chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nauseated; Miserable; Tired; This is a spontaneous report from a contactable healthcare professional (consumer) (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation; tofacitinib citrate (XELJANZ XR), oral from Dec2020 (Batch/Lot number was not reported) and ongoing, at 11 mg, daily for rheumatoid arthritis. Medical history included fibromyalgia, she was taking gabapentin for it, rheumatoid arthritis and an ongoing pain. The patient's concomitant medication included gabapentin for fibromyalgia . The patient experienced nauseated, tired and "miserable on May2021 for a few days after the vaccine. The patient stated she was not sure if it was due to the vaccine or missing XELJANZ. The action taken for tofacitinib citrate is post-therapy. The outcome of events nauseated, tired and "miserable" was recovered on an unspecified date in May2021. The patient underwent lab tests and procedures which included blood test: inflammation levels decreased.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
about 24 hours after receiving patient felt achy all over and very lethargic for 3 days. On the 4th day her tongue swelled on outside of tongue with redness. The redness is still present but swelling has gone down.
Vaccine was administered 3 cm from the elbow. Per provider's note: "Patient presents 2 days after receiving 4 year old immunizations. Patient's mother states that immunization was administrated near the elbow. Mom states over past 48 hours the immunization site has become red and swollen. Patient with some pain overnight, none currently. No fever. No loss of mobility of left arm/elbow"
Information has been received from a nurse concerning a 13 year old female patient who on an unspecified date was vaccinated with the first dose of GARDASIL (Lot# not reported) and the patient was "OK". On an unspecified date "a few weeks later", the patient was vaccinated with the second dose of GARDASIL (Lot# not reported) and broke out in hives. Hives were treated with BENADRYL. The patient did not seek medical attention. At the time of the report, the patient's outcome was unknown. Hives were considered to be an other important medical event by the nurse. Additional information has been requested.
1 day after administration of pneumococcal vaccine (PPV-23) pt reports myalgia, weakness, swelling, rash. Headache. Was treated with 5 days of prednisone. Improvement noted 2nd day of prednisone.
Vertigo. Have had this symptom for 2.5 days. No treatment  at this point, as occurred over weekend. Will call PCP on Monday, and and see osteopath asap. (Have had vertigo before but never this bad, or lingering through the day, as it is this time.) Osteopathy has helped in the past?hope it does this time too.
Fever, Chills, Nausea, Extreme fatigue, pain in injection site, pain in both shoulders radiating down into both elbows and wrists, neck pain,  left arm going numb occasionally, slight tingling in fingers during numb periods with the arm,  swelling at injection site for 3-4 days,  limited mobility in left arm.
Throbbing pain in shoulder,  that's been going on since April -2021 , been taking ibuprofen to relive pain , only helping very little
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unspecified age, gender and race received the first dose of TRUMENBA at single dose via unspecified route for immunization. On unknown date the patient 'Got wobbly' and fell to the ground resulting in a concussion. The outcome of the events was unknown. Sender's Comments: 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, as appropriate. The case will be reassessed if additional information becomes available.
Next day confusion, problems with balance and inability to walk, mumbling speech, scattered thought, unable to follow or understand speech which lasted 24 hours and resolved spontaneously without medical intervention.
O20.0 - Threatened abortion "HREATENED MISCARRIAGE ABDOMINAL CRAMPING VAGINAL BLEEDING - PREGNANT
Information has been received from a physician concerning a 17 year old female who on 22-APR-2008 was vaccinated with a first dose of GARDASIL (lot# 659964/1979U). Concomitant therapy included a dose of MENACTRA. It was reported that the patient fainted after her vaccination. On approximately 22-APR-2008 "one to one and a half weeks ago" the patient experienced an earache and had problems chewing food. The patient's events persisted. No product quality complaint was involved. Additional information has been requested.
