chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At approximately 1400 an 11 yo female patient arrived at facility to get vaccinated (pfizer kids dose 1) with parent. She was directed to the wrong table and given the wrong color armband by registration clerk. She then sat down at the pfizer adult table where nurse (RN) failed to verify age and scribed status before administering the shot. The 11 yo patient received the adult pfizer dose of 0.3 mL, after scribing patient in the system, the error was noticed, parent was notified of error, she was then assessed by NP, patient remained stable throughout visit, vitals WNL, patient denied discomfort and was observed for 30 minutes before leaving facility and instructed to seek medical attention if any discomfort is experienced.
Headaches; Swollen glands on the right side of her neck; Swollen glands on the right side of her left; lymph nodes on the arm of injection are swollen; Feels terrible; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches), LYMPHADENOPATHY (Swollen glands on the right side of her neck), LYMPHADENOPATHY (Swollen glands on the right side of her left), VACCINATION SITE LYMPHADENOPATHY (lymph nodes on the arm of injection are swollen) and FEELING ABNORMAL (Feels terrible) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced FEELING ABNORMAL (Feels terrible). On an unknown date, the patient experienced HEADACHE (Headaches), LYMPHADENOPATHY (Swollen glands on the right side of her neck), LYMPHADENOPATHY (Swollen glands on the right side of her left) and VACCINATION SITE LYMPHADENOPATHY (lymph nodes on the arm of injection are swollen). At the time of the report, HEADACHE (Headaches), LYMPHADENOPATHY (Swollen glands on the right side of her neck), LYMPHADENOPATHY (Swollen glands on the right side of her left), VACCINATION SITE LYMPHADENOPATHY (lymph nodes on the arm of injection are swollen) and FEELING ABNORMAL (Feels terrible) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Pt had episode of syncopy after receiving the pfizer covid 19 vaccination 08/23/2021 at roughly noon. Technician administered vaccine and came into pharmacy from vaccination room to inform myself the pharmacist the patient needed assistance. I entered to room to the patient sitting in a chair and losing consciousness.  Evaluated patient for signs of anaphylaxis but realized patient was going into syncopy.  Asked patients mother to help assist patient to the floor our of the chair in order to elevate her feet above her head and informed her mother to support her head as to not let it contact the floor abruptly. As soon as patient on lying on back on floor I lifted her feet to my shoulder and she almost instantly regained consciousness. Had patient lie on floor with feet elevated for several minutes then relocated her to the chair. monitored patient several minutes she stated she was doing better, but shortly after stated she was experiencing syncopy again. Mother and I had patient lay down on floor again and elevate feet. While she was laying down I took her blood pressure which was recorded as 115/72 mmHg with a HR of 60bpm at 12:15pm MST. Patient remained laying down for several minutes and then we had her sit on the floor for several more minutes prior to relocating to the chair again. Once the patient was in the chair and stated she felt better I again monitored her blood pressure and the reading was 119/78 mmHg  with a HR of 73bpm at 12:20pm MST.  Patient remained in the chair in the vaccination room until 12:30pm MST after which relocated with her mother to the pharmacy waiting area and waited until 12:45pm MST with not adverse events/syncopy. Patient left the pharmacy with her mother at approximately 12:50 pm MST. I followed up with patients mother  between 4:30 to 4:45pm mst and she stated  patient was doing well.
After 5 min, my fingers swelled. After 45-50 min, my tongue and throat swelled. I treated them with antihistamine medication. It led to following days of abdominal pain/difficulty eating and crushing chest pain. All symptoms are indicative of systemic inflammation.  It took about 9 days to mostly resolve with home care and use of anti inflammatory herbs and antihistamines.
