chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Can I get the second dose after 4 month; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Can I get the second dose after 4 month) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Can I get the second dose after 4 month). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Can I get the second dose after 4 month) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. No treatment information was reported.   Reporter did not allow further contact
stinging; burning; like itchy feeling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2, Solution for injection) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Batch/Lot number: Unknown), for COVID-19 immunization. The following information was reported: PAIN (non-serious), outcome unknown, described as stinging; BURNING SENSATION (non-serious), outcome unknown, described as burning; PRURITUS (non-serious), outcome unknown, described as like itchy feeling.  Additional information: Patient stated that I just had a question about this side effect, and I have had well 3 weeks ago, today had the second one and I am still having, I didn't know how long, I was trying to find out how long the side effect last, is it over a week. Patient also stated that stated It's 'stinging' and burning like itchy feeling and it's been a week ago today. Product details like NDC#, UPC# and Expiration Date and Pharmacy details could not be probed as the consumer was unwilling to file safety report. Hence limited information available over the call. On 18Oct2021 Phone-Out 10:57 AM: 1st attempt by phone to consumer to obtain follow-up information contained on consumer questionnaire. Phone answered by consumer who provided her mailing address details. Consumer questionnaire forwarded to AER reporting mailbox.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
itching on the back, left side of my neck; Hives/urticaria; redness; Rash on the back of patient's neck towards the left side; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching on the back, left side of my neck), URTICARIA (Hives/urticaria), ERYTHEMA (redness) and RASH (Rash on the back of patient's neck towards the left side) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 007C21A) for COVID-19 vaccination.     The patient's past medical history included Depression on 01-Jan-2010. Concurrent medical conditions included Hypersensitivity reaction, Penicillin allergy (Since Childhood - Itching/Rash when taken.) and Sulfonamide allergy (Since Childhood - Itching/Rash when taken.). Concomitant products included CITALOPRAM from 01-Jan-2010 to an unknown date for Depression.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced RASH (Rash on the back of patient's neck towards the left side). On an unknown date, the patient experienced PRURITUS (itching on the back, left side of my neck), URTICARIA (Hives/urticaria) and ERYTHEMA (redness). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form and HYDROCORTISONE from 24-Mar-2021 to 26-Mar-2021 for Rash, at a dose of 1 dosage form three times a day. At the time of the report, PRURITUS (itching on the back, left side of my neck), URTICARIA (Hives/urticaria), ERYTHEMA (redness) and RASH (Rash on the back of patient's neck towards the left side) had resolved.            The action taken with mRNA-1273 with the event was considered as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up information received contains significant information. Added medical history,outcome of the events and second dose taken.
HEART ATTACK CAUSE BY A BLOOD CLOT SHORTNESS OF BREATH, CHEST PAINS, LEFT ARM PAIN I'M STILL HAVING CHEST PAINS AND STILL SEEING A CARDIOLOGIST A STINT WAS INSERTED
SEVERE LOCALIZED SWELLING, REDNESS, AND ITCHING OF LEFT ARM  (PEAKING ON MONDAY 4/25), PATIENT HAS TAKEN OTC PAIN MEDS, USED ICE FOR SWELLING AND REDNESS, AND OTC BENADRYL FOR THE ITCHING; TODAY (THURSDAY 4/28) PT REPORTS SIGNIFICANTLY LESS SWELLING BUT VISIBLE REDNESS IN MOST OF LEFT UPPER ARM
A report has been received from a Health Professional concerning a 2 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced RED RAISED RASH ON LEGS, ARMS AND TORSO-ANTERIOR ONLY which started on 20-Nov-2012. At the time of reporting, the event of RED RAISED RASH ON LEGS, ARMS AND TORSO-ANTERIOR ONLY was ongoing. The report was considered to be non-serious.
they tested positive for Covid for the last 3 weeks; they tested positive for Covid for the last 3 weeks; This is a spontaneous report from a Pfizer-sponsored program.   A contactable consumer reported similar events for 02 patients. This is the 1st of 2 reports. This consumer reported for female patient that the unspecified age of female patient received dose 1 of bnt162b2 (COMIRNATY, solution for injection), (Batch/Lot Number: unknown) on 21Mar2021 via unspecified route of administration as single dose for covid-19 immunisation. The medical history and concomitant medication were not provided. Patient tested positive for Covid for the last 3 weeks. And patient was tested negative around 6/7April. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021442105 Same reporter/drug/event and different patient.
