chrisvoncsefalvay/vaers-outcomes huggingface dataset:
15JAN98 mom reported redness & swelling @ the site of inj noted AM as day progressed pt exp itching, further swelling & redness @ inj site, affecting the upper arm;seen in office 16JAN98;area of induration was 9x9cm, warm, red, swollen;
breastfeeding twice a day; dizziness; This spontaneous case was reported by a nurse and describes the occurrence of EXPOSURE VIA BREAST MILK (breastfeeding twice a day) and DIZZINESS (dizziness) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 07-Feb-2021, the patient experienced DIZZINESS (dizziness). On an unknown date, the patient experienced EXPOSURE VIA BREAST MILK (breastfeeding twice a day). At the time of the report, EXPOSURE VIA BREAST MILK (breastfeeding twice a day) and DIZZINESS (dizziness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.    Treatment information was not provided by the reporter Action taken with mRNA-1273 in response to the events  was not applicable.   This case was linked to MOD-2021-017385.   See case MOD-2021-017385 for details regarding the child case.
Within 10 minutes, patient was feeling weak, dizzy, and lightheaded. Patient was advised to sit and perform vasovagal maneuvers. Episode resolved within 10 minutes of onset. Patient left pharmacy of her own accord.
Patient presented from their GI to have Hep B and VARIVAX repeated prior to planned HUMIRA therapy. Vaccine given and I then contacted Infectious Disease and they advised patient is mildly immunosuppressed and recommended post exposure prophylaxis with acyclovir 5 times/d x 2wk. She is on current acyclovir.
I had a head-splitting headache and body aches. I would not take this vaccine again.
Given 4th Dose should have bee 0.25 dose but received 0.5ml
This spontaneous report as received from a physician via company representative refers to a 71 year old male patient. The patient's concurrent condition, medical history and concomitant medications were not provided. On 08-JAN-2014, the patient was vaccinated with ZOSTAVAX for prophylaxis (dose, route of administration, lot # and exp date not provided). On an unknown date, the patient developed a case of shingles on his forehead. Patient visited physician on an unknown date after having the case of shingles "for a week" at which the physician prescribed an unspecified antiviral medication as a treatment. The outcome of event was unknown. Causality assessment was not provided.
severe pain in her back and legs; severe pain in her back and legs; This is a spontaneous report received from a contactable consumer (patient) via a medical information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medication was not reported. The patient had experienced severe pain in her back and legs caused by her vertebrae and will be receiving a shot on her spine on 28Apr2021. She asked if it will be okay for her to receive the 2nd dose as scheduled. Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Two weeks of the most horrible illness; Initial information received on 24-Nov-2022 regarding an unsolicited valid social media non-serious case received from a Patient.  This case involves an unknown age and unknown gender patient who experienced two weeks of the most horrible illness after receiving vaccine INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site) for Prophylactic vaccination(Immunization).  On an unknown date the patient developed a non-serious event two weeks of the most horrible illness (illness) unknown latency following the administration of INFLUENZA VACCINE.  It was reported Author/Reporter Comment: I was averaging one flu every 10 years or so. Not any more. Haven't had the flu since 2007. I had one shot in 1981 and I thought I was going to die. Two weeks of the most horrible illness I've ever been through. NEVER, EVER AGAIN!  It was unknown if there were lab data/results available.  Action taken : Not applicable.  It was not reported if the patient received a corrective treatment for the event (Two weeks of the most horrible illness).  At time of reporting, the outcome was Unknown for the event two weeks of the most horrible illness.
Shivering, and sore at 8 pm that night. Migraine, nausea, weekness from Sunday 7 am to Monday 7am.
approx 10days p/vax pt exp fever 105f. no further info avail
Two days post vax, the pt developed myalgia and prolonged pain at the injection site. She recovered. The pt later reported that she had been lifting a lot of boxes and considered that to be the cause of the pain.
