chrisvoncsefalvay/vaers-outcomes huggingface dataset:
8 AM shot states soon after injection became nauseated, headache and itching at site. 2:30p states headache worse, site red, no swelling or warmth. 3:15 Red on upper chest states is itchy, to go home and take Benadryl. 12/16/09 states 12/15 pm had welts on lips and red on legs. Took Benadryl every 4hrs. No itching or redness today, still mild headache. States left arm is numb.
Chronic fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Chronic fatigue) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Chronic fatigue). At the time of the report, FATIGUE (Chronic fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided by the reporter.  Treatment medication include muscle relaxant prescribed by a HCP.
Fever after injection; This is a spontaneous report from a non-contactable consumer. A female patient of an unknown age received 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. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced fever after injection. The clinical outcome of the event fever after injection was unknown at the time of the report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
after the second shot I got a rash on my arms, back and stomach 20 hours after, both were bumpy, itchy, and sore; after the second shot I got a rash on my arms, back and stomach 20 hours after, both were bumpy, itchy, and sore; after the second shot I got a rash on my arms, back and stomach 20 hours after, both were bumpy, itchy, and sore; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Solution for injection, Batch/Lot Number: EW0185), via an unspecified route of administration, administered in left arm on 15Jun2021 16:30 (at the age of 61-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had allergies to penicillin, and high cholesterol medications. The patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Solution for injection, Batch/Lot Number: EW0167), via an unspecified route of administration, administered in left arm on 25May2021 16:30 (at the age of 61-years-old), as a single dose for COVID-19 immunization and experienced got a rash on my legs and arms. The patient did not receive other vaccine in four weeks of COVID-19 vaccine. The patient did not have COVID prior to vaccination and has not been COVID tested post vaccination. On 16Jun2021 14:30, the patient experienced after the second shot I got a rash on my arms, back and stomach 20 hours after, both were bumpy, itchy, and sore. The patient did not receive any treatment for the event. The outcome for the event was recovering.  Follow-Up (06Sep2021): Follow-up attempts are completed. No further information is expected.  Follow up (20Sep2021): This is a follow-up spontaneous report received from a contactable other-HCP. This other-HCP reported in response to HCP along with  letter sent for a patient which included that: The patient did not provide information to the HCP regarding the reported adverse event(s) with the use of the product.  Follow-up attempts are completed. No further information is expected.
Approximately 1/2 hour post vax, pt fell asleep and could not be aroused for approximately 7 hours, from 2-9 PM. Mother reports that pt was also "gray in color." Pt taken to ER and awoke upon arrival. The day post vax, pt was still a little more sleepy than usual.
(11/11) Thursday morning felt a Stye forming in Left eye and later produced a rash on face and arms. Antihistamine Zyrtec and Hydrocortisone taken to reduce itching and redness. (11/12) Friday following the swelling had gone down but itching was progressively worse throughout the day. Made an appointment to PCP and saw NP at office. Confirmed an allergic reaction but did not determine a trigger. Steroid for 6 days and Benadryl prescribed as a course of treatment. Follow up on Monday and was told to stay the course and it should clear up.
Information has been received from a medical assistant concerning a 12 year old male patient who was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #658432/1246U). Subsequently the patient developed an injection site reaction described as in. There was no product quality complaint. Follow-up information was received which reported that on 09-OCT-2007 the 12 year old whThis report is one of several fite male patient with no pre-existing allergies, birth defects, medical conditions was vaccinated subsquently in in the left arm with the second dose of Varivax (lot #658432/1246U). On the same day the patient was also vaccinated with the first dose of FLUZONE (lot #U2443AA) intramuscularly in the right arm. On 12-OCT-2007 the patient rom the same sourc experienced injection site itch. This is one of several reports received from the same source.
Beginning the evening of the vaccine, she developed a small erythematous wheal. This has progressed over the intervening 2 days to encompass a large area, ~10cm in length, 6cm in width around the area of injection. it is hot, and tender. Skin is mildly edematous.
20-25 pts recvd Engerix-B & exp pain @ inject site, nausea & fever;
Acute onset chest pain followed by paraplegia and L arm weakness.  Treated 11/12 with plasmapheresis, recovered some arm function, but remained with loss of use both legs and no sensation from mid-back down.  Pt d/c to rehab after hospitalization for two weeks.
