chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This solicited report was received from a consumer (patient's  daughter) and refers to a 58 year old (also reported as 78 year old) female patient enrolled in a market research. The patient's concurrent conditions and medical history were not reported. On an unknown date in March 2016 (reported as in the spring of this year), the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot number and expiration date were not reported). Concomitant therapy was not reported. On an unknown date in 2016, 3 weeks after vaccination with ZOSTAVAX, the patient got shingles. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected as there was no consent to follow up.
Patient called the pharmacy and stated that she developed increasing levels of pain in her left shoulder after receiving the Boostrix.  She stated that the pain radiates from the shoulder down the front of her bicep from the should to elbow joint causing severe discomfort.  She also stated that she is having trouble raising her arm and the pain wakes her up at night.  Patient has not received medical attention for this problem.
This spontaneous report was received from a registered nurse referring to an 11 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 29-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
Information has been received from a female physician in her late 40s who in approximately 2009 (about a year ago) was vaccinated with a second 0.5 ml GARDASIL (lot# not reported). In approximately 2009 (about a year ago) the patient experienced a "frozen shoulder" and could not lift her arm and had limited arm movement. The physician had to go to physical therapy for 6 to 8 weeks and subsequently recovered. Unspecified medical attention was sought. She did not complete the series. Additional information has been requested.
Patient came into pharmacy on 9/26/19 with signs and symptoms of redness on injection site arm. The red area was warm to the touch and was about the size of 2 palms. Patient still had her band-aid on, it was recommended that she remove her band-aid and ice the site. Patient said that she was getting better.
No adverse effects reported; received improperly stored VARIVAX; This spontaneous report was received from a medical assistant and refers to a 14-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 13-AUG-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R023513, expiration date 16-AUG-2020, strength, route of administration and dose were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot 3 S00130, expiration date 23-AUG-2021). No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of -14 Celsius degrees (C) to -10 C (also reported as -13.2 C) for 46 minutes. The digital data logger was involved in recording the temperature excursion details. There were no previous excursions reported.    This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA007512: US-009507513-1909USA007177: US-009507513-1909USA007312: US-009507513-1909USA006939: US-009507513-1909USA007312:
nausea that night, Vomited that night and the next morning , Fatigue, headache
When pharmacist went to administer vaccine in patient's right arm the needle hub detached from barrel of syringe resulting in only 1/2 dose or less being administered to patient. According to CDC documents published 03/17/2021, we were to give the dose in the opposite arm. With parental consent pharmacist administered dose again in left arm.
Redness, pain, swelling, and rash localized to the injection site. There was some oozing from the rash as well. Patient had a case of shingles in the past with similar presentation on his leg.
8/16/21 around 12pm rash appeared on face 8/17/21 8am rash began to blister and continued to spread 8/18/21 went to doctor to  have evaluated. Doctor unable to provide any other medical diagnosis other than reaction to vaccine.  Prescribe skin antibiotics to treat blisters as they pop. Follow in week if not heeling or improved
Patient had redness and swelling and warmth to touch of the left upper arm, 8cm x 10cm size. Patient had DTAP and Varicella vaccine on the left arm 2 days ago. Provider examined the arm, and instructed the Father of the patient that it is a local reaction and to treat with home care-Tylenol and cold compress. Patient had no fever, no pain, no complaints.
dehydration; cotton mouth; felt weak; fever; chills; warm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm at the injection site), DEHYDRATION (dehydration), DRY MOUTH (cotton mouth), VACCINATION COMPLICATION (felt weak) and PYREXIA (fever) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 23-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm at the injection site), PYREXIA (fever) and CHILLS (chills).   On 24-Jan-2021, the patient experienced DEHYDRATION (dehydration), DRY MOUTH (cotton mouth) and VACCINATION COMPLICATION (felt weak).   On 24-Jan-2021, VACCINATION SITE WARMTH (warm at the injection site), DEHYDRATION (dehydration), DRY MOUTH (cotton mouth), PYREXIA (fever) and CHILLS (chills) had resolved. On 25-Jan-2021, VACCINATION COMPLICATION (felt weak) had resolved.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Two minutes after flu vaccine administered, child's face flushed, made choking sounds, vomited, lost consciousness, face turned pale, decreased respirations.
