chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had an occurrence on Monday of an outbreak of herpes; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 04Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable nurse reporting for herself. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number not reported), via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously took valaciclovir hydrochloride (VALTREX). Patient stated "I stopped taking my Valtrex a week before getting the vaccine. I got the vaccine on Friday. I started having symptoms again and started taking it again". Patient also stated "I've been told that effectiveness of flu vaccine might not be as good for people taking this medication". Patient was inquiring about taking Valtrex medication before/during her 2 dose vaccine. She stated that she is a nurse in healthcare and she received an email. She received her first dose of the Covid vaccine on a Friday and had an occurrence on Monday of an outbreak of herpes. She stated she was taking Valtrex to suppress her symptoms for a year and stopped taking her medication a week before receiving the vaccine. She stated that she tested for Covid a week before receiving the vaccine as well due to exposure at work. She stopped the medication and panicked thinking it would have an interaction since reading information regarding flu vaccine. Patient states she could not get up with HCP regarding stopping her Valtrex so she called Pfizer. She spoke to someone at Pfizer that asked her if it would be okay to relay her information to someone else and she said yes. Then she received a weird email from [Company name] that said they were made aware a person that was under your care received the flu vaccine. Patient states she does not administer vaccines, she works at the hospital. Patient states she called the company and they did not have any information. She also called her HCP who told her to contact Pfizer to see what the email is all about. Her HCP told her to restart her medication and there is no interaction with Valtrex. Her HCP informed her that the only time she should stop taking her Valtrex is if she was receiving the shingles vaccine or a live vaccine. The outcome of the event was unknown.  Information about lot/batch number has been requested.
This spontaneous report as received from a registered nurse refers to an appropriately 17 year old(currently 19 year old) female patient. On 20-JUN-2011 the patient was vaccinated with her first dose of VAQTA (strength, formulation, lot#, dose/frequency, route was unspecified), which was a adult dose. On 09-JUN-2013, patient received a pediatric dose of VAQTA (injection, 25/0.5 U/ML, lot#, dose/frequency, route were unspecified) as her second dose. On 20-JUN-2011, 1 day after onset of therapy the patient experienced currently 19 year old patient received an adult dose, on 06/20/2011. No adverse symptoms reported. Outcome was unknown. Additional information has been requested.
The night after receiving the pneumococcal and flu vaccine pt experienced fatigue, chills, and redness at injection site. His white count is elevated and was seen today (11/1/10) in clinic and was sent to the ER for further evaluation.
Pt devel a high fever & grand mal sz night following OPV/DTP/TB immun; required office visit-hospitalized;
ADMINISTERED ADULT PFIZER COVID-19 VACCINE INSTEAD OF PEDIATRIC PPFICER COVID-19 VACCINE. PER PATIENT'S AUNT, PATIENT DOES NOT HAVE ANY ADVERSE EVENT AT THIS TIME
(R) upper arm swelling, redness, warmth and pain peaking 2 days following 2nd HPV. Monitored, ice, NSAIDS. Resolved w/in 3-5 days.
No additional AE information provided; lhe patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, and allergies were not provided.  On 19-MAY-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, vaccination scheme, anatomical location of injection and route of administration were not reported; lot number S035100, which has been verified to be valid, expiration date reported and validated as 31-MAY-2021) as prophylaxis (product storage error). According to the reporter, the sterile diluent (MERCK STERILE DILUENT) used to reconstitute the vaccine was properly stored. The vaccine underwent a temperature excursion of 6 degrees Fahrenheit (F) to 14F for 20 minutes; and another temperature excursion of 15F to 46F (38.8F) for 30 minutes. It was reported that no previous temperature excursion was suffered, and the digital data logger was involved. No additional adverse effects information provided.
Patient was seen for nurse visit appointment for Hep A #2 and HPV 9 #2 per her PCP. Verified no allergies, asked if ever had any reactions to previous injections which patient stated "no". About 5 min after injection patient's sibling reported she looked pale and felt dizzy. Pt put in supine position, given water, cool compress applied, monitored for 15-20 min. BP's were checked. PCP was notified, Pt improved after monitoring.
