chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5-6 hours after receiving Covid Moderna Spikevax vaccine on 10-2-23 at pharmacy, patient was home and began to feel shaky, dizzy, and started trembling while she was standing and making dinner. Patient then sat down and started seeing "tunnel vision" and "blacking out. Patient states she couldn't breath. Patient states she then 1 puff of her albuterol inhaler "and felt instant relief". Per patient, injection site was big, red, and "feverish". Today is 10-17-23, and it still feels "feverish".  This was a matter of minutes.
29JUN93 late PM w/soreness in rt deltoid progressed to tendinitis 1SEPp93; 13SEP93 unable raise rt shoulder;
No other issues or concerns noted; Caller reported that a patient was given a dose of MMRII Intramuscular instead of  Subcutaneous Administration.  No other issues or concerns noted.  Admin 5/19/2022 MMRII:  LOT:  U014655 EXP: May 7, 2023; This spontaneous report was received from a registered pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-MAY-2022, the patient was administered measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II)  intramuscularly intead of subcutaneously (incorrect route of product administration), lot #U014655, expiration date reported and established as 07-MAY-2023 (formulation, strength was not provided) for prophylaxis. No other issues or concerns noted (no adverse event).
This spontaneous report as received from a public health, healthcare professional refers to unspecified patients of unknown age and gender. On an unknown date the unspecified patients might had vaccinated with improperly stored M-M-R II (lot#, dose, frequency and route unspecified), which were exposed to 53F for 12 hours and M-M-R II (lot#, dose, frequency and route unspecified), which were exposed to 54F for five hours. No adverse effects reported. Follow up information has been received from an office manager concerning a patient. On 14-NOV-2013 the patient was vaccinated with improperly stored M-M-R II (J003791, exp. 28-MAR-2015), which were exposed to 53F for 12 hours (date excursion ended 22-JUL-2013). This is one of several reports received from the same source (linked MARRS#: 1311USA007619, 1311USA011609, 1311USA011610, 1311USA011611, 1311USA011612, 1311USA011613, 1311USA011615, 1311USA011616, 1311USA011617, 1311USA011618, 1311USA011619). Additional information is not expected.
Information has been received from a RN and follow up information from a nurse practitioner concerning a male pt who in 2004 (exact date not specified) was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 647797/0987N). Subsequently the pt experienced injection site reaction with raised hot area at site and fever. Unspecified medical attention was sought. The pt was treated with diphenhydramine hydrochloride (Benadryl). The nurse practitioner reported she was no other specific details for the case. She did however report that the pt's physician did not feel that these reactions were related to the pneumococcal 23v polysaccharide vaccine. The nurse also reported and approximately 50 year old female pt experienced injection site reaction, raised hot area on arm, temp, malaise, poor appetite and felt ill after vaccination with pneumococcal 23v polysaccharide vaccine (lot647797/0987N) (WAES0409USA01176) and another pt (age and gender not reported) experienced injection site reaction, raised hot area at site with fever (WAES0409USA01096). Additional information has been requested.
COVID; COVID; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. Reason for no lot number of Pfizer COVID shot, Caller unwilling to complete the report. The patient medical and concomitant medication history were reported. Other products, patient history and investigation assessment were not provided. Caller is calling because got the vaccine and contracted COVID-19 virus, 2 weeks later. Caller wanted to know if there was a guidance if he can still get the second shot, and when was the best time to get second dose. Caller stated that he will get second dose on 27Aug2021. In the Pharmacy they advised them to wait for 90 days, she said I hear some say 10 days. The outcome of the events was unknown.  The lot number was not provided. Information on lot number has been requested during follow up.
her friend had the same experience:has herpes and since getting the Pfizer BioNTech COVID 19 vaccine she never had an outbreak of herpes; it's the outbreak I haven't had once since I have the Vaccine; Pre-existing condition improved; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "has herpes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "her friend had the same experience:has herpes and since getting the Pfizer BioNTech COVID 19 vaccine she never had an outbreak of herpes; it's the outbreak I haven't had once since I have the Vaccine"; PRE-EXISTING CONDITION IMPROVED (non-serious), outcome "unknown", described as "Pre-existing condition improved".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021684622 Same reporter/ drug/ AE, different patient
Myalgias, joint pain, abdominal soreness, fatigue.  Symptomatic treatment: rest, ibuprofen.
