chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received form a consumer concerning her 13 year old daughter. Approximately on an unknown date in October 2011 (reported as October or November 2011), the patient was vaccinated with the first dose of 0.5 milliliter (ml) (reported as standard dose) of GARDASIL (lot number and expiry date unspecified), intramuscularly. Approximately on an unknown date in January 2012, the patient was vaccinated with the second dose of 0.5 ml (reported as standard dose) of GARDASIL (lot number and expiry date unspecified), intramuscularly. The patient did not receive her third dose of GARDASIL. No concomitant medications were reported. This is one of the two reports from the same source. Additional information has been requested.
"I lost over 25 pounds by this time"; Muscle pain on both shoulders; Decreased appetite / not feeling hungry/ eating only few bites; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Decreased appetite / not feeling hungry/ eating only few bites), WEIGHT DECREASED ("I lost over 25 pounds by this time") and MYALGIA (Muscle pain on both shoulders) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced DECREASED APPETITE (Decreased appetite / not feeling hungry/ eating only few bites) and MYALGIA (Muscle pain on both shoulders). On 19-May-2021, the patient experienced WEIGHT DECREASED ("I lost over 25 pounds by this time"). At the time of the report, DECREASED APPETITE (Decreased appetite / not feeling hungry/ eating only few bites) had not resolved and WEIGHT DECREASED ("I lost over 25 pounds by this time") and MYALGIA (Muscle pain on both shoulders) had resolved.            No concomitant medications were provided. No treatment medications were taken by the patient. Action taken with mRNA-1273 in response to the events was not applicable.  The patient stated that she was not enjoying what she was eating, and quoted " I am picky now what I eat".   This case was linked to MOD-2021-147680 (Patient Link).
double dose of polio was administered to the child; Initial information received on 29-Apr-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a nine-months old male patient who received double dose of polio while received vaccine IPV (VERO) [Ipol] and Pediarix (HepB, Polio and DTAP).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included pneumococcal vaccine conj 13v (CRM197) (Prevnar 13) for Immunisation.  On 29-Apr-2019, the patient received a 0.5 ml  dose of suspect IPV (VERO) lot P1A37, expiry date: 29-Apr-2019 via intramuscular route in left vastus lateralis.  It was as an actual medication error case due extra dose administered. There a concern that a double dose of Polio was administered to the child (Ipol & Pediarix).  It was not reported whether the patient had any adverse event or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Soreness in right arm/body ache; Headache; Tired/Just feeling drained; Dizziness; Received 2nd dose past the 42 day mark; soreness in right arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose past the 42 day mark), MYALGIA (Soreness in right arm/body ache), HEADACHE (Headache) and FATIGUE (Tired/Just feeling drained) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE, LISINOPRIL, TRAZODONE and FENOFIBRATE for an unknown indication.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose past the 42 day mark) and MYALGIA (soreness in right arm). On 18-Jul-2021, the patient experienced DIZZINESS (Dizziness), MYALGIA (Soreness in right arm/body ache), HEADACHE (Headache) and FATIGUE (Tired/Just feeling drained). On 18-Jul-2021, DIZZINESS (Dizziness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose past the 42 day mark) had resolved. At the time of the report, MYALGIA (Soreness in right arm/body ache), HEADACHE (Headache), FATIGUE (Tired/Just feeling drained) and MYALGIA (soreness in right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information were reported.   This case was linked to MOD-2021-260575
patient's description: "hives" "   The rash started about 45 minutes after I took the  vaccine. It started on my legs and arms and neck. I went home and took some  benadryl and it eased at least the itching. I had to take the benadryl for 2  days until it finally went away. The rash and hives stayed there but went to my  stomach area as well. I didn't have to seek urgent care. "
After 10 minutes RN walked over to recovery area and noticed that pt's face was red. She asked pt if she was ok and pt stated yes. RN never left pt side and then noticed her neck getting red and pt c/o ringing in ear. Pt was refusing to stay until she became diaphoretic and the she handed RN EPI pen to administered. RN sat patient down and administered epi to Right thigh. EMS was called patient taken to ED
Called PCP, from the note: I got my shot on Jan 19. But last Friday I have been down with a horrible flu. I'm wearing diapers because of uncontrollable diarrhea. I can't leave my sofa to walk over to my desk because I'll be so out of breath. I have a cough that produces a pink or gold Phelm I have dry mouth. I have no appetite I'm so weak and have lost 15 pounds. Don't know what to do. My next Covid is shot is feb 11 Called employer on 2/3/21 but hung up. Tried calling multiple times to follow up. In triage she stated she had a COVID test scheduled and had spoken with her PCP. COVID test through PCP: 2/4/21 She passed away the night of 2/4/21
Entire body weakness and muscle pain Sore throat Headache/dizziness Swelling  of the left arm Concentrated rashes on left arm near injection site and the area was swollen over a week with pain on the area where rashes appeared; underneath the arm there is a dotted dark color looking like a bruise and painful.
