chrisvoncsefalvay/vaers-outcomes huggingface dataset:
isolated spots on body associated with nerve pain; isolated spots on body associated with Sensitivity; isolated spots on body associated with itching; outbreak as appearing as measles physically; shingles recurrence would occur/ outbreak; first dose Shingrix September 30, 2019; Sore arm; isolated spots on body associated with Sensitivity; feeling sick; Runny nose; Body aches; digestive/ gastrointestinal upset; Fever; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had recurrent shingles prior to Shingrix vaccination reoccurs approximately 1 to 2 times a year.).   On 30th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 1st October 2019, 1 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm, feeling unwell, runny nose, general body pain, gastrointestinal upset and fever. In October 2019, the patient experienced hypersensitivity. On an unknown date, the patient experienced nerve pain, rash, pruritus, measles-like rash, shingles and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm, feeling unwell, runny nose, general body pain, gastrointestinal upset and fever were recovered/resolved and the outcome of the nerve pain, rash, pruritus, measles-like rash, hypersensitivity and shingles were recovering/resolving and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain in arm, feeling unwell, runny nose, general body pain, gastrointestinal upset, fever, nerve pain, rash, pruritus, measles-like rash, hypersensitivity and shingles to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in the left arm. The reporter stated that after vaccination, on following day the patient had sore arm and feeling sick described as runny nose, fever, digestive or gastrointestinal upset, and body aches for approximately 1 to 2 days. The reporter reported that, approximately 1 to 2 months after receiving Shingrix, the patient reported recurrent minor outbreaks that came and gone consisting of isolated spots on body associated with nerve pain, itching, and sensitivity. The minor outbreak reoccurred twice and on the day of reporting there was no reports of an outbreak. The patient reported that, shingles recurrence would occur if extremely stressed out around mid-back on rib cage and described outbreak as appearing as measles physically but not truly measles. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. This case has been linked with US2020133254, reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2020133254:
Had shot in morning 7/9/2007. Immediately red spots with a white pus in center form a lot of places and itched like crazy. This clinic was closed and went to see my family doctor. I'd had some scabs taken off on 6-29. Became infested; checked still infected 7/31. Still broke out of new spots daily. I'm miserable. Shingles shot has caused this infection.
Left arm started to swell 8 days after vaccine - pruritis hot, & some axillary swelling & small nodules - increased swelling dramatically in 24hrs; spread to under the arm. 8 inches L x 8" width
She could not raise her left arm until now and she had piercing pain when she moved it. It was difficult even to dress up. The piercing pain woke her up at night a lot of times; she could not move her left arm upward/ She could not tie her hair and became so difficult to remove her clothes or put them on; but her arms did not recover from pain; This is a spontaneous report from a contactable consumer reported for herself. A 60-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via intramuscular, administered in Arm Left on 24Apr2021 (Lot Number: EW0170) at age of 60-year-old as single dose for covid-19 immunisation. The patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in Arm Left on 02Apr2021 15:45 at age of 60-year-old (Lot Number: ER8732), for covid-19 immunisation, after the first dose, she was fine after 3 days of flu like symptoms. Medical history included Type II diabetes, onset date: 8 or more year ago (she was fine with blood glucose, she was on low carb keto diet) and known allergies: aspirin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. Concomitant medications included metformin (METFORMIN); glimepiride (GLIMEPIRIDE). It was reported on 24Apr2021 21:00, After the second dose, she was waiting to recover from it but her arms did not recover from pain, she could not move her left arm upward and it was now painful to raise her left arm or reach her back. She could not raise her left arm until now and she had piercing pain when she moved it. It was difficult even to dress up. The piercing pain woke her up at night a lot of times.  She could not tie her hair and became so difficult to remove her clothes or put them on. She could not lean on it when she was sleeping and it woke her up when she accidently turn to the left. It was uncomfortable even if she was not leaning on it that she needed extra pillow under it. Seriousness criteria was reported as persistence/ significant disability incapability. The events required visiting to physician office. The patient had seen her doctor. No treatment was received for the events. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
chest pain, felt like extreme pressure - lasted 4 days solid and went away by itself. bad headache on day 3 after vaccine for 24 hours. gum above teeth turned dark purple a few days after the vaccine and stayed for about a week. went away on its own.
This spontaneous report as received from a Licensed Practical Nurse refers to a 6 month old female patient. On 07-OCT-2013 the patient was given a dose of expired ROTATEQ oral (dose and indication were not provided) (lot number reported as: H010696; exp date: 06-OCT-2013). This was the child's third dose of ROTATEQ in series. No adverse effects were reported. Additional information has been requested.
