chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not provided. On unknown dates the unspecified patients received doses of improperly stored PROQUAD (rHA) (strength, dose, frequency, route were not reported, lot # N031929, expiry date 12-MAY-2019) for prophylaxis. Concomitant therapy included sterile diluent (lot # and expiry date were unknown). Sterile diluent used to reconstitute PROQUAD was stored properly. The temperature and time frame were unknown. There were no previous excursions reported. The call was because of a data logger. No adverse effects were reported. Follow up information was received on 05-SEP-2018 from the nurse and later from the physician. The reporters stated that three female children and five male children between the ages of 1 year and 4 years received doses of PROQUAD on an unspecified date in the past 3 months of 2018. The patient was 1 year old male. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided. There had been no adverse events following the administration of the improperly stored PROQUAD vaccinations. This was just temperature issue where temperature reached -12 Celsius degree. Sender's Comments: US-009507513-1809USA004058:US-009507513-1809USA004059: US-009507513-1809USA004060: US-009507513-1809USA004057: US-009507513-1809USA004061: US-009507513-1809USA004055: US-009507513-1809USA004055.
Got a 102 fever; This is a spontaneous report from a contactable consumer(mother). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via unspecified route of administration on 13May2021 as second dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a 102 (unit was unspecified) fever.  It was reported that the patient's normal temperature was 97.2 (unit was unspecified). The patient underwent lab test and procedure which included Body temperature: 102 (unit was unspecified) on 14May2021. The outcome of the event was unknown. The reporter was querying what to do to get that (temperature) down and reported that she saw on the papers that it could be one of the side effects (the fever).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient received the J&J vaccine on 5/18/21. 12 hours later, he developed nausea, vomiting, cough, weakness, headaches, sweats, and chills. On 5/19/21, he came to the emergency department. He received 1L of NS, ketorolac 30 mg, ondansetron 4 mg, and orphenadrine 60 mg.
This spontaneous report as received from a physician, via company representative, refers to a patient of unknown age and gender. On an unknown date (reported as quite a few years ago) the patient was vaccinated with hepatitis b vaccine (manufacturer unknown) (dose, strength, route and site of administration not reported) for prevention of hepatitis B. When serological testing was completed on this unspecified patient, on an unspecified date, the titers came back as negative. The outcome of the titers came back as negative was unknown. The relatedness between titers came back as negative and hepatitis b vaccine (manufacturer unknown) was not reported. Additional information is not expected, because the reporter did not want to be contacted.
I did have a sore arm the 2 days following injection.  The 5th day following the injection, my left hand fell asleep/ went numb, about 10 min later my left arm had the same feelings, approximately 10-15 min after my arm, my left leg had the same feeling and about 10 minutes after my leg,  my left foot had the same feelings. Approximately 15 minutes after my foot,  I had an intense headache.  My daughter took me to ER where I was treated for stroke symptoms.
Emergency Room visit ordered by phone triage due to numbness of left side of face (limited to and encompassing V2 nerve of trigeminal nerve) and left arm. Arm numbness had worn off prior to arriving at ER; facial numbness and pins and needles continued for 24 hours longer. No other symptoms and no muscle weakness.
Pt.'s arm that received FLUZONE HD (L deltoid) was red and sore from shoulder to elbow. Occurred the day after the vaccine.
receive vaccine on 9/27  on 9/28 experienced pain and burning at injection site with headache and general malaise with photophobia  on 9/30 in the evening notice hands and finger with tingling and numbness next morning on 10/1 also noticed it in both of my feet .  on 10/2 mid day noticed neck stiffness, It didn't go away contacted my PCP on 10/5, at this time no other treatment recommended except monitor for worsening symptoms and advised to contact my Occupation health as Ii received it from work . on 10/6 woke up with a headache in notified my practitioner advised to continue to monitor and Tylenol for headache I also contacted occ health on 10/6 only recommendation given was this website and told to complete this form and to continue to follow up with my PCP.  As of today 10/7 I still have numbness and tingling, pins and needles in my hand and feet, stiff neck, mild headache and pain and burning at the site of the injection and unable to lift my arm without pain in my shoulder and armpit.
8 x 9 cm area of eryth, warm, tender with palp, firm to touch. No streaking, AUGMENTIN 600/429 mg/5mL 5 mL BID.
p/vax pt devel a purpuric rash @ acel-immune & HIB TITER inj sites; pt recovered w/o tx;
This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 15-JUN-2016, the patient received dose of improperly stored RECOMBIVAX HB with lot# L033343 and expiration date 13-SEP-2017, via intramuscular route (dose was not reported). Administered dose underwent temperature excursions at 31 Fahrenheit degrees, for 10 hours. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected.
