chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approx. 6 hours, post vax, the pt developed facial swelling. She was seen at ER and given Benadryl.
Office made an Error in giving Monovalent Vaccine when it was supposed to be the Bivalent Covid Booster on 10-20-22
pt did not have a reaction to vaccine. Pt was given vaccine after beyond refrigeration date. Lot number was not expired.
The Group called me to report that they mistakenly administered an expired COVID-19 vaccine for my five year old. The vaccine expired on August 31st and it was injected on September 7th. I received a call on October 4th regarding this error as their office sought guidance from the CDC and Pfizer.   Administering an expired vaccine was a concern and I contacted the local department of health on where to best report this error.
Itching; induration at the injection site; Hives on top of induration; Muscle Pain; mild fever; This case was reported by a physician via call center representative and described the occurrence of injection site itching in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th February 2020, the patient received the 1st dose of Shingrix. On 4th March 2020, 5 days after receiving Shingrix, the patient experienced injection site itching, injection site induration and hives. In March 2020, the patient experienced muscle pain and fever. On an unknown date, the outcome of the injection site itching, injection site induration and hives were unknown and the outcome of the muscle pain and fever were recovered/resolved.   It was unknown if the reporter considered the injection site itching, injection site induration, muscle pain, fever and hives to be related to Shingrix.  Additional information was provided as follows: The patient experienced muscle pain and a mild fever that resided after 48 hours of receiving the vaccine. On 4th March 2020, she then developed itching and induration at the injection site which also had what appeared to be hives on top of the induration. The reporter consented to follow up.
maculopapular rash; This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. This Pharmacist (patient's wife) reported for a 43-year-old male patient (husband) who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, a day after receiving the second dose of COVID-19 vaccine, the patient had maculopapular rash. The outcome of the event was reported as unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
When the pt woke up Thursday morning (2/8/18), she noticed a rash on her face but considered it was possibly d/t her menstrual cycle. Friday 2/9/18 the rash on her face was worse and extended down to her neck and upper shoulders. She also C/O sore throat and the feeling like it was closing. Slight difficulty breathing while laying down so she sat up. Tongue also felt strange, slightly painful. Inside her mouth and tongue were really red. They did not call anyone for medical advice or seek medical attention from an MD or ER. Today, 2/12/18, they presented themselves to our office with complaint of possible reaction to vaccines, still C/O of face itching and throat hurts to swallow. Advising that she see a physician for evaluation to R/O another illness instead of reaction to vaccines or to get confirmation of a reaction to vaccines.
DIZZINESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported.  The patient's concurrent conditions included alcohol consumption 8 - 10 drinks, and smoking 4 - 6 cigarettes, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness. This report was non-serious.
Almost immediately upon injection - vertigo, nauseousness and light headed.  Within hours, rapid heart rate, fever, numbness in arms, balance issues/vertigo, throwing up, migraine, blurred vision, muscle weakness, labored breathing, 103.8 temp for 2 days unable to reduce with medication.  Since the shots, numbness, vertigo/balance issues, migraines, blurred vision, constant tiredness, muscle weakness, clear and obvious decreased lung capacity noticed when exercising or running, unexplained random overall muscle pain and struggle to do activities that were no problem the day before my first injection.
She had no appetite; She was very tired; a headache and an upset stomach; vomiting; a headache and an upset stomach; sore arm at the site of the injection; This is a spontaneous report from a contactable consumer reported that: A 77-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 25Jan2021 (Batch/Lot Number: EL3302; Expiration Date: 31May2021) as single dose for covid-19 immunization. The patient medical history was unknown. The patient's concomitant medications were unknown. Caller is calling to see if anyone experienced a reaction like a week after having the first COVID shot. She says she didn't give it a thought because it had been a week, but her friend today suggested maybe she was having a delayed reaction. She received the shot on 25Jan2021, says she only had the sore arm on 26Jan and it was only at the site of the injection like a regular shot, and then last Monday evening 1Feb2021, she started getting headache and the next morning she felt miserable. On 02Feb2021, she had an upset stomach and was vomiting. She was very tired and that went on for a couple days. She couldn't get off the couch. She had no appetite. Gradually she got a little better and she texted the doctor's office they suggested she go. they could make her an appointment 25 minutes away to get a COVID test. She was not feeling like driving or riding in the car to get it. Or they suggested that she quarantine for 10 days which is what she has been doing. She is feeling just about back to herself, but she was curious if that could have been from the shot or maybe she just had some other bug. She thinks she was 143 last time a few months ago. The upset stomach and vomiting last also on the 03Feb which made the headache better. She says headache is gone but her head still feels little not quite itself, but the headache is gone. She says the upset stomach and vomiting have recovered completely. The tiredness is ongoing but is much better. She has not had anything else happen and she has had not been around anybody with who was sick unless they were asymptomatic and that would have been only a very few people. She wants to know if it is possible that the vaccine caused a side effect to show up 8 days later. She does not see NDC on her vaccine card. She provides lot number expiration from her vaccine card. Outcome of the events headache, tiredness, she had no appetite were recovering. Vomiting and upset stomach were recovered.
