chrisvoncsefalvay/vaers-outcomes huggingface dataset:
- 7 days after receiving 1st dose of Moderna COVID19 vaccine - Pain and itching at injection site - Large area of redness/swelling on arm - "COVID Arm"
Approximately two weeks after receiving the vaccine I developed Shingles. My symptoms started as a sore/tender area in the center of my right collarbone and a red bump behind and slightly above my right ear that spread until the right side of my neck and head were covered in a thick set of rashes. It took about five days for the rash to fully develop.    I do not have an autoimmune disorder or any  other medical condition that would lower my immunity. I have not been under any undue stress nor am I recovering from a recent illness. I am also not immuno-compromised in any way that I am aware. I had a physical in February with no issues identified. I did have chicken pox as a kid.
States 1 3/4 hr. after receiving vaccine felt could not swallow and  lips felt numb - lasted about 10 min then went away and feels fine now -
Psoriasis/ Minor patches of psoriasis; Lethargy; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis/ Minor patches of psoriasis), LETHARGY (Lethargy), FATIGUE (Fatigue) and HEADACHE (Headache) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 08-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PSORIASIS (Psoriasis/ Minor patches of psoriasis), LETHARGY (Lethargy), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, PSORIASIS (Psoriasis/ Minor patches of psoriasis), LETHARGY (Lethargy), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Patient was given more Pfizer vaccine, intern pulled up 1.8 mls of sodium chloride and then pulled up in same syringe about 0.2 ml from Pfizer vial that was not reconstituted and injected into patient's arm. The error was realized after the patient had already left. We called patient multiple times and had to leave a message to call us back. We left message with dr office as well and we will keep trying to get a hold of patient. We are not aware of adverse events occurring, but will make patient aware that they are more likely to have flu like symptoms because of the error. I have spoken to my intern and trained even more about the process of giving and have reported error.
This spontaneous report as received from a pharmacist refers to a female patient of unkonwn demographics. No concurrent conditions or medical history were provided. In approximately 2013 (reported as "on an unspecified date last year"), the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route of administration, indication, lot# and expiry date unspecified). No concomitant medications were reported. The patient called pharmacy to report redness streaming down her arm further described as soreness going down the patient's arm from the site of ZOSTAVAX administration, developed on an unspecified date in 2013 (reported as "last year"). The outcome of the events was unkonwn. The relatedness between the events and ZOSTAVAX was not reported. This is one of several reports from the same source. Additional information has been requested.
Narrative:  Other Relevant Hx:  Symptoms:   Dizziness, Sedation, Fever & NauseaVomiting Treatment:
Received call from EE about known COVID + community exposure.  EE and her son, with whom she lives, were exposed on 9/3 at the game.  EE states that she found out today, that her friend tested COVID +.  Started having s/s on 9/6 of HA, fatigue, and feverish.  Which then progressed to cough, chills, dizziness, loss of smell and taste, today while at work.
This case was reported by a other health professional and described the occurrence of underdose in a 19-year-old male patient who received HAVRIX pediatric (batch number N4341, expiry date 19th February 2016). On an unknown date, the patient received HAVRIX pediatric .5 ml. On an unknown date, an unknown time after receiving HAVRIX pediatric, the patient experienced underdose. On an unknown date, the outcome of the underdose was unknown. It was unknown if the reporter considered the underdose to be related to HAVRIX pediatric. Additional informations: This 19 years old was inadvertently given a pediatric dose of HAVRIX.
Very sick with first dose; Fever; Terrible headache; Chills; Intense body aches; Joint pain; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0190) via an unspecified route of administration in the left arm on 03Apr2021 at 16:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Apr2021, with first dose the patient was very sick, experienced fever, terrible headache, chills, intense body aches and joint pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events very sick, fever, terrible headache, chills, general body pain and joint pain was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On 07-MAR-2017, the patient was vaccinated with an unspecified expired dose of M-M-R II for prophylaxis (lot # K024038 with an expiration date of 26-NOV-2016) (dosage, route and  anatomical location were not reported). Other suspect and concomitant medications were not provided. No adverse effects were reported. Additional information has been requested.
