chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe pain immediately at site of injection, redness at injection site, developed 2 pink red spots one inch below and half inch to right of  injection site, pain for 2 and 1/2 days. Monday afternoon developed stinging pain of left upper ear, then developed large amount of swelling and blisters with fluid filled pus. Also developed severe itching of ear and crusty drainage for several days. Over the next two days from Tuesday through Wednesday developed various areas of shooting pain.  Developed intermittent pain to top of right foot Developed itching and pain in left scalp that later developed a scabbed over area. Developed painful blisters to right forearm and left lower leg that later developed scabbed area.
On August 11, 2021, I noticed that my legs were becoming numb.  By the next morning, I could not walk or stand up.  I was paralyzed from my belly button to my tippy toes  My legs and feet felt like pins and needles!  I was in excruciating pain. I was rushed to Hospital where I am now presently in the Inpatient Rehabilitation Center.
Headache, Myalgia, Chills Narrative: Missed one day of work following 2nd dose of vaccine
***PT NOTES POSSIBLE REACTION TO VACCINES. WHOLE BODY IS RED, RASH-LIKE, ITCHING since administration. NO TROUBLE BREATHING OR RESPIRATORY ISSUES. ALSO NOTED PREVIOUS ALLERGY TO EGGS, BUT THOUGHT SHE WAS OVER THAT. Adv pt to seek medical attention, especially if symptoms get worse or any breathing issues present.
Pain, swelling at site of injection, body aches, pain, significant malaise/fatigue, fever.
mom stated teach @ school noticed pt arm red 7 swelling 20MAY;mom stated pt c/o arm hurting;21MAY mom noticed redness, swelling-2 inches & induration, hot to touch;taken to MD & it was celulitis;med given;
high shrill crying x 1 hr on & off all noc; unusual crying for pt;
Pt recv vax on 10/15/98; on 10/16/98 pt exp upset stomach x 2-3 day
At time of administration, pt began to cough. Nurse thought that pt may have choked on vaccine, but pt continued to cough then stopped coughing & took remainder of vaccine. Started back coughing and began gasping for air. Mother of pt felt that pt stopped breating for a few seconds, but started back when person holdig her adjusted her position. Pt gasped for air and them appeared fine. The remainder of parenteral vaccines were then given. Pt left office appearing fine. Nurse checked on her via phone call later in the day & her mom reported no problems.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient received the first doses of M-M-R II and (Oka/Merck) VARIVAX on 26-MAY-2011. The patient received the second doses of M-M-R II and (Oka/Merck) VARIVAX on 10-DEC-2014. The patient received the first doses of M-M-R II (dose was not reported, lot # K024036, exp. 26-NOV-2016, rHA) and (Oka/Merck) VARIVAX (dose was not reported, lot # L009204, exp. 17-MAR-2017) on 27-JUL-2015 (extra dose administered). No adverse effects were reported. Additional information has been requested.
white blood cell count was down to 2.3/absolute neutrophils were low/neutropenia; body ache; sore throat; chills; I've haven't had this shift before in lymphocyte; This is a spontaneous report from a contactable healthcare professional.  A 55-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration on 02Jan2021 at single dose for COVID-19 immunisation.  Medical history included MS and saw neurologist in Nov2020, prior to getting the vaccine and at that time did not have the typical blood work drawn which would have been a CBC and CMP and white blood cell could usually runs in the 3.5-3.7.  Concomitant medication included dimethyl fumarate (TECFIDERA).  The patient previously took TYSABRI and had to be taken off of that in 2010 due to evidence by CBC of bone marrow suppression. The patient had IVIG and experienced myelosuppression. Patient participated in clinical trials with rituximab and took VIOXX before it was removed from the market. The patient really loved VIOXX and used to prescribe it to her patients; first dose of BNT162B2 on 17Dec2020 for COVID-19 immunisation.  A week after the patient got the vaccine, she had a sore throat, chills and body aches.  The patient just went to bed early and was fine.  The patient reported those symptoms through the CDC VAERS site. The patient had blood work drawn on 29Jan2021 and was shocked that the white blood cell count was down to 2.3 and absolute neutrophils were low.  The patient was referred to follow up with a hematologist for the neutropenia. The patient thinks this is not related to the Covid vaccine.  The patient haven't had this shift before in lymphocyte and neutrophil count.  On 29Jan2021, CBC and CMP and that is comprehensive metabolic panel, complete blood count and lipid panel. The patient received no treatment. The outcome of white blood cell count was down to 2.3/absolute neutrophils were low/neutropenia was not recovered and other events was unknown.; Sender's Comments: Based on the information available a causal relationship between reported events and  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Information has been received from a physician, via an Agency (manufacturer # not reported), concerning a 16 year old female patient who was vaccinated with a dose of GARDASIL (date not reported). This report was part of a post-marketing surveillance program. Subsequently the patient passed out after administration and broke nose after falling. The event required a visit to the emergency room. Diagnostic tests carried out to diagnose the AE were blood work and blood pressure (results not reported). The patient recovered with sequelae. It was reported that therapy with GARDASIL was discontinued and that the events diminished after stopping therapy. The reporting investigator felt that passes out and broke nose were related to study therapy. Upon internal review it was considered that passes out and broke nose were other important medical events because the reporting investigator reported it as serious and no serious criteria were reported. No further information is available.