I am experiencing Bells' palsy and don't knowwhat to do about it.; A spontaneous report  was received from a consumer concerning a unknown age, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's palsy/facial paralysis.   The patient's medical history was not  provided by the reporter. Concomitant medications were not reported .   On unspecified date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) through unknown route for prophylaxis of COVID-19 infection.   On unspecified date, after vaccination patient experienced Bell's palsy. Treatment for the event was not provided. Lab details were not provided. The event was medically significant.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of Bell's palsy was considered unknown.; Reporter's Comments: This case concerns a female of unknown age who had a serious unexpected event of Bell's palsy (facial paralysis). Event onset occurred with unknown latency after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
The morning after my shot I noticed extreme tenderness in my left armpit of the arm I got the shot. As my day went on there was extremely noticeable swelling, tenderness, and pain when touching or abruptly moving the armor site area.
As described by patient: arm pain up through shoulder to neck, severe headache, fever, overall feeling tired. Asked patient about location of vaccine: about 4 inches below the joint. No outcomes reported yet. Advised patient to seek medical treatment if no improvement or if condition worsens.
Patient experienced a brief (less than 15 second) tonic seizure 30-60 seconds after receiving HPV vaccine. He was seated. The seizure began immediately after receiving a second vaccine (influenza).  I was present for entire event. He responded to my questions within 30 seconds. He was conversing and describing his feelings within a minute. He then had a brief vagal reaction (while seated) with diaphoresis and pallor but that was self-limited and brief and without any tonic movements. At that point we had him lie supine for 10 -15 minutes. He was observed for 25 minutes total. He left the office ambulating and stating he felt normal.
8 days later injection site became hot, swelling and hard. By morning of day 9 it covered most of upper arm.
Arm pain; Sleepy; Got tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), SOMNOLENCE (Sleepy) and FATIGUE (Got tired) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), SOMNOLENCE (Sleepy) and FATIGUE (Got tired). At the time of the report, PAIN IN EXTREMITY (Arm pain), SOMNOLENCE (Sleepy) and FATIGUE (Got tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medication was provided.  No treatment medication was reported.
The patient came in to see the doctor with a case of the shingles. Patient was advised to apply cold compresses 4 times a day for 20 minutes to relieve pain or itching. Good handwashing to prevent the spread of germs. Acyclovir 800mg tablets twice daily. Gabapentin 300mg capsule at bedtime. Zovirax 5% external ointment applied three times a day.
Peripheral vision loss the morning after the first covid vaccine, confusion over the weekend (approximately 4/2/21-4/6/21), Went to hospital Tuesday 4/6/21. Did MRI and determined patient had a stroke. Doctor said event was "fairly new." Patient was hospitalized almost 3 weeks. Doctors called it "embolic shower," said he may have had more than one stroke. They are calling in a stroke of "unknown origin" Patient currently still has short-term memory problems, blindness in right eye, and had to start dialysis treatments when in hospital, is still on dialysis.
I had a painful arm and flu like symptoms for about a day after receiving the vaccine. I tested positive for COVID-19 on 11/30/2022. I did not contact my doctor and just took over the counter medication to relieve my symptoms.