Patient developed redness and swelling at injection site left arm with anitisu center 2-3 minutes after injections.  In 10-15 minutes redness spreaded to elbow.  AT 12:30PM patient was given dipnenhydramine.  In 15 minutes redness and swelling decreased at 1:00PM redness - 2 x 2cm.  At 4:15PM - no redness, swelling left, patient was active, happy, acting as usual.
Symptoms began with rash within 24 hours of administration of vaccine.  She presented to the office one week later secondary to worsening rash and was diagnosed with vasculitis.  The rash appeared self limiting at that point and coincidentaly tested positive for Influenza B at the visit, so no further treatment was initiated.  The rash subsequently became increasingly severe and it was biopsied, labs drawn, and prednisone started. She is under continued treatment with steroids and undergoing an evaluation by a rheumatologist.
mild fever/ has low grade fever; This is a spontaneous report from a Pfizer sponsored program COVAX US Support via a contactable consumer (Patient himself). A 25-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and Lot Number: EL1283), via an unspecified route of administration on 27Jan2021 11:30 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were reported as none. On 11Feb2021, the patient underwent lab tests and procedures which included body temperature of 100.8-degree F. Patient stated that he had first dose of Pfizer COVID-19 Vaccine two weeks ago from yesterday on 27Jan2021. He was scheduled to get second dose next Wednesday. Last night on 11Feb2021 he developed very mild fever/ has low grade fever and no other symptoms besides that. Fever peaked around 100.8-degree F. Took Tylenol and his fever broke overnight. The outcome of event was recovered on an unspecified date in 2021.
This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received SHINGRIX for prophylaxis. On 21st September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, 7 days after receiving SHINGRIX, the patient experienced rash and shingles. The patient was treated with ACETIC ACID (APPLE CIDER VINEGAR). On an unknown date, the outcome of the rash and shingles were not recovered/not resolved. The reporter considered the rash and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. It was reported that about a week after receiving SHINGRIX the patient experienced rash which was stated as shingles and it appeared on both butt and cheeks. The size was 50 cent piece and lasted for a while. The patient called her physician and was told to place calamine lotion on it, but she used apple cider vinegar. She noted it never and it truly went away, but two to three weeks ago it returned but not as bad and remained. She was referred to her physician but unable to get the appointment till 30th January. The reporter gave consent to follow up.
On 08/07/2000, the patient developed a mild case of chickenpox. It was unknown if the patient had a fever or if exposure to wild type virus occurred. The patient sought unspecified medical attention. A varicella titer was drawn 08/30/2000 and the patient was not immune or indeterminate. No further information was provided.
Information has been received from a physician concerning a male patient who was vaccinated with a 0.5mL dose of VARIVAX (Merck). Secondary suspect included MMR II (MSD), for the treatment of prophylaxis (dose not reported). Concomitant therapy included poliovirus vaccine inactivated (unspecified) (manufacturer unknown) and another unspecified vaccine. The patient had localized redness and swelling within 5 minutes after vaccination, that was pretty severe, and the patient was kept at the office for about an hour. It was unknown if the vaccinations at the same site or which vaccine was administered at the site where the Adverse Event occurred. They gave him an unspecified medication to treat the adverse event. At the time of the report, the outcomes adverse events improved. Additional information has been requested.
I got the 2nd shot in my right arm and didn't have any symptoms until the 24 hour mark the next day. Mid morning I started to feel bad and I definitely didn't hold back on pre treatment with Tylenol and Advil before the vaccine and was taking it around the clock before symptoms even started. I still developed 103-104 fever I had rigors and was shaking uncontrollably for 6 straight hours. Fever wouldn't come down with NSAIDS or Tylenol. I physically couldn't move because my muscles hurt and my husband had to come home from work to help me to the bathroom. That lasted for about about 24-36 hours and then 1-2 days later after that I got the same lymph node swelling under my right arm. It was really large, swollen and painful. I also got this red rash on the same vaccine site and this one was bigger than my last and around 3-4" and it kind of stayed in arm for several days and almost melted down on my arm and as time went on over 1-2 weeks it settled into my elbow. It was a red, painful to touch spot. Then my fatigue and all got better and I started being able to work out again but not completely and then the ongoing lymph node. It has gotten better but it just hasn't went away at all. Ultimately its been 6 months and I'm concerned. I just went to my doctor today 08/25/2021 and I'll be having a mammogram. I had a really short period cycle as well after 2nd shot but I've always had normal cycle with 28 days on the spot and nothing unusual. Since 2nd vaccine I get 1-2 days of blood and I went to doctor for that today as well and they don't think it's a reason from the vaccine and doctor wants me to follow-up with hematology for some reason. Another thing is that I have diabetes and when I work out I keep track of my v02 max on my phone and it dropped after I got the vaccine and it dropped for 3 months solid without any change but it's better now.
