chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a certified medical assistant and refers to a patient of unspecified gender and age. The patient's concurrent conditions, medical histories and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored doses of PROQUAD lot # R002934, expiration date 29-JUL-2019, (dose, route, vaccination site and frequency were not reported), for prophylaxis which was reconstituted concomitantly with sterile diluent, lot# N014021, expiration date 04-AUG-2019. The suspect vaccine was exposed to a temperature of 6 Fahrenheit (°F) to 14 °F 39 hours 35 minutes and 15 °F to 46 °F 39 hours 57 minutes. There were no previous temperature excursions. A digital data logger was involved.  No adverse effects were reported in any patients. Furthermore, no product quality complaint (PQC) was involved.
I have had a excruciating migraine for 3 days. It's causing an exuberant amount of pressure feeling in my head. I'm doing light headed and in lots of pain.
I've suffered from tinnitus for 26 years and have generally been able to ignore it.  Shortly after my 2nd Covid vaccine the tinnitus got louder and it's difficult to ignore now.
Following ~1 month of intense soreness in left deltoid muscle after administration of whooping cough booster and Zostavax vaccines, I awoke to sharp burning pain along the left bicep, especially upon extension of the arm. Within 4-5 days, bicep became progressively and increasingly numb. No treatment.
Information has been received from a nurse concerning a patient who was vaccinated with a dose of Zostavax. Subsequently, the patient experienced shingles. There was no product quality complaint involved. Additional information has been requested.
Emesis for three days with diarrhea and a rash over the body.  Irritability.  Seen in the office for two visits while ill.
Redness, raised, tender, itchy, red ring around area - advised to apply ice for discomfort.
Hives on back.  Treated with benadryl. Progressed to generalized rash.  Prednisone added 10/21.  Rash still ongoing at time of report.
Patient was seen at the hospital to receive the 3rd COVID-19 Booster Vaccine. The patient had a history of previously receiving Moderna COVID-19 Vaccines. The patient was mistakenly given the Pfizer COVID-19 vaccination. The patient was notified immediately. He had no concerns other the potential side effects and was monitored for 15 minutes per protocol.
face became very red and warm, and became very swollen and somewhat itchy.; face became very red and warm, and became very swollen and somewhat itchy.; face became very red and warm, and became very swollen and somewhat itchy.; face became very red and warm, and became very swollen and somewhat itchy.; This is a spontaneous report from a contactable consumer (patient). This 67-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6201 and expiry date was not provided) via an unspecified route of administration, in left arm, on 13Feb2021 at 13:30 (at the age of 67-year-old) as a single dose for COVID-19 immunisation, at Health Clinic. Patient's medical history included Fibromyalgia, Hypertension and Hypothyroid. Patient had no Known allergies. Concomitant medications included alprenolol hydrochloride (ATENENOL), lorazepam (ATIVAN), duloxetine hydrochloride (CYMBALTA), hydrocodone bitartrate, paracetamol (NORCO), bupropion hydrochloride (WELLBUTRIN) and CEL (within two weeks of vaccination). Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID prior vaccination. Patient had not been tested for COVID, post vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL1283 and expiry date was not provided) via an unspecified route of administration, in left arm, on 16Jan2021 at 02:30 PM (at the age of 67-year-old) as a single dose for COVID-19 immunisation. Patient reported that on 14Feb2021 at 12:00 PM, her face became very red and warm, and became very swollen and somewhat itchy. It is the same today, 48 hours after my 2nd vaccine. The patient did not receive treatment for the events. Outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Headache, nausea, extreme fatigue and body aches. Left arm extremely sore.