Cheek swelling; Periorbital swelling/swelling around his eyes; feeling wiped out; Muscle pain; Joint pain; Chills; Fever; General malaise; low grade headache; Sweating; injection site pain; This is a spontaneous report from a contactable physician (patient).   A 65-year-old male patient received bnt162b2 (BNT162B2) at single dose at left deltoid on 02Jan2021 17:00 for covid-19 immunisation, administered an injection team that is part of the local hospital system.  Medical history included controlled hypertension and he has been taking the blood pressure medicine for a long time. The concomitant medications included unspecified medicines for controlled hypertension. History of all previous immunization with the Pfizer vaccine was none. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. No additional vaccines administered on same date of the BNT162B2 vaccine. On 02Jan2021 the patient experienced injection site pain. On 03Jan2021 the patient experienced cheek swelling, periorbital swelling/swelling around his eyes, feeling wiped out, muscle pain, joint pain, chills, fever, general malaise, low grade headache, sweating. No event did require a visit to Emergency Room or Physician Office. No relevant tests performed. Therapeutic measures were taken as a result of chills, fever, general malaise, low grade headache, sweating. Course of events: He said initially he had no adverse events after receiving the COVID-19 Vaccine, except injection site pain. He said he thought the injection site pain could be from the COVID-19 Vaccine being viscous, and didn't think anything else about the injection site pain. On 03Jan2021 he started to experience some. He stated he did not normally take vaccines, like the flu vaccine. He said he has been a podiatrist for 39 years, and realized the importance of getting the vaccine to protect his patients. He then developed chills, muscle pain, fever, and general malaise. He said he experienced every side effect listed on the received COVID-19 Vaccine paperwork, except he had no lymphadenopathy.  He said all the side effects he experienced appeared 24 hours to the minute from when he received the COVID-19 Vaccine. On 03Jan2021, he had swelling in his cheeks and around his eyes. He did not get sick often. He said he had a rough night on 03Jan2021 and on 03Jan2021 he still felt wiped out. Treatment: he took 2 Tylenol 325mg at the start of the side effects, and then took another 2 Tylenol 325mg at 2:00AM. He said he woke up soaking wet with chills and sweats. He said his fever broke, but he did not know how high his fever was. He took from a fresh bottle of Tylenol 325mg. The outcome of injection site pain, cheek swelling, periorbital swelling/swelling around his eyes, feeling wiped out, muscle pain, joint pain, general malaise was recovering, of chills, fever, sweating was recovered in Jan2021, of low grade headache was not recovered.  The reporter considered there was a reasonable possibility that all events were related to bnt162b2 vaccine.  He was scheduled to receive another COVID-19 Vaccine injection in 3 weeks.  Information about lot/batch number has been requested.
Fatigue; Headache; Vomiting; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), VOMITING (Vomiting), PYREXIA (Fever) and CHILLS (Chills) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), VOMITING (Vomiting), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache), VOMITING (Vomiting), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Muscle pain, redness, swelling, heat at injection site, headache, nausea - ongoing three days.
Benign acute childhood myocitis, onset 10/25 afternoon, worsened through 10/27, gradually improved starting AM 10/28, no further symptoms by AM 10/29.
POTENTIAL DEEP VEIN THROMBOSIS; SMALL BLOOD CLOT; ANKLE CALF BOTH SWOLLEN; This spontaneous self-report was received from a patient and concerned a 64 year old female. The patient's height and weight were not reported. The patient's concurrent conditions included no known allergies and smoker. Other relevant history included no alcohol intake, nor any drug abuse/illicit drug use. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of administration and dose not reported, batch number: 1805029, and expiry: unknown) administered on 14-MAR-2021 on the left arm for prophylactic vaccination. No concomitant medications were reported.  On 17-MAR-2021, the patient had "ankle calf both swollen" indicating potential deep vein thrombosis. She went to hospital emergency room, and "HCP confirmed small  clot". The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient was recovering from "ankle calf both swollen" and had not recovered from potential deep vein thrombosis and small blood clot. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This is a spontaneous report of a 64 year old female who developed a swollen calf and ankle swelling indicating a potential deep vein thrombosis 3 days after receipt of Janssen COVID 19 vaccine. Patient was seen in the emergency room by HCP, who confirmed a small clot. No other medical history was reported but patient was noted to be a smoker, reported as 2x a year. Age increases the risk of deep vein thrombosis, but the there is insufficient other details to make a meaningful medical assessment.
Constant pain near point of injection, shoulder and sometimes reaching near the neck. Received 7 physical therapy sessions with partial improvement. As a mapmaker, I walk with clipboard and pencil tanking notes, sometimes for hours. As the hours progress, the pain increase. Sometimes I have to stop, unable to continue. At the end of the day, on or off work, the pain returns. I apply Diclofenac sodium topical gel, plus sometimes commercial gels such as "Icy Hot Balm", to reduce the discomfort while I sleep. This Gel was prescribed by my Primary Care provider Dr. at the  Hospital. Before the Moderna COVID Vaccine I had no pain or discomfort ever.
10/28 gave shot at 7 PM called back 8:30 PM throat and tongue felt "thick". Took BENADRYL told to seek ASAP medical help wanted to go to urgent care. I called ahead gave them allergies and vaccine name and lot. Nausea develop. Check on her that night 10 PM. Also next 3 days.
