chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning a 25 year old female who was vaccinated intramuscularly with the third dose of GARDASIL.  Subsequently, five days post vaccination, the patient experienced seizures.  The patient was taken to the emergency room.  It was reported that the patient cannot drive according to state law for a while.  Computed tomography scan and magnetic resonance imaging were performed with no results reported.  It was reported that the patient is fine now.  On an unspecified date, the patient recovered.  No product quality complaint was involved.  The reporter considered seizures to be disabling.  Additional information has been requested.   2/24/09 Received Neuro medical records of 5/28-10/2/2008. FINAL DX: single gen tonic-clonic seizure secondary to Gardasil injection Initial examination & subsequent office visit both revealed neuro exam WNL.  Referred for EEG & MRI brain which were WNL.  No further records available.  6/19/08-ER records received for DOS 05/20/08-presented with after episode of shaking all over, loss of consciousness, unresponsive. Contusion on back due to sliding out of chair.Seizure probably secondary to Drixoral, coffee and cigarette took second dose only 8 hours after first dose. Impression probable drug reaction.  12/31/08 Reviewed GYN office records. FINAL DX: none provided Records reveal patient experienced good health on vax dates.
Vaccine was administered IM in left arm. 04/13/2017 PM myalgia, weakness, trembling in left arm. Myalgia in thighs. Thought reaction normal, due to sensitization from initial vaccine sequence administered in fall 2015. 04/17/2017 booster was administered IM in right arm. Since then, as of today (05/16/2017) intermittent myalgia has persisted, especially in arms and legs, as well as neuromuscular signs: skeletal muscle spasms/twitches in arms, legs, hands, abdomen, neck, face. Some days worse than others. Intermittent paresthesia, especially in left foot and hand. No loss of function or loss of sensation to date.
I started to get aches and pains in my hip girdle down to my knees in both legs. It has varied, but is so severe that I have great difficulty in walking. It subsides only when I am lying on my back. The intense pain is in both groins, and ischium. Walking, stretching, exercises does not make it better or worse.   Note that the same aches appeared 4 days after the second Pfizer shot, but no pains. The aches went away after 3 days. Again, between the hip girdle and both knees.   As of today, more than 10 weeks after the booster, the pain is very severe and debilitating. No medication addresses the pain, not opiods, not IBP, nor Tylenol, nor gabapentum. Note that prior to taking the booster, I was hiking in the mountains with substantial elevation with no issue. At present, I need to use my arms to climb a single set of stairs and I need to use my arms to raise up from a seat. I have lost most of the strength in my legs, and it does not appear to be returning, in fact it appears to be getting worse.   I have not other aches or pains in my body.
Beginning at 3:15pm (9 minutes post vacc) Complaints of burning at injection site and over arm (left arm) Numbness down left arm Symptoms progressed at 3:28pm, to Cold Sweats Headache Urticaria of arms and legs Vitals: 140/82 blood pressure, 99 SpO2, 18 resp, 78 pulse, 97.8 temporal temp
Ongoing diarrhea, 2-3 times a day (specially after a meal); preceded with stomach cramps onset 4th day after vaccination. Imodium and Pepto-Bismol both on 12/10/2021.
Eyesight was affected,When she was reading, one line superimposed the next line; Felt weak as a kitten; Incontinent; Shivering; Tired; Nauseated; Very achy; Freezing cold; Shaking; Couldn't hold anything in her hand; This spontaneous case was reported by a patient and describes the occurrence of FEELING COLD (Freezing cold), TREMOR (Shaking), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Couldn't hold anything in her hand), VISUAL IMPAIRMENT (Eyesight was affected,When she was reading, one line superimposed the next line) and ASTHENIA (Felt weak as a kitten) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced FEELING COLD (Freezing cold), TREMOR (Shaking), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Couldn't hold anything in her hand), INCONTINENCE (Incontinent), CHILLS (Shivering), FATIGUE (Tired), NAUSEA (Nauseated) and MYALGIA (Very achy). On 03-Nov-2021, the patient experienced VISUAL IMPAIRMENT (Eyesight was affected,When she was reading, one line superimposed the next line) and ASTHENIA (Felt weak as a kitten). At the time of the report, FEELING COLD (Freezing cold), TREMOR (Shaking), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Couldn't hold anything in her hand), VISUAL IMPAIRMENT (Eyesight was affected,When she was reading, one line superimposed the next line), ASTHENIA (Felt weak as a kitten), INCONTINENCE (Incontinent), CHILLS (Shivering), FATIGUE (Tired), NAUSEA (Nauseated) and MYALGIA (Very achy) outcome was unknown.            No Treatment medications were provided No  Concomitant medications were provided patient wants to know why do people with different statures receive the same dosages   This case was linked to MOD-2021-374747 (Patient Link).
