chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant referring to a 75 year old male patient. His concurrent conditions included allergy to "IV contrast Dye" (with rash) and also rituximab allergy (manifested as itching). The patient had none known medical history. His concomitant therapies included aspirin (manufacturer unknown), ZETIA, PEPCID, vitamins (unspecified), ZOFRAN, ROXICODONE, COMPAZINE, VIAGRA and FLOMAX. On 24-JAN-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (intramuscularly, lot # M036728 exp 20-MAY-2018) (dose not provided) for prevention of pneumococcal disease. 12 hours after vaccination still on 24-JAN-2017, the patient experienced unspecified symptoms of allergic urticaria. On 26-JAN-2017, he sought medical treatment at the emergency department and was administered with BENADRYL, KENALOG cream. No lab diagnostic studies were performed. At the time of the report, the outcome of the allergic urticarial was recovering as the patient's symptoms were 99% resolved in an unspecified was by 28-JAN-2017. The medical assistant was requesting a lot check. The causal relationship between PNEUMOVAX 23 and the allergic urticarial was unknown. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA000374: US-009507513-1702USA002230: US-009507513-1702USA002231.
Information has been received from a health professional concerning a 41 yr old female with no known drug allergies who was vaccinated with a first and second dose of varicella virus vaccine live on 17Sep04 (lot645167/0442N) and 02Nov04 (lot648322/0117P), respectively. On 15Jul05 a titer was drawn and the pt had failed to seroconvert. It was reported that the pt had an outstanding medical history, other diagnosis, but the nurse did not state what they were. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Moderna was administered to a 17 year old. EUA does not support this. Mother, was called today and informed of this administration error. Patient has not had any side effects since vaccine was administered at 1800 yesterday. She says it is OK that he got it. I explained that the CDC says the 2nd dose can be given "off label". I asked her to reach out to the patient's PCP if concerns about getting 2nd dose. She is not concerned and wants to keep his scheduled 2nd dose on 5/12/21. If she decides differently she will contact us.
dizziness; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and HEADACHE (headache) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness) and HEADACHE (headache). At the time of the report, DIZZINESS (dizziness) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Day after vaccine, pt had fatigue and ?brain fog? which he attributed to normal vaccine side effect. Over the next several days, he did not improve. Reports that people kept asking what was wrong with him as he was having memory issues and word finding difficulty. His symptoms persisted through 6/9, when first eval for sympotms in my office
starting nearly exactly 48 hours after vaccination: - fever: 99.5 - 101 (~48 hours) - chills (~48 hours)  - night sweats (~96 hours)  - fatigue (~ 7 days) - muscle aches (~7 days)  - headache (~7 days)  - bloodshot & swollen eyes & blurred vision (started 5 days after vaccine, got Rx for bacterial eye infection 9 days after vaccine)
DOSAGE ERROR: CHILD WAS VACCINATED WITH .5 ML SEASONAL 2009-2010 FLU VACCINE.
Lot of body pain; Fever; Very bad headche; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Lot of body pain), PYREXIA (Fever) and HEADACHE (Very bad headche) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced PYREXIA (Fever) and HEADACHE (Very bad headche). On 04-May-2021, the patient experienced PAIN (Lot of body pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Lot of body pain), PYREXIA (Fever) and HEADACHE (Very bad headche) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication provided by the reporter.  .
Pt developed a painful lump on the right Supraclavicular notch 3 days post vaccine booster
This spontaneous report was received from a licensed practical nurse and refers to a 6 month infant (gender not reported). There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 21-SEP-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1705USA004973: US-009507513-1608USA012794: US-009507513-1705USA004967: US-009507513-1705USA004965: US-009507513-1705USA004962: US-009507513-1705USA004960: US-009507513-1705USA004952: US-009507513-1705USA004964: US-009507513-1705USA004961: US-009507513-1705USA004963.
feverish/fever; Joint pain; back and shoulder muscle pain/muscle ache; feeling fatigue; arm was hurting at the injection site; sore arm; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration, on 09Feb2021 (at the age of 74-year-old), as dose 1, single in right arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received pneumonia shot and she did not get a rash or anything like when getting pneumonia shot, but her arm was red. On 09Feb2021, after the first dose of vaccine, the patient's arm was hurting at the injection site and sore arm for 1 day. Patient thought this was normal, every time she gets something, she gets the same reaction. On 10Feb2021, 1 day after the first dose of vaccine, the patient was feeling fatigued while doing laundry, with back and shoulder muscle pain/muscle ache, the side where she got the shot had irritated her in the back. On 11Feb2021, 2 days after the first dose of vaccine, the patient woke up with fever at 03:00 AM or 04:00 AM and joint pain. Patient enquired if this was normal. The clinical outcome of the event sore arm was resolved on 10Feb2021; events fever and feeling fatigue was resolved on an unspecified date in 2021; and clinical outcome of all other events was unknown.  Follow-up attempts are completed. No further information is expected.
Next morning had low grade fever, Pain at injection site and body aches.  Took Tylenol every 4 hours, gone the next day.