This spontaneous report as received from a registered nurse refers to a female patient with unspecified age, who on 10-NOV-2011, received his first dose of GARDASIL (dose, route, lot number were not reported). The nurse reported that the patient was in the office on 22-AUG-2012, to received his second dose of GARDASIL (dose, route, lot number and indications were not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms were reported. Additional information has been requested.
Initial and follow-up information has been received through the Merck Pregnancy registry via a healthcare professional and a physician concerning a 22 year old white female with mild cervical dysplasia and a history of 2 previous pregnancies with full term delivered (January 2002 and August 2004) who on 25-MAY-2007 was vaccinated with the first dose of GARDASIL (lot #653736/0014U). On 25-JUL-2007, the patient was vaccinated with the second dose of GARDASIL (Lot #657872/0515U). Concomitant medications included UNISOM and PREMESIS. On approximately 25-MAY-2007, the patient developed vaginitis and on 25-MAY-2007 was placed on therapy with TINDAMAX. It was reported on 10-SEP-2007, the patient was 6 weeks pregnant. On 20-SEP-2007, ultrasound revealed intra-uterine pregnancy at 7.2 weeks. The patient last menstrual period (LMP) was of 30-JUL-2007 and estimated of delivery was 05-MAY-2008. The patient underwent unspecified blood work (results not reported). Unspecified medial attention was sought. On an unspecified date, the patient developed thrombocytopenia. On 22-APR-2008, 38.1 weeks from LMP, the patient delivered a healthy male infant. Weight was 7 pounds 8 ounces, head circumference was 13 5/8 inches and length was 20.5 inches. Apgar score was 8/9. On 20-MAY, the patient was vaccinated with a third dose of GARDASIL (lot # 660387/1967U). Other medications used this pregnancy included PRIMACARE ONE. Additional information has been requested.
Herpes zoster (shingles); This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: ER8733) via an unspecified route of administration (age at vaccination 52-year) in left arm on 29Mar2021 at 10:45 AM as dose 1, single for COVID-19 immunization. Medical history included gitelman's syndrome, COVID-19 (Prior vaccination), both from an unknown date and unknown if ongoing If. Concomitant medications included metoprolol; topiramate; erenumab aooe (AIMOVIG); acetaminophen (Excedrin TH); gliclazide, metformin hydrochloride (WALFORMIN); all medications taken in twoweeks of vaccination, for an unspecified indication, start and stop date were not reported. Patient received no other vaccine in fourweeks. The patient not tested COVID post vaccination. No known allergies were reported. On 11Apr2021 at 09:30 PM the patient experienced herpes zoster (shingles) of trigeminal nerve with ocular involvement. AE resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of herpes zoster, the patient was treated with antiviral medication (valacyclovir). The clinical outcome of the event was resolving.  No follow-up attempts are required. No further information is expected.
funny sensation in the feet or extremities post vaccination.  She is 6 days post vaccination. She does not have pins and needles, loss of sensation or weakness.  She describes it as more of a ?tickly? sensation
Patient developed temp 103.8 and had simple febrile seizure approximately 9 hours after administration of vaccines.
sweating; Fever; This is a spontaneous report from contactable consumer. A 49-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot/Batch Number: EL3247), via an unspecified route of administration in the right arm on 22Feb2021 at 9:45 (at the age of 49-years-old) as first dose, single for COVID-19 vaccination. Medical history of the patient was not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination patient was not diagnosed with COVID-19. Since the vaccination patient was not tested for COVID-19. It was not known whether the patient was enrolled in clinical trial. The patient neither received any other vaccines within 4 weeks prior to the COVID vaccine nor other medications within 2 weeks of vaccination. Concomitant medications were not reported. The patient experienced fever and sweating on15March2021 at 02:00. No therapeutic measures were taken for the events. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot/Batch Number: EL3247), via an unspecified route of administration in the right arm on 15Mar2021 at 9:45 (at the age of 49-years-old) as second dose, single for COVID-19 vaccination. The clinical outcome of the adverse events fever and sweating patient was recovered on an unknown date. No follow-up attempts are needed. No further information is expected.
