chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchiness that kept her awake all night; Itchiness that kept her awake all night; Rash is warm to the touch; Rash is itchy; Ring-worm bullseye type of rash that is one inch diameter wide/rash is like COVID-arm/ rash is circular; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness that kept her awake all night), INSOMNIA (Itchiness that kept her awake all night), FEELING HOT (Rash is warm to the touch), RASH PRURITIC (Rash is itchy) and RASH (Ring-worm bullseye type of rash that is one inch diameter wide/rash is like COVID-arm/ rash is circular) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PRURITUS (Itchiness that kept her awake all night), INSOMNIA (Itchiness that kept her awake all night), FEELING HOT (Rash is warm to the touch), RASH PRURITIC (Rash is itchy) and RASH (Ring-worm bullseye type of rash that is one inch diameter wide/rash is like COVID-arm/ rash is circular). At the time of the report, PRURITUS (Itchiness that kept her awake all night), INSOMNIA (Itchiness that kept her awake all night), FEELING HOT (Rash is warm to the touch), RASH PRURITIC (Rash is itchy) and RASH (Ring-worm bullseye type of rash that is one inch diameter wide/rash is like COVID-arm/ rash is circular) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product given as birth control pills.  It was described that the itchiness was like a ring-worm bullseye type of rash that was one inch diameter wide. The rash  was circular, itchy, and warm to the touch like the COVID-arm.   Patient also disclosed that  pharmacist said she can take Benadryl (diphenhydramine hydrochloride) or hydrocortisone.   Most recent FOLLOW-UP information incorporated above includes: On 14-Mar-2021: Follow-up information received  contains non-significant information
None Stated 3/18/09-records received-office visit office visiti 12/5/08-positive ANA, fatigue and arthralgias. October had asthma flare that required steroids and never really recovered from it. Diagnoses with mycoplasma pneumonia. Since then felt exhausted and could not catch breath. Mother had similar symptoms. Hand pain. 2/20/08-ANA positive inflammatory polyarthralgias, follow-up visit since 2 months prior. C/O pain in bilateral hands and feet. No consistent joint swelling. Fatigue, all over body pain, inability to do activities like ski. Assessment:undifferentiated connective tissue dosorder suggestive of fibromyalgia. 3/5/08-swollen lips and tingling after opening new bottle of shampoo.
Pain in arm over multiple days, chills later in the day after getting shot, fever the following day from the morning to afternoon, dizziness in same time frame
Pt received pneumovax imm on 10/22/07. She reports she had her grandchildren with her, and they 'all had the flu". Pt c/o diarrhea,stomache ache,nausea, and left lower leg had bumps slightly raised since she received the imm.Pt was seen in Dr's office by PA on 10/26/07. Assessment: Gastroenteritis and Rash, possibly a localized reaction. She was treated with Phenergan 25 mg q 6 hrs PRN for nausea, stop erythromycin unitl diarrhea stops,immodium PRN, bland diet,Rash: Alternate hydrocortisone and neosporin topically and instructed to call the office or return to the office if symtoms continued or worsened.
per MD mom reported t101.5 & jerking spasms during sleep w/ one single large twitch;pt was aroused & no decrease in consciousness noted by mom;
Report of increase rash/redness to face around mouth and in brow area.  Feeling dizzy and flushed.  Report of others that he slurring his words, but did not seem to have slurred speech.  Somewhat flushed appearance.  No respiratory distress.  Moved to prison medical area.  Administered Benadryl and observed.
Swollen leg; Taken to Er w/red, swollen leg, screaming for 4 hrs on 21JUL90; 23JUL pt improved; No known allergies, no family hx noted 2nd DTP;
No adverse effects reported; improperly stored doses of PEDVAXHIB (R027325, 7/10/2021) were administered; This spontaneous report as received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 30-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # R027325 has been verified to be a valid lot number, expiration date was reported as 10-JUL-2021 and was confirmed to be valid) (exact dose, route of administration and anatomical location were not reported) for prophylaxis. The haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), was stored in the lowest temperature below 2 Celsius degrees (1.4 Celsius degrees) in time frame 42 minutes. There was no previous temperature excursion. The digital data logger was involved. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA002781: US-009507513-1907USA002782:
He developed cellulitis in his right thigh 48 hours after getting the vaccine. His whole thigh was swollen, red, hot and painful.