Hives primarily on back; He first noticed the bumps appearing primarily on his back; itching; difficulty with sleep interruption; Occasional Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives primarily on back), NODULE (He first noticed the bumps appearing primarily on his back), PRURITUS (itching), SLEEP DISORDER (difficulty with sleep interruption) and CHILLS (Occasional Chills) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced URTICARIA (Hives primarily on back), NODULE (He first noticed the bumps appearing primarily on his back), PRURITUS (itching), SLEEP DISORDER (difficulty with sleep interruption) and CHILLS (Occasional Chills). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Difficulty sleeping, at a dose of 1 dosage form. At the time of the report, URTICARIA (Hives primarily on back), NODULE (He first noticed the bumps appearing primarily on his back), PRURITUS (itching), SLEEP DISORDER (difficulty with sleep interruption) and CHILLS (Occasional Chills) outcome was unknown.            The concomitant medication was not provided. The patient experienced hives for nearly 2 months after second dose.
Per mother within 24 hrs pt developed fever of 103.9F. Pt developed episodes of limpness, paleness, cool to touch. Dr noted nothing unusual.
Muscle spasm, numbness/ tingling in R arm, R hand, R shoulder, R calf.
This spontaneous report as received from a physician assistant refers to a patient of unknown age. In April 2013, "within the last month", the patient was vaccinated with a dose of PNEUMOVAX23 (route and lot # not reported). The physician's assistant reported that on an unknown date, the patient experienced red, hard and swollen arm. The outcome of red, hard and swollen arm was unknown. The patient sought unspecified medical attention. Additional information is not expected.
The baby stopped babbling immediately.  Did not make a sound for a month, did not babble again until 4 months later, but not as well as before vaccination.  Also started within 24 hours, odd behaviors like repetative hand flapping.  Slowly developed eating issues.  Eye contact slowly decreased.  Did not respond when called name.  Did not progress much relationally and socially after shot.  Developed 50 words by 16 months, lost all words by 18 months.  Requires speech therapy, occupational therapy, feeding therapy, intensive behavioral therapy, and Relationship Development Intervention.
Information has been received from a nurse concerning a 24 year old female who on 14-SEP-2007 was vaccinated intramuscularly with her first dose of Gardasil (lot# 658560/1062U). Concomitant therapy included hormonal contraceptives (unspecified) and ZYRTEC. On 15-SEP-2007 the patient experienced redness and pain at the injection site and hives on her arms and chest. The patient needed to use her inhaler (medication not specified) the next day. Subsequently, the patient recovered from redness and pain at the injection site and hives on her arm and chest. The patient sought medical attention with an office visit. Additional information has been requested. Additional information was received on 08-JAN-2008. The doctors office received the WAES letter and will fill out the information and send it back. Additional information has been requested.
Patient came back in with a prescription for Doxycycline because she said she had redness at the injection site and went to her doctor who told her she had cellulitis and prescribed the mentioned antibiotic.
pt recvd vax 17MAY93 & 24 hrs later onset of pruritis & generalized hives devel no resp sx present; rx DPH effective;
1.  Left arm/hand numbness and some chest pain within 15 minutes of receiving vaccine.   2.  Left arm/hand numbness still continuing two weeks later.   3.  Headache for four days and some blurry vision for two days after injection.  4.  Abdominal pain - still having - it was very bad on Saturday 4 December that I almost went to the Emergency Room.   5.  Fatigue - severe (I am normally fatigued, but it has gotten worse since injection).   6.  Itching/redness/rash at injection site/.
pain/soreness at injection site, fever, muscle pain, severe joint pain, headache, tiredness for approximately 30 hours
Developed very loud tinnitus on both sides 10 days after first dose  struggled for two weeks with no signs of improvement.  Basically got little to no sleep for those two weeks without the help of sleeping medication.  ENT cleaned my ears, did a hearing test, prescribed 7 day prednisone treatment and Xanax for sleep  Noise has still not gone away and has not gotten any better  Wish this would have been listed as a possible side effect.  I might have changed my mind.
This is the third of eight spontaneous reports as received from a physician concerning a female patient between 14-15 years old who throughout this year "in 2012", was vaccinated IM with a dose of GARDASIL (lot # not provided). No other co-suspects were reported. No concomitant medications were reported. The physician stated that the patient suffered from syncope after having GARDASIL vaccination. The syncope was also more prevalent with the first dose given than with subsequent doses. Orange juice was given as treatment. The patient did not seek medical attention. The patient improved before leaving the office. The patient's outcome was recovered. The relatedness for syncope was unknown for GARDASIL. This is one of several reports from the same source. Additional information has been requested.
