chrisvoncsefalvay/vaers-outcomes huggingface dataset:
"Quadrivalent" flu vaccine administered in office on Thursday at 10 am, no details given of manufacturer or trade name.  Fairly severe muscular ache on left flank started in early evening of the day of the vaccination (Thursday).  Continued into Friday, Saturday and Sunday. On Monday morning (today) it was more of a sharp pain than an ache in the left flank.  Took two advil and the pain vanished.  Don't know how I will be tomorrow morning, so I said 'Unknown' to question about recovery below
Information has been received from a physician concerning another physician's infant with no pertinent medical history who in approximately 2007 was vaccinated PO with the first and second doses of ROTATEQ. Concomitant vaccinations administered in approximately 2007 included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose of PREVNAR and a dose of Hib conj vaccine (OMPC) (manufacturer unknown). In approximately 2007 the patient experienced diarrhea after the first dose of ROTATEQ. Subsequently the patient recovered. In approximately 2007 after the second dose, the patient experienced diarrhea. The infant sought unspecified medical attention. The father of the patient (physician), decided to discontinue therapy with ROTATEQ for the infant. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
Received Pfizer in error when she wanted Moderna for her Booster.  The two staff members before her got a dose of Pfizer and in error she was given the same instead of the Moderna which was available as well.  The nurse administering repeated the question from registration- " are you feeling well today, and which arm but not which med".
This spontaneous case, initially received from other health professional (nurse) on 06-Nov-2018, concerns a 63-year-old, adult female patient. On 01-Nov-2018, the patient was administered expired FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195216, and expiry date: 30-Apr-2018]. The patient did not experience any adverse events after vaccine administration. The reporter assessed the case as non-serious. This case was linked to 201805215 due to same reporter. Non-significant follow-up received from other health professional (nurse) on 21-Nov-2018: The reporter confirmed that, the patient didn't experience any adverse reactions after administration of the expired dose vaccine.
This non-valid spontaneous report was received from a pharmacist via a company representative and refers to two non-pregnant patients of unknown age and gender. The patients' concurrent conditions, concomitant medications, pertinent medical histories and drug reactions or allergies were not provided. In approximately September 2017, reported as "within the last month", the patients were vaccinated with PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported). The patients were administered PNEUMOVAX 23 with the same lot number. In approximately September 2017, both patients experienced swelling, which lasted two to three days. The pharmacist reported that the patients followed up with him for the swelling and he recommended that they "ice" the swollen area. The pharmacist received no follow up after this. The outcome of the event of swelling was reported as recovered/resolved (in approximately September 2017). The relatedness between the event of swelling and PNEUMOVAX 23 was not assessed by the reporter. Follow-up information was received on 17-NOV-2017 from the pharmacist. On 24-JUL-2017, the elderly female patient who was over 65 years old was vaccinated with PNEUMOVAX 23 (lot # N010106, expiration date: 15-NOV-2018). The patient had recovered from the event of swelling within a week. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA001540.
This is a breakthrough covid case. This patient is fully vaccinated and tested positive 6/29/21
She woke up in the middle of the night wiht a fever,shaking, and screaming and she had a rash patch on her abdomen. took her to the doctor in september and thye gave her DTP/HIB/IPV. after that she had the same reactions wiht the fever, screaming and rash. docotr said it was nothing to worry about and ot use neosporin and hydrocortizone and recommended that she get the flu vaccine. On october 16th 2020 she received the flu vaccine. the rash then spread over her front and back with hives and fever and she turned yellow. we took her back in 11/23 and the doctor looked at the rash and the doctor said she was yellow from foods and administered the flu vaccine again. she is now unresponsive. she stopped talking and she grunts and yells but has no coherant words. she flaps her arms and does not answer to her name or anyone speaking to her. took her to the doctor and took blood and was referred to a neurologist. neurologist said she has autism. the doctor before the neurologist also said autism. we are taking her to another neurologist for a second opion.
Flu like symptoms; Dry heaves; Fever; Chills; Frequent urination; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), POLLAKIURIA (Frequent urination), RETCHING (Dry heaves), PYREXIA (Fever) and CHILLS (Chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 048A21A) for COVID-19 vaccination.     The patient's past medical history included Atherosclerosis in 2009 and Stent replacement. Concurrent medical conditions included Drug allergy (erythromycin, tramadol.). Concomitant products included NIACIN for Blood cholesterol increased, LOSARTAN for Hypertension, KRILL OIL for Pain, ASCORBIC ACID (VITAMIN C ASC ACID), VITAMIN B COMPLEX (B COMPLEX (B50)), CURCUMA LONGA ROOT (TURMERIC [CURCUMA LONGA ROOT]), ZINC and APIXABAN (ELIQUIS) for an unknown indication.   On 10-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) (Intramuscular) dosage was changed to 2 dosage form. On 02-Feb-2021, the patient experienced POLLAKIURIA (Frequent urination) and CHILLS (Chills). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), RETCHING (Dry heaves) and PYREXIA (Fever). On 11-Feb-2021, POLLAKIURIA (Frequent urination) and CHILLS (Chills) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), RETCHING (Dry heaves) and PYREXIA (Fever) was resolving. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment of the events included , paracetamol.   This case was linked to US-MODERNATX, INC.-MOD-2021-056849 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Contact information updated On 17-May-2021: Completed ADR, additional event information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-056849:2nd dose case
Onset day 11 of synovitis, 4th right PIP joint, with marked swelling, heat, and redness. No other joints currently involved. No rashes.