Severe pain left hip all the way past knee from hip bone thru knee area. A little better now (9-29-16) but still pretty severe pain - 2 1/2 months and still hurts bad effecting joints and muscles.
On Friday 03-12-2021, went to wash my face and my whole face was red, flushed and very itchy. I then went to sleep and on Saturday morning when I woke up my right wrist was itching a lot as well as  my legs, buttocks and hands. All over my body was red and very itchy. I did not sleep due to the itchiness on Saturday night. I developed little red bumps on my entire body. I ate lentils for food but I do not think it was the food. I went to urgent care and saw a doctor who gave me Benadryl, took one dose and then it slowly started to go away.
Received Gardisil and Hepatitis A vaccine.  Noticed uncontrollable "shaking" to left side of body and face 24 hours later.  Seen in ER, bloodwork normal.  Neurological exam normal.  Sent home.  No further problems. 9/5/08 Reviewed PCP medical records which included ER medical records of 8/23/08. FINAL DX: allergic reaction to vaccine Records reveal patient experienced lower abdominal pain, uncontrollable shaking of left arm, shoulder & face.  When seen in ER, noted to have rhythmic movement of left face & arm.  Dx in ER: possible extrapyramidal symptoms & muscle contractions.
Headache, Myalgia, Arthralgia, Fever, CoughWheeze, Rash, Purpura, NauseaVomiting,  ' I had small, dark purple/black dots the size of a fingertip bruises on my back, legs and abdomen Narrative:
3 days after this COVID vax injection, onset of crop of herpes lesions on right buttock (never had herpes lesions before in this same spot; took Rx acyclovir to lessen severity and duration of lesions. (Note: patient has approx. 50-yr Hx of occasional herpes lesion outbreaks on lower back or buttocks, usually occurring after sun exposure or brought on by stressful situation or illness.)
Syringe leaked onto patient; Patient given less than a full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of SYRINGE ISSUE (Syringe leaked onto patient) and UNDERDOSE (Patient given less than a full dose) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced SYRINGE ISSUE (Syringe leaked onto patient) and UNDERDOSE (Patient given less than a full dose). On 26-May-2021, SYRINGE ISSUE (Syringe leaked onto patient) and UNDERDOSE (Patient given less than a full dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Action taken with mRNA-1273 in response to the event was not applicable.
5:08 pm - finished vaccination and sitting in chair.  5:10pm found slumped in a chair. VS 57/33 P 52.  Immediate evaluation by EMS and NP.  5:15 pm BP 95/61  p 67.  Patient placed with head down and feet up. EKG showing sinus bradycardia  and junctional  block 5:17. BP 98/68, HR 73.   Remained in observation additional 15 minutes until he felt  better and orthostatic BP changes no longer were present Discharged at 5:55 pm 110/57, p. 62 R 16. Sats always above 98%  Patient discharged home via transportation service.
Skin pain; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 04Apr2021 at 12:45 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient received pantoprazole 40 mg (MANUFACTURER UNKNOWN) for unspecified indication and from unknown start date. 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 vaccines within four weeks prior to the COVID vaccine. On 06Apr2021, the patient experienced skin pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event skin pain was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
red, swollen, painful, itchy at site of injection; red, swollen, painful, itchy at site of injection; red, swollen, painful, itchy at site of injection; red, swollen, painful, itchy at site of injection; This is a spontaneous report from a non-contactable consumer, the patient. A 52-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 04Mar2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 05Mar2021 the patient experienced red, swollen, painful and itchy at the site of injection. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events red, swollen, painful and itchy at the site of injection was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
9 cm erythema, pain and itching at site of MENVEO injection left lower deltoid. Symptoms started approximately 24 hrs after injection.
