chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt like I had a bad flu. 12 hours after injection. woke at 12:30 AM with Bad headache, chills, had low grade fever. no energy. slept on and off from 12:30 AM to 4:00 PM on Friday. Had to miss work on Friday, and I never call in sick, it was bad. Felt a bit better the next morning, 4-10-21. went to work, still not right but better
(R) arm swollen red warm to touch seen 10/25/17 dx cellulitis.
See attached. 8/11/08-records received-DX Gait disturbance possible lumbar radiculopathy. Plays sports seven days per week very little rest 4-5 hours sleep per night. Aches and pains on and off aggravated bending during field hockey season. Received physical therapy and on 3/11/08 80% improved. on 6/20/08-no longer C/O leg pain.
affecting my social life; it is worse today/not life threatening; upper lip is swollen; Extra dose administered; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (upper lip is swollen), CONDITION AGGRAVATED (it is worse today/not life threatening), SOCIAL PROBLEM (affecting my social life) and EXTRA DOSE ADMINISTERED (Extra dose administered) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A, 023M20A and 032L20A) for COVID-19 vaccination.     The patient's past medical history included Dermal filler injection (Dermatological filler called "Restylane Silk" in upper lip.).   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021, the patient experienced LIP SWELLING (upper lip is swollen) and EXTRA DOSE ADMINISTERED (Extra dose administered). On 22-Sep-2021, the patient experienced CONDITION AGGRAVATED (it is worse today/not life threatening). On an unknown date, the patient experienced SOCIAL PROBLEM (affecting my social life). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. On 21-Sep-2021, EXTRA DOSE ADMINISTERED (Extra dose administered) had resolved. At the time of the report, LIP SWELLING (upper lip is swollen), CONDITION AGGRAVATED (it is worse today/not life threatening) and SOCIAL PROBLEM (affecting my social life) had not resolved.            Concomitant drug was not reported.  It was reported that patient received 3rd dose of vaccine as suggested by her physician due to age. It was advised by dermatologist to take Motrin as treatment drug to the patient.Consumer does not have Motrin and is taking Aleve. Consumer states she has no problems to 1st and 2nd dose of the vaccine.
9 days fever off and on to 102 F. On 06/22/2006 105 F, fussy, decreased appetite for 9 days.  Increase sleep. NO meningeal signs and symptoms. Positive diarrhea every vaccine.
pt devel a fever 1wk ago; was taken to MD & found to have an ear & throat inf was placed on ATb; MD felt fever poss due to immun; pt broke out in a measle like rash;
Muscle weakness; joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 at 12:00 as dose 1, single (Lot number: HF9275) at the age of 43 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "mild asthma" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for influenza immunisation, on 19Sep2023 as dose number unknown, single; CLARITIN [LORATADINE]; ADDERALL; WELLBUTRIN; IBUPROFEN. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset 18Oct2023 at 16:00, outcome "not recovered", described as "Muscle weakness"; ARTHRALGIA (non-serious) with onset 18Oct2023 at 16:00, outcome "not recovered", described as "joint pain". Therapeutic measures were not taken as a result of muscular weakness, arthralgia.  Additional information: Patient reported that Muscle weakness and joint pain to the point where simple tasks were difficult and even typing was difficult. No covid prior vaccination and no covid tested post vaccination.
Facial spasms, Face gets stuck, drawn up to right side. Mouth, lips, teeth, right side body goes numb, Feet go numb
A report has been received from a Health Professional concerning a 9 year old, male subject, who has been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on 05-Dec-2013. It was reported that four patients were inadvertently administered with expired FLUMIST QUADRIVALENT which started on 05-Dec-2013. The outcome od the event of inadvertently administered expired FLUMIST QUADRIVALENT to four patients is unknown. The report was considered to be non-serious.
