chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered pharmacist concerning an 80 year old female patient. The patient had no pertinent medical history and no known drug allergies. On 03-OCT-2012, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX vial, 1 vial (Lot #: H012575: Expiration Date: 28-SEP-2013). Concomitant medications included: FLUZONE. In October 2012, the patient developed 2 inches of redness and soreness at the site of ZOSTAVAX. The patient sought medical attention by calling the pharmacist. No treatment was given for the events. No lab diagnostic studies were performed. At the time of the report, in October 2012, the patient's outcome of 2 inches of redness and soreness at the site of vaccination was reported as recovered/resolved. The relatedness for 2 inches of redness and soreness at the site of ZOSTAVAX vaccination was unknown for ZOSTAVAX. Additional information has been requested.
The first couple of day, Soreness and body aches and on day three fever and nausea (but that didn't last very long). The soreness and body aches lasted a good 5 days. And then I went to the doctor.  I got shingles at day 6 or so. I couldn't work because I had shingles. They gave me Valacyclovir for  one or two weeks. That helped with symptoms - it took close to two weeks  for it to resolve. They hurt but they weren't debilitating but I couldn't go to work at the hospital.
At 1:30 pm 4/6/21 I woke up from a nap with a high fever, body aches, severe headache, and hypersensitive skin. Standing up or moving hurt and made me feel dizzy. I took 2 ibuprofen between 2-5 pm, and then an Alleve around 8 pm. I used ice packs on my forehead throughout this period. I fell asleep at 10 pm and woke up at 6 am feeling fine.
Felt very tired 2 hours after vaccine. The next day had body aches, chills and a low grade fever. Large red bump at the injection site. Two days after vaccine had bad pain in legs (muscles).
4/15/21 - tingling lips, sore arm, metallic taste. 4/16/21 - flu symptoms all day - took Tylenol 4/17 & 4/18 - felt better but symptoms returned in evening of 4/19 4/20/21 - headache, fever, body aches. 4/21/21 - add loss of smell, exhaustion, nausea, sore throat, coughing, sneezing. These symptoms continued for a total of 10 days. Continued to have coughing for another two weeks, with sores in left nostril.
The next day, I had a fever, chills, nausea, fatigue, dizziness, off balance and just not myself. It got worse during the day, so I had to leave work. I was out work for two days. It continued to get worse and I was starting to get weaker. I just got a lot of rest and took Advil. Consulted doctor by phone.
About 15 hours after the injection my face became puffy. I did wake up with a mild asthma tightness in my breathing and chest. Throughout the day my breathing felt more tight and the swelling never went down in my face. Friday, I called my doctor's office and they advised taking claritin and my inhaler. On Saturday I began a dose of 40mg per day of prednisone.  The symptoms have not improved as of yet. Today is 4/4.
I developed a rash on the back of my right hand, which the documentation i was provided with at time of vaccination included rash as a severe allergic reaction.    I also developed chills that would hit me at random times of the day for a week.  These chills occurred every day for a week.
Held their breath and turned blue; Held their breath and turned blue; This spontaneous report was received from a physician via company representative referring to multiple male infant patients of an unknown age. The patient's concurrent condition included rotavirus immunization. The patient's medical history, historical drugs, drug allergies and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, oral for prophylaxis and rotavirus immunization. On an unknown date, infant patients held their breath (breath holding) and turned blue (cyanosis) during administration of rotavirus vaccine, live, oral, pentavalent (ROTATEQ). Physician reported that, this issue spontaneously resolved after administration was completed and also reported to field employee that this issue occurred more often in unspecified male infants, though it was clarified that both unspecified male infants and unspecified female infants may have been involved. Physician no longer administered rotavirus vaccine, live, oral, pentavalent (ROTATEQ) to any patients due to the issue, and instead administered ROTARIX (manufactured by GlaxoSmithKline), and reported that no patients have experienced the same issue with ROTARIX. It was not clarified if this meant any patients who experienced the issue with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) completed their rotavirus vaccination series with ROTARIX. The outcome of breath holding, and cyanosis was reported as recovered. The causality of the events was related with respect to suspect therapy rotavirus vaccine, live, oral, pentavalent (ROTATEQ).  This is one of several reports received from the same reporter.
Eye inflammation. Diagnosed with uveitis with vitritis and scleritis. Taking Prednisone 1% eye drops and will be seeing a retina specialist on 10/31/2022.
Symptoms: Mental confusion, dizziness, overall muscle weakness, fever, chills, loss of appetite
He has had 2 episodes concerning for possible hallucination since HPV vaccination 2.5 months ago. It is not clear to me that this is true hallucination.
