chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable Nurse Practitioner via Pfizer's sales representative. A male patient of an unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration at 0.5ml, single on an unspecified date for immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced cellulitis on most of his arm on an unspecified date with outcome of unknown.; Sender's Comments: The current information is very limited and does not allow a full medically meaningful assessment, especially lack of the following: complete medical history and location site of vaccination, concomitant medications, and event detailed description including onset date.  Assessment is postponed after receipt of a more complete case report.  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.
I experienced extreme fatigue and mild nausea. My diagnosis was confirmed with a PCR test.  The symptoms lasted for about 6 days.
left breast and nipple were itching on; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 1, single and administered in arm left (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PRURITUS (non-serious) with onset 01May2021, outcome "unknown", described as "left breast and nipple were itching on".  Additional information: she got both Pfizer Covid shots and they both took effect 01 May. Does not know, but her left breast is very itchy and her left nipple is very itchy in the same arm she got her shot, the left arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
According to resident's father, she filled out the online survey for the COVID-19 Vaccine clinic. Her father took her for the vaccine.  A flaw in the screening process did note note the age of 17yr until immediately after the vaccine was given.  Vaccinator understood that resident was 18yrs or older as the clinic was clearly for "persons 18 years and older" per the clinic advertisements and survey form completed.  Father was immediately notified and verbalized concern that resident might not be able to get the second vaccine.  RN explained that Moderna may soon be available to 16 years and over but until then the vaccine could not be given per EUA  until that time.   RN asked that father would allow resident to stay longer than the 15 min. monitoring period for which he agreed. No SE at this time noted or reported.  Resident was in no observable distress.  Father verbalized a clear understanding of all info provided.  LATER: RN recommended father inform resident's doctor of the issue.
Pt recv vax on 3/3/98; on same dy pt exp red, raised rash on arms, chest, stomach & back
Pt. was seen at Center for Covid vaccination. Pt. was given a Pfizer Bivalent booster when he had already received a Jansen primary vaccine on 5/26/21 and a Moderna booster on 10/31/22.
lost of her hearing in her right ear; had a "budding sound like a bee" in her ears.; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no. and expiry date were not reported), via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date in Jan2021 (reported as a couple hours or the day after the injection), the patient couldn't hear from both ears and had a "budding sound like a bee" in her ears. She specified it only persisted in her right ear and they are concerned that she will permanently lose her earing. The patient consulted an audiologist who said she has a "lost of her hearing in her right ear" after vaccination. She added she also went to the urgent care twice and once to the ER. The patient decided not to take the second dose of the vaccine. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Night vaccine given patient started with fever. Took Aleve and fever went away. Next morning 10/16/2013 shingles shot site swollen and hot to touch. Single large vesicle formed at site. On 10/17/13 site started to become painful to touch, pain 7 out of 10. Site still painful to touch today but swelling has gone down and no longer warm to touch. No additional fever and no hard lump under skin. Patient called clinic today 10/21/2013 and advised to see PCM due to site still being painful and to call clinic back if could not see PCM in next 24 hours.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt three days after vaccination) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt three days after vaccination). At the time of the report, PAIN IN EXTREMITY (arm hurt three days after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided by reporter. No concomitant medication was provided by reporter.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent, reported for his daughter (patient) .  A female patient received bnt162b2 (BNT162B2) (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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information:Agent states the reporter on the line states they took the first dose yesterday, clarifies his wife and his two daughters. States the reporter was experiencing side effects, body aches, nausea, and tiredness. States his wife was experiencing a sore arm. Agent states the reporter was asking if those side effects are normal and if they will be up until the second dose. Agent provided reporter with medical information team. reporter states his wife and daughters are experiencing a sore arm, states his wife was also experiencing the tiredness.Reporter really just wants to know how long these symptoms are going to last. States if they are going to last until the 21 days until the second dose, he may not get the second dose because he does not like the way he was feeling. Also wants to know how effective the vaccine was if he only gets the one dose. Reporter declines to provide information for a report at this time, states he does not have time, just wants the answers to his questions.  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-2021518721 same reporter/product/event, different event.
Though I did not have this for my first two shots, I got an allergic chest rash a day or two after my booster.  I did not feel sick, but a chest rash is my allergic reaction to the medication dextromethorphan.
No other adverse effects; inadvertently given one dose each of VARIVAX and PROQUAD; This spontaneous report was received from a registered licensed practical nurse concerning a patient of an unknown age and gender. The patient's concurrent conditions and medical history were not provided. The patient's concomitant therapies included sterile diluent.     On an unspecified date, the patient patient was inadvertently given one dose each of   varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot# R018932 expiration date 02-JUL-2020) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot# S012533 expiration date 20-OCT-2020) both for prophylaxis during the same office visit (strength, dose and route were not provided). No other adverse effects were reported in the patient.