body aches; chills; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (body aches) and CHILLS (chills) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Sep-2022, the patient experienced MYALGIA (body aches) and CHILLS (chills). At the time of the report, MYALGIA (body aches) and CHILLS (chills) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Patient received bivalent Moderna booster. The events had resolved within 24 hrs of onset.  No treatment information was reported.
Constant headache for the past five days. Nausea. Upset stomach (diahrrea) for the past five days straight. Unable to keep food in.  Had severe fever for two days. Extreme lower back pain that lasted for two to three days.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 68-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 09-SEP-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the events herpes zoster was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
INCORRECT DOSE OF H1N1 GIVEN TO PATIENT. .5 mL DOSE GIVEN.
Client received COVID Pfizer Bivalent 12+ as 1st dose in COVID series on 02/28/2023. Denies any adverse reactions. Presented to Clinic 03/24/23 to receive second dose. Error was noted 03/24/23. Client was given COVID Pfizer 12+ Monovalent vaccine as second dose in COVID series per CDC recommendations and guidelines on 03/24/2023.
Shortness of breath on exertion, muscle weakness, I fell down 5 times. All this lasted 3 or 4 weeks.
Red, painful, raised rash on forehead that spread from eyebrown to hairline. Went to physician next morning diagnosed with shingles. Rash lasted for 2 weeks, treated with antivirals.
Funny bone feeling on the whole arm; He had pain on the whole left arm and left shoulder; He had pain on the whole left arm and left shoulder; Numbness; He had a scab, on his left arm.; Almost like its trying to fall asleep; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient himself). A 74-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on Feb2021 as 2nd dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient didn't had any reactions. The patient previously took first dose of BNT162B2 on Jan2021 via unspecified route of administration for COVID-19 immunisation and experienced no reaction on previous exposure to vaccine. On an unspecified date, the patient experienced that he had the following side effects in his left arm, which is the arm that received the injection: funny bone feeling on the whole arm, at the site of injection, it felt like his shirt was snagging on something, and noticed he had a scab, on his left arm later on he had pain on the whole left arm and left shoulder. He stated that it was almost like its trying to fall asleep. Some pain related but mostly kind of a numbness. Patient stated that a search of the PI contains no information regarding his side effects as being reported from the vaccine. The clinical outcome for the events was reported as unknown.  Follow-up attempts are needed; Information on the lot/batch number has been requested.
Immediately after injection into patient's left deltoid, site swelling and felt firm.  Some bruising noted.   Ice applied and patient monitored for over 30 minutes.  Patient did complain of scratchy throat while being monitored, but refused Benadryl at this time.   Patient will notify her physician of this reaction to the vaccine.
This spontaneous report was received from a 66 year old female consumer. The patient's medical history and concurrent condition were not reported. On 03-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number, expiration date, dose and route of administration were not reported). Concomitant medication was not reported. The reported that after receiving the PNEUMOVAX 23 she experienced pain that continued to get worse. The pain was excruciating and she could not move her arm. The outcome of movement disorder and pain was reported as not recovered. The relatedness between movement disorder, pain and PNEUMOVAX 23 was unknown. Additional information is not expected as no reporter details were provided.
Within 10 to 15 minutes of getting the Flu shot started getting itchy and then tongue felt funny. Was given BENADRYL and symptoms improved. Took BENADRYL over night. Now feels itchy again but denies any problems with her tongue. Will continue with BENADRYL as needed and seek further medical care if needed.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25-Mar-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25-Mar-2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25-Mar-2022) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2022 at 12:24 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 25-Mar-2022 at 12:24 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.  Patient received booster vaccine past its 30-day expiry date. Vaccine went into 2-to-8-degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. Reporter no longer possess this lot number.   This case was linked to MOD-2022-542869 (Patient Link).