Extreme skin sensitivity to torso (chest & back) on left side parallel to the injection site, shingles type sensitivity without a rash or redness
A non-serious spontaneous report of "tested positive for influenza A has been received from a consumer, patient's mother, concerning a five-year-old female subsequent to H1N1.  The patient's medical history and concomitant medications were not reported.  The patient received H1N1 on 23-Oct-2009.  On 22-Oct-2009, the night before receiving H1N1, the patient had a headache.  After receiving the vaccine, on 23-Oct-2009, the patient "was in tears because her headache was so bad."  On 23-Oct-2009, the patient also experienced a fever of 100.4F, and it went up to 102.8F on 25-Oct-2009.  On 25-Oct-2009, the patient also vomited a few times, had a cough and nasal discharge.  The reporter stated that she thought her daughter had a sinus infection.  On 26-Oct-2009, the patient tested positive for Influenza A.  The reporter was not sure if her daughter experienced adverse reactions to the H1N1 or if she was infected with the circulating novel H1N1 strain.  The outcome of the event was not provided.
A few days after receiving the first dose I started having allergic reactions to certain food that I usually eat normally. After certain foods/sauces touch my lips they begin to tighten up and puff up. I suspect it may be my immune system being more active then usual due to the anti-bodies being produced. I've never had a lip allergy before. This allergy reaction has been ongoing ever since the 1st dose. It is extremely frustrating to eat foods now.
This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown gender who would be 4 years old. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M023384 and expiration date on 20-JUL-2018 of lot # M033906 with expiration date on 06-JUN-2019 (dose and route of administration were not reported) for prophylaxis. The reporter could not provide details of which lot number the patient received. The doses of VARIVAX were exposed to a temperature excursion of 14.9 degrees Fahrenheit (°F) during a time frame of 11 hours, which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported. This is one of the several reports received from the same source.; Sender's Comments:  US-009507513-1710USA008686: US-009507513-1710USA008693: US-009507513-1710USA008688: US-009507513-1710USA008689: US-009507513-1710USA008690: US-009507513-1710USA008691: US-009507513-1710USA001141: US-009507513-1710USA008685: US-009507513-1710USA008684: US-009507513-1710USA008687:
I started getting fever and chills around 11pm the night  following the vaccine. This progressed through the night with an eventual fainting episode at about 4am.
pt recvd vax & several days p/vax exp elevated liver function tests;sx subsided w/ the 5OCT94 test;
I was supposed to go back on 15Feb2022 for the 2nd one; 3-4 days later, I had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (3-4 days later, I had a sore arm) and PRODUCT DOSE OMISSION ISSUE (I was supposed to go back on 15Feb2022 for the 2nd one) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced PAIN IN EXTREMITY (3-4 days later, I had a sore arm). On 15-Feb-2022, the patient experienced PRODUCT DOSE OMISSION ISSUE (I was supposed to go back on 15Feb2022 for the 2nd one). At the time of the report, PAIN IN EXTREMITY (3-4 days later, I had a sore arm) had resolved and PRODUCT DOSE OMISSION ISSUE (I was supposed to go back on 15Feb2022 for the 2nd one) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information was reported.  Patient started to experience event 3-4 days after vaccination. Patient received full dose of dose 1 and patient did a lot of lifting at work, so guessed it took awhile to come.  No Treatment information was reported.
