chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 42-year-old female patient (not pregnant) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 41, in left arm, on Mar 31, 2021, at 03:00, single dose, for COVID-19 immunisation. The patient's medical history not reported. There were no concomitant medications. The patient experienced a menstrual disorder/menstrual cycle - increased cramping, dysmenorrhea and heavy menstrual bleeding/heavier than normal bleeding; all onset Apr 14, 2021, at 12:00, with outcome of recovering. No therapeutic measures taken. Additional information: Patient did not receive other vaccine in four weeks. She had increased cramping, and heavier than normal bleeding, 2-3 months after both shots and booster. She never had this issue before. Symptoms seemed to subside after first 2-3 months after each shot. No COVID-19 prior vaccination. No COVID-19 test post vaccination. Patient did not have any known allergies. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Patient was under age of recommended vaccination. Age reported was '12' but was 2 months shy of birthdate.
Pt was vaxed w/3.6 cc of Hep B vax on 25JUL91; vax was given by body weight; On 26JUL91 pt devel a rash & swelling on hands & palms; pt also had itching on lower back & buttocks; pt later recovered;
Patient received vaccine before turning 12 years old; This is a spontaneous report from a contactable pharmacist. A 11-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via intramuscular route of administration in the arm left on 21May2021 at 17:00 (at the age of 11-year-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. It was unknown, whether the patient received any Concomitant medications within two of vaccination. The patient had no known allergies to medications, food or other products. It was unknown, whether the patient was diagnosed with COVID-19, prior to the vaccination. It was unknown, whether the patient had been tested for COVID-19, since the vaccination.  The patient did not receive any vaccination within four weeks prior to the COVID vaccine. On 21May2021 at 17:00, the patient received vaccine before turning 12 years old (product administered to patient of inappropriate age). The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the product administered to patient of inappropriate age was recovered on an unknown date.  No follow-up attempts are needed. No further information is expected.
Awoke in the middle of the night to mild/moderate anaphylaxis - tingling throat and tongue, swelling of throat and tongue, difficulty breathing, nausea, gagging, diarrhea - lasting for about 30 minutes - all symptoms occurred at the same time
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a 11-years-old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 28-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the right upper arm for prophylaxis (lot # 1621931, expiration date on 26-JAN-2022) (strength, dose, frequency and route of administration were not reported) (incorrect product storage).  The improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without a previous temperature excursion. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.devicelotnumber: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2009USA006106:
Client received a full dose (0.5 mL) of Moderna instead of a booster dose (0.25 mL). Client not noted to have any adverse reactions
1. Local reaction at site of injection: redness, induration, warmth, swelling, itching, pain.  2. Systemic reaction: chills, body aches, headache, nausea, loss of appetite, ears ringing, exhaustion,
Taken to ER by ambulance after episode of facial cyanosis, turning limp, and not breathing for about 30sec. When tilted up had emesis and turned pink. When arrived at ER was found to have fever 38.9 degrees C.
severe lethargy, shortness of breathe and fatigue (potential blood clot), went to PCP and prescribed Eliquis and Prednisone; however, written documentation said that he had no prior history of clotting prior to the vaccine.
Rash on face, facial flushing the day after vaccines given.  Received Benadryl orally.  Also concurrent upper respiratory infection, otitis media.
Sore and practically immobile arm starting  4 hours after injection. Treated with Advil. I could lift my arm the next day and recovered the third day.  Inside of mouth felt sore and inflamed starting approximately 8 hours after injection. Lower face and lips swollen at approximately 10 hours after injection.  Treated with Benadryl for 2 days.  My breathing and swallowing was not effected so I did not seek medical treatment. Swelling disappeared 2 days after injection.   Indigestion started 1 week after injection. Treating with occasional otc antacid.  I have never had indigestion before.
fatigue; Chills; headache; body aches; This is a spontaneous report from a non-contactable Other HCP. A 26-year-old female patient received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), intramuscular on the left arm on 12Jan2021 08:30 at single dose for COVID-19 immunization. The patient medical history included allergies. Concomitant medication included unspecified medication. The patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) on 22Dec2020, intramuscular on the left arm. The patient experienced fatigue, chills, headache and body aches on 13Jan2021 06:00. The patient was recovering from the events. No treatment was received in response to the events.  No follow-up attempts are possible. Information on lot/batch cannot be obtained.
