chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Dose of pediatric presentation administered to adult patient today. Pediatric bivalent vaccine administered as booster dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Dose of pediatric presentation administered to adult patient today. Pediatric bivalent vaccine administered as booster dose.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Dose of pediatric presentation administered to adult patient today. Pediatric bivalent vaccine administered as booster dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Dose of pediatric presentation administered to adult patient today. Pediatric bivalent vaccine administered as booster dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Dose of pediatric presentation administered to adult patient today. Pediatric bivalent vaccine administered as booster dose.).    Dosage text for suspect product was reported as additional booster.  Concomitant drugs were not reported.  It was reported that pediatric bivalent vaccine was administered as booster dose to adult patient. No other symptoms were reported.  Treatment medications were not provided.
Diarrhea within 10-15 minutes on the ride home.  Nausea most of the day.  Ennui most of the day.
Nausea, abdominal pain, cramps, vomiting, diarrhea
Patient reports feeling dizzy three hours after first dose. She napped, and the dizziness was gone when she woke up. Additionally, one week after the first dose, she noticed redness near the injection area. It was not itchy and "barely noticeable". This lasted ~ one day. (She also reports a sore arm, which subsided after a couple of days.)
Complained of not feeling "well" day after vaccine.  C/o headache, feeling itchy inside, and red splotchy skin to the face, neck, and arms.
Headache, Myalgia, Fever, left arm sore at injection site Narrative:
Red hot skin appeared 48 hours after injection from injection site down 3/4 of the bicep in a large patch. Very hot to touch and tender. Injection site was not visible. Still visible after 8 days since it started. Redness and hotness has only faded in the last day. Still tender.
Complains of non itchy, non raised blotchy erythematous rash on neck and chest on same side if vaccination appearing 20 minutes after dose. No progression of symptoms after 20 minutes. Suspect reaction was heat rash.
I went to sleep and woke up 10/04/2021 at 1:00AM I woke with a very bad headache, felt very uncomfortable, I felt really bad all over, my body felt like it was burning from inside. I could not sleep after that. I did not call doctor right away because I thought it was normal from vaccine and that it would gradually go away. I did have fever. I am a healthy person so I usually don't go to ER.  On Tuesday I felt way better but I did feel weak. I got up to do my normal stuff but when I would take a few steps it was pounding really fast. I would have to stop almost every 5 steps. I went to my mom's family doctor in November 23, 2021 don't remember her name. Labs came back with Anemia. EKG came back with Tachycardia Ischemic Heart disease. In December I went to Doctor and he had me wear a heart monitor.  I have a follow-up with a Cardiologist  Doctor  in Location on 1/11/2021. He is going to Follow up on the results of the heart monitor and perform echocardiogram.  I also had a change in my menstrual cycle. I remember after 2nd dose I had tender breast and it has disrupted my cycle that was always on time.  My heart feels like it is getting worse. My labs make it seem like all my vital vitamins are low like iron, vitamin d, and Iodine.  Some days I feel like I am going to faint or dizzy and my heart hurts now.
Received 2nd Moderna shot on 03/29/21- on 04/08/21 developed an itchy rash on entire body; no fever or other symptoms; Treated with oral Steroids; Hydroxyzine; Caladryl lotion;  as of 04/13/21 still has total body rash..not as red ;itching occasionally and still taking hydroxyzine and Benadryl at night
Day 1 - fine until evening then arm pain at injection site (upper left arm) and all over headache set in Day 2 - Full body chills, pins and needles all over,  headache and seem pain + hardening at injection site. By 7pm dull pain under left eye in sinus duct area. Day 3 - arm pain, hardening  + reddening at injection site and facial swelling under left eye along with pressure, hardening and dull pain.  * reported to Covid nurse line * icing left side of face and took a Benadryl
Pt dx with right optic neuritis 8/27/10. Sx started 8/24/10.