CHEST PAIN, SHORT OF BREATH, OVERALL FELT VERY UNWELL.  I WOKE UP AT 1AM FEELING THIS WAY, IT PROGRESSED THROUGH THE MORNING.  FINALLY I WAS SCARED ENOUGH TO GO TO THE EMERGENCY DESPITE THE COVID RISK. AT THE HOSPITAL THEY DID AN EKG, TOOK LABS, AND DID A COVID TEST. THEY PERFORMED 2 TRONPONIN TESTS TO INSURE THAT I HAD NOT HAD A HEART ATTACK.  BOTH TESTS WERE NORMAL.  COVID CAME BACK NEGATIVE. THE EMERGENCY ROOM NEVER CAME TO A DEFINITIVE DIAGNOSIS BUT SUGGESTED MY COVID VACCINATION MAY HAVE CAUSED THIS.
Mom reports child was running and playing at time of vaccine, but went to sleep a while after got home. When he woke up he acted like he didn't feel good so she put him back in bed. Around 7pm a cousin went to get him up and he was hot, didn't act normal, and then had a seizure. They called 911 and he is in hosp.
By 14:30 was in a somewhat euphoric state and was having "wild thoughts".  Did not feel right.  By 19:00 had vomited, was woozy, had dyspnea, wheezing and was pale.  20:15 she was shaking with fast heart rate.  By 22:30 intense itching, no rash.  She laid down and meditated to help relax and symptoms finally subsided.  Took no meds.
Initial report received from pharmacist on 18 Jan 2010: This patient with an unknown medical history was vaccinated with 0.5 ml FLUVIRIN (batch no. 10212591), IM on left arm on 19 Dec 2009. The patient experienced a slight tremor in his right arm on 22 Dec 2009. The patient condition was unchanged.
Pt was given the adult dose of hepatitis A vaccine. This dose was given due to his age and size, was not aware that he needed the pediatric dose.
Red inflamed hard knot at injection site which continues to enlarge in size.  Currently larger than a quarter, warm to touch with axillary lymphedema, low grade fever 100.9
The side effect she had, she had the moderna; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (The side effect she had, she had the moderna) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (The side effect she had, she had the moderna). At the time of the report, IMMUNISATION REACTION (The side effect she had, she had the moderna) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication details were provided. No treatment medication details were provided.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This spontaneous report was received from a pharmacist via company representative referring to a male patient of unknown age. Patient's historical conditions included recurring past cases of shingles. On an unknown date, the patient was vaccinated with ZOSTAVAX, lot number, expiration date, dose and anatomical location were not provided, subcutaneous injection. No concomitant medication were reported. On an unknown date, the reporter stated that the vaccine did not work (vaccination failure) and the patient developed shingles again. At the time of the report, the outcome shingles and vaccination failure was unknown. The relatedness between the events and suspect therapy was not provided. Additional information has been requested.
My arm has a hard swollen knot an inch below the injection site, 8 days after the vaccination. It is not in the armpit or lymph node area.
A 15 year old male pt had received an IM injection of Menactra, lot number U1821AA, in the right arm on 25Oct05. 12 hrs after Menactra was administered the pt complained of general malaise, generalized shaking, weakness in the legs and back pain. The pt was seen in the physician's office the next day and received supportive care. Per the reporter, the pt recovered from these events on 28Oct05. Follow up information received on 19Dec05 from a health care provider. Per the reporter, Blecmycin given injection to wart on 25Oct05. Further information is not expected. A corrective version was created to amend co-manifestations to manifestations. Adverse events have been re ranked in this correction version (2).
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) 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 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  No Concomitant medication were reported.  No treatment medication were reported.
7 days after receiving the vaccine patient developed a headache which resolved on its own within 24 hours. On day 8 post vaccination patient developed a delayed cutaneous reaction at the injection site. Patient presented with 40mm erythema, and induration.  Site was warm to touch.
received an early second dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 82-year-old male patient who received Herpes zoster (Shingrix) (batch number BR7B3, expiry date 9th September 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 24th December 2020, the patient received the 2nd dose of Shingrix. On 24th December 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix, less than the recommended interval, which led to shortening of vaccination schedule. The vaccine administration facility was same as primary reporter. The reporter consented to follow up.
Quarter sized red firm warm area on Left thigh. Dime sized red firm areas on right thigh.
Flu-like symptoms, slept entire day on 8-7. Rash started 8-6 and spread from ZOSTAVAX site around upper arm. Site was itchy. By 8-9 symptoms resolving.
