chrisvoncsefalvay/vaers-outcomes huggingface dataset:
raised rash on her face/her ears; lymph nodes in her neck enlarged/lymph nodes in her collar bone enlarged; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): PFIZER INC-202101252772.  A 50 year-old female patient received bnt162b2 (COMIRNATY), administration date 12Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH PAPULAR (non-serious) with onset Sep2021, outcome "unknown", described as "raised rash on her face/her ears"; LYMPHADENOPATHY (non-serious) with onset Sep2021, outcome "unknown", described as "lymph nodes in her neck enlarged/lymph nodes in her collar bone enlarged".  Additional information: The patient stated that she noticed events on Saturday. Stated that she had a raised rash on her face and ears the first week after the vaccination shot. She can feel that there were rashes more than she saw. The vaccine had an adverse effect on her system. On all three vaccinations one listed ingredient was similar to Miralax and she was asked if she was allergic. The ingredient did not work well with her system and that it did the opposite of what it was supposed to do.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  Follow-up (22Sep2021/27Oct2021): New information from a contactable Consumer included: the case became valid, events (lymph nodes in her neck enlarged,lymph nodes in her collar bone enlarged, raised rash on her face, raised rash on her ears)
temperature excursion for PROQUAD/administered to patients; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided. On 04-JAN-2021, the patient was administered improperly stored (PROQUAD) 1 dose, 0.5 ml, subcutaneously, lot number: T005404, expiration date: 12-AUG-2021. The vaccine experienced temperature excursion of 32.4 degrees Fahrenheit for 4 hours. Previous temperature excursion was not detected. The data logger was involved.
Fever 38.5C; Body chills; Muscle ache; Severe pain around injection site; Inability to lift arm; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW 0176) via an unspecified route of administration in the left arm on 02May2021 at 15:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included aneurysm and stent in arm for blood clot. The patient had year round indoor and outdoor allergies. Concomitant medications included cetirizine (MANUFACTURER UNKNOWN), pantoprazole (MANUFACTURER UNKNOWN) and biotin (BIOTIN SOLGAR). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received shellfish, tree nuts, shellfish and first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 2613) via an unspecified route of administration in the left arm on 11Apr2021 at 12:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 02May2021, the patient experienced fever 38.5 centigrade, body chills, muscle ache, severe pain around injection site with inability to lift arm. The clinical outcome of the event ever 38.5 centigrade, body chills, muscle ache and severe pain around injection site with inability to lift arm were resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
Joint pain intensified, after 2nd dose; It intensifies after 2 dose; pain all day long. still hurts; got 2nd dose 40 days later; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain intensified, after 2nd dose), CONDITION AGGRAVATED (It intensifies after 2 dose), PAIN (pain all day long. still hurts) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got 2nd dose 40 days later) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    In May 2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Joint pain intensified, after 2nd dose), CONDITION AGGRAVATED (It intensifies after 2 dose), PAIN (pain all day long. still hurts) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got 2nd dose 40 days later). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency; NAPROXEN for Adverse event, at an unspecified dose and frequency and MARIJUANA for Adverse event, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (Joint pain intensified, after 2nd dose), CONDITION AGGRAVATED (It intensifies after 2 dose) and PAIN (pain all day long. still hurts) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got 2nd dose 40 days later) had resolved.            Concomitant medication included  asthma inhaler (as needed).   This case was linked to MOD-2021-229286 (Patient Link).
About 3 minutes after receiving Tdap vaccine the pt fainted. He was sitting in a chair and slid to the floor. Pt is know to fain in the past with tattoos & injection.
I developed severe eczema rash on my hands, fluid filled lesions, were draining.  I went to urgent care where they examined me. I had to get treated for these lesions.
