chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Lump, swelling, itchiness at the injection site; Lump, swelling, itchiness at the injection site; Injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), INJECTION SITE MASS (Lump, swelling, itchiness at the injection site), INJECTION SITE PRURITUS (Lump, swelling, itchiness at the injection site) and INJECTION SITE SWELLING (Injection site swelling) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.     On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PYREXIA (Fever), INJECTION SITE MASS (Lump, swelling, itchiness at the injection site), INJECTION SITE PRURITUS (Lump, swelling, itchiness at the injection site) and INJECTION SITE SWELLING (Injection site swelling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of Cream. At the time of the report, PYREXIA (Fever), INJECTION SITE MASS (Lump, swelling, itchiness at the injection site), INJECTION SITE PRURITUS (Lump, swelling, itchiness at the injection site) and INJECTION SITE SWELLING (Injection site swelling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2021 and was forwarded to Moderna on 22-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), INJECTION SITE MASS (Lump, swelling, itchiness at the injection site), INJECTION SITE PRURITUS (Lump, swelling, itchiness at the injection site) and INJECTION SITE SWELLING (Injection site swelling) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.     On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PYREXIA (Fever), INJECTION SITE MASS (Lump, swelling, itchiness at the injection site), INJECTION SITE PRURITUS (Lump, swelling, itchiness at the injection site) and INJECTION SITE SWELLING (Injection site swelling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of Cream. At the time of the report, PYREXIA (Fever), INJECTION SITE MASS (Lump, swelling, itchiness at the injection site), INJECTION SITE PRURITUS (Lump, swelling, itchiness at the injection site) and INJECTION SITE SWELLING (Injection site swelling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.
Severe headache - lasted to 2-6-07, pain right arm traveled to shoulder and elbow. Injection site red, swollen to armpit. Saturday unable to get out of bed 2-3-07. Sunday 2-4-07 - went to hospital, temp. 103, IV Benadryl. Issued Morphine and pain medication, temp. normal. Unable to move right arm until 2-7-07. March 1, 07 only complaint - muscle soreness in body.
pt recv vax 21OCT & reports to mom p/school that almost immed p/vax rt deltoid hurt in the same spot & also into neck;pt told mom that by next class period 1/2hr later stomach hurt & was nauseated;t noted to be 103 orally;h/a, n, sl cough
Woke at 6:00 AM with severe nausea, then started severe retching and severe vomiting, every 10 to 15 minutes. After 30 minutes,  when bile started coming up, I called the doctor's office for instructions; he said to go to the hospital emergency room immediately. By then, I was too weak to stand or walk any distance, so I called for an ambulance. Taken to Hospital(arrival about 9:00 AM) where i received Zofran intravenously, along with saline drip. Spasms gradually tapered off and stopped within an hour. I was kept for observation and rest the remainder of the day and the following night, then released from the hospital at 4:00 AM (!!) the next morning.
I received the vaccine at 06:00AM. Around 06:03 AM, I was walking towards my husband and started having pain in my right arm, like a bee sting. I told the nurse that I am not going to get the second one and she replied with, "If I knew you weren't getting the second dose, I wouldn't have given you the first!" My husband and I left around 06:25 AM and I was in serious pain. My husband drove me to a fire station and one of the men checked my blood pressure. It was 190/85. I went to work afterwards and during the day, I just felt miserable. I started having pain, like a hot sunburn, moved across my neck and my back. My husband took me to urgent care after work. At the clinic, I asked them how long this pain was going to last. All that I was told is that they didn't know anything because it's a new vaccine. That night I experienced pain across my back to my other arm and my lips became swollen. I went back to urgent care two days later. I asked them what to do because I was taking Claritin and it wasn't helping. They told me to take Benadryl. I took antihistamines from the time I went to urgent care until about 9-10 days later. After taking the antihistamines for that time period, the pain finally cleared up. While at urgent care, the nurse provided me with a prescription for an EpiPen. I did not have to use it. It was recommended to not get the second dose because of my experience after the first.
suspected vaccination failure; shingles; Pain is horrible; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-APR-2022 Reporter's Comments: The patient self-reported the case. After receiving Shingles vaccine, the patient still got the shingles. The patient stated that, pain was horrible. Additional Supportive Information: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Six days after the vaccine my injection  site felt a little itchy and warm. A few days later I looked at the site and I had a red oval very fine rash and the area was warm and firm. Very mild, not painful at all. No treatment has been necessary.  As of today (3-14-2021)I do still have the rash.
