chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever over 100 degrees F; fatigue; severe headache; diarrhea; muscle pain; chills; nausea; feeling unwell; This is a spontaneous report from a Pfizer-sponsored program, via  two contactable consumers, one of which was reporting for herself. A 65-year-old female patient received the second dose of the bnt162b2 (BNT162B2), via an unspecified route of administration on 14Apr2021 at a single dose for covid-19 immunisation. Medical history included might have had a fever before getting the vaccine. The patient's concomitant medications were not reported. On 14Apr2021 in the evening, the patient experienced fever over 100 degrees Fahrenheit, fatigue, severe headache for two days, diarrhea, muscle pain, chills, nausea, and feeling unwell. The patient underwent lab tests and procedures which included body temperature: over 100 degrees Fahrenheit on 14Apr2021. The clinical outcome of the events, fever over 100 degrees Fahrenheit, severe headache for two days, diarrhea, muscle pain, chills, nausea, and feeling unwell, was recovered on an unknown date. The clinical outcome of the event, fatigue, was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Swelling, redness, pain, warmth at site of injection. No fever. Significant redness and swelling at injection site. Went to doctor who told her that it was a local reaction to vaccine and not uncommon. Gave antibiotics in case continued to get worse. Patient picked up, but reports did not take. (Now 4 days after administration of injection.) Worse at day 2-3. Typical median time for reaction. Still reports red today, but not as fire red and warm, and not getting worse. Starting to get a little better.
Patient had a lot of anxiety and a high heart rate. Patient stated that yesterday it was bad and they called emergency services and went to the ER; Patient had a lot of anxiety and a high heart rate. Patient stated that yesterday it was bad and they called emergency services and went to the ER; rash; beginning to have GI problems yesterday; This is a spontaneous report from a non-contactable consumer. This consumer (mother) reported for a 31-year-old female patient that: A 31-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Jul2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced patient had a lot of anxiety and a high heart rate. Patient stated that yesterday it was bad and they called emergency services and went to the ER and rash. On 29Jul2021 the patient experienced, beginning to have GI problems yesterday. It was reported that, reporter was the mother of the patient who received the Pfizer COVID 19 vaccine dose 1 on Monday 26Jul2021. She stated that she had a rash that she was not sure it was from the vaccine or not. She reported beginning to have GI problems yesterday and again today. She stated that it is not nausea or diarrhea. Described that it was more of a knot in the stomach that was full of anxiety. She was having a lot of anxiety and a high heart rate. She stated that yesterday it was bad and they called# and went to the ER via ambulance. She relays that they did not do anything to help her. They did not give her any medicine or do any tests or bloodwork. We want to get this figured out and don't want to go back to the ER if they were not going to help. She stated that they would like to know if these symptoms have been seen and how long they could last. Reporter did not report, if there a medication that can be given to reverse the vaccine or to counteract it. And can she take Benadryl to help with these symptoms. The patient visited to the emergency room. The patient did not receive treatment for the adverse events. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Arm pain, headace, body ache, fever and chills, the following day after my second shot, for 24 hours, 2 days later, developed a lump in my left armpit, which I still have 3 days later.
This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (lips swelled up like balloon/lips swollen like balloons/they were worse) and HEADACHE (really bad headache) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (lips swelled up like balloon/lips swollen like balloons/they were worse) and HEADACHE (really bad headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; PREDNISONE for Adverse event, at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Heartburn and Inflammation, at an unspecified dose and frequency. At the time of the report, LIP SWELLING (lips swelled up like balloon/lips swollen like balloons/they were worse) and HEADACHE (really bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was referred to ER where she was treated in the emergency room on 22-august-2021.  Relevant concomitant medications were not provided by the reporter.
