chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report, was received from a physician, via a company representative, concerning a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 15-JAN-2019, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). On the same date, following the administration of PNEUMOVAX 23 the patient experienced headache. It was also reported that on 17-JAN-2019, the patient experienced soreness in the arm where the injection occurred. The patient sought medical attention and contacted the physician. At the time of reporting, the outcome of headache and soreness in the arm where the injection occurred was unknown. The causal relationship between the vaccination with NEUMOVAX 23 and the events was not provided by the reporting physician.
Vaccine administered 10 days after puncturing the vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 10 days after puncturing the vial) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 10 days after puncturing the vial). On 09-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 10 days after puncturing the vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received and included no new information.
At 1:50 pm in post vaccine observation, patient reported metallic taste in mouth and warm flushing sensation from head to toe and tingling in lops. Vital signs taken at 1:50pm 158/92, pulse 71, resp 20, 1:55pm: 138/64, pulse 62, 2:05pm: 112/70, pulse 60, 2:15pm: 110/72, pulse 59, 2:28pm: 130/70, pulse 60, 2:40pm: 128/74 pulse 60, resp. 18.  O2 sat remained 96-99% on room air.  After 45 minutes patient reported feeling better and left with family member.  Instructed to self monitor and to contact MD or report to ER if symptoms return or worsen.  Patient verbalized understanding. Patient received Pfizer BioNTech Covid 19 vaccine EUA.
Today the patient reported the following. Two days after receiving the vaccine (10/30/19) the injection site swelled up down to her elbow and had a bumpy rash around injection site. She also had a fever, cough and congestion and felt really weak and tired. Today 5 days after injection she said her arm is better and no longer swollen and the rash went a ways but she is still feeling tired and still congested and coughs.
Received vaccine at 7:31a, and at 7:37a I started to feel a mild swelling in throat. It did not get worse after being there under observation for 35 more minutes. I was able to swallow and breathe ok, nurse checked on me every 10 minutes or so. No need to take any medication as it was slight and I wasn't sure if it was anxiety or the start of an anaphylaxis reaction. The swelling was gone by 9:30a, and then it reappeared that evening and was more intense, around 4:40p. It did not get worse, and was gone by 5:30a the next morning (3/25/2021).
This case was reported by a nurse via sales rep and described the occurrence of needle injury in a adult female patient who received KINRIX (batch number 75F53, expiry date 9th December 2019). On an unknown date, the patient received KINRIX. On an unknown date, immediately after receiving KINRIX, the patient experienced needle injury. On an unknown date, the outcome of the needle injury was unknown. Additional details were provided as follows: The representative with the vaccine service center reported an adverse event that occurred on the day of reporting and reported to him. The reporter stated that the nurse was preparing to administer the vaccine to the patient the patient jerked. This in turn caused the nurse to prick her finger with the needle. The vaccine was not administered to the patient.
Hypertension requiring additional mediation to control. Prior to COVID-19 vaccination, patient's blood pressure was controlled.
Fever 101.7 degrees F on day one and 101.3 degrees F on day 2, headache, severe fatigue, nausea, loss of appetite, generalized weakness. On Day 3, first day afebrile and continued to have severe fatigue and generalized weakness. He had to miss one day of work.
Fever 102.1, body aches, mild headache, nausea, fatigue  Took Tylenol x2   Symptoms significantly improved and were almost completely resolved after 15 hours
Initially, just pain, redness, swelling at injection site.  about 4 days after vaccine developed pain in medial portion of ipsilateral breast and axilla.  slight swelling of nodes.  no breast lump
Patient presented on 7/29/2015 concerned about redness and itching at site of injection. Stated it was beginning to improve. Area was approximately the size of a palm. Counseled patient that redness at the reaction site was common with Zostavax and to monitor and report if it worsened.
Within 5 minutes after receiving the vaccine, patient fainted while shopping in the store. Patient gained consciousness immediately. He did mentioned that this is his first flu shot. Patient isn't diabetic.
