chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he was having confusion /  he was in a fog/cloud all day  / confusion; fatigue /  went to bed early; a concerted effort to concentrate/ loss of concentration/ inability to focus/not quite tunnel vision / had to concentrate really hard / had to concentrate on everything / inability to concentrate; arm discomfort; he felt like he was in a fog; This case was reported by a nurse via call center representative and described the occurrence of confusion in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Pfizer Covid 19 shot (1st shot received on 1st December 2020). Concomitant products included COVID 19 VACCINE PFIZER.   On 1st April 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In April 2021, less than a day after receiving Shingrix, the patient experienced confusion, fatigue, concentration loss, arm discomfort and foggy feeling in head. On an unknown date, the outcome of the confusion, fatigue, concentration loss, arm discomfort and foggy feeling in head were recovered/resolved.   The reporter considered the confusion, fatigue, concentration loss, arm discomfort and foggy feeling in head to be related to Shingrix.  Additional details were reported as follows: The patient reported the case for himself.  He got the shot around 6 pm at a local pharmacy.  He did not experience any immediate problems during or shortly after the injection.  No problems that evening. He went to bed.  He woke up in the middle of the night due to left arm discomfort.  He woke up the next morning at his regular time.  He proceeded with his normal routine of drinking coffee and going to the pool to swim.  During his swimming he stated that he felt like he was in a fog.  He said that he really had to concentrate on swimming which was unusual because he swims every morning and normally did not have to think about it as he performs this routine task.  He described it as a heavy fog, a concerted effort to concentrate or loss of concentration or inability to focus or not quite tunnel vision. Then as he was driving and the whole time while he was at work he had to concentrate really hard.  He said he had to concentrate on everything like he was having confusion and this lasted through his whole work day and he could not wait to go home.  He said he was in a fog or cloud all day Friday 2nd April 2021 with confusion, inability to concentrate and fatigue.  When he came home he went to bed early.  He woke up Saturday 03rd April 2021 and felt good.  He did not have a fever or a rash or gastrointestinal symptoms.  The reporter consented to follow up.
high fever, extreme fatigue, nausea, brain fog, dizziness, lack of taste lasting 36 hours upon outset at 10:00pm 4/09/2021 following vaccination at 10:00am earlier that day. 48 hours following injection, the worst of symptoms (fever, fatigue) began to recede, however as of today, 04/12/2021, symptoms of nausea, brain fog, dizziness, lack of taste are improving but remain.
Patient presented with radiating pain up through jawline. Patient was instructed to take 50mg of BENADRYL, to call 911 and/or go the hospital immediately.
Patient was given in error HPV vaccine that had already been punctured on 2/1/22.  We figured this out when completing reconciliation. Patient has not been informed at this time. We have already reached out to Merck- there is no known harm to patient due to dose and they said it was up to provider to repeat dose . I have reviewed with provider and we plan to inform patient and request they come back to repeat first dose .
Patient received vaccine the day prior to my evaluation with him. He drank alcohol then had an episode where he fell, seemed to not be breathing normally, then had several episodes of tremors and shaking movements, though he was able to talk through these and did not have a postictal period. Concern for anxiety reaction or reaction to alcohol, but also feel could be related to vaccine.
I have had chronic headaches since receiving the vaccine. Combining ibuprofen and acetaminophen provides temporary relief.
About 2 weeks after the Moderna COVID-19 booster dose the client began to experience  a deeper pain in the right shoulder that felt like it was down in the joint and was so sore it would wake her when she rolled over in the night.  Although she can move her arm and shoulder she feels like she has a decreased range of motion and continues to have pain in that shoulder joint area still now almost 7 weeks later.  She also this week developed some redness at the injection site with a small bump or pimple at the injection site that formed a type of scab looking spot.  Level of pain continues to be a 4-5 on a scale of 10.
Patient would not stop crying, would not take bottle very unsettled. Hardly moved his leg. His mother called Dr. who told her to give him Tylenol that he would be fine. He continue to cry off an on for the next few days. He broke out in a red rash like with his 2 months vaccine on 9/01/2010 followed by huge quarter size hives on 09/02/2010. Will submit photos if you would like them. Had a runny nose and cough 09/12/2010 to 9/19/2010. Hives continue until 9/22/2010. No hives now.
Sore arm started almost immediately. At 1 AM that night I woke up with chills. When I got warm, I started sweating and was very hot, took off the blankets, and then became extremely cold. I was nauseous, had a headache, and my whole body ached. I was very uncomfortable and couldn't sleep for 3 hours. The chills and body aches lasted until I went to bed the next night. The nausea and headache was gone after I woke up the next morning. The day after the vaccine was received I was very lethargic, weak, and my had body aches.
PATIENT STATES HAS LIGHT HEADNESS. PATIENTS VITAS ARE BP 138/82, HR 83, O2 SAT OF 98%. PATIENT SYMPTOMS RESOLVED AND PATIENT RELEASED.
In 24 hrs has large, red, warm to touch local reaction - 5 1/2" x 2 1/2". No c/o systemic reaction.