Systemic: Dizziness / Lightheadness-Medium, Additional Details: Checked in on patient within 5 minutes and he reported some dizziness. Directed patient to place his head between his legs for several minutes.  Checked in on him again in another 5 minutes and he said he was feeling better. He continued with his head between his legs.  After 15 minutes, patient was seated and stated he was no longer dizzy. Told him to stay seated longer if he would like and to get up slowly when he was absolutely sure he was fine.  Patient got up within another 5 minutes.
Client indicated she received her vaccine wihout incident at 1330. She sat in observation for 15 mins and denies having experienced any side effects. Client reported as she walked to her car, she began to experience vertigo, nausea and tingling. She sat under the tent near the observation area. MD and EMS paged. MD assessed client and recommended client remain in observation until she felt better. Client requested her adult daughter's presence as she waited. Client was observed to be crying during her assessment with MD. Client remained for continued observation. Client exited observation with her adult daughter by her side in stable condition at 1416, denied any side effects at time of departure.
Client given the  Covid BV vaccine in lieu of the 2 nd dose of the primary series.
On 11/9/99 left upper arm was warm to touch, had redness, mild swelling & minor itchiness. By 11/10/99, the site was feeling warmer with diffused redness & intermittent pain, also the swelling and itchiness had increased. Finally, on the
rt thigh afternoon of vax w/swelling/redness;to use DPH;
Vaccine given: Diphtheria, Tetanus, Pertussis ( VIS edition 1/2012 provided) symptoms: hard to breath, stopped eating, lost 10pounds on 2 weeks, swallow face, specially around the mouth, rush around the mouth, crying, not sleeping, agitate, etc.
Patient walked in Monday complaining of redness and swelling at arm and chest area and shortness of breath.
headache; tired; sore arm; This is a spontaneous report from a contactable consumer (patient, self-reported). A 74-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6203 and expiry date: Jun2021), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization at hospital. The patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9261 and expiry date: May2021), via an unspecified route of administration, in Arm Right, on an unknown date at 11:00 AM, as a single dose for COVID-19 immunization at hospital and had pain in esophagus, tightness in throat and joint pain, headache, and tired. The patient received first vaccine at 11 AM, left hospital and picked up lunch and came home. After eating meat ball sandwich soon after her throat was tight and painful. The patient's medical history included oral Lichen planus, chronic dry eyes for long time, and extreme dry mouth. The patient mentioned that she had a difficult intubation, unable to swallow large pills and had EpiPen (for Peanut intolerance). Concomitant medications were not reported. The patient was treated by oral Surgeon and biopsy was done on 13Nov2020 of inside of cheeks, sores on tongue, salivary gland, and lip which resulted in not being Sjogrens, oral lichen planus. The patient reported some mild symptoms like Sjogrens disease, joint pain (took Ex strength Tylenol), and throat felt like it was closing which lasted- 3 to 4 hours (no treatment received). Second vaccine side effects were mild in comparison to first headache, sore arm, tired. On an unknown date, after unspecified time, the patient experienced headache (seriousness: hospitalization), tired (seriousness: hospitalization) and sore arm. The patient received Tylenol for headache and no treatment was received for tiredness. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Error made, gave PEDIARIX and also IPV instead of PCV on 5-16-08.  No adverse reactions.
Information has been received from a registered nurse concerning a 17 year old female who on 18-JUN-2007, 30-AUG-2007 and on 24-JUN-2008 was vaccinated IM with a 0.5 mL dose of GARDASIL. In approximately June 2008, a short time after the third dose, the patient experienced pain and blurry vision in her left eye. The symptoms have continued to the present. The patient had sought unspecified medical attention. A magnetic resonance imaging was done but the result was normal. Additional information has been requested.
Redness, swelling along the back of the arm down into the elbow with pain upon movement  which began the evening after the immunization and has lasted for 2 days since.
Experiences expected arm soreness one day after receiving shot and some malaise for subsequent 2-3 days. On 3/15/2020 during routine mammogram/sonogram enlarged lymph nodes under left are were observed during sonogram, as well as an indeterminate area in left breast, which will be re-checked during a follow up sonogram . Testing center did inquire regarding when I had received shot and in which arm.  On 3/20/2021 began to experience sore breast, and on 3/25/2021 began to experience a mid-cycle menstrual cycle or vaginal bleeding event that is still occurring as of date of this report 3/29/2021. Date of my previous menstrual cycle began 3/12/2021 and ended 3/17/202.   It should be noted, this is completely unusual, I have only ever experienced menstrual cycles that have a regular  schedule between 24-32 days between cycles and the nature of this bleeding was different than usual.
sneezing fits and  consistent runny nose -- sneezing ~3 times every 5 minutes  for over 3 hours
Patient was sitting receiving vaccinations - immunizations for Typhoid Fever, Yellow Fever, and Hepatitis A on September 8, 2009 when he fainted and when awoken by nurses calling his name was lying on the floor.  He was unconscious for a brief time. He had low blood pressure.  The nurse reported that this is a common occurrence but that patient had recovered well and was being monitored before being released from the clinic.
