chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I thought was dying; never got sick i took that shot it gave me the PII(32; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I thought was dying) and VACCINATION COMPLICATION (never got sick i took that shot it gave me the PII(32) 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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (I thought was dying) and VACCINATION COMPLICATION (never got sick i took that shot it gave me the PII(32). At the time of the report, FEELING ABNORMAL (I thought was dying) and VACCINATION COMPLICATION (never got sick i took that shot it gave me the PII(32) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment reported.
patient complaint "blood taste in the throat". Pt was conscious, alert, and confirmed to have no breathing issues. BP/HR was taken at 11:55am( results are 122/89, 83). Pt rested for additional 15 minutes without other symptoms or progression of symptoms. Pt was advised to seek medical attention from her pcp for further checkup if needed. Pt left around 12pm with husband and son.   Pt was monitored by myself and RN.
This spontaneous report was received from a Nurse and refers to unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates, vaccines of PROQUAD (which had a lot # L031602, expiry date on 18-FEB-2017, exact doses and route of administration were not reported), were improperly stored as the freezer was out of range on an off since February 2016. Other doses of PROQUAD which had a lot # L040415 with expiration date on 13-APR-2017; Lot # L021601 expiration date on 10-DEC-2017. Nevertheless, no symptoms were reported. The vaccines experienced the following temperature excursions during 50 minutes: 7.8 grade Fahrenheit. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same source. Additional information has been requested.
PATIENT STATES THAT HE FEELS THAT HIS BLOOD PRESSURE IS UP AND HE IS DIZZY SINCE GETTING THIS
Client received vaccine at 12:40 and waited the required 15 minutes for observation. After leaving the building, he felt unwell and starting coming back inside where he had multiple episodes of syncope. EMS was called. The client wasn't able to make it to sitting without syncope so he was transported to the hospital via ambulance.
During the night I began to itch the site of injection and noticed redness around the site as well.
Hives.  Red blotches on body and scalp.  Eye lids and lips swollen.
EDD 04/15/2021 Pregnancy history: hyperemesis gravitorium POTS pSVT Started feeling bad and fatigued  around 9pm. Woke up with chills, severe body aches and bone pain, severe left arm pain, headache, nausea at 11pm. Felt worst I had ever felt in my life. Couldn?t get out of bed due to severe pain. Temp max 101. Lasted until 1pm next day and then resolved however felt tired for several days after and had episodes of tachycardia and pSVT for 2days after (h/o POTS and pSVT and think dehydration from episode with nausea and fever probably caused that)
Patient was very fearful of needles and was looking the other way after rolling sleeve over the shoulder.  I administered the vaccine to the patient...He passed out and then experienced a tonic-clonic like seizure.  It seemed like a psychogenic seizure on presentation but unsure.  It lasted 30 seconds or so.  His wife was visibly upset and crying.  When he came to, he didn't realize that anything had happened.  I held on to him and made sure he did not fall off the chair.  I was going to try to put him on the ground but he came to before I could attempt to do that.  We gave him water which he consumed quite quickly.  We talked to him and his wife and they felt comfortable to leave.  We advised him to see a physician and told the wife that she should drive him home.
High fever 102, swollen lymph nodes, enlarged lymph node under right armpit, right arm throbbing pain, lower left neck area enlarged lymph node. Inflammation throughout body, face, severe pressure feeling in head, headache, severe heart palpitations, high resting heart rate. ER visit with ultrasound, confirmed swollen lymph nodes, Decadron and Mobic shot given, with 3 days worth of prescription to take. Follow up with doctor - week later not feeling well still with inflammation throughout body, back of neck muscle pain, headache/ pressure in the head feeling, lethargic. Prescription to calm inflammation Hydroxyzine 25mg every 8 hours with Montelukast.