Shingles; spot on neck; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. In May 2019, less than a year after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. In the beginning of April 2019, the patient received her 1st Shingrix vaccine. At the end of May 2019, she was diagnosed with shingles. It developed on her neck.   Shingles had healed but there was a spot. The reporter did not have further information regarding the event to provide.
Reflex syncope (vasovagal reflex); Decreased blood pressure 60/40; This is a spontaneous report from a contactable consumer (parent). A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced decreased blood pressure 60/40 and reflex syncope (vasovagal reflex) on unspecified date. The clinical outcome of decreased blood pressure 60/40 and reflex syncope (vasovagal reflex) was unknown. Information about lot/batch number has been requested.
12 hours after receiving the shot I began to have severe chills, sweats, body aches, headaches, and fever.  Fever reached a high of 101 degrees.  These symptoms last approx 30 hours.
Patient received vaccine @ 11:55 AM on 01/20/2021. She left our office and went to another appt. that was scheduled at 2 PM in a different office. Patient came back to our office around 3 PM c/o her left arm hurting, nausea, chills, thought she was going to vomit, spine was burning, headache, and dizziness. Patient laid in our exam room shivering excessively where we took her vitals (which were normal), gave her 4 MLs of Motrin, a popsicle, and checked her blood sugar (125). Patient left our office around 3;45 PM and stated she felt much better.
administered expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patients, after the manufacture date of expiration) in a 79-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported. the total number of doses administered from this batch was 173 doses. The vial did not undergo any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up contains non significant information.
No Adverse Event; 3 patients received 1 COVID-19 Vaccine Bivalent booster on 20Jan2023 but then they realized that patients already received a previous bivalent booster on Sep2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (3 patients received 1 COVID-19 Vaccine Bivalent booster on 20Jan2023 but then they realized that patients already received a previous bivalent booster on Sep2022) and NO ADVERSE EVENT (No Adverse Event) in a 50-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     Patient had no relevant conditions.  Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) (MODERNA COVID-19 VACCINE and BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) in September 2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE and BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5).    On 20-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 20-Jan-2023, the patient experienced EXTRA DOSE ADMINISTERED (3 patients received 1 COVID-19 Vaccine Bivalent booster on 20Jan2023 but then they realized that patients already received a previous bivalent booster on Sep2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXTRA DOSE ADMINISTERED (3 patients received 1 COVID-19 Vaccine Bivalent booster on 20Jan2023 but then they realized that patients already received a previous bivalent booster on Sep2022) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (3 patients received 1 COVID-19 Vaccine Bivalent booster on 20Jan2023 but then they realized that patients already received a previous bivalent booster on Sep2022).    No concomitant information was reported. HCP stated 3 patients received 1 COVID-19 Vaccine Bivalent booster on 20Jan2023 but then they realized that patients already received a previous bivalent booster on Sep2022. Reporter mentioned no AEs were reported for patient number 1. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-705243, US-MODERNATX, INC.-MOD-2023-705947 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-705243: US-MODERNATX, INC.-MOD-2023-705947:
I was a little dizzy and within a couple of weeks I had Neuropathy that started to set in. I went and saw my PCP and was prescribed two medications (Gabapentin and Tizanidine). I went to the ER/Hospital due to an adverse reaction to the Gabapentin that I was prescribed. I had a medical work up at the ER and that's when I got the diagnosis of the Neuropathy.
Narrative: PATIENT WAS VACCINATED IN A TIMELY MANNER 2/11 AND 3/11 WITH MODERNA MRNA VACCINE OUTSIDE. PT WAS ADMITTED 10-9 AND HAD POSITIVE BIOFIRE AT THAT TIME. PATIENT HAD A LENGTHY, BUT UNEVENTFUL HOSPITAL STAY DUE TO COVID PNEUMONIA RESULTING IN EXTREME WEAKNESS. HE REMAINED ON RA ENTIRE STAY. HE WAS TREATED WITH REMDESIVIR, RECOVERED, AND WAS DISCHARGED FOR REHABILITATION.
Patient came into pharmacy complaining of large red bumps and itching in the arm that the Prevnar injection was administered.  Patient showed the area to me (the pharmacist on duty) which was distinctively hives on the arm in which the injection was given.  I gave patient a couple diphenhydramine 25mg to help with the itching for the next couple days and told patient we would follow up with her on Monday (the next day the pharmacy is open).
This case was reported by a pharmacist via sales rep and described the occurrence of chills in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills and fever. On an unknown date, the outcome of the chills and fever were unknown. It was unknown if the reporter considered the chills and fever to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The age group was not reported, but was captured as adult as per the vaccine indication. The reporter did not have any patient information. The reporter had not agreed to follow-up with GlaxoSmithKline. This case was linked with case US2018100654, reported by the same reporter.
swollen gland; very sore throat; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen gland) and OROPHARYNGEAL PAIN (very sore throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced LYMPHADENOPATHY (swollen gland) and OROPHARYNGEAL PAIN (very sore throat). At the time of the report, LYMPHADENOPATHY (swollen gland) and OROPHARYNGEAL PAIN (very sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded
This spontaneous report as received from a other health professional refers to a female patient of unknown age. The patient was vaccinated with dose 2, 1 DF GARDASIL on 04-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced inappropriate schedule of vaccine administered. No treatment information was reported. The outcome of inappropriate schedule of vaccine administered is unknown. Inappropriate schedule of vaccine administered is not related to GARDASIL. (Additional information has been requested. / Additional information is not expected.)
