chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was not viable due to refrigerator temperature had been below freezing for an extended period of time. Verified with manufacturer the vaccine was not viable.
10/16/21.  a 16 years old child and her mother were in the store for the second dose of Pfizer covid-19 vaccine. the 16 year old got her vaccine first, then the mother. (same vial).     the 16 years old then complained she is feeling nauseous and wants to throw up. I pulled the trash can to my right close to her. she tried but could not throw up. she then starting panting for air, her eyes were rolling backwards and she was sweating heavy and her hands and body were cold.     I called for help (911). The ambulance team came and she was taken to Hospital. I followed up with the mum about 2 hours later, she told me she is about to be discharged home. The mother also said while at the hospital, they started some kind of an IV infusion on her left hand and she had very similar reaction that she had while at the pharmacy.
Developed large softball size knot at shot site. Painful and hot for 7 days.
All over itching - onset 5/2/17 in the evening. Redness on cheeks - left cheek mainly. Left thumb to elbow pain - "feel like fracture" - patient was wearing sling. Reported by patient on 5/5/17 to pharmacy.
pt recv vax 13AUG97 then pt not feeling well;pt fainted;pt in semi-conscious mentality brought into clinic VS taken;
Your Covid 19 vaccine (described as flu shot) killed my friend (patient); This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (003110).  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "Your Covid 19 vaccine (described as flu shot) killed my friend (patient) ". The patient date of death was unknown. It was not reported if an autopsy was performed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Your Covid 19 vaccine (described as flu shot) killed my friend (patient)
started experiencing discomfort in her calvies and described it as a tightness; started experiencing discomfort in her calvies and described it as a tightness; feeling pain at the injection site; felt pain in her pelvic area and bones in her legs, discomfort in arm muscles.; felt pain in her pelvic area and bones in her legs, discomfort in arm muscles.; felt pain in her pelvic area and bones in her legs, discomfort in arm muscles.; felt pain in her pelvic area and bones in her legs, discomfort in arm muscles.; She has lingering pain in her knee caps, discomfort in joints; She has lingering pain in her knee caps, discomfort in joints; a slight headache; Arm pain; This is a spontaneous report from a contactable consumer. This female consumer (Patient reported for herself) that:  A 66-year-old female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Unknown) via an unspecified route of administration, on unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. On an unspecified date, the patient started to experience discomfort in her calvies and described it as a tightness. Four hour later the patient had feeling pain at the injection site. Patient woke up and felt pain in her pelvic area and bones in patient legs, discomfort in arm muscles. Patient had lingering pain in kneecaps and discomfort in joints. Patient stated that pain in her legs had gotten a tiny bit better. Patient also reported that she experienced a slight headache after receiving the vaccine. Patient called her doctor's office and spoke with the physicians assistant who told her that there was not a lot of information on the vaccine and also told that her she had 3 patients with severe side effects over 3 weeks later. The patient was concerned that she was having symptoms still 72 hours after the first dose when most people she spoke with do not even have a reaction after the first dose. Patient queried if this was "normal" or not. Patient filed a report. Patient raised concerned about whether or not to take second dose of the vaccine. Patient received the response that as noted in the fact sheet for recipients, patient should not get the Pfizer-BioNTech COVID-19 Vaccine if patient had a severe allergic reaction after a previous dose of the vaccine or if patient had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer patient to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Patient healthcare provider knows your health situation and has access to information that can better help inform this decision. The outcome for the reported of arm pain was recovered on an unspecified date and was unknown for other reported events.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Patient states that the evening after the injection, she developed some soreness and redness at the injection site. The next morning she woke up and had redness and swelling from her upper elbow down to her elbow. She went to her primary care's office the next day and was prescribed prednisone, which she picked up and began taking. After taking the prednisone, the swelling and redness resolved.
Donor states he began having diarrhea and flu-like symptoms (not feeling good, achy) later in the evening post injection. On waking the next morning, donor states his lymph nodes were swollen on left side of his neck, arm was sore from shoulder to wrist, painful to move fingers on left hand. Donor states he felt his pain level was over 10 (from pain scale of  0-10). Donor took 4 Ibuprofen pills and states his pain level decreased to 4/10 within an hour post self-medication. Contacted donor at 1330 and he states pain is now 2/10.
