chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed local reaction to injection site of varicella vaccine about 12 days post-injection. Had vague fatigue 3 days post-injection, (+) sweats 1 week post-injec. txed w/ibuprofen and cold packs.
Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 68-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: NDC-59267-1000-01) via an unspecified route of administration on 22Aug2021 at 03:45 in the left arm (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included shrimp allergy. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Jul2021 at 04:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. On 23Aug2021 at 16:00, the patient experienced diarrhea. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event diarrhea was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
No taste Muscle pains over the entire body Sore Throat Constant Cough Weak & Extremely Fatigued Nausea - throw up after eating Started within 7-8 hours of receiving the vaccine Took 2 Tylenol Felt better by the third day (Monday)  - nausea has persisted and throat remains a bit sore and still cannot taste food
Patient said he is unable to move his arm and it is in extreme pain. He picked up a medrol dose pack, tramadol, and ibuprofen.
Patient received both vaccines around 4pm, she reports that she started feeling nausea around 7pm and began around 9pm which continued until 3am. She took a zofran and the nausea/vomiting resolved.
elevated blood pressure; fever (102.4); cough; nausea; rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (non-serious), outcome "recovered", described as "elevated blood pressure"; PYREXIA (non-serious), outcome "recovered", described as "fever (102.4)"; COUGH (non-serious), outcome "recovered", described as "cough"; NAUSEA (non-serious), outcome "recovered", described as "nausea"; RASH (non-serious), outcome "recovered", described as "rash". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The symptoms lasted approximately 7 days first time and lasted approximately 4 days most recently. The patient underwent lab tests and procedures on an unspecified date which included: blood pressure measurement: elevated; body temperature: 102.4.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Took shot about 2:00 then went to Emergency room at 5:30 for complains of swollen jaw, stiff neck, slumped shoulder.  Had jumped off cabinet about 8:30 same day.  Emergency room physician could not say whether from jump or shot.  Saw private physician on 4-29-2005 and said same thing.
Developed a 2.5 inch lump on the left arm at the site of meningitis vaccine.  Reported muscle twitches for the 2 days prior to the lump developing.
bodyache; feeling bad/It was hitting him pretty hard; Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PAIN (bodyache) and FEELING ABNORMAL (feeling bad/It was hitting him pretty hard) in a 21-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect products included non-company products UPADACITINIB (RINVOQ) for Atopic dermatitis, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   On 20-Sep-2022, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram. On 27-Oct-2022, the patient received dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), PAIN (bodyache) and FEELING ABNORMAL (feeling bad/It was hitting him pretty hard). At the time of the report, CHILLS (Chills), PAIN (bodyache) and FEELING ABNORMAL (feeling bad/It was hitting him pretty hard) had not resolved. Not Provided      The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was unknown if patient was enrolled in COVID-19-Vaccine Trial. The patient received the Bivalent covid Vaccine and Flu Vaccine on 26 Oct 2022and 27 Oct 2022. He was experiencing. Chills and body aches and feeling bad. It was hitting him pretty hard. He felt like it was a reaction to one of the vaccines, but not sure which one.  The MPID number for Moderna COVID-19 vaccine is 4782591. The MPID number for Pfizer BioNTech COVID-19 vaccine is 4782534.  No Concomitant medication was reported. No treatment information was provided.
pt recvd  vax;to er w/ swelling of upper lt arm;inject site was erythematous & swollen & it burned; 9feb95 still swollen; tx dph & recovered
Hives/urticaria - started BENADRYL cont to spread and break out. Added ZYRTEC once daily, ZANTAC BID. Hives resolved on approx. 7-31/8-1.