Bone spur; Severe arthritis in both hips; Patient took 2nd dose on 19th aug and 3rd dose on 28th Oct 2021; A lot of runny nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (A lot of runny nose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 2nd dose on 19th aug and 3rd dose on 28th Oct 2021), EXOSTOSIS (Bone spur) and ARTHRITIS (Severe arthritis in both hips ) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Oct-2021, received third 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) Solution for injection in pre-filled pen. In 2021, the patient experienced RHINORRHOEA (A lot of runny nose). On 28-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 2nd dose on 19th aug and 3rd dose on 28th Oct 2021). On an unknown date, the patient experienced EXOSTOSIS (Bone spur) and ARTHRITIS (Severe arthritis in both hips ). At the time of the report, RHINORRHOEA (A lot of runny nose) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 2nd dose on 19th aug and 3rd dose on 28th Oct 2021), EXOSTOSIS (Bone spur) and ARTHRITIS (Severe arthritis in both hips ) outcome was unknown.            The reporter's causality for the event(s) of A LOT OF RUNNY NOSES AFTER LAST INJECTION OF COVID VACCINE, SEVERE ARTHRITIS IN BOTH HIPS WITH BONE SPURS unknown onset and SEVERE ARTHRITIS IN BOTH HIPS WITH BONE SPURS unknown onset with HUMIRA(ADALIMUMAB) was no reasonable possibility.  Concomitant product use was not provided by the reporter. Treatment information was not provided.   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
muscle aches; headache; tiredness; aches; This case was reported by a consumer via interactive digital media and described the occurrence of myalgia in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th November 2020, the patient received Shingrix. On 26th November 2020, 1 days after receiving Shingrix, the patient experienced myalgia, headache, tiredness and pain. On an unknown date, the outcome of the myalgia, headache, tiredness and pain were not recovered/not resolved.   It was unknown if the reporter considered the myalgia, headache, tiredness and pain to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The patient received the Shingrix shingle vaccine and felt muscle aches, headache and tiredness.  The reporter wanted to know was it safe to take Ibuprofen for the aches and headache.
Heaviness in chest; Racing heartbeat; Fatigue; This is a spontaneous report from a contactable other hcp (patient). The 41-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), via an unspecified route of administration on 13Jan2021 10:15 in Left arm at single dose for covid-19 immunisation. Medical history included none. No other vaccine in four weeks, no other medications in two weeks, increased protein. No covid prior vaccination. No covid tested post vaccination. No Known allergies. The patient's concomitant medications were not reported. The patient experienced Heaviness in chest, racing heartbeat, fatigue on 22Jan2021. No treatment received. The outcome of the events was not recovered.  No follow-up attempts are possible, information on batch number cannot be obtained.
Vomiting with blood; Throwing up; Gagging; Loss of appetite; Stomach not feeling good; Head throbbing; Bedridden; Weakness; Chills; Achy body; Puffiness; Throbbing; A spontaneous report  was received from a consumer concerning a 65-years old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced vomiting with blood, throbbing, puffiness, chills, weakness, bedridden, loss of appetite, stomach not feeling good, gagging, throwing up, achy body and head throbbing.   The consumer's medical history was not reported. Relevant concomitant medications included metformin, atorvastatin and levothyroxine, all were used for an unknown indication.  On 08 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 08-MAR-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 031L20AA) intramuscularly in left arm for prophylaxis of COVID-19 infection.  Later, on the same day, the patient experienced throbbing and then puffiness at the site of injection. Then as time progressed, she became achy and she couldn't get out of bed next morning due to chills, weakness. Patient reports being bedridden all day and didn't have an a appetite. Patient drank more fluids and tea, then she ate a little. Patient then felt that her stomach was not feeling good (thought it was acid reflux) so she took an acid reflux. Patient reported lying down, falling asleep and waking up and gagging and throwing up. Chills was not disappeared and her body feels achy and head was throbbing. The patient reported that she was better than the two previous days.  Treatment provided included motrin for headache.  Action taken with mRNA-1273 in response to the events was Unknown.  The outcome of the events, vomiting with blood, throbbing, puffiness, chills, weakness, bedridden, loss of appetite, stomach not feeling good, gagging, throwing up, achy body and head throbbing was considered as recovering.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