The day after I had pain in the injection arm shoulder to elbow, I felt hungover with fatigue and headache. Very under weather. I had diarrhea after every meal.
finger flange break after administration; The removal flange safety guard not present; Syringes that had the finger flange break after administration; This non-valid spontaneous report was received from a health care professional via a company representative referring that multiple hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringes (lot# and expiration dates not reported) had a finger flange break and the removable flange safety guard was not present.   The reporter advised that she was made aware of 2 hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringes that had the finger flange break after administration on 08-FEB-2021. She reported that at least 1 of these episodes resulted in a finger laceration to the administrator (MARRS # 2102USA006456). It was reported that the syringe was not cracked, the syringe was broken into 2 or more pieces at syringe finger flange.  This is one of several reports received from the same source.  Follow up information has been received on 19-FEB-2021. The photographs of one syringe flange was received. The other broken syringe was discarded prior to pictures being taken.  Follow up information has been received on 16-MAR-2021. The office manager reported that her clinic only had 1 of the 2 broken hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number S028738, which has been verified to be valid, the expiration date was not reported but upon internal validation established as 03-APR-2022) syringes that were reported. Additionally, she added that there was "no way that the 2 syringes carne from the same package". combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S028738; expirationdate: 03-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: Yes; deviceusage: Initial; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA006456:
Mom noticed today at 1:00PM  a dime sized red, raised bump with a yellow center on her left leg. Mom states she has not had a fever or any other problems.
GENERALISED ACHING; NUMBNESS IN FINGERS; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced fever, chills, generalized aching, headache, and numbness in fingers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, generalized aching, headache and numbness in fingers was not reported. This report was non-serious.
Redness to site day of vaccine and spread to entire body started 4-1-2021 and getting  worse redness and itching.  Patient has taken 1 benedryl due to on muscle relaxer  and did not want to over do it with the meds.  Encouraged to see PCP.
hands went numb w/tingling; no other sx; severe enough that could not drive; works in the power plant; As of 8NOV93 still has some tingling; 25JAN94 has recovered;
Pt had coughing and gagging within minutes of Hep A and VZV vaccines. Within 10 minutes had wheezing and urticaria all over her body and respiratory compromises. Given 20mg of Diphenhydramine IM. Ambulance arrived and taken to ER. Pt had severe angioedema almost requiring intubation but resolved with epinephrine and Solumedrol. Admitted to hospital for continued treatment and discharged after 24 hours on steroids, antihistamines and epi. pen. Will also see allergist.  7/17/2008 MR received for DOS 6/2-/2008 with DX: Allergic reaction with angioedema and anaphylaxis. Pt presented to ER from MD's office . Pt developed hives, breathing and swallowing difficulty, rash, itching and swelling which began just after receipt of Hep A and Varicella vax. PE (+) for facial angioedema, muffled voice, drooling and urticaria. Sx resolving with Epi, Benadryl, solumedrol. Admitted o/n for observation.
62 yo M with no known medical history awoke 12:15 am on 3/11/2021 and told his wife he had "pain all over". When she asked if it was chest pain, he said he didn't know.  He went downstairs, vomited, slumped over against the wall behind the couch, and became unresponsive.  Wife called 911 and was instructed to begin CPR.  EMS crew arrived shortly after that and performed prolonged resuscitation efforts as per ACLS protocol.  Pt pronounced at 3:15 am.  Patient had not seen a physician in many years, had not had any vaccines in over 20 years, took no medications, and had no known medical history.  He did have a strong family history of heart disease and had told his wife the week prior to his death that he had suffered a several-hour bout of chest pain that resolved spontaneously 2-3 days prior to his telling her about it.  He refused to seek medical evaluation despite her urging.
Slight fever; Pain in arm; Swelling of lymph node under the chin on the opposite side of injection; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Slight fever), PAIN IN EXTREMITY (Pain in arm) and LYMPHADENOPATHY (Swelling of lymph node under the chin on the opposite side of injection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Slight fever), PAIN IN EXTREMITY (Pain in arm) and LYMPHADENOPATHY (Swelling of lymph node under the chin on the opposite side of injection). At the time of the report, PYREXIA (Slight fever) had resolved and PAIN IN EXTREMITY (Pain in arm) and LYMPHADENOPATHY (Swelling of lymph node under the chin on the opposite side of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. Treatment medication included Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021.
When patient reported the reaction to me on March 19th, her arm was reddened and warm to touch. The hot, red area was approximately 4 inches across her arm and 5 inches in length. Patient states the reaction has been very itchy and painful over the weekend. States she took NAPROSYN for the pain. I gave her an ice pack to put over the site. She stated this helped her discomfort. I had her return the following day to check her arm. She stated the arm felt much better. No more pain. The reddened area was now light pink and no longer hot to the touch.