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-163-4261290-00 (RA). A 63-year-old female patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, on 19Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 18Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for Covid-19 immunisation; adalimumab (HUMIRA), first regimen (Lot number: 1155267) till 2021 at citrate free and second regimen since Oct2021 (Lot number: 1155267) at citrate free (increased to weekly dosage (1 in 1 wk.)), all subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The reporter's assessment of the causal relationship of "polymyalgia rheumatica", "fatigue", "sore arm with all Pfizer Covid vaccines", "inflammation", "abdominal distress" and "nausea" with the co suspect product adalimumab (HUMIRA) was not provided at the time of this report and the reporter's assessment of the causal relationship of "fatigue", "sore arm with all Pfizer Covid vaccines and "abdominal distress" was possible with suspect product BNT162b2 and of the event Polymyalgia rheumatica and Inflammation  was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on available information the events of  Inflammation, Pain in extremity, Abdominal discomfort, Fatigue, Nausea, Polymyalgia Rheumatica are assessed as possibly related to the suspect vaccine BNT162B2 based on causal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Arm in which injection was given (left arm) became swollen and sore. There was a small rash around the injection site-she had taken Ibuprofen and was feeling better the next day.
upon rising from a sitting position my legs would not hold me up.  I could not walk without someone helping to keep me from falling.  My legs around the knees and lower thigh area were having spasms  just momentarily.  I went to bed, slept well and next day everything was fine.  No pain associated with episode.
Pt come in for a flu vaccine, patient received flu vaccine, but did not get the one that was appropriate for her age. Due to being 64, she should have received regular flu quad vaccine, but was given fluad quad instead.  PT waited 15 after vaccine, no adverse reactions observed.    Attempted to contact patient about the mix up, no contact information has been given to us. As of today, there has been no attempted contact from the patient to report any adverse reactions for the vaccine.
Feel sick; This spontaneous case was reported by another health care professional and describes the occurrence of MALAISE (Feel sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.   On 05-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced MALAISE (Feel sick). At the time of the report, MALAISE (Feel sick) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter stated that their son who was the patient took the shot on 05-Jan-2022, Wednesday night. And got up this morning on 07-Jan-2022, feeling sick and can smell.  No treatment information was provided.
Sore arm; Achy arm worse earlier; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and MYALGIA (Achy arm worse earlier) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Nov-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and MYALGIA (Achy arm worse earlier). At the time of the report, PAIN IN EXTREMITY (Sore arm) and MYALGIA (Achy arm worse earlier) was resolving.            No concomitant medications were provided.  Patient's sore, achy arm that was worse earlier but now was little better on 15-Nov-2021.  No treatment medications were provided   Reporter did not allow further contact
Pain made sleeping extremely difficult; significant pain in muscle between right shoulder and base of skull/severe pain in muscle between right shoulder and base of skull; significant pain in muscle between right shoulder and base of skull; sleepy; This is a spontaneous report from a contactable Other HCP.   A 71-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6203), via an unspecified route of administration in left arm on 04Mar2021 at 10:45 as a single dose for COVID-19 immunization. The patient's medical history included idiopathic grand mal epilepsy. The patient's concomitant medication included phenobarbital, primidone, phenytoin and atorvastatin. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient had no known allergies. . On 04Mar2021 at 16:00 (Thursday), the patient experienced sleepy. On 05Mar2021 at evening (Friday), the patient experienced significant pain in muscle between left shoulder and base of skull and on 06Mar2021 (Saturday evening) experienced severe pain in muscle between right shoulder and base of skull and pain made sleeping extremely difficult. The patient received Motrin 800mg somewhat alleviated with pain. The patient did not undergo COVID test post vaccination. The outcome of the event was not resolved.  No follow up attempts are possible. No further information was expected.
This spontaneous report was received from an adult female patient referring on herself via company representative. The patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date in February 2008, the patient was vaccinated with the first dose of GARDASIL (strength, lot number, anatomical location and expiration date were unknown) for prophylaxis when she was 13 years old. On an unknown date in September 2008 and in July 2009 the patient had received 2nd and 3rd doses of GARDASIL (strength, lot number, anatomical location and expiration date were unknown) (inappropriate schedule of product administration). On an unknown date, the patient was diagnosed with cervical cancer (cervix carcinoma) after receiving a CIN1 (Cervical intraepithelial neoplasia) during a pap smear test. On an unknown date in March 2019 a lead producer was performed to scrape out part of cervix. The patient sought medical attention and visited physician. The outcome of cervix carcinoma was reported as recovered. The causality assessment between the GARDASIL and cervix carcinoma was not reported. Upon internal review the event cervix carcinoma was considered as medically significant.