Experiencing super bad headache and it's a long way like weird symptoms where the room is spinning; She can't even walk, eat or drink anything/can't walk on her own; vomiting; vertigo; dizzy; can't walk by herself; nausea; is still is not well; she has not been eating; being dehydrated; This is a spontaneous report from a contactable consumer (Daughter). This consumer reported for a 50-year-old female patient (Mother).   A 50-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number Expiry date, NDC number, UPC number was not reported), via an unspecified route of administration on 10Jul2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number Expiry date, NDC number, UPC number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Reporter stated, I just don't know if you can tell me, my mom and I got the shot on Saturday, but she is experiencing a super bad headache and it's a long way like weird symptoms where the room is spinning, she can't even walk, eat or drink anything and went to the Hospital, and they gave her pills and sent her home and it had been 4 days she had the symptoms. Her mom had her 2nd COVID shot on July 10th and on the Sunday 11Jul2021 she woke up 2 o'clock at the morning. She was vomiting and she has sense then vertigo type symptoms, super dizzy and she has been like that for 4 to 5 days now, can't walk by herself, pounding headache. Daughter took her to the ER yesterday 15Jul2021 at 1:30 and they her gave her fluids because of being dehydrated and they also gave her unknown nausea, anti-nausea pills as treatment. I guess, they gave her, the doctor in the emergency room. She feels a little better with the not being dehydrated. But she is still not well that's why she is calling. She thinks she might get some medical advice. Alright so she disconnected. I guess it took too long. Can you call back? Well yeah, she said I am at a loss at what to do. And so, my interpretation to that she is thinking that we were medical that helps but not really, product not specified. The patient received treatment for the events. At the time of reporting, the outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Saturday, October 3, 2020  Flucelvax given 13:00 IM Left arm  Monday, Oct 5 Extreme fatigue in evening  Tuesday, Oct 6 Awakes with drenched pillow, has myalgias and chills in the morning at work, some relief with apap.  Returns home with extreme chills, no fever.  Begins isolation at home.  Wednesday, Oct 7 Chills and sweats.  Covid tests at hospital collected  Thursday, Oct  Chills and night sweats.  Friday, Oct 8 Chills and night sweats 2 neg Covid tests resulted.  Saturday Multiple night sweats, drenching and requiring 3-4 changes of clothes.  Discovered painful left axillary lymph nodes in morning.  Rides bike  Sunday 10/11/20 Night sweats, changing clothes, functional during the day  Monday 10/12/20 Night sweats Sees Dr in afternoon.  Tuesday 10/13/20 Night sweats  Wednesday 10/14/20 Night sweats decreasing,  only one change by morning Attempts to have blood test, refused at lab because covid test was also ordered - employee states that tests cannot be drawn until covid done and negative.  He states that he has 2 negative test posted in the last week, but is still denied.  Confirmed by Dr that this is not lab policy. Gets CXR in the evening at hospital  and starts Zpak at beditime.  Thursday 10/15/20 Awakes in am- no night sweats! Has blood drawn at lab.  Friday 10/16/20 Feeling better, no night sweats.  Continues Zpak.
This spontaneous report as received from a healthcare worker refers to 10 unspecified patients of unknown age and gender. No concurrent conditions and medical history were reported. On an unknown date (also reported as on either 14-AUG-2015 or 15-AUG-2015) the patients were vaccinated with improperly stored GARDASIL (Lot Number L020162, expiry date 23-JUL-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The action taken with the therapy with GARDASIL was unknown. The outcome of events was unknown. The relatedness of the events to the therapy with GARDASIL was unknown. No product quality complaint was reported. Additional information has been requested.
Pt received PNEUMOVAX & flu vax on 4/28/11, both in (L) deltoid. Pt quickly developed a very large abscess w/warmth, induration and severe pain. Elevated HR in the 160s, temp of 36.7 degrees C. Pt seen at medical center & ED as well as by this examiner in office. Required abx & pain meds.
Muscle Aches, headache, Nausea, no appetited and fever of over 101 for 1-1/2 days.  Arm was a little sore, red a swollen.  In bed for almost 2 days and thought I had a the flu or even COVID.
Patient in perfect health, 18 years old - no prior condition. Patient took 3 doses of Gardasil. Within 1st dose, started feeling constant tiredness and soreness in muscles.  The second dose, started rashes all over arms and joint pain. Upon further investigation was diagnosed with LUPUS. Third dose caused an entire lupus flare up.  Lupus only started upon onset of vaccination. No previous symptoms were ever reported prior to vaccination.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium
Chest pain, SOB, increase HR, increased BP, increased troponin levels. Takotsuba Cardiomyopathy confirmed.
The next day the patient experienced arm pain. It has persisted until the date reported to the pharmacy (10/15/17).
Pt said after getting the vaccine on 6/14, her arm swelled up after a couple of days. The doctor had to drain 2 cups of fluids from her arm. She was diagnosed with cellulitis.
A consumer report has been received. The report concerned a 4 month old, male consumer. On 15-Nov-2012 the patient started receiving nasal FLUMIST. The patient experienced fever and sore throat which started on 16-Nov-2012. Consumer reported that the patient was not sitting upright when he received his dose of FLUMIST. The action taken of FLUMIST was not applicable. The outcome of the event of fever and sore throat was unknown. The report was considered to be non-serious by the reporter.