Moderate local reaction.  Swelling, redness, pain, hot to touch, itchy for 5+ days.
Information has been received from a health professional concerning an 8 yr old white female who on 30Jan98 was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccination on the same day included a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). It was noted that the vaccinations were not given at the reporter's office. On 25Nov05, the pt's mother called the office and reported that the child had spots. An appt was made in the office and on 26Nov05 the pt was seen. She had spots on her chest, back, face, and head. She was treated with diphenhydramine hydrochloride (Benadryl) and subsequently recovered. Additional information is not expected.
Child received LAIV - dev. sneezing at monitoring station. Sneezing progressively got worse with mucus production. Started coughing. Offered water. C/o sore throat. 110/68 98.9. No difficulty swallowing. Notified parents. Coughing progressed. Appeared to have difficulty catching her breath during coughing episode. Called 911 EMT - not avail - fire unit to be sent. Coughing subsided & pt caught her breath. Declined fire rescue. 911 said if grandpa taking child nurse must go with them. Grandpa & child walked to car, RN followed with ER kit. In vehicle child noted to have change in breathing. Child crying asked if she was having difficulty EPIPEN Jr given. Administered in ER.
Complete right side facial paralysis, came on extremely suddenly (minutes). ER visit (09/11/2021) diagnosed as Bell?s Palsy. Treatment consists of a 60mg dose of Prednisone once per day, and a 1g dose valACYclovir three times per day. treatment to last 1 week, and to be reevaluated at that time by PCP.  First week of treatment is still ongoing. Full symptoms still ongoing.
I have developed a rash since my second dose and it have spreaded over areas of my body especially my stomach and shoulders and areas of my back
This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (Lot #: N021315, Exp Date: 07-AUG-2019) (Lot#: N029632, Exp Date: 23-OCT-2019) or (Lot#: N030571, Exp Date: 31-OCT-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK) (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1805USA009899:Original Case : 1805USA006787; US-009507513-1805USA009900:Original Case : 1805USA006787; US-009507513-1805USA009901:Original Case : 1805USA006787; US-009507513-1805USA009902:Original Case : 1805USA006787; US-009507513-1805USA009903:Original Case : 1805USA006787; US-009507513-1805USA009904:Original Case : 1805USA006787; US-009507513-1805USA009905:Original Case : 1805USA006787; US-009507513-1805USA009906:Original Case : 1805USA006787; US-009507513-1805USA009907:Original Case : 1805USA006787; US-009507513-1805USA009908:Original Case : 1805USA006787; US-009507513-1805USA009909:Original Case : 1805USA006787; US-009507513-1805USA009910:Original Case : 1805USA006787; US-009507513-1805USA009911:Original Case : 1805USA006787; US-009507513-1805USA009912:Original Case : 1805USA006787; US-009507513-1805USA009913:Original Case : 1805USA006787; US-009507513-1805USA009914:Original Case : 1805USA006787; US-009507513-1805USA009915:Original Case : 1805USA006787; US-009507513-1805USA009916:Original Case : 1805USA006787; US-009507513-1805USA009917:Original Case : 1805USA006787; US-009507513-1805USA009918:Original Case : 1805USA006787; US-009507513-1805USA009919:Original Case : 1805USA006787; US-009507513-1805USA009920:Original Case : 1805USA006787; US-009507513-1805USA009921:Original Case : 1805USA006787; US-009507513-1805USA009922:Original Case : 1805USA006787; US-009507513-1805USA009923:Original Case : 1805USA006787; US-009507513-1805USA006787:Original Case : 1805USA006787; US-009507513-1805USA009925:Original Case : 1805USA006787; US-009507513-1805USA009926:Original Case : 1805USA006787; US-009507513-1805USA009927:Original Case : 1805USA006787; US-009507513-1805USA009928:Original Case : 1805USA006787; US-009507513-1805USA009929:Original Case : 1805USA006787; US-009507513-1805USA009930:Original Case : 1805USA006787; US-009507513-1805USA009931:Original Case : 1805USA006787; US-009507513-1805USA009932:Original Case : 1805USA006787; US-009507513-1805USA009933.
