chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient  received shot then 5 minutes later patient was standing on bench and stated he felt like throwing up; leaned over and fell face first to the ground.  His mother picked him and we gave an ice pack. I was with mother and child; he was making eye contact with us and after about 15 minutes he was ready to go home with his mother.  Patient was advised to go see a Dr. to check for fall injuries.
SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received on 13 March 2008 from another manufacturer, case number not reported.  The reporter to this manufacturer had been a health care provider.  A 13-year-old male patient had received an injection of Menactra, lot number not reported, on an unspecified date.  At an unspecified time post-vaccination, the patient experienced syncope.  Recovery status was not reported.  Additional information was not provided.  The reporter in this case was the same as in case 2008-00775.
Vesicular rash-papules scattered on trunk, arms and legs onset 4/25/06. Course of illness now.
Information has been received from a registered nurse concerning a 79 year old female with no medical history or allergies who on 25-APR-2008 was vaccinated SQ with a second or third dose of pneumococcal 23v polysaccharide vaccine (Lot# 659199/1541U). Concomitant therapy included FOSAMAX, PROCARDIA, ZOCOR and folic acid. On 29-APR-2008, the patient experienced cellulitis from the injection site to the whole upper arm. On that same day, she was treated with an unspecified antibiotic. No laboratory diagnostic studies were performed. At the time of this report, the patient was recovering. No product quality complaint was involved. This is one of three reports from the same source. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.
swelling, redness, warmth and pruritis beginning 24 hours after vaccine.  No fever.  Examined 3 days after vaccine with warmth, redness of approx 2.5 by 3 inches
Around 10-15 minutes after receiving 2nd dose of Covid vaccine, pt complained of feeling dizzy/nauseous and having lightheadedness. She had a brief moment of blackouts. 911 was called and she was transferred to the hospital.
arm soreness; This is a spontaneous report via a Pfizerfrom a contactable consumer (patient's wife). This contactable consumer reported the same events for two patients (herself and her husband). This is the second of two reports.   A 73-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer Covid 19 vaccine along with his wife on an unspecified date (reported as 'Tuesday night'). The patient complained of arm soreness on an unspecified date. The outcome of the event was unknown.   Information on the lot/batch number has been requested
NAUSEA; FATIGUE; BODY ACHES; TINGLING IN EXTREMITIES; NUMBNESS OF EXTREMITIES; DULL HEADACHE; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced tingling in extremities. On 01-APR-2021, the subject experienced numbness of extremities. On 01-APR-2021, the subject experienced dull headache. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced fatigue. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dull headache on 03-APR-2021, and had not recovered from body aches, tingling in extremities, numbness of extremities, nausea, and fatigue. This report was non-serious.
pt recvd vax 16OCT92 & an inject site reaction @ the pnu-imune site; seen in office on 19OCT-inject site reaction was 3cm in diameter & consisted of redness, swelling, hematoma & numbness @ the site;
The vaccine  (Pfizer, 2nd dose) was administered too high on my shoulder and entered into the bursa, which was much more painful than the  first vaccine had been. The pain in my left shoulder worsened over the next several days and I lost range of motion in the joint. I could tell the bursa was inflamed because I once had a shoulder injury in my right arm that felt and acted exactly the same.  It has now been three weeks since my second dose and I am still experiencing some inflammation/limitation in my left arm, though I expect it will heal over time.
Information has been received from a pharmacist concerning a 67 year old male with adverse drug reaction/allergy to ADVIL, who was hospitalised for an unrelated condition, and who on 03-JUN-2008 was vaccinated with PNEUMOVAX 23, subcutaneously to the right arm.  Within 24 hours, 04-JUN-2008, the patient developed swelling at injection site 9 x 7 centimeters, erythema and induration at injection site. It was reported that the patient had not recovered, but the reaction did not prolong his hospitalisation. Additional information has been requested.
A couple die from COVID and left 5 kids behind; This is a spontaneous report from a contactable consumer. A patient of an unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at an unknown dose via an unknown route on an unknown date for Covid-19 immunization. Medical history and concomitant drug were not provided. A couple died from COVID and left 5 kids behind. Patient knew the family. Outcome of the event was fatal.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : PFIZER INC-202101211957 same reporter, same event, drug/ different patient; Reported Cause(s) of Death: a couple that die from COVID.
RECEIVED PFIZER COVID VACCINE DOSE ON 02/14/21 WENT TO ER ON 02/28/21 WITH COMPLAINTS OF HEADACHE SHORTNESS OF BREATH, AND 02 SAT 60% ON ROOM AIR.  HAD CT HEAD WO CONTRAST THAT WAS POSITIVE FOR HEMORRHAGE AND PLAN IS TO ADMIT TO HOSPITAL
No adverse effects; improperly stored MMR II was inadvertenly administered to the patient; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 26-SEP-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, lot # R028003 with expiration date on 01-OCT-2020 (dose and route of administration were not reported) for prophylaxis. The sterile diluent used to reconstitute the vaccine was properly stored. The vaccine underwent a temperature excursion of above 47 degrees Fahrenheit (52) for 10 hours. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported.