Delayed adverse events; Not feeling well; Fever of 102degrees; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Delayed adverse events), ILLNESS (Not feeling well), PYREXIA (Fever of 102degrees) and FATIGUE (Felt tired) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced ADVERSE REACTION (Delayed adverse events), ILLNESS (Not feeling well), PYREXIA (Fever of 102degrees) and FATIGUE (Felt tired). On 16-Mar-2021, ADVERSE REACTION (Delayed adverse events), ILLNESS (Not feeling well), PYREXIA (Fever of 102degrees) and FATIGUE (Felt tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: 102 (High) 102 degree.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD21-059464 (Patient Link).
Rash on face, cheeks and eye lids.  Swollen lips.  Tingling full face.
30min p/vax fingers (nail beds) & toes turned blue, body stiff, non responsive, then body jerked for a short time w/circumoral cyanosis;fever devel p/sz
Outbreak of genital warts that was worse in severity than any prior outbreak; lot of stress; This spontaneous report was received from a physician via company representative refers to an adult female patient of age between 30 to 32 years old. The patient's prior history included genital warts. Information drug reactions or allergies were not reported. On unknown dates, the patient was vaccinated with 2 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, route, dose, lot # and expiry date unknown) for prophylaxis. On an unknown date, following administration of the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient experienced a new outbreak of genital warts which was worse in severity than any prior outbreak (anogenital warts). The patient received two weeks treatment with "TCA" (Trichloroacetic Acid). On an unknown date, the patient also was under a lot of stress (stress) and she felt that the new outbreak of genital warts was related to the stress. The outcome of the events anogenital warts and stress was unknown. The reporter assessed the event anogenital warts to be not related with the suspect drug hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The reporter did not provide the causality assessment between the event stress and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). There were no cancer or overdose involved to this report.
pt recv vax; immediate grayish pallor lasting 31-40 mins;?- sleepy;
2.0 inch x 2.75 inch area of erythema at left deltoid injection site. Also complains of soreness and pain with movement.
Symptoms included feeling lightheaded shortly after vaccinated, after 10 minutes or so general weakness, slight nausea, then another several minutes severe leg weakness, flutter sensation in upper leg muscles and brief tightening in throat.  Documented in employee computer data base by EH nurse. At 20 minutes or so only weakness remained. Experienced chills and nasal drainage at night. On 12/8 had some daytime improvement only to have extreme fatigue in evening.  12/9 legs weak and low back/spine ache - primary doctor notified- nurse advised antihistamine and to get checked if it got worse.  Worked all weekend.  12/12 PM severe headache/neck ache, ringing ears, leg weakness with migrating burning/stabbing pain in front leg muscles.
This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot# L019287, 14-SEP-2017, L037339 09-FEB-2018, L013429 21-JUL-2017. No adverse effects were reported. This is one of the 4 reports received from the same reporter. Additional information has been requested.
My whole arm hurts so bad can't stand it. Clear to bone. Arm swollen pure misery.
This is a non-serious spontaneous case, initially received from pharmacist on 12-Jan-2018, concerning a 30-year-old, adult, female pregnant patient. The patient previous pregnancies were unknown. The patient's last menstrual period (LMP) was unknown. On an unspecified date, it was reported that syringe completely fell apart while trying to vaccinate. since the adapter piece (where syringe was screwed to needle) fell off from the syringe and the same thing happened with the second syringe. This case was associated with product technical complaint (PTC) and the corresponding reference number was 1027149. Based on the investigation performed, it was concluded that FLUCELVAX Batch 195243 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the syringes or stopper components, and no trends were identified for the batch for syringes for Luer Lock separation during administration due to using of the Easy Point retractable needles. The most likely root cause was attributed to improper handling by the user. On 12-Jan-2018, the patient was administered with FLUCELVAX QIV pre-filled syringe (PFS) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195243 and expiry date: 30-Jun-2018) on an unspecified week of pregnancy. It was reported that, the patient had not experienced any adverse event. The estimated date of delivery (EDD) was on unspecified date in May-2018. Non-significant follow up received on 30-Mar-2018: The reporter had no information on patient's last menstrual period (LMP) and exact estimated date of delivery (EDD). No changes were made in the narrative. Follow-up report received from QA (quality assurance) department on 28-Jun-2018: Based on the investigation performed, no internal root cause was identified in the manufacturing process, or relating to the syringes or stopper components, and no trends were identified for the batch for syringes for Luer Loc separation during administration due to use of the Easy Point retractable needles. The most likely root cause was attributed to improper handling by the user. The narrative was amended accordingly.