Information has been received from a pharmacist concerning a 50 year old female with chronic obstructive pulmonary disease who on an unknown date was vaccinated with a dose of Zostavax. Concomitant therapy included high dose inhaled corticosteroids (unspecified). The pharmacist reported that within 24 hours of receiving Zostavax the patient complained of trouble breathing. The patient stated that her diaphragm felt as if it was paralyzed. The patient was taken to the emergency room but was not admitted. Subsequently, the patient recovered. Trouble breathing and diaphragm felt as if it was paralyzed were considered to be other important medical events. There was no product quality complaint involved. No further information is available.
Breakthrough case admission after 2 vaccines Pfizer 3/27/21 Lot# Er8732;  Pfizer 4/17/21 Lot# EW0169
Potential AE due to doses administered from vials that may have been compromised.; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised.), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised.), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised.), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Moderna ordered date was 01-Nov-2021 and 15-Nov-2021 The BUD of the vaccines was reported as 01-Dec-2021 to 15-Dec-2021. No concomitant medications information was reported.  Reporter stated that they had a group of 13 pharmacies and had administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware that in some of the freezers there was a temperature excursion that their data logs showed. They were preparing for a CDC audit and wanted to reach out to see if the vaccines had been compromised. The vaccines had never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had paper logs to monitor those temperatures.   Reporter queried whether they need to take any action since they stored them in the freezer without a digital data logger. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log.  No treatment medications were provided.
Six weeks after the vaccine I started to get headaches. It is a dull headaches at the back of my head where my neck connect. I have not been able to find any medication that helps. I have the headache all day every day.  Occasionally my eyes get blurry and I get some numbness and pins and needles on the right side of my face. I have been experiencing these headaches for ten weeks to date. I have seen a Neurologist and other specialists.
low grade fever; nausea; diarrhea; stomach pain; This spontaneous case was reported by an other health professional (subsequently medically confirmed) and describes the occurrence of PYREXIA (low grade fever), NAUSEA (nausea), DIARRHOEA (diarrhea) and ABDOMINAL PAIN UPPER (stomach pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder on 17-Feb-2021.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 ml. On 17-Feb-2021, the patient experienced PYREXIA (low grade fever), NAUSEA (nausea), DIARRHOEA (diarrhea) and ABDOMINAL PAIN UPPER (stomach pain). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) on 17-Feb-2021 for Diarrhea, at an unspecified dose and frequency; ONDANSETRON (ZOFRAN [ONDANSETRON]) on 17-Feb-2021 for Nausea, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (low grade fever), NAUSEA (nausea), DIARRHOEA (diarrhea) and ABDOMINAL PAIN UPPER (stomach pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications reported.
a dose of expired Moderna Covid-19 vaccine was administered to one of our employees; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a dose of expired Moderna Covid-19 vaccine was administered to one of our employees) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (a dose of expired Moderna Covid-19 vaccine was administered to one of our employees). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (a dose of expired Moderna Covid-19 vaccine was administered to one of our employees) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications and no treatment medications were reported.
On 1/29/00, pt awoke with a rash over whole body. On 1/31/00, pt was taken to DR. The rash did cover whole body including face, face was more red & inflammed around mouth & cheeks. On 2/3, per mom, still has rash, but is fading.
injection site soreness; Chills; Weakness; Headache; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9264; Expiration Date: Sep2021), via an unspecified route of administration on 03Feb2021 at 12:05 (at the age of 48-year-old) as 2nd dose, single, in left arm for COVID-19 immunisation. The patient's medical history included type 2 diabetes mellitus which was diagnosed probably more than 10 years, hypertension for which she was taking high blood pressure medication for 5-6 years and sleep apnoea syndrome. Concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL8982), via an unspecified route of administration on 13Jan2021, as single dose for COVID-19 immunization. On 03Feb2021, the patient experienced headache. On 04Feb2021 at 07:30, she experienced chills and weakness. Patient had a headache prior to getting her second dose of the vaccine, as she had issues with her sinuses, so she took medicine before getting the vaccine because she assumed it was sinuses. There was no further details provided about medication she took for her sinuses. After the vaccine she had injection site soreness, and had a headache, chills, and weakness, which she knew it was common symptom of vaccine. Patient took Tylenol prior to the shot, so the soreness to injection site was minimal. The patient underwent lab tests and procedures which included blood cholesterol: normal, blood glucose abnormal: normal, blood pressure measurement: normal. The clinical outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
inflam,ation to elbows, fingers, wrists, knees, toes, ankles.   Inflammed still after two weeks of receiveing my second dose.  fatigue, dizzy, fever, muscle pain lasted for 4 days and inflammation has continued.