Persistent swollen lymph node: armpit of arm where injection made; This is a spontaneous report received from a non-contactable reporter (consumer). The reporter is the patient.   A 12-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date unknown (Batch/Lot number: UNKNOWN) as dose 1, single for COVID-19 immunisation and received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 11Nov2021 (Batch/Lot number: UNKNOWN) at the age of 12 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "persistent swollen lymph node: armpit of arm where injection made". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient did not receive any medication within two weeks of vaccination. Since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Arm twitches/she was experiencing some muscle twisting in the arm she got Flucelvax vaccine; This spontaneous case was received on 27-Oct-2021 from pharmacist (reference number: SEQW21-04647) and concerned a 49-year-old, female patient.The patient's medical history and concomitant medications were not reported.On 08-Oct-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid, arm) for influenza prophylaxis. The batch number reported was 308477 and expiry date: 30-Jun-2022.On the same date, the patient was vaccinated with non-company co-suspect COVID-19 vaccine (brand not specified; anatomical location: arm, dose, route of administration and indication: not reported). The batch number was not reported. The patient got vaccines in separate arms.On the same day, after receiving Flucelvax Quadrivalent and non-company co-suspect Covid-19 vaccine, the patient's arm twitched and she was experiencing some muscle twisting in the arm she got Flucelvax vaccine. The patient did not receive any treatment measures.The outcome of the event was unknown.The reporter did not provide a causality assessment. The case was assessed as non-serious.Company comment: On the same day, after receiving Flucelvax Quadrivalent and non-company co-suspect Covid-19 vaccine, the patient's arm twitched. As reported the patient experienced some muscle twisting in the arm where she got Flucelvax vaccine. Considering suggestive time relationship and biological plausibility, causal role of the suspect vaccine is assessed as possibly related. Sender's Comments: On the same day, after receiving Flucelvax Quadrivalent and non-company co-suspect Covid-19 vaccine, the patient's arm twitched. As reported the patient experienced some muscle twisting in the arm where she got Flucelvax vaccine. Considering suggestive time relationship and biological plausibility, causal role of the suspect vaccine is assessed as possibly related.
ON  DAY # 8 AFTER VACCINE;  HEADACHE,  REDNESS, SWELLING. TREATMENT OTC: TYLENOL, BENADRYL, CALADRYL LOTION PLUS  COLD COMPRESSES
Narrative:  Patient completed Pfizer COVID-19 vaccination series in February 2021. Presented after fever, cough, nightsweats, and light-headedness with falls and hospitalized 9/17/21 and initially treated with supportive cares and Lovenox. Developed acute hypoxic respiratory failure and started remdesivir and dexamethasone (9/20-9/23). Discharged to rehab center 10/5/21. Stay prolonged due to COVID isolation protocols and rehab placement.
Left leg weakness/tightness resulting in fall. Chest racing, mild cough, body aches/stiffness, mild headache, soreness at injection sight
Fever Chills Mod-Sev - leg pain Vomiting x2 Slight Headache  Symptoms last for approx 12 hours
localized pain, swelling, and induration that has persisted >24 hours after injection; intermittent head and neck pain most prominent on the same side as the injection for >24 hours after injection
From initial information received on 24/Mar/2005 from a health care professional regarding an adverse event, it was reported that a 54-year-old female patient received a dose of DECAVAC vaccine, lot number U1209BA, administered subcutaneously in error in the mid-upper area of her left arm on 20/Mar/2005. She received the vaccine as part of treatment for a dog bite. Two days later, on 22/Mar/2005, the patient developed a large local reaction of redness and swelling, measuring 15cm from the injection site above the elbow and 10cm below the elbow. The patient was seen by a physician and was treated with compresses and ibuprofen. The patient was on antibiotics for the dog bite. At the time of this report, the patient had not recovered from the events. Follow-up information received on 24/Oct/2005 from a health care professional. The physician reviewed the case and reports that the patient had an uneventful full recovery from these events, date not reported. No further information is expected.
