chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She is terrified of the side effects/Terrified of the Second Shot; Injection Site Hurt a little if touched; Extremely Tired; Dull Headache; Not feeling like her usual self; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection Site Hurt a little if touched), FATIGUE (Extremely Tired), HEADACHE (Dull Headache), FEELING ABNORMAL (Not feeling like her usual self) and ANXIETY (She is terrified of the side effects/Terrified of the Second Shot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer and Radiation therapy in March 2021.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced VACCINATION SITE PAIN (Injection Site Hurt a little if touched), FATIGUE (Extremely Tired), HEADACHE (Dull Headache) and FEELING ABNORMAL (Not feeling like her usual self). On 08-Jun-2021, the patient experienced ANXIETY (She is terrified of the side effects/Terrified of the Second Shot). On 15-May-2021, VACCINATION SITE PAIN (Injection Site Hurt a little if touched) had resolved. On 18-May-2021, FATIGUE (Extremely Tired), HEADACHE (Dull Headache) and FEELING ABNORMAL (Not feeling like her usual self) had resolved. At the time of the report, ANXIETY (She is terrified of the side effects/Terrified of the Second Shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 02-NOV-2017, the patient was vaccinated with an expired dose of M-M-R II lot # L041456 (expiration date: 22-OCT-2017) (route of administration and frequency were not reported) for prophylaxis. No adverse effects were reported.
Information has been received from a medical assistant concerning a 26 year old female with no pertinent medical history and no drug allergies, who on 29-JAN-2009 was vaccinated with the 1st dose of GARDASIL, 0.5ml, IM, and the 2nd dose on 31-MAR-2009, 0.5ml, IM. Concomitant therapy included unspecified birth control pill. Subsequently the patient experienced urinary tract infection (date unknown) after receiving the first and second dose of GARDASIL. The patient was evaluated at an unspecified urgent care facility and was prescribed CIPRO, the patient's symptoms were improving. The patient would be receiving her 3rd dose on 04-AUG-2009. The patient sought unspecified medical attention. At the time of the report, the patient's status was recovering. No further information is available.
Moderna COVID-19 Vaccine EUA About 2 days after vaccine injection I noticed redness and swelling approximately 2 inches below the injection site. It was not hot. It was tender to the touch.  It was approximately 2 inches in diameter. It was faded/cleared by 9th day after injection
Mom called 7/22/10, stating child vomited in crib during nap, woke up screaming. Eyes were closed and he was stiff. Dad called 911. He had a seizure in the ambulance and at ER. Child was admitted for overnight observation and EEG. Child will follow up with neurologist.
HCP stated some refrigerated pre-filled syringes of Spikevax Vaccine experienced a temperature excursion during 8 hours approximately; No adverse event; dose was administered after the excursion happened; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated some refrigerated pre-filled syringes of Spikevax Vaccine experienced a temperature excursion during 8 hours approximately), POOR QUALITY PRODUCT ADMINISTERED (dose was administered after the excursion happened) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 205F232A) for COVID-19 prophylaxis.     No medical history was reported.  Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    On 22-Sep-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. On 22-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose was administered after the excursion happened). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated some refrigerated pre-filled syringes of Spikevax Vaccine experienced a temperature excursion during 8 hours approximately) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated some refrigerated pre-filled syringes of Spikevax Vaccine experienced a temperature excursion during 8 hours approximately), POOR QUALITY PRODUCT ADMINISTERED (dose was administered after the excursion happened) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated some refrigerated pre-filled syringes of Spikevax Vaccine experienced a temperature excursion during 8 hours approximately) and POOR QUALITY PRODUCT ADMINISTERED (dose was administered after the excursion happened).    Some refrigerated pre-filled syringes of Spikevax Vaccine experienced a temperature excursion for 8 hours approximately. Maximum temperature reached was 57°F. This was the first and only excursion. 1 dose was administered on 22 Sep 2023 after the excursion happened, but no adverse events were reported.  Treatment medication not reported.
Initial information received on 11-Feb-2019 regarding an unsolicited valid non-serious case received from non-healthcare professional. This case involves a patient with unknown demographics who received once an expired IPOL (Exp. Date 09-Feb-2019) vaccine, on 11-Feb-2019 (route, site, batch number not reported). Patient medical history and concomitant were not reported. It was a case of actual medication error due to expired vaccine used. It was unknown whether patient experienced any adverse reaction. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
This child had mild induration, erythema right leg on Thursday 03/15/01 @ 19:00. She had mild pain, better on 03/19/01. Instructed to take Tylenol for the pain.  Doctor informed patient discharged without complaints.
Eight hours after receiving the vaccines, Patient had muscle pain, nausea and hard time sleeping. Patient had headaches and fever 101 degree the morning after.