During injection, left deltoid muscle pain and spasm. No anaphylactic allergic response.  Within 1 hour of vaccine, tingling in hands and feet. Started with left then all four extremeties. Tingling lasted until March 3. Second dose scheduled for March 5.   Other symptoms that arose within 8 hours of vaccine and lasted approximately 3 days: Headache, Severe Nausea, Fatigue, Body aches, Chills (No Fever)
Breakthrough case admission after 2 vaccines MOderna 4/8/21 lot# 017B21A;  Moderna 5/6/21 lot# 040B21A
7cm x 8cm localized erythema and pruritic reaction starting approx 8 hours after vaccine administration. No respiratory complaint. Treated with Loratidine 10mg once a day and Diphenhydramine 25mg every pm until symptoms resolve.
Sore to touch; Itchiness; Red mark/Small oval patch of redness and Increased its size until reached elbow/Outer part of arm was red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE ERYTHEMA (Red mark/Small oval patch of redness and Increased its size until reached elbow/Outer part of arm was red) and VACCINATION SITE PAIN (Sore to touch) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since 1994, Hypertension since 1994, Hypercholesterolemia since 1994 and Glaucoma since 2004. Concomitant products included LEVOTHYROXINE, TIMOLOL MALEATE, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ), ROSUVASTATIN CALCIUM (ROSUVASTIN), ROSUVASTATIN CALCIUM (CRESTOR), VITAMIN B12 NOS, CARTILAGE, HYALURONIC ACID (MOVE FREE ULTRA), VITAMIN D NOS, LACTOBACILLUS BREVIS, LACTOBACILLUS BUCHNERI (FLORA BALANCE), LINUM USITATISSIMUM SEED OIL (FLAX SEED OIL) and UBIDECARENONE (CO Q10) for an unknown indication.    On 10-Feb-2021 at 5:25 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness) and VACCINATION SITE ERYTHEMA (Red mark/Small oval patch of redness and Increased its size until reached elbow/Outer part of arm was red). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore to touch). At the time of the report, VACCINATION SITE PRURITUS (Itchiness) and VACCINATION SITE PAIN (Sore to touch) outcome was unknown and VACCINATION SITE ERYTHEMA (Red mark/Small oval patch of redness and Increased its size until reached elbow/Outer part of arm was red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood pressure pill, Advil as needed, Citracal as 1 tablet thrice a week, Vitamin C 100 milligram 1 tablet daily, Centrum silver 1 tablet once daily, Omega 3 1200milligram  gel once per day.  Treatment medication were not provided.    Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up received on 06-JUL-2021 contains no significant information On 16-Jul-2021: Added patients demographics, added patients medical history, added first and second dose details, added concomitant medication, updated event outcome
Tested positive for COVID in between the doses for the vaccines; Tested positive for COVID in between the doses for the vaccines; This is a spontaneous report from a Pfizer sponsored program. A contactable registered nurse (not the patient) reported a patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; COVID Vaccine a Pfizer product; lot number: EK9231) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Reporter added they were exposed before getting it and did not realize that they were exposed. The patient was tested positive for COVID in between the doses for the vaccines, on an unspecified date. She was wondering what we suggest they do with the second dose. The outcome of event was unknown.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.
Pt returned 6/8/12 7:30 pm with warmth & redness at inj site. Tx = monitor, Pt called 6/9/12 am sx gone. Pt called center Monday night 10:30 pm saying rash down to elbow after using hydrocortisone cream told to stop using and try oral BENADRYL & seek medical attn prn. Gone for 3 wks.
Severe itching all over body & when scratched causing red marks & hives. The itching started approximately an hour & a half after getting the shot
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 15Dec2020 as dose 1, single (Lot number: EK5730), in left arm, on 05Jan2021 as dose 2, single (Lot number: EL3246), in left arm, on 24Sep2021 as dose 3 (booster), single (Lot number: EW0185), in left arm and on 29Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), all with latency 11 days after the suspect product(s) administration, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No known allergies. Patient received other medication in 2 weeks was Atorvastatin. Coivd-19 treatment with Paxlovid day 1-5 completed from 12May2022 to 15May2022. Rebound Covid-19 symptoms at day 12 on 23May2022 and was not recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Covid arm 9 days following vaccine.  Tenderness, itching, round red patch approx 2 inches in diameter at injection site.  Injection site warm to the touch.  Itchy arm and shoulder same side as injection.