Sick, in hospital for RSV December 5,  2021, , kidney stage 3, Lost feeling in feet received flu vaccine approximately December 17, 2021, lost feeling in feet, January 28, 2022, paralyzed waist down on February 1, 2022, diagnosed with Transverse Myelitis, treated 2 weeks, electrolytes unbalanced while in rehab, continued getting worse when he came home on March 12, 2022, back in hospital March 25, everything went crazy.  He died at home March 30, 2022.  Death Certificate , cause of death, Metabolic Encephalopathy, or as a consequence of Transverse Myelitis
intense headache, muscle pain, chest pain, chills, nausea, vomiting, lightheadedness, lethargy  I took Tylenol Extra Strength tablets for the headache & muscle pain.  The headaches lasted for 3 days.  The muscle pain for 3 days.   The vomiting occurred on the day after the shot - 1 time.  I remained nauseous for the next 3 days.  The chest pain has been on and off for the past 2 days.  It has been mild.  The lightheadedness lasted for 4 days.  The lack of energy is still ongoing, but is getting better.
This spontaneous report was received from a Registered nurse regarding an 11 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1804USA005153:
Extreme fatigue about 4 hours after receiving the shot, that lasted roughly 3 days. I have felt "unwell" since then. At Day 8, I am now experiencing what is being called "Covid Arm".  My arm is very red and swollen around the injection site. Also, the tissue feels think and somewhat rigid. There is also itching.
Didn't make me feel good; Arm sore; Didn't get much sleep/sleep loss; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received in 2022).   On 6th January 2023, the patient received the 2nd dose of Shingles vaccine. In January 2023, less than a day after receiving Shingles vaccine, the patient experienced feeling unwell, pain in arm and sleep loss. On an unknown date, the outcome of the feeling unwell, pain in arm and sleep loss were unknown.   It was unknown if the reporter considered the feeling unwell, pain in arm and sleep loss to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that he/she never had a shingles. The patient stated that he/she received his/her last Shingles shot on Friday. The patient reported that last shot did not made him/her feel good for several after going to bed on that night. The patient experienced arm sore, did not get much sleep and he/she was sure that his/her sleep loss on last night. The patient reported that from stories he/she heard, he/she sure did not want it. Additional supportive information: Follow-up would not possible as no contact details were available.
pt recv vax 6MAR96 & 21MAR96 sx began AM arthritic joint pain,gen flu-like sx;red-round raised area 5" diameter on lt thigh;lt thigh inc in swelling,redness & 8" x 10" irregular borders;seen by MD dx cellulitis;
After 48 hours I woke up with a fever of 102F . I also felt dizzy and nauseous . I felt weak as well, even after a good night sleep I felt like I have been up for 3 day straight, and also my body was in pain.  I  just took basic Aleve for the body ache and ibuprofen for the fever. That lasted  about a week an half.
Plus one day: prickly all over; don't touch me feeling similar to the feeling at the beginning of a common cold or herpes outbreak. 600 mg ibuprofen mitigated symptoms  Plus two days: rash covering 80% of abdomen
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-338542, MOD-2021-338560 (Patient Link).
BURNING STOMACH; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination.The batch number was not reported. Per procedure, no follow-up will be requested for this case No concomitant medications were reported. On an unspecified date, the patient experienced burning stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning stomach. This report was non-serious.
Unsure if this reaction could be Osteoarthritis because it is "symmetrical, definitely a trend of RA"; Unsure if this reaction could be Osteoarthritis because it is "symmetrical, definitely a trend of RA"; Excruciating joint pain in my body; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 11Feb2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included Sjogren's autoimmune syndrome. The patient's concomitant medications were not reported. In Feb2021, the patient had excruciating joint pain in the body. The patient was unsure if the reaction could be osteoarthritis because it was "symmetrical, definitely a trend of RA". The outcome of the events, 'excruciating joint pain in the body', 'osteoarthritis' and 'RA', was unknown. The patient was due to receive the second dose of vaccination on 04Mar2021.  Information about lot/batch number has been requested.
