chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Small golf-ball size lump on my arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Small golf-ball size lump on my arm at injection site) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 037B21A) for COVID-19 vaccination.     The patient's past medical history included Pneumonia (pneumonia or some virus) from 03-Mar-2021 to 01-May-2021 and COVID-19 on 22-Jun-2021.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced VACCINATION SITE MASS (Small golf-ball size lump on my arm at injection site). On 21-Apr-2021, VACCINATION SITE MASS (Small golf-ball size lump on my arm at injection site) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jun-2021, Antibody test: inconclusive (Inconclusive) Blood donation- Antibody Test.         Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-080407 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Added patient demographics,relevant medical history(pneumonia,COVID-19),and event stop date.Updated outcome of the event.; Sender's Comments:  MOD-2021-080407:wife case
Patient experience nausea and vomiting and diarrhea.  She became dehydrated and had to go the ER.
RECEIVED PFIZER MONOVALENT INSTEAD OF BIVALENT AS 4TH SHOT.
Bruise at injection site and large area of redness with some swelling on arm under injection site. Reaction was local and no systemic reaction occurred. Patient will go to the emergency room.
fatigue; chills; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fatigue and chills. On an unknown date, the outcome of the fatigue and chills were recovered/resolved.   It was unknown if the reporter considered the fatigue and chills to be related to Shingrix.  Additional information was provided as follows: The reporter reported for her brother in-law.  The age at vaccination was not reported. Batch number details were not available. The received Shingrix year ago and experienced fatigue, chills, the symptoms resolved within 48 hours. The reporter did not consent to follow up. Medical doctor follow up was not provided. This case linked with US2020075689, reported by same reporter.
irritable p/1st immunizations; short lived tonic clonic sz right p/shots & 3 wk later;
Began to feel ill ( stomach pain / Headache ) ..  my skin became flushed ( face was very red ) blood pressure was elevated ( 180/90) I normally have low BP.
It feels like looking out of a train sitting in a forward position. So not looking in the reverse.; This is a spontaneous report from a contactable healthcare professional, nurse. A 44-year-old non-pregnant female patient received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in left arm on 04Mar2021 at 15:15 (at the age of 44-years-old). as a single dose for COVID-19 immunisation. The patient's medical history included allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications included montelukast sodium (MONTELUKAST), azelastine (MANUFACTURER UNKNOWN), fluticasone (MANUFACTURER UNKNOWN) and olopatadine (MANUFACTURER UNKNOWN) for unknown indications from an unknown duration. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in left arm on 11Feb2021 at 17:00, as a single dose for COVID-19 immunisation. On 05Mar2021 at 07:00, the patient had felt like she was looking out of a train sitting in a forward position, so not looking in the reverse. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as a result of adverse events. The clinical outcome of the event, felt like she was looking out of a train sitting in a forward position, so not looking in the reverse was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
severe swelling in joints for days-now over a wk;knees wrist, ankles swelled x 2 nl size, feels like needles pricking fingers;
Information has been received from a physician concerning a male pt who in approx 1979, 26 years ago plus, was vaccinated with a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Subsequently, the pt suffered from paralysis for two weeks. Unspecified medical attention was sought. Subsequently, the pt fully recovered. No product quality complaint was involved. It was noted that it was unclear if this was measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)  or measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (HPV-77). Upon internal review, paralysis was considered to be an other important medical event. No further information is available.
pt. had local reaction to the pneumovax vaccine in upper arm within 6 hours of vaccination, then this resolved after 3 days, then patient developed generalized lower exetremity arthralgias.  He is limited in his ability to walk, 2 Aleve have been unable to relieve his discomfort. of Note pt. had history of pneumonia in remote past.
Patient notified of PEDIARIX given in error, was to receive PREVNAR 13 (pneumococcal).
PATIENT WAS TO HAVE RECEIVE A BOOSTER DOSE (0.25ML) OF MODERNA COVID-19 VACCINE BUT WAS ADMINISTERED A FULL DOSE (0.5ML).  PATIENT REPORTED SORE ARM, FATIGUE AND SLIGHT FEVER UPTO 24-48 HOURS AFTER ADMINISTRATION.   AFTER 48 HOURS FELT FINE.
