chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she woke up feeling like she was getting a cold; shivering; sweating; running a fever; feel uncomfortable; armpit swelling and soreness; armpit swelling and soreness; arm being sore; This is a spontaneous report received from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left (left upper arm, near the top of her shoulder) on 06Apr2021 14:00 (Batch/Lot Number: EW0151) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Her arm started to feel sore immediately after getting the vaccine on 06Apr2021. It stated that as the day went on, the soreness was getting more pronounced. When the syringe went in, she felt it, like it had crossed the cartilage or something. A few hours after that, the soreness was settling in and it was getting more sore. By the end of the day, it was more sore. Her arm was sore most of the day yesterday (07Apr2021) and was uncomfortable. Her arm is still sore today (08Apr2021) but not as bad as it was. Wednesday morning, yesterday, she woke up feeling like she was getting a cold, she was shivering. Yesterday, she spent the whole day in bed, shivering, and sweating, and running a fever. By the time she got to bed, she was feeling a little better so she thought she would be feeling better this morning. Her fever started yesterday mid-morning around 9:30 or 10:00 am. The fever lasted the whole day and subsided in the evening. She clarifies she may have a little bit of a fever now but she has not taken her temperature yet. If she does have one, it is very mild. In the middle of the night, she started to feel uncomfortable, like right under her armpit, it was sore. She woke up this morning and stated it was pretty noticeable, there was swelling kind of like under her armpit, but its more towards her chest a little. The area was very uncomfortable and very sore. She confirmed she started feeling the armpit swelling and soreness overnight last night. It's still very uncomfortable and sore. Treatment included she took 2 Acetaminophen pills, 500mg each, yesterday around 2pm and took 2 pills before going to bed last night around 8:00pm. The adverse events didn't require a visit to emergency room or physician's office. Patient had blood work in Mar2021 that showed that she had antibodies in her system. In Dec2020, patient's husband was positive for Covid and she was negative. The outcome of event feel uncomfortable unknown, armpit swelling and soreness was not recovered, the other events was recovering.  No follow-up attempts are needed. No further information is expected.
Pt received PENTACEL and Hib on the same day. No adverse events, just vaccine error.
Never changed anything in my routine and started getting unlocalized rashes around the body about 10 days following the 3rd shot. Spoke to the CDC and they said that a localized arm rash is common and that unlocalized rashes are not. Itching happening on legs, arms, stomach, face, top of the head.
Vaccine was around 5PM, close to 30 minutes later, throat felt tight. Quickly got tighter until I felt like I couldn't breathe. Tongue  and side of next was swollen. Crushed two benadryl and put under tongue.  Went to ER and was monitored for a few hours. Was advised not to get second dose at the Hospital, and my main Dr. agree. Went home around 9PM.
I received the first dose on 27Jan and got diagnosed yesterday with Covid; His son tested positive for COVID-19 on Monday and he tested positive on Tuesday, 02 Feb 2021; Loss of smell; This is a spontaneous report from a contactable lawyer. A 55-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no: EL8982, expiration date: May2021), intramuscular on the left arm on 27Jan2021 at a single dose for COVID-19 immunisation. The patient medical history was none. Prior Vaccinations (within 4 weeks) was none. Concomitant medications were not reported. The patient previously took penicillin and aspirin [acetylsalicylic acid] and experienced Allergies. The patient explained he was calling for some advice. He received the COVID-19 vaccine on 27Jan2021, time the vaccination was given was 10:30, maybe 10:45am. His son tested positive for COVID-19 on monday and he tested positive on tuesday, 02Feb2021. Patient was eligible to receive the monoclonal antibody therapy. He wanted to know since he had already one vaccine and questioned will this create any conflict with receiving the second vaccine. Patient also questioned will there be any danger with receiving the monoclonal antibody therapy since he already had the first COVID-19 vaccine. Reporter stated he worked with healthcare professional, but he was not one. He worked as an attorney and works in the hospital on occasion. Patient wanted to know what the best protocol was to protect him, will the vaccination he took protect him to some degree and will it interfere with him having monoclonal antibody therapy tomorrow morning questioned. He wanted to contact Pfizer first to see if there was anything he needed to know or if there was some sort of bad synergy with the injection. Description of complaint was patient stated he had a COVID-19 Rapid test done yesterday (02Feb2021) which was positive. He was certain he was positive. He loss his sense of smell the night before (01Feb2021). Patient stated he had COVID-19 PCR test too, but he had not got the results back yet. The outcome of the events was unknown.  No further information was provided or obtained.