SkinRash, Rash, UrticariaPruritus, FAINT RASH TO RIGHT FOREARM AND RIGHT UPPER ARM, ITCHING TO LEFT ARM NO RASH Narrative:  EMPLOYEE WAS EVALUATED BY EMPLOYEE HEALTH NP AND GIVEN BENADRYL 50 MG PO
Nurse reported the patient was administered an improperly stored dose of VAQTA; This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 26-MAY-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated(VAQTA)(strength, route, dose, frequency, and anatomical location were unknown) with lot # S020241 and expiration date 23-AUG-2020 for prophylaxis.    The administered dose of vaccine experienced the temperature excursion of 12.1 °C degrees Celsius for 16 hours 11 minutes. There was a digital data logger invloved, but there was no previous temperature excursion. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S020241; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patient's of unknown age. On 01-Mar-2016, 09-MAR-2016 and 29-MAR-2016, the patients were vaccinated with improperly stored and unsupported doses of M-M-R II) (lot reported as L011079, Expiration Date: 08-JUNE-2016), which were stored under 9.5 Celsius degree for 10 hours. There was no data logger and no previous temperature excursion. No adverse effect reported. Lot number L011079 is an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live. Additional information has been requested.
On 3 Oct 2011, parent called to say that the child had hives all over body starting next day. She gave him Benadryl for 3 days. He did not have any trouble breathing or any other symptoms. Temperature remained normal. Parent also reported at this time that child has food allergies to shellfish, chocolate, oranges, Tree nuts, and bananas. Parent reports that child did not have any of these around this time but that the Hives is the same reaction he has to his food allergies.
Information has been received from a registered nurse concerning an 18 year old female with an allergy to naproxen who on 23-APR-2008 was vaccinated with a second dose of GARDASIL. The patient was vaccinated with a third dose of GARDASIL at college so exact date was unknown. Concomitant therapy included NUVARING. After the 3rd dose of vaccination, in early November 2008 the patient developed intermittent chest pain. She had been having "sharp left-sided chest pain that radiated up the chest". It was typically moderate but sometimes severe. On occasion it had radiated to the right side and one time it went down her back. It happened with rest and activity. It happened randomly without an identified precipitating factor. Typically the pain lasted 2 minutes and happened 4 to 5 times daily. Her longest episode happened only one time and lasted 45 minutes. She had a hard time catching her breath when the pain occurred but otherwise normal breathing. She denied palpitations, crushing chest pain and no sweating. The patient sought medical attention via phone and on an unspecified date the patient went to the ER and was not admitted to the hospital. Tests were normal. She had a negative magnetic resonance imaging, chest X-ray and electrocardiogram. A complete metabolic panel, complete blood cell count, erythrocyte sedimentation rate, C-reactive protein, rheumatoid factor, antinuclear antibodies choice screen and thyroid tests were conducted in the city where the patient attended college and all the results were normal. Her internist tried a "prednisone burst" with no improvement, then tried PRILOSEC for acid reflux with no improvement. She was being followed by an internal medicine specialist who believed the problem was musculoskeletal and her mom felt it was a "muscle spasm". She was given  FLEXERIL, ibuprofen and heat. The patient refused physical therapy. She was waiting additional lab work (results unknown). The patient missed her last appointment so her current condition was unknown. Additional information has been requested.
1st dose given 2/10/2021 with no event. 2nd dose Lot#002B21A- On April 3rd, both ears started ringing with a low buzz/humming sound. I had not been sick or had any allergies at the time. I have no history of auditory issues or have not had any circumstances that would trigger or make me predisposed to auditory problems. I took over the counter decongestants with no relief.  On 4/7, I made a appointment with my PCP office. Upon exam, there was no infection and no blockages noted. I was prescribed a methylprednisolone staggering dose pack. The pack was completed as prescribed and there has been no decrease in the ringing.