Sore and painful at vaccination site. Left upper arm leading to persistent shoulder and elbow pain and tingling; concurrently its pain/flare right thumb IP R>L 1st metatarsal; less so all toes. Also general malaise, this symptom subsiding.
Both lymph nodes under both arms been swollen for last two weeks but producing much burning pain and spasm in muscles in chest. And shivering inside at night in particular. Some shooting muscle pain in legs early on. Fading last day a bit. Had to get muscles relaxants and strong antiinflamatory but getting batter last day on just Tylenol. Had to get heart and chest X-ray but all looks normal. Saw doc twice. Believing it will get better soon as doc said it should subside bc had to postpone second shot til a week later April 26.
Pain behind head near left shoulder. The vaccine when injected felt as if it was hitting the bone.
Pt recvd 1st dose of Engerix-B vax on 02AUG90 & 2nd dose on 18SEP90 & exp sore arm & lightheadedness for a few minutes; sx disappeared; w/in 2 min of 2nd dose, pt exp chest tightness & lightheadedness for several hrs;
A nurse reported that a 51 year old female inadvertently received an overdose of vax. On 11/5/99, she developed flu symptoms. As of 11/12/99, her symptoms persisted.
Insomnia since day 2 after vaccine can only sleep an hour or 2 at a time with sleep meds. Get jolted awake, never experienced anything like this.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 14Jul2021 at 11:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not had any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19.The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient previously received cefalexin (KEFLEX) and erythromycin (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and experienced drug allergy. On 16Jul2021 at 23:00, since day 2 after the vaccine the patient experienced insomnia can only sleep an hour or 2 at a time with sleep medicines. Get jolted awake, never experienced anything like this. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event and included treatment with Trazodone for sleep but it didn't help. The clinical outcome of the event insomnia was not resolved at the time of this report.
This spontaneous report as received from a healthcare worker refers to a infant female patient of unknown age. The patient's pertinent medical history and drug allergies were none. On 29-JAN-2016, the patient was vaccinated with oral, ROTATEQ 2 ml (lot # L026740 and expiry date: 16-APR-2017) via oral route. Concomitant medications were none. The patient experienced constipation for 2-3 days immediately after wards. The patient's mother sought medical attention by calling the physician's office on 02-FEB-2016 and a treatment of corn sugar syrup (KARO) syrup and water was prescribed. The reporter stated that on 02-FEB-2016, the following directions were given to the mother: That the mother should call back if the constipation does not resolve and no further contact was made to the physician's office by the patient's mother. The reporter also stated that another physician did not want to give the next dose in the series due to the adverse effect. The outcome of constipation was reported as recovered. The causality of the event was not reported. No product quality complaint (PQC) was reported for oral ROTATEQ. Additional information has been requested.
Bell's Palsy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's Palsy) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bell's Palsy) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered BELL'S PALSY (Bell's Palsy) to be possibly related.    Concomitant medications were not reported.  The patient reported that a few days after the first dose, he experienced numbness in mouth and drooping of face on one side with very little movement  On an unspecified date, he went to the emergency room (ER) and was diagnosed with Bell's palsy. He reported some improvement, but drooping of eye and lip on left side continued.  No treatment information was provided.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up received and does not contain any new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
According to patient the morning after receiving the vaccines her right arm was really sore but no swelling. She had aches and pains all over body including: feet,knees, hips, buttocks, and stomach. The following day 10/14 she felt much better but had 100.5 temp.
Breakthrough Case of COVID-19,  I was sick for a week or two after COVID-19, My symptoms we flu like symptoms.
Headache, Myalgia, NauseaVomiting, Fatigue. Narrative:
100 degrees fever, body aches, ill after 1st injection 8-10 hours sore all over, lymph nodes tender (neck, axilla,groin), more intense body aches 8-10 hors after 2nd injection, missed work the next day, still felt off on Sat. Fever also. Took Tylenol.
This spontaneous report as received from a vaccine coordinator and refers to three unspecified patient of unknown age and gender. Information on medical history, past drugs, concurrent conditions were not reported. On 24-JUL-2017, the patient was vaccinated with VARIVAX, (lot # N001528, exp date: 13-JAN-2019, dose, frequency were not reported) for prophylaxis. Concomitant therapy included sterile diluent (Merck injection, lot #N006322; Exp date: 11-JUL-2019). No adverse effects were reported. All adverse event fields were applicable to all the patients. Temperature was 11 degree Celsius (C), (incorrect product storage). Time frame was for a duration of 46 hours and 30 minutes. There was no previous temperature excursion. Data logger was involved. The outcome of events was unknown. This case is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA010634.
I have a sore throat, runny nose. Also, I am having chest discomfort as my chest feels heavy, the mask did not effect my breathing,  but now since I received the shot it is hard for me to breath while wearing a face mask. I am taking deep breaths to try and catch my breath. My hands are swelling with fluid and going numb. I feel warm/hot but no temperature
sick since April; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick since April) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick since April). At the time of the report, ILLNESS (sick since April) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications reported. No treatment reported.  The patient was sick since April of unknown year. The reporter asked if there was any compensation program and did provide any further AE details.