Fever with Shingrix?; This case was reported by a consumer via interactive digital media (Shingrix GSK ) and described the occurrence of fever in a adult 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 fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported however it was captured as adult as per vaccine indication. The patient posted as question fever with Shingrix?' No further information could be obtained.
Mild fever beginning sometime in the early morning of March 11 and mild acheyness in joints, which became noticeable by mid-morning.  Temperature rose to 100.5 by noon.  Took one Aleve gel tablet then slept for two-three hours.  When I awoke, the fever and acheyness were both gone.  No other side effects since then.
7 year old patient came to clinic for seasonal influenza vaccine (FLUZONE - Sanofi Pasteur - .5mL SDV (Ages 36 months+) Thimerosal and Preservative Free). Injection site, on upper left arm, was swabbed with alcohol prior to injection.  Approximately 4 hours after injection, patient developed redness at the site.  Oral Benadryl was administered in the age-appropriate dose, but redness nevertheless worsened.  Topical Benadryl cream was administered, but did not alleviate redness.  For the next +/- 48 hours, the red area gradually became larger, more swollen, and harder; the redness became darker, and site eventually became hot to the touch.  Benadryl, alternating both orally and topically, continued to be administered, but did not help.  At this point (roughly 52 hours following injection) patient was taken to his pediatrician - by this time, red swollen area was more-or-less an oval roughly 5 inches wide, and 7 inches long (along length of arm with injection site as center point).  Pediatrician suspected cellulitis was developing.  Prescribed both oral steroids (Orapred) and oral antibiotics (Clindamyicin).  Swelling, hardness, and red coloration gradually subsided over the next several days.  To date (roughly 3 weeks following injection), some redness of area persists. Patient never complained of pain in area, however there was moderate itching.  Patient was told not to scratch, and appeared to comply.  Patient has no known food, substance, or medication allergies, other than a history of reactions to the influenza vaccine.  No egg allergies whatsoever.  In two prior years, patient had similar or more sever reactions to influenza vaccine (one year, site started to develop Necrotizing Fasciitis, which eventually subsided after I.V. administration of vancomysin).  During 2 years that he was not vaccinated (due to fear of reaction due to history), patient developed severe influenza, which precipitated asthma attacks (in one case, a life-threatening asthma attack that required a 2 weeks I.C.U. admission).  Due to patients reactions to influenza vaccine, parents are reluctant to continue having them administered.  However, due to patient's propensity to get the flu when vaccine is not administered, and the sever impact it has on his asthma, failure to administer vaccine can have severe consequences.
Extreme Fatigue; Headache; Nausea; Body Ache; Cold Sweats; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via intramuscular route of administration (age at vaccination 53-year) in left arm (deltoid) on 19Jun2021 at 02:20 PM as dose 2, single for COVID-19 immunization. Medical history reported none. There were no concomitant medications. Historical vaccine includes first dose of BNT162B2 received via Intramuscular route of administration in Left arm (deltoid) on 08May2021 at 02:00 PM for COVID-19 immunization; after first dose the patient experienced extremely tired/extreme fatigue, headaches, nausea, flu-like symptoms, body aches, felt less tired but still not back to normal. Reported facility type was pharmacy or drug store. Prior vaccination with in 4weeks was reported none. On 25Jun2021 the patient experienced extreme fatigue, headache, nausea, body ache, cold sweats. As reported her side effects came in 2-3days periods, then went away for 3-4days and came back again, 2 times with first and twice with second vaccine. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 29May2021. Patient received no treatment for the adverse events. The seriousness of the events was reported as non-serious. The clinical outcome of the events was resolved on 27Jun2021.   Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Initial unsolicited report received from a consumer on 30-Mar-2018 and additional information received on 30-Mar-2018. This case involves a female patient of unknown age who was vaccinated with 0.5 ml of ADACEL (batch number, expiry date and dose in series were not reported) via subcutaneous route incorrectly at the back of the right arm on 28-Mar-2018. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced pain at the injection site immediately and there was bleeding immediately after the vaccine that required brief pressure and a band aid. States that now the whole back of her right arm is bruised. Says it's not painful and doesn't feel it requires medical attention at this time. It was also reported Site bled quite a bit, and patient now have 1" diameter bruise on upper arm. patient asked that Was vaccine actually delivered into my body, or did it flow out with blood? Patient was concerned that she was not protected, and that pharmacist didn't know correct was to inject vaccine. It was also a case of actual medication error due to vaccine administered at inappropriate site as pharmacist who administered the vaccine placed the shot incorrectly to the back of the right arm and also inappropriate route of vaccination as vaccine administered subcutaneously. Lab data and corrective treatment were not reported. On unknown date, patient recovered from the event vaccination site pain. Outcome of the events bruise, vaccination site bleeding, vaccination site reaction were recovering. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none
Approximately 16 hours after the vaccination, my daughter experienced high fever (101 degrees at the highest) then would be cold and clammy.  She also had diarrhea; 4 or 5 stools per day.  The stools were very watery but also appeared mucousy - an almost jello consistency.  She also slept more than usual and when awake was somewhat lethargic.  When awake she experienced extreme hunger eating approximately twice the normal.  Though better today she is still experiencing runny stools.  Fortunately, through this all, she has remained in goods spirits and has been a happy baby. I did contact the clinic on Wednesday, January 26, 2005 to inform them of her symptoms.  They felt she simply had the flu and suggested coming in to see the doctor.  We declined on the visit and chose to continue to monitor her.  We feel that this is not the flu and truly an adverse reaction to the DTaP.
SOB,Rash,4/14 anaphylactic  shock admitted to Er remained overnight for observation, 5/9 rash returned after prednisone ER , 6/10 dermatolgist Dr rash returned.  Took scrapping of skin, came back as Grover,s Disease.
This spontaneous prospective pregnancy reprot has been received from a registered nurse via a company representative referring to a pregnant female patient of unknown age. Pertinent medical history and drug reactions/allergies were not reported. On approximately 24-SEP-2015 (reproted as approximately 1 week ago), the patient was vaccinated with a dose of M-M-R II) (dose, route, lot# and expiration date were not reported) when she was 3 weeks pregnant. Concomitant drug was not reported. The patient became pregnant with estimated last menstruation period (LMP) of 03-SEP-2015 and estimated date of delivery (EDD) of 09-JUN-2016. No adverse effect was reported. Outcome of the events was unknown. Additional information has been requested.
Client reports feeling chest pressure, nausea and shortness of breath. Fire Rescue on scene to evaluate client.  No resolution, Fire Rescue arrived for transport the patient to Medical Center for further evaluation at 10:00am.
Itching and redness on site increasing on day two then slowly  decreasing today redness gone but still itching a little.  Applying cold to site helped itching,. last few days.
fever; chills; headache; shaking; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), HEADACHE (headache), TREMOR (shaking) and FATIGUE (fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills), HEADACHE (headache), TREMOR (shaking) and FATIGUE (fatigue). At the time of the report, PYREXIA (fever), CHILLS (chills), HEADACHE (headache), TREMOR (shaking) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Arm at injection sight started to itch. Ended up looking like hives. Next morning hives were gone and just a red flat spot at sight. Slightly warm to the touch. 3 days later it was gone.  No fever, headache or any other symptons.  Just red spot.
Patient said her arm was sore immediately after getting vaccine. Came back to pharmacy the next morning with a big bruise on arm. Said her arm was very sore the night after getting vaccine and still sore the next day. Counseled her to visit her doctor because she said the soreness was also in her neck, but she didn't feel that it was severe enough to go to doctor.