Prior to shot I had a very small lump "pea size" in my left groin area, this lump was hard and painless and had been like this for several months and up to a year or more. One week or seven days after the shot I noticed the lump had started growing in size and was now  the size of a small marble. Having no pain however, now after 23 days it has grown to approximately walnut size and is slightly painful or sensitive to touch. I have tried to schedule an appt. with my Primary Care Dr. and I finally just today have a phone appt. on 3/24 at 11:50 am.
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 06-SEP-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 intramuscularly (dose was not reported; lot # L038503 with an expiration date on 18-DEC-2017). Administered dose of GARDASIL 9 was exposed to the temperature of 33.9 Fahrenheit degrees for 34 minutes, on an unknown date. There was no information about previous temperature excursion or digital data logger. No adverse effects were observed or reported. This is one of several reports received from the same reporter. Additional information has been requested.
Painful injection.  Left with pain in upper arm.  Limited mobility.  Very painful during the night and in morning.  Cannot sleep without pain waking me up about every two hours.
Sick to my stomach. Arm hurt for a week. Tingleling and Itching in my chest area secretions from both nipples. My shirt was stuck (This occured 4 days post vaccine
Crohn's disease flare; Temporomandibular joint issues; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4485286-00 (RA).  A 62-year-old male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and in 2022 as dose 3 (booster),single (Batch/Lot number: unknown) at the age of 60 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for crohn's disease. The patient's relevant medical history included: "Crohn's Disease", start date: Jan2020, stop date: Jan2020. The patient's concomitant medications were not reported. The following information was reported: CROHN'S DISEASE (medically significant), outcome "unknown", described as "Crohn's disease flare"; TEMPOROMANDIBULAR JOINT SYNDROME (non-serious), outcome "unknown", described as "Temporomandibular joint issues". The action taken for adalimumab was unknown.  Clinical course included on an unknown date, the patient experienced TEMPOROMANDIBULAR JOINT ISSUES. In Jan2020, the patient experienced CROHN'S DISEASE FLARE. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter contact for lot number information was unsuccessful.   The reporter's assessment of the causal relationship of "crohn's disease flare" and "temporomandibular joint issues" with the suspect product(s) BNT162b2 was provided as possible. The reporter's assessment of the causal relationship of "crohn's disease flare" and "temporomandibular joint issues" with the suspect product(s) adalimumab (HUMIRA) was not provided 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.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between reported events and the suspect drug BNT162B2 cannot be excluded.
pt recvd vax 3PM 23AUG, 25AUG & 24 hrs later tingling in scull, disoriented, vertigo lasting 4 hrs; sx reduced if distracted by activities; tightness/muscle tension in neck, abdo cramps;
Rash appeared on 1/2/2021, last 36 hours and disappeared. Rash re-appeared on 1/5/2021 in the AM, large and red, slightly warm. No fever, no itching, no tenderness to touch. Got bigger over night and on 1/6/2021 rash still present.
Still has loss of appetite; Cant taste her food; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration Date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller mentioned she got flu shot and had a reaction, received pneumovax 23 - had two trips to Emergency Room post administration, and received Prevnar 13 and she was okay with that. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: unknown, Expiration Date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. After the first dose of vaccine, the patient experienced tiredness. The caller stated that she had bad side effects from vaccine. First dose didn't have any issues just tiredness. She stated that she still had loss of appetite and can't taste her food. The caller wanted to know if the booster dose of Pfizer vaccine will be the same ingredients as the first two doses. The caller mentioned that she seemed to have a reaction to every vaccine she got. She thought that she had allergies to ingredients, caller wanted to know if that was possible. The case was reported as non-serious. The outcome of the events was not resolved. Information about batch/lot number has been requested.