Had a flu like/sick feeling for 3 days; Had a flu like/sick feeling for 3 days/ Didn't feel well; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), in Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 Immunization, reaction(s): "Had a flu like/sick feeling for 3 days", "Feeling unwell", "Had a flu like/sick feeling for 3 days"; Bnt162b2 (DOSE 2), for COVID-19 Immunization, reaction(s): "Had a flu like/sick feeling for 3 days", "Didn't feel well", "Had a flu like/sick feeling for 3 days". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "Had a flu like/sick feeling for 3 days"; MALAISE (non-serious), outcome "unknown", described as "Had a flu like/sick feeling for 3 days/ Didn't feel well".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Large, painful  lump formed under skin armpit in right arm where I had vaccination shot. Two days later a second, smaller lump formed.  They have slowly grown. Was told this is a vaccine side-effect and wait but they do not seem to be going away. I?ve never had anything like this happen to me before.
I have been in menopause since November of 2017. Five days after my booster in 2021, I started my period.
Latent onset of weakness around shoulder joint of left arm; Severely swollen lymph node on left side at juncture of neck and shoulder. Lymph node and affected muscle could be felt as a knot under the skin; Pain in lymph node and surrounding muscle; Pain in lymph node and surrounding muscle; This is a spontaneous report from a contactable consumer(patient). A 27-years-old female (Non pregnant) patient received second dose of bnt162b2 (COVID 19, Formulation: solution for injection, Lot Number: EN6203, Expiry date: unknown), via an unspecified route of administration in arm Left on 03Mar2021 at 16:15 as single dose for covid-19 immunisation. Historical vaccine included patient received first dose of bnt162b2 (COVID 19, Formulation: solution for injection, Lot number: EM9809, Expiry date: unknown), via an unspecified route of administration in arm left on 10Feb2021 at 03:45 PM was reported. The patient had no known allergies. Patient concomitant medications included desvenlafaxine (DESVENLAFAXINE) taken for an unspecified indication, start and stop date were not reported; paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. Patient medical history was not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 04Mar2021, the patient experienced severely swollen lymph node on left side at juncture of neck and shoulder. Lymph node and affected muscle could be felt as a knot under the skin, pain in lymph node and surrounding muscle, latent onset of weakness around shoulder joint of left arm on 01Apr2021. The patient didn't receive treatment for the events. The events were considered as non-serious. The outcome of the events was reported as not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
increased anxiety; Increased agitation; This is a spontaneous report from a contactable consumer or other non hcp (Patient) via medical information team. A 38-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9561, Expiry date: unknown) via an unspecified route of administration, administered in right arm on 04Feb2021 12:10 (at the age of 38-years-old) as dose 1, single for COVID-19 immunization. The patient medical history included ongoing anxiety from a child, ongoing agitation; and also included hashimoto's disease and thalassaemia both from 20 years ago however thalassemia minor. The patient concomitant medications were not reported. There was no prior vaccinations within 4 weeks. Patient does not require a visit to physician or ER for any adverse event. Vaccine administered at military facility was no. On 04Feb2021, the patient experienced increased anxiety and increased agitation. Patient stated that she already had anxiety and agitation but it was worse now and she inquired that if anyone reported a reaction like that and can it be a side effect and whether it is permanent or temporary. Patient reported that she didn't have this feeling right after and it started suddenly around 6-7 hours after the vaccine and she was not the same as before but maybe it's a little better. Patient checked with her doctor regarding information on mental and psychological changes and he suggested as it may possible, but he did not know what are the possible side effects; most likely not; it can be temporary. Patient stated she was very nervous. Patient reported as she was scheduled for the second dose on 25Feb2021. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Liquid portion given to patient; Liquid portion given to patient; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 9K2MA, expiry date 24th September 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 17-Jan-2023 Reporter's comment: An anonymous reporter called in to inquire about the possibility of using a diluent other than the one provided in the Shingrix package. Only one patient received the dose and she was calling in to ask if there were a way to use another diluent to reconstitute a dose for the second patient, but had not given it yet. The reporter explicitly stated that she wished her information not be stored in their database.  