I received high temperature of a 100.1; Muscle aches; muscle pain; Body aches; nausea; I was developing soreness at the injection site of the arm; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) via an unspecified route of administration, on 31Dec2020 at 12:20, at a single dose, as preventive measure for COVID. The patient has no relevant medical history. There were no concomitant medications. The patient received the vaccine on 31Dec2020 about 12:20. On the same day, midafternoon, patient developed soreness at the injection site of the arm. The following day (01Jan2021), in the morning, she had a high temperature of a 100.1 along with some muscle aches/ muscle pain, body aches, and nausea. Outcome of the events was unknown.
Headache; redness; Chill; Nausea; Body aches; severe arm soreness and swollen arm where the injection was given.
Information has been received from a healthcare worker concerning a female patient who was vaccinated with a dose of GARDASIL (lot# not provided).  Subsequently the patient experienced arm discomfort after receiving the vaccination, related to the vaccine feeling cold.  Unknown medical attention was sought in the physician's office.  The patient's outcome is unknown.  No product quality complaint was involved.  This is one of two cases from the same source (WAES# 0805USA04694).  Additional information is not expected.
Light reddish patchy rash on arms, legs face, c/o itching.  Mother says she took her to Dr. who gave her Benadryl, Zantac, steroids, Itching/rash continued until 5/10/06.
24 hours post vaccine headache. 9 days post vaccine developed Covid-19 c.o fever, chills headache, cough, muscle aches. Complained of headache for the past 14 days. Past 48 hours headaches have worsened and not reileved by Over the counter medication
site of injection, LUA,  muscle soreness and unable to life L arm. Still unable to life left arm completely without pain. I'm a nurse, so doing my own physical therapy.  BUT, main issue has been daily headaches. I've had more headaches in the last 3 months since vaccine, then I have had in my entire life.  no treatment except Tylenol or ibuprofen.  Although, the other day I had a severe headache, with visual disturbance, vertigo with dizziness and nausea.  Was treated at local ER for possibly stroke. MRI showed no issues.  I am now diagnosed with migraines.
pt c/o leg sore @ site of inj approx 0900AM on 17AUG96;site warm to touch;welt size of fifty cents piece noted in evening 17AUG96;APAP given all day ice applied to area;comes to clinic on 19AUG95;site red, swollen, warm to touch 4"x5 1/2" ;
intense migraine headache with light/sound sensitivity, vomiting lasting the evening after the vaccination. symptoms resolved by next morning
Age Requirement confused with Pfizer, Pediatric patient received the vaccine; A spontaneous report was received from a consumer regarding a 16 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25-FEB-2021, the patient received her first of two planned doses of mRNA-1273 (lot/batch: 023J202A) intramuscularly for prophylaxis of COVID-19 infection.  On 25-FEB-2021, the patient received the vaccine in error as the event age requirement was confused with Pfizer's.   No treatment information for the events was provided.   Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event was resolved on 25 Feb 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old female) for mRNA-1273 (lot number 023J20A) with no associated AEs reported.
PATIENT WAS GIVEN SECOND PFIZER DOSE 11 DAYS AFTER FIRST DOSE. PATIENT WAS CONTACTED AFTER ERROR WAS DISCOVERED, SHE REPORTED FEELING SOME FATIGUE AFTER THE VACCINE ADMINISTRATION BUT REPORTED NO OTHER ADVERSE EVENTS/SIDE EFFECTS FROM THE VACCINE. SHE WAS INSTRUCTED TO REPEAT HER SECOND DOSE 21 DAYS AFTER THE INAPPROPRIATE DOSE AND AGREED SHE WILL COME IN TO PHARMACY 11/27/21 FOR HER SECOND PFIZER DOSE. SHE HAS SUFFERED NO ADVERSE EFFECTS AS A RESULT OF THE ERROR DOSE(GIVEN 10 DAYS EARLY).
Patient was hospitalized for heart problems. Patient died due to COVID-19. Patient was fully vaccinated.