None after 1st shot,  about a month after 2nd shot sharp muscle pain in left arm - inconsistent - can't say it happens with anyone event - lifting even pillows can cause it, putting on a jacket/sweater, making a bed are some examples. After booster it started in the right arm as well, while not as sharp any more in the left arm it is still there and still ongoing in right arm., sometimes muscles in both arms just ache.  Saw doctor on 12/22/21 and his notes say: " I feel she has de Quervain's tenosynovitis or localized myositis most likely related to COVID-19 vaccine."
This spontaneous report was received from a licensed practical nurse and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates (within an 18-month period), the patients were vaccinated with improperly stored doses of VAQTA (dose, route of administration, lot# and expiration date were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 52 degrees Fahrenheit (the highest temperature) and 29 degrees Fahrenheit (the lowest temperature), for an unspecified period of time. It was unspecified, if the data logger was involved. Product quality complaint (PQC) was not involved. This is one of the two reports received from the same reporter. Additional information has been requested.
lt deltoid area, red, swollen, warm to touch; full ROM however tender on movement 4x5cm are of erythema; no induration; post vax inj, mom applied heat to area;
This is a spontaneous report from a contactable consumer via Pfizer sales representative. This consumer reported similar events for 3 patients. This is the 2nd of 3 reports. A patient of unspecified age, race/ethnicity and gender received PREVNAR 13 on an unspecified date, at single dose, for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a red blotchy rash in the area surrounding the injection site, not directly at the injection site. This rash lasted approximately 7 days and resolved on its own. There was no itching or pain associated with the rash. No follow-up attempts possible. No further information expected. Sender's Comments: Linked Report(s): US-PFIZER INC-2017492889 same reporter/drug/event, different patient; US-PFIZER INC-2017492903 same reporter/drug/event, different patient.
Swollen, red, warm to touch. Treated with Keflex, Motrin and warm compresses.
Tingling on lips, thick tongue, rash on neck and chest, metallic taste on tongue within 1 hour of injection. Pain in both knees which would wake me up at night lasted for 3 days. Metallic tasted lasted for 2 days. Today is day 7 and I am free from symptoms.
3 days p/administration of DTP/OPV/HIB vax pt had a sz lasting 45 mins; afebriel initially thought to be a dystonic reaction w/stiffening of all extremities & back, head turning & eyes deviating upward & laterally; required Phenobarbital
Red, itchy rash on arm where vaccine was administered. Noticed red mark on arm on Monday 03/29. It has been slowly getting bigger and more red. It is extremely itchy.  I have tried antihistamine and spray benadryl to help with the itch but neither one has helped so far. Oral benadryl makes me sleepy so I havent tried using. I moved on 02/01/2021 so I do not have a doctor yet.
