chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On 30-JUN-2015 the patient was vaccinated with improperly stored ROTATEQ (dose, lot# and expiration date were not reported; route of administration defaulted to oral) and RECOMBIVAX HB (dose, anatomical location, route of administration, lot# and expiration date were not reported). No adverse events were reported. This is one of the two reports received from the same source. Additional information has been requested.
My tongue was numb, tire, headache, fever, chills, body aches, pain on my arm and a little red on the shot area
Tenderness at injection site, ear aches & ringing in both ears like (nat'l alert) severe headaches on top of head with chills. Aches and pain on left side of face , neck and down the  left side of my body.  Joint pains, Nausea  and heart palpitations. Dizziness and deep sleepiness.
couldn't breathe through nose, hands shaking, nausea, had elevated blood pressure and pulse when checked. (162/104 and 122 hr)
tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable nurse (patient). A patient of unspecified age and gender received bnt162b2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, and then via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single, all for covid-19 immunization. Medical history and concomitant medications were not reported. The patient was fully vaccinated and had been for just about six months. The patient recently tested positive for COVID. Whom should the patient send this information to, to better support the need for a third vaccine. Also, if there somewhere the patient can get his/her blood drawn to distinguish which variant he/she was exposed to, further support scientific study and research. Please keep him/her informed. The patient was a withheld and did not mind contributing to this research. The patient underwent lab tests and procedures which included tested positive for COVID on an unknown date. The outcome of event was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the temporal relationship the causal role between the events  Drug ineffective and COVID-19 cannot be fully excluded. However the possibility of Covid being an intercurrent condition cannot be ruled out.
Information has been received from a licensed practical nurse concerning an 8 year old female with allergy to pertussis vaccine (limplegs) and ZYRTEC and autism who on 29-AUG-2002 was vaccinated subcutaneously in right thigh with a 0.5 ml first dose of VARIVAX (Oka/Merck) and on 11-APR-2008 was vaccinated subcutaneously in right thigh with a 0.5 ml second dose of VARIVAX (Oka/Merck) (LOT# 659353/1778U). There was no concomitant medication. On 12-APR-2008 the patient developed redness and swelling at the injection site of the right thigh (Size of 50 cent piece). The patient was examined in the office on 17-APR-2008 and the injection site reaction was resolved. No therapy was prescribed. There was no product quality complaint. Additional information is not expected.
07-16-10 Pt with low grade fever (99.9) through 7-22-10 report date 7-21-10 in evening, pt started stuttering before each word; 7-21-10--9:30 pm, pt having shortness of breath and tremors, increasing moodiness/tearful; all symptoms continued though 7-22-10 per Mother; pt referred to ER/PMD for evaluation of symptoms, unknown outcome at present.
This case was reported by a pharmacy via a pharmacy claims management company and described the occurrence of adverse reaction in a female subject of unspecified age who was vaccinated with FLULAVAL TETRA (GlaxoSmithKline). On 6 January 2014 the subject received a dose of FLULAVAL TETRA (unknown details). At an unspecified time after vaccination with FLULAVAL TETRA, the subject experienced adverse reaction. At the time of reporting the outcome of the event was unspecified.
Internal bleeding; Had trouble breathing; Chronic obstructive pulmonary disease; This is a solicited report FACILITATED COLLECT from a contactable consumer (patient) based on the information received by Pfizer from (MFR Control No. 21K-163-4072803-00).   A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 15Jun2021 (Batch/Lot number was not reported) as dose 1, single at 70 years old for COVID-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported), at an unknown dose citrate free for moderate to severe chronic plaque psoriasis. The patient's medical history and concomitant medications were not reported. On unknown dates, the patient (an elderly female) experienced internal bleeding and non-serious chronic obstructive pulmonary disease. The patient had internal bleeding. She had trouble breathing and was diagnosed with chronic obstructive pulmonary disease. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken for adalimumab was unknown. The outcome of the events internal bleeding and chronic obstructive pulmonary disease was not recovered while for the event had trouble breathing was unknown.   Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the events of internal bleeding and chronic obstructive pulmonary disease was not provided. opinion is that the events of internal bleeding and chronic obstructive pulmonary disease are not assessable.  Causality for bnt162b2 for Internal bleeding and Chronic obstructive pulmonary disease: Causality as per reporter: Possible.   The reporter's assessment of the causal relationship of the event had trouble breathing with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events internal bleeding, dyspnoea and COPD cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Initial unsolicited report received from a patient on 21 November 2016. This case involves a female patient (onset age was not reported) who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, dose and dose in series were not reported) and one other vaccine both in an unknown route on an unknown date in 2013. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and Illness at the time of vaccination were not reported. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 2013, unspecified timeframe following the vaccination, the patient had developed fever of 103F. The patient's Laboratory investigation and corrective treatment were not reported. The outcome of event was reported as recovered. List of documents held by sender: none.
The following day after the flu vaccine employee reports "shoulder was sore and achey then about 4 days later I started getting shooting  pain down my arm and waking me out of a sound sleep. This is still going on and it's been a month. When I raise my arm my entire bicep is tender. I feel the tender area where the vaccine was given and it feels tender at the site like it's black and blue but it is not visibly discolored. I get random shooting throughout the day."