Approx 25 mins p/inject PC that pt c/o itching & breaking out; had taken benedryl, but no relief; advised to take pt to ER immediately; hives noted on back; face feeling "funny & puffy"; felt hands swelling;
Feeling dizzy, hot, vision blurred and then eyes rolled back and dropped to ground. Eyes opened less than a minute later but wasn?t aware for another 2 minutes. Laid down for another 5mins. Then sat up slowly. Got to walk to room and another dropping to the ground. Again not fully aware for 2minutes after the drop. Sat her up and put cool rag in her head and gave Tylenol for the heat she felt. After 15minutes she was able to get up and walk around.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6205), in left arm, on 18Mar2021 as dose 2, single (Lot number: ER2613), in left arm, on 23Sep2021 as dose 3 (booster), single (Lot number: FF2588), in left arm and on 31Mar2022 at 14:00 as dose 4 (booster), single (Lot number: FK9729) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Known allergies: cipro, reaction(s): "Known allergies: Cipro". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti-viral details for COVID 19 treatment started from 12Jun2022 to 15Jun2022. There was no other medications in two weeks
Information has been received from a medical assistant concerning a 72-year-old male who on 21-FEB-2007 was vaccinated with a single dose of Zostavax. On 07-MAR-2007 the patient was seen by a physician and he showed him dried and red crusted blisters on his stomach and back. He denied pain or itching. It was reported that the patient was seen for office visits on 15-MAR-2007 and 27-MAR-2007 and the patient did not mention the blisters again. No outcome was reported. No product complain was involved. Additional information has been requested.
1/27/2021 vaccination  Flushed, heat head to toe. Increasing in size. I went to the back. 15 minute mark; anxiety. Pulse in 130's. BP was 159/80.  I left the facility about 90 minutes later. BP was back to normal. No more heat.  1/28/2021 Extreme body aches, chills, HA all day; 'Felt like I had been run over'.  By 6pm I started shivering; temp went to 102 for 6 hours straight. Took Tylenol. Low grade fever for another 6 hours.  1/29 symptoms persisted but 'tolerable' and my temp was back to normal.
Approximately 2-3 weeks after the second dose I started having severe itching and welts all over my body occurring every two days till this day. This started after I had minor surgery  on my left wrist.
Skin rash; This is a spontaneous report from a contactable consumer. A non-pregnant adult female patient (patient's occupation was reported as nurse) of 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. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date, the patient experienced skin rash. The reporter had described a skin rash which was followed up with the dermatologist and questioned about the possible relation to the vaccination. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, it was unknown whether the patient was tested for COVID-19. The clinical outcome of the event skin rash was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pharmacist calling to request dosing guidance on a 46 year old male patient who received his first dose of GARDASIL 9 10/2022, second dose 3/2023. He has since turned 46 years old and is looking to receive his last dose of GARDASIL 9. No PQC. No addi; Information has been received from a pharmacist, referring to a 46 years-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in October 2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On an unspecified date in March 2023, he received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).   The reporting pharmacist stated that the patient has since turned 46 years old and was looking to receive his last dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) .
hypertension like 190/90; I had tachycardia to 165; Flushing; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EK9231, intramuscular on 06Jan2021 at single dose for COVID-19 immunization. Medical history included migraine. Concomitant medication included cyproheptadine for migraine, unspecified multivitamins; and diphenhydramine (BENADRYL) and famotidine as pre-medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Dec2020 for COVID-19 immunization, and experienced dizziness, palpitations, tingling in face and legs, myalgia, nausea, headache, fatigue. It was reported that patient got the second dose and had tachycardia to 165 and hypertension like 190/90 and had some flushing (event onset: 06Jan2021). Patient was no longer tachycardiac or hypertensive; lasted for about 30-40 minutes. Outcome of the events tachycardia and hypertension was recovered on 06Jan2021. Outcome of the event flushing was unknown.