No reaction within the first 24 hours, within two weeks, I started having numbness when I would wake up in the morning my arm and thumb and finger would go numb, I started having intermittent shooting pain in my right arm. I reached out to Doctor, The nurse said to wear a wrist band 24/7 which helped me sleep. I do take tylenol to take the edge off. I still have numbness there all the time.
Mom came in to speak  about the situation. Mom thinks the shot was given to high. Pt has been using ice and ibuprofen.  Pt is have some soreness in the arm.
Within 2 hours of recieving Influenza Vaccine patient had a 2inch wide by 1 inch long egg shaped pink swollen area below the site of injection.Complaint of itching not warm to touch Seen by physcian on duty given tylenol benadryl and a cold pack.
This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender, who on unspecified dates were vaccinated with improperly stored doses of GARDASIL 9 (lot# M030380, expiry date 30-APR-2018) (dose and route were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA014070: US-009507513-1612USA011604: US-009507513-1612USA014072.
Muscle tightness; soreness at the injection site; This is a spontaneous report from a non-contactable consumer (patient). A 25-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration (left arm) on 14Jan2021 13:15 at single dose for Covid-19 immunization. The patient's medical history included Penicillin allergy (reported "known allergies: Penicillin". Concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Jan2021 (20:00), the patient experienced muscle tightness and soreness at the injection site up to 24 hours post injection. There was no treatment received for the adverse events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Mom states child would sleep for long intervals then wake up screaming until he threw up. Reports fever of 101.6 last pm, this AM low grade fever, left leg has large knot, red and swollen. On phone call  all night with 250Kids hotline.
intense pain in shot arm, headaches, fatigue, inability to focus.  muscle spasms in back and hamstrings.  Joint pain in back, knees, and wrists.
Onset of Left deltoid pain 24 hours after vaccine with numbness tingling to fingers 2-4
Patient had no symptoms or adverse effects/ No other adverse event; An expired dose of PROQUAD was given to a patient.; This vial had a different lot number and expiration date than all other vials of PROQUAD in the box./a box of PROQUAD came from Merck with one vial having a different lot number.; This spontaneous report was received from a medical assistant referring to a 4-year-old. child of unknown gender. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided.  On 08-JUL-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) subcutaneous injection, at the dose of 0.5 milliliter (mL), once (route of administration was not provided; lot number T030761 has been verified to be a valid lot number with expiration date on 08-MAR-2022) and was reconstituted with sterile diluent (MRK) at the dose of 0.5 milliliter (mL), once, both given as prophylaxis (lot number T025911 has been verified to be a valid lot number with expiration date on 08-MAR-2023).   The vial had a different lot number and expiration date than all other vials of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) in the box (product lot number issue) It was attempted to clarified whether the caller has mixed lots/expiration dates because of storage procedures at the clinic or whether she was reporting that a box of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) came from Merck with one vial having a different lot number. Caller stated she was unsure; she initially stated that she thought that this was a human error, but then later stated that "maybe it came from Merck this way". She stated that the vials were in the original Merck box and came to the clinic as part of a vaccines for children shipment but did not want to provide any further information. It was reported that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) had no history of temperature excursions. No other information and no other adverse event reported. .
Pfizer-BioNTech COVID-19 Vaccine EUA Symptoms: injection site pain, tiredness, headache, muscle pain, chills, nausea, feeling unwell  Outcomes: since I didn?t feel well I rested on 4/7 and lost my consciousness at around 6pm on 4/7 and fell down  to the front on floor. When I wake up, I found the I got injuries with my lip and teeth. My upper front teeth was broken.
On morning of 11/27/07 pt awoke with c/o itching and pain to upper left arm. On inspection noted area to be red and swollen approx size of a silver dollar. At 1230pm site reassessed a measured 3"x2" with increased swelling. Reported to Imm and then to Dr.
Sore injection site, headache, extreme fatigue, weakness, muscle aches, chills, 100 d fever, vomiting, nausea & diarrhea. Lasted 2  1/2 days.