After second dose on 09/20/2021, I got a fever, chills and body aches at 6pm. At 8pm l, a small red rash appeared on my arm where the injection was given. Fever continued throughout the night. On 09/21/2021 I woke up 6am to a fever, chills, body aches and a larger red spot on my arm that was painful and itchy. Lasted throughout the day. I was also very foggy headed and sleepy. Noticed my left armpit was sore.  Lasted all night. On 09/22/2021 I woke up to a fever again , very achy, my arm was very red, hot to touch and itchy. Also noticed the lymph node in my armpit was swollen as well as one by my collarbone. Fever broke around 12pm after taking Tylenol. Contacted my doctors office and they advised taking Benadryl and reporting symptoms.
Narrative:  Had reaction of vomiting x 2 days after covid vaccine dose #1; also experienced severe dizziness that had him "crawling on hands and knees" as he had lack of balance for 9 days following the injection. Wife monitored vitals throughout symptoms and they were always wnl. Never tested for COVID-19 at this facility.
OFF-LABEL USE; WRONG TECHNIQUE IN PRODUCT USAGE PROCESS; This spontaneous report received from a pharmacist concerned multiple patients. 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 expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced off-label use, and inappropriate dose of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off-label use and inappropriate dose of vaccine administered was not reported. This report was non-serious.
Case number PHEH2013US023745 is an initial spontaneous report received from a pharmacist on 11 NOV 2013. This report refers to a 66-year-old female patient. She was vaccinated with an expired vaccine of FLUVIRIN 2012/2013 (batch number 123303, expiry date: JUN 2013) at a dose of 0.5 ml intramuscularly on 18 OCT 2013. No adverse event was reported following this medication error (expired vaccinated used).
Information has been received from a physician concerning a 19 year old female who received a first dose of varicella virus vaccine live on 8/1/97 without any problems. On 9/14/04 she was vaccinated with a second dose of varicella virus vaccine live (647263/1136N). On 9/17/04 the patient complained of non-specific myalgia. On 9/18/04 she developed on the ventral aspect of her forearm small lesions which were red macules, not quite vesicular, pruritic and erythematous. The patient had received the injection in the right arm, but the rash was greater on the left arm. It was noted that the patient only had one lesion on her trunk/lower abdominal area. The physician questioned whether treatment was needed and if the patient can continue to attend college classes. No additional information was available regarding the patient's event. Follow up received from a physician who reported that the patient has not been seen and the practice is unaware of any changes. The physician mentioned that she has not seen the patient since that last visit. No additional information is expected.
sore arm; nausea; headache; fatigue; ; got a sore throat and rash but the rash happened two days after the vaccine - rash was on my feet, knee and hands. It was pretty itchy, got really red bumps; had to put some cortisone cream on it. The rash lasted through day four (so had it day three and four). The rest of the symptoms got the worse the next day after the vaccine and slowly disappeared within about four days after vaccine. Sore throat went away at day 3. When the rash got to my fingers, I had a healthcare screen telemed through my doctor's office -  and they had me go to Urgent care where my PCP is located.  Just did visual examination and they did not tests.
Pt's husband called saying that wife is experiencing sharp pains on the left lower side of back. Pharmacist advised pt's husband that she should go to an urgent care facility.
We traveled in May 23, 2022, to get home we had to take a COVID19 test to board a plane to come home. The test was negative. I thought I was getting a cold, I took a test on June 22, 2022 and that test came back negative. I was still feeling unwell on June 23, 2022 so I tested again and this time it came back positive. I called the doctor and she prescribed PAXLOVID for five days. The first two days I was really fatigued and slept a lot but after that it felt like a summer cold.
Pt received injection and immediatly has syncopal episode.  911 Called and pt transport to local ED
Fever, chills, rapid heartbeat, muscle aches, headache, abdominal pain, weakness, fatigue, nausea
No Adverse events noted. Father told all that asked daughter was 16 years old and lied.