Patient developed hives and swelling of multiple joints the day after receiving her vaccinations. The site of the MenB vaccine had a rash around it. The site of the MENACTRA was normal, no rash or swelling.
Diarrhea since 3-6-09; Bloody nose today 3-9-09, Cranky/fussy since 3-6-09; No rash, or fever.  Referred patient to physician for care.
Injection site started itching; Injection site started redness; Injection site pain; Felt tired; Headache; Her arm was sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Her arm was sore), INJECTION SITE PRURITUS (Injection site started itching), FATIGUE (Felt tired), HEADACHE (Headache) and INJECTION SITE ERYTHEMA (Injection site started redness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Her arm was sore), FATIGUE (Felt tired) and HEADACHE (Headache). On 19-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Injection site started itching), INJECTION SITE ERYTHEMA (Injection site started redness) and INJECTION SITE PAIN (Injection site pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event NOS, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date for Allergic reaction, at an unspecified dose and frequency. On 26-Jan-2021, PAIN IN EXTREMITY (Her arm was sore), INJECTION SITE PRURITUS (Injection site started itching), FATIGUE (Felt tired), HEADACHE (Headache), INJECTION SITE ERYTHEMA (Injection site started redness) and INJECTION SITE PAIN (Injection site pain) had resolved.        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 relevant concomitant medications were reported.
6 patients tested positive between doses 1 and 2 of the vaccine; 6 patients tested positive between doses 1 and 2 of the vaccine; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported similar events for six patients. This is the 4th of six reports. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient was tested positive on an unknown date for covid-19 between doses 1 and 2 of the vaccine, in which the patient was hospitalized and had received antibodies. And had tested negative upon and continuously since returning to the nursing home on an unknown date. Those patients were tested every day. One patient was administered the second dose and then somebody said, "Oh, they were given antibodies in the hospital''. A fellow pharmacist in which they said, "we're under the impression that you wait 90 days if you have been given antibodies after that to give the second dose". One of the patients inadvertently received a second dose, not knowing that they received antibody therapy prior to administering the vaccine. The rest of who were hospitalized did not receive their second injection. Caller asked, "What is the policy on antibodies and the second dose? When is the earliest date they can administer that second dose? The individual who was given it inadvertently, should they be given a third injection? Do you give them shot number two or do you start over and give them both shots?'' The outcome of events was recovered on an unknown date.   Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021199894 same drug/reporter/event, different patient;US-PFIZER INC-2021222956 same drug/reporter/event, different patient
Arm has been extremely sore in the deltoid/shoulder region since the shot was administered 3 weeks ago, with no improvement (possibly worsening).  Range of motion is limited.  Shot was administered unusually high in the deltoid.  Shot was administed at a shot clinic, and done very quickly and without much attention.
Severe Hives; Vomiting; This spontaneous case was reported by a pharmacist and describes the occurrence of URTICARIA (Severe Hives) and VOMITING (Vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 URTICARIA (Severe Hives) and VOMITING (Vomiting). At the time of the report, URTICARIA (Severe Hives) and VOMITING (Vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
tingling and weakness in lower legs and feet 2 days after receiving MCV, Tdap, INF (nasal) and VZV.  11/14/08 Reviewed PCP medical records or 10/3-11/3/08. FINAL DX: none provided Records reveal patient in usual state of good health on day of vaccination. Seen in ER 10/23 w/numbness feet & legs & had low grade fever.  No treatment provided, observation.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's concurrent conditions, medical history or concomitant medications were unknown by the reporter. On an unspecified date, the patient was vaccinated with ZOSTAVAX, 1 dose for prophylaxis (dose, route of administration, lot number and expiration date were not reported). Other suspect therapies included sterile diluent, for an unknown indication (dose, frequency, lot number and expiration date were not reported). On an unspecified date, 8 days after receiving ZOSTAVAX, the patient developed a rash. It was unknown by the reporter if the patient seek medical attention, if treatment was given for the adverse events or if laboratory tests were performed. No product quality complaint was involved. The outcome of the event of rash and the causal relationship between the event and therapy with ZOSTAVAX were not reported.