Rash throughout body (wrists, stomach, waistline, face, legs). Rash developed 15 days after vaccine.
Information has been received from a registered nurse concerning a 64 year old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown. In approximately 2004 (reported as 10 to 12 years ago), the patient was in an unspecified clinical trial for ZOSTAVAX (study site, investigator name, protocol number, patient number all unknown), and was vaccinated with ZOSTAVAX (dose, route and lot# unknown). On approximately 09-JUN-2016 (reported as two weeks ago), the patient developed shingles on his torso. The shingles was painful. The patient visited the physician. The outcome of the event was unknown at this time of reporting. The causal relationship between the event and ZOSTAVAX was not provided. Additional information is not expected because there is no consent to contact the physician.
19APR96 mom called stated pt had high fever p/vax 9APR96;taken to MD on 10APR96 MD thought poss d/t vax but fever did come down;now 10 days later pt has fever & vomiting;mm concerned about  MMR;MD stated could be flu
GOT SIDE EFFECTS; FELT LIKE DYING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported. On MAR-2021, the subject experienced got side effects. On MAR-2021, the subject experienced felt like dying. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the got side effects and felt like dying was not reported. This report was non-serious. This case, from the same reporter is linked to 20210331319, 20210331262, 20210331801, 20210331104 and 20210332072.
Heart pain; Kidney pain; This is a spontaneous report from a contactable consumer or other non hcp.    A 33-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 23Jul2021 19:00 (Batch/Lot Number: EWOI98) as single dose for covid-19 immunisation  .  The patient medical history and  concomitant medications were not reported.  The patient experienced heart pain  and  , kidney pain  on an unspecified date with outcome of unknown.  Therapeutic measures were taken as a result of heart pain and  kidney pain and included Tylenol.  Follow-up attempts are completed. No further information is expected.
Pt's father reported "pea sized welts on her stomach". Also reported "one welt by eye" and "slight drowsiness". Dr. recommended BENADRYL liquid-2.5mL PO Every 6 hours PRN. Instructed to go to ER if worsening rash or difficulty breathing, swelling of tongue and lips.
Inability to move my left arm AT ALL. Frozen in place with arm across my stomach.  Continuous excruciating throbbing pain in shoulder, radiating down to elbow, shoulder blade, breast area, and up neck.  Uncontrollable shivering, nausea, horrible headache, I'm pretty sure low grade fever (but I didn't have a thermometer so can't be positive).  All this lasted from 2/24/15 at 11:00am until around Thursday morning after taking 2 Aleve every 4 hours.  Went back to Dr. on 2/26/15 @ 2:40 pm where she was able to release my arm to my side, but thats all the movement I got.  Then it was frozen to my side.  Dr. gave me RX for 600mg Ibruprofen, to be taken every 6 hours with Tylenol inbetween.  By 3/3/15 still could not move my arm, shoulder, so started physical therapy.  Will continue with PT for now.
Did not receive 2nd dose; Tingling in her tongue; Swelling of tongue; Itching and rash on arm at injection site; Itching and rash on arm at injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of PARAESTHESIA ORAL (Tingling in her tongue), SWOLLEN TONGUE (Swelling of tongue), INJECTION SITE RASH (Itching and rash on arm at injection site), INJECTION SITE PRURITUS (Itching and rash on arm at injection site) and PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Clotting disorder.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced INJECTION SITE RASH (Itching and rash on arm at injection site) and INJECTION SITE PRURITUS (Itching and rash on arm at injection site). On 19-Apr-2021, the patient experienced PARAESTHESIA ORAL (Tingling in her tongue) and SWOLLEN TONGUE (Swelling of tongue). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose). At the time of the report, PARAESTHESIA ORAL (Tingling in her tongue), SWOLLEN TONGUE (Swelling of tongue), INJECTION SITE RASH (Itching and rash on arm at injection site) and INJECTION SITE PRURITUS (Itching and rash on arm at injection site) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported No treatment medication reported It was reported that the patient said 10 days later she still had swelling and itching and rash on the arm at the injection site. Patient went to her family doctor who said she should switch to Pfizer for the 2nd dose of the vaccine. She was also advised to not get the Johnson and Johnson vaccine because of a history of clotting. However, she did not received any vaccine for her second dose, and it had been about 10 months since her first dose of the Moderna COVID-19 vaccine.