Hospitalization for COVID Pneumonia 8/25-8/29/2021. Treated with dexamethasone IV daily and Remdesivir
Itching; Rash; Headache, severe headaches; Hives; Could not sit up because of pressure; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), MOBILITY DECREASED (Could not sit up because of pressure), PRURITUS (Itching), RASH (Rash) and HEADACHE (Headache, severe headaches) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 036B21A) for COVID-19 vaccination.     Concurrent medical conditions included Environmental exposure (Exposure to the roach spray.breathing issue,Hives) in 1997. Concomitant products included PROGESTERONE, THYROID, VITAMIN B COMPLEX (VIT B COMPLEX), VIT D [VITAMIN D NOS], DHEA, FISH OIL and COLECALCIFEROL, MAGNESIUM OXIDE, VITAMIN B1 NOS (MAGNESIUM 400) for an unknown indication.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced URTICARIA (Hives), MOBILITY DECREASED (Could not sit up because of pressure), RASH (Rash) and HEADACHE (Headache, severe headaches). On an unknown date, the patient experienced PRURITUS (Itching). On 26-May-2021, URTICARIA (Hives), MOBILITY DECREASED (Could not sit up because of pressure), RASH (Rash) and HEADACHE (Headache, severe headaches) had resolved. At the time of the report, PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient didn't not go to the doctor treated symptoms at home.   This case was linked to MOD-2021-193704 (Patient Link).
Information has been received from a medical assistant concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot# not reported) that after delivered, had sat on the counter overnight and for half the next day before it was refrigerated. Subsequently, the patient complained of muscle soreness at the injection site and painful arm. The patient mentioned it on their next office visit. It was unknown if the patient sought sought medical attention. On an unspecified date the patient recovered. The medical assistant contacted during telephone follow-up could not supply the following information: patient name, date of birth, date of vaccination, lot number or date of event. This is one of several reports received from the same source. No further information is available.
Arthralgia, NauseaVomiting, exacerbation of PVD, renaud's chest pain Narrative:
Information has been received from a registered nurse concerning an 11 year old female student who on 02-MAR-2007 at 11:50AM, was vaccinated IM into the left deltoid with a first dose of Gardasil (Lot# 654389/0961F). There was no illness at the time of vaccination. On 02-MAR-2007, immediately post injection, the patient experienced acute pain bringing her to tears. The patient complained of hot flash surrounding her face, lightheadedness and stiff arm with difficulty raising her arm due to pain. The nurse indicated that the symptoms subsided in five minutes except the pain continued. Additional information is not expected.
4/17/15 office visit seen for redness, swelling, warmth and pain. Treated for cellulitis.
A few minutes after VX, I started feeling really hot and had pain my right arm that would happen sporadically every few minutes. That night I started feeling lightheaded and my heart was racing and I was having difficulty breathing so I took Benadryl, Advil and using my inhaler. Then overnight I was still having a lot of difficulty breathing and I started getting rashes on the back of my hands. The next morning (3/26/2022) I went to the urgent care and was given an IV of Benadryl, Tylenol and albuterol. When I left they recommended that I take 2 Benadryl every 4 hours. I tried to sleep that night and every 4 hours like clockwork, my hands would started extremely itching with the rash coming back. It was so strong that it woke me from my sleep. As long as I took it exactly every 4 hours it started keeping it at bay. The next day I tried to decrease the dose to 1 pill every 4 hours, then that evening, I woke up again having a hard time breathing. It took me about 2 hours to fall back asleep and was still having a hard time breathing. I am still feeling some effects of it and trying to take it easy and heal.