This case was reported by a nurse and described the occurrence of seizure in a 4 month old female patient who received DTaP adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. Medical history was significant for seizures and pan-hypopituitarism. On an unspecified date, the patient received the first dose of Pediarix. At an unspecified time post-immunization, she experienced irritability and low grade fever. These events resolved on an unspecified date and were not considered serious by the reporter. The reporter considered fever and irritability possibly related to Pediarix. On 23JUNE2003, the patient received the second dose of Pediarix. On that date, she also received Haemophilus influenza type b conjugate vaccine and a growth hormone injection. On the following day, 24JUNE2004, the patient had a seizure of 10 minutes duration. The seizure resolved. The reporter considered the seizure to be possibly related to Pediarix and possibly related to the patient's panhypopituitarism. Seizures were considered medically serious by manfacturer. (OMIC)
Fever; Nausea; Chills; Headaches; Arm numbness; This case was reported by a physician via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced fever, nausea, chills, headache and numbness of upper extremities. On an unknown date, the outcome of the fever, nausea, chills, headache and numbness of upper extremities were recovered/resolved.   It was unknown if the reporter considered the fever, nausea, chills, headache and numbness of upper extremities to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The physician on the chat reporting a patient experienced nausea, fever, chills, headaches and arm numbness the day after the first dose.  The events went away within a couple days.  The contact had a patient waiting and left the chat without providing any further information.  No other information captured.
She does not recall the time, but she began having swelling and redness in the area that she received her vaccination approximately 1 day afterwards.
I have epilepsy. I have seizures about ever 9 months or so usually because I forgot to take my medication. I know I have been taking my medicine prior to the event. I had an epileptic seizure one day after the first does of the Pfizer vaccine.
Td vaccine administered 3/26/04. Symptoms began 6 hours after administration. Client could not sleep due to pain in left arm and back. Arm became hot, red, swollen to 4 inch circumference at injection site. Client vomited twice. Physician wife administered Motrin and Benadryl PO. Two days of work missed by client as a result. Client also complained of chills.
Pain and weakness in my right arm.  Inability to lift things above shoulder height.  Pain when trying to sleep at night.  Pain when trying to do certain things at my job with my right arm.
Covid19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid19) 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 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid19). At the time of the report, COVID-19 (Covid19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment and concomitant medications were reported.; Sender's Comments: Based on the established profile for mRNA-1273, a causal association between the event of COVID-19 and the product administration is assessed as unlikely.
This spontaneous report was received from a pharmacist, concerning a patient of unknown age and gender with no pertinent medical history or unknown drug reactions/allergies. No information regarding the patient's concurrent conditions was provided. On 13-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9. (route of administration, lot# and expiry date were not reported). On 13-OCT-2015, the patient received the second dose of GARDASIL 9 (route of administration, lot# and expiry date were not reported). On 05-MAR-2016, the patient was vaccinated with a dose of GARDASIL injection, lot # L004601, expiry date on 04-NOV-2016 (dose, route of administration were not reported) instead of her third dose of GARDASIL 9 lot # L004601, expiry date on 04-NOV-2016, due to an unspecified reason. Concomitant therapies were not reported. At the time of this report, no adverse effects were reported. No product quality complaint was filled. This is one of two reports received from the same reporter. Additional information has been requested.
hip replacement; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  An 87-year-old 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; estrogens conjugated, medroxyprogesterone acetate (PREMPRO). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization; Bnt162b2 (Dose 2), for Covid-19 Immunization; Bnt162b2 (Dose 3 (Booster)), for Covid-19 Immunization; Bnt162b2 (Dose 4 (Booster)), for Covid-19 Immunization. The following information was reported: HIP ARTHROPLASTY (medically significant), outcome "unknown", described as "hip replacement". The action taken for estrogens conjugated, medroxyprogesterone acetate was unknown.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
chest pain and in my back; burping a lot; I got my third Pfizer booster shot; I got my third Pfizer booster shot; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received third dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) dose 3 via an unspecified route of administration on 31Aug2021 16:00 as DOSE 3, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: not reported) via unspecified route of administration on unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Patient previously received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: not reported) via unspecified route of administration on unspecified as DOSE 2, SINGLE for covid-19 immunisation. The patient experienced I got my third Pfizer booster shot on 31Aug2021, chest pain and in my back on 01Sep2021, burping a lot on 01Sep2021. The outcome of the events chest pain, eructation, extra dose administered, off label use was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a doctor of pharmacy concerning a patient, who on 04-MAR-2011 was vaccinated with an expired 0.65 ml dose of ZOSTAVAX (Merck) (Lot # 664637/0748Y Exp 23-NOV-2011) SQ. No adverse reactions were reported. Follow up information has been received from the doctor of pharmacy concerning the 65 year old female patient with no known drug reactions or allergies, who was vaccinated with ZOSTAVAX (Merck) subcutaneously in the left arm. The patient experienced just normal soreness at the site of injection. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Initial report received on 20 November 2009 from a pharmacist. A female patient received an injection of Influenza A (H1N1) - Preservative (lot number and date of administration not reported), and on an unspecified date post-vaccination she developed vertigo and possible vestibular neuritis. No additional information was reported. Documents held by sender: None.