I had joint pain in my knees, lower back, hands, shoulders; I had joint pain in my knees, lower back, hands, shoulders; muscle pain; pain in my stomach; numbness in my arms, legs and face; weaknesses in her body; neck pains; mild headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on 15Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history included OA (osteoarthritis), RA (rheumatoid arthritis), both from unknown date and unknown if ongoing. Concomitant medications were not reported. Patient was petrified to get the 2nd dose and had a reaction after receiving the 1st dose on 15Mar2021. On an unspecified date patient had joint pain in my knees, lower back, hands, shoulders, had muscle pain, pain in my stomach, and had numbness in my arms, legs, and face. Patient not having so many effects anymore. It was reported that my doctor recommended I call Pfizer, I also will see a rheumatologist. I heard the second shot can be worse. 30 years ago, I had a vaccine that affected my joints as well. I am m trying to decide if I should risk getting the 2nd dose. Consumer had first COVAX on 15Mar2021 side effects of woke in the morning had effects like attacking her joints, she does have RA and OA, weaknesses in her body, mild headache, arms, and legs went numb and lower back and neck pains that came and went. Scheduled out for second one for 40 days out and she is afraid to have it. It was asked that what is the maximum of time between the 1st and 2nd dose and what happens if I dont get the 2nd dose, what if down the road in 1 year I decide to take it will I have had to start from scratch and does the vaccine contain any of the ingredients found in Besphosphanate drugs (like Actonel, Fosomax) which can cause Osteonecrosis. Revised, 06Apr2021 regarding osteonecrosis. Will there be any booster shots for other variants and response received was no information found on booster shots for variants. Studies still on going. Had anyone else reposted osteonecrosis with the product. No information found regarding osteonecrosis, no statistical data available to know if this has been reported. Did not find that there is fosomax, actonel, bisphosphonate in the product + disclaimer from attached VR provided. I explained that Bisphosphonates are a family of drugs used to treat osteoporosis referred to HCP to give more information on ingredients in those types of products and which would be the cause of the Osteonecrosis. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Dosing error (deviation for the recommended 100 mcg dose); A spontaneous report was received from a healthcare professional concerning a unknown patient who received Modern's COVID-19 vaccine (mRNA-1273) and doing error (deviation for the recommednded 100 mcg dose).  The patient's medical history and concomitant medication were not reported.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  The health care professional deviated the recommended dose 100 mcg (dosage error) on an unknown date.  No Laboratory details provided.  No treatment information was provided.   Action taken with second dose of mRNA-1273 in response to the events was not reported.  The event was considered resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273,  with no associated AEs.
Skin reaction starting night of 12/29. 12/30 swelling down to elbow & red on upper arm lasting until 12/31. 1/1/2020 redness & swelling improving.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 62-year-old male patient who received SHINGRIX (batch number B9739, expiry date unknown) for prophylaxis. On 12th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th June 2018, 1 days after receiving SHINGRIX, the patient experienced fever, general body pain and chills. On 13th June 2018, the outcome of the fever, general body pain and chills were recovered/resolved. It was unknown if the reporter considered the fever, general body pain and chills to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) reported that the patient who was a co-worker experienced fever, chills and body aches the day after receiving the SHINGRIX. The symptoms lasted for 4 hours and resolved.
Swelling, red raised area-diameter 3 inches, pain, heat, pain when wet (shower), sore arm.
Red rash developed on lower part of left arm from a few inches above elbow to half-way down forearm-- red blotchy rash -not raised - no itch - no reaction at site of administration on left arm - pt used otc hydrocortisone --2 applications the evening on 12/31/09 -- this was about 36hrs after injection - pt said this made some improvement in the rash - pt presented to pharmacy at 10:30 AM on Jan 1, 2010 and I witnessed the rash - instructed pt to continue wih hydrocortisone and moisturize with vaseline or Aquaphor or Eucerin- pt said he used Aveeno to moisturize - pt also was instructed to buy Benadryl tabs or caps.
Red blotches all over body; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red blotches all over body) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 040A21A) for COVID-19 vaccination.     Concomitant products included TAMSULOSIN for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced RASH MACULAR (Red blotches all over body). The patient was treated with TRIAMCINOLONE for Rash, at an unspecified dose and frequency and PREDNISONE ongoing since an unknown date for Rash, at a dose of 20 mg twice a day. At the time of the report, RASH MACULAR (Red blotches all over body) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter stated that the patient still has all red quarter size spots on his body, some days they are more clear, and some days they got very red. The Patient's doctor had said  that it might take about 6months for them to clear.   Most recent FOLLOW-UP information incorporated above includes: On 11-Sep-2021: Follow-up received added event details.