25 yo G2P0 @ 37+1 pregnant with longstanding immune thrombocytopenia purpura with a routine CBC showing PLTs of 56 down from 119 1 month ago. Had J&J vaccine on 4/9.    - Lab repeated and confirmed - D/w MFM and Hematologist.  In an abundance of caution, will get coags, CMP, and P/cr urine ratio to evaluate for HELLP.  Will also get HIT antibodies to evaluate for possibility of Vaccine induced thrombocytopenia(VIT). - Will plan on treating with Dexamethasone 40mg Daily x 4 days to increase platelet count.  D/w hematologist, and he will see the patient and run the test for HIT antibodies (PF-4) and initiate IVIG treatment, which would help treat the low platelets either from exacerbation of ITP or VIT. If these come back positive, will likely transfer patient to HN for admission and delivery to be followed by therapeutic anticoagulation with non-heparin based therapy, consistent with usual therapy for HIT.
cellulitis; "reaction" started 1 day post-vaccination, "progressed rapidly", diagnosed as cellulitis by HCP 2 days post-vaccination
Pt recvd dose of Engerix-B on 19JUL91 & 8AM & @ 2PM same day exp itching sensation around neck, upper chest & arms; mild outbreak of hives, redness in this area became flushed; pt also felt clammy & dizzy; exp mild nausea;
Rash, UrticariaPruritus, NauseaVomiting, see below, one hive, tired Narrative: dose #1 2a redness itching, hive near hairline, face neck, tired; sore L arm, kept employee up all night, telehealth appt with PCP
30 minutes after my vaccination i had really bad chest tightness and heaviness it lasted about a week. I could not reach out and grab anything and was out of breath all the time. I had body fever and tiredness. I went to the doctor but they didn't run any test and just said that i was diagnosed with chest inflammation.
Pain and swelling of injection site (right deltoid) and swollen axillary lymph nodes on right side. 12 hours post injection: low grade fever (99.2), swelling of injection site, joint pain, fatigue. 24 hours post injection: fever (100), chills, joint pain, fatigue, sore throat, nasal stuffiness. 36 hours post injection: fever (102), chills, joint pain, fatigue, sore throat, nasal stuffiness. 48 hours post injection: joint pain, fatigue, sore throat, nasal stuffiness, cough. 5 days post injection: severe nosebleeds, 10x/day, heavy bleeding resulting in lightheadedness and pallor, nasal stuffiness, cough. 6 days post injection: moderate nosebleeds, 6x/day, moderate bleeding, nasal stuffiness, pallor 7 day post injection: mild nosebleeds, 3x/day light bleeding, nasal stuffiness, fatigue, pallor. 8 days post injection: fatigue, nasal stuffiness.
Headache; Itching; Feels like a bee sting, soreness; Whole arm is swollen; Red; Tired; Had fever; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 08-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), PAIN (Feels like a bee sting, soreness), SWELLING (Whole arm is swollen), ERYTHEMA (Red) and FATIGUE (Tired) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included IRBESARTAN and ATORVASTATIN for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PRURITUS (Itching), PAIN (Feels like a bee sting, soreness), SWELLING (Whole arm is swollen), ERYTHEMA (Red), FATIGUE (Tired), PYREXIA (Had fever) and CHILLS (Chills). On 06-Mar-2021, the patient experienced HEADACHE (Headache). At the time of the report, PRURITUS (Itching), PAIN (Feels like a bee sting, soreness), SWELLING (Whole arm is swollen), ERYTHEMA (Red), FATIGUE (Tired), PYREXIA (Had fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
Started w/numbness & tingling in hands & legs & then ascending paralysis; now diagnosed w/GBS;
received the first dose of GARDASIL 9 then did not come back for her second dose until a year.; No additional adverse event; This spontaneous report as received from a nurse via agent, referring to a 54 year old female patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not reported) and she did not come back for the second dose until a year later. No additional adverse events.
Narrative:  88 y/o male with a PMH significant for dementia, CVA hx, DM, HN, HLD, and GERD who received a first dose of COVID-19 vaccine on 3/2/2021. Patient had a "dizziness and weakness" reaction to Covid vaccine that made him go to local hospital (documented) sometime soon after. He was admitted for observation and then sent to rehabilitation for 3 weeks recovering. Treatment meds unknown as no document uploaded from hospital in patient EMR. Patient continues to have dizzy episodes and has been falling according to daughter (11/8/21). Patient is not planning to have second COVID-19 vaccine at this time.