The initial reporter continued the call, yet upon receiving medical information interrupted the operator, stating that she already knew and had the data, and that she wanted to know if it were possible to receive a replacement for the diluent for Shingrix.  It was clarified that she was speaking to the medical information department and than in order to continue, she would need to speak to the vaccine service center.  Before being transferred, she was told that information needed to be collected for the adverse event report, to which she answered by asking if it were possible to place the call o hold and when the call continued, a second anonymous reporter spoke, whom gave information about the patient and vaccine, did not know about the specific details of how, when and where the event unfolded.  The second reporter was consented. The consent for follow-up was marked as not available because during the call, both health care professionals that were contacted refused to provide their contact information or for information to be stored in internal database, yet, they did agree for follow-up by safety. Due to this paradox this parameter could not be completed. Additional supportive information: The patient received the liquid portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Clt. received the first 2 GARDASIL'S at Dr's office. 1st injection on 05/10/2007, the 2nd was given on 07/16/2007. Clt. states that she told the Dr. about her symptoms and was told that is was a normal reaction. Clt.noted numbness after the 1st gardasil. Her symptoms began approx. 2 days after the 1st injection. She C/O  tingling and weakness in both arms, more weakness in the left arm/hand. The 3rd injection was given at county health dept. on 11/16/2007 along with recieving Menningococcol vaccine.  Client did not mention any of her symptoms at that time. We became aware of her C/O until 08/06/2008. S/S continue.  10/31/08 Reviewed PCP medical records provided by CDC of 3/20/2007-4/17/2008. FINAL DX:  allergic reaction Records reveal patient experienced good health on 5/10/07 for HPX #1, lot # 0011U.  Seen 5/31 for school physical & all WNL.  RTC 7/16/07 for HPV #2, lot # 0011U.  RTC 8/15/07 for persistent epigastric, LLQ pain, bloating, gas, nauseous & pain getting up.  Dx w/gastritis & tx w/meds.  RTC 4/14 w/lips, eyes & hands swollen, rash on neck follwing tylenol, motrin & alka seltzer,  Dx urticaria & tx w/steroids & antihistamine.  RTC 4/17 for itchy body rash/hives.  Dx w/allergic reaction & tx w/IM steroids & antihistamine.  Sent home w/tapering steroids.
This case was reported by a consumer via call center representative and described the occurrence of insomnia in a 81-year-old female patient who received Shingrix for prophylaxis. On 10th September 2018, the patient received Shingrix. On 10th September 2018, less than a day after receiving Shingrix, the patient experienced insomnia. On 11th September 2018, the patient experienced pain in arm. On an unknown date, the outcome of the insomnia and pain in arm were unknown. It was unknown if the reporter considered the insomnia and pain in arm to be related to Shingrix. Additional details were reported as follows: The patient reported that should could not sleep the evening after receiving a Shingrix dose. She reported that she was up all night and alert. The patient reported that the next morning, she felt some soreness in the arm. The patient had denied permission to contact their physician.
pt recvd vax;inadvertently recvd pnu-immune instead of PPD mantoux;exp itching & burning immed p/ vax; had red area, tender to touch w/in 24 hrs; tx antihistamine & ice;
Weakness in legs, hands and feet curled in and right side facial droop. Dr. is calling this dystonia. Antibiotics (Rocephin and Omnicef) Benadryl and Decadron.
Weeks after ZOSTAVAX developed few blisters on forehead and (R) eyelid, a month or so later developed vision loss in (R) eye, ID as herpetic per ophthalmologist. Had a recurrence a month later, retreated by Dr.
Sent to ER 1/14/2021 due to drop in blood pressure with LOC during dialysis.  Imaging revealed right lower lobe pneumonia given script for amoxicillin. According to staff patient was on dialysis had pneumonia and was on hospice, dialysis stopped resulting in death.
Patient presented with severe lightheadedness about 3-4 hours post vaccination. He also presented with nausea and feeling cold. Patient was monitored for 30 minutes post presentation notification and symptoms completely resolved by 6 hours post vaccination.