Information has been received from a nurse practitioner concerning a patient who on 11-OCT-2010 was vaccinated with PNEUMOVAX 23 0.5 ml IM (LOT # 664556/1307Y, EXP 21-JAN-2011). The patient experienced injection site swelling and pain. Follow up information from the nurse practitioner who reported that apparently the patient encountered severe injection-site reactions (redness, swelling pain radiating to the armpit and difficulty moving the arm on the patient) after vaccination which eventually improved. The clinic would like Merck to initiate an investigation of this lot but they would not use the lot unless Merck checked it again. This is one of several reports received from the same source. At the time of the report, the patient was recovering. The nurse requested a lot check. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question (lot # 664556/1307Y) were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
The patient first came to pharmacy on 9/30 complaining of bruising and soreness at the injection site. There was extensive bruising below the injection site down to her elbow. It occured around her arm except the back. She asked the advice of the RPh, and he said that should could bruise easily due to her age.  She came back again on 10/8 complaining that the injection site wasn't healing.  Told the patient to put Neosporin on the wound.  She told the RPh she has been but the scab would come off and not heal completely.  The RPh said the injection may have been given in the Bicep muscle instead of the Deltoid.
I had spontaneous uncontrolled vomiting and diarrhea at the same time, which I treated with hydration. This occurred on the same day of the vaccine.
Migraine headache 17 hours after vaccine.  Took Maxalt about two hours later.
I broke out in a bumper crop of psoriasis - legs, arms, buttock, female private area, and scalp; My immune system go bonkers from an injection; This case was reported by a consumer and described the occurrence of psoriasis in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced psoriasis and immune system disorder. On an unknown date, the outcome of the psoriasis and immune system disorder were not recovered/not resolved.   The reporter considered the psoriasis and immune system disorder to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix and she broke out in a bumper crop of psoriasis included legs, arms, buttock, female private area and scalp. She never had psoriasis before and for 5 months this plaque psoriasis was so annoying and it was ugly in her scalp. Her primary physician looked that and mentioned that many do break outs this way. Her immune system went bonkers from an injection. The follow up consent has been requested. This case has been linked with US2020AMR039762 for the same reporter.
About 20 min after I received the vaccine, I was driving home and all of a sudden I got extremely hot, flushed, very sweaty. I was sweating so much my hands were slipping on the steering wheel. I was shaking and felt faint, dizzy. I almost pulled over and and called an ambulance, I never felt this way before, there was this crazy rushing feeling through my whole body. I made it home and sat down, after  some time I slowly started to feel better, about two hours later it completely went away.
Left thigh had 14.5 x 8 cm erythema and induration. Treated with Prelone, Benadryl, and cold compresses.
No adverse event; Patient received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap).    Patient was never vaccinated with any other COVID-19 vaccine in the past. Patient age was between 6 months to 5 years.  Concomitant product use was not provided by the reporter.  It was reported that the incidents started in May-2023 and they just noticed it (Lot number 215K22A and Exp. Date: unknown), (Lot number 216K22A and Exp. Date: unknown).  Treatment information was not provided.  This case contains information about patient 4 out of 11 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-740029.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-740029:Patient 04 out of 11
Rapid, pounding heart beat. Resting heart rate of 150+ 48 hours after shot. Consistently over 100 bpm for 3 days. Shot was Monday, Was taken by ambulance Wednesday night for chest pain, rapid heart rate, shortness of breath, disoriented. Was monitored and given fluids until heart rate came down. Friday at 1:30 pm ended up back in the ER for chest pain, rapid heart rate, dizziness. Was admitted and received bloodwork, ekg, chest X-ray, CT scan for blood clots. Today is Saturday and rapid heart beat and chest pains still happening.  Injection site also still very swollen red and hot to the touch. I feel weak and exhausted.
p/vax pt exp paresthesia of extremities;pt stated not able to feel body & tingling, general bad feeling upon waking from nap;
Shingles; Dose 1: 26Dec2020 ; dose 2: 12Jan2021; This is a spontaneous report from a contactable other healthcare professional, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283) via an unspecified route of administration on 12Jan2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1685) via an unspecified route of administration on 26Dec2020 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. On 30Oct2021, the patient experienced shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and was unspecified. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles was unknown at the time of this report.
