chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 26-SEP-2017, the patient was vaccinated with VARIVAX lot # N019127 with expiration date 22-JUN-2019 (strength, dose, frequency, route of administration were not provided) for prophylaxis. The sterile diluent (unknown lot and unknown expiration date) use for reconstitution did not undergo a temperature excursion. No adverse effects reported. Administered doses of vaccines experienced the temperature excursion of -9 degrees Celsius to 8 degrees Celsius for 1 hour/53 minutes. Previous excursions included -14 degrees Celsius to -10 degrees Celsius for 4 hours/45 minutes and -9 degrees Celsius to 8 degrees Celsius for 1 hour/44 minutes. Data logger was involved.
Pt stated following day after the vaccine, there was swelling at injection site and numbness going down the arm and leg (starting at the thigh).  Numbness lasted for 2 days.  Pt did not take any medication or seek any medical attention.  After two days, pt regained sensations again.
This is a spontaneous report from a contactable consumer via a Pfizer sales representative. A patient of unspecified age, race/ethnicity and gender received TRUMENBA on an unspecified date, at single dose, for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm soreness and arm swelling, both on an unspecified date after vaccination, with unknown outcome.
CHILD WAS SENT HOME FROM SCHOOL BECAUSE SHE WAS THROWING UP SHE STAYED IN BED FOR THE NEXT 3 DAYS & SO I TOOK HER TO DR & SHE TESTED POSITIVE FOR COVID
4-6-21 PT RECIEVED PFIZER AS SECOND DOSE OF COVID VACCINE INSTEAD OF MODERNA.   4-7-21 9AM TC: PT STATES SHE GOT DOSE #1 OF MODERNA EXPLAINED ERROR OF PFIZER DOSE #2. EXPLAINED THAT THERE IS NO ADVERSE EFFECT AND THAT SHE WILL STILL HAVE PROTECTION (ANTIBODIES) AND THAT THERE IS NO NEED TO REPEAT DOSE #2. PT VOICED UNDERSTANDING. STATES SHE IS NOT HAVING ANY SYMPTOMS.
Patient's sister, called to inform us that patient received her Pfizer booster vaccine on 10/5/21. Patient did not experience any symptoms/side effects (sister) on 10/5/21; however, patient had a heart on 10/6/21 and later passed away on 10/7/21.
Pain lymph node after first shot; Swelling lymph node after first shot; Loss of appetite after first shot; Fatigue after first shot; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite after first shot), LYMPH NODE PAIN (Pain lymph node after first shot), FATIGUE (Fatigue after first shot) and LYMPHADENOPATHY (Swelling lymph node after first shot) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced DECREASED APPETITE (Loss of appetite after first shot) and FATIGUE (Fatigue after first shot). On 02-Nov-2021, the patient experienced LYMPH NODE PAIN (Pain lymph node after first shot) and LYMPHADENOPATHY (Swelling lymph node after first shot). On 01-Nov-2021, DECREASED APPETITE (Loss of appetite after first shot) and FATIGUE (Fatigue after first shot) had resolved. On 04-Nov-2021, LYMPH NODE PAIN (Pain lymph node after first shot) and LYMPHADENOPATHY (Swelling lymph node after first shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.   This case was linked to MOD-2021-405144 (Patient Link).
Mom noted redness in (L) thigh, with induration. Minimal pain. Noted the following morning after injection. See in clinic today 2 x 2.5 cm macule with 1 cm induration. Rec: observation and reassurance.
Woke up 14 hours after the shot feeling like I was going to vomit and hot sweats.  Also, has a slight headache.  Did not have a temperature.  I went back to sleep and had a headache until 24 hours after the shot.  Arm was sore after the shot and still slightly sore.
Vaccine administered that was outside the allowed time frame at  room temperature.; vial that had been set out at room temperature; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered that was outside the allowed time frame at  room temperature.) and PRODUCT STORAGE ERROR (vial that had been set out at room temperature) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 017B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jul-2022 at 10:30 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Jul-2022, the patient experienced PRODUCT STORAGE ERROR (vial that had been set out at room temperature). On 08-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered that was outside the allowed time frame at  room temperature.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered that was outside the allowed time frame at  room temperature.) and PRODUCT STORAGE ERROR (vial that had been set out at room temperature) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported. It was reported that the Moderna (red-capped) had been set out at room temperature on 7/Jul/22 at 9:40 AM.