Hives in her body/Hives started in her back and stomach, then in her ankles and forehead/Hives come and go and appear in big patches/Hives appeared in her arm and face on her eyes, shin,thighs, calves and neck; Behind her ear it was really hot/Ear was burning out/Ear was really hot; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA and EAR DISCOMFORT in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067821A, 026120A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced EAR DISCOMFORT. On 24-Dec-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA. The patient was treated with BENADRYL for Hives, at an unspecified dose and frequency and ZYRTEC for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA and EAR DISCOMFORT had not resolved.            No relevant concomitant medications were reported. It was reported that on 24-Dec-2021 the patient started hives in her back and stomach, then in her ankles and forehead. Her ear was burning out, really hot. The patient repeated that behind her ear it was really hot. The hives came and go, and appear in big patches. Then they disappear, and reappear all over the body. The hives appeared in her arm and face, on her eyes, shin, thighs, calves, and neck. Symptoms was still ongoing.
Information has been received from a registered nurse referring to an unknown number of unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On unknown dates (reported as "starting on or after 20-AUG-2016"), an unknown number of unspecified patients were vaccinated with doses of improperly stored PEDVAXHIB (dose and route unknown, lot # M014926 expiration date: 05-SEP-2017). The vaccines were stored at 31.5 Fahrenheit degree for 27.5 hours. There was no previous temperature excursion. The call was due to a "data logger". No adverse effect was reported. This is one of three reports received from the same reporter. Additional information has been requested.
1-2 days after vaccination, had "itching in lungs", itchy hives on back of neck and shoulders and back. Took BENADRYL - 2 pills 2/day x 3 days.
large lump on L thigh where he had received vaccines on 5/3/19. No redness or bruising. Not painful
Pt had flu shot on 10-19-10. States at 11:00A on 10-21-10 noticed a rash on trunk area front & back. Rash was pink & warm to touch. BENADRYL 25mg 1 po was given.
Pericardial effusion noted on follow up Echo s/p Kawasaki disease, admitted to hospital, noted to be enlarging so had pericardiocentesis and drain placed 5/22/15.
This spontaneous report was received from a Physician assistant concerning an 11 year old male patient with slightly overweight. Within the last week on approximately 22-APR-2013 the patient was vaccinated in one arm with GARDASIL (Lot # not provided), 0.5 ml, intramuscular. On the same date (approximately on 22-APR-2013), the patient was also vaccinated in the other arm with ADACEL and MENACTRA. The physician assistant reported that the patient developed redness and swelling on the arm in which he received ADACEL and MENACTRA (approximately 22-APR-2013). The patient was administered BENADRYL (manufacturer unknown) and ibuprofen (manufacturer unknown) as treatment for the adverse events. The outcome of redness and swelling was reported as recovered/resolved (approximately in April 2013). The patient was seen in physician assistant's office. This is one of several reports from the same source. Additional information has been requested.
Hard lump, fever, rash at injection site for 6 days. Achy joints throughout body for 7+ days. Mother who is immune suppressed (RA medication) became severely ill after contact and touching injection site.
Sharp pain and swelling in lymph nodes under left arm. A viral itchy rash around torso and thighs. Diarrhea and very tired and foggy.
This case was reported by a health professional and described the occurrence of fever in a male patient who received hepatitis B vaccine injection for prophylaxis.  In approximately 2000 or 2001, the patient received hepatitis B vaccine.  At an unknown time after immunization with hepatitis B vaccine, the patient developed a fever of 103 to 104 degrees Fahrenheit.  Hepatitis B vaccine was not re-administered.  The outcome of the event is unknown.
pain and itching to affected arm; pain and itching to affected arm; This is a spontaneous report from a non-contactable consumer. This consumer (patient) reported for herself that a female patient of unspecified age received first does of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was complaining of pain and itching to affected arm, wanted to know what do about it. Patient stated was unpleasant from the beginning, and sounded upset. She expressed frustration over the long hold wait. She became more upset when informed of the common side effects and did not want to hear explanation of how long symptoms may last. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fever 103 3hrs, 101-102 18hrs, severe muscle and joint aches.  Symptoms decreasing at 48hrs.
pt mom stated pt began having some difficulty breathing & red rash on face, neck, upper back @ 9PM on 7/14/98;took to family MD next day & was rx DPH by family MD for allerg rxn;
Tinnitus, both ears. Noticed symptom within 2-3 weeks of vaccine. Symptom has continued since then without abatement. Symptom was new/not experienced with any prior migraines or illnesses.