This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (don't want to eat, not quite nauseas / not have a lot of appetite), DIZZINESS (light headed), BONE PAIN (Horrible bones and muscle pains), ASTHENIA (felt really weak/feels weak/no energy and kind of weak) and CHILLS (horrible chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Depression and Insomnia. Concurrent medical conditions included Osteoporosis. Concomitant products included TRAZODONE from 15-Jan-2021 to an unknown date for Anxiety, MARIHUANA for Depression, DENOSUMAB (PROLIA), VITAMIN D [VITAMIN D NOS] and CALCIUM for Osteoporosis, MAGNESIUM for Restless leg syndrome, PROBIOTICS NOS and VITAMIN C [ASCORBIC ACID] for an unknown indication. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced DECREASED APPETITE (don't want to eat, not quite nauseas / not have a lot of appetite), BONE PAIN (Horrible bones and muscle pains), CHILLS (horrible chills), PYREXIA (99.4°F fever), MYALGIA (Horrible bones and muscle pains) and NAUSEA (extreme nausea). On 12-May-2021, the patient experienced DIZZINESS (light headed), ASTHENIA (felt really weak/feels weak/no energy and kind of weak), VOMITING (made herself vomit) and FATIGUE (fatigue). The patient was treated with FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 12-May-2021, BONE PAIN (Horrible bones and muscle pains), ASTHENIA (felt really weak/feels weak/no energy and kind of weak), CHILLS (horrible chills), PYREXIA (99.4°F fever), MYALGIA (Horrible bones and muscle pains), NAUSEA (extreme nausea) and VOMITING (made herself vomit) had resolved. At the time of the report, DECREASED APPETITE (don't want to eat, not quite nauseas / not have a lot of appetite), DIZZINESS (light headed) and FATIGUE (fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, Body temperature: 99.4°f 99.4°F. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient administers Migraine Medication as treatment. This case was linked to MOD-2021-133265. Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up document received on 06-Jul-2021, concomitant medication updated.
A serious report of abscess and postsurgical state/complication has been received from a study investigator concerning a four-year-old female participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 07-NOV-2008, the subject received FLUMIST. The subject was admitted to the hospital for abscess and postsurgical state/complication on 27-Nov-2008. The length of stay was one day. The outcome of the events was not reported. The investigator assessed the causality for the events to FLUMIST as not related. The severity of the events was mild. The sponsor also assessed the causality for the events as not related to FLUMIST.
Night sweats, reported fever, headache, weight loss of 10 lbs, loss of appetite, generalized aches and discomfort from 3 days following vaccine administration on 8/11/22 until evaluated by provider on 9/12/22.
Felt some of the vaccine go down her arm; Not administered at time with second dose; Felt some of the vaccine go down her arm; Inadverdant exposure; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date more than 6 moths ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced accidental underdose, drug dose administration interval too long, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the accidental underdose, drug dose administration interval too long, exposure via skin contact and inadvertent exposure to vaccine were unknown.  Additional details were provided as follows: The case was reported by patient who was nurse. The age at vaccination was not reported The patient was late on the 2nd dose of Shingrix, which led to lengthening of vaccination schedule. The nurse, stated when she received the 2nd dose, she felt some of the vaccine go down her arm, but the pharmacist who administered the vaccine does not recall this happening, which led to accidental underdose, exposure via skin contact and inadvertent exposure to vaccine.  The health care professional was asking if they could go ahead and administer another dose (possibly a 3rd dose) or was this dose valid. The patient had not received another dose at the time of reporting. The reporter was consented to follow.
