chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 14-FEB-2017 at 09:11, the patient was vaccinated with improperly stored VARIVAX injection (lot # M031969) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
Tongue swelling, mouth swelling, throat itching and swelling started almost immediately...two hours later nausea, vomiting, sweating, body aches, fever, chills. Extreme fatigue, slept for over 6 hours. Extreme, intense headache 12 hours later. Fever, chills, body aches for next 4 days. 24 hours after vaccine, hard red lump at injection site, sore and hot to touch. Still swollen and painful 5 days later. Hives and intense itching all over body.
Itching; This is a spontaneous report from a non-contactable consumer or other non hcp. A 66-years-old female patient (consumer) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history included asthma. Concomitant medication(s) included omalizumab (XOLAIR) taken for asthma, start and stop date were not reported. On an unspecified date patient experienced itching. The outcome was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1 of 3 pts vaxed from the same lot# who exp an inj site rxn;pt devel red, swollen, indurated area-size of an egg following vax;required MD visit;tx included cool compresses, topical steroid cream & DPH
No other AE information; improperly stored vaccine administered; patient was given RECOMBIVAX HB that was recalled; Information has been received from a nurse reporting on a 10-week-old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 23-OCT-2020, the patient was vaccinated with a recalled, improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) thimerosal free, 0.5 mL, lot# T007984 has been verified to be a valid lot number, expiration date 01-NOV-2022 for prophylaxis (route of administration and anatomical location were not reported). No other AE information was given at this time.
Dizziness; Weakness; Tiredness; Joint pain/Wrist pain; Low grade fever; Headache; This is a spontaneous report facilitated collect based on the information received by Pfizer.  A contactable consumer reported for herself that a 73-year-old female patient received 2nd dose of BNT162B2 (lot#EL9261) Intramuscular on 12Feb2021 for COVID-19 immunization; adalimumab (HUMIRA, Solution for injection in pre-filled pen) Subcutaneous from an unspecific date and ongoing at 40mg for Rheumatoid arthritis. Medical history was Rheumatoid arthritis, Swelling, Low in potassium, High cholesterol, Abstains from alcohol, non-smoker. Concomitant drugs methotrexate for rheumatoid arthritis therapy, folic acid, Torsemide for Swelling, Potassium for Low in potassium, Simvastatin for High cholesterol. Historical vaccine was 1st dose of BNT12B2 (lot number: EK9231) subcutaneous (as reported, pending clarification) on 22Jan2021 for COVID-19 immunization. On 14Feb2021, the patient experienced dizziness, weakness, very tired, joint pain, wrist pain, low grade fever and headache. COVID-19 VACCINE was also considered suspect causality for Humira (adalimumab): The reporter's causality for the event(s) was Probable. On 14Mar2021, the low-grade fever resolved. On 20Mar2021, the dizziness resolved. On 31Mar2021, the headache resolved. Outcome of Joint pain/Wrist pain was recovering, other events were not recovered.  No follow-up attempts are needed. No further information is expected.
fever; Initial information was received on 20-Sep-2020 regarding an unsolicited valid non-serious case from a patient via email.  This case involves a male patient (age was not reported) who experienced fever (pyrexia), while he received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].   The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   On 15-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (batch number and other dosing details were not reported) for prophylactic vaccination.  On 22-Sep-2020, the patient developed non-serious fever (pyrexia), 7 days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  The patient was visited to emergency room for this event.  From 22-Sep-2020, body temperature ranging from 101.8-100.7.  The patient received corrective treatment with Tylenol (Paracetamol) and Ibuprofen.  At the time of reporting, the patient had not recovered from the event.  There will be no information available on the batch number for this case.
arms were swollen, very painful and she can't barely lift her arms; arms were swollen, very painful and she can't barely lift her arms; arms were swollen, very painful and she can't barely lift her arms; very tired and is having fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 10May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious), MOBILITY DECREASED (non-serious) all with onset 10May2021, outcome "unknown" and all described as "arms were swollen, very painful and she can't barely lift her arms"; FATIGUE (non-serious) with onset 10May2021, outcome "unknown", described as "very tired and is having fatigue". Additional Information: It was reported that, patient experienced sore arms immediately after receiving the 1st dose of the vaccine yesterday, 10May2021. Patient would like to know what she needed to put on her arms whether a warm or cold compress to lessen the swelling of it on injection site or forearm, but particularly on injection site. Was very tired and was having fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
High fever (100.6) , intense headache, my entire body ached (including the injection site), my skin hurt when touched, cough, itching of extremities.  I felt terrible and still don't feel 100%.  I can't imagine receiving this shot in conjunction with a flu shot.  NOT a good idea.
