chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of runny nose in a 66-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included high blood pressure. Concurrent medications included BENICAR. On 12 October 2010 at 14:25 the subject received a dose of FLULAVAL at 0.5 ml in the right arm. On 12 October 2010 (at night), less than one day after vaccination with FLULAVAL, the subject experienced runny nose, feeling very tired and low grade fever. The following day on 13 October 2010, the subject developed a sore throat on the left side. Other events reported included injection site tenderness, redness of eyes, lip discoloration (blue in color), voice loss, productive cough, chest congestion due to phlegm (green, yellow in color), nasal congestion and fatigue. Low grade fever resolved by 14 October 2010. Other events with resolution on unspecified dates were sore throat, red eyes and lip discoloration. Events indicated to be improved included runny nose, feeling tired, injection site tenderness, loss of voice, productive cough and chest congestion due to phlegm and nasal congestion. Outcome of fatigue was not specifically stated. The consumer reported that she was "sick" for three weeks and at the time of reporting was just starting week four and feeling better, but not completely resolved. Attribution of the symptoms to treatment with FLULAVAL was not provided.
A nurse reported that an 18 month old male patient received his fourth dose of Prevnar (pneumococcal 7-valent conjugate vaccine) on 07-APR-2003. On the morning of 08-APR-2003, the child developed a fever and "sore" leg. During the evening of 08-APR-2003, the child developed a "trigger" finger of the thumb. The reporter indicated that child's "thumb was flexed back and remained rigid in this flexed position." ON 09-APR-2003, the child was examined by a pediatrician and referred to an orthopedic surgeon. As of the date this was reported, the thumb remained "rigid and flexed." No further information was available at the date of this report.
Arm swelled up and was extremely painful at the injection site. The injection site turned black and red and was inflamed until Thursday  07/06/2023. Right arm was noticed to be black by observation of healthcare professional a week later 07/08/2023, but inflammation was not clinically significant. Patient experienced severe diarrhea for 4 days after the vaccine. Patient reported a migraine on starting Monday 07/03/2023 to 07/07/2023.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 27-FEB-2017, the patient was vaccinated with an improperly store dose of VARIVAX, subcutaneously, lot number M033212 with expiration date 13-SEP-2018 (dose and anatomical location were not reported). The vaccine was exposed to temperatures between 6 F (Fahrenheit) (-14 C (Celsius)) to 14F (-10C) during 6 hours. There was no previous temperature excursion. Data logger was filled. No adverse effects were noted for the patient. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA003697: US-009507513-1703USA012498:
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL 0.5 ml intramuscularly on 27-OCT-2011, the second dose of GARDASIL on 30-JAN-2012, and was in the office on 03-MAR-2013, to receive the third dose of GARDASIL. No adverse effects reported. Additional information has been requested.
Swollen, red, warm to touch at site of injection, patient c/o pain pain medication acetaminophen given.
Felt good after the vaccine.  Then that night I has chills, fever, body aches.  Next day feel very fatigued, body aches, terrible headache and nauseous.
Redness and heat at site of PNEUMOVAX injection (most likely - FLUVIRIN administered same arm but higher). Redness spread accompanied with itching. Saw ER DR regarding reaction - ER DR prescribed Cephalexin to treat/prophylax. for cellulitis, per the patient.
ASTHMA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced asthma. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of asthma was not reported. This report was non-serious.
Dtap vaccine - administered expired vaccine exp. date 12-3-16. No adverse reactions.
Chills, joint pain, fatigue the night of injection. The next day, my left underarm was swollen and sore if I let my arm hang down at my side.
Sore throat with a runny nose; Sore throat with a runny nose; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A female patient of an unspecified age received BNT162B2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as second dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient had sore throat with a runny nose and wanted to know if Tylenol can be taken or if it would interfere with the efficacy of the vaccine. She asked if she could take Tylenol or allergy pills for her symptoms, after the vaccine. The outcome for the events was reported as unknown.  Information on the lot/batch number has been requested.