Couldn't even drive home; As soon as I took the shot I was sick; 15 minutes after the first shot got COVID; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED DRIVING ABILITY (Couldn't even drive home), ILLNESS (As soon as I took the shot I was sick) and COVID-19 (15 minutes after the first shot got COVID) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011620A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced IMPAIRED DRIVING ABILITY (Couldn't even drive home) and ILLNESS (As soon as I took the shot I was sick). 05-Jan-2021, the patient experienced COVID-19 (15 minutes after the first shot got COVID). At the time of the report, IMPAIRED DRIVING ABILITY (Couldn't even drive home), ILLNESS (As soon as I took the shot I was sick) and COVID-19 (15 minutes after the first shot got COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were reported.  The patient was on a high risk category. Patient had pre existences. The patient will have a total knee replacement.  This case concerns a 59-year-old male patient with no details on previous relevant medical history, who experienced the unexpected non serious event/AESI of Suspected COVID after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred immediately after the first dose of Spikevax. The patient reported that 15 minutes after the first dose he felt ill and on the following day was diagnosed with COVID-19. Confirmation test was not reported. The rechallenge for the event COVID-19 is not applicable. The benefit-risk relationship of Spikevax vaccine is not affected by this report.   This case was linked to MOD-2021-361662 (Patient Link).; Sender's Comments: This case concerns a 59-year-old male patient with no details on previous relevant medical history, who experienced the unexpected non serious event/AESI of Suspected COVID after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred immediately after the first dose of Spikevax. The patient reported that 15 minutes after the first dose he felt ill and on the following day was diagnosed with COVID-19. Confirmation test was not reported. The rechallenge for the event COVID-19 is not applicable. The benefit-risk relationship of Spikevax vaccine is not affected by this report.
Information has been received from a RN concerning a patient that tested nonimmune to varicella and who on 06/28/2000 was vaccinated with varicella virus vaccine live. On 07/16/2000 the patient experienced a chickenpox like rash. The patient is very concerned about this  in that at least one other family member, a brother received the vaccine and developed chickenpox and quickly thereafter shingles. The patient stated that he does not have any known immunodeficiency and is very worried since he works with the public. The patient sought unspecified medical attention. Additional information has bee requested.
Vaccine with expiration  date on june 15, 2021.  We receive the vials on may 19,2021 at 9:00am.
Pt developed rashes on both upper & lower extremities. Psr DC. Benadryl 25mg given PO.
Began developing hives on my legs and butt a little over 24 hours after my 2nd dose of Pfizer vaccine. Throughout the evening and overnight, hives extended to other regions of the body and all areas were affected by approximately 7am 4/26/2021. Rash on arm near injection site, and itchy, raised hives over rest of the body have continued throughout the day (current time is 5pm 4/26/2021). I took 50mg Diphenhydramine HCl approximately 7 hours ago with minimal effect.
fever, irritability 8 days after vaccination.  Fever lasted 3 days and ranged from 100.3 to 104.2  1 episode of vommitting on day 3.  Treated fever with motrin and tylenol
Patient was given vaccine past beyond use date of 12/30/22. Vaccine given on 1/4/23.
Muscle weakness, fatigue easily, slight balance instability and small motor control, aches, tiny underskin tics, slight memory sluggishness.  These  have eased a little but not gone away and have affected my day to day ability to perform day to day tasks.
Blistering on right side of face...Forehead...Chills....Eye Lid Swollen..Blurry Vision...Weak...Put on Acyclovir..4 Days Into treatment...Pharmacist did not give me lot number or expiration date.
17OCT92 sl h/a all day, abdo cramping, then diarrhea x 2- nothing 18OCT-19OCT but cramps; also chills 17OCT92; vomited x 1 17OCT92;
Patient broke out on back 4 days later. Looks like shingles or chickenpox bumps.
12/11 Pfizer booster 11:30 pm body tremors.  Temp normal. 12/12 2am 102.4 body aches headache 0605 101.6 body aches headaches Fever stayed low throughout the day 5:15p 102.7 7:20p 101.1 8:45p  101. 12/13 7Am 98.7 Sometime after 12/14, cold sores in left nostril.   Lasted for about 4 days. 1/7/22 Sore throat 1/8/22 Swollen throat.  White spots on back of throat and uvula. 1/9/22 Tried to gargle with warm salt water.  Swelled throat.  Throat still hurts.  Feels like there is something on the back of my tongue.
I developed a dime sized lump on my left palm.  It's firm, and raised.  It became slightly larger over the 2nd and third day.  It's like having a large firm  lima bean under by skin,  There's no pain, no redness, no heat. .  I wouldn't know it was there except when I see it.  I don't  know exactly when after the vaccine that it developed, because I drove home and didn't see my palm until I got home.  I noticed it when I washed up for the evening.  It wasn't as large the first evening, and I thought it would go away.  By Friday it was larger so I called the pharmacy.  They told me to wait until Monday and call back.  On Sunday it was larger and I called back and they told me to report it.