Celluitis with 50 mm induration, 30mm erythema and 10 mm vesicle with pain and lymph adenopathy
4/8 vaccination 4/13 swelling both extremities. No pain, rash, nor fever.  5/4 Physical. Blood panel, Kidney function, and echocardiogram; neg.  Unsure what is causing the swelling at this point.  *Upcoming appt with endocrinologist at end of June  for goiter.  *unsure of Lot #; hard to read handwriting
6-year-old male received an inadvertent dose of Pentacel and Quadracel 0.5 mL intramuscular in the left deltoid on 11Nov2019 instead of MMRV; 6-year-old male received an inadvertent dose of Pentacel and Quadracel 0.5 mL intramuscular in the left deltoid on 11Nov2019 instead of MMRV; 6-year-old male received an inadvertent dose of Pentacel and Quadracel 0.5 mL intramuscular in the left deltoid on 11Nov2019 instead of MMRV; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 years old male patient who received an inadvertent 0.5 ml dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE [QUADRACEL] Lot number- C5656AA, expiry date 13-Aug-2021 instead MMR VACCIN (lot: UJ110AAA, expiry date: 14-Oct-2020, intramuscular in the left deltoid) on 11-Nov-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to wrong vaccine administered, Inappropriate age at vaccine administration and Extra dose administered.  At the time of reporting the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Breathing problems starting on March 10th. Walk in health care did lung X-ray and other tests on the heart. Had to see regular doctor on the 18th. Doctor did a CT scan and it showed I had blood clots in the lungs. Doctor put me on Xarelto 30mg tablets
Body aches; Body weakness; Right upper abdominal pain; Chills with shakes; Headache; SHAKES; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (4 times in life. Once in 1985 on right hip, once in 2017 in right eye, and twice in 2018) and corneal scar (had twice in 2018).   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced general body pain, weakness generalized, upper abdominal pain, chills, headache and tremor. On an unknown date, the outcome of the general body pain, weakness generalized, upper abdominal pain, chills, headache and tremor were unknown.   It was unknown if the reporter considered the general body pain, weakness generalized, upper abdominal pain, chills, headache and tremor to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving vaccine the patient had body weakness, aches, right upper abdominal pain, chills with shakes, and a headache. The patient asked whether the provided information was helpful.
seconds p/vax-stopped breathing, eyes red, body stiff, dizzy, seemed very out of it;unable to walk;
Pt. noticed left deltoid to be red and swollen the next day of vaccination. Pt. denies major discomfort. Redness and swelling noted to left deltoid and partial upper arm. Pt. to use cold compresses and OTC ADVIL if needed.
Rash on arm started one week after first vaccination shot. Rash has lasted 6 days, is very itch and hot. The rash has moved from the injection site and spread up and down upper arm.
Pt developed pain, redness and heat that measured 4 1/2" by 3 1/2", at the injection site. Pt was given Diprolene cream to help with itching.
pt recv vax 15MAR97 & 3 to 4wk p/vax pt exp SOB;an allergist stated exp was possibly vaccine related;
Vaccine given on 12/30/20 On 12/31/20, developed 101 .0 fever, chills, body aches, and severe arm pain.  On 1/1/21, developed swollen lymph nodes/armpit pain in armpit of arm that vaccine was given. The pain was 5 or 6 out of 10 and limited daily activities and was present from 1/1/21 to 1/11/21 at which point it started to feel better. On 1/9/21 developed large (3 inch diameter) raised, red rash which mostly resolved by 1/11/21.