Information has been received from a nurse concerning a 9 year old female patient with a history of migraine headaches and no known drug allergies who on 24-FEB-2009 was vaccinated with her first dose of GARDASIL (lot number 661766/0652X, site not reported) by subcutaneous route for prevention of the human papilloma virus. There was no concomitant mediations or past drug history. The nurse reported that the patient was fine, no syncope, and the injection site looked fine. There was no relevant laboratory date. As of 24-FEB-2009, it was unknown if the patient would continue to get GARDASIL injections and the patient was fine. Follow-up information was received from the nurse indicating that the patient was given GARDASIL Subcutaneous in her right arm in error and the patient experienced pain at the injection site which lasted for 2 days. There were no further problems. No further information was available.
The vaccine was given on 4/5/21 @ 2pm. At approximately 7am on 4/11/21, Hives developed over the body and persisted for 24 hours. The hives were treated initially with 50mg of Benadryl at 7am on 4/11/21 with no relief. Clariten 10mg and famotidine 20mg was given at 1pm with no relief. Benadryl 50mg was then given at 5am on 4/12/21 and symptoms finally resolved around 7am.
Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 7 months old male patient who was inadvertently vaccinated with an dose of PENTACEL (lot number not reported via unknown route in unknown administration site) in which the nurse not use the liquid IPV/DTA portion to mix with the ACTHIB portion on an unknown date. It was reported that the pharmacist (reporter) was uncertain if it was mixed with sterile water or sodium chloride. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate reconstitution technique. It was not reported if patients had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Got shot Friday afternoon and reaction started Saturday night. Injection site had a blue coloration about 1/4 inch and began feeling like 1.5 inch of pencil was in my arm. I was feeling very warm and cold at the same time with a normal core temperature. Extreme pain on any movement of arm that caused to muscle to tense. Having a fan on me  really help my heat/cold sensation be normal.  Most of symptoms went away Sunday afternoon, pain in arm reduced and I felt lethargic but OK. Pain in arm had subsided a lot and just felt like injection pain. most range of movement pain free but it did hurt if I moved my left arm up across my chest. Monday morning  had no issues with anything and injection site had no pain on movement or touch. I could just tell I had the shot there and the discoloration was lighter.
1st dose: fainted that night (about 12 hours after the shot) and got a few hives 2nd dose: fainted, many large and itchy red hives (arms, legs, neck, abdomen)
Swelling and pain in her arm; Swelling and pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Swelling and pain in her arm) and SWELLING (Swelling and pain in her arm) 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. On an unknown date, the patient experienced PAIN IN EXTREMITY (Swelling and pain in her arm) and SWELLING (Swelling and pain in her arm). At the time of the report, PAIN IN EXTREMITY (Swelling and pain in her arm) and SWELLING (Swelling and pain in her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-056043 (Patient Link).   Reporter did not allow further contact
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 23-MAR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 32 degrees Fahrenheit (0 degrees Celsius) (lowest recorded temperature) for 304 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. No pertinent medical history was reported. On the morning of 30-JUN-2015, PNEUMOVAX 23 (SDV, MDV OR ADDITIVE) (EA) 25 was improperly exposed to 9.6C for 7 minutes. Then later that same morning on 30-JUN-2015, the patient was vaccinated with improperly exposed PNEUMOVAX 23 (SD, MDV OR ADDITIVE) (EA) 25 (lot # K006681 and expiration date 21-OCT-2015), intramuscular. No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Patient was out of breath after walking down to clinic from her room. She said she just needed to catch her breath and was given a few minutes to sit prior to vaccination. Pharmacist asked her if she felt okay today, which she replied yes. She stated the nurse assisting her down the hall was walking to fast for her. After her vaccination patient remained seated for 20 minutes and still reported shortness of breath. A pulse ox was placed on her finger and her pulse was ranging between 44-80 and O2 range was 94-98. When her pulse rate would drop, she had uncontrollable body tremors. EMS was dispatched within an hour after vaccination and patient was transported to the ED.