Case number PHEH2014US005017 is an initial spontaneous report received from a healthcare professional on 07 MAR 2014. This report refers to an adolescent female patient whose age was not reported. Her past medical history and concomitant medications were not reported. It was reported that his patient under 18 years of age was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly at a dose of 0.5 ml in DEC 2013. No adverse events were reported following this medication error (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 07 MAR 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Information has been received from a physician concerning a 9 week old female with a medical history of sleep apnea without heart deceleration. Vertex presentation with no perinatal problems and no family history of musculoskeletal problems or dyplasia of the hip who on 04/23/2003 was vaccinated with a dose of Hib conj vaccine (OMPC) (manufacturer unk.). Concomitant therapy on 04/23/2003 included diphtheria toxoid(+) pertussis vaccine (unspecified) (+) tetanus toxoid and poliovirus vaccine. The patient was seen by an orthopecidic speciallist on 05/01/2003 with regard to her neck. On approximately 04/23/2003, "in the last few weeks" , it was noted that she tended to keep her left ear towards her left shoulder and her chin to the right. "Over the last week or two", she had been positioned and stretched by her mother and she seemed to be improving. The patient was diagnosed with positional torticollis. On exam, the child was healthy and well proportioned. The physicain did not see signifigant posturing towards the left ; however the  patients' mother mentioned that she did not keep her ear to the left shoulder and her chin to the right. There was no nodule in the sternomastoid muscles. There was full range of motion of the cervical spine. Her hips had 85 to 90 degrees of abduction. There was a negative Barlow's and a negative Ortolani's test. Internal rotation was 40 degrees and external rotation was 50 degrees. Her kneess had full extension. There was no significant metatarsus adductus. The physician recommended that the child sleep with her chin to the left and that she should be stretched with her right ear to the right shoulder and she should be made to look up to the left as much as possible. A follow up visit was recommeded in the two months. The physician also noted that he expected this would resolve "without a lot of treatment". A follow up visit with the orthopedic specialist on 07/24/2003 revealed persistant mild torticollis which was improving. It was noted that the child had changed in her positions and was monitored in how she slept. Her mother stated that she still saw a tendency for the child to positon to the left, however, the physician "could not see any evidence of that". She had active and passive motion in both directions which were equal. There were no nodules in the neck and passive range of motion was full. Hip abduction was 85 degrees bi laterally. The diagnosis was positional torticollis, resolved. The physician reassured the mother that as long as she made sure the child did not sleep in one position, this would  continue to improve and by 9-12 months, she shouldn't notice any differences. The reporter also mentioned the patients' mother (WAES#0208USA01862) who experienced an exposure during pregnancy with varicella virus vaccine live (MSD). No further information is expected.
Client with c/o (R) arm "tingling"-radiating down forearm to 4th & 5th digits. Radiating pain also reported on right side up to (R) shoulder & base of neck.
Respiratory virus infection; Covid arm on 07Jan2023; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT INFECTION (Respiratory virus infection) and IMMUNISATION REACTION (Covid arm on 07Jan2023) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:MS, osteoporosis - both conditions she already had prior to getting the Moderna vaccine.  The patient's past medical history included Multiple sclerosis and Osteoporosis. Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (lot number - EW0217) on 02-Jun-2021, PFIZER BIONTECH COVID-19 VACCINE (lot number -EW0181) on 23-Jun-2021, PFIZER BIONTECH COVID-19 VACCINE (1st booster dose, lot number SF8764) on 09-Dec-2021 and HERPES SIMPLEX 1 VACCINE; for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (2nd booster dose and lot number 059A22A) on 21-Jun-2022. Past adverse reactions to the above products included No adverse event with HERPES SIMPLEX 1 VACCINE, Moderna COVID-19 Vaccine, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concomitant products included TRIAMCINOLONE and HERPES SIMPLEX 1 VACCINE from 21-Jun-2021 to an unknown date for an unknown indication.    On 05-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 07-Jan-2023, the patient experienced RESPIRATORY TRACT INFECTION (Respiratory virus infection) and IMMUNISATION REACTION (Covid arm on 07Jan2023). At the time of the report, RESPIRATORY TRACT INFECTION (Respiratory virus infection) and IMMUNISATION REACTION (Covid arm on 07Jan2023) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicine were reported. It was reported that the patient got the shingles vaccine on the same day (05Jan2023) on the same arm (left). Also reported that last year when the patient got her 1st Moderna booster dose on 21Jun2021, she also had the shingles vaccine but on the opposite arm. She did not have COVID arm then. She started applying Triamcinolone Cream to the COVID arm area since 08Jan2023 and the area looks smaller today.  Also reported that she had a respiratory virus infection prior to getting the bivalent booster dose.  No treatment medicine were reported.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 04-MAR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml VIs 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 32 degrees Fahrenheit (0 degrees Celsius) (lowest recorded temperature) for 304 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional has been requested.