Swelling of Tongue and headache after receiving the vaccine, patient was given Benadryl 50mg PO BID x 3days and Prednisone 60 mg PO daily x 3 days
pt recv vax 20JUN96 & 22JUN96 pt devel significant redness, itching, warmth & swelling @ the inj site, then extending from the elbow to the shoulder which lasted for at least 2 days;
Woke up at 2am the night of with chills, throbbing headache, and a fever
This spontaneous report was received from a licensed vocational nurse referring about a 62 year old male patient with excessive sweating on hydrocodone and allergy to sulfamethoxazole with unspecified reaction. No pertinent medical history. Years ago the patient received the first dose of pneumococcal vaccine with no problem. Dose, route and lot number not provided. On 04-DECT-2013, the patient was vaccinated with the second dose of PNEUMOVAX23 (route and dose no reported), lot #J004332, expiration date 26-SEP-2014. There were no concomitant medications reported. On 04 December 2013 during the same evening the patient experienced big, swollen, red knot the size of a baseball on the arm where the PNEUMOVAX23 was administered; the arm was also tender and sore. No labs diagnostic test studies were performed. The patient also experienced chills and fever. the patient is felling better as of 05-DEC-2013. The patient received treatment with TYLENOL. The patient is recovering. The patient seek medical attention reporting this event via email to the office. Additional information has been requested.
the cases were received on 20 March 2014 at GPV.  Initial misuse report received from a healthcare professional on 27 September 2013. A 10-year-old patient had received 0.25 ml of FLUZONE. It's a vaccine over dose. No adverse event was reported. List of documents held by sender: none
Hive reaction on injection arm approximately 10-12 cm; very red with itching and stinging
My taste increased so much that even my bland toothpaste burned my tongue and could overtaste everything.; Also, my sense of smell increased a lot.; Also had increase in GI issues; I did have the sharp pain in throat; Fever and soaking wet bed in morning from head to toe.; Toothpaste burned my tongue; Because my chest felt like it had a 100 pound weight on it.; This spontaneous case was reported by a patient and describes the occurrence of TASTE DISORDER (My taste increased so much that even my bland toothpaste burned my tongue and could overtaste everything.), PAROSMIA (Also, my sense of smell increased a lot.), GASTROINTESTINAL DISORDER (Also had increase in GI issues), OROPHARYNGEAL PAIN (I did have the sharp pain in throat) and SWEATING FEVER (Fever and soaking wet bed in morning from head to toe.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised.    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 TASTE DISORDER (My taste increased so much that even my bland toothpaste burned my tongue and could overtaste everything.), PAROSMIA (Also, my sense of smell increased a lot.), GASTROINTESTINAL DISORDER (Also had increase in GI issues), OROPHARYNGEAL PAIN (I did have the sharp pain in throat), SWEATING FEVER (Fever and soaking wet bed in morning from head to toe.), TONGUE DISCOMFORT (Toothpaste burned my tongue) and CHEST DISCOMFORT (Because my chest felt like it had a 100 pound weight on it.). At the time of the report, TASTE DISORDER (My taste increased so much that even my bland toothpaste burned my tongue and could overtaste everything.), GASTROINTESTINAL DISORDER (Also had increase in GI issues), OROPHARYNGEAL PAIN (I did have the sharp pain in throat), SWEATING FEVER (Fever and soaking wet bed in morning from head to toe.), TONGUE DISCOMFORT (Toothpaste burned my tongue) and CHEST DISCOMFORT (Because my chest felt like it had a 100 pound weight on it.) outcome was unknown and PAROSMIA (Also, my sense of smell increased a lot.) had not resolved.            No concomitant medications were reported. No treatment medications were reported.
GOT COVID; This spontaneous report received from a patient concerned a female of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On DEC-2021, the patient experienced got covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid was not reported. This report was non-serious. This report was associated with product quality complaint: 90000210015.
Patient has developed a red rash on the left arm that began this morning (6 days post-injection). The rash begins approximately 3 inches below the injection site and is about 2 inches in diameter. Rash is not raised and there is no blistering. Pt denies a fever. She did not develop any side effects during the first 6 days post-injection. Pt is going to monitor the rash for any spreading and also for warmth or for development of a fever. Suggested follow-up with MD if any of these symptoms develop or worsen.
After 6 hours developed very severe pain in upper right arm at vaccination site,  In addition for 24-30 hours felt some chills, on and off fever of 100-101.  Headache .   After 48 hours just now able to lift my arm againbut still some pain, other symptoms seem to have subsided.
Vaccine was administered subcutaneously rather than Intramuscular and  I have injection site pain, tenderness, swelling, redness and general ill-feeling.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 29-MAY-2012, the patient was subcutaneously vaccinated with dose of ZOSTAVAX (dose, lot# and frequency were not reported). On 10-DEC-2015 (reported as "today"), the patient received another dose of ZOSTAVAX (dose and frequency were not reported, lot # L020482 with expiration date: 02-SEP-2016, subcutaneously). No adverse effects reported. Additional information has been requested.