Sore joints for over a month; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient (age at vaccination: 22 years) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0150 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 08Apr2021 at 08:30 AM, as dose 1, single dose for COVID-19 immunization and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8731 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 29Apr2021 at 08:30 AM, as dose 2, single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included Covid 19. The patient did not have any known allergies. Concomitant medication included birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. On 09Apr2021 at 08:00 AM, the patient experienced sore joints for over a month. The patient did not receive any treatment for the event. Outcome of the event was not recovered. Follow-up attempts completed. No further information expected.
330PM immun given-340PM itching @ site, chest heaviness & dizziness; DPH given; pt flushed & sore throat & jaw hurting; BP 130/90;
Additional dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 77-year-old male patient who received Herpes zoster (Shingrix) (batch number M9F2T, expiry date 06-AUG-2024) for prophylaxis.   On 26-JUN-2023, the patient received the 3rd dose of Shingrix. On 26-JUN-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Additional dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 29-JUN-2023 Nurse reported that the patient inadvertently received a third dose of Shingrix, which led to extra dose administered. The reporter consented to follow up.
More frequent  menstrual cycles. Right now every 14 days. Heavy flow days have increased by 2 additional days. Heavy clotting. More than usual. I have had the Paraguard  IUD for almost two years, used to heavy periods but they are regular in cycle length and usually only have one very heavy day. I keep track in a period calendar. It has only been 5 days since my last period ended, which also lasted two weeks?one week light spotting, one week heavy flow. Today I?m having menstrual cramps again.
Late in the day on 8/31/22, the FDA rescinded the EUA order for the use of the monovalent Pfizer and Moderna vaccine as boosters for people aged 12 years and older. The information took a little time to trickle from the staff and then to the staff administering vaccine. Because of this delay, some monovalent vaccine throughout was inadvertently given after 8/31/22. The CDC stated that any monovalent vaccine administered as a booster dose after the EUA was rescinded would be considered a vaccine error. At a recent meeting, we discussed this and our medical providers stated that any monovalent vaccine given as a booster dose on 9/1/2022 or after should have VAERS report completed on them per the CDC's requirements.
Terrible Itching at injection site; redness at injection site/ recurrence with more severe redness at the injection site; sore arm at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 91-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown arm). On 11-MAR-2023, less than a day after receiving Shingrix, the patient experienced injection site erythema (Verbatim: redness at injection site/ recurrence with more severe redness at the injection site) and injection site pain (Verbatim: sore arm at injection site). On 14-MAR-2023, the patient experienced injection site itching (Verbatim: Terrible Itching at injection site). On 13-MAR-2023, the outcome of the injection site pain was recovered/resolved (duration 2 days). The outcome of the injection site erythema and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain and injection site itching to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site pain and injection site itching to be related to Shingrix.   Additional Information: GSK Receipt date: 15-MAR-2023 She experienced redness and a sore arm at the injection site beginning the day after receiving her vaccine. These symptoms resolved after a day or two, but beginning on March 14, 2023, she noticed a recurrence with more severe redness at the injection site and terrible itching. The patient was asking how long to expect these effects to last and if they are something she should be concerned about. The reporter was offered medical disclaimer, referred to HCP, spoke per package insert and content. The reported consented to follow up.
Mild symptoms; No energy; A really bad headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Mild symptoms), ASTHENIA (No energy), HEADACHE (A really bad headache) and NAUSEA (Nausea) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Mild symptoms), ASTHENIA (No energy), HEADACHE (A really bad headache) and NAUSEA (Nausea). At the time of the report, VACCINATION COMPLICATION (Mild symptoms), ASTHENIA (No energy), HEADACHE (A really bad headache) and NAUSEA (Nausea) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.  The patient may have gotten a full dose of the vaccine instead of the booster dose.
SEVERE ECZEMA  ON LEGS SHOULDERS ARMS BACK SIDES , CORTAZONE 10 IS NOT WORKING AT ALL
Patient reported having very severe nausea, diarrhea, vomiting and dehydration starting the day after the vaccine. She says the vomiting was the most severe vomiting she has ever experienced and lasted the entire day following vaccination. She was dehydrated and exhausted for several days after that. It is now one week after vaccination and she is feeling better but wanted to report this episode to us.
About 6pm after the vaccine I just did not feel well.  Developed a low grade fever resulting in me taking an Extra Strength Tylenol and laid down and the next day all symptoms had subsided
Pfizer vaccine was improperly stored in the freezer for greater than 14 days.
Symmetrical and sever lesions to the basal ganglia, anti NMDA receptor encephalitis. Symptoms began with a gait (walking) abnormality April 25th, 2020. Her symptoms worsened including dystonia, losing ability to walk, crawl, and talk. Went to the hospital May 27, 2020 where symptoms were severe. She screamed and cried constantly, was severely agitated, lost ability to eat orally, and dystonia worsened. MRI showed continued worsening of basal ganglia lesions. CSF showed positive anti NMDA receptor encephalitis. Seizures started August 2020. As of today, March 12, 2021 she is non mobile (cannot hold her head up or move any of her body voluntarily) and nonverbal.