Information has been received from a pharmacist referring to a 75 year old male patient. The patient had no pertinent medical history or drug allergies/reactions. On 16-JAN-2015 the patient was vaccinated with 0.65ml dose of ZOSTAVAX (lot# was reported as K010969, expiry date 07-NOV-2015, subcutaneous) in his left arm. The pharmacist also reported that the patient received an unspecified tetanus shot in his right arm on the same day. Other concomitant therapies included generic of CELEXA, SYMBICORT, ZOPITAN, hydrochlorothiazide (manufacture unknown), LOPRESSOR and simvastatin (manufacture unknown). On 17-JAN-2015, the patient developed an unspecified rash at the injection site of his left arm and swelling "like the size of a grapefruit" of his left arm after receiving ZOSTAVAX in his left arm. On 20-JAN-2015, the patient called the pharmacist for medical attention and didn't receive any treatment for the adverse events. No lab diagnostics study was performed. The outcome of the events was reported as not recovered. Additional information has been requested.
Nausea vomiting throughout the day and continuous the next night,  sense on impending doom
Patient was given an adult dose of Pfizer that was diluted using 1.3mL of sodium chloride and drawn up to administer a 0.2mL dose. Patient was observed for 15 minutes with no signs of allergic reactions. Patient's parents were contacted by Dr. and they report only injection site soreness.
IN ERROR, LPN, GAVE 0.25ML OF MODERNA COVID-19 VACCINE BOOSTER DOSE TO THIS PATIENT. PATIENT WITHOUT ILL EFFECTS.  MOTHER AWARE.
I went to a salon to have my haircut.  While i was getting my hair washed I commented that the water was  ice cold. Hairdresser said no its not but will make it hotter.  I still felt freezing water on my scalp.  I reached around and felt the water and it was hot. Today when I took a shower I had normal sensation.  Hot water felt hot on my scalp today.  It was the strangest experience!
5X6cm redness and swelling; warm to touch; pt. and caregiver deny pt. having any shortness of breath and/or difficulty breathing
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. In approximately July 2014 (reported as approximately 18 months ago), the patient was vaccinated with the first dose of GARDXASIL (dose, lot #, route of administration were not reported). No further doses of GARDASIL were administered to the patient. On 26-JAN-2016 (on the day of the report), the patient would be switched to GARDASIL 9 (dose, lot #, route of administration were not reported). A dose of GARDASIL 9 would be administered on 26-JAN-2016  and this would be counted as dose 2 of the HPV vaccination series. No symptoms were reported. No further information was provided. Additional information has been requested.
Received varivax on 11-7-2006.  On 11-18-2006 patient's arm became swollen,red,sore, and difficult to move.  No fever or pox present. Patient went to Urgent Care and no treatment given.  After three days the arm returned to normal.
I have body aches and an all over feeling of Malaise, flushed face and headache
Initial report received from a healthcare professional on 07 June 2013. A 36-year old female patient had received an intramuscular dose 1 of ADACEL vaccine (Lot number: C4418BA, site of vaccination was not reproted) on 18 May 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was unknown. The patient's estimated date of delivery was 15 June and medical history were not reported. The patient had not received any treatment for infertility. At the time of this report, the patient had not experienced any adverse events. Documents held by sender: none.
Initial report received on 07-Dec-2005 from a health care professional in USA. A 30 year old female patient with a medical history of no known allergies experienced nausea and dizziness at the beginning of the day of immunization with influenza vaccine (Fluzone SV 2005-2006), lot no:U1811AA in the month of Oct-2005. The symptoms gradually worsened and patient was not recovered at the time of the report.
Swelling, redness, warm to touch to anterior surface of left thigh tender approx. 10cm in diameter Patient Diagnosed with Cellulitis prescribed CLEOCIN 75/5 10ml TID for 10 days.