Pt had one grand-mal sz-afebrile- 5hrs after receiving vax. Pt has a known sz disorder & is on Tegretol. Also had arthralgias in arms. No specific treatment given. 1 mo f/u  still c/o arthralgia.
This spontaneous report was received from a medical assistant via physician and refers to a 21 year old female patient. The patient's pertinent medical history, concurrent conditions, past drugs and drug allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 (lot # M009116) for prophylaxis (number of previous doses was 1). This is one of the several reports received from the same reporter (1703USA010036, 1704USA010412 and 1704USA010413). Additional information has been requested. Sender's Comments: US-009507513-1704USA010413: US-009507513-1703USA010036: US-009507513-1704USA010412.
The patient experienced itching after the first dose of the COVID-19 vaccine.; This is a spontaneous report from a contactable pharmacist. A 26-year-old female patient (not pregnant) received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0140), intramuscularly on 20Dec2020 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced itching after the first dose of the covid-19 vaccine in Dec2020 with outcome of unknown.
Narrative:  PATIENT WAS IMMUNIZED IN A TIMELY MANNER 1-23-21 AND 2-13-21 RESPECTIVELY WITH PFIZER MRNA VACCINE. PATIENT WAS PRESENTED TO ED APPROX 15 DAYS POST SYMPTOM ONSET WITH HYPOXIA (77% RA) AND WEAKNESS. PATIENT WAS PROVIDED SUPPLUMENTAL O2 UP TO 5L NC FOR A FEW DAYS. HE WAS TREATED, RECOVERED, AND WAS DISCHARGED HOME
The ringing was worse after the second vaccine; The ringing was worse after the second vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Mar2021 10:00 (Lot number: EP6955) at the age of 74 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "small hearing loss in her left ear" (unspecified if ongoing), notes: Caller states she has a small hearing loss in her left ear, but that is from age. Family history included: "ringing in her ears" (unspecified if ongoing), notes: her sister has ringing in her ears, after getting the Pfizer Covid 19 vaccine. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1, Time the Vaccination Was Given: afternoon, Anatomical location: Left arm, Lot number: EN6202), administration date: 25Feb2021, when the patient was 74 years old, for COVID-19 immunization, reaction(s): "ringing in her ears". The following information was reported: CONDITION AGGRAVATED (non-serious), TINNITUS (non-serious), outcome "not recovered" and all described as "The ringing was worse after the second vaccine". The event "the ringing was worse after the second vaccine" and "the ringing was worse after the second vaccine" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller answers as it was getting a little better, and then on last Thursday, the ringing came back like it was when it started, and never went away. Caller states she went to the doctor and was told that it was alright to get the second vaccine. Caller reports that the ringing was worse after the second vaccine, but started getting better until last Thursday, and then it worsened, similar to when the ringing first started. Caller states she was given a test and it was reported as normal. Caller states she has a small hearing loss in her left ear, but that is from age. Prior Vaccinations within 4 weeks/within four weeks prior to the first administration date of the suspect vaccines: No  No follow-up attempts are possible. No further information is expected.
Body aches; Chickenpox; Fever; Information has been downloaded from Agency (US-CHIRONMA-PHHY2016US032372).  This spontaneous report was received from a healthcare professional concerning a 58 year old male patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.       On 18-DEC-2015, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), 1 dosage form, for immunization (route of administration and lot number were reported as unknown, strength and expiration date were not provided); with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 1 dosage form, for immunization (route of administration and lot number were reported as unknown; strength and expiration date were not provided; with influenza virus vaccine (unspecified) 1 dosage form, for immunization (route of administration and lot number were reported as unknown, strength and expiration date were not provided); and with diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid 1 dosage form, for immunization (route of administration and lot number were reported as unknown, strength and expiration date were not provided).  On 31-DEC-2015, the patient experienced pain, pyrexia and varicella. The outcome of the aforementioned events was reported as not recovered.   The causality assessment between the suspect drugs and the events occurrence was reported as related.   The healthcare professional reported the events pain, pyrexia and varicella as medically significant.; Sender's Comments:  617319:
Developed cellulitis at injection site 2.5 days after immunization seen by MD in 2-18 started on Cephalexin 500mg.
Seizure face and lips blue, had + LOC, body shook, lasted only minutes.
burning itching and having welts over her body; burning itching and having welts over her body; This is a spontaneous report from a non-contactable other healthcare professional (technologist, patient).  A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date in Dec2020, the patient experienced burning itching and having welts over her body. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt received moderna vaccine #2 at 1:30pm. No s/s of adverse reactions. Ate dinner at 4pm. She was in her room at 430pm and she slid out of her chair and was laying on her Right side. She reported she slid out of her chair because she needed to go urinate per staff. She denied pain. At 630p complained of right hip pain. mobile xray was ordered. At 825pm resident was sleeping x 30 mins in her bed when she was found to have no pulse or respirations. She ceased to breathe. Mobile xray did not make it on time.