Dose administered after published expiration date; The vaccine was stored in refrigerated on 30-Mar-2022, it got expired on 24-Mar-2022 but was administered on 31-Mar-2022.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after published expiration date) and PRODUCT STORAGE ERROR (The vaccine was stored in refrigerated on 30-Mar-2022, it got expired on 24-Mar-2022 but was administered on 31-Mar-2022.) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2022, the patient experienced PRODUCT STORAGE ERROR (The vaccine was stored in refrigerated on 30-Mar-2022, it got expired on 24-Mar-2022 but was administered on 31-Mar-2022.). On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after published expiration date) and PRODUCT STORAGE ERROR (The vaccine was stored in refrigerated on 30-Mar-2022, it got expired on 24-Mar-2022 but was administered on 31-Mar-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. Reporter states, it was unaware if the patient was immunocompromised. Vial was initially stored in the refrigerator on 30-March-2022 and Vial did not undergo any temperature excursions. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2022: Live Follow-up document received .
Pt received 2nd dose on the same day 3hrs post injection, became dizzy & developed headache.  Dizziness lasted 45 sec /w disorientation & then lightheadedness that lasted X 5 min.
Received my fourth covid vaccine on 5/12/22 Sneezing, congestion and allergy type symptoms on 6/11/22 Began having low grade fevers (99.6 max), fatigue, muscle aches, cough, worse congestion and generally not feeling well 6/12/22 Took a home test 6/12 and tested positive for covid Called my doc and she called in paxlovid 6/13. Took two doses and felt dramatically better by 6/14. No more fevers or aches. Still tired and a cough which continued another day or two. By 6/16 felt completely normal and returned to work.
Mom reported no problems after immunizations.  Infant stopped breathing at daycare while sleeping.  Autopsy pending. 8/9/06 Received autopsy report which revealed COD as Sudden Unexplained Infant Death.  Pathologic diagnoses: mild chronic epiglottitis & tracheitis, pulmonary congestion & edema.
sweating (even wet the bed); Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating (even wet the bed)) and ARTHRALGIA (Joint pain) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-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 HYPERHIDROSIS (sweating (even wet the bed)) and ARTHRALGIA (Joint pain). At the time of the report, HYPERHIDROSIS (sweating (even wet the bed)) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.   This case was linked to MOD-2021-063906 (Patient Link).
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 19-AUG-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number K011562, expiry date: 08-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
kept waking up; would be hot and then cold; felt like a truck running over him; fever; headache,head is hurting so bad; body ache,body hurt; nauseous; This spontaneous case was reported by a patient family member or friend and describes the occurrence of POOR QUALITY SLEEP (kept waking up), FEELING OF BODY TEMPERATURE CHANGE (would be hot and then cold), FEELING ABNORMAL (felt like a truck running over him), PYREXIA (fever) and HEADACHE (headache,head is hurting so bad) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19, Pneumonia and Bypass surgery (Quadruple). Concurrent medical conditions included Headache (after Covid). Concomitant products included VALSARTAN, OMEPRAZOLE, METOPROLOL, ROSUVASTATIN and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced POOR QUALITY SLEEP (kept waking up), FEELING OF BODY TEMPERATURE CHANGE (would be hot and then cold), FEELING ABNORMAL (felt like a truck running over him), PYREXIA (fever), HEADACHE (headache,head is hurting so bad), MYALGIA (body ache,body hurt) and NAUSEA (nauseous). At the time of the report, POOR QUALITY SLEEP (kept waking up), FEELING OF BODY TEMPERATURE CHANGE (would be hot and then cold), FEELING ABNORMAL (felt like a truck running over him), PYREXIA (fever), MYALGIA (body ache,body hurt) and NAUSEA (nauseous) outcome was unknown and HEADACHE (headache,head is hurting so bad) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No treatment medications were reported
I woke up 7 days after receiving the vaccine with shooting sharp pains across my abdominal / midsection. While attempting to go to the bathroom, I must have passed out because I woke up some time later on the floor with a busted face and nose, and a severe headache.  Initially the day after the shot, I had sharp shooting pains down my right leg. I have also had a headache on more days since getting the vaccine.  Mental fog and tiredness is also occurring a few days after the initial shot.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with dose 1 and 2 of GARDASIL IM, on 31-OCT-2011 and 01-AUG-2012 respectively (dose and lot number not reported). No adverse effect reported. Additional information has been requested.