At a community flu shot clinic, patient received high dose vaccine even though they were not yet 65 years old. Contacted patient in 48 hours and patient reported no unusual discomforts or adverse effects from the flu shot. Stated just  like "last year's" flu shot.
is uncomfortable; uncomfortable; big bubble of swelling under their right arm, on the lymph nodes; tender lymph nodes; felt kind of feverish, but with no temperature; achy; felt a little sluggish; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (felt a little sluggish), MALAISE (is uncomfortable), DISCOMFORT (uncomfortable), MYALGIA (achy) and LYMPHADENOPATHY (big bubble of swelling under their right arm, on the lymph nodes) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020K21A, 007M20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Systemic lupus erythematosus (immunosuppressed since the patient have Lupus) and Immunosuppression. Concomitant products included LOSARTAN, LEVOTHYROXINE, RABEPRAZOL [RABEPRAZOLE], MONTELUKAST, ATORVASTATIN, FAMOTIDINE and CICLOSPORIN (RESTASIS) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced SLUGGISHNESS (felt a little sluggish) and PYREXIA (felt kind of feverish, but with no temperature). 30-Aug-2021, the patient experienced MYALGIA (achy). On 31-Aug-2021, the patient experienced MALAISE (is uncomfortable), LYMPHADENOPATHY (big bubble of swelling under their right arm, on the lymph nodes) and LYMPH NODE PAIN (tender lymph nodes). 31-Aug-2021, the patient experienced DISCOMFORT (uncomfortable). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, SLUGGISHNESS (felt a little sluggish), MALAISE (is uncomfortable), DISCOMFORT (uncomfortable), MYALGIA (achy) and PYREXIA (felt kind of feverish, but with no temperature) outcome was unknown and LYMPHADENOPATHY (big bubble of swelling under their right arm, on the lymph nodes) and LYMPH NODE PAIN (tender lymph nodes) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No lab investigations were provided.
mild Headache; mild temperature; mild joint pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (mild Headache), PYREXIA (mild temperature) and ARTHRALGIA (mild joint pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from February 2020 to March 2020 and Tendon repair (Right hand). Concurrent medical conditions included Asthma (Currently under care of pulmonologist) and Pulmonary disorder (Lung issue, currently on breathing treatment for low oxygen saturation in the blood, currently under care of pulmonologist).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced HEADACHE (mild Headache), PYREXIA (mild temperature) and ARTHRALGIA (mild joint pain). At the time of the report, HEADACHE (mild Headache), PYREXIA (mild temperature) and ARTHRALGIA (mild joint pain) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication use was not reported.   Treatment information included steroid medication after the first dose with symptom improvement.   This case was linked to MOD-2021-074918 (Patient Link).
It was reported that a 52 year old female patient received a Fluzone SV '01-'02 vaccination lot #UO682AA was administered on 10/16/01 in the left deltoid. On 10/17/2001, the patient experienced a local reaction of redness, swelling, knot formation and soreness in the lymph nodes under the left arm. Physician evaluation was obtained and no therapy prescribed.
stomach hurts; moderate nausea; moderate vomiting./ threw up everything he tried to eat; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ABDOMINAL PAIN UPPER (stomach hurts), NAUSEA (moderate nausea) and VOMITING (moderate vomiting./ threw up everything he tried to eat) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     The patient's past medical history included Bleeding.    On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach hurts), NAUSEA (moderate nausea) and VOMITING (moderate vomiting./ threw up everything he tried to eat). At the time of the report, ABDOMINAL PAIN UPPER (stomach hurts), NAUSEA (moderate nausea) and VOMITING (moderate vomiting./ threw up everything he tried to eat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatments were reported.
I had a stinging sensation after the Moderna shot, like a bee sting.  I woke up two weeks ago and my arm felt like someone punched it really hard, like a Charley horse.  My arm went numb, fingers are tingling, and at the site of injection it still feels like a Charley horse. I couldn?t sleep for three days and family started getting worried. My brother took me to Urgent Care this last Sunday. The doctor at Urgent Care told me it looked like a nerve issue, prescribed me Gabapentin and told me to do a follow up with my doctor. I saw my doctor on Wednesday and he suggested I report my symptoms because he is going through something similar. He prescribed me a stronger dose of Gabapentin and I?m waiting to see a neurologist. I have been missing a lot of work and I wish I never got the shot.