chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable Other-HCP on behalf of Physician. A 43-year-old male patient received PREVNAR 13, (lot number: X49142, Expire Date: 30Nov2020, NDC number 0005197101) via an unspecified route of administration at left deltoid on 11Mar2019 04:25 at single dose for immunisation. Medical history included hypothyroidism and not a smoker. There were no concomitant medications. The patient phoned in on 13Mar2019, and stated his arm was very red and sore, all the way down his arm to his elbow. The patient brought a picture and his whole arm turned red with swelling, and a month later it was all gone. The events occurred within 48 hours after the injection (13Apr2019). The events arm red and arm swollen were considered serious due to medically significant. The patient did not visit emergency room or physician office due to events. Relevant tests was reported as none. The patient had completely recovered from the events, in about a month. The reporter considered the event arm red and arm swollen were related to pneumococcal 13-val conj vac (dipht crm197 protein). Sender's Comments: Considering a plausible drug-event temporal association and the consistency of the event with the known safety profile of the suspect product, a reasonable possibility that vaccination site erythema/swelling/pain are related to PREVNAR 13 administration cannot be excluded.
A report was received from a health care professional on 11/13/2002, concerning a 26 month old female vaccinee who was inadvertently administered Fluvirin on 11/13/2002. On 11/13/2002, the vaccinee was inadvertently administered Fluvirin subcutaneously instead of polio vaccine. The vaccinee had not received any previous influenza vaccinations. The vaccinee did not experience any adverse reactions. There was insufficient information to determine the reporter's causality assessment. Update 1 01/27/2003 - A report was received from a health care professional concerning a vaccinee of less than 6 months old who experienced a mild temperature and slight tenderness at the injection site after receiving Fluvirin.
swelling in arm to the size of a softball, raised area, hot to touch, red in color. itching at injection site.
No doctor's visit or hospitalization. Sometime probably 0200 plus or minus 30 I woke up with chills, shivering while also feeling like I was running fever. For 12 hours I had extreme fatigue, chills, insomnia, uncontrollable shaking, muscle aches, fever, inability to focus, I am not 100% sure how to describe but I had racing thoughts and inability to focus. I think there may have been some slight nausea but I cannot confirm that. I took a OTC dose of Tylenol around 8 or 9AM, fluids, and eat what I could. There was a degree of loss of balance as well I had trouble maintaining balance during the 12 hour period. I wear a fitness tracker 24/7 at the time I got the dose on a highly active day I would burn to 3000-3500 calories. In the 24 hours after getting my 2nd dose I spend a majority of time bed and got maybe 1000 steps total and  ended up burning 7000-7500 Calories that day. Within 36 hours I was feeling completely fine and recovered.
This literature report concerns a 2-year-old male. His medical history was unremarkable. On an unknown date the patient received influenza vaccine (brand unspecified) and hepatitis A vaccine. The patient presented with a two week history of an asymptomatic cutaneous eruption involving his arms, legs and cheeks. Physical exam revealed monomorphous erythematous papules distributed over his extremities and cheeks with  sparing of the palms, soles and trunk. Review of systems was negative except for hepatitis A and influenza vaccination 10 days prior to the onset of the eruption. His parents declined a biopsy. Given the temporal sequence of events and lack of any other relevant precipitant, a clinical diagnosis of Gianotti-Crosti syndrome (GCS) was made. Because GCS is usually a self-limited eruption, and in this case asymptomatic, the patient and his family were given reassurance and the rash resolved over the course of 6 weeks. Reporter comments: The authors concluded that this case represented a rarely reported instance of GCS associated with hepatitis A and influenza vaccination. Their findings reinforce the link between highly immunogenic vaccines, such was hepatitis A, and GCS. To the best of their knowledge, only one other case of GCS in association with influenza vaccine has been published in 1995 [non CSL vaccine]. A number of other immunizations have been implicated as a cause of GCS, such as hepatitis B, measles and polio.
Swelling, itching, redness of Rt arm 2 days after taking IM PEDIARIX & S/C MMR in right arm.