Developed case of shingles / Herpes zoster; This spontaneous report was received from an other health professional and refers to a 80-year-old female patient. The patient's concurrent conditions included depression, osteoporosis and dementia. There was no information about patient's concomitant therapies or medical history provided.  On 14-OCT-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), subcutaneously in the right arm (strength, dose, indication, lot# and expiration date were not provided). On the same date, the patient was also vaccinated with influenza virus split virion 3v vaccine inactivated (AFLURIA) intramuscular injection in the right arm, lot# U57907 (strength, dose and expiration date were not provided) for unknown indication and pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) intramuscularly in the right arm (strength, dose, indication, lot# and expiration date were not provided).  On 22-OCT-2015, the patient experienced herpes zoster. The outcome of the event was unknown.  Causality assessement was not provided.  Upon internal review, the event od herpes zoster was determined as medically significant.
First felt a sting and then noticed the red area which had the shingle sore on the front right shoulder.
THE NEXT DAY PATIENTS ARM WAS SWOLLEN PAINFUL RED AND WARM TO THE TOUCH SHE STATED IT LOOKED LIKE SHE HAD A RED RASH AROUND THE INJECTION SITE. RECOMMENDED SHE CALLED HER PRIMARY CARE DOCTOR TO EVALUATE
There was redness, swelling, and a knot at the injection site two weeks later. She broke out in eczema one week after the vaccine was administered. She had a hard time sleeping and controlling her moods.
had sore muscles all over; can barely walk; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced muscle pain and walking difficulty. On an unknown date, the outcome of the muscle pain and walking difficulty were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The case was reported by the sister of the patient. The patient received Shingrix and had sore muscles all over. She could barely walk. The reporter asked was this normal and what should she do.
(1) Tightness in chest. (2) Slight soreness at injection site. (3) Slight lightheadedness. BP: 140/90 recheck 120/96 no wheezing audible.
I started to feel tired. My arm hurt so bad I couldn't touch it or move it. I started sweating and had chills. When I went to bed, I had to sleep with multiple blankets. When I woke up the next morning, I was sweating. I checked my temperature. I had a 100.4-degree fever. I developed body aches and continued fatigue. The symptoms were bad until I went to bed that night. Then, I started feeling better.
Feeling uneasy, malaise, 2:00 PM (pain in right leg, NOT injection sight)  7:00 PM (continuous pain in right leg, more so when walking). 1/30/2010 He still had pain in right leg, it had not gotten worse, but it hadn't gone away either.
p/vax pt devel fever to 102 APAP given;got rash, hives taken to ER rxn from shots-tx w/DPh-soreness;
PT SEEMS TO GET SICK TO HER STOMACH AND NAUSEOUS FOR 2-3 DAYS.
Patient started experiencing lymphodema under left arm. Arm is painful to touch. Slightly red. Encouraged warm compress, Tylenol alternating with ibuprofen.
RASH; TIRED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry date: unknown) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 17-MAR-2021, the subject experienced tired. On 19-MAR-2021, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 19-MAR-2021, and had not recovered from rash. This report was non-serious.
March 16 I started feeling a slight loss of muscle control on right side of my mouth.  March 17 the loss of control continued to worsen and my lunch time, a noticeable facial drop presented and unable to close right eye. Went to hospital ER and was admitted and examined with negative results for stroke.  Consensus opinion after numerous tests was that it was Bell's Palsy.
Received vaccine 11/13 am. Fri 11/14 afternoon developed left axillary lymphadenopathy. Sat 11/15 extreme tenderness of left axillary area. No problems at shot site. Took anti inflammatory to relieve pain.
Approximately a week and a half after vaccine my senses of smell and taste changed. Most food smells and tastes a bit  like acetone and slightly moldy. I also perceive that my breath and hands have this same smell. I had a mild case of Covid-19 in December 2020 and did not have these symptoms at that time. I had typical reactions to the vaccine for the 2 days after injection - fever, headache - but the impact on senses took some time to kick in. Those impacts have persisted, at least as of today.
heart pain; mild headache; I do get, sometimes, like a hard beat in my heart so there is some similarity there; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 23-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 09Sep2021 (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was inquiring about additional information regarding side effects of the Pfizer COVID-19 vaccine. On an unspecified date in Sep2021, the patient experienced a mild headache and heart pain. The patient stated that he did get, sometimes, like a hard beat in his heart so there was some similarity there. The patient stated that the heart pain now was rare but it was still there. The patient asked if that was normal. This case was reported as non-serious. The outcome of the event mild headache was unknown. The outcome of the other events was not resolved.   The lot number for BNT162b2 was not provided and will be requested during follow up.