Spontaneous hives beginning on the scalp, ears, and neck; progressed to arms and torso in 24 hours; itching/scratching interrupting sleep; intense for approx. 2 weeks and decreasing with time; treating with 1 benadryl before bed; however, benadryl had little to no effect during intense period
Pt recvd vax 14SEP92 & on 21SEP92 pt devel a rash; No further details were provided;
Tinnitus?almost immediate and has not let up at all.  It?s life changing in a very negative way.
Mother of child noticed a bump on the child's right anterolateral thigh on approximately 12/13/07.  Bump the approximate size of a dime.  Child had a fever of 101 degrees Farenheit the night of 11/29/07 and throughout the day on 11/30/07.
Received shot on Tuesday at 11:30am.  On Thursday morning at 5:00am, left arm injection site red, warm, painful and swollen. Redness at injection site measures 5 x 3cm.  Swelling is close to 8 x 5cm.
Phone call attempted 9/20/04 at 10:30 a.m. Left message on answering machine. Phone call attempted 9/20/04 at 11:30 a.m. No answer.
Pain; Fever; numbness on right side of shoulder and then going down now the area is expanding; This is a spontaneous report from a contactable consumer. This consumer (patient's husband) reported for a female patient (reporter's wife) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown), via an unspecified route of administration on an unknown date in 2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain, fever and numbness on right side of shoulder and then going down now the area is expanding. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100994036 same reporter/ AE/ drug, different patient;US-PFIZER INC-202100993856 same reporter/ AE/ drug, different patient
On 9/5/02, pt awoke with L sided facial paralysis assoc with L eye watering, L frontal headache. Pt presented to health center on 9/8/02. Tested negative for Lyme disease. Treated for Bell's palsy with Acyclovir 400mg sx's/day and Prednisone. On 9/17/02. pt recovering from sx's.
Patient (15 yo) was given Moderna vaccine which is only approved for 18+ yo.
2 blisters around the injection site in her left arm. Blisters were approximately the size of pencil eraser; it feels warm at the injection site; arm was initially sore and that was all/a sharp pain in her arm/it was very sore/arm hurt; I didn't realize if a 'lesion' (not clear over the call) kind of formed overnight; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown, Expiry Date: Unknown), via an unspecified route of administration in left arm on 25Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were none. It was reported that patient had her 1st Pfizer vaccine dose on Monday, 25Jan2021, her arm was initially sore and that was all. Then sometime today (on 28Jan2021) she has developed 2 blisters around the injection site in her left arm. Blisters were approximately the size of pencil eraser. She was driving home from work and felt a sharp pain in her arm. She pulled her car over because it was "very sore". "she was glad that she was close to home when this happened. It was kind of freaked her out." Patient also stated that she got the vaccine on Monday and today (on 28Jan2021) she was driving home. She hadn't had any issues other than her arm hurt but it feels warm at the injection site and she just got in to her house, she wanted to stretch, she didn't realize if a 'lesion' (not clear over the call) kind of formed overnight in Jan2021, it hurts, her arm hurts." No lab work was done. No treatment was received for the events. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
She got her vaccine, she did have some soreness, but that has been normal from shots.  During the night she felt chills.  Then she got up and had a headache, took her temperature and it was elevated to 101.  She took Tylenol and that alleviated the fever, and the fevers start going down but she hs been waking up with a fever almost every day since.  They are in the range of 100 to 100.6 range, and are still continuing today as well.  After the first day when she took the Tylenol she felt OK for a couple of days, and then she woke up and she was nauseous which she is hardly ever that way.  When she got up to use the bathroom and got back in the bed she was feeling shortness of breath.  The shortness of breath is main mainly when she wakes up, uses the restroom and goes back to bed.  She is having some problems with her breathing which she previously did not have.  It catches her breath, which she cannot describe as she has never had this reaction before.  She is still continuing to have that as well.  For a couple of days she was sweaty, but hasn't been consistent.  Yesterday at 5:00 AM it was 99.8, when she woke up at 8:30 it 100.6, at 9:30 it was 100.2, 11:00 it 99.6 and it continued to go down.  This morning it was above 100.3.  She has continued to take the tylenol with her fevers, and as soon as she takes it it starts to go down.  She called her pharmacist when she had the throat symptoms a week ago and she past Thursday called her PCP because she felt that it was not going away.  Yesterday she spoke with a different pharmacist to see when it would be out of her body, and he said that it takes around 2 weeks.  Her PCP told her to continue to take the Tylenol and was concerned if she had any respiratory issues.  She called the doctor back on Friday and was told to go to the ER/UC as it was the weekend.  She decided not to go to the ER as it was 30 minutes away, and she wasn't feeling well so she decided not to do that.  She is still suspecting that it is the Spike protein and is waiting for a CB from her rheumatologist to see if the rheumatoid medication that she is on could be one of the causes of her symptoms.  She feels that the Spike protein may be the issue.    She has had 5 previous vaccines and did not have any AE from those.