Information has been received from a registered nurse refers to a current 48 years old female patient with no pertinent medical history. It was reported that the patient who was a nurse came down with rash after receiving M-M-R II(lot number reported as H012142, expiration date 29-JUL-2014) on 28-NOV-2012. No other co-suspects were reported. There were no concomitant medications. The patient received M-M-R II as a child vaccine however, her titer was negative for rubella and therefore, patient had to receive another dose. On 10-DEC-2012, patient started developing rash all over her body. Rashes were described as little raised and a few spots were clustered together on different parts of her body but on patient's chest, rash looked more generalized. The patient also complained of itching around rash. No treatment was given for adverse event. No diagnostics studies were performed. The patient had sought medical attention via office visit. The outcome of adverse event was not provided. This is one of several reports received from the same source. Additional information has been requested.
Patient came for a COVID 19 vaccine filled out consent form and put DOB of 5/1/2005. Patient had not been to any pharmacies previously so a new patient profile was created. Patient's actual DOB as provided by the MIIC after the vaccination was 1/19/2006. We called the patient to let them know that they would be unable to get a second dose, however the FDA approved the vaccine for ages 11-15 the next day so we called the patient back to tell them to schedule their second dose. No answer from patient. Patient did not answer when we initially called if there were any adverse reactions.
After the 1st injection I couldn't catch my breath 10 minutes after the injection.  My blood pressure was 180/95 - my normal pulse is 120/70.  In the weeks after that injection I was more tired than usual.  My reaction to the second injection was similar - BP was 150/90 and I couldn't catch my breath.  In the weeks after the 2nd injection I was even more tired.  4 weeks after the second injection I couldn't engage in any activities for 96 hours.  Since then, my physician tentatively diagnosed me with systemic exertional intolerance syndrome (myalgic encephalomypathy).
Dry mouth; rapid heart rate; fuzzy feeling in middle of forehead; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date was not provided) solution for injection, intramuscular from 21Dec2020 11:15 at a single dose for Covid-19 immunisation. Medical history included PVC's (Premature ventricular contractions). Concomitant medication included ibuprofen. The patient received the dose number 1 of the vaccine at a hospital and experienced dry mouth, rapid heart rate, and fuzzy feeling in middle of forehead on 21Dec2020 11:15. No treatment was administered. The events were reported as non-serious. Patient was not pregnant. Patient was not diagnosed with Covid-19 prior to vaccination and has not been tested. Outcome of the events was recovering.    No follow-up activities are needed. No further information is expected.
Pt returned to clinic after 20 minutes c/o puffy, itchy eyes and headache. Gave benadryl 50mg po at 9:45. BP 12/64, respirations 14. After 20 minutes pt was feeling better and left clinic.
8/4/21: Pt presents with fever cough SOB and low oxygen saturation. Pt states that he went to a family gathering around 7/23/21. He started having symptoms with low-grade fever cough general malaise and eventually worsened, specifically the cough and lack of energy.  His oxygen saturation was dropping and decided to come to the hospital for further evaluation and treatment.  Many other members of the family got sick as well.  He denies any chest pain at this moment and he reported that the fever subsided already. Of note, pt received Pfizer COVID vaccine, last admin March 2021 8/4/2021: Pt tested COVID Positive  8/16/21: Patient still admitted as of this report submission
Stomach cramps; Diarrhea; My stomach is so sore and I cannot stand it, it is like the nervous stomach; My stomach is so sore and I cannot stand it; Some anxiety with the taste, it is kind of like something stuck in my throat and still going on; it is kind of like something stuck in my throat; it's like something in your throat; anxiety; arm got sore; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 07Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. About 3 or 4 days after vaccine, took on the 07Aug2021 and was due to take the next one on the 28th. On an unspecified date, the patient experienced stomach cramps, diarrhea, my stomach is so sore and i cannot stand it, it is like the nervous stomach, my stomach is so sore and i cannot stand it, some anxiety with the taste, it is kind of like something stuck in my throat and still going on, it is kind of like something stuck in my throat, it's like something in your throat, anxiety and arm got sore. The outcome of the event taste abnormality was unknown and rest events was not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient slumped to her right while sitting. She jerked twice while mother tried to sit her up.  She then was alert but skin was damp and clammy.  She also experienced nausea a few minutes later and tried to vomit but did not
SARS-COV-19 Infection. Congestion, runny nose, fever, headache, shortness of breath. Fully vaccinated as of 26 January with second booster of Moderna, Lot No. not recorded in patient record.