Headache, Myalgia, NauseaVomiting, FATIGUE Narrative: MISSED WORK DUE TO SYMPTOMS  Other Relevant History:
face/head was numb on and off for just over 2 hours; Severe arm soreness stiffness for 2 days; Severe arm soreness stiffness for 2 days; fatigue; nausea; This is a spontaneous report from a contactable consumer.  A 22-years-old non-pregnant female patient received BNT162b2 (Pfizer-BIONTECH Covid-19 Vaccine) Lot number=EL9262, via an unspecified route of administration in left arm,  on 25Jan2021 at 09:00 ( at the age of 22) as a single dose  for covid-19 immunisation.   There were no other vaccinations within 4 weeks. Medical history included Asthma, rheumatoid arthritis, and insomnia.  Concomitant medication included ethinylestradiol, levonorgestrel (DAYSEE).  On 25Jan2021, the patient experienced severe arm soreness stiffness for 2 days, fatigue for 2 days, nausea, and on day 4 (29Jan2021) face/head was numb on and off for just over 2 hours. No issues with speech or motor function, but the numbness came and went in various parts of her face, scalp, and outer ears for 2 hours. The outcome of the events was recovered. It was unknown if the patient tested for COVID-19 post-vaccination.
Patient came for his Moderna bivalent booster.  He requested this vaccine and had questions about how this one covered new omicron variants. Answered his questions and noted his last vaccine was September 16, 2022.  I  did note his previous vaccine was moderna but not that it was a bivalent .  He reported no previous reactions besides slight sore arm.   His wife later called and asked about getting second bivalent booster.   No known adverse event besides incorrectly administration of second bivalent booster
Case number PHEH2015US025076, is an initial spontaneous report received from a healthcare professional on 25 Nov 2015. This report refers to a 50-years-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 173538) at a dose of 0.5 ml intramuscularly on 21 Nov 2015 which was out of temperature range (35.4 F) for two days. No adverse event was reported following this administration error.
No additional AE; The vaccine was administerd after a temperature excursion/Temperature: -14.1 degree Celsius, time frame: 12 minutes.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 19-JAN-2022, the patient was vaccinated with improperly stored (temperature: -14.1 degree Celsius, time frame: 12 minutes) varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, lot #: U022321, expiration date: 15-JUL-2023 (strength, site and route of administration were not provided) for prophylaxis (product storage error). There was no additional adverse event reported (No adverse event).
On 1/10/2023, I noticed a tick behind her left ear. The tick was attached but not engorged. By 1/11, the tick bite was itchy at school. On 1/12, her scalp was horribly itchy. I checked for lice and gave her 1/2 tsp of Benadryl. I had to pick her up early from school because she was so itchy, and I took her to a quick care clinic. They recommended administering Benadryl regularly and using topical steroid cream. She had a rash with raised bumps all over her lower back, under her arms, and in other places on her trunk by the time we went to the clinic. It later spread to her arms. On 1/13, she remained very itchy and got a 99-100 fever in the evening. The fever was controlled with Motrin but continued through the weekend. On 1/17, she woke without a rash, so we sent her to school. She needed Benadryl by noon because the rash returned. On 1/18, she woke with a few itchy spots. The rash persisted intermittently through that week.  We had not changed cleaning products or detergents or other things that would have contributed to contact dermatitis. She has no known food allergies.
A month later I ended up with a sinus infection. I'm not sure if I had it before my vaccine. I have chronic symptoms in the falls.
Evening of vax started shaking outstetched arms got stiff eyes got big for 5-10 mins poss rxn;
?Covid arm? red itchy swollen area hot to the touch. Paired with fatigue.
*ADMINISTRATION ERROR*   38 Y/O MALE PATIENT RECEIVED SECOND BOOSTER DOSE (MODERNA) BEFORE 5O YEARS OF AGE AS RECOMMENDED BY CDC.
Pt called today she saw MD after 2 wks of pain in arm that shot was administered.
Blistering on the rashes over my right hands and fingers; Rashes [over my right hands and fingers that] are painful to touch.; Right hand had a small rash; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 05Apr2021 at 16:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on an unknown date (at the age of 33-years-old) as a single dose for COVID-19 immunisation. 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 other medications or vaccines within 4 weeks prior to the vaccination. On 05Apr2021 at 16:20, 20 minutes after vaccination the patient experienced a small rash on his right hand. On 07Apr2021, 2 days later it  turned into blistering on the rashes over his right hands and fingers, that were painful to touch. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events right hand had a small rash, blistering on the rashes and rashes painful to touch were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt recv vax & 10FEB started running temp-given motrin on 11FEB temp higher gave motrin;temp reached 106.8 & mom put in tub to cool down;while in tube started shaking, eyes rolled & said i'm dying;mom states did not loose consciousness;sz