chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the soreness of the shot subsided I noticed pain in my left shoulder joint when I lifted 2 lb. weight when doing my cardio exercises I was doing at the time.  This pain continued to worsen over the weeks and got real bad after the 2nd dose of Covid vaccine on 4/1/2020.  I was not able to sleep on my side because of the pain and would wake up during the night if i rolled over onto my shoulder.  In addition to the shoulder pain I noticed I had developed heart palpitations in early May.  I have never had palpitations before and had just completed a stress test in late March or early April had gotten a clean bill of health; certainly nothing showed up on the EKG.  I then saw a Orthopedic Doctor and was diagnosed with a "frozen shoulder" and did PT at home for 2-3 weeks.  I returned to the orthopedic doctor because the pain was not getting any better.  I was then ordered an MRI and completed that in late August.  Results did not show any structure damage.  It did show normal thinning of the rotator cuff and arthritis in the joint.  But I told my orthopedic doctor in November that the pain has now gone for the most part and I had stopped doing PT several months prior.  We both agreed that the shoulder pain was the result of the covid injection.  As for my heart palpitations, I wore a heart monitor for 6 days in August (then had to stop because of a reaction to the adhesive) but during the 3rd day of wearing this monitor the palpitations stopped and I no longer have them.  These palpitations were noticed at night when I laid my head on my pillow and happened 1-5 times per minute (when I laid down).  I again link the vaccine to these palpitations.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration from an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced pain, redness, swelling at the injection site on an unspecified date. Outcome of the events was unknown. Information on the lot number has been requested.
Started feeling a sore throat, fever, headache, and fatigue. Took a home COVID-19 test and was positive and was prescribed Paxlovid the same day. Symptoms gradually decreases over 5 days. Two weeks later I tested positive for COVID-19 again. Rested and quarantined.
Vaccine administered as ordered per protocol on 08/21/2003.  Patient had no visible reaction or problem immediately after administration or before leaving office.  On 08/25, patient phoned office stating she was having area of redness and warmth involving area of and surrounding injection site.  Was seen and evaluated on 08/25 initially, then again 08/26.
I was driving and pulled over, stopped to vomit and someone came over to my car and called 911. That's about all I remember. I went to the hospital and was there for several days and transferred to another hospital for additional care, I was there for three weeks and came home.
Extreme fatigue, joint pain, headache and lack of appetite. Took TYLENOL and later naproxen - neither of which helped. Currently at close to 36 hours since onset and still feeling horrible.
Pt was administered a Shingrix shot. called Next day & said he could barely move his (R) arm. Taking ibuprofen & somewhat better today. States shot was too high on shoulder.
RPH took a phone call from pt on 11/7/14 saying pt had swelling, redness at both injection sites that were significant. She went to her dermatologist to show. He told her to ice the area. Both were on pt's left arm per RPH. It was warm to touch.
Patient c/co - lightheadedness, tingling on L side of jaw, w/ peripheral tingling in bilateral feet. Pt given water for hydration, VS taken: 121/75 BG of 105 HR of 85 w/ O2 sat. of 98%. ED (Dr.) contacted, assessed for anaphylactic events - none noted. After 20 mins, patient reported relief w/ only dry mouth remaining. Pt believes it may have been an anxiety attack. Continuous monitoring applied. Patient washed face w/ water and relayed he was feeling fine and will now get something to eat. Pt released w/ no s/s reported.
tested positive for COVID/persistent cough; tested positive for COVID/persistent cough; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right on 14Jan2021 14:00 (Lot Number: EL3247) as dose 1, single; and administered in arm left on 04Feb2021 13:00 (Lot Number: EL3247) as dose 2, single both via an unspecified route of administration for covid-19 immunisation. Age at vaccination: 60 years old. The vaccine was administered at the workplace clinic. The patient medical history included she was diabetic type 2 from an unknown date. Concomitant medications included lisinopril; linagliptin, metformin hydrochloride (JENTADUETO); ezetimibe (ZETIA); semaglutide (OZEMPIC); and pravastatin; all were taken for an unspecified indication, start and stop date were not reported. She did not have any adverse event during or after her 2 vaccinations, 14Jan2021 or 04Feb2021. She started having a persistent cough on 17Sep2021. On 21Sep2021, she was notified that she was a primary contact of a person who had tested positive for COVID. She was tested on 21Sep2021 and her positive results was reported to her on 22Sep2021. She tested positive for COVID. It was explained that on 15Sep2021, she went to her daughter, home and found her daughter dead. She had passed away after she had talked with her three hours earlier with no indication of feeling bad or sickness. She was picking her up to go with her to an appointment. Her youngest daughter, tested positive for COVID on 21Sep2021 and notified her of this result. She immediately got tested and her results came back the next day (22Sep2021). During this time she was emotional and not thinking clearly about reporting this positive result. She returned to work on 15Oct2021 and then was out again on 18Oct2021. She was still very distraught over the sudden loss of her daughter. No treatment was received for the reported events. The outcome of the events was recovered in 2021.  As per Product Quality Complaint Group on 21Oct2021 it was concluded that the complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EL3247 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3247, fill lot EL3230, and the formulated drug product lot EL3223. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. No follow up attempts are needed. No further information is expected.