Development of painless, asymptomatic Left palmar tendon nodules about 2 weeks following the second Moderna COVID 19 vaccine
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 13-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two time. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
I experienced: fever, tiredness, feeling unwell, headache, muscle pain,  joint pain, injection site pain, rapid heartbeat. These gradually subsided. By about 6 p.m. on March 11, I was just tired. On March 12, I felt better. The only treatment pursued was rest.
Pt developed normally until 18 months and then stopped developing. He has been diagnosed with autism. He had only echolalic speech, touch, sound sensitivity, detachment and lack of eye contact, no social interaction. Pt has had tests showing high mercury and other heavy metals. Other vaccinations include on 07/12/1996 he received DTP/DTaP/DT/TD vaccine, oral polio vaccine, and Hep b vaccine; on 09/30/1996 he received DTP/DTaP/DT/TD vaccine and oral polio vaccine; on 01/27/1997 he received DTP/DTaP/DT/TD, oral polio, and hep b vaccines; on 11/14/1997 he received DTap vaccine, and hib baccine; and on February 1999 he received Varicella vaccine. On annual report dated 05/02/2003: Delayed social development, inappropriate noises and touching strangers. Language delays, short attention span. He has made significant progress with chelation and other detoxificatin and medical interventions and recovery is still possible.
bad case of Vertigo; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of vertigo in a 69-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included surgery and nerve damage (nerve damage from the surgery which is also very painful.).   On 08-JUN-2023, the patient received the 1st dose of Shingles vaccine. On 09-JUN-2023, 1 days after receiving Shingles vaccine, the patient experienced vertigo (Verbatim: bad case of Vertigo). The outcome of the vertigo was not reported.   It was unknown if the reporter considered the vertigo to be related to Shingles vaccine.     It was unknown if the company considered the vertigo to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 25-JUN-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received Shingles on Thursday and bad case of Vertigo on Friday, that was 2 weeks ago. The patient states that if it's related or not but Vertigo is no fun, & his/her Dr said he/she could have it another 2 weeks and also mentioned that never had this before. The patient states that he/she just had surgery 2 months ago & had nerve damage from the surgery which is also very painful.  From the sound of what people are saying about shingles, he/she think It still better get the 2nd shingles shot. Follow up was not possible, as no contact details were available.
p/vax noticed lump size of quarter, hot, red, & swollen;applied ice pack;was itching & took DPH on 8/9/99 lump had inc to size of grapefruit;saw MD 8/9/99;8/10/99 has some tightness in throat & jaw area but states no diff breathing;
Swelling and pain at injection site for 5 days. Fever, shivering, fatigue muscle aches several hours after injection for 22 hours (stayed home from work because I felt so sleepy). This was my 2nd injection. The only side effects I experienced from the first injection were soreness and swelling at the injection site for about a week.
Phone call from mother 8/25/2005 2:00pm states 24 hours post vaccine administered daughter started with 20 minutes of starring followed by about 5-7 minutes of tonic-clonic movements unresponsive for a few hours and taken to hospital
Received Covid 19 injection in afternoon at medical clinic on right shoulder. The same evening I could hardly lift my arm above my head. Soreness ensued which was debilitating however it finally subsided and became tolerable. As of this date I am still having shoulder pain. Also?about 10 days after my first c-19 shot I came down with hives. I had hives come and go for over two weeks but became symptom free prior to my next injection.
Loss of balance and coordination, disorientation, severe nausea/vomiting, muscle weakness, fatigue, chills, dizziness
Body pain; Sore arm; Fever 101.6; This is a spontaneous report from a contactable company representative, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the right arm on 25Mar2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any concomitant medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Mar2021, the patient had sore arm, body pain and fever 101.6. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events sore arm, body pain and fever 101.6. The clinical outcomes of the events sore arm, body pain and fever 101.6 were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
diagnosed with rosacea/Psoriasis; rash; diagnosed with rosacea/Psoriasis; This is a spontaneous report from a contactable consumer (patient). A 54-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FD8448), via an unspecified route on 19Aug2021 (at the age of 54-years) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications included Multivitamins from an unknown date and unknown if ongoing. On unspecified date, the patient received first dose of the vaccine five days later he developed a rash which has not gone away and was diagnosed with rosacea/Psoriasis and was told by his dermatologist the rash should go away within two months. Patient was past due on his second dose and missed dose because of this rash. Patient stated that "I just went to see my doctor today, he told me to talk to (Incomplete sentence) I went to see a dermatologist, he told me to talk to my primary physician and my primary physician wont give me any direction." Patient stated, "I tried an anti-fungal, I was given a diagnosis, I do not know if you want to get ahead with that or you want to continue with the question." The outcome of the events rash was not recovered, and other events was unknown.  Follow-Up (04 OCT2021): Follow-up attempts are completed. No further information is expected.
Information has been received from a physician concerning a 15 year old female who was vaccinated with a first dose of Gardasil.  Subsequently the patient developed a migraine shortly after receiving the first dose.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  On an unspecified date, the patient was vaccinated with a second dose of Gardasil.  The migraine did not reappear after the second dose.  Additional information has been requested.
Fever 101 - 103 degrees for 12 hours Fever 99-101 degrees for 12-36 hours Chills 3 hours Nausea 24 hours, vomiting for 3 hours Headache 48 hours Muscle aches 48 hours Fatigue 48 hours
bicep where admin. got swollen to twice the size and very hard and hot.   from the flu vaccine appt was monday morning did not see any reaction til wednes. morning  I don't know what manufactor .
Prolong headache and heart discomfort (after more than a week from the vaccination date).
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 20-JUN-2014, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # J002302 and expiry date: 22-AUG-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Pt recv vax on 7/27/98; on same day pt exp pain at vax site
DROWSINESS; SORENESS; SHIVERS; FEVER; This spontaneous report received from a patient via a company representative concerned a male 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced drowsiness, soreness, shivers, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from drowsiness, soreness, shivers, and fever. This report was non-serious.
On 18-Apr-2022 the vial was initially stored in the refrigerator and administred on 23-Aug-2022; No adverse event; expired Moderna Covid-19 vaccine (Monovalent) to 27 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine (Monovalent) to 27 patients), PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administred on 23-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (Unspecified COVID-19 Vaccine Dose 1), COVID-19 VACCINE (Unspecified COVID-19 Vaccine booster dose 1), COVID-19 VACCINE (Unspecified COVID-19 Vaccine  Dose 3) and COVID-19 VACCINE (Unspecified COVID-19 Vaccine  Dose 2). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, COVID-19 VACCINE, COVID-19 VACCINE and COVID-19 VACCINE.    On 23-Aug-2022 at 1:57 PM, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 23-Aug-2022 at 1:57 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine (Monovalent) to 27 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administred on 23-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine (Monovalent) to 27 patients), PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administred on 23-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine (Monovalent) to 27 patients) and PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administred on 23-Aug-2022).    No concomitant medications was reported.  On 18-Apr-2022 the vial was delivered and stored in the refrigerator on same date. The vial size is of 5.5mL. The vial did not undergo any temperature excursions. Vaccines were only offered on Tuesdays from March-2022 forward to the patient. For each Tuesday vaccine date, only removed one vial from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator).  No treatment drug details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2022: Follow-up received: Patient details updated, dosage regimen updated (vaccination date, dose number and batch number).
c/o feeling flushed started 19OCT93 1500 lasted & 3 hrs woke up @ MN 19OCT w/bad h/a; hx cchronic h/a; 22OCT still has h/a, malaise;
First headache, lightheadedness, nausea, then rapid onset of red eye/pink eye symptoms with bleeding starting within right eye. Severe head pressure and very blurry eyesight,. One instance of double vision. Lots of goop coming out of eyes and worsening. Some throat soreness, tightness. Eyes and vision were clear before vaccination.
Painful and swollen area traveling down arm from injection site. Area is raised and warm. Itchy.  Fever of 100.5
51 Y/O female, BMI 32.6, PMHx of Asthma, Cirrhosis, DM, hepatic encephalopathy, HTN, NASH, AFib, portal HTN, admitted for SOB due to Covid and encephalopathy on 11/13/21. Pt had concern for bacterial component due to imaging results from Integris hospital indicating possible atypical pneumonia at the time (in October). Pt was treated with supportive measures and vancomycin, cefepime, and Mycamine. Pt discharged home with home health on 11/15/21.
Patient had no reaction to her first Pfizer-BioNtech shot on June 2, 2021.  However, in the hours immediately following her second shot on June 24, she developed a fever.  That evening, the fever worsened, she developed a terrible headache, and started experiencing abdominal muscle contractions.  These contractions continued for approximately 12 hours causing her to twitch/bend as her abs contracted (like a jerky sit-up almost).  The muscle spasms began to slow, but also changed.  They migrated from her abdomen to her neck and shoulders, causing her head to twitch to one side randomly.  This was accompanied by a verbal tick that interrupted her (almost like hiccups would) and prevented her from finishing words and sentences.  Even when she wasn't trying to talk, she continued twitching, and began vocalizing, making strange "eee" noises.  She was unable to control this, and the combination made it increasingly difficult for her to speak.  She also began to suffer cognitive symptoms - she had trouble word finding and would either be unable to remember the basic words she was trying to say, or would attempt to say one word, only to have another come out.  The symptoms were worst in the week to 10 days following the vaccine, and then began to slowly subside.  Within one month, all the symptoms were gone.
Two weeks after her vaccine was given the following symptoms were noted: weakness of mouth muscles with drooling and liquids running out of mouth, difficulty swallowing, slurred speech, and numbness of left side of face. She was seen at a local hospital and was diagnosed with Bell's Palsy. On 2/26/09 she was started on treatment of Zovirax and Prednisone. An eye patch and Artifical Tears were used to treat her dry eye from incomplete of eyelid closure.  04/15/2009 MR received for DOS 2/22-23/2009 with DX:  Bell's Palsy. Pt presented with 24 hr hx of slurred speech and L facial droop. PE (+) for L facial droop with drooling, unable to speak. Admitted to r/o CVA.  W/u (-). Dx: Bell's Palsy.
8 cm X 7 cm redness swollen, 0 fever, TDAP on left side noticed the same day.
Loss of sight,loss of hearing/ringing in ears,inability to stand,pale,nausea,headache,dizziness.    Note: The same reaction occurred when taking second dose of Pfizer COVID vaccine 6/28/21 and the third dose (booster) of Pfizer COVID vaccine 3/6/2022.   On  the second dose  6/28/21 the fire department\paramedics responded to Pharmacy and waited until she recovered her vision\sight\paleness\ability to stand and did not recommend that she needed to go to the hospital as she was recovering.      After a few months after the second dose she had 4 months of harsh stomach issues, headaches, nausea, vomiting.   Where ultra sounds, mri, endoscopy, blood tests were done and it was not conclusive what is causing this.
Breakthrough COVID-19 infection. Pt received Pfizer on 4/1/21/ and 4/22/21
This case was reported by a consumer and described the occurrence of dizziness in a 26 year old female subject who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. Concurrent medical conditions included family history of Multiple Sclerosis (mother). On an unspecified date in May 2005, the subject received the first dose of Engerix-B (lot number not specified). At an unspecified time later after the administration of Engerix-B, the subject experienced dizziness, numbness of extremities, blurred vision and nausea. The subject reported to her mother that she had "low sugar" and "all symptoms resolved after eating something sweet." The mother state the symptoms occurred "because my daughter got over-heated." All symptoms resolved within 24 hours.