Patient began having hives throughout her body (Legs, back, Bottom, feet, chest, head)
Patient had received a TDAP in 2007. Physician and CMA made the decision to give the TDAP because they were unsure just looking at one page of MCIR.
NOTIFIED PHYSICIAN FIRST, THEN LEFT VOICEMAIL FOR MOTHER WITHOUT RESPONSE
3" X 5" area at injection site became swollen, red, warm to touch, itchy and tender. All symptoms resolved within 7-14 days.
gout attack; red as a beet; A spontaneous report was received from a consumer concerning a male patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273)  experienced gout and redness.   The patient's medical history and relevant concomitant medications were not reported.   On 05 Jan 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   The patient experienced a gout attack and was red as a beet on 06 Jan 2021.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events gout and redness were not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
26 hrs after 2nd shoot vison became blurry in right eye (pain behind eye) and left and right could not focus together. Created an unsteady feeling and had to lie down.
Low grade fever (~100), chills, headache, nausea, muscle aches, feeling of fatigue and sore arm. Symptoms lasted about 24 hours.
This spontaneous report as received from a physician refers to a patient of unknown age. The patient was administered 3 separate doses of  M-M-R II injection (lot number, dose, route and injection site were not reported) on three separate unspecified dates. Post-vaccination titers were performed on an unspecified date in 2012 and the results were negative to measles, mumps and rubella antibodies. The action taken was not provided. The outcome was unknown. The patient has seen at the physician's office for medical attention. Additional information has been requested.
blood clot; infection in stomach; This is a solicited report from a contactable consumer (patient) via marketing program based on information received by Pfizer from Agency (Manufacturer Control Number#: 21K-163-4150638-00).   Solicited report by a consumer of a 43-years-old male with events of non-serious blood clot, shipping caused humira medication to come warm and infection in stomach with humira (adalimumab). There was no reported medical history. On unknown dates (2021), the patient experienced blood clot, shipping caused Humira medication to come warm and infection in stomach. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 20Jan2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 15Mar2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. Causality for Humira(adalimumab) The reporter's causality for the event(s) of blood clot with HUMIRA (adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of shipping caused Humira medication to come warm and infection in stomach was not provided. The action taken in response to the events for adalimumab was unknown. The outcome of the event blood clot was not recovered, of  other event was unknown. Causality as per reporter for clot blood, incorrect product storage and gastric infection with BNT162B2 was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The information provided is very limited to make a meaningful medical evaluation of the case. However, based on the current information available a possible contributory role of the suspect BNT162B2 for the reported events of Thrombosis and Gastric infection cannot be completely excluded. The case will be reassessed further upon receipt of additional information. 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.
9 days later on 12/11/21, I started getting itchy and breaking out in hives all over my body. This continued on and off for the next 24-36+ hours until I went to the hospital where I received steroids and antihistamines. The next day I saw an allergist who gave me a different course of antihistamines and Pepcid. These controlled the outbreaks but I was and still am having hives outbreaks especially if I try to go off the antihistamines. I do believe this is caused by the booster shot as I have found, literally thousands of people online dealing with the same issue about 1-2 weeks after their booster and some since their 2nd covid vax shot.
Influenza vaccine administered 08/31/11 at 12PM. Patient notices swelling of the eye at approximately 3AM on 09/01/11. At approximately 6AM patient vomited. Steroid eye drops administered by patient.
Saturday, March 13 I started experiencing burning on my stomach and back. Sunday morning, March 14 I noticed a rash on the right side of my stomach and side body. I went to the nurse practitioner at CVS minute clinic on Monday, March 15 who diagnosed me with shingles. I was given an anti-viral medication to take 3 times a day for 7 days. I continue to experience burning on my stomach and back. Although I have had chicken pox as a child, this is the first time I have had shingles.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In 2011, a physician at an office administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). In 2016, the patient was treated by a healthcare provider at a medical center for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.