Pat complained of low grade fever after 2nd dose of Moderna. Temp ranges from 98.7 to 99.6F, subsided at noon.  This has been going on since 2nd dose on 3/6/20 to 5/3/2021.
12 patients were administered expired dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (12 patients were administered expired dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (12 patients were administered expired dose). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (12 patients were administered expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Itchy, redness, has spread around area where vaccine was administered. Symptoms started 4-13.
Had a large mass surrounding injection site that appeared 24 hr after injection, large reddened area and warm to the touch. Mass was painful and was there for about 3 days.
Blister (approx. 3/4 inch long) around site (left arm) where vaccine was administered with track of smaller lesions below.
tested positive for Covid the 1st week of May.; tested positive for Covid the 1st week of May; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer (patient) reported for himself that a male patient of an unspecified age received bnt162b2, dose 1 via an unspecified route of administration on 19Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received 1st Pfizer Covid vaccine on 19Apr2021 and tested positive for Covid the 1st week of May2021. The patient underwent lab tests and procedures which included Covid test: positive in May2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
administered booster dose 26 days early; This spontaneous case was reported by another health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered booster dose 26 days early) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered booster dose 26 days early). On 30-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered booster dose 26 days early) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. She declined that the patient experienced any side effects or symptoms that she is aware of.   Reporter did not allow further contact
102F fever from 9pm to 5am. Crushing headache top of head. Elevated heartrate of 120 bpm when resting heartrate is normally 60 bpm. These symptoms l lasted until 5am next morning (about 7.5 hrs total). Then fever broke, heartrate decreased slowly back to normal, headache went away. Next day just tired,  but didnt feel like I toyed eat anything until late afternoon.
The first time she had a "little flare up" that took her a couple of months to return to normal from; This is a spontaneous report from a contactable other health care professional. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 2, single for COVID-19 immunization. Medical history included unable to get up or get out of bed, joint plus ligaments painful, little swollen places on the bottoms of feet, rheumatoid arthritis. Concomitant medication included tofacitinib citrate (XELJANZ XR) taken for rheumatoid arthritis from 2020 to an unspecified stop date. The patient experienced a little flare up that took her a couple of months to return to normal from. The outcome of the event was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Based on the reported information ,a causal relationship between the event Rheumatoid Arthritis and suspected drug cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Per patient she could hardly move her arm for 2 to 3 wks & lost strength in same arm. Pain radiated up to her neck. Currently still has pain but not as severe as previously. Taking NSAIDS.
This is a spontaneous report from a contactable pharmacist. This report was received via a Pfizer sales representative. A patient of unspecified age, ethnicity and gender, received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced swelling and redness at the injection site after use of the product. The patient was ok. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
The left arm of the patient start with temperature and swelling at the injection site of the left arm on 2/14/19 one week later that the vaccine were administer.
injection site pain - 4 hours after the shot cold chills - 8-10 hours after the shot muscle pain - >24 hours after the shot fatigue -  8-10 hours after the shot headache - >24 hours after the shot
1 X 1  ? /vesicular area surrounded by firm warm now tender Pruritic red area 20 X 20 cm
Chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (fever) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 18-Feb-2021, the patient experienced CHILLS (Chills) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 20-Feb-2021, CHILLS (Chills) and PYREXIA (fever) had resolved. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-068489 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068489:Dose 1
24 hours post vaccine, experienced malaise, fatigue, and headache all of which persisted for 36 hours.  Eight days thereafter, experienced rapid onset of vertigo, vomiting, and slight diarrhea. Also notable were pressure in both ears, pain in both ears, headache, loss of balance, and dizziness. Upon seeing physical therapist, I was diagnosed with vestibular neuritis with BPPV.
lt peripheral (cranial nerve #7) facial nerve palsy;pt given pred to taper every day by 10mg;pt was advised to stay home & drink plenty of fluids until feels better;sx are slowly fading;
covered head to toe in hives; This case was reported by a consumer via call center representative and described the occurrence of hives in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had covered head to toe in hives.