12 hours after receiving my second dose I started feeling restlessness, extreme tiredness, elevated heart rate, and general malaise.  I was unable to sleep. Overnight  I also developed body aches, chills, low-grade fever, nausea, headache, and fatigue. These symptoms increased throughout the day on 01/07, leveling out in the evening. I was unable to sleep again. The morning of 01/08 I was feeling slightly better and my symptoms improved throughout the day. As of now, the evening of 01/09, my symptoms have almost fully resolved but the ordeal taxed me physically and generally prevented sleep so I have residual fatigue.
8/8/08 12:00 - Client's mother called stating that client has 3 pimple like raised red areas, swelling and itching to L deltoid. Treatment recommended cool compress to site. Tylenol/advil for discomfort. Antihistamine if absolutely necessary.
My reaction started around 10 pm on 30 Nov 17 with unexplained hoarseness. puffy eyes, and fatigue.  No signs of coughing or sneezing. I woke up this morning, 1 Dec 17 around 04:25 with swollen right eye, mainly underneath my eye. I am fatigue, which is never the normal reaction of my body functions.
1st dose on 9/16/2021. 2nd dose on 10/1/21; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number HM24H, expiry date 25th March 2023) for prophylaxis.   Concomitant products included ZOSTER VACCINE RECOMBINANT, ADJUVANTED (NON-LIVE) (SHINGRIX).   On 1st October 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 1st October 2021, unknown after receiving Shingrix and an unknown time after receiving SHINGRIX, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: On 16th September 2021, the patient received 1st dose of shingrix 0.5 ml intramuscular in right deltoid.  The patient received 2nd dose in left deltoid. The pharmacist stated that a patient received the second dose early which led to shortening of vaccination schedule. The pharmacist seeking guidance on early second dose of Shingrix given to a patient. The reporter consented to follow up.
At 1105 patient a 40-year-old Male received an injection Pfizer Lot # 0191.  Patients skin color went yellow green. Patient  was able mumble incomprehensible sounds mildly arousable to sternum rub and finger nail pressure, but wouldn?t open his eyes and follow commands.  Alert and Oriented 0/3.  Called 911.  Assisted lifting patient to wheel chair.  Wheel chaired to cot assisted standing and laying patient down.  First set of vitals supine at 1110 AM 110/80 Pulse 60 Respiratory Rate 18 SpO2 92% on room air.  Second set of vitals at 1120 AM sitting 104/64 Pulse 73 Respiratory Rate 14 SpO2 92% on Room air.  Third set of vitals at 1125 AM were standing 118/70 Pulse 73, Respiratory Rate 14, SpO2 94 % on room air.     Police arrived and radioed. Response terminated  At 1110 patient was Alert and Oriented four of four. Syncopal Episode history when getting injections or blood draws.  A- No Known Drug Allergies.  M- No medications taken.  P- Syncopal Episodes from injection.  L- Trail Mix an hour and a half ago.  E- IM injection in left deltoid Pfizer.  Clear bilateral lung sounds.  At 1130 AM patient was able to ambulate without impairment.   Alert and Oriented 4 of 4.  Spoke with wife about contacting family physician, ER or Urgent Care.  Patient assisted to car by wife and kids.
APPROXIMATELY 5 MINUTES AFTER VACCINATION, DEVELOPED ITCHINESS ON FOREHEAD AND NOSE. GAVE 25MG DIPHENHYDRAMINE AT 9:20AM, FOLLOWED BY 25MG AT 9:40AM. PATIENT STATED THIS WAS HER 'TYPICAL DOSE' AND WNET ON HER WAY BACK TO WORK AND STATED SHE FELT FINE.
I have experienced a fever two days after receiving the covid vaccine, headache, cold chills, fatigue
Client called clinic at about 0859 1/28/19 with complaint of sharp pain on the right arm and mild on the left arm. Client reported taking ibuprofen which helps but still had the discomfort. Client was seen at about 1440 in the clinic same day. She told writer that the left was better, kind of mild and the right still has a sharp pain. On examination both arms appear normal, no edema, no swollen area, no red area. Client was told to rest and apply ice pack to both arms and follow up with writer. Client was also told to contact her PCP if it does not resolve in 2 days. 2/1/2019 at 10 am client report she is better, the pain has completely resolved.
