chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She got the first dose in 8Feb2022 but didn't get the second dose.; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (She got the first dose in 8Feb2022 but didn't get the second dose.) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (She got the first dose in 8Feb2022 but didn't get the second dose.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (She got the first dose in 8Feb2022 but didn't get the second dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (She got the first dose in 8Feb2022 but didn't get the second dose.).    No concomitant drugs were reported.  No treatment drugs were reported.   Reporter did not allow further contact
Information has been received from a nurse referring to multiple unspecified patients. The patients' concurrent condition, medical history and concomitant therapy were not provided. On an unknown date, the patients were vaccinated with improperly stored ZOSTAVAX (lot # M032638, expiration date: 04-OCT-2017; lot # L035283, expiration date: 15-DEC-2016; dose and route were unknown) for prophylaxis. The nurse reported no adverse effects noted. The temperature for the vaccine stored was 12.9 Fahrenheit degree with 2 hours 10 minutes time frame. Previous temperature excursion was reported as exposure to 13.8 Fahrenheit for 3 hours. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA008934: US-009507513-1701USA001205:
Wife presented to HD stating she saw physician for redness, swelling at pneumococcal vaccine. States husband had same reaction. States husband was treated with steroids and antibiotics just as she was.
Dizziness, Headache, Myalgia, tiredness ibuprofen prn, referred to PCP, icing injection site
Patient noted that 2 days after vaccination that her left shoulder became very sore and achy. She was  unable to left her shoulder. She denied redness or swelling at the site. Used tylenol. Did not contact MD. States her shoulder hurt for approx. 3 weeks post vaccination. Was massaging her arm to help relieve pain and it eventually felt better.  Also shared that her left thumb also was sore and reddened post vaccination but unsure if it was related. Does not recall an injury.
Pt had H/A, general malaise, myalgias, and generalized left arm pain.  Pt felt "flu" like.  No fever, no local reaction, on nuchal rigidity.  Symptoms started about 5 hours after immunization, around 9:30 PM.
01/19/2021 FELT DIZZY, ELEVATED HEART RATE,153, THROAT FELT LIKE IT WAS GETTING TIGHT 1/20/2021 WENT TO ER
pt recv vax & exp inj site redness;this is one of ten patients from this site who exp the above rxn;
VOMITING; HOT AND COLD FLASHES; ALLERGIC REACTION; This spontaneous report received from a consumer concerned a female of unspecified age. 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: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced vomiting. On APR-2021, the subject experienced hot and cold flashes. On APR-2021, the subject experienced allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vomiting, hot and cold flashes and allergic reaction was not reported. This report was non-serious.
Pt fainted in office hall 1 min after vaccine given; LOC; to ER pt now in ICU-skull fx, contusion, hemorrhage. Still in ICU.
Pt started to have hives on bilateral forearms on 4/15/21 evening. Then they disappeared without treatment. Next day  5/16/21 hives on arms and legs came back. Pt started to take expired Zyrtec. Contacted Health Unit on 4/21/21 reporting being late with her period, but did not mentioned having hives at this time9per pt report she forgot). Pt called HU today am reporting persistent hives, denied difficulty breathing, scheduled to be seen. DR.  prescribed Ranitidine 150 mg po bid, Zyrtec 10 mg po qd, Benadryl 25 mg po prn and Ventolin 1-2 puffs prn.
Patient turned pale (white), blurred vision, ringing in the ears, felt dizzy. He had to lie down on floor for few mins. Checked BP which was fine. Called 911. Paramedics came, but patient felt fine within 15-20 mins. and Mom decided to take him home. Had vagal reaction.