Xrays showed covid Poss pockets all in her lungs on 15Jan; Xrays showed covid Poss pockets all in her lungs on 15Jan; This is a spontaneous report from a contactable consumer. An 85-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunisation. Medical history included dementia. Concomitant medications were not reported. Patient popped hot 02Jan2021 along with 4 others on the hall she lived. Within 9 days 50+ patients were positive. All had the vaccine the same day. Patient was test positive on 02Jan2021. She was on day 12 of her quarantine when she started to get worse. She was unresponsive by 16Jan2021 and passed 18Jan2021. We were with her from 14Jan2021 to 18Jan2021. But had not been allowed to visit with her since Mar2020. And what post treatment pairs well with it? Publicly we hear Remdesivir and Bamlanivimab but these patients only received a general antibiotic and some vitamins. Death cause was Xrays showed covid Poss pockets all in her lungs on 15Jan2021. No autopsy was performed.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information; Reported Cause(s) of Death: Xrays showed covid Poss pockets all in her lungs on 15Jan
slight fever; not feel good; Initial information was received on 08-Nov-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient (unknown demographics) who had slight fever (pyrexia) and not feel good (malaise), while received INFLUENZA VACCINE.  Medical history, past medical treatment, vaccination, family history and concomitant medications were not provided.  On an unknown date, the patient received an INFLUENZA VACCINE (Produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, patient had slight fever (pyrexia) and not feel good (malaise), (unknown latency), following the administration of INFLUENZA VACCINE for few days. It was reported that events were experienced twice.  Details of laboratory data not reported.  Corrective treatment and outcome were unknown for both the events at the time of reporting.  There will be no information available on the batch number for this case.
A report was received from a health care professional on 11/19/03 concerning a 46 year old female vaccinee who experienced a localized red wheal at the injection site which was raised and warm to touch one day after receiving Fluvirin on 11/18/03. On 11/19/03 the vaccinee experienced a localized red wheal at the injection site, which was a nickel to half a dollar in size, raised and warm to the touch. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Body aches, sore joints, swollen glands, mild sore throat, rash-covering almost entire body-rash-started on arms, spread to legs, then to trunk.
patient has trouble sleeping because of the skin condition.; skin in her chest is getting hard and it was changing color/became brownish and in some places red/spread to her back,belly button,groin/ skin hardness has spread all over /Morphea; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (patient has trouble sleeping because of the skin condition.), MORPHOEA (skin in her chest is getting hard and it was changing color/became brownish and in some places red/spread to her back,belly button,groin/ skin hardness has spread all over /Morphea), CHILLS (Chills) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 015M20A) for COVID-19 vaccination.     Concomitant products included TACROLIMUS and BETAMETHASONE for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced CHILLS (Chills) and HEADACHE (Headache). In April 2021, the patient experienced SLEEP DISORDER (patient has trouble sleeping because of the skin condition.) and MORPHOEA (skin in her chest is getting hard and it was changing color/became brownish and in some places red/spread to her back,belly button,groin/ skin hardness has spread all over /Morphea). At the time of the report, SLEEP DISORDER (patient has trouble sleeping because of the skin condition.), MORPHOEA (skin in her chest is getting hard and it was changing color/became brownish and in some places red/spread to her back,belly button,groin/ skin hardness has spread all over /Morphea), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported. No medical history was provided by the reporter.  Patient went to see a Dermatologist in the spring of 2021 and thought she had a heat rash, Dermatologist diagnosed her condition as Morphea. Patient is seeing a Dermatologist and a Rheumatologist, Rheumatologist ordered an MRI for the patient's chest. MRI has not yet been taken
Swelling, hardness and redness at left arm injection site; Had a headache all day yesterday; Redness at left arm injection site; Hardness at left arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling, hardness and redness at left arm injection site), HEADACHE (Had a headache all day yesterday), VACCINATION SITE ERYTHEMA (Redness at left arm injection site) and VACCINATION SITE INDURATION (Hardness at left arm injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swelling, hardness and redness at left arm injection site), HEADACHE (Had a headache all day yesterday), VACCINATION SITE ERYTHEMA (Redness at left arm injection site) and VACCINATION SITE INDURATION (Hardness at left arm injection site). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Swelling, hardness and redness at left arm injection site), HEADACHE (Had a headache all day yesterday), VACCINATION SITE ERYTHEMA (Redness at left arm injection site) and VACCINATION SITE INDURATION (Hardness at left arm injection site) outcome was unknown.            Concomitant medications were not reported.  Treatment details were not provided.