Patient received the first dose of the Moderna COVID-19 vaccine on Tuesday (03/23/2021) at 10 AM on her left arm. She did not feel the injection. No immediate symptoms after the injection. Before 1 PM, she developed itching at injection site and started to scratch her arm. Noticed ~5 visible bumps around injection site. She started to feel hotness on the injection site. Patient noticed that she also had hives on her right arm and one hive on her abdomen. She was on her way to work. Went to the pharmacist and told them about her hives. Was recommended to take cetirizine. Took cetirizine, hives were relieved but notes she was still feeling itchy. Had itching on legs, stomach, arms, face throughout the day. Patient worked from 1:30 - 11:00 PM. Did not do a lot of heavy lifting. Was working in her office and around the store. After her shift, patient still had itching. She also noticed swelling on her cheeks, from her outer lips towards her cheeks. Took diphenhydramine and went to sleep. On Wednesday (03/24) morning, she had red lips and lip swelling, as well as facial swelling. Has never had dermal fillers. She was feeling very itchy, especially on her face. Took diphenhydramine, swelling improved. Patient was taking diphenhydramine every 6 hours. Took one diphenhydramine yesterday 3/25. Has not been taking cetirizine. When she is taking diphenhydramine, patient does not have itching. Patient still feels some itching if she does not take diphenhydramine. No lip tingling. Ongoing itching and hives. I instructed her to take Xyzal tablets (which do NOT contain polyethylene glycol) instead of Zyrtec or Benadryl tablets.   She is scheduled for allergy testing in 2 weeks, if her urticaria has resolved.
Diffuse erythematous papular eruption, itchy, on fore/arms/trunk/thighs.
Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Arm pain) in a female patient of an unknown age who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced INJECTION SITE PAIN (Arm pain). At the time of the report, INJECTION SITE PAIN (Arm pain) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Arthritis in knee; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis in knee) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ATORVASTATIN for Joint pain.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and ATORVASTATIN (unknown route) at an unspecified dose. On an unknown date, the patient experienced ARTHRITIS (Arthritis in knee). At the time of the report, ARTHRITIS (Arthritis in knee) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medications was provided.
swollen face; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swollen face) 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 (No medical history was reported. ).    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced SWELLING FACE (swollen face). At the time of the report, SWELLING FACE (swollen face) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Patient came to the emergency department on 02/02/2020 at 2:30 pm to be evaluated for possible stroke due to sudden acute numbness, weakness in right wrist and arm, but no pain. Patient has no prior history of sudden acute numbness in arm and did not report any recent injury to his arm. Neurologist evaluated patient for possible stroke and patient was unable to lift right wrist and hand. Patient was able to lift both arms overhead, lift both legs, smile normal, open and close mouth and move tongue.  Both CT Scan and MRI were normal. Neurologist and emergency medical specialist determined that patient did not have a stroke and diagnosed acute brachial plexus palsy possibly due to patient sleeping in an awkward position. Emergency specialist said it was unlikely but could not rule out the possibility of an adverse reaction to the Moderna vaccine, which patient had received 10 days earlier (second dose, see details above.)
Myalgia, Fever, chills Narrative: Stayed home from work on 1/21/21 for subjective fever, chills myalgia after recieving covid vaccine 1/20/21
I had body ache and pains. I had little bit of chills. These lasted about 2 days.
The evening after the injection and the next day she got a headache, chills, was feverish and "felt very out of it." She also had pain and weakness in her left arm, which was followed by redness, pain, and a feeling of hardness to the skin about 3 inches above her elbow.
Pt reports 2 days after vaccine  having swelling in joints, hands, and facial area.  Numbness/tingling in hands b/l. Reports still having numbness/tingling in hands as well as swelling in facial area
EXPIRED DOSE OF THE VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-SEP-2021, the patient experienced expired dose of the vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired dose of the vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211012114, 20211012141, 20211012209 and 20211012383.