12/5/13 10:00 AM received TC from client. Sxs rash on abd x 1 day after taken (1) dose oral typhoid vaccine on 12/4/13. Instructed to not take any more of the Typhoid, and offered the inj. Typhoid vaccine.
pt recv vax & approx 6 wk later devel a nodule of the rt axilla, which was dx as a foreign body granuloma;
Information has been received from a medical assistant concerning a female patient who on approximately 04-JUN-2007 "three weeks ago", was vaccinated with a dose of Gardasil. On approximately 25-JUN-2007, the patient came into the office and complained of pain at the injection site. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Within 5 mins of injection, pt developed some tingling with shortness of breath. Benadryl 25 mg was given, mild relief but still complained of shortness of breath, coughing, feeling 'tightness in throat.'
Vertigo started 04/14 along with headache.  Vertigo has went away but the headache is still present. Episode of vertigo has passed, she has had an episode in the past.  I recommended that she gets her second dose of the vaccine with the confirmation of her PCP.
Pain at injection site, fatigue, nausea, headache, muscle aches, minor itching. On day two still experiencing weakness and pain.
Area around injection is bright red, hard knot to area, tenderness. Redness extends out in circular pattern from injection site.
Within approximately 2-3 weeks of the booster on October 15, 2021, I noticed an inflamed lymph node in my neck on the left side. I would describe it as 'slightly' inflamed. I could easily notice it when comparing it to the right side of my neck, which was normal in appearance. The inflammation has diminished I'd say 60%, but it is still there as of this writing on September 17, 2022.  It does not cause me discomfort, and I have had both an ultrasound and a CT scan to rule out any other conditions.
Child received vaccines around 6:30 P.M. Tues, arm was sl red that evening.  Motrin given for discomfort. Child did not complain about arm. Wednesday, redness from upper Left arm to elbow but child acted fine, did not complain.  Left arm was looking "bad". By Thursday, The left arm was twice the size of the right arm.  Red, swollen on top of shoulder, and hard, feverish,the size of a "baseball".  By Thursday evening, the large area was darker, a brownish red color.  At 7:30 P.M. child c/o that her arm hurts.  At 9:00 P.M. little blisters appeared on arm in the dark brownish red area.  Child seen in ER blisters had grown to pencil eraser size with smaller blisters appearing.  Steroids (approx. 2 tsp) given in ER.  Friday child was taken to her doctor.  The redness was decreasing approximately 1/2" from top and bottom of arm.  All the blisters had increased in size to nickle and quarter sizes. Swelling and redness was decreasing.  Dr. prescribed burn cream, Silver Sulfadiozine 1% cr. wat., Liquid steriods for the allergic reaction, Prednisolone 15mg/5ml; Antibiotics for possible staph. infection Cleocin 75mg/5ml 4xdaily x 10 days.  Pictures were taken at the doctor's office. Return visit today at the doctor's office. Child is improving, arm is now covered, some blisters have broken.  No secondary infections noted at this time.  Skin on arm is rough at present.
tingling metallic taste on her tongue; tingling metallic taste on her tongue; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer reported that, a female patient of an unspecified age received first dose of BNT162B2 (Pfizer Covid-19 Vaccine; solution for injection) via an unspecified route of administration on 29Jan2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced tingling metallic taste on her tongue for the first 18 hours after taking the first dose in Jan2021. The outcome of the event was unknown.  Information about lot/ batch number has been requested.
Four hours after injection suffered severe body pains with nausea for several hours, and red rash about two inches in diameter popped up. The next day the injection site was red, with an expanding hard tissue underneath the skin, about five inches in diameter. Seven days later the rash was almost gone. Eight days later the rash came back with a vengeance, extremely itchy and expanding to three inches in diameter. As of this report, at ten days post-injection, the rash remains at three inches diameter and itchy.
Patient called pharmacy explaining she has a 101.2 fever, body aches and flushing. I explained to patient that this is an adverse effect of the vaccine and is common. She asked that I still report it.
Rash (pruritic) was first noticed the morning after injection. Started on one wrist and expanded throughout arm. Started the same way on the other arm a few hours later. By the evening, the rash encompassed both arms and started at both ankles. After 24h, the rash was over all 4 extremities. Took benadryl (50mg once) without effect on rash.