Total body urticaria/hives-esp B/L thighs-but also-arms, legs, upper trunk. Not soles, hands or face.
red raised bumps around injection site, hot to touch, swollen and injection site itself is red was given in the left deltoid
w/in several hrs of receiving immun, pt devel urticaria which lasted several days; Seen in MD office; approx 2 months later a skin scratch test w/1:10 dilution;
pt recv vax 22JUN96 & 29JUN96 pt presented to the MD w/approx 100 lesions all over chest & abd;
Patient received Pfizer COVID vaccine on 3/8/21 (lot # EP6955), 3/29/21 (lot # ER8730), and 10/7/21 (lot # FC3184). On 3/24/22, patient tested positive for COVID. On 4/5/22, patient admitted to our inpatient facility (med/surg unit) with sepsis due to pneumonia, recent COVID19 pneumonia, and a confirmation of COVID positive result. Patient was discharged home on 4/9/22.
My arm started to hurt the first night. Took Tylenol to help. Saturday I felt like I had been run over. Every bone and joint in my body hurt. I could barely get out of bed. I felt nauseas and had a bad headache. By Monday I didn't hurt as bad, but I still had a lingering headache. Monday mid day my arm was hurting and felt extremely hot. When I took a look at my arm it was swollen and very red. I marked the area  that was swollen and red and took pictures.     Tuesday it had gone down my bicep to almost the elbow crease and around the back of the bicep area. Around the red swollen area there was a distinct white outline. The red area was raised. My arm and hand started to tingle and be somewhat numb in the area where it was red. . Still had a headache, it lasted a week. My arm redness and swelling lasted until May 31st. You can still see where it was red. Its like the red is staying, just a lighter red.
Information was received from a registered nurse via a company representative referring to a female patient of unknown age. The patient's medical history and concurrent condition were unknown. Approximately on 12-AUG-2015 (reported as 'two weeks ago'), the patient was vaccinated with an unspecified dose of GARDASIL 9 (strength, dose, lot number and route unknown). Concomitant therapy was not reported. After receiving the GARDASIL approximately on 12-AUG-2015 (reported as 'two weeks ago'), the patient fainted in the parking lot when walking to the car. The patient was not injured during the fainting spell. The patient did not seek any medical attention and no treatment was given to the patient. The outcome of the event was recovered on an unspecified date in August 2015. Additional information is not expected as the reporter did want to be contacted.
After 2nd dose, I would say about 5:15PM, my eyes were kind of pink, but I have allergies to outdoors and I take Zyrtec and so I contributed that to my allergies. It kind of continued into June and by July I started getting dark red and swelling under my eye and at the end of July I made an appointment with a dermatologist, and he gave me cortisone cream for the eye, a Kenalog cortisone injection, and that was it. The eyeball itself hurt and I went to optamologist and she gave me cortisone eye drops and she didn't know if it was allergies or what it was and I had the steroid eye drops and then it started getting better. I had a routine appointment with my PCP on 10/13/21 and I updated him on everything. Told him I felt like it was a reaction to the vaccine since I never had that in my life before and he wasn't sure either. I told him what treatments I had and that they hadn't improved it and that is about it. It's much better now. The redness is gone.
Since the vaccine, I've developed asthma on top of all the other things. I've developed rheumatoid arthritis as well as pain in the extremities. Depression, anxiety. We're still not sure what else. I've now developed seasonal allergies. I've had skin falling off and leaving bloody messes. I haven't been able to sleep.
Working @ desk, began to feel lightheaded, tingling in arms, felt like was going to pass out and turned very pale. Denies diaphoresis.  Also, face & arms felt numb.  Arms & face are still feeling numb today, 10/18/12.  Saw a nurse practitioner today and is taking a cortisone pack.  States she had numbness of face and arms last year about 2 days after receiving vaccine, but went away after a couple of days.
Arm immediately swelled twice its size, fire engine red rash, heat, pain, bleeding and child said she was itchy all over, then suddenly said she felt very tired.  Physician was sent for, came in 1 minute later and administered Benadryl.  Swelling and redness subsided in 20 minutes.  Patient was irritable and cried off an on for 4 hours afterwards.
red dots on her legs below her knee on her legs; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red dots on her legs below her knee on her legs) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (red dots on her legs below her knee on her legs). At the time of the report, ERYTHEMA (red dots on her legs below her knee on her legs) outcome was unknown.            No treatment was taken.