24 hours after patient received Shingrix vaccine she began to notice a shingles like rash on her left chest that radiated down her left arm. She began experiencing a burning, painful rash in the same area as her blisters. She presented to the clinic 9/22/21 for evaluation of her rash and was diagnosed with shingles. Valacyclovir 1 gm every 8 hours for 7 days prescribed.
I have had 3 shots. 2-10-21 (016m2014), 3-10-21 (041l2014) and 8-31-2021 (038c21a).  I started having sinus problems the week of April 5 and was coughing a lot during the month of April. Mid May I started losing a lot of weight, (50 lbs.!!) and started having pain and swelling in my lower extremities. During June and July I was in extreme pain and could barely walk. I started feeling better in August, but still had the problems with my feet and ankles. I was sent to a Rhuemotologist  at the end of August who diagnosed me with Vasculitis and have been taking Steroids since then which made a difference. I did not think there was any connection to the vaccine until my doctors recommended I get the booster shot as my immune system was compromised and I was taking steroids. The day after I got the booster shot my symptoms came back and I am still not feeling as good as I was before it.
Lost smell; lost taste; legs got real weak; itchy arm; A little lump and going down now; redness; Sleepy and weak; Sleepy and weak; Left eye swelled up; Knee and legs painful; problem walking; swollen arm; Knee and legs painful; Hot and Cold chills continued for 24 hours; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Knee and legs painful), GAIT DISTURBANCE (problem walking), PERIPHERAL SWELLING (swollen arm), ANOSMIA (Lost smell) and AGEUSIA (lost taste) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced HEADACHE (Headache). On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Knee and legs painful), GAIT DISTURBANCE (problem walking), PERIPHERAL SWELLING (swollen arm), MUSCULAR WEAKNESS (legs got real weak), PRURITUS (itchy arm), VACCINATION SITE MASS (A little lump and going down now), ERYTHEMA (redness), SOMNOLENCE (Sleepy and weak), ASTHENIA (Sleepy and weak), EYE SWELLING (Left eye swelled up), ARTHRALGIA (Knee and legs painful) and CHILLS (Hot and Cold chills continued for 24 hours). On 27-Feb-2021, the patient experienced ANOSMIA (Lost smell) and AGEUSIA (lost taste). At the time of the report, PAIN IN EXTREMITY (Knee and legs painful), GAIT DISTURBANCE (problem walking), PERIPHERAL SWELLING (swollen arm), ANOSMIA (Lost smell), AGEUSIA (lost taste), MUSCULAR WEAKNESS (legs got real weak), PRURITUS (itchy arm), VACCINATION SITE MASS (A little lump and going down now), ERYTHEMA (redness), SOMNOLENCE (Sleepy and weak), ASTHENIA (Sleepy and weak), EYE SWELLING (Left eye swelled up), HEADACHE (Headache) and ARTHRALGIA (Knee and legs painful) outcome was unknown and CHILLS (Hot and Cold chills continued for 24 hours) had resolved.            No concomitant medications were reported.  No laboratory details were  provided.  Treatment medication included Tylenol.  Action taken with mRNA-1273 in response to the events was not applicable.
16-17 Feb:  low fever (99.8), chills, headaches, dizziness, gas; no meds taken 18 Feb:  intermittent abdominal pain for first 3 hrs upon waking, hasn't re-occurred, no meds taken 19 Feb:  rash on chest, triceps, ankles, dissipated by end of day, no meds taken 20 Feb:  upon waking had hives in groin area, inside of right arm, wrists, around waist area, dissipated after ~6 hrs, no meds taken 20 Feb:  upper lip swollen, so far for 3.5 hrs, 25 mg Benadryl taken at 3 hr mark (1 hr ago), no impact yet
pain in the injected arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in the injected arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Arthritis.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain in the injected arm). The patient was treated with NAPROXEN SODIUM (ALEVE) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (pain in the injected arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included high blood pressure and arthritis medications. Treatment information include: applied Ice and heat on painful areas.
During the week following the vaccine, I developed significant muscle/tendon pain in neck as well as forearms, and signficant "buzzing" in nerves in my forearms and to a lesser degree the tops of my feet. It mostly subsided by 8 days later.  6-7 days after the vaccine, I developed the "COVID arm" which is a large red, flat, 2" x 4-5" oval at injection site. It is itchy and sore.