Excessively heavy menstrual flow for 24 hours, 6 days after my second dose, excessive menstrual cramps; Excessively heavy menstrual flow for 24 hours, 6 days after my second dose, excessive menstrual cramps; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6955), via an unspecified route of administration at the age of 41-year-old administered in arm left on 31Mar2021 12:30 PM at single dose for COVID-19 immunization. The patient medical history was not reported. There was no covid prior vaccination. Concomitant medications included sertraline hydrochloride (SERTRALINE); loratadine, pseudoephedrine sulfate (CLARITIN-D); acetylsalicylic acid (ASPIRIN ANALGESIC); colecalciferol (D3); zinc. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247) at left arm on 10Mar2021 12:30 PM for COVID-19 immunisation. There was no other vaccine in four weeks. The patient experienced excessively heavy menstrual flow for 24 hours, "6 days" after her second dose,  excessive menstrual cramps on 06Apr2021 01:30 AM. There was no covid tested post vaccination. There was no treatment. The outcome of event menstrual flow excessive was recovered on 07Apr2021 01:30 AM and other event was recovered on unspecified date. This report was reported as non-serious.  No follow-up attempts are needed. No further information is expected.
Narrative:  91yo with CURRENT PROBLEM LIST:  Vitreous Detachment/Degeneration (PVD) Actinic Keratosis Personal History of BCC/SCC Pain in joint involving forearm (ICD-9-CM 719.43) Attention- Deficit/Hyperactivity DisorderSprain (ICD-9-CM 599.7) Nephrolithiasis (ICD-9-CM 592.0) CA PROSTATE SKIN LESION CAD HYPERLIPIDEMIA HYPERTENSION died at outside community hospital on 12/27/2021. Pt had received 3 covid vaccines on 1/15/21, 2/12/21, & 9/2/21. Circumstances of pt's death not known. Likely pt's death is not related to covid vaccines given pt's advanced age, comorbidies, and long length of time between death & date of vaccine administrations.
Patient came in complaining of symptoms or poor arm movement, tingling and use of arm compared to prior shot. MD gave x-ray.
This case was reported by a nurse via sales rep and described the occurrence of injection site warmth in a adult female patient who received FLULAVAL Quadrivalent (batch number Y7X9Z, expiry date 30th April 2017). In September 2016, the patient received FLULAVAL Quadrivalent. In September 2016, 1 day after receiving FLULAVAL Quadrivalent, the patient experienced injection site warmth, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site warmth, injection site erythema and injection site swelling were recovered/resolved. The reporter considered the injection site warmth, injection site erythema and injection site swelling to be almost certainly related to FLULAVAL Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced warm, raised and red areas around the injection site. The area was noted to be approximately 2 to 3 inches in diameter. In about 2 days all events were resolved without further medical attention. The health care professional stated that no other vaccines were administered on the same day. No further information was provided. This case was one of the 4 cases, reported by same reporter. The reported lot number (Y7X92) for FLULAVAL Quadrivalent did not exist and was updated to Y7X9Z, according to sales database.
Red splotches, itching, tingling in face and lips   Given Benadryl
mild tension in the muscles / muscle stiffness; This case was reported by a consumer via call center representative and described the occurrence of muscle stiffness in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2022, the patient received the 1st dose of Shingrix. In August 2022, less than a week after receiving Shingrix, the patient experienced muscle stiffness. On an unknown date, the outcome of the muscle stiffness was unknown.   It was unknown if the reporter considered the muscle stiffness to be related to Shingrix.     Linked case(s) involving the same patient:  US2022123179   Additional Information: GSK Receipt Date: 24-AUG-2022 Reporter's Comment: The reporter was the patient. After receiving Shingrix vaccine the patient experienced mild tension in the muscle or muscle stiffness. The reporter did not consent to follow up. Additional supportive information: For tolerance of 2nd dose refer case US2022123179, reported by same reporter for same patient.; Sender's Comments:  US-GSK-US2022123179:Same patient
pt recvd vax;devel a hard,red,swollen area at inject site; cellulitis was dx;pt tx w/ Kef tabs BID for 2 days;recovered w/in 3 days;
Nose bleeding; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose bleeding) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jul-2021, the patient experienced EPISTAXIS (Nose bleeding). At the time of the report, EPISTAXIS (Nose bleeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported. No treatment medication was reported.