18 hours later, woke up with headache, fever, arm very hard & some swelling. Four hours later, temperature for 101, extreme headache, chills, extreme joint pain. Arm now swollen to elbow & extremely hot and bright red skin on outside and underside of arm. Twenty four hours later, symptoms have all diminished a little but still miserable & inner arm is extremely itchy. Ten days later swelling gone & redness but still hard at injection site and inner arm still itchy at times. (No other reason for itchiness).
Local swelling upper arm x 5 days. Low grade fever (99-100) with malaise, fatigue, headache, myalgias x 8 days.
Administered Fluarix in left arm.  Took needle out and arm began swelling in egg shape, hard mass.  Applied ice pack, gave Benadryl 50 mg capsule.  Swelling was the only sign of adverse reaction.
10 days after the vaccine I got COVID arm from my shoulder to elbow. My arm itched, ached, hot to touch, and appeared to be a fluid under the skin. I took Tylenol which didn't really help. That lasted about two weeks. It was gradual as it decreased. I did have a doctor appointment for something else, but I did tell her about it and she took a picture. She she was on a COVID panel and she was taking the picture for the research panel. She did acknowledge it was COVID arm.
body aches, fever 100.0; treated with 2 doses Aleve; fever resolved in 12 hours
Tachycardia,  arms and hands tingling, and flu-like symptoms. Wide spread muscle cramping (arches, hamstrings, chest)
Headache, muscle soreness, dull kidney pain, exhaustion, slept all day so far. 4-23-2021
Screaming behavior for many days,  Often Crying without reason,  loss of attention issues,  less active. developed various tics
Child almost bumped in the door as she left the office after the 1st GARDASIL and felt dizzy but got betters quick. Today after the 2nd GARDASIL - she got dizzy again and very pale (within minutes of the shot) - she recuperated very quickly with no "LOC".
Injection site arm pain, redness, swelling pretty immediate; felt faint by 2pm; felt feverish with body aches by evening, getting worse after 6pm  with chills, bad headache & fever of 101. Fever around 100, headache & body aches continued until Monday 10/21/2019. Arm redness & swelling persisted for a week. Treated with Tylenol and Advil. Injection site is still sore to the touch today, but redness & swelling gone.
A patient received Flublok instead of the Fluzone High Dose with no adverse event; Initial information received on 07-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involved a 65 years old female received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number- QFAA2028, Expiration date- 30-Jun-2021) via an unknown route in unknown administration site for prophylactic vaccination on 03-Oct-2020 instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (wrong product administered).  The patient's medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.  It was a case of an actual medication error due to wrong vaccine administered (latency: same day).  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Pt. was at least 15 minutes post receipt of his second dose of Moderna COVID vaccine. He began complaining of dizziness and a headache. We monitored him for over an hour and during that time, he continued to c/o dizziness, frontal headache, photophobia, and worsening when opening his eyes are trying to look straight ahead. We had him isolated in a dim room and had air blowing on him as he complained of being hot. His O2 Sat, pulse , and BP all stayed stable and within normal range. Pt. denied sx of swelling around face/neck or difficulty breathing. RR was stable and unlabored at all times. Pt. refused EMS services and after some time, insisted he needed to get up and leave. Our staff and his co-worker assisted him out of the facility and to a vehicle where we was transported off the premises.  We were informed later through his supervisor that he got worse after leaving and went to the hospital where he "seized." He is reportedly stable at this time but further information on his condition is unavailable.