No additional AEs reported; Nurse reports the administration of PROQUAD to a 17 year old patient; This spontaneous report has been received from a registered nurse referring to a 17 year old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 07-JAN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (0.5 milliliter, lot # U015481, expiration date 13-NOV-2022, route was not reported) for prophylaxis (Inappropriate age at vaccine administration). No additional adverse events (AEs) was reported. No product quality complaints was reported. No further details was provided.
Patient called today to report cellulitis at the site of injection (given Zostavax). Patient reported a lump under the skin and some pain up to the arm pit on the arm.
Developed right leg swelling from site of shot down to knee with limping which occurred over 24 hour period.
Ted, swollen, itchy so far 8 days out-so far no treatment required. Just bothersome.
feverish; chills; upset stomach; headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th December 2019, the patient received the 2nd dose of Shingrix. On 13th December 2019, 1 days after receiving Shingrix, the patient experienced fever, chills, upset stomach and headache. On an unknown date, the outcome of the fever, chills, upset stomach and headache were unknown.   It was unknown if the reporter considered the fever, chills, upset stomach and headache to be related to Shingrix.  Additional case details were reported as follows: The patient got 2nd Shingrix vaccine about this time on day before reporting. On day of reporting the patient became feverish and had some chills, upset stomach and headache. The patient enquired about how long could he or she expect to feel like this. The permission to follow up was denied.
Narrative:  Pt was admitted to MICU on 6/24/21 from the ER after positive covid blood test with illness (covid pneumonia). Pt had received both covid-19 vaccinations from outside clinic on 2/20/21 & 3/12/2021. Pt was discharged on 7/1/21 requiring home health. Of note pt had domestic travel within 14 days prior to illness. Pt's symptoms were fever, chills, fatigue, cough, shortness of breath. Pt had hx of htn, pvd, RA, peripheral neuropathy, and recent PE on apixaban therapy approx. 2 months prior to this admission.
Symptoms began 24 hours after immunizations, red and slightly swollen left thigh. 4cmx3cm at site of injection.
Pt recvd vax & devel granuloma @inj site. Pt began tx w/anti-inflammatory meds & physical therapy 03Oct97.As of 24Nov, granuloma persisted.
I started with Fever, general body pain.weakness ,chills  on March 31 at 10:00pm. Yesterday I still have fever. Today I  feel weak. Without energy and still have pain in my body .
Dizziness, numbness in pinky finger of left hand, and large baseball size red rash around injection site
Dizzy; Nausea; Vomited; I had chills; Whole body like aching; Headache too, my head hurts too; Fever; My right arm was so sore; weak; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: WS2736, expiry date: not reported, Age at vaccination: 53-year-old) via an unspecified route of administration in arm right on 13Aug2021 as DOSE 1, SINGLE for COVID-19 immunization. Medical history included blood pressure high and diabetes. Concomitant medications included INSULIN, AMLODIPINE BESYLATE, HYDROCHLOROTHIAZIDE, LISINOPRIL, METFORMIN. On ana unspecified date, patient experienced dizzy, nausea, vomited, i had chills, whole body like aching, headache too, my head hurts too, fever, my right arm was so sore, weak. Patient also stated I took the vaccine (confirmed as Pfizer COVID-19 Vaccine), my first vaccine shot two days ago (confirmed as 13Aug2021) on Friday and yesterday I started to get dizzy, nausea and I vomited, I had chills and my whole body is like aching, I know some of those side effects are some of the side effects. I am having headache too. I said still experiencing weak, I am still feeling dizzy and weak. I took Tylenol (for fever). Patient stated, the day the vaccination happened all I feel was dizzy then the next day, yesterday, I am diabetic and I take insulin as I got over, I took my Insulin and then I started aching all over, getting chills, vomiting and my head was hurting. I got my vaccination shot in right arm and I took my, my other shot, I took it in my left arm. Because that arm was, my right arm was so sore. I usually take (insulin shot) in right arm every day, since it was so sore, I took the shot of Insulin in my left arm. The outcome of fever was unknown and for other events, was recovering.  Information about lot/batch number has been requested.