A PINECONE SHOVED DOWN HER THROAT; SEVERE HIVES; RECURRENT URINARY TRACT INFECTION; CHEST PAINS/HEART PAINS; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included anaphylactic shock, anaphylaxis, and urinary tract infection, and concurrent conditions included penicillin allergy, and sulfa allergy, and other pre-existing medical conditions included allergy to 20 unspecified drugs. The patient was previously treated with doxycycline for urinary tract infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced chest pains/heart pains. On APR-2021, the subject experienced recurrent urinary tract infection. Treatment medications included: doxycycline. On an unspecified date, the subject experienced a pinecone shoved down her throat, and severe hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pains/heart pains, a pinecone shoved down her throat, and severe hives, and the outcome of recurrent urinary tract infection was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
15-20 minutes post injection symptoms included tingling and numbness in the limbs, flushed face, racing heartbeat, fogginess, confusion, extreme fatigue, panic/anxiety. Symptoms increased in severity over the course of 9-10 hours and dissipated following sleep. Migraine headache followed at 24 hours post injection.
Tachycardia with vertigo hours after receiving booster. Tachycardia has not resolved despite propanolol rx use. I continue with feeling light headed several times throughout the week
Acute headache for 48 hours Acute  lethargy for 48 hours Minor pain at injection site for 36 hours
Moderna 3/25/21 and 4/22/21. Positive on 1/13/22
Red/purple bruising slightly larger than a quarter on  back of L calf noticed at 11am morning after vaccine administration. No known injury to bruise site.
I woke around midnight feeling like I had been drinking alcohol, only I had not had a sip. The room was spinning,  my mouth was horribly dry, and my muscles ached with fatigue, almost as if I was dehydrated. For the remainder of the day I had a headache accompanied by sore muscles and fatigue. I awoke the next morning feeling back to normal.
01/26/22 presents to ED for "fall". PMHx of "HTN, Gout, Arthritis, TIA, CAD, CHF"
devel sty in rt eye;fever 101-103,persistent cough;post nasal drip;rt sided chest,shoulder,neck pain;dec breath sounds on rt side;x ray showed focal consolidation in rt middle lobe w/rt middle lobe pneumonia;wbc inc;abd pain,HA;recovered
This spontaneous report as received from a doctor of pharmacy refers to a 84 years old female patient with no pertinent medical history and drug reactions/allergies. On 17-OCT-2012, the patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot # reported as H012521 exp: 09-OCT-2013). Concomitant medications included lisinopril, atorvastatin, metformin and alendronate sodium. The pharmacist stated that 2-3 days after vaccination on approximately 19-OCT-2012, the patient had an approximately 1/2 dollar size raised red area at the injection site. The patient sought medical attention with pharmacy visit, and the patient was told to follow up with the physician. No treatment was given for the event and no labs/diagnostic studies were performed. At the time of the report the patient's outcome was unknown. The relatedness for the event was unknown for ZOSTAVAX. Additional information is not expected. This is one of several reports from the same source.
Site: Bruising at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Additional Details: BRADYCARDIA, RECOVERED IN 30-40 MINUTES. PATIENT FAINTED AND GOT INJURED BECAUSE OF THE FALL
Local erythema & swelling peaking approx 36 hrs post vax @ site of DTP vax;
flu-like aches; mild fever (100.3); exhaustion; headache; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot was not reported), via an unspecified route of administration, administered anatomical location not reported, on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date (event took place after use of product), the patient experienced flu-like aches, mild fever (100.3), exhaustion, headache. On an unspecified date, the patient underwent lab tests and procedures which included body temperature: 100.3 Fahrenheit. 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.
Numbness starting in feet, now hands and mouth. No muscle weakness 12/11/07-records received for DOS 10/30/07 C/O numbness to hands and feet began last week 10/17/07. Numbness in hands and lower arms as well as lips and face. 11/12/07-seen by neurologist, DX Postinfection cerebelitis, improving. Right Bell's palsy, improving. Current clinical events are not related to vaccination with Gardasil.
Fever (100.2 F),  SaO2 saturation decrease to 79%, confusion, weakness (lasted 2 days)
No additional AE reported.; Customer reporting administration of expired dose of MMR II.; This spontaneous report was received from a Licensed Practical Nurse (L.P.N.) and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.     On 14-JUL-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot number S018594, which has been verified to be valid, the expiration date was reported and validated as 17-JUN-2021), 1 dose as prophylaxis (expired product administered) (exact dose, route of administration, and anatomical site of vaccination were not provided). The vaccine was diluted with a sterile diluent (MERCK STERILE DILUENT) (lot number S021105, which has been verified to be valid, the expiration date was reported and validated as 14-MAY-2022). No additional adverse events were reported.