Numbness in upper lip - began 3.5 weeks following second shot, lasted continuously for 4 months on upper right; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17May2021 12:15 (Lot number: EW0177) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0171, Location of injection: Arm Right, Vaccine Administration Time: 12:15 PM), administration date: 26Apr2021, for COVID-19 immunization, reaction(s): "reddish, itchy spot at injection site of right arm", "reddish, itchy spot at injection site of right arm", "injection site of right arm  Continued to be hardened", "Light-headed", "nauseas". The following information was reported: HYPOAESTHESIA ORAL (disability) with onset Jun2021, outcome "recovering", described as "Numbness in upper lip - began 3.5 weeks following second shot, lasted continuously for 4 months on upper right". The event "numbness in upper lip - began 3.5 weeks following second shot, lasted continuously for 4 months on upper right" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Dec2021) negative, notes: Nasal Swab; (20Dec2021) negative, notes: Nasal Swab; (01Nov2021) negative, notes: Nasal Swab; (15Nov2021) negative, notes: Nasal Swab; (23Nov2021) negative, notes: Nasal Swab; (20Aug2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of hypoaesthesia oral. Clinical course: Numbness in upper lip - began 3.5 weeks following second shot, lasted continuously for 4 months on upper right spot on upper lip being 85-90% total numbness. At 5 months it began coming and going, but also spread to the upper left side of the upper lip and now at 7.5 months later is still flaring. Will go down to 10-20% numb for a few days to a week and then flare back to 80-90% numb for a few weeks.  No follow-up attempts are possible. No further information is expected.
Pfizer Covid-19 vaccine administered on 04/08/2022 date has been determined to be outside of the recommended stability guidelines by Pfizer and a repeat dose is recommended.
Within 15 minutes, patient right upper arm is broken out with hives, red, swollen 20mm in diameter. Benadryl 12.5mg PO given. Advised to see MD for evaluation.
Started first night (3/24), extreme soreness in first left then right arm then right, shakiness, weakness,extreme fatigue. Next morning, more intense pain in arms down to hands, joint pain on level 6 of 1-10 in all joints, tingling in arms, hands red and cold to the touch ( similar to reynauds), extreme chills and feeling cold.  Afternoon: Increase in joint pain level 8. Ringing in ears for brief time.  Evening:  Joint pain still high, spiked fever of 100.8F. Could not securely hold objects ( dog leash) in hand. Loss of appetite, smell and taste blunting, but not 100%.  Next morning (3/25)Fever to 100.8, severe headache. Joint pain better level 5.  Next evening fever 99.5, headache and joint pain gone.Smell and taste start to return   Next morning (3/26) all symptoms gone
Case number PHEH2013US009533 is an initial spontaneous report received from a nurse on 26 Apr 2013 and a follow up report from the physician received on 21 May 2013. This report refers to a 28-year-old female patient. Her medical history included exposure to bat. It was reported that she was not immunized to any rabies vaccine prior to RABAVERT. Concomitant drugs included VYVANSE XR for attention deficit disorder and LAMICTAL as a mood stabilizer. She was vaccinated with first, second and third doses of RABAVERT (batch number: 517011A) on 11 Apr 2013 at left deltoid, on 14 Apr 2013 and on 15 Apr 2013 at right deltoid respectively. Reporting nurse stated that the patient came for the fourth dose and developed rash (on unspecified date). Hence the fourth dose was not given. It was reported that she did not know where the rash was located. She was the patient advocate employee and did not know the details other than rash and the clinicians decided not to give the RABAVERT and she believes that the clinician was going to resume the series with IMOVAX once the rash resolves. Her physician reported that after third dose of RABAVERT, she felt "spacey or blacking out". It was also reported that she had periods of time which she could not remember and had visual hallucinations. The outcome of the event rash was not reported. The outcome of other events was reported as recovered. The causality and seriousness of events were not reported. Follow up report from the physician received on 21 May 2013: Medical history, concomitant drugs and events (visual hallucinations, spacey or blacking out and she could not remember) were added. The information related to RABAVERT (batch number, vaccinations dates, dose and site of vaccination) and patient details were updated.
Since receiving 5th AVA vaccine March 2004, experiencing severe fatigue, vertigo, memory problems, urinary incontinence, tremors, and visual problems. I was told by my case manager I was the fourth patient to be diagnosed with Multiple Sclerosis (dx in May 2005).