Patient says flu shot gave her a "frozen" shoulder and she will follow up w/her PCP.
Vaccination site bruising; Inappropriate route of vaccination; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE BRUISING (Vaccination site bruising) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010AZIA and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy. Concomitant products included LEVOTHYROXINE for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (Vaccination site bruising) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination). At the time of the report, VACCINATION SITE BRUISING (Vaccination site bruising) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was  not reported.   This case was linked to MOD-2021-027009 (Patient Link).
5 minites after receiving vaccine felt lightheaded, dizzy Passed out with brief LOC No SOB, chest pain Resolved after lying down, oral hydration
Fatigue, sleepy, headache, Body jerks( like convulsions) nausea, rash
On Saturday, 2/27/21, a little over 24 hours after receiving vaccine, sudden death occurred.
3rd booster dose was expired; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3rd booster dose was expired) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A, 023M20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (3rd booster dose was expired). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (3rd booster dose was expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.    This case was linked to MOD-2021-365085, MOD-2021-365086 (Patient Link).
Patient's husband states patient started vomiting the same night and vomited throughout the night. The next morning patient passed out after getting out of bed and patient's husband gave her CPR and contacted the emergency services. After she came back to, the EMTs were able to stabilize her but after many labs and tests, they could not find anything wrong with her. ER doctors suggested it may be due to the vaccine she received the day prior.
injection site rash; small rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (injection site rash) and RASH (small rash) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (injection site rash) and RASH (small rash). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (injection site rash) and RASH (small rash) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was provided.   This case was linked to MOD-2022-541538 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2022: Follow-up source document contains no new information.
A non-serious spontaneous report of hallucinations was received from a physician concerning a five-year-old female subsequent to FLUMIST. No known medical history or concomitant medications were reported. The patient received FLUMIST on 14-Aug-2009. It was reported that about 24 to 30 hours after FLUMIST administration the patient complained of having spiders on her and started grabbing things out of her hair. According to the parents it seemed like she had nightmares while awake which lasted about two hours. There was no report of fever, new medications or head trauma. The event lasted for two hours.
Patient was given Pediarix vaccine at 2 months and 4 months old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received Pediarix at an unknown dose. On an unknown date, unknown after receiving Pediarix, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered was unknown.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter stated that the doctor advised to give patient Kinrix instead of Pediarix, which led to inappropriate schedule of vaccine administered. No further details were provided. This case has been linked with case US2020045975, reported for same reporter.
pt recvd vax & started having sensations that the muscles in neck were pulling head around;head seems to be wobbling around neck like its not connected to body;
my face was swollen; right side of my mouth and jaw hurting; right side of my mouth and jaw hurting; This is a spontaneous report from a contactable consumer (patient). A 50-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0186), dose 2 via an unspecified route of administration, administered in left arm on 16May2021 at 08:45 as 2nd dose, single for COVID-19 immunization (at the age of 50-years). Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0175), dose 1 via an unspecified route of administration, administered in left arm on 25Apr2021 as 1st dose, as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Neither the patient diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received no other medications within 2 weeks of vaccination. On 18May2021, the patient woke up with the right side of my mouth and jaw hurting and her face was swollen. The first day, she tried to rinse with salt water and applied hot compresses to her face it didn't do anything. So she decided to do a tele doc video call the after the second day it wasn't getting better. The doctor prescribed antibiotics and told to her it was her tooth, however, she knew that it wasn't her tooth. The outcome of events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021582710 different patient, same drug and event
3/16/150- Redness, heat, edema at site of injection. Employee states c/o nausea and emesis. 3/17/15- Patient contacted office, evaluated by physician and treated with antibiotics.
Client felt light-headed and had to be helped to the ground.  She described not being able to hear very well and a faint feeling.