12/16/09 ROTARIX #1-developed belly pain and vomiting. 1/20/10 ROTARIX #2-on 1/23/10 intussusception.
Information has been received from a female consumer concerning "someone she knows" who on an unspecified date was vaccinated with GARDASIL (lot no. not reported). It was reported that the patient had experienced fever as well as other unspecified side effects after receiving GARDASIL. It was also reported that the patient was currently hospitalized. At the time of the report the patient's outcome was not specified. No further information is available.
Fainted within 5 minutes of vaccine injection.  Low grade fever and headache for 24 hours following.
Transient numbness and tingling of left cheek lasting 7 minutes. No allergic signs or symptoms.
Extreme headache; Chills; Fever; Body aches; Nauseous; This is a spontaneous report from a contactable other healthcare professional, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ew0167) via an unspecified route of administration in the left arm on 14May2021 at 15:45 as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and sulfonamide allergy. Concomitant medication was not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8731) via an unspecified route of administration in the left arm on 16Apr2021 at 16:30 (at the age of 27-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 vaccines within four weeks prior to the vaccination. On 15May2021 at 12:00, the patient experienced extreme headache, chills, fever, body aches and nauseous. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events extreme headache, chills, fever, body aches and nauseous were recovered with sequelae.  No follow-up attempts are needed. No further information is expected.
I was walking home from the gym on Wednesday, November 10 and felt a burning sensation on my bicep. Looked down and saw a lot of tiny spider veins on my bicep.  As the days progressed I noticed that the spider veins seem to be getting thicker.  By Saturday, November 13 noticed that my arm was beginning to swell.  By Tuesday, November 16 my arm was so swollen I was in pain.  I elevated it and iced it all night.  It was still swollen Wednesday morning so I went to the ER.  The ER did an ultra sound from my neck down my arm and found that I had DVT in three of the major veins going to my arm.   I was given Eliquis to take for 3-6 months.
Patient received the seasonal flu (Influenza) vaccine. The manufacturer and the type of vaccine is unavailable on the patient portal. He developed pityriasis rosea which he had never had before during his childhood. We noticed the rash a few days after receiving the vaccine and mistook it for eczema. He was seen by a dermatologist a few weeks after as the rash was getting worse. The dermatologist diagnosed him with pityriasis rosea.
This spontaneous report as received from a nurse refers to  a patient of unknown age and gender. On an unknown date the patient was vaccinated with RECOMBIVAX HB, 0.5 ml, intramuscular for an unknown indication. Past medical history and concomitant medications were not provided. On 29-OCT-2013 the patient was administered an expired dose of RECOMBIVAX, Lot # 0571AA. No adverse event was reported. The outcome of administered an expired dose of RECOMBIVAX is unknown. The reporter considered administered an expired dose of RECOMBIVAX to be not related to RECOMBIVAX HB. No further information was provided. Additional information has been requested.
Mouth was dry right after injection, but water seems to help. Small white spots developed inside my mouth along my cheeks and lips a couple of hours later. The spots do not itch or bother me too much but they feel like I chewed on my lip. More of an annoyance than anything. I did not go to a hospital or have to take anything else. I do not know if the white spots are actually from the injection or if it was caused by a medication I am taking. But since it was a weird occurrence I thought I would report it
Noticed a odd shaped rash, not round, at the injection site and the area surrounding.  Pain from injection site up to shoulder.  Felt more bruised, but by sight was more of a red rash than a bruise.  Also noticed a lump on her left side of neck about an hour following her flu injection.  Had the same lump last year following the flu vaccination for about a week after the injection.  Today the injection site looks normal without any swelling and minimal redness.
1st vaccination  and two days later hives on right forearm and back   2nd vaccination and two days later hives on site of vaccination, stomach, shoulder, leg and arms
Patient said her lips started tingling 5 minutes after the vaccine.  I gave the patient 25mg of diphenhydramine solution orally.  She states she can take oral diphenhydramine.  The patient stated she felt fine 15 minutes later and left the pharmacy.
Initial report received on 15 September 2008 from a healthcare professional.  A 5 year old male patient, with no medical history, no illness at the time of vaccination, and no previous reactions to vaccines, received on 22 AUGUST 2008 a fifth left deltoid intramuscular injection of DAPTACEL (lot number C2950AA) and a second right arm injection of MMR (Merck, lot number 00182U).  Twenty-four hours after vaccination, the patient had swelling of the left arm with a rash and red itchy bumps (as reported by the patient's mother on 28 August 2008).  BENADRYL and ice had been recommended.  On 29 August 2008, the patient was seen by a doctor and had a large area of induration, and "c/o redness and itchiness 2 cm area, palpable hive like lesions".  There was no shortness of breath and no fever.  The patient's recovery status was reported as unknown.  Follow-up information was received from the healthcare professional on 13 October 2008, and confirmed that the patient had recovered fully.  No diagnostic testing was performed.