Patient developed a raised bubble under the skin at injection site. Patient said vaccine hurt more than previous vaccines that she had received in her lifetime. The patient bled through barrier bandage. Barrier bandage was changed to a regular band aid after multiple alcohol swabs were use clean area and sooth area. Patient said that she did not feel pain during applied pressure to injection site after administration. The raised bubble was hard to touch. Patient refused a cotton swab under the band aid as she said it made the injection site hurt. Patient was advised to take acetaminophen or NSAID to sooth pain and an antihistamine if she was able to take one to help with any interaction. Patient waited about 30 minutes before leaving to allow pharmacist to apply  pressure to the site. She said that she felt better before leaving and was told that the pharmacist would contact her the next day to follow up.
This spontaneous report was received from a pharmacist via company representative refers to a 57 year old female patient. The patient was on unspecified blood pressure medication. On an unknown date approximately in May 2013 (reported as 7 months ago) the patient was vaccinated with ZOSTAVAX, single dose injection. On an unknown date approximately in December 2013 (reported as recently) the patient experienced tingling, itching, sensitivity and pain in varying spots on her body, including the bottoms of her feet. The patient had not presented with any rash, blisters or lesions. It was also reported that the injection site was also not involved. The patient did not seek medical attention. The outcome of the events was reported as not recovered (also reported the patient present status unspecified by the reporter). Reporter's causality was not provided. Additional information has been requested.
This spontaneous report was received from a physician refers to a 2 month old male patient. No concomitant medications and medical history were reported. On 16-OCT-2015 the patient was vaccinated with M-M-R II with batch number-L009214, expiry date 17-MAR-2017, dose, route and anatomical location unspecified) in error (inappropriate schedule of drug administration). No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. The events were considered to be not related to M-M-R II. Additional information has been requested.
Pt was awakened the morning following the vax w/ringing in the ears; no dizziness or hearing loss; Is present at all times but worse at noc;
Patient developed myocarditis after the 1st dose of Moderna COVID19 vaccine.  Myocarditis was confirmed by patient's cardiologist.  Cardiologist advised that patient refuse the 2nd dose of Moderna COVID19 vaccine.
Pt stated he was fine after receiving vaccine. Within 5-10 minutes he was in waiting room and passed out. After 10-15 minutes of observation he left accompanied by his mother. Vomited in the parking lot and continued to c/o nausea couple hrs later. 3 hours past injection Dr did F/L
Pregnant; Soreness at injection site; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) and VACCINATION SITE PAIN (Soreness at injection site) in a 35-year-old female patient (gravida 4, para 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy on 13-Aug-2003, Pregnancy on 03-Nov-2008 and Pregnancy on 24-Nov-2014.    On 06-Mar-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 05-Feb-2021 and the estimated date of delivery was 12-Nov-2021. On 06-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant) and VACCINATION SITE PAIN (Soreness at injection site). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  On 06-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. On 08-Mar-2021, VACCINATION SITE PAIN (Soreness at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment was reported for the events.
Made me menstruate for 32 days after. And I haven?t had a breakout of my herpes since I had contracted it in 2003 and it cause me to have a bad outbreak. And has made acyclovir the normal prescription I?ve always received if I was ever feeling a breakout coming would prevent it from becoming fully broke out. ?. Did not work at all with just one cycle. Been dealing with the breakout for 9 days now. Having to miss work for 2 weeks now
Adverse  event: Body Rash located all over abdominal area, back, and neck.   Treatment: Benadryl  Outcome: Unknown
Myalgia, Arthralgia, muscle weakness of left arm (injection site) Narrative:  The evening after receiving the vaccine, the patient reported injection  site pain and feeling warm (no fever). The following day, he was unable to lift his left arm (the arm that received the injection). Over these two days, he reports taking 1000mg of acetaminophen a total of two times to treat his symptoms.
within minutes of vaccine administration - shortness of breath; difficulty breathing, sweating, bp 150/104 p 48 and 142/75  p 54; pt left on ambulance
Report 20010037831 describes rash in a 52 year old female who received Engerix-B for the prophylaxis of hepatitis B. The vaccinee has no known drug allergies. Her medical history includes hypertension and she takes blood pressure medication (NOS). On 02/09/2001, the vaccinee received her first left deltoid dose of Engerix-B. Post-vaccination, on 02/19/2001, she noticed a rash on her chest. No treatment was given, and Engerix-B was not discontinued. As of 02/12/2001, the outcome of the event is unknown.
Information has been received from a consumer on 02-AUG-2010. The female's grandson (initials and DOB unknown) received the flu vaccine (manufacturer unspecified) in the past and developed high fever. Medical history included high fever from the polio vaccine in the past. This case was originally reported to Merck & Co., Inc. (case number: 1007USA04068). Additional information has been requested. The company considers the event as unassessable due to insufficient information. Information derived from this AE report does not change the current safety profile of the product.