Pt states on 4/7/21 she received her pneumonia vaccine around 1230 pm. She states she woke up at 2 am with severe pain in her arm at the injection site. She went to the bathroom, felt nauseous/sweaty and then fainted. She woke up crumpled on the floor with neck pain/shoulder pain. She took aspirin. She had 1 episode of diarrhea and then was able to go back to bed.
This spontaneous report has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored ROTATEQ (lot#, expiration date, dose, frequency and route were unknown). No adverse effects was reported. This is one of several reports from the same reporter. Additional information has been requested.
experiencing flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (experiencing flu-like symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (No reported medical history).    On 12-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (experiencing flu-like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (experiencing flu-like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment details reported.
Extreme muscle soreness / deep, aching pain, traveling down left arm to elbow.  Pain increased with range of motion of arm/shoulder.  Became significant three/four weeks following vaccination. It has resolved some.   Discontinued use of Lippitor thinking soreness was a side effect. Scheduled appointment with Orthopedic surgeon when problem did not complete resolve after being off of Lipitor for three weeks.   Daughter was give tetanus shot for dog bite, literature from doctor described symptons that I was experiencing.
12/18/1998 Influencia Vaccination given at Kaiser 12/26/1998 Hospitalized at Kaiser Hospital with severe case of Guillain-Barre Syndrome (GBS).  I was given plasmapheresis (blood exchange) treatment at Kaiser Hospital.  Recovery took over 2 years.  Physical recovery after 2 years was about 90% of before GBS disease. The 60 day follow up received on 9/3/03 states after 2 years, pt was 90% recovered. Residual symptoms that remained were partial paralysis of face, toes and finger not working right, nerve damage, speech problems.   Nurse follow up on 08/31/04 states: "Headache, pain lower extremities, urinary retention,
Approximately 5 minutes post vax, the pt became pale, clammy and cold. She then felt hot and felt as if she were going to pass out. Sometime later, she recovered without treatment. The pt reports having the same reaction with ferrous sulfate. (Case number 19990233372 for Havrix)
1. Skin Rash.  Still ongoing. 2. Swelling in my left and right foot and lower leg, more pronounced on left.  Started in mid-December and resolved in 2 1/2 weeks. Swelling returned, primarily in my left foot and leg toward the beginning of February and resolved in about 4 1/@ weeks, except for an enlarged big toe knuckle.   I cannot be sure the swelling is related to the vaccination; however, I do not believe I ever had this before.
102.5F Fever, chills and shivering.  Fever increased t0 104.3 at 2:30AM.  Fever reduced to 101.1 by 6AM and remained there until 3PM.
Rash on both forearms; Muscle pains; Tiredness; Weakness; Headache; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er2613) via an unspecified route of administration in the arm left on 02Apr2021 at 13:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine, arthritis and heart murmur. The patient was allergic to penicillin, sulfa and tramadol (MANUFACTURER UNKNOWN). Prior to the 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. Concomitant medications included nifedipine (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), oxybutynin hydrochloride (OXYBUTIN) and naproxen (MANUFACTURER UNKNOWN) 500 m started on an unknown date for unknown indication. On 03Apr2021 at 12:00, the patient experienced rash on both forearms, muscle pains, tiredness, weakness and headache. The events 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 events. The clinical outcome of the events rash on both forearms, muscle pains, tiredness, weakness and headache were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
expired dose of Daptacel was inadvertently administered to a 4 year old patient, NO AE.; Initial information received on 11-Feb-2020 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a four years old male patient who was vaccinated with an expired 0.5 ml dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (fifth dose in series, lot number: C5366BA and expiry date: 07-Feb-2020) via intramuscular route in the left thigh on 10-Feb-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE INACT (IPV); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE).  It was actual medication error due to expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report as received from a pharmacist refers to an unspecified patient. On an unknown date the patient might have received less than a full dose of ZOSTAVAX (lot# not reported) due to excessive foaming of the vaccine following reconstitution, and dues to leaking of the vaccine vial during withdrawal of the vaccine. No adverse effect was reported. It was unknown if the patient sought medical attention. The outcome of adverse events was unknown. Additional information has been requested.
nausea, vomiting, dizzy, severe headache, chills but no fever. Temp has been 97.5.  then it dropped to 96.6
14 hours after the injection I woke up and my teeth were hitting each other. I was not cold or hot. Within a few minutes my body muscles began twitching  uncontrolably. My arm,, legs,, jaw were all fluttering.. This lasted for one hour.