4 days after receving vaccinations DTAP, IPV, MMR AND VARICELLA, patient had a seizure episode at day care on 03/08/13 at 10:00am. She also had 2 seizure episodes after being admitted in the PICU on 03/08/13 at 7:00 PM.
at the pharmacy, pt is 12+ years old (specifically 16 years old), was given 0.25 ml moderna bivalent when it should've been 0.5 mL full dose. pt was feeling ok, parent ok
Cellulitis at or around the spot that the vaccine would have been given in the left thigh
Td given, next day had rash on upper left arm and shoulder and both arm pits. Not on site of Td. Rash on 3 wk old tattoo, red raised rash now present x 1wk.
7 hours after the vaccination, muscle aches, chills and fever started.  By 10 hours, the fever was 102+ and stayed high for the next 10 hours.  The muscle aches, chills and fever made it almost impossible to sleep.   Also my sinuses ached.   I was extremely uncomfortable.  The next day the fever reduced to 100 - 101 but the other symptoms persisted, and I could barely stomach food or water.  This went on for another 12 hours.  On the third day I was able to get out of bed but was very weak.  I will not take Moderna vaccines in the future.
The first 14 hours I had fevers with up to 102.9, rigors, fatigue, headache these symptoms lasted over 6 days. Significant swelling of tongue where I couldn't close my mouth. I also  had a sore throat with pustules that were treated with antibiotics as well as swollen glands in my throat. Very similar to my symptoms from when I had COVID back in March 2020.  I was prescribed antibiotics for the swollen tongue and pustules.
Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced FATIGUE (Tiredness). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 04-Feb-2021, FATIGUE (Tiredness) had resolved.            This case was linked to MOD-2021-060833 (Patient Link).
magnet sticking/He can stick a magnet to arm and it sticks; 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 UNEVALUABLE EVENT (magnet sticking/He can stick a magnet to arm and it sticks) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 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 UNEVALUABLE EVENT (magnet sticking/He can stick a magnet to arm and it sticks). At the time of the report, UNEVALUABLE EVENT (magnet sticking/He can stick a magnet to arm and it sticks) outcome was unknown.      No concomitant medication information was provided.  Reporter stated that, he had 2 family members who got the vaccine. Reporter stated that 100 plus days later, which he had been tracking. He could stick a magnet to arm and it sticks. He had seen many videos online showing similar situation.   No treatment medication information was provided.
Hot, cold; EXTREME fatigue; joints on fire; knee caps tender to touch and painful; headache; strange dreams; inabilty to fully wake, unbalanced when standing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient. ~ A 69-year-old patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Aug2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Primary Immunization series complete), for COVID-19 immunization. The following information was reported: FEELING OF BODY TEMPERATURE CHANGE (non-serious), outcome "unknown", described as "Hot, cold"; FATIGUE (non-serious), outcome "unknown", described as "EXTREME fatigue"; ARTHROPATHY (non-serious), outcome "unknown", described as "joints on fire"; ARTHRALGIA (non-serious), outcome "unknown", described as "knee caps tender to touch and painful"; HEADACHE (non-serious), outcome "unknown"; ABNORMAL DREAMS (non-serious), outcome "unknown", described as "strange dreams"; DYSSTASIA (non-serious), outcome "unknown", described as "inabilty to fully wake, unbalanced when standing".  Additional information: the patient was vaccinated with the update COVID vaccine on 23Aug2023. The patient also have had all the Pfizer vaccines, but this one had the worst side effects. The patient is now 69 years old and thought the company may want to know for data. Hot, cold, EXTREME fatigue, joints on fire, knee caps tender to touch and painful, headache, strange dreams and inabilty to fully wake, unbalanced when standing.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
swelling  and redness of the arm .By Feb. 18th The swollen be came bigger and more red.
Patient came in 9 days after vaccine. Said a few days after administration she had swelling, redness and itching. Symptoms resolved after another 2-3 days.