I developed facial swelling approximately 3.5 weeks after the first injection. My eyelids swelled, and my cheeks and under eye area as well.
About 2 hours after injection 1/29/21  lymph nodes swelling in neck, face, both arm pits; with tenderness and pain; slight headache; fatigue; dry eyes. 1/29/21 some 8 hours after injection worsening headache, onset of runny nose, body aches, sweating with chills, and lymph node pain, swelling face, neck and arm pits; very dry eyes.  Low fever, extreme fatigue and flu symptoms persisted for 7-8 days; little appetite; lymph nodes in neck, both arm pits and  breasts persistently swollen through and including 2/13/2021 with fatigue persisting. Am scheduled for vaccine second dose 2/26/21, but am hesitant to receive since my adverse reactions remain strong.
pt exp lt eye edema & lips edematous; vomitted since Thurs 5-6 times last 24 hrs); t99R; P 152, R28; dx allerg react; lips & eyelids are swollen; devel edema to eyelids;
Patient states that her back right shoulder and front right clavicle started hurting badly a few days (Saturday) after the vaccine. On Sunday, the pain spread down her arm. She said her muscles hurt. Patient also began having trouble twisting caps. She is still struggling with her symptoms. She wants us to contact her MD and is not comfortable continuing the series.
Approximately 30 minutes after receiving the vaccine, I experienced shortness of breath, dizziness, tingling of my arms and fingers and could feel my heart racing. I called 911 and an ambulance came to a parking area just a short drive from the pharmacy where I received my vaccine. I was checked out by the paramedics. My blood pressure was elevated, my heart rate was elevated. My oxygen saturation was only 92. I chose not to be taken to the hospital because my symptoms began to improve after some time had passed. I attempted to drive home shortly after and had to pull over and call a family member to come get me as the dizziness had returned.
Information has been received from a 28 year old female consumer, who was vaccinated with the first dose (date unspecified) of Gardasil.  Subsequently she reported that she felt dizzy; the outcome of feeling dizzy was not provided.  The patient was later vaccinated with the second dose (date unspecified) of Gardasil and experienced flu-like symptoms.  She reported her symptoms had improved, though it was unknown if she had recovered at the time of this report.  The consumer refused to provide additional information.  No further information is available.
Skin: Skin is warm and dry. No rash is noted.There is erythema (right lateral arm softball size erythema.mildly warm).
Pt describes sore arm and limited range of motion with pain not subsiding. Patient has not yet seen ortho or a primary care doc but she will follow up with primary care.
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were administered improperly stored ROTATEQ (lot # M011832, expiration date: 25-JAN-2018; M017558, expiration date: 27-FEB-2018) (dose unknown), orally for prophylaxis. The vaccines were stored for 1 hour and 24 minutes at 35 Fahrenheit degree (F) as per data logger information. There was no prior excursions for these vaccines. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as there is no consent for follow up. Sender's Comments: US-009507513-1701USA004645.
?COVID arm? rash.  Large red rash. Somewhat itchy.  Applied cortisone and Eucerin.  Looking better several days later.  Improving daily.
fainted; HR - 46-48 beats per minute; cold sweats; chest pains localized in the apex of her heart; inflammation in the left upper arm extending to the back; hard time breathing; weak; This spontaneous case was reported by a nurse and describes the occurrence of SYNCOPE (fainted) and HEART RATE DECREASED (HR - 46-48 beats per minute) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 074M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant), HEART RATE DECREASED (HR - 46-48 beats per minute) (seriousness criterion medically significant), COLD SWEAT (cold sweats), CHEST PAIN (chest pains localized in the apex of her heart), VACCINATION SITE INFLAMMATION (inflammation in the left upper arm extending to the back), DYSPNOEA (hard time breathing) and ASTHENIA (weak). On 01-Apr-2021, SYNCOPE (fainted), HEART RATE DECREASED (HR - 46-48 beats per minute), COLD SWEAT (cold sweats), CHEST PAIN (chest pains localized in the apex of her heart) and DYSPNOEA (hard time breathing) had resolved. At the time of the report, VACCINATION SITE INFLAMMATION (inflammation in the left upper arm extending to the back) and ASTHENIA (weak) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Crying from 11AM to 9PM-screaming  pt taken to MD recommended inc APAP gtts; 13MAR92 pt slept p/9PM seems fine this AM;