chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle aches; bad migraine; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 14:00 (Lot number: ER 2613) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Shrimp" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D NOS; CRANBERRY; DOTERRA BALANCE. Past drug history included: Sesame, reaction(s): "Known allergies: sesame"; Avoid z-pak, reaction(s): "Known allergies: Avoid Z-pak". The following information was reported: MYALGIA (non-serious) with onset 17Mar2021 14:30, outcome "recovering", described as "muscle aches"; MIGRAINE (non-serious) with onset 17Mar2021 14:30, outcome "recovering", described as "bad migraine"; DIZZINESS (non-serious) with onset 17Mar2021 14:30, outcome "recovering", described as "dizziness". Therapeutic measures were not taken as a result of myalgia, migraine, dizziness.  Additional information: Reporter stated that, patient didn't take other vaccine in four weeks. Patient didn't have COVID prior vaccination. Patient didn't test COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Patietn noted non-pulsatile tinnitus  couple weeks ( unable to specify) after 2nd dose of Covid vaccine 2/10 (moderna) She did not not associated hearing loss or vertigo
Information has been received from a pharmacist concerning a patient, who on 07-MAR-2014 was vaccinated with an expired dose of VARIVAX (Merck) (dose not provided, lot # 0082AE, expiry date 03-JAN-2014). No adverse effects were reported. Additional information is not expected.
Extreme sleepiness and sleeping more than 20 hours in one 24 hour timeframe.
missed appointment for second dose 5/2/21 due to illness and caller wanted to know whther they could still get vaccine.... ill after first dose of vaccine; This is a spontaneous report from a Pfizer  from a non-contactable consumer. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient missed appointment for second dose 02May2021 due to illness and caller wanted to know whether they could still get vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient received (dose 1) of Shingrix on 7-10-22 and (dose 2) of Shingrix on 8-5-22.    Minimum interval is 4 weeks (28 days) Second dose was given at 26 days.
Pt adm 1st dose of vax w/no adverse rxn; 26NOV90 received a second dose of vax & five days following  second dose exp sore arm, nausea & chest pain; tx Ibuporfen; No further details were provided;
PATIENT SEEN HEAD HANGING WHILE SITTING IN CHAIR FOR 15 MINUTES AFTER VACCINATION SEEMING UNCONCIOUS WHEN APPROACHED BY PHARMACIST IMMEDIATELY AND TECHNICIAN  PATIENT WAS CONCIOUS AND STATE DTHAT HE FELL ASLEEP HAND CURLED UP AND PATIENT WAS TENSE. PATIENT WAS RESPONSIVE TECHNICIAN INSTRUCTED TO CALL 911 CODE WHITE FOR MANAGEMENT WAS CALLED TO THE PHARMACY PATIENT WHOLE TIME CONCIOUS BUT BEGAN TO SHAKE A LITTLE AND SKIN BEGAN TURNING PALE PATIENT ASKED FOR WATER AND WAS GIVEN WATER AN ICE PACK WAS PLACE ON PATIENTS NECK TO HELP COOL DOWN BECAUSE PATIENT BEGAN SWEATING . PATIENT REFUSED TO LAY DOWN ON THE FLOOR FLAT SO WE ELEVATED PATIENT LEGS IN CHAIR 5:06PM EMT CAME AND WAS GIVEN NOTES TAKEN AND TOOK THE PATIENT AWAY
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: anxiety-Mild, Systemic: Hypertension-Medium, Systemic: Hyperventilation-Medium, Additional Details: ems called, gave oxygen, patient refused transport to hospital
3/9/05  Receives vaccinations for MMR, DaTP, and Varicella. She has an ear infection without fever and Dr assures it is ok for vaccination. 3/10/05  starts antibiotics for ear (amoxicillan) 3/13/05  becomes very lethargic and feels feverish. 3/14/05 -  has 103 degree fever underarm.  Very unhappy.  Motrin helps for a little while. 3/15/05 - breaks out with a rash near her hair line and spreads down her torso.  Red & raised bumps.  Last day with a fever 3/16/05 - Rash worse. Take her to Dr. who diagnoses her with a measles rash and pneumonia They change antibiotics to Zithromax.  Ear looks better, but a little fluid remains. 3/17/05 - is still very ill and unhappy.  Rash is no longer raised, but still present as flattened discoloration. 3/21/05 - is finally well enough for daycare.
Tinnitus in right ear (Loud ringing and loss of hearing in right ear), doctor examined and prescribed amoxicillin and over the counter Flonase.