Information has been received from a nurse concerning a 23 year old female who on 09-JAN-2008 was vaccinated with Gardasil. There was no concomitant medication. There was no illness reported at the time of vaccination. On 10-JAN-2008, the patient developed raised, red and itchy rash all over her abdomen, thighs and arms and called the physician. No physician visit was indicated. No laboratory/diagnostic tests were performed. The nurse reported that they advised the patient to take Benadryl. The patient outcome was unknown. Additional information has been requested. Follow-up received 04/16/2008. Initial and follow-up information has been received from a nurse concerning a 23 year old female with penicillin allergy who on 09-JAN-2008 was vaccinated with her second dose of GARDASIL (Lot #659653/1448U) intramuscularly in the left deltoid at approximately 9-9:30 am. There was no concomitant medication and no illness reported at the time of vaccination. On 10-JAN-2008, the patient developed a raised, red, itchy rash all over her abdomen, legs, thighs and arms and called the physician. No physician visit was indicated. The patient was told to take BENADRYL 50 mg orally. The patient phoned the physician's office 11-JAN-2008 and reported that she never took the BENADRYL and the rash went away on its own. The patient has recovered from the itchy rash as of 11-JAN-2008. No further information is expected.
Nose bleeds; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW967) via an unspecified route of administration in the left arm on 03May2021 at 10:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient previously had taken latex. The patient did not receive any other medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8374) via an unspecified route of administration in the right arm on 05Apr2021 at 10:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021 at 12:00, the patient experienced nose bleeds . The clinical outcome of the event nose bleeds  was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Severe headaches and body aches; Severe headaches and body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Severe headaches and body aches) and HEADACHE (Severe headaches and body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Severe headaches and body aches) and HEADACHE (Severe headaches and body aches). At the time of the report, PAIN (Severe headaches and body aches) and HEADACHE (Severe headaches and body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
This spontaneous prospective pregnancy report as received from a physician refers to a 24 year old female pregnant patient, with no drug reactions or allergies. On 27-APR-2015, the patient was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot# and expiration date were not reported). No concomitant medication was administered. At the time of vaccination the patient was in the first week of gestation. It was the first trimester of exposure. The Last Menstrual Period (LMP) was calculated based on gestational age as 20-APR-2015, the Estimated Date of Delivery (EDD) was 25-JAN-2016. At the time of report the pregnancy outcome was pending. The patient sought medical attention during office visit. No treatment was given. Additional information has been requested.
The patient is a 36 y male with the resident of home with PMH of schizophrenia presented to ED Hospital on 01/20/2022 for making aggressive and suicidal statements.   He admits to auditory hallucinations. Per guardian, patient has been wandering the streets and acting erratically. On presentation, there was concern that if he were to return to home in present state that he would potentially hurt someone.    Upon work up, patient was found to be positive for COVID-19 without hypoxia.   UDS positive for marijuana.   Patient was admitted for further management of aggressive behavior with COVID-19 infection with marijuana abuse.   Patient was petitioned and had clinical certification completed.   Psych was consulted and said patient does not need inpatient psych placement and to continue current medications.   There is concern that patient is triggered by a individual at the home and psychiatry recommends alternate home if possible. Patient's current guardian is working to have guardianship switched to a public guardian and patient is in the process of transitioning back to area and to a different home.  At this time patient has been accepted back to his current home.  Negative certification is done by psychiatry service today on 01/26/2022.   Over the course in the hospital pt,s aggressive behaviors got resolved. Pt feels well, eating good and his vitals are stable.   He is d/ced to home with follow-up with PCP.
