chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I went to pharmacy and I had got the whooping cough shot because my niece had a baby and I was trying to protect him from getting it because his grandma got the shot and the mother and I'm older than the grandmother which is my sister I have been having this constant coughing and I have not been able to get rid of the doctor has tried me on different medication I am still going through this today this happened eight months ago it affects my back which I have two herniated disc arthritis and a pinched nerve which messes with my legs and my feet because of the constant coughing it is pushing down on the nerves and affecting my bodies why I can't get it to a point where I can hardly walk I coughed so hard that it makes me pee on myself and it makes me also have ball movements without any notice now I'm wearing underwear for bladder control and keeping toilet paper in between my cheeks to keep it from messing up my underwear this is a inconvenience for me now that's trying to send me to a bladder surgeon and send me to a colon surgeon because it's making the muscles in my area that hold in the feces is weak and it also trying to push me into getting back surgery because all the constant pain I'm in and the pinching down on my nerves in my back and making my herniated disc worse because it's not stabilize it moves like a grinding because racing against each other and the other ones because of the constant coughing my doctor have had tried me on an inhaler that didn't do nothing but make it worse Seaside these Pearl looking pills for coughing that doesn't work and nasal spray also and that doesn't help I get the sweats I get chills and the coughing is making my chest hurt
Patient reported headache, sweating, slight fever (99-100), muscle aches. She said it was "flu like" symptoms.
pt stated when she got the vax she instantly had a pain in the right arm that went to her into neck.  She states from 9pm to 1:00 am she was in a delirium state and that she felt like she was melting from the inside out was running a fever but did not have one.  She had swear pouring off from her body. Her ears were ringing and her body was tingling.  Pt has not contacted her PCP at this time since she is now feeling better.
I tested positive on the February 26th and was prescribed PAXLOVID. My body ached all over and I had a very sore and swollen throat. No fever but I felt like I had a very bad head cold. Then I tested negative for two days in a row, and on March 9th I took another at home test, and it showed positive once again. Then I tested negative March 15th, but I still had all the symptoms on March 29th. My tonsils and throat were still swollen, and I had so much phlegm. No coughing accompanied with any of these symptoms.
Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diptheria crm197 protein) injection) was received from a healthcare professional regarding a 2-month-old male patient who experienced fever, an injection site reaction characterized by injection site swelling and injection site redness. The patient received his first dose on 02-Jul-2003. The patient also received his first dose of Hib-Titer vaccine (Haemophilus b conjugate vaccine (diptheria crm197 protein conjugate), the first dose of Infanrix (diptheria/tetanus toxoid/acellular pertussis vaccine) (GlaxoSmithKline) and the first dose of Polio vaccine (poliomyelitis vaccine inactiviated) "Pasteur" (Pasteur Vaccine) on 02-Jul-2003. Medical History: Relevant medical history was not provided. Product Details: Indication for Prevnar was immunization. Product was administered on 02-Jul-2003. Dose regimen was one dose. Concomitant therapy: Concomitant medications were not reported. Event Details: The patient experienced fever (pyrexia), injection site swelling (injection site swelling), injection site redness (injection site erythema) and injection site reaction (injection site reaction NOS) on 03-Jul-2003. No additional information was available at the time of this report. Manufacterer's comment: This report was received from GlaxoSmithKline manufacturer of Infanrix (Ref. No. A0415375A).
Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, chills and fatigue. pain at the injection site. Narrative:  Other Relevant History:
Shingrix sub q; This case was reported by a nurse via sales rep and described the occurrence of intramuscular formulation administered by other route in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix subcutaneously which led to intramuscular formulation administered by other route. The reporter agreed to follow up.
Developed chronic fatigue syndrome which progressed in severity with each anthrax injection. Fatigue, malaise >60days, flu-like symptoms >96 hours. Weight loss, unexpected.
Pt received (PEDIARIX) DTaP, IPV, Hep B and separate dose of Hep B (RECOMBIVAX) during this visit 2/14/2011. 2/15/11 - followed up with parent. No ill effects reported.
Body aches; Tired; This case was reported by a consumer and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 7th December 2020, the patient received the 2nd dose of Shingles vaccine. In December 2020, less than a week after receiving Shingles vaccine, the patient experienced general body pain and tiredness. On an unknown date, the outcome of the general body pain and tiredness were unknown.   It was unknown if the reporter considered the general body pain and tiredness to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced body aches and Tiredness after second shot of Shingles vaccine. The patient wanted to know how long do the side effects last .
Information has been received from a physician concerning "several" patients who were vaccinated with varicella vaccine. The physician reported that the patients subsequently developed a mild case of "chicken pox breakthrough." The physician reported in follow-up that she had identified every one of which she knew at that time. Additional info is not expected.
Bivalent vaccines have undergone several temperature excursions and have been administered to patient; No Adverse Event; Bivalent vaccines have undergone several temperature excursions and have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No Adverse Event) in a 47-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2022 at 10:58 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 26-Sep-2022 at 10:58 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient).    No concomitant product reported by the reporter. Patient had received previous 3 doses of Moderna vaccine via intramuscular with anatomical site as deltoid. Dose 4 anatomical site was also reported as deltoid. It was reported that the vaccines had undergone several temperature excursions in August 2022. Refrigeration excursions identified and vaccine was housed in the units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. No adverse reactions reported for any patient at the time of report. Date vials moved from freezer to refrigerator was 07-Sep-2022 both monovalent vaccines. No treatment medication reported by the reporter.