Knocked me on my butt; Knew I wasSick; Feeling pretty weak; in bed for 4 days; This case was reported by a consumer via other manufacturer and described the occurrence of feeling unwell in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date, refer case US2022AMR163793). Concurrent medical conditions included immunosuppression. Concomitant products included etanercept (Enbrel).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell, bedridden, sickness and weakness. On an unknown date, the outcome of the feeling unwell, sickness and weakness were unknown and the outcome of the bedridden was recovered/resolved.   It was unknown if the reporter considered the feeling unwell, bedridden, sickness and weakness to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR163793   Additional Information: GSK Receipt Date: 07-NOV-2022 Reporter's comment: The patient was taking an immunosuppressive medication (Enbrel). The patient reported that the second dose of shingrix knocked him on his butt and he was in bed for 4 days. The patient also reported that within 30 seconds after 2nd shot he knew was sick. The next week felt pretty weak. The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2022AMR163793:Same Reporter
By accident they gave a vaccine to a 16 year old; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (By accident they gave a vaccine to a 16 year old) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 immunisation.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (By accident they gave a vaccine to a 16 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (By accident they gave a vaccine to a 16 year old) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided.   No treatment information provided.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old) for mRNA-1273 (lot number 001B21A) with no associated AEs reported.
This spontaneous report as received from a nurse, via other company (Pfizer # 2015293822) refers to some patients of unknown demography. The patient's concurrent conditions and medical history were not reported It was reported that PREVNAR 13 was administered to a lot of adults and about 8 adults have experienced local reactions. On an unknown date, patients were vaccinated with PNEUMOVAX 23 injection (strength, dose, route and lot number or batch number unspecified). Nurse reported that they saw more local reactions with PREVNAR 13 compared to PNEUMOVAX 23. The outcome of the event was unknown. The reporter's causality for the event was not provided. Additional information has been requested.
After administration the following day 9/12/11 patient's arm was sore & got progressively worse with each passing day pnt took ADVIL, with little effect. Pnt went on vacation and had trouble lifting luggage, driving & everyday activities. Vacation was on 9/30/11. On Oct 5th pnt went to MD, MD said pnt had tendonitis & injection was given not rear enough of the shoulder. Pnt was given a strong anti-inflammatory & exercise routine, if condition persists MD may give cortisone injection (per patient).
Fatigue that interferes with my normal daily activities continues 4 weeks after second dose. Rash at injection site started on 04/04/21, 4 weeks after injection.
Information has been received from a health professional concerning a female who "two weeks ago" on approximately 02-OCT-2009 was vaccinated with a first 0.5ml dose of GARDASIL (injection, lot# not reported). On approximately 02-OCT-2009 the patient fainted after getting the vaccine. The patient sought unspecified medical attention. At the time of the report, the patient had recovered. Additional information has been requested.
horrible headache; Hotness; strong chills; sore and swollen arm; could not sleep; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (horrible headache), FEELING HOT (Hotness), CHILLS (strong chills), PERIPHERAL SWELLING (sore and swollen arm) and INSOMNIA (could not sleep) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METOPROLOL, ISOSORBIDE and LOSARTAN for an unknown indication.    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 HEADACHE (horrible headache), FEELING HOT (Hotness), CHILLS (strong chills), PERIPHERAL SWELLING (sore and swollen arm) and INSOMNIA (could not sleep). At the time of the report, HEADACHE (horrible headache), FEELING HOT (Hotness), CHILLS (strong chills), PERIPHERAL SWELLING (sore and swollen arm) and INSOMNIA (could not sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
pt recv vax NOV96 & devel an inj site rxn w/redness, swelling & itching;the affected area is about the size of a BP cuff (4" x 10");this was reported by MD;cross reference w/DER 0010150960093/98, DER0010150960100/102;
Post vaccine - Day 7: itching  Day 8: hive like rash began at area injection; itching Day 9: erythema about 4-6 inches in diameter around vaccine injection site (right arm); itching Day 10: same as day 9 Day 11: erythema about 6 inches now with large central clearing  I have taken Zyrtec during this and used topical cortisone to help with the itching. Has made no difference in rash size.