About 2 hours after injection a very sharp pain between shoulder blades lasting about 4 minutes, felt like I was having a heart attack. About 5 hours after injection began feeling nausea, and 10 hours later had a 37.7C fever that lasted about 16 hours.
Swelling, deep muscle ache/spasm at injection site. Tylenol taken and ice pack at site
Patient vaccinated and Covid + on 10/06/2021. Patient hospitalized Per ED Note: The patient is a 59-year-old male past medical history significant for insulin-dependent diabetes, HTN, HLD, COPD who is presenting to the emergency department with chief complaint of elevated blood pressure.  Patient is non-English speaking and interpreter was offered through the Martti system however patient's brother is at bedside and patient would prefer his brother to translate.  Went to his primary care physician because he was having subjective fevers and chills patient states that he was sent in by his primary care physician after being seen in clinic for elevated blood pressure.  Patient states that he and a productive cough for approximately 24 hours prior to arrival in the emergency department.  Patient states that he got a dose of his metoprolol at the clinic which she had not taken earlier in the day.  Patient states that he is overall feeling feverish and "weak."  Patient did receive his Covid vaccinations approximately 3 months prior to arrival in the emergency department.  Patient denies any sick contacts.  Patient denies any other acute complaints at this time. Patient denies any chest pain, abdominal pain, vomiting,  focal paresthesias, headache, blurred vision, decrease in urine output, dizziness, change in bowel or bladder habits, leg pain or edema or history of blood clots, or changes in medications. He denies any other modifying precipitating or relieving factors.
Treatment of COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Treatment of COVID-19) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 030A21A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Contrast media allergy (Contrast dyes) and Drug allergy (Novacaine).   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced COVID-19 (Treatment of COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 16-May-2022 to 20-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. In May 2022, COVID-19 (Treatment of COVID-19) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  It was reported that the patient had rebound Covid Infection after paxlovid on 25-May-2022 with outcome recovering/resolving.  Company comment: This is a spontaneous case concerning a 67-year-old, female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 which occurred 6 months after the third dose of mRNA-1273 vaccine. The patient was treated with Nirmatrelvir, Ritonavir. Outcome of the event COVID-19 was resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 67-year-old, female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 which occurred 6 months after the third dose of mRNA-1273 vaccine. The patient was treated with Nirmatrelvir, Ritonavir. Outcome of the event COVID-19 was resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) 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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration. No concomitant medication reported. No treatment medication reported. This case pertains to the 41th patient of the total 190 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Severe chest, back pain starting 1 1/2 hrs after injection, culminating in mild heart attack early Wednesday a.m.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 10-JAN-2017, the patient was vaccinated with an improperly stored dose of PROQUAD, lot number L040415, expiration date 13-APR-2017 (dose, route and anatomical location were not reported) for prophylaxis (incorrect product storage). The vaccine was exposed to temperature of -5 Fahrenheit (F) (-20 Celsius(C)) and to the lowest recorded temperature of -14 F (-25C) during 4 hours and 5 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA012890: US-009507513-1701USA013083: US-009507513-1701USA013084: US-009507513-1701USA013085: US-009507513-1701USA013086: US-009507513-1701USA013088: US-009507513-1701USA013089: US-009507513-1701USA013090: US-009507513-1701USA013091: US-009507513-1701USA013092: US-009507513-1701USA013093: US-009507513-1701USA013094: US-009507513-1701USA013095: US-009507513-1701USA013096: US-009507513-1701USA013097: US-009507513-1701USA013098: US-009507513-1701USA013099: US-009507513-1701USA013100: US-009507513-1701USA013101: US-009507513-1701USA013102: US-009507513-1701USA013103: US-009507513-1701USA013104: US-009507513-1701USA013105: US-009507513-1701USA013106: US-009507513-1701USA013107: US-009507513-1701USA013108: US-009507513-1701USA013109: US-009507513-1701USA013110: US-009507513-1701USA013082:
Woke up on Monday Dec 13th 2021 with a headache around left temple head area, took Ibuprofen and it faded for that day. Woke up on Tuesday Dec 14th 2021 with a headache across front of forehead area, took Ibuprofen and it faded for that day. During Wednesday Dec 15th 2021 headache moved to back of head and felt 'inside' of head and increased in intensity. There were no other symptoms. From Wednesday Dec 15th 2021 to Monday Dec 27th 2021 the headache remained around that position and varied in intensity from a base pain level of 1-2 up to worst cases around 7-8. At times during the day the headache would suddenly increase in intensity up to a pain level of about 7. Pain was reduced with regular Tylenol, around 650mg 2-3 times a day reducing over the last 5 days of the symptom remaining. During times of increased pain levels, I was unable to do my normal daily activities. On Tuesday Dec 21st, I visited a walk-in clinic about the condition, the resulted suggested diagnosis was a "stress headache" due to there being no other symptoms than the headache in that location. Two Covid tests during the time of the symptoms were taken and both returned negative results.