Presented to hospital with altered mental status. pt was asymptomatic for Covid. Pt treated for pulmonary edema from CHF. Diuretics given. Pt failed to repsond to diuretics and was put on hospice. Pt deceased on 6/11.
6 months pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (6 months pregnant) in a 30-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029AZIA) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy (Sensitivity to latex) and Gestational diabetes (pregnancy-related complications or other acute illnesses). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), CHOLINE, MAGNESIUM OXIDE, RUBUS IDAEUS LEAF (RED RASPBERRY) and APPLE CIDER VINEGAR for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 02-Sep-2020 and the estimated date of delivery was date. On 02-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (6 months pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fifth week of the pregnancy. The vaginal delivery occurred on date, which was reported as Full-term. For neonate 1, the birth weight was 4064 grams (8lbs 15oz). The outcome was reported as Delivered NOS. On 02-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (6 months pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Oct-2020, Pregnancy test: positive (Positive) Positive. On 01-Mar-2021, Ultrasound scan: normal growth (normal) Normal growth. On 29-Mar-2021, Blood glucose: diagnosis of gestational diabetes (abnormal) Diagnosis of gestational diabetes. On an unknown date, Ultrasound scan: normal (normal) 20 week anatomy scan.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's concomitant medication include Prenatal Vitamins in 2018 for her previous pregnancy. Previous pregnancy ended on date with live, full term birth.   This case was linked to MOD-2021-267640 (Parent-Child Link).   See case MOD-2021-267640 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Significant follow up received on 26-JUL-2021 updated Patient demographics, Pregnancy details, lab data, concomitant medications and Pregnancy outcome.
pt stated that she had chest tightness after 30 minutes of observation. She was brought to urgent care where they took blood pressure. They stated the following:   EKG obtained, nsr, similar to 7 years ago, no ST changes or tachycardia.  BP somewhat elevated, likely reaction to situation. Pt reported improvement in symptoms.  BP improved.  Pt will return home and monitor her symptoms, returning or calling emergency number if symptoms get worse.
HEADACHE; MUSCLE ACHE; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number.  No concomitant medications were reported. On an unspecified date, the subject experienced headache, muscle ache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, muscle ache and fever was not reported. This report was non-serious.
12:24PM HAS CHEST TIGHTNESS AND SOB. A/O, PINK, W/D, RESP REG WITH EASE. VITAL SIGNS STABLE. TO SQUAD PER WHEEL CHAIR TO GO TO ER. 12:26PM BP 121/74, HR 81, R 16. 12:30PM BP 121/80, HR 83, R 16. 4-2-21 10:20AM PATIENT: STATES HE IS DOING BETTER. SAW PCP AND IS TAKING PREDNISONE X5 DAYS AND WILL HAVE A STRESS TEST.
Fever  dizziness  pounding headache body aches,  weak lethargic
Gave injection in the left arm. Patient stated that she felt lightheaded and laid down.  She bent her knees on the bed and we put a damp cloth on her head.
BODY ACHES; GASTROINTESTINAL PAIN; MILD JOINT ACHES; SKIN TINGLING; DIARRHEA; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with Janssen covid-19 vaccine on an unspecified date. The patient subsequently received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1822811, expiry: UNKNOWN) dose was not reported, administered on 25-OCT-2021 as a booster for for prophylactic vaccination. No concomitant medications were reported.  On 26-OCT-2021, the morning after the vaccine booster, the patient woke up with with mild joint aches and a sensation of tingling in the skin throughout the body. Some mild gastrointestinal pain (also reported as GI distress) developed during the afternoon. No fever or headaches. Symptoms were generally mild and "expected" and did not limit activity or functions.  The patient also developed diarrhea and body aches..  The patient's symptoms seemed to be tapering during the day.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from the events.   This report was non-serious.
AFTER 1ST DOSE ON 6/15/2021 I HAD A MILD NUMB SENSATION ON THE TIPS OF MY FINGERS IN LEFT HAND STILL REMAINING  AT TIME OF 2ND DOSE.  AFTER 2ND DOSE, INCREASED NUMBNESS ON LEFT HAND AND RIGHT SIDE EFFECTED WITH NUMBNESS AS WELL.  NUMBNESS AND A FEELING OF NAILS THROUGH FINGERS COMES AND GOES  STILL.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information on patients' concurrent conditions and medical history was provided. On the unknown dates, multiple unspecified patients were vaccinated with improperly stored ROTATEQ oral (dose, lot # and expiration date were not provided). No adverse effects were reported. This is the one of several reports from the same reporter source. Additional information has been requested.
itchy; muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy) and MYALGIA (muscle soreness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchy) and MYALGIA (muscle soreness). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (itchy) and MYALGIA (muscle soreness) had resolved.            No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Outcome updated