Fatigue, H/A on 10/26/2009...Extreme fatigue, H/A, cough still present as of 10/27/2009 9:10 PM
Patient was vaccinated with moderna bivalent vaccine after a temperature excursion due to hurricane  and vaccine was not viable; No adverse event; Patient was vaccinated with moderna bivalent vaccine after a temperature excursion due to hurricane and vaccine was not viable; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated with moderna bivalent vaccine after a temperature excursion due to hurricane and vaccine was not viable), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated with moderna bivalent vaccine after a temperature excursion due to hurricane and vaccine was not viable) and NO ADVERSE EVENT (No adverse event) in a 57-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Sep-2022 at 11:09 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 30-Sep-2022 at 11:09 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated with moderna bivalent vaccine after a temperature excursion due to hurricane and vaccine was not viable). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated with moderna bivalent vaccine after a temperature excursion due to hurricane and vaccine was not viable) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated with moderna bivalent vaccine after a temperature excursion due to hurricane and vaccine was not viable), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated with moderna bivalent vaccine after a temperature excursion due to hurricane and vaccine was not viable) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated with moderna bivalent vaccine after a temperature excursion due to hurricane and vaccine was not viable) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated with moderna bivalent vaccine after a temperature excursion due to hurricane and vaccine was not viable).    Concomitant product use was not provided by the reporter.  Patient did not reported any adverse events.   Treatment information was not provided.
Dizziness  light headedness, backache, chills, sore at injection  site
Hives; This is a spontaneous report based on the information received by Pfizer (Reference ID: NVSC2021US101382_NS) from a contactable Other HCP. A patient of unspecified age and gender received Unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration and on unspecified date as dose number unknown, single for covid 19 immunisation. The medical history and concomitant medications were not reported. Few weeks later upon receiving the Pfizer vaccine the patient experienced hives. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I was diagnosed with rhabdomyolysis. Beginning saturday, september 4th, i begun feeling not well. That night, extreme soreness and intense pain began to set in making it impossible to sleep. The effects only got worse, and worse, and i was admitted to the hospital at a HCF on tuesday, the 7th. The only treatment was hydration through iv. I was released from the hospital on thursday, the 9th. two nights and three days. I could have stayed longer if i was not intent on going home. This was one of the hardest weeks of my entire life. it was hell. I was nearly useless for a week, and then I had to take it very easy for a couple of more weeks. My fitness level was sliced in half. I am still not back to where i felt before this event.
Random hard chest pains that spontaneously happens throughout the day. Has been going on everyday since I was given the shot.
Urticarial lesion at injection site with surround red pruritic skin 1.5x2.0 cm.
VERTIGO; CHEST PAIN; PANICKED AT 3 AM; THOUGHT WAS GOING TO DIE; CHILLS; VOMITING; DIARRHEA; FEVER; This spontaneous report received from a parent via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced vertigo, chest pain, panicked at 3 am, thought was going to die, chills, vomiting, diarrhea, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vomiting, diarrhea, chills, vertigo, chest pain, fever, panicked at 3 am and thought was going to die was not reported. This report was non-serious.
feeling more pain/achiness; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (feeling more pain/achiness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRALGIA (feeling more pain/achiness). At the time of the report, ARTHRALGIA (feeling more pain/achiness) outcome was unknown.            Patient had a physical therapy on 25-May-2021  No concomitant medications were not reported. No treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: No New Information.
2 days post initial vaccination. Pt noticed pustules on arm, pruritic with paps now scabbed over. Today pt noticed onset of scattered , asymmetrical maculopaplar erythemic rash on extremities and torso. Some pustules noted.
This case was reported by a pharmacist via sales rep and described the occurrence of welts in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced welts. On an unknown date, the outcome of the welts was unknown. It was unknown if the reporter considered the welts to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The patient had welts following vaccination only over the entire arm that was injected. The patient's initials, gender and date of birth were unknown. The reporter did not agree to be contacted for follow up.
Facial swelling and rash. Evaluated by onsite pediatrician Dr. Given 3mg BENADRYL and 160mg Acetaminophen.
admitted to hospital with covid -19 with symptoms of chills,lethargy,no appetite to eat and trouble breathing; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program.   A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: UNKNOWN) via an unspecified route of administration on 14Mar2021 (Sunday) at SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 15Mar2021 (Monday) night after the first dose of vaccination patient was having symptoms such as chills, lethargic, and no appetite to eat. Reporter wants to know if these are the normal side effects of the vaccine. On 24Mar2021 (A day before the follow up report), the patient admitted to the hospital with COVID-19. She states she came to hospital yesterday (24Mar2021) because she was still "so lethargic" and reports having trouble in breathing. patient would like to know if it was possible that the Pfizer BioNTech COVID-19 vaccine could have caused her to develop COVID-19. At the time of this report event outcome was unknown.   Information on the lot/batch number has been requested.