Patient received vaccine after published expiration date. Moderna Company analyzed lot 007B21A and advised vaccine maintained activity necessary to protect against covid 19 at time of administration. Also patient did not call in with any adverse event.  This is administration error  without adverse event.
ONE OF FOUR PATIENTS WHO EXPER. EPISODE CONSISTING OF FAINTING AND/OR SHORTNESS OF BREATH, INCREASE IN PULSE RATE, DIAPHORESIS AND LIGHT-HEADNESS FOLLOWING IMMUNIZATION.
REDNESS AND HARDNESS AT INJECTION SITE FOR OVER TWO WEEKS  FOLLOWING INJECTION. PAIN,  SORENESS AND HARNESS LASTED FOR OVER ONE MONTH AT THE INJECTION SITE
At approximately 7:30p.m.; pain at injection site  10 minutes later at 7:40p.m. ; severe headache and fatigue  At approximately 8:00p.m.; severe fever and chills At 8:30p.m.; dizziness
Pfizer COVID- 19 Vaccine EUA Pt received 0.3ml Pfizer-BioNTech(Lot EL3249 exp 5/2021) at 15:25 today in left deltoid. Pt expressed "scratchy throat" and strange feeling radiating from shoulder to upper rhomboid muscles after 5 minutes. Gave patient drink of ice water with Diphenhydramine 25mg po (Lot 502605 exp 10/31/2021). After 10 minutes reassessed and still experiencing little improvement. Gave second dose Diphenhydramine 25mg po, and observed for next 30 minutes. Patient expressed feeling better and not so scratchy in her throat. Escorted to vehicle after stating that she felt well enough to drive home. Recommended she f/u with her physician and may need to pre-medicate with diphenhydramine 25mg prior to booster.
tested positive for COVID; This is a spontaneous report from Pfizer sponsored program. A contactable consumer (patient) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on 02Sep2021 as single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of Pfizer COVID 19 Vaccine on 02Sep2021. The patient tested positive for COVID on Monday, 13Sep2021. She did receive the antibody infusion. Her second vaccine was scheduled on 23Sep2021, on her tenth day of isolation. Patient was asking if there are any recommendation on proceeding with the second vaccine after being diagnosed with COVID. She stated that she tested positive for COVID on 13Sep2021. Patient stated since she's had COVID, it will be her 10 days quarantine on 23Sep2021. Therapeutic measures were taken as a result of the event. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Pt states that he was vaccinated for COVID x2. Now testing positive for COVID during hospitalization. Admitted for non-healing wounds
The person who received the vaccine got very sick 5 days after the receiving the vaccine.  The patient  was talking at 2:00 pm on the 28th and he was on a ventilator a few hours later.   The doctors were never able to determine why he got so sick suddenly.   He passed away on April 6th.
Pt participated in Clinic. Unable to check accuracy of information while doing clinic. Pt had already received a dose of Pfizer on 4/5/2021. Received a dosage of J&J on 6/1/2021
Felt tingly all over in pelvis, arms, face and mouth.  Heart rate up a little (100) but felt anxious. It subsided with in a few minutes
patient was administered 1st dose of covid-19 pfizer 4/20/21 at 2:29 pm and was counseled to wait for 15 minutes in case of reaction. about 10 minutes later the patient began pounding on the door stating he was having a reaction and he was having difficulty breathing. I had him sit down in the counseling room. 911 was called and ems was dispatched. in the mean time store management brought him water. I asked the patient again if he was having difficulty breathing and he said no, but he felt dizzy and his heart rate was elevated. I asked him if he had any difficulty swallowing, or any swelling of the lips, tongue, mouth or throat - pt denied all symptoms. patient also denied a rash or any itching when asked. I also asked the patient if he had any nausea, which he stated he did. he continued to deny all symptoms except dizziness, and nausea when asked, and in talking to him while waiting for emt he never displayed any symptoms that would lead me to believe he was having difficulty breathing, or a true allergic reaction. when emt arrived and examined him his pulse, blood pressure and oxygen saturation was normal, and the patient stated he felt better and had a history of anxiety. patient declined to go to the hospital, waited in the pharmacy for a while longer, and had a friend come pick him up
4 chest pain events that mimic heart attack symptoms for a female, chest pain and tightness that radiates up in the jaw. After 20 min or longer the symptoms begin to dissipate. 1st event 1/8/21 in the evening. The following week another episode while driving home from work. During work 1/21/21 another episode took place and EKG done with negative result. That same evening during sleep another episode woke me up, although it was not as bad as the other ones and 20 minutes later i was able to go back to sleep.  As of today 1/25/20 no other episodes. I do take Famotidine daily and have been for several years due to acid reflux and heartburn, but never have I experienced chest pain.