A spontaneous report was received from a 30-year-old, female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nausea and fatigue.   The patient's medical history was COVID-19 and autoimmune disease. Concomitant medications were antidepressants and alprazolam.  On 06 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 07 Jan 2021, the patient experienced nausea and fatigue. Treatment for the events was not provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome of the events of nausea and fatigue was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
The patient presents with Left flank pain x5 days with associated nausea since 2pm. Pt who was here on 8/19 for the same complaint reports he presents to the ED due to worsening pain from an 8.5mm stone on his left that hasn't been able to pass on its own. Pt states he tried to get an appointment with his urologist but was unable to.  Associated symptoms: nausea, denies chest pain, denies vomiting, denies diarrhea, denies back pain, denies shortness of breath, denies fever, denies chills, denies headache and denies dizziness.    (Covid 19 incidental finding)
Two days after the shot, my arm was bright right around the injection site, and the rest of the upper arm had red/bluish splotches - worst of all, the outer portion of my upper arm had gone partially numb/tingly. Expecting it to be temporary, I let it go. After a week, the redness around the injection site had faded, and the splotches were less obvious but still present - and the numbness had spread to most of my upper arm. I saw my family doctor, who ordered an ultrasound to rule out a blood clot - which it did. The symptoms persist, and the numbness is spreading further down my arm. It is currently from just below the shoulder joint al the way to just above my wrist. It remains on the outer side, with the inner side of the arm remaining pretty much normal.
Generalized urticaria.  2ml of Benadryl and 3 ml of Pedia pred given.
Case number PHEH2016US029280, is an initial spontaneous report received from a nurse on 03 Nov 2016. This report refers to a 40 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUCELVAX (batch number: 187276) at a dose of 0.5 ml intramuscularly on 13 Oct 2016. The nurse reported that, the patient received FLUCELVAX while breastfeeding. The outcome of the event was reported as complete recovery on 13 Oct 2016. The seriousness of the event was reported as non serious. The causality of the event was not reported. The case was lost to follow up at initial.
No adverse effects reported; the patient was inadvertently administered a dose of VAQTA which expired; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, drug reactions and allergies were not reported.      On 04-APR-2019, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) lot # N032753 with expiration date on 23-MAR-2019 (strength, dose, route of administration, and anatomical location were not reported) indicated for prophylaxis.        No adverse effects were reported.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 38-year-old male patient received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 38 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Chronic sinus" (unspecified if ongoing), notes: Chronic sinus and upper respiratory infections; "Upper respiratory infections" (unspecified if ongoing), notes: Chronic sinus and upper respiratory infections; "Exercise tachycardia" (unspecified if ongoing), notes: Exercise tachycardia; "Seasonal allergies" (unspecified if ongoing), notes: Seasonal allergies. Concomitant medication(s) included: FLONASE [MOMETASONE FUROATE]. Past drug history included: Epinephrine, reaction(s): "Known allergies: Epinephrine", notes: Known allergies: Epinephrine. The following information was reported: FRACTURE (medically significant), INTERVERTEBRAL DISC OPERATION (medically significant) all with onset Jan2022, outcome "unknown" and all described as "Recent L4/5 microdiscectomy (Jan) and right ankle arthroscopy/micro fracture treatment (Apr)"; SUSPECTED COVID-19 (medically significant) with onset 2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "head fog"; PARANASAL SINUS DISCOMFORT (non-serious), outcome "unknown", described as "sinus pressure". The patient underwent the following laboratory tests and procedures: Arthroscopy: (Apr2022) Unknown results, notes: Right ankle arthroscopy. Therapeutic measures were taken as a result of drug ineffective, suspected Covid-19, fracture. Clinical course: Patient received other medication in 2 weeks. Patient received Paxlovid for Covid-19 treatment. Return of symptoms on 24Apr after initial symptoms resolved on Paxlovid by 20Apr. Recurring symptoms include sinus pressure, head fog, congestion, dry cough, strong headache, and fatigue. He had a history of chronic sinus and upper respiratory infections. He was currently being treated with Augmentin and Methylprednisolone with improving symptoms within 24 hours.
Patient noted having a shingles infection lasting four weeks beginning four days after vaccination with prevnar 20
Patient presented to ED on 4/5/2021 with 3 day history of dyspnea and productive cough.  Patient was hypoxic at 76% on room air at doctor's office prior to presentation at ED.  Patient had a known COVID-19 exposure (daughter) in past 1-2 weeks.  Patient tested positive for COVID 19 on 4/5/21.  Patient was treated with oxygen, antibiotics, steroids, remdesevir, and convalescent plasma.  Patient underwent CTS chest to rule our PE--this study was negative for PE.  Patient improved and was discharged to home with new oxygen therapy.