Patient received the flu shot on 10/20/04 in the left arm. Sore arm was noted upon administration on 10/21. Patient had a migraine headache: frontal/temporal: Nonchal rigidity: a pounding (force of contraction) But not racing heart (rate of contraction) HR80s. Symptoms gradually subsided. Symptoms totally dissipated by 10/23/04.
This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. The patients' medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, route, lot# and expiry date were not reported). The vaccine was exposed to 0 degree Celsius for 440 hours. There was no previous temperature excursion. No adverse effect was reported. Additional information has been requested.
pt recvd vax 19MAY93 & temp started 22MAY93 afebrile until then started vomiting; MD notified ear canal red, UA ordered, Maalox given, put on Pedialyte; 24MAY93 MD ordered cult 25MAY93;  27MAY93 throat cult returned amoxicillin started;
Urine smells like burnt plastic . Went to do doctor twice to have urine tested for an infection but there is no infection just a terrible smell.
Mom reports that patient received Tdap on Thursday, started having swelling and redness to right arm on Friday, blisters noted to area on Saturday by Sunday the blisters were gone but redness and swelling remained, On Monday area remains hard to touch, no swelling area continued to improve daily. Child had no fever, sickness or difficulty breathing. Child complained of just throbbing to area. Mom gave child ibuprofen and ice to area. Mom contacted Dr and he advised her to call the Health Department..
Patient received 2nd vaccination from Hospital during a hospitalization. When patient returned back to the long term care facility, and facility requested another vaccination for patient. Patient recieved 2nd dose on 09/30/2021 and then another dose on 10/01/2021.
Dizziness and feeling sick to my stomach and feeling like I was going to pass out. Slight blacking out. Lasted around 5 minutes. Followed by general weakness and fatigue and some tingling in extremities. Lasted for about 2 hours.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 11-APR-2016, the patient was vaccinated with an improperly stored dose VARIVAX injection, lot #L044524, expiration date 09-NOV-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 9.9 degrees Fahrenheit for 163 hours and 30 minutes. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt received Pfizer vaccine x2. Pt found to have COVID 8/7 after exposure to COVID + person. Admitted into the hospital. Pt remains on room air currently.
Information has been received from a physician concerning a 12 year old female (reported as 10 year old) who was vaccinated with two doses of MMR II (lot #s not reported) respectively on 08-JUN-1999 and 12-FEB-2002.  The patient did not received a third dose of MMR II.  On 20-JAN-2010 the patient developed mumps and she was diagnosed with mumps on 21-JAN-2010.  The patient also had swelling under her left ear and left parotitis.  It was unknown if the patient had orchitis.  On 21-JAN-2010 the first blood work was performed.  IgM was <1:10 (normal range <1:10), IgG was 5.66 (normal range > 1.10), serum amylase was 131.  At the time of this report, the patient's outcome was unknown.  Additional information has been requested.
(R) arm red, warm to touch, red rash covering deltoid down to halfway mark of upper arm.
Initial unsolicited misuse report received from consumer via other company (Pfizer) (Manufacturer Report Number: 2016466975) on 24-Oct-2016. This case involves a female patient (age not reported) who was vaccinated with a dose of FLU SHOT (lot number, Expiration date, route of administration, site of administration and dose details were not reported) on an unspecified date in 2001. Patient's ongoing illness reported as chronic lymphocytic leukemia and had history of chemotherapy. Concomitant medications were not reported. On an unspecified date in 2001, following the vaccination the patient experienced flu. The patient's laboratory data reported as white blood count as 65000(units not reported). Corrective treatment was not reported. On unspecified date in 2001, patient recovered from event. List of documents held by sender: none.
Patien received dose, waited the customary 15 minutes then left.  At 6:45pm he started feeling like his eyes couldn't focus and experienced blurry vision.  He did not report any other events other than a sore arm. He contacted the pharmacy and spoke to me.  Patient was advised to take an antihistamine (he took cetirizine he had on hand.  I contacted the patient at 7:30pm and he said his vision had resolved.  Patient advised to seek immediate medical attention should any other symptoms arise.