Varicella vax. given at 9:15 am, 1-22-04 Telephone call from patient at 2:00 pm. He states he has fine, red rash on face, no rash else where. No rash on trunk nor limbs. No rash around injection site. No fever. States he feels "fine".
vaginal bleeding; felt head pressure; swallowing issues; felt terrible; pain in her right thigh, arm and knee; pain in her right thigh, arm and knee; pain in her right thigh, arm and knee; lost 20 pounds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 51 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization. The following information was reported: VAGINAL HAEMORRHAGE (medically significant), outcome "unknown", described as "vaginal bleeding"; HEAD DISCOMFORT (non-serious), outcome "unknown", described as "felt head pressure"; DYSPHAGIA (non-serious), outcome "unknown", described as "swallowing issues"; MALAISE (non-serious), outcome "unknown", described as "felt terrible"; PAIN IN EXTREMITY (non-serious), PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "pain in her right thigh, arm and knee"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "lost 20 pounds". The patient underwent the following laboratory tests and procedures: investigation: everything was negative; weight: lost 20 pounds. It was reported that, she got the call from (withheld) in patient assistance program CEP 5570. The caller was a consumer who according to DSU agent stated that, after her second dose of the Pfizer BioNTech COVID-19 vaccine she felt terrible for about four months, she had vaginal bleeding, pain in her right thigh, arm and knee, lost 20 pounds, she felt head pressure and had swallowing issues. Stated that, she got follow up testing and everything was negative. She was due for her booster dose and her doctor told her to hold off, she was nervous to get it because of all that she experienced after her second dose. Asked whether they had additional reports of this side effects.  The lot number for bnt162b2 was not provided and will be requested during follow up.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
pain at injection site. Just below left elbow to the tip of fingers c/o burning and has shooting pain sensation.
pt recvd vax;allergic rxn of unk type w/in 1 hr of vax;12may f/u: angioedema of lips w/ 1/2 hr of vax;pt returned to ofc for exam & was given po anti-histamine;phone f/u next am revealed complete recovery;
The patient developed light-headedness and dizziness along with headache the evening after vaccines were given
This case was reported by a healthcare professional via a sales representative and described the occurrence of not responding to therapy in a 13-year-old female subject who was vaccinated with Hep B (manufacturer unspecified). Concurrent vaccination included Hib (manufacturer unspecified) and DTaP (manufacturer unspecified) both given on 9 October 1998. On 9 October 1998 the infant subject received the final dose to complete the Hep B vaccination series. Years later, at the age of 13, serology showed that the subject did not have protective antibodies. It was reported that the subject did not convert or had not responded to therapy. No additional details were provided. This event occurred in 4 separate subjects. Linked cases are A0941134A, A0941136A and A0941137A.
Pt received Pfizer x2.  Pt tested COVID + on 8/11/21 and admitted to hospital for COVID on 8/11/2021. Pt received remdesivir x2 doses and dexamethasone.
pt rcvd vax; pt died of SIDS aprox 12 hrs after vax;
1/24/22 Attempted to contact patient related to test results. Patient unavailable  No notes listed
Swollen Eyes; Double Vision; Swollen Salivary Glands; Swollen Face; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Swollen Eyes), DIPLOPIA (Double Vision), SALIVARY GLAND ENLARGEMENT (Swollen Salivary Glands) and FACE OEDEMA (Swollen Face) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced EYE SWELLING (Swollen Eyes), DIPLOPIA (Double Vision), SALIVARY GLAND ENLARGEMENT (Swollen Salivary Glands) and FACE OEDEMA (Swollen Face). On 15-Mar-2021, EYE SWELLING (Swollen Eyes) had resolved. At the time of the report, DIPLOPIA (Double Vision), SALIVARY GLAND ENLARGEMENT (Swollen Salivary Glands) and FACE OEDEMA (Swollen Face) outcome was unknown.            Action taken for suspect drug MRNA-1273 Moderna COVID-19 vaccination was not applicable. No concomitant medications reported by investigator No treatment medications provided by the reporter.
The patient received the below vaccination at 12:42. About 25 minutes after the vaccine, he developed a mild rash all over his chest and stomach. The M.D. was called. BENADRYL was ordered, 1.5 ml, 4 x day, for 2 days; and to call PMD on Monday. Baby still has slight rash on abdomen and chest 12/15/08.