Information was received from a medical assistant concerning a 13-year-old patient of an unknown gender. the patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number: L037339, expiration date: 09-FEB-2018, dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS, MALAISE, BACK PAIN, BONE PAIN, and PRURITUS in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 07C21B, 003A21A, and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No concomitant medications were provided by the reporter.  Concurrent medical conditions included Arthritis (The patient was taking her medication for arthritis).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced EXTRA DOSE ADMINISTERED. On 06-Nov-2021, the patient experienced DIZZINESS, MALAISE, BACK PAIN, BONE PAIN, PRURITUS, DYSKINESIA, INSOMNIA, VACCINATION SITE PAIN, and NAUSEA. The patient was treated with ONDANSETRON for Sickness, at an unspecified dose and frequency. At the time of the report, DIZZINESS, MALAISE, DYSKINESIA, VACCINATION SITE PAIN, and NAUSEA outcome was unknown, BACK PAIN, BONE PAIN, PRURITUS, and INSOMNIA had not resolved and EXTRA DOSE ADMINISTERED had resolved.            No concomitant medications were provided by the reporter. patient tried hot and cold compresses, and her medication for arthritis, but nothing seems to help. She cannot sleep and feels like somebody was stabbing her in the back.   Patient contacted her doctor, who told her to take Tylenol and alternate hot and cold compresses. The doctor also suggested calamine lotion, but it was not helping.   This case was linked to GB-MODERNATX, INC.-MOD-2021-162562, GB-MODERNATX, INC.-MOD-2021-162563, GB-MODERNATX, INC.-MOD-2021-162519 (E2B Linked Report). GB-MODERNATX, INC.-MOD-2021-162562: Cases crosslinked: MOD21-162562 and MOD21-162563. GB-MODERNATX, INC.-MOD-2021-162563, GB-MODERNATX, INC.-MOD-2021-162519.
This spontaneous report was received from a physician and refers to a 13 year old female patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date in approximately 2015 (reported as two years ago), the patient was vaccinated with GARDASIL injection via intramuscular route (dose, lot number and expiration date were not reported). On an unknown date (reported as recently), the patient was vaccinated with GARDASIL 9 injection via intramuscular route, lot # reported as M002606 with expiration date 30-APR-2018 (dose was not reported). No side effects were reported. There was no product quality complaint involved. Lot M002606 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine. Additional information has been requested.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a male. Neither medical history nor concomitant medications were reported. On an unspecified date in Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.
Roughly four days after receiving my booster shot I developed hives all over my body. It is now a week later and they have not gone away. I have tried taking a multitude of antihistamines but find little relief in them. Nothing else in my life changed including diet, environment, etc.
Minor headache, moderate nausea, dizziness occurred the evening of the injection.  Those symptoms continue the following day, along with vomiting and fatigue.  Vomiting occurred late in the evening after bending over to clean up cat vomit, which always sets off my gag reflex, but I was feeling like I could vomit before that anyway.  Also, I had just started taking Hydrochorothyozide the day of the injection and some of the things I experienced can be side effects of the medicine as well.
Patient called this nurse stating she had an allergic reaction to COVID vaccination given on Friday 1/15/21. States she felt fine for the 15 minutes post immunization, was on her way home and started feeling dizzy, short of breath, chest heavy, throat felt full "like a ball in it". She came back to clinic which was closed but sat in the parking lot for a while. While in parking lot trying to figure out what to do, her symptoms lessened. She got home safely but started to feel jittery/shaky and her BP was very high (couldnt remember exact number). She then went to urgent care where they told her she was having an allergic reaction and given a pill of something and steroid for 6 days. Went home from urgent care and BP still high but got better at bedtime. Saturday she had a "really bad headache and just layed around all day. I was not able to function at all."  Sunday she still had a headache and added muscle aches. Monday she started feeling "a lot better" until 8 PM when she was walking around doing her nightly routine and started to feel a wave of dizziness, throat felt funny so she sat down and took her BP with result of 207/131. Says this reaction felt worse than Friday's reaction so she went to ER where she was again told she was having an allergic reaction and the steroid given to her at Urgent Care was not helping and to stop taking them. Given Benadryl in the waiting room, had labs and EKG which came back "normal", and given a different med Vistaril to take with any future symptoms. Was also told to NOT take the second dose of COVID vaccination. Says she has not had to take the Vistaril yet and has not had any sign of reaction today so far. Said she did report the initial headache on the V-safe app.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On 11-AUG-2016 the patient was vaccinated with improperly stored GARDASIL (dosing details were not reported) (lot # K026246, expiry date: 28-JAN-2016 (incorrect product storage). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Redness,rash at injection site appeared later in the day. Tylenol and ice pack treatment. Patient also put anti-itch cream on 10/22/16.
Stiffness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second 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) at an unspecified dose. In 2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness) was resolving.            Concomitant Drugs Not Reported.  The reporter's causality for the event(s) of stiffness with Hmira(adalimumab) was no reasonable possibility.  Treatment Drugs Not 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.
Patient states arm was sore/a little red the day after administration. It has itched her some and been red but when she applied sunscreen yesterday (7/15/18) it turned bright red in blotches and became swollen in about a 4in circumferance right around the injection site. She got the TDap vaccine in her left arm and had no issues with it even after applying same sunscreen.