Bullseye itchy  raised  rash around injection site of the LT arm. (Shingrix Vaccine) The raised rash then exceeded 3cm out  towards the inner part of the arm.
No additional adverse event reported.; Nurse calling to report an adverse event on improperly stored administered PROQUAD; This spontaneous report was received from a registered nurse, referring to a 4-year-old patient of unknown gender. The patient's pertinent medical history, current conditions, previous drugs reactions or allergies and concomitant medications were not reported.   On 24-FEB-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), administered at a dose of 0.5 milliliter (ml), as prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not provided; lot number T023919, which has been verified to be valid, expiration date reported and validated as 09-JAN-2022). The vaccine administered, experienced a temperature excursion of -5.2 degrees Celsius (C), for a time frame of 15 minutes as recorded by a data logger (product storage error). There was no previous temperature excursion reported. No additional adverse events were reported.
patients mother forgot vaccine card, lied about stating he was due for second shot and when brought vaccine card up it was found to be given at day 15. Site was not pulling up and loading at time of administration
runny nose; Chills; This is a spontaneous report from a contactable male consumer via Pfizer-sponsored program Pfizer First Connect. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on 07Feb2021 (on Sunday) as dose 1, single for COVID-19 immunisation. Patients medical history and concomitant medications were not reported. On 09Feb2021, (this morning) patient experienced runny nose and chills. The outcome of the events was unknown.   Follow-up (07MAY2021): Follow-up attempts completed. No further information expected.
Pt was given Varicella vaccination on 2/20/07 and had generalized itching and skin breaking out dime size welts on left forearm, chest, trunk on 3/9/07.
only first dose received; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (only first dose received) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (only first dose received). At the time of the report, PRODUCT DOSE OMISSION ISSUE (only first dose received) had resolved. 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.   No concomitant medications were reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Non-Significant information.
slipping nose; shaking in the body; eyes are watering; normal sore arm; congestion; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (slipping nose), TREMOR (shaking in the body), LACRIMATION INCREASED (eyes are watering), PAIN IN EXTREMITY (normal sore arm) and NASAL CONGESTION (congestion) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (slipping nose), TREMOR (shaking in the body), LACRIMATION INCREASED (eyes are watering), PAIN IN EXTREMITY (normal sore arm) and NASAL CONGESTION (congestion). At the time of the report, RHINORRHOEA (slipping nose), TREMOR (shaking in the body), LACRIMATION INCREASED (eyes are watering), PAIN IN EXTREMITY (normal sore arm) and NASAL CONGESTION (congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
doses administered after excursion; No adverse event; Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 56-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, 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 14-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    Concomitant medications details were not reported by the reporter.  The pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. The excursion was found out in an audit and all the vaccines were viable.  Treatment details were not reported by the reporter.
Chills Fatigue Nausea  Pounding headache  Extreme arm pain Crying
The patient received his first dose into his left arm in the consultation room.  He was asked to wait in our reserved seating for COVID-19  Vaccine Appointment chairs for 20 minutes.  Very quickly (under 5 minutes, I feel)  thereafter my delivery driver vocally alerted me the patient was falling from the chair.  The patient landed on  our concrete floor,  face up, his legs were interwined with the stanchion sign.  I immediately woke the patient by speaking to him directly in his face (through our masks and my shield) .  I asked if he was ok, and if I could elevate his head with some slippers, he allowed it, says he felt bad, had called his dad on his phone. I moved the sign away from his legs.   I had my staff call 911 and bring a blood pressure cuff.  Before I got the cuff on a police officer arrived and took over the medical response and right after the EMTs arrived, about 13 total.  The patient said his head hurt but he seemed cognitive of the entire situation.  He left with the EMTs on a stretcher but he was able to get off the floor and onto the stretcher with very light assistance.
The two injections were given in the left arm. Due to either one of the shots being too high, it missed the muscle and caused severe pain similar to a soft-tissue shoulder injury. This was not injection site pain, this was shoulder pain. It caused me to discontinue my workout routine for my upper body. I started doing shoulder PT exercises daily. Finally, as of this past week (May) the pain is about 90% gone. This was a chronic pain which turned acute during certain movements like reaching forward, reaching backward and putting my arm up over my head.
Subsequent to receiving vax pt developed a large lump at the injection site. Additional information indicated that the pt had a very large injection site reaction characterized by redness, swelling and warmth with her previous tetanus and diphtheria toxoid vaccine.