On 12/20/99, post vax, pt developed chickenpox with approximately 14 lesions on his body. These lesions remained very small and he was afebrile. The pt recovered three days later. No further information is available.
Patient received first J&J vaccination and when he got to observation area, had a fainting spell that lasted around 15 seconds (per his wife). He has a history of syncope pells after recieving vaccinations. A&Ox4, denies dizziness, does not appear to be in distress. Vital signs at 1625 were as follows: 117/74 blood pressure, 61 heart rate, 16 respirations, 95% SPO2. Patient was in the passenger seat when he left site, without being transferred, 30 minutes after syncope episode. He did not have any lasting symptoms.
The pityriasis rosea rash began on my legs three days after the second vaccine injection. Over the next three weeks this rash became progressively worse and is now all over my body. This rash is said to last up to 10 weeks. It is extremely itchy, burns and is uncomfortable.
Tingling in hands/feet, something in throat 3 weeks after vaccination. Dx with Guillain Barre 7/9/12.
Runny nose; Stiffness in my throat; Symptoms of COVID; He was in contact with someone who had COVID-19; Fever; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), THROAT TIGHTNESS (Stiffness in my throat), SUSPECTED COVID-19 (Symptoms of COVID), EXPOSURE TO SARS-COV-2 (He was in contact with someone who had COVID-19) and PYREXIA (Fever) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-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 08-May-2021, the patient experienced RHINORRHOEA (Runny nose), THROAT TIGHTNESS (Stiffness in my throat), SUSPECTED COVID-19 (Symptoms of COVID), EXPOSURE TO SARS-COV-2 (He was in contact with someone who had COVID-19) and PYREXIA (Fever). On 08-May-2021, EXPOSURE TO SARS-COV-2 (He was in contact with someone who had COVID-19) had resolved. At the time of the report, RHINORRHOEA (Runny nose), THROAT TIGHTNESS (Stiffness in my throat), SUSPECTED COVID-19 (Symptoms of COVID) and PYREXIA (Fever) had not resolved.            No relevant concomitant medications were reported. Treatment for the events included Over the counter cough medicine.
Patient with 3rd shot in november 2021. By March 2022 she newly complained of bilateral paresthesias in her hands, diffuse joint pain and stiffness, and fatigue. Routine CT chest for cancer screening showed prominent lymph nodes. In September 2022 she was diagnosed with diffuse lymphoma on CT chest.
nausea, headache, vomiting, feeling the urge to pass out every 15 minutes for a week after receiving the vaccine.
Patient is 12 years old but was administered the pediatric Pfizer dose (PEDS). He did not have any reactions to the vaccine and stayed for the entire observation time.
11/15/2022 Before this day, I had had a mild cold and light cough, then I started having a balance problem, crackling in my right ear, coughing quite a bit more and quite a bit of phlegm. It progressively got worse. I started taking Guaifenesin and Tylenol. I continued to feel bad and called my doctor and was unable to get in. On 12/3/2022 I went to a clinic, and she examined my ears. They had a lot of fluid and pressure. I was prescribed Amoxicillin. I have still not recovered. I still have a lot of pain in my right ear.
pt rcvd vax; w/in 10 mn of 3rd dose of vax, pt exp'd heat sensation that resulted in swelling, redness, numbness & tingling of right index finger;
Information has been received from a health professional concerning a 13 year old female, with an allergy to penicillin (Unspecified, who at 12 months of age, in approximately 1995, was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck), and subsequently developed a varicella like rash. The patient was vaccinated at a practice unrelated to the reporter; therefore a further description of the rash and lot number is unavailable. The patient recovered on an unspecified date. There was no product quality complaint. Additional information has been requested.