This spontaneous report as received from a medical assistant refers to a 1 year old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 05-OCT-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1809USA002868: Original Case : 1809USA002868 US-009507513-1902USA009324: Original Case : 1902USA009323 US-009507513-1902USA009325: Original Case : 1902USA009323 US-009507513-1902USA009326: Original Case : 1902USA009323.
Neurological issues including tremors and shaking (started off in the mornings after getting up out of bed and now is happening throughout the day) Hair falling out in huge clumps (2 times) Headaches (daily) Heart palpitations (often, comes and goes) Brain fog (Everyday, all day) Stuttering (goes along with the brain fog) Chronic exhaustion (everyday all day long)  Exhaustion including falling asleep in chair, driving and anywhere that I sit within 5-10 minutes (24/7) Hands swelling and random red rashes or streaks on skin (started off here and there but is now daily and several times a day and can last for minutes to hours) Nausea  (often, every couple of days) Falling and imbalance (several times a week) Body is heavy (mostly every morning) Red/glazed eyes (24/7) Arm pain (happens with the hand swelling) Ringing in ears (here and there) Cold/Hot intolerance with body feeling like have fever, but I have no fever (24/7)
Although I do have seasonal allergies for which I have been given allergy shots for, I have not received any shots since the start of the year.  I did not have any symptoms on the day of the vaccination or a few days after.  I felt tired after about 5 days and my asthma-like symptoms started about a week after the vaccine, with shortness of breath and coughing.  I have been taking my regular asthma medications and supplements ever since.
This spontaneous report received from a parent concerned an 18 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced high fever. On 07-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced diarrhea. On 08-APR-2021, the subject experienced pressure in ears. On 08-APR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever, diarrhea, headache, chills, pressure in ears and injection site pain was not reported. This report was non-serious.
7/2/14 Tdap administered. 7/3/14 (L) deltoid/arm swelling - resolved over a few days. 7/12/14 Parent noted swelling and red rash on hands and feet. 7/13/14 Multiple red, non painful papules went to urgent care. 7/14/14 Report fading c/w erythema multiforme minor.
This spontaneous report received from a medical assistant refers to a 50-year old female patient. The patient had no pertinent medical history but was allergic to CYMBALTA. The patient's concomitant medications included MOBIC, FLONASE, VENTOLIN, ZANTAC, methotrexate (manufacturer unknown), RESTASIS, amitriptyline hydrochloride (manufacturer unknown), PLAQUENIL and estradiol (manufacturer unknown). On 13-Oct-2016, the patient received a dose of PNEUMOVAX 23 intramuscular injection (lot number: M027552; Expiry date: 04-FEB-2018) 0.5 ml in the right arm. On 14-OCT-2016, the patient began feeling achy and was not well. The patient went to the emergency room on 15-OCT-2016 because she was getting worse-her blood pressure got very low, she had a 103 F fever and her right arm, by the injection site and the whole upper arm was swollen. The medical assistant stated that the patient was admitted to a medical center on 17-OCT-2016, as she was not getting any better and did not know why it took so long to admit her. The outcome of the events was reported as not recovered. Causality assessment was not provided. The reporter considered the events to be serious due to hospitalization. Additional information has been requested.
swelling and redness -on the face lumpy heat rash-also on the  face water blisters- looks like chicken pox on the face I use steroid cream on them swelling around the eyes
My kids tested positive for COVID-19 on 3/6/2023, so I tested that day and also got a positive result. On the morning of 3/7/2023, I had chills, fatigue, headache, sore throat, sinus congestion, coughing, and body aches. I felt really bad, so I called my doctor and was prescribed PAXLOVID. I felt pretty bad for three days (3/7/2023-3/10/2023), but by 3/12/2023, I felt better. I still feel tired a lot and have head cold symptoms. I took another COVID-19 test on 3/14/2023 and got a positive result.