Large local site reaction measuring   6 in x 4.5 in- erythema, edema, tender
very mild reaction to Moderna/very little reaction to the Moderna; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (very mild reaction to Moderna/very little reaction to the Moderna) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Johnson and Johnson (1st dose), Johnson and Johnson (1st Booster dose) and Johnson and Johnson (2nd dose). Past adverse reactions to the above products included Vaccination adverse reaction with Johnson and Johnson, Johnson and Johnson and Johnson and Johnson.    In 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced IMMUNISATION REACTION (very mild reaction to Moderna/very little reaction to the Moderna). At the time of the report, IMMUNISATION REACTION (very mild reaction to Moderna/very little reaction to the Moderna) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-645554 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-645554:Wife's case
right tricep pain, swelling, heat, redness extending from underarm to elbow for 3 days, much better on the 4th day. Full body muscle aches starting 12 hrs after injection, tiredness, stomach ache lasting 2 days then went away.
Information has been received from a physician concerning a baby patient who on an unknown dates was vaccinated with 3 doses of ROTATEQ (doses, routes and lot numbers not reported). The physician reported that a baby received 2 doses of ROTATEQ with a resolved episode of intussusception and then received the 3rd dose of ROTATEQ. It was unknown if the baby had intussusception prior to starting ROTATEQ series or if intussusception occurred after the 1st dose or 2nd dose of ROTATEQ. Follow up information has been received from a physician concerning a 26 week (reported as 6 month) old female patient with no illness at time of vaccination and no drug allergies who on 14-OCT-2011 and 19-DEC-2011 was vaccinated with a first and a second dose of ROTATEQ, (dose unknown), (Lot# 670243/0921AA known only for second dose) respectively. On 14-FEB-2012, the patient experienced intussusceptions with symptoms of abdominal pain, the patient was admitted for observation following reduction of an ileocecal in intussusception, one episode of bloody stools, no pain, no vomiting. Kidneys, Ureters, and Bladder examination on 14-FEB-2012 demonstrated a paucity of gas in colon, abdominal ultrasound on 14-FEB-2012 confirmed intussusception. On 13-FEB-2012 the patient underwent medical examination. Patient P was 143, CO2 sat 99, R 42, T 96.8, rotavirus antigen test was negative, abdominal USG confirmed intussusceptions. On 14 FEB-2012 the patient's glucose was 77, BUN 7, creatinine 0.2, calcium 10.5, sodium 138, potassium 5.0, chloride 105, CO2 23, WBC 20.62, RBC 4.12, HGB 10.3, HCT 31.5, MCV 76.5, MCH 25.0, MCHC 32.7, RDW 14, MPV 9.5, platelets 410, neutrophils 30, immature granulocyte 1, absolute neutrophils 6.12, absolute immature granulocyte 0.10, lymphocytes 61, monocytes 7, eosinophils 2, basophils 0, absolute lymphocytes 12.51, absolute monocytes 1.51, absolute eosinophils 0.34, absolute basophils 0.04. The patient was admitted to the hospital on 14-FEB-2012 (and spent there 1 day). The patient was treated with barium /air contrast enema. At the time of the report the patient status was recovered (recovery date was 15-FEB-2012). No further information is available.
PATIENT DEVELOPED A LARGE ERYTHEMATIC AND EDEMATOUS AREA AT THE SITE OF THE INJECTION.
Vaccine was administered as SQ and not as IM. Patient stated and showed injection site reaction. Recommended patient take ibuprofen and apply cold compresses two to 4 times daily. informed that reaction site should resolve within 2-3 days. Informed patient this is considered a valid dose by the CDC however is still an administration error. Also, informed patient to still received IM shingrix in 2-6 months
This is a spontaneous report from a contactable consumer reporting for herself. This 19-year-old female patient received the first single dose of TRUMENBA via an unspecified route of administration on 02MAR2015. The patient medical history and concomitant medications were not reported. She had stopped an unspecified antibiotic two weeks prior to the vaccination. On 03MAR2015 the patient experienced swelling and warm to touch underneath the area where she received the vaccination, tiredness, chills and her arm hurt. The patient did not recover from the events swelling and warm to touch underneath the area where she received the vaccination and arm hurt, she recovered from tiredness and chills on an unspecified day in MAR2015. Follow-up (01MAY2015): Follow-up attempts completed. No further information expected.