My son went in for his well visit on 12/19 and got his last hib shot and his chicken pox shot and by the time we got home he had spiked a 103.8 fever which I knew was from the shots so I just gave him some Motrin and kept and eye on him. Well by the next morning, 12/20 the fever was still up there but he had developed this hive and just wasn't himself. So I called the doctor. We brought him in they are telling me it's from a virus he got because his throat is a little red and his nose his runny.( which I knew it wasn't a virus because he didn't have it before the shots) she said to give him some benedryl for the hives every 6 hrs when they come and Motrin every 6 hrs for the temp because he's throws up to Tylonal so we can't alternate. So the next day comes (12/21) and I realize that after giving him milk he broke out in a hive so I'm questioning weather or not he is allergic to milk all of a sudden. So I called the dr. They told me to switch to almond milk so I did. And to stop all milk products and schedule an allergist asap and see what's going on. So then we went on the day and he had lunch and I gave him a peanut butter sandwich with some almond milk . After lunch he was tired so I put him down for a nap. Heard a strange noise on the monitor so I go to check on him and he's throwin up everywhere. So I quickly clean him up. Put him in the tub and what do ya kno more hives all over. So what is he now allergic to peanut butter to. So I called the dr. So now I have to stop all nut products and switch to lactaid and since yesterday his skin has broke out all dry, patchy and rash like and I can't put anything on it because we are seeing an allergist tomorrow. So all because of these damn shots he has had on the 19th my poor 1 year old is no longer playful, barley eats a thing and crys 24 7. This was all the week of the 19th. We saw the allergist and she put him on Zyrtec and he now still has this dry patchyness on his rear but that's it.
After several days of usual bilateral arm soreness, I began to develop bilateral severe muscle aches in my pelvis, bilateral hips, upper arms, shoulders and along my lower posterior rib cage.  I went to the doctor on 10/04/2022 after not being able to dress myself.  It was very painful to walk.  I was started on a three week course of Prednisone for probable Polymyalgia Rheumatica.  The CRP was 29.4.  The steroid relieved the pain.  At my next Doctor appointment  it will be decided how long I will remain on Prednisone
At end of administration of Flu vaccine, patient stated felt faint. Patient pale, eyes fluttered slightly, mild tremor to both hands, P-46-48, BP 104/74, BP #2 102/80 Glucose 77, P-59 (15 min after). No loss of consciousness. Near syncopal episode. Reports 3 similar episodes in last year positive family hx valve problem. Discussed with CP - probable vasovagal response.
fever; chills; aches and pains/body aches and pains; aches and pains/body aches and pains; light headedness; head was spinning like she had vertigo; head was spinning like she had vertigo; felt sick; dizzy; nausea; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Expiry date, NDC number and batch/Lot number: not provided), via an unspecified route of administration on 18Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medication were not reported. Additional context reported as, the patient calling about the vaccine experience. The patient first dose was on 18Jan2021 and she felt sick on 19Jan2021 after the next day of vaccination. The patient was able to go to work the rest of the week but on Saturday, 23Jan2021, her head was spinning like she had vertigo, patient never had vertigo before but some of her friends told her maybe it was vertigo but it was not. The patient was dizzy and had nausea the next week, on an unspecified date in Jan2021. The patient says she did not have the rest of the side effects except she had fever and chills on an unspecified date every now and then. The thing was that she has a work injury so it adds up more to the aches and pains on an unspecified date. The patient says that was all with the first dose, with the second dose experience that was last 09Feb her side effects were, she worked the whole week last week then Thursday she had light headedness she was sure that was a side effect, the patient experienced it on an unspecified date with her first dose. The patient asks were she any pain reliever in her case, patient had a work injury and she was taking Tramadol also, the patient asks would that be any side effects from that pain medication. Outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Swollen, hot, red left arm 8" x 8" area. Still affected 1 week later. No medical treatment.
Nausea, vomiting, weakness, came to our office then went to see neurologist and was diagnosed with Guillain Barre syndrome, we have received confirmation from Dr's office of the Guillain Barre syndrome.
Headache Chills Dizziness Shakiness Memory loss Until 09/17/2011 the patient felt better
Severe, sudden weight gain, all over hair loss, cystic acne, menstrual cycle disruption, Raynaud's Syndrome, cervical cancer, 1/4" of cervix taken out due to cervical cancer cells, food intolerance of-wheat, corn, soy, dairy, eggs, canola, cold intolerance, numbness in arms, hands, and feet, chronic UTI's, chronic yeast infections, chronic, severe stomach aches, severe constipation, random, unexplainable aches and pains, gallbladder pains, hands and feet turning purple/blue/black, arms and hands shaking (nervous system damage), anxiety and depression, chronically low B12, DNA damage, strep virus all over body (internally).
This spontaneous report has been received from a pharmacist concerning a patient of unknown gender of currently 1 year old. Concurrent conditions and pertinent medical history were not reported. On 20-MAY-2015, the patient was vaccinated with PROQUAD (Lot # K025764, expiration date 08-JUN-2016), injection (route, strength and dose were not provided) and a dose of VARIVAX (Merck) (Lot # L001325, expiration date on 13-JAN-2017), injection (route, strength and dose were not provided), simultaneously on the same date. The patient did not demonstrate any adverse effects. Additional information has been requested.