Female patient 27 year old with 9 weeks of pregnancy, oriented to time and place. While waiting 15 minutes in observation after receiving her first dose of PFIZER, she reports a cutaneous eruption on the forehead and chest area. Patient is cared for in the observation area by EMT, her vital signs are taken 99% saturation, 62 pulse, 16 respirations and 110/70 BP. She is kept under observation and at 12:58pm patient presents with clear lungs at auscultation. There is no edema in the airway and there is no redness or swelling. The case is consulted with Doctor and refers to keep her hydrated and in observation for 30 minutes.
SWOLLEN RIGHT LEG; PAIN AT CALF IN RIGHT LEG; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, Laboratory data included: Chest X-ray (NR: not provided) Normal, and Diagnostic ultrasound (NR: not provided) Normal. On 15-APR-2021, the subject experienced swollen right leg. On 15-APR-2021, the subject experienced pain at calf in right leg. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient recovered from swollen right leg, and pain at calf in right leg on 2021. This report was non-serious.
A 53 year old female was exposed to a flying bat in the house while sleeping on 08/11/02. She received post-exposure therapy for possible exposure to rabies. On day 0 (08/14/02), she began treatment with HRIG and Imovax. She developed anaphalaxis-like reactions following the second-dose of Imovax. She was switched to RabAvert as her third post-exposure dose, given in incremental doses until the full dose (1 ml ) was given. She developed "mild an anphylaxis" to RabAvert which consisted of chest tightness. increase in secretion,and itchiness, however, no reports of tachycardia and hypotension were noted. The symptoms resolved in 5 to 6 hours after the RabAvert administration.
Information has been received from a female consumer who on an unspecified day was vaccinated with a dose of VARIVAX (Merck) (Lot#: not reported). On an unspecified date, the consumer developed chicken pox after she was given the VARIVAX (Merck). It was unknown if the patient sought medical attention. At the time of the report, the patient's outcome was unknown.
I administered the vaccine at approximately 2:30pm. Patient stood up and fainted after taking a few steps. Her mother caught her, and we provided a chair to sit in. No head injury occurred. Water and Gatorade were provide immediately. The patient did not report any trouble breathing or present signs of anaphylaxis. She had a pale and clammy appearance, and described a brief loss of vision before the fall. The patient reported not having any water since previous night, and the only fluid was a yogurt drink after breakfast. Once she started feeling relief from the fluids, I took her blood pressure reading at 2:44pm, which was low (105/71). We continued to monitor her for signs of an allergic reaction, and took another blood pressure reading at 2:57pm (108/68). She stood up at 3:00pm, and we had her walk around the store to make sure she did not still feel faint. She left the store shortly after. Patient was also given a granola bar as well since she reported not having anything to eat today other than a yogurt drink for breakfast. She ate that in between blood pressure checks. I followed up with the patient at 5:00pm. She was doing fine and felt better after eating shortly after leaving the store.
Burning sensation (feels like bee sting), red blotch, nodule 1 inch, heat to touch, itching. Pt started BENADRYL 1 hr afterwards.
Pt was admitted on 3/25/2021 with a TIA and sudden word finding difficulty along with a headache and a sudden inability to make decisions
Patient reported a bruised, sore arm on 10/15/2016. Patient has used ice packs, but her arm is still bothering her.
Symptoms:Shortness of Breath, Racing Heart, Anxiety, some Dizzyness,  These symptoms got progressively worse over the course of 2 weeks.  The symptoms appear(ed) to get worse when I ate/eat.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 23-year-old female patient received the first dose of TRUMENBA, via an unspecified route of administration, in the arm, on an unspecified date at 0.5 ml, single dose for immunization. The patient's medical history was not reported was not reported. Concomitant vaccine included HPV vaccine in the same arm and may have received other vaccines (unspecified) as well in the opposite arm. The patient experienced burning and pain at the injection site on an unspecified date. The outcome of the event was unknown. Information on batch number has been requested.
Flu-like symptoms, fatigue for 48 hours.  Patient went to doctor but received no treatment.  Doctor thought she could possibly have gall stones.  Gall stones was ruled out.