her face got swollen something like that; This is a spontaneous report. A contactable consumer (patient) reported that a 77-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 16Jan2021 at a single dose for COVID-19 immunization. Medical history included tooth canal/a tooth it's going bad on Jan2021. Concomitant medication included celecoxib (CELEBREX), and levothyroxine sodium (SYNTHROID). The patient took the first vaccine and what happened is that she had a tooth canal then right after. The first dose happened on the 16Jan2021 which is last Saturday then after that it seems that the effect that her face got swollen something like that on an unspecified date in Jan2021. The patient stated, "Yes, but it has nothing to do with the vaccine or an allergic reaction. It's just a tooth it's going bad. So I needed to go to the dentist and probably get an antibiotic (Unspecified medication captured as suspect) for it but I wanted to make sure that's not going to negate the strings of my vaccine. I didn't know what it would do to that. No, it's not because of the vaccine. I had actually had it X-rayed on the 13th and he didn't see anything that looked bad but it's gotten worse and it has pores, two pores it has nothing to do with the vaccine. I just I am concern about getting an antibiotic because I don't want it to affect my vaccine. As I said before the vaccine has nothing to do with my problem." The patient underwent lab tests and procedures which included X-ray: didn't see anything that looked bad but it's gotten worse and it has pores, two pores on 13Jan2021. The outcome of the event was unknown.; Sender's Comments: Face swelling is not related to the vaccine use but due to the underlying tooth canal issue.
After first dose, I developed a sore, swollen arm with a rash after 7 days. After the second dose, my throat, neck, and tongue swelled nearly shut.  I have had joint pain that is very painful and randomly moves around ever since the vaccine.
This spontaneous report as received from a registered nurse refers to incorrect product storage due to on 02-FEB-2015 unknown number of patients of unknown ages and genders were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, lot #, expiration dates and route were not reported). No adverse effects reported. This one of several reports from the same source. Additional information is not expected because we cannot contact the physician.
PFIZER COVID 19 VACCINE EUA: ADMINISTRATION ERROR.  INDIVIDUAL RECEIVED VACCINE DOSE FROM VIAL STORED FOR MORE THAN 12 HOURS AFTER PUNCTURE BUT LESS THAN 24 HOURS OF PUNCTURE.  PFIZER STATED THEY HAD ADDITIONAL STABILITY INFORMATION FOR UP TO 24 HOURS AFTER PUNCTURE OF VIAL BUT NO EFFICACY DATA FOR THIS OFF LABEL USE.  RECOMMENDED MEDICAL DIRECTOR AND NURSING FACILITY DISCUSS WITH INDIVIDUAL THAT THEY MAY BE REVACCINATED IF THEY CHOOSE BASED ON LACK OF EFFICACY DATA.  ALSO RECEIVED BOOSTER DOSE 7 DAYS BEFORE DUE. (1ST BOOSTER DUE 5 MONTHS AFTER PRIMARY SERIES).
pt recv vax & w/in short period noticed hives, blotches of redness on chest & legs;red streaks on legs;no RDS notified hosp ER of episode & told to watch for RDS along w/notifing HED & discont of pills;sx lasted couple of hr;
HCP doesn´t remember if the patient received 0,5ML or 0,25ML as a first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (HCP doesn´t remember if the patient received 0,5ML or 0,25ML as a first dose) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (HCP doesn´t remember if the patient received 0,5ML or 0,25ML as a first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (HCP doesn´t remember if the patient received 0,5ML or 0,25ML as a first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.
3/25/21 Day of vaccination:  6:00 PM: arm itching, no rash, cold feeling (no chills) 8:30 PM:  Hives and rash on arms, wheezing, coughing, voice changed (hoarse, airy), trouble swallowing Patient took extra 2nd dose of Zyrtec 10mg and Benadryl 25mg and Albuterol inhaler  3/26/21: Physician advises patient to continue doubling Zyrtec & Benadryl.  If worse, go to ER.  Patient did not require further medical attention.  Injection site 2-3 inch area raised 1.5".  Hives still present on arm. 4/5/21: still some itching at injection site, but hives and breathing issues improved.  PCP advises to forego second dose of Moderna.
Covid infection after completing primary vaccination series; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPOSURE TO SARS-COV-2 (Covid infection after completing primary vaccination series) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (Covid infection after completing primary vaccination series). At the time of the report, EXPOSURE TO SARS-COV-2 (Covid infection after completing primary vaccination series) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.   Reporter did not allow further contact
Discovered 6/13/22, that patient above had received a vaccination that expired 5/20/2022. The date of vaccination was 5/24/2022.
Generalized malaise, low grade fever, achy joints, fatigue all started about 12 hours post vaccine and ended 72 hours later. Headaches and neck spasms started shortly after the other symptoms and are still present however not as severe. During the worst of it I could not move my head in any direction. The pain would start in my neck and wrap around the top of my head and down through my shoulder.
Develop shingles on the head with extreme headache mild rash, did not progress towards eye.  Had the shingrix vaccine 4 years ago.