burning kidneys and lower back pain plus UTI; went to doctor and received antibiotic macrobid but urine test came back negative for UTI; though UTI symptoms have dissipated, I still very fatigued plus feel constipated plus mild headache
Elevated BP for 12 hours beginning 24 hours after receiving injection.  Generally BP 120/75. Ran 150/90 to 162/101 from 10 am to 10 pm.; This is a spontaneous report from a 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: ER8732) via an unspecified route of administration in the arm left on 26Mar2021 at 10:00 (at the age of 68-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, cholesterol, thyroid, osteoporosis and mild reactions for penicillin. Concomitant medications included lisinopril dihydrate (LISINOPRIL), levothyroxine (MANUFACTURER UNKNOWN), lovastatin (MANUFACTURER UNKNOWN) and alendronate sodium (ALENDRONATE); all for unknown indication from an unknown date. The patient previously received blue dye for unknown indication on an unknown date for 2 weeks and experienced elevated BP. The patient previously received macrobid (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the arm left on 05Mar2021 at 11:30 (at the age of 68-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021 at 10:00, the patient experienced elevated BP for 12 hours beginning 24 hours after receiving injection. Generally, BP 120/75. Ran 150/90 to 162/101 from 10 am to 10 pm. The patient previously experienced elevated BP as a reaction to maintenance meds with blue dye after taking them for 2plus weeks. This was unanticipated, more immediate and extensive. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event Elevated BP was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Left arm pain at the site of the injection; headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Mar-2021 and was forwarded to Moderna on 08-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Left arm pain at the site of the injection) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced INJECTION SITE PAIN (Left arm pain at the site of the injection) and HEADACHE (headache). At the time of the report, INJECTION SITE PAIN (Left arm pain at the site of the injection) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
HEART PALPITATION (FAST HEART RATE) LASTING ABOUT 3 TO 5 MINUTES; STOPPED AFTER I LAID DOWN. THEN ON 10/28/09 APPROX. 10:00 AM EXPERIENCED HEART PALPITATIONS (FAST HEART RATE) AGAIN REQUIRING EMERGENCY ROOM BECAUSE IT LASTED MORE THAN 20 MINUTES.
Pt. states after receiving the Moderna 2nd dose 04/18/2021, immediate Leg/Feet (left) pain, diagnosed with Adema. ER visit treated with  Lasex, Primary took off of it, Lost ability of driving, fever of 101.0. Coughing up mucus *clear sometimes/green others.
pain in both calves; Shortness of breath; swelling of hands and calves; booster; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.   A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 09:30 (Batch/Lot number: unknown) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; ANNOVERA. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion , Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 26Feb2021, when the patient was 40 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 05Feb2021, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021, outcome "unknown", described as "booster"; PAIN IN EXTREMITY (non-serious) with onset 19Nov2021, outcome "not recovered", described as "pain in both calves"; DYSPNOEA (non-serious) with onset 19Nov2021, outcome "not recovered", described as "Shortness of breath"; PERIPHERAL SWELLING (non-serious) with onset 19Nov2021, outcome "not recovered", described as "swelling of hands and calves". The events "pain in both calves", "shortness of breath" and "swelling of hands and calves" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of pain in extremity, dyspnoea, peripheral swelling.   Additional Information: It was reported that patient received dose 3, No other vaccine in four weeks, No covid prior vaccination, No covid tested post vaccination. It was reported that patient known allergies was not reported.   No follow-up attempts are possible. No further information is expected.
Hands shook like had Parkinson's, was hard to hold a glass of water/shaking; 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 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "chills"; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "chills"; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "chills"; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "chills".  The following information was reported: TREMOR (non-serious), outcome "recovered", described as "Hands shook like had Parkinson's, was hard to hold a glass of water/shaking". Relevant laboratory tests and procedures are available in the appropriate section.   Additional information: The caller was calling about the Pfizer vaccine, clarified and confirmed the newest one, the Pfizer bivalent vaccine. Caller has had 5 shots, the 2 original vaccines, no specific product name provided, which caller thinks were 21 days apart, then 2 parts of the monovalent, no specific product name provided, then 6 months ago had the first bivalent. The caller knew he was eligible for the 2nd bivalent because the caller was 76 years old, which caller thinks was the latest booster even in existence right now. The first 4 shots the caller had no reaction other than chills one or two times, which caller thought was common, and one time maybe had a temperature of about 100 which was no big deal. The last bivalent, which was the only bivalent caller has had, that evening after caller got home for about an hour and a half, caller's hands shook like had Parkinson's, was hard to hold a glass of water, then went away, had no more symptoms like that. The caller understands that was a neurological response to the bivalent, from what caller was able to understand maybe such a thing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left arm was red; Left arm was red, irritated, and warm to touch; Left arm was red, irritated; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 75P7G, expiry date 17th April 2022) for prophylaxis.   On 21st August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced erythema of extremities, skin warm and skin irritation. On an unknown date, the outcome of the erythema of extremities, skin warm and skin irritation were unknown.   It was unknown if the reporter considered the erythema of extremities, skin warm and skin irritation to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm and reporter reported after the vaccination, the left arm was red, irritated and warm to touch. Consented to follow up.
Area around shot site of either DTP or Hib titer 2 in. in diameter, mild erythema, slight warmth but no tenderness and no induration.
4 thunderclap headaches so far. No prior history of such headaches or migraines. Trying sumatriptan tablets to relieve pain.