Suspected vaccination failure; shingles rash; discomfort; rash; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On 19th April 2019, the patient received the 1st dose of Shingrix. On 25th June 2019, the patient received the 2nd dose of Shingles vaccine. On 8th January 2020, 264 days after receiving Shingrix and 197 days after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, discomfort and rash. The patient was treated with valaciclovir hydrochloride (Valtrex (Valaciclovir Hydrochloride)). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, discomfort and rash were recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles, discomfort and rash to be related to Shingrix and Shingles vaccine.  Additional details were provided as follows: The patient thought that he was experiencing discomfort from chigger bites that lasted several days. The patient went to a physician and was diagnosed as having shingles.  The patient was prescribed Valtrex and is on his 3rd day of treatment. The rash was subsiding. This case was considered as suspected vaccination failure, since the details regarding laboratory confirmation for shingles were not provided.
Mild headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer). The reporter is the patient. A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 03Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "don't smoke" (unspecified if ongoing); "occasional drink" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "Mild headaches". Clinical information: Patient received the vaccine 28 days ago and getting his second one today (31Mar2021). He had no reaction for the first few days but have been having mild headaches recurring more frequently. Patient stated he do not normally get headaches and need to know if it was anything he need to be concerned about. He is 71-year-old and in good health don't smoke and only an occasional drink.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
07/06/2022, I was exposed to a individual that was COVID-19 positive and coughing. I purchased a test and took it 16 hours after I experienced runny nose and scratchy throat. I started sneezing like jet propelled and explosive. I felt like my ear drums were going to burst. I tested positive on Saturday 07/09/2022. I called my doctor via telehealth and was prescribed Paxlovid and started it on 07/10/2022. I finished my 5 day regime, I now feel well.
I had flu like symptoms and strong fatigue for about 24hr after the vaccination but I got 10hr worth of sleep and was fine the next day. EDD-8/31/2021
pt recvd vax & w/in 12hrs p/vax exp a macular papular rash,& roughness 2 1/2inches around inj site;sx were treated w/oral DPH;sx resolved w/o diff in 3-5 days;
pt recv vax 2OCT97 & 6 days later 8OCT97 pt exp rash that from the inj site downward covering 1/3 of the pt arm;pt tx w/DPH;
DTaP, IPOL vaccines given on 6/30/03. On 7/3/03 patient has temp to 101.5 and grand mal seizure. Pt is autistic. Pt had 1 previous febrile seizure on 5/4/01.
Patient received above noted COVID19 Vaccine on Friday morning and reported symptoms starting Saturday morning. Symptoms include lip swelling, lip rash, and erythema only affected the lip area of the face. Symptoms have persisted for 3 days and that is when the pharmacy was contacted. Mother has given Benadryl to patient to help with itching/swelling. Pharmacist recommended close monitoring for worsening symptoms and to follow-up with primary care provider for further guidance.
Chills on 10/08/2006 - Followed by 102 temperature for 2 days, upper arm completely inflamed and painful to motion. Left with a hard lump, throbs and itches. Still have lump - throbbing and itching.
No adverse event; The patient was given the Moderna monovalent for 6m-5y instead of Pfizer bivalent booster; This spontaneous case was reported by a physician and describes the occurrence of WRONG PRODUCT ADMINISTERED (The patient was given the Moderna monovalent for 6m-5y instead of Pfizer bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 6-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1 at the beginning of 2022) in 2022, Pfizer (0.25 ml of second dose at the beginning of 2022) in 2022 and Pfizer (Dose 3 (monovalent booster)) in July 2022. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 23-Nov-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (The patient was given the Moderna monovalent for 6m-5y instead of Pfizer bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (The patient was given the Moderna monovalent for 6m-5y instead of Pfizer bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (The patient was given the Moderna monovalent for 6m-5y instead of Pfizer bivalent booster).    No concomitant medications were reported.  It was reported that the patient was supposed to get a Pfizer bivalent booster on that day so it would be her fourth shot, instead she was given the Moderna monovalent vaccine that was indicated for use in 6 months - 5 years of age.  No treatment medications were reported.
Off-label use of Moderna Covid-19 vaccine, first dose on 07/21/21. Patient is under 18 years old. Per Patient's mom, patient is doing fine without any side effects.