It really hurts to even wear a bra because  of the elastic and the skin feels hot.; It really hurts to even wear a bra because  of the elastic and the skin feels hot.; Around my waistline and the tops of my legs I have been breaking out in hives and it just worse around my waistline, my bra line; it's big red; it was itching around my waist and tops of my legs.; Around my waistline and the tops of my legs I have been breaking out in hives and it just worse around my waistline, my bra line; it's big red; it was itching around my waist and tops of my legs.; Around my waistline and the tops of my legs I have been breaking out in hives and it just worse around my waistline, my bra line; it's big red; it was itching around my waist and tops of my legs; Sore arm that day; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 20Mar2021 14:30 (at the age of 61-year-old) (Lot Number: EN6208) as dose 1, single for COVID-19 immunization. Medical history included epilepsy and hives (4 or 5 years ago). Concomitant medication(s) included phenobarbital (PHENOBARBITAL) taken for epilepsy, start and stop date were not reported; phenytoin (DILANTIN [PHENYTOIN]) taken for epilepsy, start and stop date were not reported. The patient experienced sore arm on 20Mar2021 and around her waistline and the tops of her legs she has been breaking out in hives and reported that it just got worse around her waistline, her bra line. The patient reported that it was big red; it was itching around her waist and tops of her legs on 28Mar2021. The patient reported that it really was hurting to even wear a bra because of the elastic and the skin felt hot. The patient's arms, face and neck were not swollen, and did not have a fever. The patient reported it was really around the tops of her legs. Patient stated that on 26Mar2021, she was outside in the sun and was molding grass and after that she went inside and took her shower, cleaned up, changed clothes all that kind of stuff and then nothing happened on 27Mar2021. The patient stayed inside on same day and on 28Mar2021. When patient woke up, she reported that she felt she can feel them, the little red places around the tops of her leg, and felt like it was more than usual around her breast and around her waistline. The patient reported that events started on the night of 28Mar2021. The patient has put cold compresses on it and had on a loose gown. The patient reported that she could feel the red bulbs rubbing against her paint and her pants were not tight or elastic but they were soft cotton pants but the patient could feel the heat on her skin around waistline.  No follow-up attempts are possible. No further information is expected.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 10-JAN-2018, 12-MAR-2018 and 11-JUN-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N003984 and expiration date 19-NOV-2018; lot# M022173 and expiration date 15-MAR-2019; lot# N028258 and expiration date 30-MAY-2019) orally for prophylaxis, respectively (Incorrect product storage). The sterile diluent (MERCK) (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
After my second Shingrix shot, approximately 3 hours after the injection, I begin having jaw/teeth pain, chills and body aches. Also mild pain at the site of the injection.  These symptoms lasted approximately 30 hours, the worst was the first 8 hours. No body temperature, nothing that concerned me enough to contact my health care provider.    Contrary, after my first Shingrix shot, I only had mild pain at the site of the injection....none of the other symptoms.  This is really the first time I have had any concerning side effects after any vaccination during my entire life.
Very, very hot burning feeling internally, with coldness in extremities.  My nerve endings (inside) felt like butterflies fluttering (tingling) all over.  On 3/5 my joints, where my thighs meet my torso, were very painful, as is my my lower left side above and running down the top portion of my buttock.   It feels like people describe sciatica, but I've never had that and haven't done anything to have pulled anything.
This is a spontaneous report from a contactable physician. A 65-year-old male patient receive pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (trade name, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization  The patient's medical history and concomitant medications were not reported. The patient experienced allergies with pneumococcal vaccine, hives and extreme pain on an unspecified date. The outcome of the events was unknown. Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) in the reporter's country. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.
mom reports high temp (mom didn't take) & lethargy;pt sleeps x 48hr & was difficult to awake;only woke once to eat in 48hr & fell asleep while eating;
8/24/16 Received VARIVAX left upper arm. She returned to clinic on 8/26/16 to have PPD read and reported to RN that arm was sore. She has erythema 40 mm x 40 mm to left upper arm that is warm to touch. She was evaluated by provider at the Center. Provider advised cold compresses.
Within 24 hours of the 2nd vaccine, significant injection site soreness; visible swelling of the injection site, lymph node(s) under the affected arm, and through the entire chest/shoulder/back region for 2-3 days.    First menstrual period since 11/2020 began with occasional brown spotting on 5/1, along with breast tenderness.  On 5/7 the flow became bright red, clotty, and heavier than my previous norm.  As of 5/17, flow continues to be bright red, clotty, and heavier than my previous norm.  It seems more abundant/heavier after exercise.  It is no worse than on 5/7 but also does not appear to be significantly abating.