Body chills; Fever; Soreness; Felt out of sorts; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Body chills), PYREXIA (Fever), MYALGIA (Soreness) and IRRITABILITY (Felt out of sorts) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Body chills), PYREXIA (Fever), MYALGIA (Soreness) and IRRITABILITY (Felt out of sorts). At the time of the report, CHILLS (Body chills), PYREXIA (Fever), MYALGIA (Soreness) and IRRITABILITY (Felt out of sorts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications reported. no treatment details reported.
Information regarding PREVNAR was received from a healthcare professional regarding a 5 month old patient who experienced facial rash and hives. At 5 months of age, the patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for PREVNAR was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. On an unspecified date in 2010, the patient experienced facial rash and hives. Treatment was not reported. On 11 Jun 2010, the patient recovered from the events. No additional information was available at the time of this report.
Soreness in feet, ankles and calves starting on March 24th, then soreness started progressing up the body with numbness and tingling within my trunk, skull, arms, hands, legs and feet. Lightning Strikes throughout my whole body
Pt experienced heavy post vaccination bleeding. Pharmacist applied compression and pt stated that he was feeling like he might faint. Pt then layed his head on the table. He blacked out for several seconds at that point. When pt regained consciousness, he was given water and a cool towel. Pt remained in clinic area for 10-15 minutes post vaccination. Pt stated he felt better and remained in pharmacy area for an additional 15 minutes.  Pt was called an hour post vaccine to follow up and he stated he felt normal.
Palpitations & HYPERtension Narrative:  Patient reported that he was walking up the stairs and noted he felt his heart racing and had noted it several times since the vaccine on 01/08/2021. He went to his PCM and the ER. Received and EKG and was released.
arm swollen; arm a little red; arm with a bump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (arm swollen), VACCINATION SITE ERYTHEMA (arm a little red) and VACCINATION SITE INDURATION (arm with a bump) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included CALCIUM and VITAMINS NOS for an unknown indication.    On 29-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 VACCINATION SITE SWELLING (arm swollen), VACCINATION SITE ERYTHEMA (arm a little red) and VACCINATION SITE INDURATION (arm with a bump). At the time of the report, VACCINATION SITE SWELLING (arm swollen), VACCINATION SITE ERYTHEMA (arm a little red) and VACCINATION SITE INDURATION (arm with a bump) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow up received and Contact information was updated.
Patient had redness and swelling at area where vaccine was given.  Patient complained of arm feeling hot in same area.  Patient was given medication for swelling.
no other AE; vaccines were administered following a temperature excursion.; This spontaneous report has been received from a vaccine coordinator, concerning a 2-month-old patient of unknown gender.  Information regarding the patient's medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies was not provided.  On 27-SEP-2022, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot number W004501 has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent (ROTATEQ), expiration date reported and confirmed as 20-APR-2023) (exact dose was not provided) administered orally as prophylaxis. The vaccine administered had been suffered a temperature excursion of 8.6 Celsius (C) degrees for a time frame of 18 minutes and had also suffered the following previous temperature excursions: 11.5C for 1 hour 6 minutes; 8.8C for 21 minutes; and 9.6C for 6 hours 41 minutes (Product storage error).   No other information was available. No other adverse event (AE) or product quality complaint (PQC) were reported.  This is one of nine reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA010935: US-009507513-2209USA010921: US-009507513-2209USA010910: US-009507513-2209USA010908: US-009507513-2209USA010884: US-009507513-2209USA010833: US-009507513-2209USA010983: US-009507513-2209USA010940:
04-05-21. Client reported had first vaccine on 02-17-21 with only sore arm at injection site/Left deltoid.  Had 2nd vaccine on 03-17-21 and the 2nd day had feeling in top of head/scalp feeling full, tight, and swollen with a "flu-like" taste in mouth.  Reported this went away, but then on 04-02-21 she experienced Bell's Palsy on the left side of face and top of her head felt full, tight, and swollen again.  Client reported she went to her local physician and was dx with Bell's Palsy .  The  physician felt this was related to the COVID injection.  Physician prescribed prednisone and meloxicam for inflamation, to get rest, and do gentle massage to face.  Client reports her left eye burns, is using eye drops, wearing sunglasses and a patch over her left eye.  Physician reported this may resolve in 1 to 5 weeks.
They administered the second dose at that point of second. I got very ill. I ended up in emergency room; They seemed to think in the emergency room that I was administered the double dose; They administered the first dose. It was pharmacy and then I was told that dose was empty, that syringe was empty; They administered the first dose. It was pharmacy and then I was told that dose was empty, that syringe was empty; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0191), via an unspecified route of administration on 04Aug2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications was not reported. It was reported that patient received first dose of vaccine on Wednesday, 04Aug2021. Patient stated they administered the first dose, It was pharmacy and then patient was told that dose was empty, that syringe was empty, and they administered the second dose at that point of second. patient got very ill and ended up in emergency room and not sure, they seemed to think in the emergency room that patient was administered the double dose. Patient need to know that if patient going to require the actual second dose. Patient was hospitalized due to got very ill and ended up in emergency room. Outcome of the events was Unknown.