Swelling occured immediately after injection of vaccine. Hive formed next to site of injection. Dr. evaluated. Benadryl given. waited in office for 30 mins. Hive went away, arm was red by site. No pain. No swelling. No trouble breathing.
Cramping/locking; This is a spontaneous report from a contactable consumer(Patient herself). A 65-year-old female patient received first dose of bnt162b2 (BNT162B2,PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 2021 as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 2021 as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included wears hearing aids (Caller wears hearing aids) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took hizentra. Reporter stated that, Fever for months sporadically. Six specialists. None of them know what's going on to cause this. People in the hospital, fever? Weakness.  Part of the thing she took infusion. By normal she practically had no side effects with the other two. A couple years ago. Hizentra. She thought she could do them together. The patient experienced cramping/locking on Jul2021. The clinical outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 22-JAN-2016, the patient was vaccinated with VARIVAX (Merck) (strength, dose, route unknown) (lot# L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) after being improperly stored (incorrect product storage) (Temperature: 9.5 F, Time frame: 2 hours). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Hearing dimming, like someone turned the volume down on life.   Also arm pain and swollen lymph nodes all over but mostly painful in left axilla
1st day Confusion and hot face; difficultly with motor function  Delirium while sleeping  Arm pain in the evening   2nd day  Severe arm pain Severe dizziness at 3pm followed by passing out Woke up with extreme fatigue, chills, onset of headache  Rash on thighs all day   3rd day Bedridden from weakness and terrible headache Rash spread to back of lower legs Headache could not be relieved with Tylenol or aleve   4th day Woke up feeling normal Motion sickness set in at 11am followed by weakness and persistent headache Felt ok between between 5:45-7:45 Headache and weakness returned  5th day Body weakness moderate to severe
Expired on  09/30/2022. Vaccine Administered today 10/03/2022
Shortly after the second dose, I had trouble swallowing liquids and difficulty speaking.  Those gradually worsened and in January of 2022, I was diagnosed with Bulbar ALS.
Sudden onset of Hypertension with out history; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received first single dose of BNT162B2 (Pfizer, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (Vaccine location: Left arm) on 11Jan2021 07:15 for Covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered: Hospital. Medical history included allergy to beer. The patient was not pregnant. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications patient received within 2 weeks of vaccination. The patient experienced sudden onset of hypertension (without history) on 12Jan2021 06:00. Event required doctor or other healthcare professional office/clinic visit. The event was considered as non-serious by the reporter. Treatment received for the adverse event included oral lisinopril 10 mg. Nasal swab (PCR) on 18Jan2021 was negative. The patient had not recovered from sudden onset of hypertension at the time of reporting.  Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.
Oximeter marked the first number as 85 something; She wasn't feeling well; Temperature was 100.4/ she felt like fever; Chills; This is a spontaneous report from a contactable consumer. The consumer reported for a female patient (daughter) of an unspecified age that she received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and expiry date were reported as unknown) via an unspecified route of administration on 09Feb2021 at 12:30 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 09Feb2021 at 12:30, the patient got vaccinated with the Pfizer vaccine. On 10Feb2021, in the morning she didn't felt good, her temperature was 100.4, she felt like fever, chills and oximeter showed the first number as something like 85. She was completely fine before the vaccine. The consumer wanted to know if that was a problem with the vaccine or the patient needs to be taken to emergency room. The patient underwent lab tests and procedures which included body temperature as 100.4 and oxygen saturation as 85 on 10Feb2021. The outcome of all the events was unknown.  Information on Lot /Batch Number has been requested. Follow-up attempts are completed. No further information is expected.
I have developed Bell's Palsy; paralysis of the left side of my face on 27Aug2021. Preceded by left ear, head; neck pain; This is a spontaneous report from a contactable consumer (patient).    A 36-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in the right arm on 21Jun2021 17:45 (Lot Number: EW0178) as single dose (at the age of 36 years old) for COVID-19 immunisation  .  The patient medical history was not reported. here were no concomitant medications. Previously the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE on 28May2021 (at the age of 36 years old) in the right arm for COVID-19 immunisation. The vaccine was administered at Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.  On 27Aug2021 10:00, the patient experienced: I have developed bell's palsy (medically significant), paralysis of the left side of my face on 27aug2021. Preceded by left ear, head (medically significant), neck pain. No other infection, trauma or virus is found to be to blame. The outcome of the events was not recovered. Therapeutic measures were taken as a result of the events (Medications are underway). The events required a visit to the emergency room and a visit to the physician's office.  Follow-up attempts are completed. No further information is expected.