Hurting from left behind down leg to foot, went to ER given something for pain when home and followed up with PCP taken test on leg Doppler , CT , bloodwork , eltra sound , and nerve meds and muscle relaxers
10 min after administrating ROTATEQ baby developed redness on face - chest & back. Administered @ 11:50 am - rash 12 pm (on 3-6-09).
Patient returned to pharmacy 6 days post-vaccine w/moderate-severe bruising of left shoulder and continued pain. Pt stated that she had also had excessive bleeding after vaccination. No treatment given.
minor soreness in my arm; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0150) via an unspecified route of administration in the right arm on 02Apr2021 at 16:30 (at the age 35-years-old) as a single dose for COVID-19 immunisation. Medical history included blood clot from an unknown date and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in the four weeks prior to the COVID vaccine. Concomitant medications included apixaban (ELIQUIS) from an unknown date for blood clot. The patient reported experiencing minor soreness in her arm with the first shot on an unspecified date. The patient received the second dose of BNT162B2 (lot number EW0170) in Apr2021. The clinical outcome of minor soreness in arm was unknown. It was also reported that since vaccination the patient had not been tested for COVID-19.
headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and CHILLS (Chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced CHILLS (Chills). On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown and CHILLS (Chills) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided.
Redness, warmth, and swelling around injection site. Given BENADRYL.
Redness and swelling of upper arm, pain at injection site. Redness continues up over shoulder ending before scapula. Low temperature reported.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, approximately in July 2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 injection (lot# L003188, expiry date 06-JUL-2015), 0.5 intramuscularly. There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Pt recv vax on 10/27/98; post vax pt exp fatigue, muscle aches, red & swollen vax site w/ red lines(LA), nausea, headaches x 2 day
Abdominal pain resulting in hospital visit. CAT scan showed inflamed pancreas; Abdominal pain resulting in hospital visit. CAT scan showed inflamed pancreas; This is a spontaneous report from a contactable consumer (reported for himself). A 43-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 21Aug2021 at 11:00 (at the age of 43-years-old) as dose number unknown, single for COVID-19 immunisation at Workplace clinic. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication(s) included omeprazole (OMEPRAZOLE), high blood pressure med and advanced, taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received benadryl and experienced drug hypersensitivity, wellbutrin and experienced drug hypersensitivity. On 23Aug2021 at 07:00, the patient experienced abdominal pain resulting in hospital visit. cat scan showed inflamed pancreas. The event assessed as serious (hospitalization). The reporter stated the events result in Emergency room/department or urgent care visit. The patient underwent lab tests and procedures which included computerised tomogram: inflamed pancreas on 23Aug2021 (inflamed pancreas). Therapeutic measures were taken as a result of events included treatment with CAT scan, morphine, pancreatic diet. The outcome of the events was resolving.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
patient developed left upper arm reaction post covid vaccine.  also had to use regular inhaler more often than normal (patient has seasonal allergies).  arm developed red circle around the injection site (covid arm) give albuterol and solumedrol in the ED. discharged home
Information has been received from a nurse concerning a female, who on 13-OCT-2008, was vaccinated with a first 0.5 ml dose of GARDASIL (lot # was not reported). On 13-OCT-2008, the patient experienced headache after the vaccination. The patient sought medical attention. At the time of reporting, it was unknown if the patient recovered. Additional information has been requested.