Patient received DTAP #2 (imms delayed per parents) at age 2 7/12.  Returned 6 days later with large area erythema, swelling at the sight of injection.
blood in urine...first time was the day after the first dose of the vaccine.  ..continuall intermittent blood in urin e , never for mor e than one day, and randomly to present day
temperature 102 for 3 days body aches/pains headache for 3 days itchy skin 1 day wheezing 1 day no treatment symptoms disappeared by 12/09/2019
Patient called and stated back of right arm at immunization site was reddened and swollen. Told the patient to go see her primary MD. Primary MD gave her antibiotics, BENADRYL, and MOTRIN, the patient stated. The patient also stated that the MD said this is a normal adverse reaction. No increase in temperature. Called and checked on the patient at 16:00 PM and patient stated was better.
The patient presents with localized, right sided chest wall pain onset last night (Oct 10) ~7 hours prior to arrival. He endorses worsening pain with deep breaths, and is improved with massaging or holding the area. He tried icing the area and took ibuprofen and tylenol last night that subsided his pain from a 9/10 to a 2/10 at rest. The pain was persistent into this morning that increases to a 4/10 with breathing. He has a history of inflammation in the rib cage that normally presents in the left chest wall or sternum. In the past, he has been prescribed antibiotics and oral steroids to treat inflammation with improvement. He states this pain presents in a similar character to previous episodes, and normally occurs this time of year. He does not have history of blood clots and denies recent prolonged travel.
Chills, lasting approximately 4 hours.  Low grade fever (range 99 to 101), fatigue, lasting approximately 22 hours.  Nausea and vomiting for approximately 2 hours--cumulatively.  The day after inoculation at about 10:00 pm, everything back to "normal".
stomach ache; Dizziness; headache; vomiting; fatigue; numbness in fingers; pain at injection site; radiating into shoulder; This is a spontaneous report from a non-contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6203) via an unspecified route of administration on 18Feb2021 at 13:30 (47-year-old at vaccination) as a Dose number unknown, Single for COVID-19 immunization. The patient's medical history included Sleep apnea, Gastrooesophageal reflux disease. The patient had no known allergies. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID prior to vaccination. The patient was not tested for Covid post vaccination. On 20Feb2021 at 06:30 AM, the patient had experienced dizziness, headache, vomiting, fatigue, stomach ache, numbness in fingers, pain at injection site and radiating into shoulder. The patient had received aspirin as treatment medication for resulted events. The outcome of the events was recovering.  No follow up attempts are Possible. No further information was expected.
Pt's knee was hurting off and on beginning about 10 days after immunizations. Normal exam.
suspected vaccination failure; shingles in his eye; eye pain; This case was reported by a consumer via media  and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and eye pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and eye pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and eye pain to be related to Shingles vaccine.  Additional details were provided as follows The case was reported for the reporter's brother. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles in his eye in terrible pain. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
No additional AE/PQC reported; PROQUAD that was stored improperly and experienced a temperature excursion; This spontaneous report has been received from a nurse referring to a 3-year-old patient of unknown gender. The patient's medical history, concurrent condition, and concomitant therapies were not reported.  On 16-OCT-2023, an improper storage dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis, (strength, dose, anatomical location, and route of administration were not provided; lot number X018571 was a valid number with an expiration date on 05-JAN-2025) was administered after temperature excursion to a patient (improper storage of product in use).  The excursion occurred with a temperature of 3.9 Degree Celsius (C) for 70 hours and 0 minutes and 0 seconds. There was no previous temperature excursion reported and the event was not called because of the data logger. No additional adverse event provided (No adverse event).
Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Mild, Systemic: Tinnitus-Mild
Had typical soreness and red area for 3 days after vaccine.  Had low grade fever 12 hours post vaccination. 7 days post vaccination developed  signs of ?Covid arm?: redness, swelling, painful to touch, extremely itchy.  Ibuprofen did make much difference, used topical NSAID which helped the itching, topical diphenhydramine helped somewhat but less than NSAID, icing the area  alleviated the  itching the most but painful to touch, redness, hard swelling did not change.  Have not used oral diphenhydramine as it has induced tachycardia in the past.
Had Td  3-1-04- reaction that evening 3-1-04 severe itching, redness + slightly swollen + warm to touch at site left deltoid. Pt put Benadryl on area. Pt seen 3-10-04 at doctor's office. Area still red (approx 6 inches, 4-5 inches wide)
3 days after receiving my shot, I woke up to find an enlarged lymph node on my right collar bone. It is not painful, but is about the size of a very large grape. I did discover that I should just watch it for about 6 weeks then see my doctor if it doesn't resove. On the second day after I found the lump is is slightly larger but still not painful.
Flu vaccine given at 0900. Pt states at 1900 developed rapid pulserate of 100, developed body aches. Went to bed with pulse of 100, when Patient awoke the following morning pulse was normal.