Post flu shot started vomiting, shortness of breath, beefy tongue. 911 called; epinephrine administered (0.5mL). Transported to hospital.
3 days post injection, patient c/o shoulder/arm pain with movement-treated with ice and Tylenol. Seen in office on day 7 post injection, also on day 19-high dose steroid taper w/no effect.
T/C with mother - states rash (red, blisters) noted 11/3 to trunk, groin area, increase in rash noted over 3 days - contacted health Dept 11/6 - no fever, itching noted.
Urticarial reaction @ vaccine site with erythema began 1 week after injection.
Dizziness; Vertigo/everything would start to spin (upon sitting or lying down); This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and VERTIGO (Vertigo/everything would start to spin (upon sitting or lying down)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A(Or4)21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced DIZZINESS (Dizziness) and VERTIGO (Vertigo/everything would start to spin (upon sitting or lying down)). The patient was treated with MECLIZINE [MECLOZINE] for Vertigo, at a dose of 12.5 milligram twice a day. At the time of the report, DIZZINESS (Dizziness) and VERTIGO (Vertigo/everything would start to spin (upon sitting or lying down)) outcome was unknown.            The  concomitant medications on use were not provided.    This case was linked to MOD-2021-361049 (Patient Link).
Patient developed hives on her arm and then on trunk approximately 3 hours after administration of 2nd HPV vaccine.
This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VAQTA (Strength, dose, frequency, route and anatomical location were not reported) of lot # M002268 with an expiry date of 20-SEP-2017, for prophylaxis. There were no concomitant therapies reported. The vaccines were exposed to 47 to 77 Fahrenheit degree (F) for 21 hours and 6 minutes. There was previous temperature excursion which involved exposure to 47°F to 77°F for 6 hours. Digital data logger was involved. There were no adverse effects reported. There was no product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA006435: US-009507513-1708USA007256:
He has 9-10 level pain, feels like his GI tract will explode; feels like his GI tract will explode/ Gastrointestinal discomfort; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GASTROINTESTINAL PAIN (medically significant), outcome "unknown", described as "He has 9-10 level pain, feels like his GI tract will explode"; ABDOMINAL DISCOMFORT (medically significant), outcome "unknown", described as "feels like his GI tract will explode/ Gastrointestinal discomfort". The patient underwent the following laboratory tests and procedures: Pain assessment: 9-10 level pain. Clinical course: He had 2 shots and 2 boosters. He had 9-10 level pain, felt like his GI tract will explode.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
DIZZINESS WHEN STANDS UP OR ROLLS OVER (WHILE LAYING FLAT IN BED OR UNDER A CAR DURING MAINTENANCE WORK) OR MAKES QUICK MOVEMENTS AND FEELS VERY DISORIENTED; MILD BODY ACHES; FEELS VERY CONFUSED; FEELS VERY NAUSEATED; MILD FATIGUE; DULL HEADACHE LOCATED MORE TOWARDS THE BACK (2 BY10 PAIN LEVEL); This spontaneous report received from a patient concerned a 50 year old male. The patient's weight was 219 pounds, and height was 72 inches. The patient's concurrent conditions included: hypertension, non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-AUG-2021, the patient experienced dizziness when stands up or rolls over (while laying flat in bed or under a car during maintenance work) or makes quick movements and feels very disoriented. On 07-AUG-2021, the patient experienced mild body aches. On 07-AUG-2021, the patient experienced feels very confused. On 07-AUG-2021, the patient experienced feels very nauseated. On 07-AUG-2021, the patient experienced mild fatigue. On 07-AUG-2021, the patient experienced dull headache located more towards the back (2 by10 pain level). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness when stands up or rolls over (while laying flat in bed or under a car during maintenance work) or makes quick movements and feels very disoriented, mild body aches, feels very nauseated, and feels very confused, and had not recovered from mild fatigue, and dull headache located more towards the back (2 by10 pain level). This report was non-serious.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 59-year-old male patient who received SHINGRIX (batch number YE9YL, expiry date 6th February 2021) for prophylaxis. On 17th July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, 10 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The healthcare professional reported that the patient had to start a course of VALTREX 10 days after a dose of SHINGRIX because the patient developed shingles.
EXTREME underarm pain.   Pain and swelling at injection side but not extreme.  Sweats and chills, upset stomach, headache.