Leg pain, fever, malaise. 4/28/06, 15:00, Pt attempted to get out of a chair and walk from the kitchen to the playroom but crumpled onto the floor, crying about how his legs hurt. He was unable to stand. I picked him up and sat down on the sofa and noticed that he was hot and flushed. His temperature was 102 degrees and his entire body was warm with red flushing. 14:00-He was about the same. I remained on the sofa with him while he was in a daze, staring and intermittently whimpering, crying and complaining of leg pain. 16:30-I called your office and spoke to the message service. 17:00-He was the same. He was given homeopathic remedy thuja IM. 17:30 Fever was gone. Pt's spirits came back although he was unable to walk and complained of pain in his legs. 18:00=He began walking unsteadily with stiff legs. 19:00-Did a little rough playing with his younger brother and even ran a few steps. 19:30-Went to bed and slept through the night. On 4/28-ate and played fairly normally although there was stiffness in his gaits, increased clumsiness and a general loss of agility. Stuttering, which had disappeared completely several months ago, reappeared. Although normally, he does not nap, at 14:30, he lay down and slept until 17:00. He woke from his nap with a 99 degree temperature. He complained about pain in his legs and had difficulty walking. He was given thuja remedy. 17:30-He began to perk up but would not walk. Participated and played from a chair. Some capsaicin cream was rubbed onto his legs. 18:00-He began walking and running a bit, but stiffly. His abilities came back, little by little. Seemed much better at bedtime, 19:30. 4/30-He was fairly recovered. For the first time, the DPT injection site in his right leg was red and swollen like a pimple. I also noticed leg stiffness, clumsiness and stuttering. Mostly, he attempts to mask his ailments and only admitted once during the day to any pain. 5/1-He got up complaining about the DPT injection site. It appeared that he had been scratching it. There was a bloody pus discharge. Bacitracin and a band aid were applied. His mental and physical well being seemed improved and he went to nursery school as usual. He received the thuja remedy. 5/2-The injection site had a scab. He received a thuja remedy and went to nursery school. In the future, due to his and my family's medical history, please do not administer more that one vaccine at a time to either he or to my other son.
she had some mild redness; swelling in the whole arm; This is a spontaneous report from a contactable Nurse (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. She already received the first dose and she had some mild redness and swelling in the whole arm. The outcome of the events was unknown.  Information on lot/Batch number has been requested.
Hot flash, dizziness, nausea, cold chills, headache. Right side of body numbness and tingling, no sensation of hot/cold.
Fever; Slight headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 60-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via unspecified route of administration in left arm on 22Jul2021 at 12:15 (at the age of 60-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient included arthritis and pain. The concomitant medications of the patient included ibuprofen (IBUPROFEN) taken for pain. No prior vaccinations within 4 weeks. The AE(s) following prior vaccinations was reported as none. No family medical history Relevant to AE. The relevant tests were reported as none. On 22Jul2021, the patient experienced slight headache and experienced fever on 23Jul2021. The patient stated she got the vaccine the previous day and they said there might be side effects. The previous night, she had a slight headache but no other side effects. Then 24 hours later, she had a fever, and she asked was that normal that it would take that long to develop. Was noticed just that afternoon and had stayed the same. She stated slight headache it went away. No investigation assessment. Treatment included: she took Ibuprofen. She also takes Ibuprofen as needed for her arthritis pain. The outcome of the event fever was reported as not resolved and the patient recovered from slight headache on an unspecified date in Jul2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.