Client stated on 01/14/2021 @ 1327 she had numbness/tingling with some noted swelling and redness to left deltoid at injection site.  Nursing staff called EMT who arrived at 1337 to evaluated client.  Client stated she refused transportation to hospital, but instead, she went back to her worksite where she took Benadryl.  Client stated Benadryl helped reduce reaction symptoms. Client stated she had same reaction for several days and each time she took Benadryl to reduce symptoms.  Client stated all symptoms were resolved on 1/16/2021.
Narrative: Patient received one dose of the covid vaccine. Patient with PMH of COPD, CHF, CAD. Unclear cause of death, no details documented in chart. Reporting per facility instruction.
a 12 year male patient received expired Ipol vaccine which was expired on 02May2020, no AE; Initial information received on 17-Jun-2020 regarding an unsolicited valid non-serious case received from a office staff via medical assistant.  This case involves a 12 year old male patient who received an expired dose of vaccine IPV (VERO) [IPOL].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE for prophylactic vaccination.  On 17-Jun-2020, the patient received a 0.5 ml fourth dose of suspect IPV (VERO) (lot number: P1A25 and expiry date: 02-May-2020) via an intramuscular route in the left arm for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
wife states that evening of immun, pt devel a high fever & welts on lt arm; fever has cont through 9NOV92; low grade now by 7NOV92 welts were over entire body;
She presented with a painful, hot and red left outer upper arm that measured 5-6 cm of redness. There was no swelling, it was tender and warm to touch. She had normal function of her arm. No respiratory symptoms. VS BP 126/76, T 97.9, P 76, R 14, O2Sat 98%, Pain 6/10. Advised to take an antihistamine like Benadryl or Zyrtec, an anti-inflammatory and to ice the area. To return to the clinic if any further problems.
Rash/redness came and left within 4 days initial (imz given 4/28), then recurred 5/5 with worsening/spreading by 5/6. Rash is red, bumpy, warm to touch, and itches.
This spontaneous report has been received from a registered nurse concerning a patient of unknown gender under the age of 50 years. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. The reporter stated that the patient was administered ZOSTAVAX outside of the age recommendation from the prescribing information as on 19-SEP-2017, the patient was vaccinated with ZOSTAVAX one shot, with lot number M038864 and expiration date on 12-DEC-2017 (concentration, dose number, route of administration and anatomical location were not provided), administered for prophylaxis, reconstituted using the sterile diluent (MERCK). The reporter denied any adverse effects with the patient. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1710USA011252.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 03-DEC-2015 at time- 08:44, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L025738 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.4 and 3.1 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Received 4 mo vaccines 1/21/11. That evening, while being held, vomited x 1, suddenly went limp; eyes rolled back, shallow breathing, looked grey - x 15 min. EMS called - to ER - ok, admitted for observation, D/C next day 1/22/11. Readmitted 1/23 with lethargy; sepsis w/u (-) including BC, CSF, Lytes, CBC.
No Adverse Event; inadvertently administered with a dose of 0.5 mL of the primary series of Moderna COVID-19 Vaccine instead of the bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (inadvertently administered with a dose of 0.5 mL of the primary series of Moderna COVID-19 Vaccine instead of the bivalent booster) and NO ADVERSE EVENT (No Adverse Event) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 055A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (inadvertently administered with a dose of 0.5 mL of the primary series of Moderna COVID-19 Vaccine instead of the bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (inadvertently administered with a dose of 0.5 mL of the primary series of Moderna COVID-19 Vaccine instead of the bivalent booster) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (inadvertently administered with a dose of 0.5 mL of the primary series of Moderna COVID-19 Vaccine instead of the bivalent booster).    No concomitant medications were reported. Patient was not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The reporter does not have information on the previous doses given to this patient. No treatment medications were reported.
Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crml97 protein) injection) was received from an attorney regarding a 4 month old male pt who experienced alleged shaken baby syndrome. The pt received the vaccine on an unspecified date. Event Details: The reporter stated that the defendants "may claim Prevnar(which was given to the baby) cause the alleged shaken baby syndrome in this 4 month old infant. This event occurred in December 2001. No additonal information was available at the time of this report.
Information has been received from a pediatrician concerning a 11 year old female patient who received a dose of ProQuad. It was noted that the patient was to get plain varicella but because she already had her 12-13 month dose of MMR II and her 4-5 yr old dose. She did not need this MMR II.
Extreme dizziness; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 11Feb2021 12:00 (Batch/Lot Number: 9810) as SINGLE DOSE for covid-19 immunisation. Medical history included Known allergies: Sulfur. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no medications the patient received within 2 weeks of vaccination. The patient experienced extreme dizziness (non-serious) on 13Feb2021 08:00 am. Treatment was not received for the adverse event. The outcome of event was not recovered.
Heat, malaise, pain - glandular swelling on left side. Cervical to epitrochlear - followed by rash spreading the course of left arm. All within 24 hour time period.