Patient developed burning sensation in lips as well as hives across chest one day after having 1st dose of Moderna COVID vaccine.
The day after shot was give (3/19/21) the client experienced a headache, sore throat. Then on Saturday she was achy and very tired. Then on Monday (3/22) she called her Dr and they said this was a normal side effect from getting the vaccine. Then on Tuesday (3/23) she got a large rash on her hands, feet, face and neck.  Her eyelids were a purple color, she felt very weak and tired; she said her blood sugars were in the 400 range also. She then went to the Dr office on Thursday (3/25) that week and Dr checked blood work and told her it was an allergic reaction to the vaccine and that she shouldn' t get the second one. He put her on Benadryl and steroid. She felt better 2 days later.
Rash started next day, to face and now over body itching all over. Fever started that night after injection. Patient started treatment on 3-18-2013 MOTRIN 800mg, Hydroxyzine HCL 25mg, Hydrocortisone 1% topical ointment.
Myalgia; Shortness of breath; chills; sweats; rapid heartbeat; chest pain; stomach pain; nausea; headache; syncope
No adverse event; 20 patients who were over 65 years old. They were given today 25-May-2023 0.25ml instead of 0.5 ml; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (20 patients who were over 65 years old. They were given today 25-May-2023 0.25ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 25-May-2023, the patient experienced UNDERDOSE (20 patients who were over 65 years old. They were given today 25-May-2023 0.25ml instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (20 patients who were over 65 years old. They were given today 25-May-2023 0.25ml instead of 0.5 ml) 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 UNDERDOSE (20 patients who were over 65 years old. They were given today 25-May-2023 0.25ml instead of 0.5 ml).    No concomitant medication was reported.   No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:Patient no 1
2 weeks after had swelling in eyelids - resolved after several days 3 weeks after had localized hives on neck and face - taking Zyrtec
Patient reported feeling fine for the first 15 minutes after the vaccination was given then reported itching of her face excluding her forehead. Patient was given 25mg IM diphenhydramine. Pulse ox was taken and read within normal limits. Within 5-10 minutes after the diphenhydramine was given patient reported itching involving her arms, facial flushing but no shortness of breath. An extra dose of 25mg IM diphenhydramine was given and an IM EpiPen.
SEVERE ANAPHYLACTIC REACTION; EXTREME HEADACHE; This spontaneous report received from a nurse (health care professional) concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, 1 total administered, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced immediate severe anaphylactic reaction, and an extreme headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe anaphylactic reaction and extreme headache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221120933- severe anaphylactic reaction. The event has a compatible/suggestive temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The date of refrigeration was on 07-MAY-2021.  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of erythema in a subject of unspecified age and gender who was vaccinated with KINRIX, (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of KINRIX (.5 ml, route unknown).  At an unspecified time after vaccination with KINRIX, the subject experienced erythema, hardness injection site, swelling injection site and injection site warmth.  At the time of reporting the outcome of the events was unspecified.  The healthcare professional considered the events were possibly related to vaccination with KINRIX.  This case corresponds to a pharmaceutical product complaint.  The healthcare professional reported that 15 subjects experienced the same events in the same time period after vaccination with KINRIX.  At the time of reporting, no additional information was available.  This is case 2 of 15 (see case IDs A0860669A, A0860690A - A0860702A for the other reports).