When child woke up on the morning of the 8-15-07 at 8am she had hives covering all of her body except in the diaper area.  She was crying and was scratching herself.  Her mom took her to Dr. that morning and she was given a prescription of oral medication called Prednisol 2ml BID X 2-3 days as symptoms persist and was also instructed to get Benadryl cream to apply to the  hives prn for itching. Their pediatrician said she had an allergic reaction to the vaccination that was given the day previously. When I spoke to mom today, she said her child still has hives, she called the pediatricians office and they said it may take awhile longer before the hives will resolve.
HEADACHE ON RIGHT TEMPLE SHOOTING PAIN BELOW LEFT EAR ON THE EVENING OF THE 26TH AFTER THE INJECTION. WOKE UP ON THE 27TH AROUND 9:30 AM WITH MY LIPS AND FACE FEELING STRANGE. APPROXIMATELY 11 AM FACE FEELING NUMBNESS. WENT TO BED WITH HEADACHE AND NUMBNESS IN FACE. WOKE UP AT 8AM ON 28TH HAVING TROUBLE SPITTING (LIPS NOT WORKING PROPERLY) CALLED MY FAMILY DOCTOR WHO ADVISE I GO TO THE ER. WENT TO THE ER AND WAS EXAMINED BY DR. WHO STATED I HAV BELL'S PALSY
Pt was given PNEUMOVAX IM on 7/11/17. She developed swelling in arm on 7/12. She called to report on 7/13. Deltoid area warm and swollen.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. It was reported that 20-30 doses of VARIVAX (Merck) that were exposed to temperatures outside of the range in the prescribing information have been administered (dates of administration, lot/batch numbers and expiration dates not reported). No adverse effect reported. Additional information has been requested.
48 hours post developed fever of 102.8,  fatigue,  rash/swelling on arm began at 24 hours post (warm, red, itching) and redness continued to enlarge through 72 hours to approximately 6" x 3".   Fever and fatigue subsided after 12 hours.   Rash subsided after approximately 4-5 days.     Also had arm pain in deltoid beginning 24 hours post.  This pain subsided but had pain from swelling/rash.
Pt 28 y/o female found sitting in a chair at USC vaccination site. c/c Allergic reaction post COVID-19 vaccination. Pt was instructed to wait in the "30 minute" monitoring area due to allergies to shellfish. After approximately 15 minutes in the monitoring area the pt notified CORE staff stating she felt her lips swelling. CORE staff notified LAFD and Carbon AP who immediately responded to the pt. Upon arrival it was noted that pt had moderate swelling of her lips and minor airway involvement. Pt was assessed and given 2 doses of EPI 1:1000 for a total of 1.0mg (0.5mg each). Swelling subsided and pt denied any further airway involvement. Pt denied any chest pain or severe shortness of breath. No nausea or vomiting, pt had equal grips and pushes. No headache, blurred vision or tinnitus. Abdomen was soft and non tender on palpation. Gravida 0, para 0. LMP 28 days ago. Pt has a Hx of severe allergic reaction to shellfish. LAFD RA10 was dispatched and pt was transported to hospital #133 for further evaluation and care.   Hx: Cardiomyopathy, Borderline anemic, HTN Allergies: Shellfish Meds: Birth control
Blacking out (everything went black I thought I was going to pass out); Fever; Headache; Body aches; Chills; Nausea; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female non-pregnant patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 05May2021 16:00 (Lot Number: EW0167) as single dose at 30 year old for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Other. Medical history included allergies to Penicillin. No covid prior vaccination and Covid was not tested post vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose on 14Apr2021 16:45 (lot number: EW0164) at 30 year old in the Left arm at single dose for covid-19 immunization, cipro [ciprofloxacin] and experienced allergies. Day after shot on 06May2021 10:45 AM, the patient experienced a Fever, headache, body aches, chills, nausea, blacking out (everything went black the patient thought she was going to pass out). No treatment received. The patient was recovering.