Expired vaccine kept on refrigertaor; no adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Expired vaccine kept on refrigertaor) and NO ADVERSE EVENT (no adverse event) in a 45-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 06-Apr-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Apr-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine kept on refrigertaor) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Expired vaccine kept on refrigertaor) and NO ADVERSE EVENT (no adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Expired vaccine kept on refrigertaor).    No concomitant medications were reported.  HCP stated that when they had received the Moderna monovalent vaccine, the expiration date stated 31-Dec-2069 and they did not realize that they had to check for the manufacturer expiration date.   The patient did not report any adverse reactions to this invalid dose administration.  The vial was initially stored in the refrigerator on 5-Apr-2023. The vial did not undergo any temperature excursions.  No treatment medications were reported.
h/a, joint pains in thumbs & index fingers; onset 16 hrs p/inject; sx abating 24 hrs p/onset; pt took APAP for h/a;
Initial report was received on 20 December 2013 from another manufacturer national service center (service request number 1-962816342), who received the report from a health care professional. A patient had received a Smallpox vaccine (lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced a rash with pustules. According to the reporter, he believed that it was not an allergic reaction, but a reaction to the vaccine itself. No further information was provided. The patient's outcome was not reported. Documents held by sender: none.
Patient states that she is experiencing pain, numbness and swelling at injection site. She also feels nauseous and have sore joints.
Case was hospitalized.          **date of 2nd vaccine was 2/11/2021
After 1st Dose: Arm pain for 16 days after first dose (shoulder of injection site), on 9th day developed hot, red, hard rash on injection site. Some mild fatigue. Took ibuprofen as needed, did not provide relief. Unable to sleep on arm for 2 weeks due to pain. Rashed cleared after a week.
Miscarriage; tested positive for pregnancy on 9/4/21 and 9-9/21. Began cramping and bleeding 9/11/21, miscarriage confirmed 9/13/21.
This spontaneous report as received via a field representative from a physician refers to a 64 years old female patient. The patient was vaccinated with VAQTA (dose and lot number unknown, intramuscular) on 14-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On 21-NOV-2012 the patient experienced fatigue and swelling of the roof of the mouth which lasted for 10 days, 8 days after onset of therapy. It was further reported that the patient had come from another practice and it was noticed in her records that there were recommendations for her to receive VAQTA in 2/2010 and 8/2010, but the physician had no confirmation that the vaccine was actually administered. No treatment information was reported. The outcome of swelling of the roof of the mouth and fatigue was reported as recovered/resolved. The reporters relatedness for fatigue and swelling roof mouth is unknown for VAQTA. Additional information has been requested.
Pt received PNEUMOVAX immunisation in left upper arm on 1-15-2019 and developed redness of left upper arm later that same day. Redness spread to involve entire left upper arm and extended to left upper chest on 1-16-2019. She also developed pain in left upper arm on 1-15-2019 and pain continued into 1-16-2019. She took a single dose of acetaminophen on 1-16-2019. Temp of 100.6 on 1-16-19. Had chills on 1-16-19, 1-17-19, 1-18-19.
Itchy from his trunk down to his arms; This is a spontaneous report from a contactable pharmacist.  A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, as single dose on an unknown date (Lot number: not provided) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient became well itchy from his trunk down to his arms and lasted about a day or so after he received his first shot. Event outcome was recovered.  Information on the lot/batch number has been requested.
administered an improperly stored VARIVAX; No adverse effects; This spontaneous report was received from a health professional (medical assistant) refers unspecified patients of unknown demographics. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, frequency, anatomical location and route of administration were not reported) of lot # R020654 and expiration date 18-JUL-2020 for prophylaxis (product storage error). The concomitant medication included sterile diluent which was reported to be stored properly. No adverse effects were reported. It was reported that the vaccine was exposed to a temperature of 15 degree Fahrenheit (F) to 46 degree Fahrenheit (F) (29.1 C) for a time frame of 3 hours. There was no previous temperature excursion reported. Data logger was not involved. No product quality complaint (PQC) was associated with this report.