pt recv vax 17NOV97 & that same day pt exp pain @ site, itching all over, hives on chest & muscle aches all over;
Rash; Swelling on my collar bone; High Fever; Dizziness; Headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EW0177, Expiration Date was not reported), via an unspecified route of administration, administered in Deltoid Left on 16May2021 (at the age of 60-year-old) as single dose for COVID-19 immunisation. Anatomical site of vaccination was left shoulder. The patient medical history included thyroid. Concomitant medications included levothyroxine (LEVOTHYROXINE); acetylsalicylic acid (ASPIRIN (E.C.), 81mg); metoprolol (METOPROLOL). The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization. It was reported that, patient stated that she was calling because she had her second shot on Sunday, she had a reaction to the shot which was normal, which was the high fever and dizziness and a headache but today she had rash and it was swelling on her collar bone. She did not know if that was another reaction to that, she knew the rash was normal, but she did not know about the swelling on her collarbone. Patient was asking was that okay or there was something she should do. Consumer stated, she just was wondering about the swelling on the collarbone was that something she need to worry about, or should she just take some like Benadryl or something for allergic reactions to it or what she should do. Events still experiencing includes the rashes and swelling on the collar bone. Consumer stated, just today, she got her blood work done. She did not know it was just her thyroid check and her cholesterol check. The patient underwent lab tests and procedures which included blood test: unknown on 18May2021. Consumer stated, "Rosuvastatin" (Not appropriately clarified hence, not captured in tab). No treatment received. The outcome of the event swelling on her collar bone was not resolved and unknown for other events.  Information on lot/batch number was available. Additional information has been requested.
1.  AFib event .  First time SYMPTOM  2-21-21 2.  AFIB event  2nd time symptom 3-21-2021 3.  AFIB event 3rd time Symptom 12-25-22
Patient states the day after her booster dose (she states she is immuno-comprimised) her arm was sore, which she expected.  She states that after a couple days it went away- but that after a day or so of being fine, the soreness has returned, and has now affected her entire arm and neck. She states it is difficult to move, and she has extreme weakness to where she struggles to lift or hold things with her left arm.
Information has been received from a registered nurse (R.N.) concerning a patient who was vaccinated with a dose of VARIVAX (Merck) (lot # not reported). Subsequently the patient experienced negative titer. Patient is asymptomatic. Patient sought medical attention, and not recovered at the time of reporting. Additional information is not expected.
6 month old infant receive the Fluzone HD, no AE; 6 month old infant receive the Fluzone HD, no AE; Initial information received on 21-Dec-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a six months old patient who vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).   Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On 18-Dec-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to product administered to patient of inappropriate age and overdose (latency on 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.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 05-MAR-2018, the patient was vaccinated with GARDASIL 9 lot number N021475 with expiration date on 31-JAN-2020 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1805USA003078:
Initial information received from a consumer (the patient) on 23 January 2014. An 62-year-old female patient had received a dose of TETANUS TOXOID, (lot number, route, site of administration were not reported) on an unspecified date. The patient's medical history includes high blood pressure and arthritis. On an unspecified date, the patient's skin swelled to size of dime. Treatment details were not reported. The patient outcome is unknown. Documents held by sender: None. Follow up information was received on 07 April 2014: It was updated that the patient had received TETANUS TOXOID little under the skin at the age of 21 years and had an event of skin swelled to size of dime.
This spontaneous report was received from a healthcare worker and refers to a 46 year old female patient with sulfa and cefprozil allergy. She did not have any pertinent medical history. On 26-AUG-2015, the patient was vaccinated with PNEUMOVAX 23 injection, 0.5 ml, intramuscularly, lot # L003188, expiration date 06-JUL-2016. The patient's concomitant therapies included unspecified thyroid medication and unspecified "supplements". On 27-AUG-2015 (also reported as "next day after receiving PNEUMOVAX 23", the patient developed redness, swelling and "hot" at the injection site as well a fluid around the elbow. She sought medical attention and was seen by an unspecified physician on an unspecified date. The patient was not given any treatment for the events. No lab diagnostic studies were performed. Approximately on 02-SEP-2015 (reported as "about a week after receiving PNEUMOVAX 23)", she recovered from the events. Relatedness between the events and PNEUMOVAX 23 was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Covid 19 Moderna- I had right arm pain, stuffy head, cough, fever, chills, all over body aches, weakness, tired, feeling terrible.
Child spiked fever to 105.5 @ 11PM. Fever continued intermittently until 19JAN when it returned to normal. Seen by MD tx tylenol; child vomited x 1 on 16JAN & x1 on 17JAN. Eyes noted to "roll back in head" x 1 2AM 17JAN.