On Dec. 20, 2020 around 11:30 PM, 2 days after patient received her COVID-19 vaccination, she was found on the bathroom floor , obtunded, very pale, diaphoretic, nauseous, and complaining of severe chest pain.  Paramedics was called and patient was transported to the nearest emergency room. According to paramedics, on the way to the ER while  patient was in the ambulance,she was noted with a sudden drop in heart rate  about 19 beats/minute and have to be given Atropine IV Push, oxygen and was connected to transcutaneous pacing which improves her heart rate.  In the ER patient continued to have chest pain and she was given Morphine, Oxygen, Nitroglycerine and Aspirin. IM had an EKG which showed Sinus Bradycardia with a Right Bundle Branch Block. She had serial ekgs,  a chest x-ray, laboratory testing which included Troponin. Her first Troponin level came back elevated prompting her hospital admission to Telemetry. Her next 2 Troponin level improved and return to normal range and her chest pain has resolved.. She underwent a Stress Test which came back negative. Patient was admitted for a total of 20 hours in the Telemetry unit with Cardiology consultation before being discharged home last . She  was re-evaluated by the cardiologist yesterday which diagnosed her a chest pain of unknown origin.
First dose / december of 2019 / wants her to get her second dose now; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The patient's primary care physician wanted the patient to get her 2nd dose now, it had been approximately a year and a half since 1st dose. The reporter consented to follow up. No further information was provided.
Muscle spasms like charley horses in foot and calf; few back spasms; Numbness and tingling in hands; Numbness and tingling in hands; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 21May2021 at 16:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine. The patient had no known allergies. Concomitant medications included birth control pills (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and lamotrigine (MANUFACTURER UNKNOWN), all taken for unspecified indications from unknown dates. Prior to the vaccination, it was unknown whether the patient was 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. On 21May2021 at 22:00, the patient experienced muscle spasms like Charley horses that lasted for hours at a time in foot and calf, a few back spasms, numbness and tingling in hands like arm fell asleep even though not laying on it. 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 muscle spasms like Charley horses in foot and calf, a few back spasms, numbness and tingling in hands were not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Per mom, redness and swelling noted 2 days after injection on the site where Kinrix was injected.
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 25-NOV-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot No. K001631, exp. 24-FEB-2017) (dose and site not reported). On an unspecified dates, the GARDASIL vaccine had six temperature excursions: 80, 1172, 336, 168, 24 and 416 hours respectively. The lowest recorded temperatures were 30 (-1.111111111 Celsius degrees) and -3 (-3 Celsius degrees). The highest recorded temperatures were 49 (9.444444444 Celsius degrees), 47 (8.333333333 Celsius degrees), 59 (15 Celsius degrees) and 48 (8.888888889 Celsius degrees). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Proquad given to 14 year old and only indicated until 13 years old.
After receiving Shingrix shot, patient experienced swelling, redness, hot, pain at the injection site for a week. the swelling subsided but she is still experiencing itchiness. She didn't have a reaction to the flu shot area.
Received meningococcal vaccine on 6/25/04 - on 6/25/04 arm was quite red and swollen. On 6/27/04 - fever and sore throat. On 6/28/04 - seems to be better. Symptoms treated with ibuprofen.
Information has been received from a 36 year old male registered pharmacist with codeine allergy and allergy-induced asthma, and a history of Gastrooesophageal reflux disease who in February 2010 was vaccinated intramuscularly with the first dose of PNEUMOVAX 23 (lot number 665904/0866Z, exp date 04-JUL-2011). On 19-OCT-2010 the pharmacist was vaccinated intramuscularly with the second dose of PNEUMOVAX 23 (lot number 665904/0866Z, exp date 04-JUL-2011). Concomitant medication included: PRILOSEC and vitamins (unspecified). On 19-OCT-2010 he developed soreness at the injection site, swelling, muscle pain and heat at the injection site that lasted 2 days. The pharmacist did not seek medical attention. There was no lab diagnostic test performed. At the time of report the patient's soreness at the injection site was not recovered. Additional information has been requested.
has been under lot of stress and that her dad had been diagnosed positive with COVID and her husband were both exposed.  Her husband developed COVID as well and then on the 26th of May she tested positive for COVID and was treated with remdesivir.  Is noted in her medical records in 2008 she had had episodes of palpitations and chest pain.
I got the shot around 4:30PM on Friday and woke up in the middle of the night that night with a fever (100.5) and aches. I had both symptoms all through Saturday as well.  I was also very tired and slept most of the day Saturday. When I woke up on Sunday I felt totally fine again.
shingles after Covid 19 vaccine; This is a spontaneous report from a contactable other health care professional (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6198, Expiration date: Jun2021), via an unspecified route of administration in right arm on 25Feb2021 at 08:30 as 1st dose, single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included over the counter antacid tablet at night, other than that she was not on any medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive additional vaccines on same date with the Pfizer vaccine. She had her first dose on 25Feb2021 and she was supposed to have her second Covid 19 vaccine on 18Mar2021 but she woke up with shingles on 18Mar2021. She called the pharmacy where she received the first Covid 19 vaccine and was told she would have 45 days to get her second Covid 19 vaccine. She did not know if it was 45 days from when she received the first shot or 45 days from when she was supposed to get the second shot. The shingles was on her right side around her waist and belly button on the right side on her torso. No relevant tests were performed. The patient did not visit emergency room or physician office. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Called client and informed her that she was given the wrong Pfizer. Recommend to get Bivalent in 2 months.