episodes of pain in the joints; episodes of fatigue; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of joint pain in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 07-SEP-2023, the patient received the 2nd dose of Shingrix. In SEP-2023, an unknown time after receiving Shingrix, the patient experienced joint pain (Verbatim: episodes of pain in the joints) and fatigue (Verbatim: episodes of fatigue). In SEP-2023, the outcome of the joint pain and fatigue were resolved.   It was unknown if the reporter considered the joint pain and fatigue to be related to Shingrix.     It was unknown if the company considered the joint pain and fatigue to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-SEP-2023 The pharmacist reported after the administration of Shingrix 2nd dose the patient experienced episodes of joint pain as well as episodes of fatigue. These episodes of joint pain and fatigue lasted for hour or two hours. These episodes were not every day. The reporter consented to follow up.
scars on my face; Shingles; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old female patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: FC3182; Expiration Date: 31Oct2021 via an unspecified route of administration in Arm Left on 28Aug2021 (age at vaccination: 58-Years-old) as DOSE 2, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4 weeks prior to vaccination, patient didn't receive other medications. The patient medical history and concomitant medications were not reported. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: FA6789) via unspecified route of administration on 07Aug2021 in Arm Left (age at vaccination:58-Years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced shingles on 30Aug2021 with outcome of unknown, scars on my face on an unspecified. Therapeutic measures were taken as a result of shingles, scars on my face was Valacyclovir (Dose: 1000mg, 3 times a day, Tablet), pain meds, Gabapentin, one time a day or as needed, 300mg.The outcome of the events herpes zoster, scar was unknown.  No follow-up attempts are possible. No further information is expected.
Pt received AVA #6 on 10/25/11 at 8am in the right arm (pt is right handed). The pt also received JE and Meningococcal in the left arm. When the pt woke on 10/26/11 both injection sites were slightly sore. At 1800 on 10/26/11 the pt noted that his right arm was swollen, red and painful. The pt's wife (a nursing student) measured the erythema as 14cm and his right upper arm circumference as 40cm. The pt started MOTRIN 800mg, BENADRYL 25mg and applied heat. At 1230 on 10/27/11 the area of erythema was 19cm and his right upper arm circumference was 45.6 cm. The pt went to Urgent Care Clinic; was prescribed MOTRIN and ice compresses and SIQ'd for 24 hours. Upon return to his unit, the flight surgeon gave the pt a RX for antibiotics and BENADRYL. On 10/27/11, Immunizations requested that that pt be seen. He complained of right upper arm and right shoulder pain (2-3/10). The pt also complained of "slight" numbness and tingling in his fingers of his right hand. He denied headache, N, V, skin rashes or other joint or muscle pain. On PE he had full range of motion of his right shoulder although painful. The right upper arm circumference measured 48cm and the area of erythema and induration was 22.5 x 22cm and was TTP (left arm circumference was 41.5cm). The right arm was slightly paler in color than left but equal warmth to the touch. Capillary refill to nail beds was brisk and equal. Radial pulses were strong and equal. No right axillary lymphadenopathy was noted. The was prescribed Prednisone 50mg po qd for 4 days; WESTCORT 0.2% ointment to AAA bid; cool compresses for 15-20 min qd and prn; MOTRIN 800mg tid prn (with food) for pain; continue BENADRYL; instructed not to start the antibiotics at this time. The pt was reevaluated on 10/28 and 10/31 with improvement of his symptoms On 11/31/11 all induration, swelling and erythema had resolved. The pt stated that his symptoms were 90% improved with "slight tightness" of his right shoulder. As of 11/9/11 all of the patient's symptoms had resolved.
Swollen and very tender lymph nodes in my left underarm; Swollen and very tender lymph nodes in my left underarm; dose number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 15:00 (Lot number: 30145BA) at the age of 58 years as dose 3, (booster) single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SYNTHROID and multi vitamins. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EWO175, Location of injection: Arm Left, Vaccine Administration Time: 01:45 PM), administration date: 29Apr2021, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EWO158, Location of injection: Arm Left, Vaccine Administration Time: 01:45 PM), administration date: 08Apr2021, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 26Nov2021 15:00, outcome "unknown", described as "dose number=3"; LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 28Nov2021, outcome "recovered" (2021) and all described as "Swollen and very tender lymph nodes in my left underarm". Therapeutic measures were not taken as a result of lymph node pain, lymphadenopathy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts are possible. No further information is expected.