day 1, red swollen  arm on the place where it was injected, dry itchy skin,  day 2 rash patches on my  left leg, dry itchy skin day 10 rash patch on my belly, dry itchy skin day 15 rash behind my left ear, dry itchy patchy skin and several additional patches of dry itchy skin on my legs. day 22  rash  under my left  breast
Information has been received from a nurse practitioner (NP) concerning a 14 year old female patient with family history of a blood clotting disorder and MTHFR gene abnormality who on an unknown date, was vaccinated with the first dose of GARDASIL (lot# 0298AA, expiration date: 21-JUN-2013) (dose and route were not reported). The patient did not receive any concomitant medication. Two days later, on 07-DEC-2011, the patient fainted. The nurse practitioner stated that before the patient was placed on hormonal contraceptives (unspecified) on 05-DEC-2011, she had laboratory test drawn, to test for blood clotting abnormalities. The patient was diagnosed with MTHFR gene abnormality. The patient was hospitalized in an unknown hospital for an unspecified period of time. The Nurse practitioner stated that the patient's mother reported that on an unknown date, the patient had taken her first dose of birth control medication and the day after the patient fainted at school. The patient was taken to the hospital. Then the patient was transferred to another hospital. The patient again was transferred to another hospital. The patient's mother reported that it was determined that the patient's MTHFR gene abnormality was not related to the patient's fainting. It was also reported that on an unknown date the patient had weakness and she had just "started to walk again". At the time of the report patient's outcome was unknown. Follow up information was received from the nurse practitioner concerning a 14 year old female student with no pre-existing allergies, birth defects or medical conditions (previously reported as having a history of blood clotting disorder and MTHFR gene abnormality) and no illness at the time of vaccination who on 05-DEC-2011 at 16:00, was vaccinated in the left deltoid with the first dose of GARDASIL (lot# 0298AA, expiration date: 21-JUN-2013) (dose and route were not reported). The nurse reported that at the time of injection no problems occurred. Seven days later, on 12-DEC-2011, the mother called and said that on 12-DEC-2011 at 13:00, the patient had passed out at school and was taken to ER (previously reported also as on 07-DEC-2011). The patient was hospitalized off and on since the event because of neurological deficit, low extremities (LE) weakness, foot drop and inability to walk. At the time of the report, the patient had not recovered. Passed out, neurological deficit, low extremities (LE) weakness, foot drop and inability to walk were considered by the nurse to be disabling. Additional information has been requested.
Information has been received from a neurologist concerning a 16 year old female with a history of urinary tract infection, a few weeks before reporting, treated with unnamed medication, who in May 2008, was vaccinated with the first dose of GARDASIL.  There was no concomitant medication.  In approximately June 2008, two weeks later, the patient had a syncopal episode, rose to her feet and had another syncope.  This was immediately followed by a seizure with starting, rolling of her eyes, jerking of all limbs lasting for a moment or two.  This was followed by confusion.  An electroencephalogram was performed and resulted negative.  She is scheduled for a computed tomography of her brain.  The physician referred her to the neurologist for medical attention.  Upon internal review, seizure was considered to be an other medical important event.  Additional information has been requested.
Mild redness that has persisted for several days at site of injection. Redness approximately the size of the palm of a hand and patient reports not getting better.
Previous Hep B vaccines hurt for about 2 weeks then were fine. On 8/2/10, Hep B #3 was given and her arm hurt for a month. It is still sore and aches and throbs. No redness or swelling. Hurts when she move it and has a sharp pain when she doesn't. She has used ibuprofen and warm packs and it is some what better but the pain, which is located about 4 inches down from her shoulder just won't go away.
dyspnea SOB on and off after second dose of COVID19 vaccine Moderna 5/2021 and developed this 3 days after. Not on exertion. States developed very high fevers, headaches, chest pain and SOB 3 days after the vaccine which lasted 2 weeks and has resolved but still having on and off SOB. NO palpitations. NO cough or sputum production.