brain fog; sleepy; basophils are a little elevated; orthostatic hypotension; dizziness; weakness; extreme burning in her lower extremities and hands; nerve pain 9 out of 10; This is a spontaneous report from a contactable nurse. A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ON5318), via an unspecified route of administration in the left arm on 08Feb2021 at a single dose for covid-19 immunisation. There were no medical history and concomitant medications. The patient has been having a lot of side effects. The patient experienced common weakness on 09Feb2021 which was expected, extreme burning in her lower extremities and hands but it was worse in her lower extremities which occurred 4-7 days after vaccination in Feb2021, orthostatic hypotension and dizziness on 12Feb2021, nerve pain 9 out of 10 in Feb2021 which has subsided as of 20Feb2021 or 21Feb2021, super weak, brain fog and sleepy on unknown date. As of 24Feb2021, patient still had orthostatic hypotension and weakness. Stated they have done a CBC on her and everything looks good, her basophils are a little elevated but it is nothing serious. The patient is concerned about the second dose, does not think patient is going to get it. Outcome of events weakness, orthostatic hypotension and dizziness was not recovered, events extreme burning in her lower extremities and hands and nerve pain 9 out of 10 was recovered in Feb2021. Outcome of other events was unknown.; Sender's Comments: The causal association between the reported event nerve pain which was 9 out of 10 according to the patient and the BNT162B2 COVID-19 vaccine 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 RAs, Ethics Committees, and Investigators, as appropriate.
tested positive for COVID-19; swelling; redness; fever; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19), SWELLING (swelling), ERYTHEMA (redness), PYREXIA (fever) and HEADACHE (headache) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced SWELLING (swelling), ERYTHEMA (redness), PYREXIA (fever), HEADACHE (headache) and FATIGUE (fatigue). On 14-Feb-2021, the patient experienced COVID-19 (tested positive for COVID-19). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN (ROBITUSSIN DM) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive for COVID-19), SWELLING (swelling), ERYTHEMA (redness), PYREXIA (fever), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, SARS-CoV-2 test positive: positive (Positive) Tested positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
2/15 pain to right deltoid through the night and complains of discomfort treated with APAP for 3 days. 2/18/2022 Resident requires help with eating due to pain in right shoulder 2/21/2022 Requires more assistance with transfer via Hoyer lift instead of 2 person assist 2/22/2022 Pain 9/10 to right shoulder, unrelieved with APAP. 2/22/2022 NP see's resident for clinic visit. Reports inflamation to right shoulder at injection site. Prescribes ice packs, continue aPAP and voltaren gel as needed for pain,
Low grade fever, decreased oral intake and rash about 12d after vaccine blanching papular rash in crop - 1 mm papules on trunk and arms. - vesicles - crusting, + vesicles and papules in posterior pharynx
Within one hour of receiving the shot, had severe arm soreness. Within the next five hours, developed GI problems (diarrhea), nausea, light headedness, chills, and lower abdominal cramps. All of these symptoms persisted to the next day (01/21/21).
This case was reported by a nurse practitioner and described the occurrence of wrist and hand swelling in an adult female pt who received hep B vaccine recombinant (Engerix B). The pt had a medical history of allergy to intravenous pyelogram dye. Concurrent medications included aspirin, progesterone and estrogen. On 05Jan04, the pt received the first dose of Engerix B injected into her left arm. The following day, the pt telephoned the physician's office and reported that on 05Jan04 she experienced swelling, pain and soreness in her right wrist and hand and difficulty sleeping. The reporter noted that the pt had been in the midst of a home remodel, but did not recall any specific injury. According to the nurse practitioner, the joint complaints had not been evaluated by a physician. At the time of reporting on 23Feb04, the immunization series had been neither discontinued nor delayed; however, no further doses had been administered. The events resolved. The nurse practitioner considered the events to be possibly related to vaccination with Engerix B.
Chest pain focused beneath breast bone. Worsen with exertion like running. At worst it was 6/10 but relieved with rest. No SOB, N/V, no radiation or other symptoms. Reported symptoms to primary care provider who referred him to cardiologist. The cardiologist diagnosed him with pericarditis due to COVID-19 vaccination. Recommended treatment with ibuprofen 800mg TID x 5d. Patient's symptoms resolved after a few days.
Headache, Myalgia, Arthralgia, Fever, Chills,Shivering, Right arm soreness, Fatigue, Weakness Narrative: