chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore throat; Difficulty in swallowing; This is a spontaneous report from a contactable Nurse. This 54-year-old female nurse (patient) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0171), via an unspecified route of administration (on the right arm) on 30Jun2021 at 16:00 (at the age of 54-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included migraine, depression and fibromyalgia. Concomitant medications were not reported. Nurse stated, "I wanted to just report a side effect. It just hurts to swallow. It is a sore throat and difficulty in swallowing which started about an hour after I got the vaccine which was about 4'o clock yesterday afternoon and it got a little better with the Tylenol but it comes back again". The patient took some medications for depression, for sleep and some PRN medication for migraine. The reporter provided the causality as related (method of assessment: global introspection) to the drug. The therapeutic measures were taken in response to the events. Outcome of the events was not resolved.
symptoms of bells palsy, droopy left side of face and eyelid; droopy left side of face and eyelid; droopy left side of face and eyelid; sore arm; headache; This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st March 2022, the patient received the 1st dose of Shingrix. On 1st March 2022, less than a day after receiving Shingrix, the patient experienced pain in arm and headache. On 5th March 2022, the patient experienced bell's palsy (serious criteria GSK medically significant), facial muscle weakness and eyelid disorder. On an unknown date, the outcome of the bell's palsy, facial muscle weakness and eyelid disorder were not recovered/not resolved and the outcome of the pain in arm and headache were recovered/resolved.   It was unknown if the reporter considered the bell's palsy, facial muscle weakness, eyelid disorder, pain in arm and headache to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient experienced a sore arm and headache that went away after a few days. On Saturday,4 days after vaccination, the patient started to exhibit symptoms of bell's palsy, droopy left side of face including eyelid. The patient went to emergency room on 5th March 2022. The reporter consented to follow up. This case had been linked with US2022042580, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022042580:same reporter - different patient
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. In November 2015 (during the time frame of 05-NOV-2015 through 15-NOV-2015), the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L007560, expiry date 15-JUN-2017; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
1104 a.m. felt shaky, lightheaded, funny feeling in her chest; moved to 30 min observation status;  1105 a.m. BP 142/92, P 128, Resp 18, SpO2 99%; A&O x 3; skin cool and clammy; resp/lungs clear and unlabored; EMS called; Moved to gurney; juice given.  Pt has hx of Hashimoto's  1110 a.m. BP 136/100, P 100, R 18, SpO2 91%; A&O x 3; skin cool and dry; remains shaky; resps unlabored; EMS arrived; Care handed off to emergency crew and taken to hospital.
Pt. reported feeling itching in her mouth, "feeling like tongue was swelling, dry throat, indigestion, heartburn sensation." Pt. was given water, tolerated secretions, swallow intact, and Benadryl 25 mg po given with benefit, no further itching mouth, tongue was never swollen, airway intact, history of Gerd, indigestion and plan for Pt. to take if worsens at home, her own preferred medicine for indigestion. Recommended follow up with her primary if worsening symptoms of heartburn, airway trouble, itching persisted. Pt. left without symptoms reported present, and agreed to plan for follow up if concerns persisted after arriving home. Pt. had a driver after taking benedryl 25 mg po.
Received Moderna vaccine as minor, age 17; A spontaneous report was received from a consumer concerning a 17-years-old, female patient who received Moderna's COVID-19 Vaccine, and the patient received Moderna vaccine at the age 17.  The patient's medical history included a positive Covid-19 test in Aug 2020, symptoms resolved, and she completed her quarentine. Concomitant product use was not provided by the reporter.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number 026L20A) intramuscularly for prophylaxis of COVID-19 infection.    On 28 Dec 2020, patient received Moderna vaccine as minor, age 17.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event received Moderna vaccine as minor, age 17 was resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 17-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot number 026L20A), reporting Product administered to patient of inappropriate age without any associated adverse events.
More rash on legs and arms worsened from before, fever. Fussy for weeks. On 9-15-16 has upper respiratory infection, otitis media, fever, and really fussy.
Patient has sore arm from the injection and is has been more than 2 months since the vaccine. He claims it only hurts when he lifts it above 45 degrees. He has not tried any physical therapy or attempted
pt inadvertently given Moderna even though Moderna is not approved for ages 12 and over. Moderna company contacted, patient is not at and increased risk of side effects or adverse events. Per their information emailed to nurse: "If given at age 12 to 17 years as the first dose, may administer the second vaccine dose 28 days later even though it is considered off-label use."
Day after injection: Chills, 102 fever, joint pain, migraine, blurry vision all lasted approximately 10 days-2 weeks or more Injection site was hot, swollen to the size of a golfball, and red for 2 weeks post injection. Swelling went down over the course of 2 months. Insomnia for about a month  Fatigue still present Chest pain day after injection lasting 2-3 days Missed period for 4 months after injection
Information has been received from a pharmacist concerning a female pt who works in a nursing home who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot649694/0396P). Subsequently the pt experienced swelling and severe redness at injection site which lasted 2-3 days. The pt self medicated with diphenhydramine hydrochloride (Benadryl). Subsequently, the pt recovered from swelling at injection site and severe redness at injection site. Additional information has been requested.
Case number PHHY2011US67132 is an incomplete spontaneous report received from a healthcare professional on 19 Jul 2011. This report refers to multiple patients. They received only the CYW-135 liquid component of MENVEO (batch number: 100003 and 028011) intramuscularly on an unknown date. No other adverse event was reported.
Pt vaccinated with Influenza developed nausea, diarrhea, depression, upset stomach.
After the first dose of SHINGRIX my body reacted within 24 hours. I was sick, flat in bed for 10 days. Mild fever, headache, nausea, rash over much of my body. Partially sick for much of the next three weeks. Determined not to get the 2nd dose of the drug (to be done within 6 months). About six months after the initial dose, (in Oct 2018) I gradually developed a chicken pox- like rash over my back, and upper arms. This rash has a slight burn to it. Have tried CORTIZONE, Calamine lotion, regular body lotion to treat it with no impact.
Gastric distress 1 hour after first shot;  Slight headache, Gastric distress for 5 days.  After second shot,:  Sore arm, slight headache, extreme fatigue on the second day, some fatigue on the third day. Two weeks after the vaccination :  no issues
I woke up this morning with swelling (angioedema) around my eyes. I took 50 mg of Benadryl and the swelling reduced, but isn't gone. About an hour after Benadryl I had some shortness of breath and dizziness that improved with sitting down. I have also had stomach cramping and diarrhea that began aroun noon. Diarrhea symptoms have improved with use of Imodium.
Pt had a fever on 11/1 which completely resolved within 12 hours. 11/3 a red lump appeared at injection site along with SOB and "achiness".  Also had pain along bilateral anterior ribs that were tender to palpation.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021 at 11:55 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 5 ml. On 02-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 02-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided.  Treatment information was not provided.
0835 Vaccine received. Pt recommended to predmedicate with Zyrtex and Motrin by PCP due to medical hx of lupus, Sjogrens, Fibromyagia. No other regularly scheduled medications.    20 minute Observation with no issues.  Returned at 1030 with "All over itching".  No breathing difficulty.   Benadryl 50 mg PO given.   BP 189/92 HR 122 RR 12. 02 Sat 100%. Temp 98.4. Similar VS after 5 mins .  After 15 mins, BP 183/95, HR 72.  Facial edema.  No breathing difficulty or concerns. Transported to ED for continued care.   Scheduled FU with Dr for today at 1530.
a patient may have received just the liquid and not the powder; a patient may have received just the liquid and not the powder; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follow: The age at vaccination was not reported.  The reporter does not have a patient name or any other information. The patient may have received just the liquid and not the powder. The reporter wanted to know what exactly was the liquid that was used to reconstitute the powder of Shingrix.  She explained that they were not 100 percent sure but they thought that a patient might had received just the liquid and not the powder mentioned that she was not sure if the Shingrix vaccine was administered to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. She thought it was never administered.  She said she checked with her staff and they said they believe it was not administered.
Child exposed to sibling with chicken pox 2 weeks ago. Now has developed low grade fever and about 200 lesions in past 3 days.
5-9-13 mild swelling left deltoid in AM becoming excessive after school. Redness extending from shoulder to elbow. Afebrile. To Dr evening of 5-9-13 low-dose steroid given.
No adverse event occurred.  Patient was administered the vaccine under age, however, per parent's consent vaccine was administerd
o adverse event was reported; Wrong vaccine administered; Inappropriate age at vaccine administration; This spontaneous report was received from a healthcare professional via Sanofi (2021SA096454) and refers to a 12-month-old male patient. The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On 01-MAR-2021, the patient was by mistake vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, exact dose, route of administration, lot number and expiry date were not reported) for prophylaxis and with diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (QUADRACEL), 0,5 milliliter, intramuscularly in the right tight (lot #C5763AA, expiry date not reported) for prophylactic vaccination, instead of being vaccinated with hepatitis a vaccine, inactivated (manufacturer unknown), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and varicella virus vaccine live (oka/merck) (manufacturer unknown). At the time of report, no adverse events were reported.
Acute asthma attack on 12/03/04. Symptoms were shortness of breath, wheezing. Treated in ER : resp albuterol nebs and Solumedrol Visc. in 5 hours with oral Prednisone and albuterol MDI.
Swelling of Throat approx. 5hrs after vaccine admin. Fever day after vaccine admin. Hoarse, sore throat. Took diphenhydramine for swelling, ibuprofen for fever.
Administration Error. Patient already had received Moderna Bivalent booster on 9/27/22
Patient complains of weakness, shakiness and very painful right arm; pts mother who is taking care of her is unsure about when it started; after following up about 6 hours later patient is feeling a bit better.
Death; guillain barre syndrome; respiratory failure; This case was reported by a lawyer and described the occurrence of death in a patient who received Herpes zoster (Shingrix) for an unknown indication.   On an unknown date, the patient received Shingrix (unknown). On an unknown date, unknown after receiving Shingrix, the patient experienced death (serious criteria death and GSK medically significant), guillain barre syndrome (serious criteria GSK medically significant) and respiratory failure (serious criteria GSK medically significant). On an unknown date, the outcome of the death was fatal and the outcome of the guillain barre syndrome and respiratory failure were unknown. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the death, guillain barre syndrome and respiratory failure to be related to Shingrix.  Additional details were provided as follow: The initial information received via legal attorney indicating a client whose relative experienced Guillain Barre syndrome and resulting respiratory failure and death an unspecified amount of time after receiving Shingrix.; Reported Cause(s) of Death: unknown cause of death
Chills and fever (104.5 , 103.8 for 10 hours then 102-103 second night now 100.2 11:27 am 3/15/2021
Headache, Diarrhea, Fatigue, sweating, chills Narrative:
Patient describes as light pink spot 2 1/2 inches by 1 1/2 inches. No pain nor itching.
Patient has a history of heart disease. Post vaccine patient experienced abnormally high blood pressure, even for that of a patient with preexisting disease. Blood pressure was monitored and recorded at least three times a day. Around 48 hours post vaccine, patient experienced sweats and shortness of breath while at work. Heart rate per monitoring device recorded around 145+ even reaching a max heart rate of 160. 72 hours post dose on New Years Eve around 23:00 patient experienced high blood pressure and sinus arrhythmia resulting in admission to the emergency department. Labs and an ECG were ordered.
Suspected vaccination failure / have gotten the Shingrix shot / Since having / Shingrix series / continues to have shingles outbreaks; have shingles for over 20 yrs have gotten outbreak now / has the shingles outbreaks at least twice a year; she does get blisters; blisters / they do itch; blisters/ are painful; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (for over 20 yrs). Previously administered products included Zostavax.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister, pruritus and pain. On an unknown date, the outcome of the vaccination failure, blister, pruritus and pain were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, blister, pruritus and pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was repored by patient herself. The patient had the Shingrix 2-dose series in 2018. Since having the Shingrix series, she continued to have shingles outbreaks. She had the shingles outbreaks at least twice a year. She stated they were not as severe as they were prior to being vaccinated with Shingrix but she did get blisters and they do itch and were painful. They were treated with (unspecified) antiviral prescription medications. She usually goes to urgent care when she had an outbreak. She tried to go to urgent care as soon as the symptoms begin but with her last outbreak she was hesitant to go to the urgent care due to the Covid-19 epidemic and so she waited over a week to go and due to that her outbreak lasted 3 weeks.  The patient was calling to see if she could receive a third dose of Shingrix. She states that her shingles outbreaks were triggered by stress such as the stress of wearing a mask while at the gym.  The patient was currently on an anti-viral drug being have gotten outbreak now. Also yearly, the patient get the shingles minimum of 2 times a year and need to take the anti-viral drug. This case was considered as suspected vaccination failure since the details regarding laboratory test were unknown at the time of reporting.
Site: Pain at Injection Site-Mild, Additional Details: Child was very afraid while getting vaccinated. Mother asked if lidocaine spray would be allowed before administration. I agreed and used the spray and tehn sterilized his arm with an alcohol wipe. When the child appeared still enough with his mom holding him still, I inserted the needle, before I was able to depress the plunger at all, the child pulled away quickly and I was then forced to reinject the needle to administer the vaccine.
Left arm/shoulder pain persisting beyond 11 days after the vaccine was given Concern for SIRVA despite the clinician recalling the location of the injection as being properly placed
This spontaneous report as received from a Nurse Practitioner refers to an unknown number of patients were inadvertently vaccinated with GARDASIL, RECOMBIVAX HB, VAQTA, and PEDVAXHIB had been improperly store. No further information was provided. Additional information was received from Nurse practitioner, who reported that GARDASIL, RECOMBIVAX HB, VAQTA, and PEDVAXHIB went through multiple unsupported temperature excursions from 10/09/2013 to 10/17/2013. The Nurse practitioner reported GARDASIL (Lot# J003727, expiration date 11/07/2015) was administered to 2 unspecified patients on 10/10/13 (MARRS# 1310USA015162), 2 unspecified patients on 10/12/13 (MARRS # 1401USA000269), 1 unspecified patient on 10/14/13, 1 unspecified patient on 10/17/13(MARRS#1401USA000271) and 1 unspecified patient on 10/19/13 (MARRS# 1401USA000272). GARDASIL (Lot# J008423, expiration date 01/21/2016) was administered to 3 unspecified patients on 10/25/13(MARRS# 1401USA000268) and 1 unspecified patient on 10/26/13 (MARRS# 1410USA00027). VAQTA (Lot# J008090, expiration date 08/23/2015) was administered to 1 unspecified patient on 10/17/2013 (MARRS# 1401USA000279) and 1 unspecified patient on 0/25/2013(MARRS# 1401USA000278). RECOMBIVAX (Lot# H012250, expiration date 02/06/2015) was administered to 1 unspecified patient on 10/26/2013(MARRS# 1401USA000277). PEDVAXHIB (Lot# J005670, expiration 12/17/2015) was administered to 1 unspecified patient on 10/15/2013(MARRS# 1401USA000275), 1 unspecified patient on 10/25/2013 (MARRS# 1401USA000276) and 1 unspecified patient on 10/29/2013 (MARRS# 1401USA000280). No adverse effects reported. No further information was provided. Additional information has been requested.
Localized rxn at site of injection - red, firm cellulitis 3 inch diameter - 1 small papulovesicle at inj site.
Information has been received from a health professional concerning an approx 80 year old pt who in Oct 2005 was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine. In Oct 2005, the pt experienced cellulitis and was hospitalized. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information is not expected.
After client received last vaccine (HPV) he began to lose consciousness, this lasted for less than one minute. When client loss consciousness his body went forward, with his head hitting the desk. No injury to forehead sustained. His body was supported to prevent him from falling onto the floor. Client gained consciousness without assistance, within a minute. He appeared flushed and slightly disoriented.  In less than five minutes he was fully aware of the situation. He was given water and an ice pack. He complained of feeling nauseous and hot. Client was monitored for 30minutes. Before leaving client denied any pain to his head and generalized. He was able to stand and walk without assistance or c/o dizziness. Client?s mother was present. She was advised to monitor patient and contact healthcare provider for further guidance. Prior to leaving clinic BP 134/56 HR 62 RESP 18
About 7 hours after receiving the shot, I started having severe burning here and there all over my body. But it traveled around and did not stay in one place very long at a time.  Approx. 3 minutes and then it would go to another area.  The worst burning pain was in my right big toe and then on the top of my right foot. These traveling pains only lasted that night.  But last night, 5 nights since my shot, I was wakened by the worst pain in my right big toe that I have ever had.  It burned like crazy!  Was a burning pain, on and off for about 2 hours. I don't think you need to tell my doctor or pharmacists any of this unless I let you know that it is chronic. It isn't. And I hope it won't be.
Sore to injection site-first day Palpitations up to 120bpm in resting lasting 4-5 hours-second day
sore throat; colds; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received second single dose BNT162B2 (Pfizer Covid-19 Vaccine, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 01Feb2021 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first single dose of BNT162B2 (Pfizer Covid-19 vaccine) on an unspecified date for COVID-19 immunization.The patient received 2nd dose on a Monday and tolerated the dose she received without adverse reaction. On an unspecified date in Feb2021 (last Friday) she had a sore throat and colds and was wondering if this was due to the weather. Patient wanted to know if she should be tested for Covid-19. The outcome of events was unknown.  Information on the Lot/Batch number has been requested.