unknown number of patients of an unknown gender and age. Medical history and current conditions were not reported. On an unknown date, the patients were vaccinated with doses of VARIVAX (Merck) (dose, dose number and route were not reported)with lot numbers reported as J013066 expiration date 16-OCT-2015, J013068 expiration date 16-OCT-2015, K007785 expiration date 28-MAY2016, and K005182 expiration date 10-APR-2016, that were improperly stored. No adverse effects were reported. Additional information has been requested. This is one (1) of two (2) reports from the same source.
This spontaneous report was received from a registered nurse and refers to a 13 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-JUL-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N012132 with expiry date: 17-APR-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
1)I began experiencing dizziness starting the day after the injection, lasting daily since (currently 12 days).  The dizziness has not resolved yet.      2)7 days after the injection I developed a rash over the injection site (my left deltoid) which was approximately 4 finger-widths long by 3 finger-widths wide.   I took 10 mg of children's liquid Benedryl at night for 3 days, and the rash resolved.
This is a spontaneous report from a contactable consumer (patient). A patient, of unspecified age and gender, received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiration date: not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient previously took the first dose of BNT162B2, via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient took the first Pfizer shot and never had any symptoms or anything. On an unspecified date in 2021 (reported as Friday), patient went to get the shot. The next day, patient had a soreness on left arm where they did it. In the evening, patient felt a little chill. On an unspecified date in 2021 (reported as Sunday), underneath the armpit, patient felt soreness and now it was swollen-up (getting reaction to it). Underneath the armpit, next to chest was swollen-up. The outcome of the events: unknown. Batch/lot number not available despite the follow-up attempts made. Follow-up attempts completed and no further information expected.