she got mono; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFECTIOUS MONONUCLEOSIS (non-serious), outcome "unknown", described as "she got mono".  Additional Information: The patient's immune system was weak.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a pharmacist refers to a 68 years old male patient. The patient was vaccinated with ZOSTAVAX (lot# reported as H012577, exp 28-SEP-2013) on unknown date. No concomitant medications were reported. The patient came down with shingles 11 days after receiving ZOSTAVAX. The patient visited office for medical attention. No treatment information was reported. The outcome of shingles was not reported. Additional information has been requested.
I do not know if there is any relationship between vaccine and illness, but patient  had Menactra vaccine on 7-8-05 and was diagnosed with type I diabetes mellitus on 9-27-05 (also had HAV given on 7-8-05) Additonal terms from Discharge summary rec'd 12/28/2005: Hyperglcemia, inc. thirst, inc. urine, ketosis, fever, vomit, diarrhea/sr Information from 60 day follow-up report states: Please understand I do not know if the vaccines were related to the development of diabetes in this patient. Admitted to hospital 9/27/05 with new onset diabetes mellitus. Onset would have proably been several weeks prior. Discharge summary states blurred vision. msv
Patient was administered an expired dose of the Moderna COVID-19 vaccine; The patient received her first and second dose of the Pfizer COVID-19 vaccine/ The patient received a booster dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received her first and second dose of the Pfizer COVID-19 vaccine/ The patient received a booster dose of the Moderna COVID-19 vaccine) in a 103-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: PFIZER BIONTECH COVID-19 VACCINE (The patient received her first and second dose of the PfizerCOVID-19 vaccine.).    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received her first and second dose of the Pfizer COVID-19 vaccine/ The patient received a booster dose of the Moderna COVID-19 vaccine). On 23-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received her first and second dose of the Pfizer COVID-19 vaccine/ The patient received a booster dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   pharmacist reported that he had administered the expired vaccine to 5 patients, The pharmacist had a batch of the Moderna COVID-19 vaccine vials with lot 050E21A Upon finding out that the expiration has not been extended. vaccination facility. no concomitant and treatment medications are provided.
Patient first came to me today 2/1/18 complaining of immobility in left arm. She said it started about 10 days after her vaccine, and she's not sure if it's due to that or due to her hitting her arm around that same time period. She says she can only lift her left arm up about 1/3 of the way. She said she's seen her PCP Dr. about this, who said she has "frozen shoulder" according to pt.  Not sure when she first saw doctor for problem. She didn't mention trying anything for it as far as treatment. She will see orthopedic surgeon soon she said.
Developed redness and warmth of right arm from elbow to shoulder and swelling circumvents arm, no pain, pimple heads at injection sites, fever. Sent to ER and diagnosed with bacterial infection and placed on Clindamycin 11mg PO Q8 hours x 7 days. On 7-15-17 at 3:10 pm arm looks better, much less swelling per mom.
full body rash and welts, very itchy.  Pt started having symptoms very quickly after administration on 5/17/22.  took benadryl and allegra around the clock for 2 days, but was still very itchy.  went to ER on 5/19/22.  was prescribed vistaril 25mg 1 TID prn itching and Prednisone 20mg/day for 5 days.  did not receive much relief from prednisone and vistaril.  patient went back to ER on 5/23/22 and was prescribed Zyrtec 10mg daily. stopped taking benadryl, vistaril, prednisone, and allegra.  has been experiencing a relief of symptoms for the last few days since starting zyrtec.
Fever 102,  for 30 -60minutes  chills several hours muscle aches 24 hours,hours  joint pain 24 hours
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for routine adult health maintenance and the intended purpose for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of his shingles and associated injuries. On an unknown date in 2014, the patient was treated by a physician for vesicular outbreak, which was diagnosed as shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Pt was administered vaccine by Pharmacist on 7/31. She started having difficulty breathing that night and thought it was due to her asthma. The condition continued to worsen and she had a terrible headache since the injection. She also started having nausea/vomiting, dizziness, and pain/redness and swelling at injection site that got increasingly painful starting the following day. The pain in the arm started to radiate and give the patient radiating pain into the shoulder. She went the ER the night of 8/2. They gave her medications (inc steroid shot). She had three medications sent in to us to fill for allergic reaction (zantac, prednisone, and vistaril).