Induration, vesiculation in area of injection. Needle scratch result from pt. Child kicking at time of injection.
Initial unsolicited report received from a Healthcare professional via other company (Pfizer) on 04 March 2016. Manufacturer Report Number: 2016114783. This case involves a female patient (age was not reported) who was vaccinated with a dose of Flu Shot (batch number, expiration date, route and site of administration was not reported) on an unspecified date. It was reported that patient had no problem when she received flu shot this year. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had sore arm. Lab data and corrective treatment was not reported. Patient was recovered from event as it was reported that patient had sore arm for a day or two. List of documents held by sender: none.
pt admitted to hospital and tested positive for COVID 10/30/21 s/p receiving 2 doses of Moderna on 1/22/21 & 2/19/21
Complaint of chills, elevated temperature, headache, runny nose/congestion, myalgia and malaise.
Moderna COVID-19 Vaccine EUA Soreness at the injection site.  Fever (101).  Stiffness and pain in every joint in my body. Duration 24 hours.
May 14, 2021: Went to a bar with friends and only had 1/2 beer until began feeling nauseous and anxious. These symptoms went on for 10 minutes or so. Figured it would go away until my vision began getting blurry/tunnel vision and my hearing faded. I began walking to the bathroom to escape the public crowd but fainted while walking to it. My friend came over and helped me up and brought me into the bathroom and that is when I subsequently fainted again and  both vomited and passed a bowel movement. Woke up and felt completely normal. I was fainted for a total of a minute or so.  September 17, 2021: Went to the with dad and uncle. Had a couple drinks that night but was not intoxicated. Was standing in a circle talking to group of people when I suddenly fainted with no warning. Vision and hearing faded in a matter of seconds. Fell forward and hit my head on the corner of a 3-foot tall brick wall. I would have split my head open and potentially died, but a man's hand was on the wall and it acted as a buffer between my head and the wall. Was out for ~30 seconds and woke up. Stayed sitting down but felt completely normal.   NOTE: I have never fainted in my life prior to these two events which occurred after getting the vaccine.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with expired ZOSTAVAX (lot #: 669639/0613AA, exp date: 30-JUN-2012) on 03-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Additional information has been requested.
Within hrs of receiving vaccine, become febrile, body aches, dry cough. Went to Emergency clinic w/in 48 hrs. after symptoms became worse. Over the course of days, diagnosed with pneumonia then ARDS & ventilated in ICU for awhile. Still recovering (lungs) nonsmoker - nonasthma.
booster; blood clot behind his left knee; pulmonary emboli; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for Covid-19 Immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; THROMBOSIS (medically significant), outcome "unknown", described as "blood clot behind his left knee"; PULMONARY EMBOLISM (medically significant), outcome "unknown", described as "pulmonary emboli". The clinical course was reported as follows: The reporter had a gentleman friend who was a friend of their family that experienced a blood clot behind his left knee just like the reporter did after he had his booster and pulmonary emboli.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : PFIZER INC-202200038366 same reporter/RA, different patient
Patient developed a few days of low grade fever and then a prolonged febrile seizure (20 minutes in length per the family); the febrile seizure was 15 days after the vaccines. There were no other obvious signs of illness. Flu testing in the ED was negative.
I woke early a.m. shaking uncontrollably and continued to shake for approximately 2 hours.  I put extra blankets on the bed and tried to stay calm until the shakes subsided.   The following day  I had a soreness on the left side of neck for two days.  No treatment.  I assumed both episodes were vaccine related and so reported it.  I have not experienced any further problems.
For the past 4 weeks, I?ve had a low-grade fever, chills, sweaty hands/feet, cough, sore throat (on and off),  sore tight muscles throughout body,  and vomiting/diarrhea.  NSAIDS do nothing to reduce the fever.