Pregnant and received moderna vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 (Pregnant and received moderna vaccine). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received moderna vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medications were not reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
I'm a little off balance; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer(patient) reported that a patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Lot number was not reported, expiration date: Not reported), via an unspecified route of administration on Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient called due to takin the Pfizer-BioNTech COVID-19 Vaccine and stated that they gave the Pfizer vaccine yesterday, patient was little off balance on Mar2021. Patient had seizure medicine changed on Monday or Tuesday and feel like patient was off balance. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient had a syncopal event after the vaccination. She responded immediately to stimuli and was pale and diaphoretic upon assessment.
From initial correspondence received at manufacturer on 8/29/02 regarding an adverse event occurring during a Phase IV study for Tripedia. It was reported that a 4 year old male patient received a Tripedia vaccination on 8/26/02. Reportedly on 8/27/02 the patient was taken to the ER by his mom for evaluation of shortness of breath. He has a history of asthma and has only had one hospitalization in the past. He has a history of asthma and has albuterol only on a P.R.N. basis. His asthma in the past has been triggered by viral infections. Yesterday (8/27/02), he started with URI symptoms and shortly thereafter started to wheeze. His mom gave him two albuterol nebs this morning (8/28/02) and subsequently went into clinic. There, he was given another albuterol neb and was not started on prednisone. After returning home, the patient had continued ongoing wheezing and mom gave him another neb immediately prior to coming to the ER at 20:30. There are no fevers or chills. No cough. The patient received a total of three 5mg albuterol nebs. He also received 2 per kilo dose of Prelone. His weight is 18 kilograms. After his third neb the patient was reexamined. His respiratory rate at that time was still 40 with a heart rate of 175. He had bilateral wheezing with continued retractions. However, he did sound somewhat improved compared to his initial exam. The patient is going to be admitted to the hospital with a diagnosis of asthma flare. Laboratory studies were sent and are pending at the time of dictation. The patient was admitted to the floor in good condition. Subject hospitalized for exacerbation of asthma. On admission, there was an 8cm area of erythema and warmth over the left deltoid. Prescribed antibiotics during hospital stay due to local reaction at injection site. Upon examination several hours later, the injection site reaction had completely resolved. A small amount of tenderness remained, but no edema, erythema or warmth. Patient will receive intravenous fluids at maintenance until his appetite returns and vomiting ceases. Nebulized albuterol will be continued and spaced as soon as possible. Patient will be discharged when he is needing them no more frequently than 4-6 hours. From additional correspondence received at manufacturer, the resolution date of 8/29/02 was provided. **Follow-up report on 9/18/02: From follow-up #1 correspondence received at manufacturer on 9/5/02, it was reported that the PT had nebulizer treatments every hour overnight, but on discharge, treatments were spaced to every 4 hrs. No oxygen required. The PT was in the hospital for less than 3 days. PT was discharged on 8/29/02 w/the following treatment prescribed: Prednisolone 15mg by mouth 2x day for 2 days. Albuterol 2.5 mg nebs every 4 prn. Flovent 2 puffs every day. No further info. is anticipated, case closed.
experienced dizziness for 4 days following the shot then on day 7 following the vaccine, she developed an eye hemorrhage.
Swelling left arm, left breast, pain in left arm, breast area, lymph nodes, fever of 101.9
Rash first appeared 2-3 days post vaccines. Increased distribution entire body soles/palms by 06/04/02. Took infant to ER for eval, then follow-up at clinic 06/06/02. Hypersensitivity-drug induced urticaria probable vaccines. Baby well, normal activity level in process. Alert pending from ER visit. No medications at diagnosis, Diphenhist post diagnosis.
4th shot - PT 2 days after shot developed large local reaction to mid forearm with erythema, edema, mild tingling. No systemic Sx's.
Localized injection site reaction with significant arm pain that developed the night of the injection. Nausea, fatigue, headache developed within a few hrs of injection.
Patient received routine vaccines as above. Mom noted a few days later a small subcutaneous nodule in right thigh at administration site that has persisted at her 4 month visit