On 1/12/2021 around 2:30 pm  , one week after vaccine, my right upper arm became extremely swollen with a red area ~ 3 1/2  inches by 3 1/2 inches.  Later in the evening my lymph nodes in my arm axially became swollen. The red area is burning and itchy . I am fatigued as well.
Itching and a red ring at injection site; Itching and a red ring at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching and a red ring at injection site) and VACCINATION SITE ERYTHEMA (Itching and a red ring at injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OLMESARTAN, APIXABAN (ELIQUIS) and METOPROLOL for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching and a red ring at injection site) and VACCINATION SITE ERYTHEMA (Itching and a red ring at injection site). At the time of the report, VACCINATION SITE PRURITUS (Itching and a red ring at injection site) and VACCINATION SITE ERYTHEMA (Itching and a red ring at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Claritin and antihistamine.
Herpes Zoster Ophthalmicus; mild vesicular cutaneous eruption along the skin of the eye lids; This case was reported by a physician via call center representative and described the occurrence of ophthalmic herpes zoster in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant) and vesicular eruption. On an unknown date, the outcome of the ophthalmic herpes zoster and vesicular eruption were recovered/resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster and vesicular eruption to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The patient received 1st dose of Shingrix on 25th or 26th April 2019.   The patient had a mild vesicular cutaneous eruption along the skin of the eyelids and mild form of HZ (herpes zoster) ophthalmicus, after receiving the first dose of Shingrix. The events lasted for about 2 to 3 weeks.   The patient was not sure if he would receive the 2nd dose of Shingrix. The patient did not know the address of facility where the vaccine was administered and no vaccine specifics were available. The patient did not consent to follow up.
Redness and swelling of the left arm 3 x 4 circumference, and itching.
Left arm sore, swollen and red to mid forearm. Jowls amd left cheek swollen. Small bisters on back of left arm
I drew up 0.25ml when I should have drawn up 0.3ml. Submitted incident report with facility and supervisors aware.
arm really hurt when getting it/pain in the arm the shot was given/uncomfortable pain/in their arm after receiving the injection; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for two patients. This is the second of two reports.  A male patient of an unspecified age received BNT162B2 via an unspecified route of administration in his left arm on 06Jan2021 at a single dose for COVID vaccine. Medical history and concomitant medications were not reported. The reporter remarked that on 06Jan2021, with this shot her arm really hurt when getting it and that day but that was all (pain in the arm the shot was given). She and her husband both ooo'd and ahhh'd after getting their shot, she was referring to the very uncomfortable pain they experienced in their arm after receiving the injection. They both had the same exact pain in the arm the shot was given but he had no headache on 06Jan2021. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021026017 same reporter and product, similar event, different patient
Several hours after vaccination, patient experienced severe whole-body pain and myalgia. Went to emergency room where they administered IV opioid and anti-inflammatories. Patient states felt fine a few hours later.
5 days after taking the second dose of the covid-19 vaccine, my mother had a bad suizure. She had to be hospitalized for a few day and relearn how to walk. She never had suizares prior to the vaccine .
Fainted, passed out for less than 1 minute; was pale in color; BP 120/76,  pulse, 80; respirations 20.
Mom noted onset high fever 2 days after vaccines; reduced by Tylenol/Ibuprofen, cooler ambient temp and decreased clothing, temp spike occurred (>105 deg) while with another caregiver who "bundled baby up, "when noted to be shivering"; febrile seizure occurred x 1 lasting about one minute taken to ER.
On night one after midnight, I began to have severe soreness at injection site, chills, sweats and a headache.  Then, next day on 5/16/21, felt fatigue, really achy, slight sore throat, runny nose, throbbing headache.  My symptoms worsened as the evening progressed.  I felt like I was coming down with the flu or a bad cold.  Today is 5/17/21, I am feeling better but still feel fatigued, slightly sore throat and a really bad headache (that doesn?t go away with Tylenol).   Otherwise, the other symptoms have now subsided.
5/23/2000 Urticaria on face, eyelid, unbilicus, foot and groin,  no SOB, no wheezing, no fever. Treatment with Benadryl.  5/24/00, rechecked rash, much improved.