Dizziness Narrative: Employee reports began feeling symptoms of injection site discomfort, dizziness, weakness, and "heavy breathing" approximately 12 hours after receiving first dose of vaccine. Reports no medications were used for symptom relief. No further information provided.
This hospice patient lives in facility and our team went to give vaccinations to all elderly resident on 1/26/2021. The facility reported to our nurse that patient received Pfizer vaccine at 12;37pm and went unresponsive at 12:55pm and immediately given 1st dose of epinephrine and followed by another doe of epinephrine after (total of 2 doses was given) has an allergic reaction. Patient recovered.
This case was reported by a nurse and described the occurrence of vomiting in a female pt in her early twenties who received hep B vaccine recombinant (Engerix B). On 13Apr04, the pt received the first dose of Engerix B in her right leg (lot ENG5466A4). On the same day of the admin of Engerix B, on 13Apr04, the pt experienced an itchy rash on her leg. The reporter did not state which leg was affected. The itchy rash resolved in a couple days on an unspecified date in Apr 2004. On 25May04, the pt received the second dose of Engerix B. On the same day of the admin if Engerix B, the pt experienced vomiting. The vomiting resolved in 24 hrs, on 26May04.
I was 14 weeks and 6 days pregnant at the time of my COVID booster. This was my third pregnancy, the first resulted in a full term healthy baby, the second in a miscarriage at about 8 weeks. At the time of my booster my pregnancy was healthy with no complications. At 33 weeks and 3 days I noticed no movement of my baby and went to the doctor the following day, at which point my baby was delivered (33 weeks 4 days) via emergency caesarian due to an extremely rare pregnancy complication, a fetal maternal hemorrhage, that was causing my baby to become dangerously anemic. My baby was born weighing 2440 grams and spent 17 days in the ICU. I have no idea if this was related to the vaccine but given the rarity of the condition I wanted to report it.
Janssen COVID-19 Vaccine EUA  Pain under my left armpit. Pain lasting for longer than 2 days.
Seizures as reported by mom (21 seizures observed).  Nurse follow up on 05/18/04 states: tonic-clonic, lethargy, irritable.
arm really hurt/ pain; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In September 2021, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced pain in arm. The patient was treated with non-drug therapy (Cold Compress). On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received a dose of Shingles vaccine and his/her really hurt for 3 days. The patient would go for the second shot in November. The patient was told to keep moving the arm and keep the medication moving through. The patient even applied ice on it for the pain. The patient do believe it was good move getting it. Follow-up would not be possible as no contact details available.
A non-serious spontaneous report of chest tightness, itching, and head to toe hives has been received from a MedImmune Sales Representative concerning a 46-year-old female, subsequent to FLUMIST. The patient's medical history and concomitant medications were not provided. The patient received her first dose of FLUMIST on 23-Oct-2009. Within five hours of receiving FLUMIST, the patient experienced head to toe hives, chest tightness and itching. She was treated with steroids. The outcome of the events was not provided.
SWOLLEN AND HOT TO THE TOUCH LEFT TRICEP.  DIAGNOSED WITH CELLULITS BY AN E.R. PHYSICIAN. GIVEN IM SHOT OF ANCEF AND 20 DAYS AUGMENTIN.
Approximately 5 minutes post vaccination patient had numbness from shoulder to hand; This is a spontaneous report from a contactable other healthcare professional. A 53-years-old female patient (pregnant: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6203), via intramuscular on 26Feb2021 at 15:30 (at the age of 53-years-old) as dose 1, single for COVID-19 immunization at public health clinic/veterans administration facility. Medical history included MS (multiple sclerosis). The patient's concomitant medications were not reported. No known allergies. It was unknown if the patient received any other vaccine in four weeks or other medications in two weeks. It was unknown if the patient had COVID prior to vaccination and unknown if tested for COVID post vaccination. On 26Feb2021 at 15:35, approximately 5 minutes post vaccination patient had numbness from shoulder to hand. Numbness improved approximately 15 minutes post vaccination. Continued observation for additional 15 minutes. The patient was discharged at 15:38. The patient did not receive treatment for the adverse event. The outcome of event was resolved on an unspecified date in 2021.  No follow up attempts are possible; no further information expected.