No further AE; patient given Gardasil 9 u008316 exp 8/15/2023 given on 8/24/2023; This spontaneous report was received from an office manager referring to a 23-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.  On 24-AUG-2023, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection for prophylaxis (dose frequency: one time, lot#: u008316, expiration date: 15-AUG-2023, product circular number: 090143508a08bf3f; strength, dose, and route of administration were not reported) (expired product administered). Per the post expiry memo, the vaccine was supported.  No reaction. No further adverse events (AE) were reported (no adverse event).
By 08/22/09 around 3:30 pm there was an approximately 3" X 5" area on the L upper forearm that was red, raised and swollen and warm to touch. PA prescribed "cephalexin" 500 mg. 3 X day and "diphenhydramine" 50mg 1 every 4-6 hrs. for urticaria. Instructed to return for follow-up on 08/24/09.
I was okay after the injection, other than a little itchiness the next day.  It was not until the following week when I awoke to find a red spot on my arm located at the injection site.  I continued to monitor the area as it was growing in size.  It has started to fade, although it is still itchy.
6 weeks after the doctor's second COVID-19 Vaccine dose, the doctor got the COVID-19 Virus; 6 weeks after the doctor's second COVID-19 Vaccine dose, the doctor got the COVID-19 Virus; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), on unspecified dates, as dose 2, single and dose 1 single, both via an unspecified route of administration, for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was stated that, 6 weeks after the doctor received her second covid-19 vaccine dose, the doctor got the covid-19 virus. The doctor (patient) stated that, she gave the COVID-19 Virus to her family. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
I was sitting and watching TV and I got the worst headache that I have ever had. Stabbing pain felt like it was coming from the left side almost on top - it was the worse pain I have every experienced. For about 15 minutes or so. It was so excruciating that I thought I was dying. After that subsided,  My left eye - I was seeing things were slightly fuzzy. Went to ER. By the time I got to the ER, I wasn't experiencing anything further with headache. My blood pressure is normally low but it was higher than mine would normally be at ER (It was 149/74   - that was out of the norm for me.) They did not give me any medication. They told me to follow up with Primary care or return if it came back. It hasn't happened again but they said it could.  I had my flu shot on October 22, 2021 and a TDAP shot that day, too. It was at regulatory authority.
No adverse reaction; On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml) and NO ADVERSE EVENT (No adverse reaction) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.     It was unknown if the patient had acute illnesses at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long-standing health conditions.    On 10-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 12-May-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .25 milliliter. On 12-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction). At the time of the report, PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml).    No concomitant medication was reported.  Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event was unknown.  On 10-May-2023, 27 patients received 0.25ml of the Moderna bivalent vaccine instead of the 0.5ml booster dose.  On 11-May-2023, 26 patients were contacted.  On 12-May-2023, 18 patients received additional 0.25ml.  No treatment medication was reported.  This case contains information for the 12th of 27 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723833 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723833:Master case
STRONG CHEMICAL SMELL IN THE URINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced strong chemical smell in the urine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of strong chemical smell in the urine was not reported. This report was non-serious.
Onset of swelling Right SQ (upper extremity) 1630 - 1700. (+) TTP, (+) erythema, (+) itching. Took Ibuprofen 800 mg (also again 3/9th c 930 AM). Measured area of concern 3/8 2115 (8.5x5 cm) - circled. Today c 11:30 AM - 8x10 cm. (+) palpable firmness with area of erythema with warmth. No systemic Sxs - (rash, SOB, fever).
Client reported that he woke up with dizziness the following morning on 06/13/21 which lasted all day until he went to sleep. During the day the client noted he felt "lightheaded when I stood up from a squatting position." The client stated he woke up on 06/14/21 and the dizziness had resolved. The client did not take any medications for the initial dizziness and did not seek any medical care regarding the dizziness. The client denied any s/s of anaphylaxis following the first dose of COVID vaccine Pfizer.