Upon receiving the injection the patient had a syncopal episode which included pallor, pupil dilation tonic/clonic movements of upper extremities, and a brief loss of consciousness.
treated for shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 16-OCT-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) at a pharmacy, for the long term prevention of shingles and zoster related conditions. Subsequently, the patient was treated in a hospital, since he experienced shingles on unspecified date. As a direct and proximate result of the patient's use of zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was not provided and the causality of the events was related.
Spontaneous extreme chills, severe loss of energy for hours at a time, headache behind eyes.this all started several days after the first dose
Fever of 100° for 33 hours. Chills off and on for 33 hours. Sore arm for 60 hours. Fatigue for 33 hours. Aching joints and muscles for 24 hours.
16 year old; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information provided. No treatment information provided.
missed the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed the second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed the second dose) had resolved.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided by the reporter.
Approx 36 hr after vaccine admin, developed itching over body. Next morning awakened with hives and severe itching over body. Developed severe swelling of upper and lower lips. No respiratory involvement. Self treated with antihistamines. Symptoms resolved completely approx. 72 hr after onset.
Patient stated her throat felt tight. Requested call to 911 and Epi pen was given. 911 arrived all vitals were normal. patient requested to go to the ER
Pt describes unusual pain at time of vaccine and said the pain only got worse throughout the day.  She now reports additional pain throughout her arm.  No swelling, no redness, no site tenderness.  Told pt to f/u in am and she states that overnight she took 3 IBU 200 and a Vicodin and still in immense pain.  Referred her to talk to her PCP because pt reported calling her orthopedist who told her it wasn't in their scope.
A week later itching during sleep then next day, day 8,I noted a large red raised itchy welt at injection site of 3 inch diameter. Rash lasted about ten days with fading itching. It was hard day after vaccine to raise my arm to shoulder height without pain for couple of days.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. No Medical History information was reported. On 31-Mar-2021 at 2:49 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 2:49 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 48.16 years. Concomitant products were not provided. On 30-Mar-2021, the vaccine with batch number 030B21A was moved to fridge. On 31-Mar-2021, 14 vials were moved to the clinic. On the same day between 08 AM to 09 AM, vials underwent temperature excursion with temperature of 32 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 29-Apr-2021. It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit. Treatment medications were not reported. This case was linked to MOD-2022-566976 (Patient Link).
rash/pimples/small warts-like spots (3) on penis, tender to touch/water. Started healing on their own within a week.
Rash started on 10/19/2001. Vaccines administered on 10/18/2001.
UPON GIVING INJECTION PATIENT BEGAN TO HAVE IMMEDIATE SWELLING AT INJECTION SITE.
ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a 62 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 29-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958321, 20210958423, 20210958716, 20210958502, 20210958405, 20210958366, 20210958249, 20210958892 and 20210959620.
pneumonia; Information has been received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On or around 26-OCT-2017, the patient was inoculated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving Zoster Vaccine Live (ZOSTAVAX), suffered upper respiratory symptoms and shortness of breath requiring hospitalization. Plaintiff was diagnosed with pneumonia. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using Zoster Vaccine Live (ZOSTAVAX) and caused by the Zoster Vaccine Live (ZOSTAVAX). The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of Zoster Vaccine Live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Zoster Vaccine Live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event pneumonia was not recovered and the reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).  The reporter considered the event pneumonia to be disability. Upon internal review, the event pneumonia was determined to be medically significant.
mom called 20OCT93 & reported pt devel fever of 102 ax approx 1 1/2 hrs p/vax;
Chills; Fever; This case was reported by a consumer via call center representative and described the occurrence of chills in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of adverse drug reaction (received 1st dose on an unknown date, refer case US2020AMR008872).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills and fever. On an unknown date, the outcome of the chills and fever were unknown.   It was unknown if the reporter considered the chills and fever to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient experienced chills and fever with second dose of Shingrix. The patient did not want to provide demographics and did not want to provide any adverse event information.
Rec varicella vaccine x 9 days ago. Started with redness and swelling at the site x 3 days ago. Also with low grade fever x 3 days. Advice of TYLENOL for fever, prn and BENADRYL w/warm compress.
Information has been received from a physician assistant concerning a 10 year old female with no allergies or medical history who on 22-APR-2002 was vaccinated with a first dose of Varivax without any problems and on 16-JAN-2007 was vaccinated SC in the left deltoid with a 0.5 mL second dose of Varivax (lot # 654131/1150F). Concomitant vaccination on the same day included a dose of Gardasil in the other arm. There was no illness at the time of vaccination. On 17-JAN-2007, the patient developed an injection site rash. The rash was described as a cellulitis that was swollen, warm, and tender to the touch. The patient was seen in the office on 18-JAN-2007 and the cellulitis was determined to be 4 cm in diameter and reported to be larger than it was on 17-JAN-2007. The patient had a fever of 102 degrees Fahrenheit on 18-JAN-2007. Unspecified medical attention was sought and the patient was told to take Benadryl and to use a warm compress. No diagnostic laboratory tests were performed. At the time of the report the patient had not recovered. Follow-up information was received from the physician assistant who reported that on 17-JAN-2007, the patient had red, indurated, warm cellulitis of the left upper extremity around the injection site. It was greater than four inches in diameter with a central vesicle. Her temperature was 102.5. She was treated with Rocephin and Augmentin. The patient recovered on 19-JAN-2007. The patient's experiences were considered to be disabling and other important medical events by the reporter. No further information is expected.